Federal Register / Vol. 89, No. 243 / Wednesday, December 18, 2024 / Notices 102919 

Date: January 23–24, 2025. 

Time: 10:30 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institute of Health 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Sheila Pirooznia, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Review, 

National Institute on Drug Abuse, NIH, 301 

North Stonestreet Avenue, MSC 6021, 

Bethesda, MD 20892, (301) 496–9350, 

sheila.pirooznia@nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; NIDA 

REI: Research at Minority Serving 

Institutions on Neurocognitive Mechanisms 

Underlying the Impact of Structural Racism 

on the Substance Use Trajectory. 

Date: February 3, 2025. 

Time: 3:00 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institute of Health 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Shareen Amina Iqbal, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, Division of Extramural 

Research, National Institute on Drug Abuse, 

NIH, 301 North Stonestreet Avenue, MSC 

6021, Bethesda, MD 20892, (301) 443–4577, 

shareen.iqbal@nih.gov. 

Name of Committee: National Institute on 

Drug Abuse Special Emphasis Panel; 

Developing Digital Therapeutics for 

Substance Use Disorders. 

Date: February 5, 2025. 

Time: 1:00 p.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institute of Health 

National Institute on Drug Abuse, 301 North 

Stonestreet Avenue, Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Shareen Amina Iqbal, 

Ph.D., Scientific Review Officer, Scientific 

Review Branch, Division of Extramural 

Research, National Institute on Drug Abuse, 

NIH, 301 North Stonestreet Avenue, MSC 

6021, Bethesda, MD 20892, (301) 443–4577, 

shareen.iqbal@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.277, Drug Abuse Scientist 

Development Award for Clinicians, Scientist 

Development Awards, and Research Scientist 

Awards; 93.278, Drug Abuse National 

Research Service Awards for Research 

Training; 93.279, Drug Abuse and Addiction 

Research Programs, National Institutes of 

Health, HHS) 

Dated: December 12, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–29831 Filed 12–17–24; 8:45 am] 

BILLING CODE 4140–01–P 

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. 

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 peerreviewed 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/PLAW111publ8/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/wpcontent/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-nationalinstitutes-of-health-draft-public-accesspolicy 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/wpcontent/uploads/2024/10/CompiledPublic-Comments-on-RFI-on-the-NIHDraft-Public-Access-Policy-508C.pdf 

were received in response to the NIH 

Draft Public Access Policy. Written 

comments were received from a variety 


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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-thenih-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-resultsof-research-supported-by-thedepartment-of-health-and-humanservices-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 peerreviewed 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 


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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 peerreviewed 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, peerreviewed 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 postpublication 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 postpublication 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 timelimited, 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 


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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 machinereadable 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 


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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-forfederal-financial-assistance#sectnoreference-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 


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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 noncompeting 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 NIHfunded 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; 


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1This happens typically through the NIH 

Manuscript Submission (NIHMS) System. 

• 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/subjectgroup-ECFR8feb98c2e3e5ad2/section200.315, 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, publicfacing 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-ECFR8feb98c2

e3e5ad2/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. 


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2The author’s pre-accepted version of the 

manuscript that is submitted to a journal or 

publisher. 

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 


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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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; HHS–NIH–CDC–SBIR PHS 

2025–1 Discovery and Development of Oral 

Small-molecule Direct-acting Antivirals 

Targeting Viruses of Pandemic Potential 

(Topic 146). 

Date: January 15, 2025. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F52A, 

Rockville, MD 20892 (Video Assisted 

Meeting). 

Contact Person: Shilpakala Ketha, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institute of Allergy and Infectious 

Diseases, National Institutes of Health, 5601 

Fishers Lane, Room 3F52A, Rockville, MD 

20892, (301) 761–6821, shilpa.ketha@

nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: December 12, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–29838 Filed 12–17–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Substance Abuse and 

Mental Health Services Administration 

(SAMHSA) will publish a summary of 

information collection requests under 

OMB review, in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

documents, call the SAMHSA Reports 

Clearance Officer at (240) 276–0361. 

Project: Substance Abuse Prevention 

and Treatment Block Grant Synar 

Report Format, FFY 2024–2026—(OMB 

No. 0930–0222)—Extension 

Section 1926 of the Public Health 

Service Act [42 U.S.C. 300x–26] 

stipulates that Substance Use 

Prevention, Treatment, and Recovery 

Services Block Grant (SUPTRS) funding 

agreements for alcohol and drug abuse 

programs for fiscal year 1994 and 


khammond on DSK9W7S144PROD with NOTICES