Policy on Enhancing Public Access to Archived Publications Resulting From NIH-Funded Research, 6891-6900 [05-2542]

Agencies

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

[Federal Register Volume 70, Number 26 (Wednesday, February 9, 2005)]
[Notices]
[Pages 6891-6900]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2542]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Policy on Enhancing Public Access to Archived Publications 
Resulting From NIH-Funded Research

ACTION: Notice; final policy statement.

-----------------------------------------------------------------------

SUMMARY: The National Institutes of Health (NIH) announces its policy 
on enhancing public access to archived publications resulting From NIH-
funded research. Beginning May 2, 2005, NIH-funded investigators are 
requested to submit to the NIH National Library of Medicine's (NLM) 
PubMed Central (PMC) an electronic version of the author's final 
manuscript upon acceptance for publication, resulting from research 
supported, in whole or in part, with direct costs\1\ from NIH. The 
author's final manuscript is defined as the final version accepted for 
journal publication, and includes all modifications from the publishing 
peer review process.
---------------------------------------------------------------------------

    \1\ Costs that can be specifically identified with a particular 
project or activity. NIH Grants Policy Statement, Rev. 12/2003; 
https://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_
Part2.htm#_Toc54600040.
---------------------------------------------------------------------------

    This policy applies to all research grant and career development 
award mechanisms, cooperative agreements, contracts, Institutional and 
Individual Ruth L. Kirschstein National Research Service Awards, as 
well as NIH intramural research studies. The policy is intended to: (1) 
Create a stable archive of peer-reviewed research publications 
resulting from NIH-funded research to ensure the permanent preservation 
of these vital published research findings; (2) secure a searchable 
compendium of these peer-reviewed research publications that NIH and 
its awardees can use to manage more efficiently and to understand 
better their research portfolios, monitor scientific productivity, and 
ultimately, help set

[[Page 6892]]

research priorities; and (3) make published results of NIH-funded 
research more readily accessible to the public, health care providers, 
educators, and scientists.
    This final NIH Public Access Policy (the ``Policy'') reflects 
modifications and clarifications to the proposed policy released 
September 3, 2004, in the NIH Guide for Grants and Contracts and 
September 17, 2004, in the Federal Register and the more than 6,000 
public comments received through November 16, 2004. The most 
significant change in the Policy from that originally proposed is to 
provide more flexibility for authors to specify the timing of the 
posting of their final manuscripts for public accessibility through 
PMC. The proposed policy indicated a six-month delay of posting through 
PMC. The Policy now requests and strongly encourages that authors 
specify posting of their final manuscripts for public accessibility as 
soon as possible (and within 12 months of the publisher's official date 
of final publication). The Policy also clarifies that the publication 
date is the publisher's official date of final publication.

DATES: Effective Date: May 2, 2005.

FOR FURTHER INFORMATION CONTACT: Office of Extramural Research, 
National Institutes of Health, 6705 Rockledge Drive, Room 350, 
Bethesda, MD 20892-7963 or by e-mail to PublicAccess@nih.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Public Comments and NIH Response
III. Text of Final Policy Statement

I. Background

    It has long been NIH policy that the results and accomplishments of 
the activities that it funds should be made available to the public. 
Principal Investigators (PI) and grantee organizations are expected to 
make the results and accomplishments of their activities available to 
the research community and to the public at large.\2\ It is estimated 
that the results of NIH-supported research were described in 60,000-
65,000 published papers in 2003.\3\ We believe that widespread access 
to and sharing of peer-reviewed research publications generated with 
NIH support will advance science and improve communication of peer-
reviewed, health-related information to scientists, health care 
providers, and the public.
---------------------------------------------------------------------------

    \2\ NIH Grants Policy Statement, Rev. 12/2003; https://
grants2.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm.
    \3\ These figures are derived from searching the PubMed database 
for citations with 2003 publication dates that include a reference 
to a specific NIH grant number. The data provide useful estimates of 
articles funded by NIH, although individual journal counts may vary 
slightly if calculations are performed using other sources or search 
strategies.
---------------------------------------------------------------------------

    As part of on-going efforts to gather perspectives on the issue of 
public access to research publications, the NIH held a series of 
meetings to hear and consider the opinions and concerns of publishers, 
scientists, patient advocates, and representatives of scientific 
associations and other organizations. The meetings were designed to 
ensure that discussions of stakeholder issues could occur. The NIH 
extended invitations to a broad base of participants to ensure balanced 
representation of opinions. In many cases, a participant represented 
more than one perspective, such as a scientist who was also a journal 
editor and reviewer of scientific manuscripts.
    After carefully considering the views of publishers, patient 
advocates, scientists, university administrators, and others, the NIH 
published its proposed NIH Public Access Policy in the NIH Guide for 
Grants and Contracts on September 3, 2004, https://grants1.nih.gov/
grants/guide/notice-files/NOT-OD-04-064.html and in the Federal 
Register on September 17, 2004, https://a257.g.akamaitech.net/7/257/
2422/06jun20041800/edocket.access.gpo.gov/2004/04-21097.htm for public 
comment. During the comment period, the NIH received over 6,000 
comments via web, fax, mail, and e-mail. Many comments were received 
from organizations representing multiple constituents. The NIH 
developed Questions and Answers to clarify the proposal as issues were 
raised regarding it; these are available at: https://www.nih.gov/about/
publicaccess/publicaccess_QandA.htm.
    This final Policy reflects consideration of public comments 
received on the proposed policy through November 16, 2004, i.e., 60 
days from the date of publication of the proposed policy in the Federal 
Register.
    The Policy is intended to: (1) Create a stable archive of peer-
reviewed research publications resulting from NIH-funded research to 
ensure the permanent preservation of these vital published research 
findings; (2) secure a searchable compendium of these peer-reviewed 
research publications that NIH and its awardees can use to manage more 
efficiently and to understand better their research portfolios, monitor 
scientific productivity, and ultimately, help set research priorities; 
and (3) make published results of NIH-funded research more readily 
accessible to the public, health care providers, educators, and 
scientists.

II. Public Comments and NIH Responses

A. Need for the Policy

    The public comments were largely supportive of the proposed policy 
to enhance public access to archived publications resulting from NIH-
funded research. Comments noted that this policy provides equal and 
timely access to all via the Internet and that this accessibility 
should improve individual health outcomes. Many scientists appreciated 
that the policy would improve the visibility of their work. A large 
number of comments suggested that publicly-funded research publications 
should be made accessible to the public in full-text version in a 
timely manner. Many commenters expressed support for the policy given 
their concerns about the high and rising cost of subscriptions to 
scholarly journals, especially in the areas of science, technology, and 
medicine.
    Other commenters questioned the need for the policy and considered 
it redundant to existing information sources and systems. Some 
questioned the added value of the policy and noted that journals 
increasingly are making full-text articles available immediately upon 
or within one year of publication through a variety of sources. 
Commenters noted that many of these articles are already linkable 
through the NLM PubMed web-based literature retrieval system that 
contains citations and abstracts from thousands of journals, dating 
back to 1950.\4\ A significant number of comments also questioned why 
the NLM could not simply provide a link to the publisher's Web site, or 
work with existing vendors to broaden offerings to include peer-
reviewed publications not associated with NIH funding.
---------------------------------------------------------------------------

    \4\ PubMed includes links to full-text articles in PMC and to 
several thousand journal websites. PMC is an electronic archive for 
full-text journal articles, offering unrestricted access to its 
contents. Every full-text article in PMC has a corresponding entry 
in PubMed.
---------------------------------------------------------------------------

    The primary purpose of the NIH Public Access Policy is the creation 
of a stable archive to ensure the permanent preservation of vital, 
peer-reviewed research publications resulting from NIH-funded research 
findings now and for future generations. While links exist to journal 
articles that are publicly accessible, these are not sufficient because 
publishers' Web sites are not permanently available nor consistently 
maintained. Additionally, the formatting of journal articles may vary

[[Page 6893]]

significantly among publishers' Web sites. The Policy addresses this 
deficiency in that all articles in PMC, regardless of their original 
format, are converted into a single, explicit, and well-specified data 
format. This format is known as the NLM Journal Article Extensible 
Markup Language (XML) Document Type Definition (DTD). Further, as new 
needs arise, and as technology and applications change, there is a 
single, uniform base upon which to build.
    Preservation of the biomedical literature is a responsibility that 
is specifically mandated in NLM's authorizing legislation, found at 42 
U.S.C. 286(b)(1), and one that has successfully been carried out by the 
NLM since 1836. It is logical in this electronic era to expect 
libraries, and particularly national libraries, to continue this vital 
function, including keeping pace with the ever-changing technology 
surrounding document preservation. Updating the data formats to keep up 
with the changes in technology and the needs of biomedical research 
requires an ongoing investment in research and development, which is 
within the NIH mission. As the electronic article increasingly becomes 
the authoritative and most useful document for researchers and as 
scientists are actually computing on the contents of these documents--
the text itself as well as the associated data--the impermanence of the 
publishers' Web sites presents a substantial risk. Creating such an 
archive is a historical and necessary NIH responsibility.
    NIH believes that the NIH Public Access Policy will effectively 
advance its stated goals. By storing research publications from diverse 
sources in a searchable, electronic archive with a common format, PMC 
facilitates greater integration with related resources in other NLM 
databases such as DNA and protein sequences, protein structures, 
clinical trials, small molecules (PubChem), and taxonomy thus providing 
the opportunity to develop unprecedented scientific search and analysis 
capabilities for the benefit of science. One of the primary goals of 
PMC is the creation of a permanent, digital archive of journal 
literature, which by definition, means the full text must be deposited 
in PMC. This searchable archive will enable NIH program officials to 
manage their research portfolios more efficiently, monitor scientific 
productivity, and ultimately, help set research priorities. This 
strategy also will enable NIH to advance its goal of creating an end-
to-end, paperless grants management process. Finally, it will make the 
publications of NIH-funded research more accessible to and searchable 
for the public, health care providers, educators, and scientists.
    A few commenters asked NIH to strengthen the proposed policy to 
make submission to PMC a requirement instead of a request. We believe 
that the voluntary nature of the final policy is preferable to a ``one 
size fits all'' requirement, as it permits sufficient flexibility to 
accommodate the needs of different stakeholders and leaves the ultimate 
decision in the hands of our scientific investigators who are the best 
to judge the scientific circumstances and the time frame under which 
their work may be made accessible to the public at large. It is worth 
clarifying that NIH does not require or expect that PMC be the sole 
repository for NIH-funded research publications. Others may choose to 
post and/or archive peer-reviewed publications resulting from NIH-
funded research, subject to applicable laws or permission from any 
copyright holders.

B. Scope of the Policy

    The NIH Public Access Policy applies only to peer-reviewed research 
publications that have been supported, in whole or in part, with direct 
costs from NIH. Numerous comments reflected misunderstandings about the 
scope of the policy as it was proposed. Some comments sought to broaden 
the Policy to include publications from non-NIH-supported 
investigators, and others asked that it include publications that did 
not contain original research findings, e.g., book reviews.
    The Policy does not apply to contributed book chapters, editorials, 
reviews, or conference proceedings. Although PMC does contain articles 
from non-NIH-supported research, the Policy is focused on final, peer-
reviewed manuscripts and publications that result from research 
supported, in whole or in part, with direct costs from NIH.

C. Potential for Public Misunderstanding of Research Findings

    A number of comments questioned the lay public's ability to 
understand fully original research publications, and expressed fear 
that potential harm could result from misinterpretation of them.
    We believe that individuals who seek to read publications 
concerning a particular disease, health condition, or treatment should 
not be denied access because of the possibility that they will 
misunderstand the publications. Rather, NIH encourages such individuals 
to become educated consumers about their health care and related 
research, and to consult with health care professionals for specific 
guidance. It is important that NIH-supported research publications be 
made more readily available to provide credible information and to 
improve public understanding of the benefits of scientific research. 
The public demand for credible health information is clear. About 93 
million Americans searched for at least one of 16 health topics online 
within the past year.\5\ In a 2003 survey, 58 percent of Internet users 
said they brought information obtained from the Internet to their 
doctor's office.\6\
---------------------------------------------------------------------------

    \5\ Internet Health Resources, Pew Internet and American Life 
Project, Washington, DC 2003: https://www.pewinternet.org/pdfs/PIP_
Health_Report_July_2003.pdf.
    \6\ Cybercitizen Health 3.0 Survey, Table 10 (Manhattan 
Research, New York, 2003).
---------------------------------------------------------------------------

    The NIH is strongly committed to conveying the importance of the 
research it funds to the public. Each NIH Institute and Center has an 
active staff that produces high-quality educational and informational 
materials on various health and research topics, many of which 
highlight the publications of NIH-funded researchers. Institute and 
Center staff, often with the assistance of third parties and patient 
advocacy groups, works diligently to develop, review, and disseminate 
these products. For example, the National Library of Medicine's 
consumer health site, Medline Plus (https://www.nlm.nih.gov/medlineplus/
) houses extensive information on over 650 health conditions. NIH 
believes that these products effectively advance NIH's strong 
commitment to improving public health through research.
    The Policy specifically relates to original research publications. 
NIH needs to compile these publications into a single archive in order 
to manage its research portfolio better and monitor its funding 
choices. NIH recognizes that providing public access to this electronic 
archive, may also help scientists, policymakers, doctors, patients and 
the lay public to understand better the research that NIH funds.

D. Version Control and Quality of Manuscripts

    Some commenters raised concerns about potential confusion resulting 
from differences between the author's final manuscript within PMC and 
the published version of the corresponding article at journal-sponsored 
websites. Others questioned how corrections, retractions, and other 
post-publication changes will be accommodated.
    Through this Policy, NIH is requesting that NIH-funded 
investigators submit an

[[Page 6894]]

electronic version of the author's final manuscripts resulting from 
research supported, in whole or in part, with direct costs from NIH, 
after all changes resulting from the peer review publication process 
have been incorporated. A growing number of journals are currently 
posting final author manuscripts to provide timely access to their 
subscribers prior to final publication of the publisher's copy edited 
version. In addition, under the Policy, the final manuscript will not 
be made available to the public through PMC until after the copyedited 
version is published by the journal. Corrections and other necessary 
revisions of author's final manuscripts will be accommodated. 
Furthermore, when publicly available, the published article on the 
journal-sponsored website and the author's final manuscript in PMC will 
be appropriately linked through PubMed. Corrections and post-
publication comments referring to a publication are currently 
identified and linked in PubMed, and this capability will be linked to 
the corresponding manuscript in PMC. If publishers wish to provide PMC 
with the publisher's final version, this version will supersede the 
author's final manuscript in PMC.

E. Potential for Acceleration of Medical Cures

    A few commenters questioned whether the proposed policy, and 
enhanced access to NIH-funded publications, will facilitate scientific 
progress and accelerate research for medical cures.
    We believe that improved access through PMC to peer-reviewed, final 
manuscripts of NIH-supported investigators will facilitate scientific 
progress because it will enable NIH to manage better its research 
portfolio and funding choices. The NIH encourages the sharing of ideas, 
data, and research findings to help accomplish its important public 
mission to uncover new knowledge that will lead to better health for 
everyone. As such, we envision that the PMC resource will have 
widespread and varied uses for the research community. It will create a 
stable, permanent, and searchable archive of peer-reviewed research 
publications that NIH and the public can access, without a fee, to 
review scientific productivity, monitor the state-of-the-science, and 
apply such knowledge in other ways to accelerate medical research. 
Greater interconnectivity and functional integration between the 
multiple and large research data bases (e.g., Genbank and PubChem) and 
an archive of NIH-funded publications has the potential to enhance 
research in novel ways.

F. Potential Economic Impact on Journal Publishers

    Commenters contended that NIH had not carefully considered the 
potential adverse economic impact of its proposed policy on publishers, 
in particular, not-for-profit professional and learned societies and 
associations that rely on subscriptions to cover costs. The 
consequences of the proposed policy for many small journals, as well as 
bimonthly and quarterly journals, were of particular concern to some. 
Concern also was raised that relative to commercial publishers, not-
for-profit publishers would be more disadvantaged because they often 
support highly specialized areas that tend to draw greater 
representation by NIH-funded researchers. Others questioned the 
fairness of allowing publishers to continue to profit by restricting 
access to health-related information.
    Publishing patterns vary from year to year and from one journal to 
another. Using 2003 data, NLM estimates that, on an annual basis, 
publications resulting from NIH-funded research represent approximately 
10 percent of the articles in nearly 5,000 journals indexed by PubMed. 
In addition, for only one percent of these journals do NIH-funded 
articles account for more than half of the total published articles.\7\ 
As such, it is unlikely that scientists and libraries would use the NIH 
Public Access Policy as the rationale for replacing their journal 
subscriptions. If they did, they would be able to access only a 
fraction of a journal's content. It also is important to note that 
there are many other journal offerings, such as science news, industry 
information, literature reviews, job announcements, functional Web 
sites, and other time-sensitive products that bring value to the reader 
but are not a part of the PMC archive. Access to journal articles 
through the NIH archive might increase Internet traffic to those 
journals, by both the scientific community and the general public.
---------------------------------------------------------------------------

    \7\ These data are derived from searching the PubMed database 
for citations with 2003 publication dates that acknowledge funding 
from either NIH specifically or from an agency of the Public Health 
Service (PHS). Because some journal citations do not include a 
reference to the specific NIH grant number, a broader search was 
done for citations where the Public Health Service (PHS) is 
identified as the sponsor of the research. These data provide useful 
estimates of articles funded by NIH/PHS, although individual journal 
counts may vary slightly if calculations are based on other sources.
---------------------------------------------------------------------------

    The NIH supports the current publishing process by providing its 
funded investigators with an estimated $30 million \8\ annually in 
direct costs for publication expenses, including page and color charges 
and reprints. In addition, NIH provides funds, through indirect costs, 
to research institutions for library journal subscriptions and 
electronic site licenses. NIH also supports the current process by 
encouraging publication of NIH-supported original research in 
scientific journals.
---------------------------------------------------------------------------

    \8\ The estimated $30 million is a conservative figure based on 
amounts spent on page charges and other publication costs on a 
sample of R01 grant application budgets, scaled up to provide an 
estimate of direct costs paid on all research grants.
---------------------------------------------------------------------------

    NIH has made modifications to the proposed policy to provide 
greater flexibility to accommodate the range of business models 
represented by large commercial publishing houses through the smaller 
specialized journals of learned societies. The most significant change 
is to allow authors to specify the timing of the posting for public 
accessibility through PMC of their final manuscript. The NIH intends to 
maintain its dialogue with publishers and professional and learned 
societies as experience is gained with the Policy.
    A NIH Public Access Advisory Working Group of the NLM Board of 
Regents \9\ will be established. The Working Group will be composed of 
stakeholders that will advise NIH/NLM on implementation and assess 
progress in meeting the goals of the NIH Public Access Policy. Once the 
system is operational, modifications and enhancements will be made as 
needed with the Working Group, or a permanent subcommittee of the 
Board, providing ongoing advice on improvements.
---------------------------------------------------------------------------

    \9\ Established pursuant to 42 U.S.C. 286a, section 466 of the 
Public Health Service Act, as amended. The Board is governed by the 
provisions of the Federal Advisory Committee Act, as amended (5 
U.S.C. Appendix 2).
---------------------------------------------------------------------------

G. Potential Impact on Journal Peer Review

    NIH recognizes the enormous value and critical role that peer-
reviewed journals play in the scientific quality control process. Only 
peer-reviewed articles accepted for publication will be posted in PMC. 
Some commenters asked if scientific integrity would be compromised if 
journals were to go out of business, thus significantly narrowing 
journal options for authors. A few commenters feared that the NIH 
proposed policy would limit an author's freedom to publish how, when, 
and where he or she chooses.
    We do not believe that the Policy will compromise scientific 
integrity or significantly narrow journal options for

[[Page 6895]]

authors. While NIH encourages investigators to publish and share the 
results of the research that it funds, NIH does not dictate the means 
of publishing the research it supports. This Policy is designed to 
preserve the critical role of journals and publishers in peer review, 
editing, and scientific quality control processes. It is not intended 
to alter in any way the manuscript submission process, investigator 
choice of journal for publication, or existing publication process.
    NIH highly values traditional routes of research information 
dissemination through publication in scientific, peer-reviewed 
journals. Peer review is a hallmark of quality for journals and is 
vital for validating the accuracy and interpretation of research 
results. Publication in peer-reviewed journals is a major factor in 
determining the professional standing of scientists; institutions use 
publication in peer-reviewed journals in making hiring, promotion, and 
tenure decisions. NIH also values the communities of research created 
by scientific organizations and the journals they publish. By not 
mandating but instead requesting from our investigators that access be 
provided to the public within a range of acceptable delays extending 
from 0 to 12 months, the NIH believes that its Public Access Policy 
addresses the concerns raised by both for-profit and not-for-profit 
publishers and will ensure that peer review of scientific articles is 
preserved. The NIH believes that archiving and making publicly 
accessible NIH-funded biomedical and behavioral literature after a 
reasonable time delay can preserve the critical role of journals and 
publishers in peer review, editing, and scientific quality control. The 
policy should have no effect on the author's choice of journal. We 
expect that greater access to research publications will increase the 
impact of the publicly-funded research. For example, there is emerging 
evidence that easier access increases impact as measured by the number 
of times a paper is cited.\10\
---------------------------------------------------------------------------

    \10\ https://opcit.eprints.org/oacitation-biblio.html
_____________________________________-

H. Potential Impact on Scientists

    A number of comments expressed the concern that researchers would 
be adversely affected by the proposed policy if publishers experienced 
a decline in subscriptions and subsequently chose to increase charges 
to authors. It was suggested that higher charges would disadvantage 
disproportionately researchers with more limited resources. In 
addition, some researchers were concerned that the proposed policy 
would create an additional burden on them.
    NIH-funded investigators are expected to make the results and 
accomplishments of their activities available to the research community 
and to the public at large. Consequently, NIH considers publication 
costs, which include fees charged by a publisher, such as color and 
page charges, or fees for digital distribution, to be allowable charges 
to NIH research awards.
    Concerning burden, public access submissions will provide NIH-
supported investigators with an alternate means by which they can meet 
and fulfill the current requirement to provide a copy of each 
publication in their progress reports and other application and close-
out procedures. It is anticipated that investigators applying for new 
and competing renewal support from the NIH will utilize this resource 
by providing links in their applications to their PMC-archived 
information. NIH, therefore, anticipates that this process may reduce, 
rather than increase, burden for investigators.
    It is also worth noting that the development of a searchable 
archive of published findings from NIH-supported research will be a 
rich resource for all scientists. Access to such information not only 
will make it easier to investigate a specific area of research, but 
also may lead to identification of new research questions.

I. Open Access Publication and the NIH Public Access Policy

    Some commenters believed that the NIH Public Access Policy 
constitutes an open access model of publishing. The NIH Policy is not a 
form of publishing; rather, it creates a stable archive of peer-
reviewed research publications resulting from NIH-funded research. In 
addition, the Policy does not dictate the means of publishing but is 
compatible with any publishing model that authors and journals choose 
to employ. For example, some subscription journals already allow free 
electronic access to published manuscripts directly from their websites 
after an embargo period. In addition, one survey reports as many as 92 
percent of journals allow authors to self-archive either a postprint 
(79 percent) or preprint (13 percent) of the article on personal Web 
sites or on their institution's Web site\11\. Copyright to all material 
deposited in PMC remains with the publisher, individual authors, or 
awardees, as applicable. PMC currently includes a copyright notice 
alerting the public to the rights of copyright holders and will 
continue to post this notice as it has done in the past.
---------------------------------------------------------------------------

    \11\ https://romeo.eprints.org/stats.php
_____________________________________-

J. Waiting Time to Public Access

    The proposed policy published in September 2004 indicated that with 
the author's permission, the NIH would make the author's final 
manuscript available to the public no later than 6 months after the 
date of official publication as determined by the publisher. Many 
commenters considered the 6-month waiting time to be a reasonable 
compromise, though some believed the waiting time should be 
considerably shortened. Some recommended that the waiting time be 12 
months or longer, particularly because 12 months rather than 6 months 
is currently the prevailing model among journals that already provide 
free, delayed, full-text access. Some commenters also noted that the 
vast majority of journals currently offer no free public access at all, 
thus arguing that a 6-month waiting time is too aggressive.
    The NIH has tried to balance the legitimate needs of journal 
publishers with its interest in creating a permanent archive of peer-
reviewed research publications resulting from NIH-funded research. 
There is a wide range of time-to-access policies within the publishing 
world. Some of the variables that affect time-to-access include 
differences among scientific fields (e.g., clinical versus basic 
research), and variability in business models determined by a range of 
issues including number of article submissions, acceptance rate and 
subscription base.
    After considering the views of scientists, publishers, patient 
advocates, librarians, research administrators, professional societies, 
and others, the final Policy provides authors with the ability to 
specify when their final manuscript will be made available to the 
public through PMC. Posting for public accessibility through PMC is 
strongly encouraged as soon as possible (and within twelve months of 
the publisher's official date of final publication). This Policy 
provides greater flexibility for participation. Further, it addresses 
the agency's interest in establishing a permanent archive of peer-
reviewed research publications resulting from NIH-funded research in a 
timely manner.

K. Politicization of Science

    Some commenters suggested that a centralized, government-operated 
repository could compromise the integrity of the scientific record, be 
subject to government censorship, and be susceptible to the 
politicization of

[[Page 6896]]

science and the variability of funding levels and changes in agency 
management.
    Congress assigned to the NLM the responsibility to acquire, 
organize, disseminate, and preserve biomedical information for the 
benefit of public health. As part of this responsibility, the Policy 
will create a stable archive of peer-reviewed research publications 
resulting from NIH-funded research to ensure the permanent preservation 
of these vital published research findings. Agency policy is not to 
restrict or suppress the content of PMC.

L. Implementation Costs

    Many commenters expressed concern that the costs associated with 
archiving NIH-funded manuscripts in PMC have not been clarified, or 
that costs are understated. Some publishers reported spending on the 
order of hundreds of millions of dollars over the past decade to 
improve online access to their journal offerings, which led to 
skepticism about the validity of NIH's estimates. These commenters are 
concerned that allocating funds for an expanded PMC archive would 
compete with funds available to support original research. Other 
commenters expressed concern that continued funding for the system may 
not be available in the future.
    By building on an existing information technology infrastructure 
housed at the NLM, the NIH Public Access Policy can be an exceptionally 
cost-effective means to accomplish its goals of archiving, facilitating 
program management, and enhancing accessibility. Estimates of $2-$4 
million per year reflect incremental costs to create and then maintain 
a Web site for submitting authors' final manuscripts and for Extensible 
Markup Language (XML) tagging of the manuscripts into PMC's archival 
format. These estimates reflect PMC's experience with a back-scanning 
project which has generated and tagged electronic versions of more than 
200,000 printed articles in the last year. The roughly 50,000-70,000 
manuscripts a year for the new NIH Policy will be tagged in a similar 
manner and incorporated into PMC using a single, consistent digital 
format. The NIH is committed to maintaining and enhancing the existing 
PMC infrastructure to achieve the agency's goals.
    Some questioned if additional support will be provided to 
investigators to cover potential increases in publication costs. The 
NIH awards direct costs to many investigators who request publication 
costs in their proposed budgets. The NIH estimates that it pays over 
$30 million annually in direct costs for publication and other page 
charges in grants to its investigators. Generally, page charges for 
publications in professional journals are allowable, if the published 
paper reports work supported by the grant and the charges are levied 
impartially on all papers published by the journal, whether or not they 
are submitted by government-sponsored authors. As with all other costs, 
NIH expects its investigators to be careful stewards of Federal funds 
and to manage these resources appropriately. Grantees may rebudget 
funds to support these costs, but NIH will consider all other options 
to ensure that budgets are not affected unduly which should be 
achievable given the voluntary nature of this request.

M. PMC's Capacity and Functionality

    Comments supporting the proposed policy noted that online access 
was desirable because it was centralized, cheaper than accessing a 
print version, and easier to access. Some comments expressed limited 
confidence in PMC's ability to keep pace with the current volume of 
publications, or to handle a large influx of additional manuscripts. 
Several comments requested that PMC add more functionality to address 
the increased amount of content.
    NLM's National Center for Biotechnology Information supports many 
large production services, including GenBank, PubMed, and PMC, handling 
over 3 million queries daily from more than 1.2 million unique users. 
Since PMC went live in 2000, there have been no delays for any active 
production PMC journal due to production lags or technical problems at 
PMC. In addition to incorporating content provided by publishers, the 
PMC back-scanning project has generated and tagged electronic versions 
of more than 200,000 printed articles in the last year. The roughly 
60,000 manuscripts a year for the new NIH Policy will be tagged in a 
similar manner and incorporated into PMC using a single, consistent 
digital format.
    A commercial service monitors PMC's Web site performance and 
reliability. Based on over 22,000 measurements in a recent two-week 
period, articles were successfully returned for 98.5 percent of the 
requests to PMC. This compared during the same two-week period to a 92 
percent average success rate for 40 of the largest commercial Web sites 
monitored by the same service. The average response time to download a 
PMC article has been 2.8 seconds.
    Another key advantage of PMC is that the articles returned by a PMC 
search are automatically linked to a variety of research-related 
resources in other NLM databases, such as DNA and protein sequences, 
protein structures, clinical trials, small molecules (PubChem), and 
taxonomy. These databases also provide linkage to a broad collection of 
other biological and health-related information resources. 
Investigators applying for new and competing renewal support from the 
NIH can also utilize this resource by providing links in the 
applications to their PMC-archived information.

N. Domestic and International Coordination

    A number of commenters urged the NIH to coordinate with other 
scientific agencies in the United States and internationally, while 
others countered that providing unrestricted access to non-U.S. 
individuals would represent a subsidization of scientific knowledge 
outside the United States that disadvantages American scientists.
    We believe that American scientists and global health will benefit 
from greater access to research publications leading to increased 
collaborative efforts worldwide. In an increasingly interdependent 
world, the United States and nations around the globe not only share 
the risk of diseases, but also the challenge to respond. This can best 
be accomplished in an environment in which rapid communication is 
possible, wherein scientific knowledge is readily available to all, and 
where research is conducted based on partnership. This environment will 
also foster continued U.S. leadership in science.

O. Timing of the Policy's Implementation

    Many commenters sought to delay the Policy's implementation, 
expressing strong concerns that the proposed policy had not been 
adequately analyzed for short- and long-term impacts. Commenters called 
for more dialogue and consideration. Others called for more formal 
studies before Policy implementation.
    The request for investigators to submit the authors' final 
manuscripts to PMC is not a requirement. The NIH instead is providing 
guidance to conform to a long-standing NIH policy that the results and 
accomplishments of NIH-funded research activities should be made 
available to the public. The Policy encourages voluntary cooperation of 
investigators, and it does not penalize investigators who choose not to 
use PMC to submit pre-print hard copy versions of their manuscripts as 
part of their progress reporting requirements.
    Timely implementation of the Policy will allow NIH to manage more 
efficiently and to understand better its

[[Page 6897]]

research portfolio, monitor scientific productivity, and ultimately, 
help set research priorities. Also, because many commenters highlighted 
the public's desire for enhanced access to scientific publications in a 
timely manner, NIH is confident that this Policy will not only advance 
science but will benefit the scientific community, the public, and the 
NIH.
    This Policy is subject to periodic review based upon lessons 
learned in the course of its implementation. Issuance of this Policy is 
the beginning of a process that will include refinement as experience 
develops, outcomes are evaluated, and public dialogue among all the 
stakeholders is continued.
    A NIH Public Access Advisory Working Group of the NLM Board of 
Regents \12\ will be established. The Working Group will be composed of 
stakeholders that will advise NIH/NLM on implementation and assess 
progress in meeting the goals of the NIH Public Access Policy. Once the 
system is operational, modifications and enhancements will be made as 
needed with the Working Group, or a permanent subcommittee of the 
Board, providing ongoing advice on improvements.
---------------------------------------------------------------------------

    \12\ Established pursuant to 42 U.S.C. 286a, section 466 of the 
Public Health Service Act, as amended. The Board is governed by the 
provisions of the Federal Advisory Committee Act, as amended (5 
U.S.C. Appendix 2).
---------------------------------------------------------------------------

P. Legal Issues

    NIH received several comments and objections of a legal nature.
    1. Request vs. Required: Some commenters argued that the proposal 
is mandatory, even though the proposal requests, rather than requires, 
submission of final manuscripts to NIH. As evidence, they note that NIH 
plans to monitor submissions as part of the grants close-out process 
and that the proposal states that the submission will fulfill the 
current requirement to submit one copy of each publication in the 
annual or final progress reports. One commenter also asserted that 
reading the proposal as a requirement would be consistent with House 
Appropriations Committee Report language in H.R. Rep. No. 108-636.
    The final Policy reiterates that submission of the electronic final 
manuscript is voluntary and that it can serve as an alternate means for 
meeting current progress reporting requirements as well as application 
and close-out submissions in the future. The monitoring referred to in 
the proposed policy referred to determining whether the final 
manuscripts had already been submitted electronically. We have removed 
that language from the final Policy to avoid any confusion. The House 
Appropriations Report did propose requiring submission; however, the 
NIH Policy requesting, rather than requiring, submission is consistent 
with the final report language found on page 1177 of the Joint 
Explanatory Statement in H.R. Rep. No. 108-792.\13\
---------------------------------------------------------------------------

    \13\ https://thomas.loc.gov/home/omni2005/index.htm.
---------------------------------------------------------------------------

    2. Copyright: NIH received comments that the proposal infringes on 
copyright interests of Federal grantees. These commenters argued that 
copyright interests are well-established under Federal law, that NIH 
has no authority to alter them, and that the proposal is not consistent 
with controlling Department of Health and Human Services (HHS) 
regulations. They believe the proposal fails to recognize the need for 
copyright permission from authors and/or publishers. They argue that 
neither the principle of fair use, nor the Federal purpose license, can 
be used by NIH to implement the proposal. Finally, they argue that the 
PMC ``open access'' submission agreement constitutes a forced license 
and undermines copyright.
    The Policy explicitly recognizes and upholds the principles of 
copyright. First, submission of final manuscripts is voluntary rather 
than mandatory; the voluntary submission to NIH by authors and 
institutions under the Policy constitutes permission to post the 
manuscripts on PMC and release to the public after the submitter's 
specified post-publication delay time. The fair use exemption to 
copyright infringement does not apply to the government's request for 
the manuscripts. It applies to the public use of the manuscripts as 
posted on PMC and provides a limitation on such use consistent with the 
terms of that exemption.
    NIH does not need to seek permission from journals who may acquire 
copyrights from authors or institutions because any copyright transfer 
or assignment is currently subject to the government purpose license 
pursuant to 45 CFR 74.36. Although the NIH is relying on permission, 
rather than the government purpose license, as the basis for its 
Policy, the government purpose license is fully available as a legal 
authority under which manuscripts could be reproduced, published, or 
otherwise used for Federal purposes. The comment that the proposal is 
not consistent with controlling HHS regulations granting copyright is 
not persuasive, since those same regulations grant the agency its 
government purpose license.
    Finally, authors can indicate what copyright restrictions, if any, 
apply to their manuscripts when submitting them to PMC and can choose 
an appropriate PMC submission agreement that recognizes those rights.
    3. Government purpose copyright license: NIH received a comment 
that the government purpose license of 45 CFR 74.36 cannot be used by 
the government as a basis to post final manuscripts on PMC.
    Although the NIH, at this time, is not relying on the government 
purpose license, it is an available means for NIH to reproduce, publish 
or otherwise use copyrighted works resulting from NIH funding for 
Federal purposes, as well as to authorize others to do so. Arguments 
put forth and cases cited by the commenter as support for the premise 
that the government purpose license could not be used as a basis for 
PMC to post the manuscripts are not persuasive. None of the cases 
address circumstances where a government agency is acting to fulfill 
its own statutory purposes with regard to publications resulting from 
its own research funding. Creation of a publicly accessible, permanent 
archive of NIH-funded research publications is squarely within the 
statutory authorities of the NIH and the NLM and clearly constitutes a 
Federal purpose.\14\
---------------------------------------------------------------------------

    \14\ See, e.g., 42 U.S.C. 241(a)(1); 42 U.S.C. 286.
---------------------------------------------------------------------------

    4. Other intellectual property concerns: One commenter suggested 
that the proposed policy undermines other aspects of intellectual 
property because problems would result if the principle that ``the 
taxpayers have already paid for the research'' were also applied to 
patents, pharmaceuticals, and other products of government-funded 
research.
    The NIH Public Access Policy is not based on the principle of 
delivering a product to the taxpayer in return for research support. 
The Policy calls for the voluntary submission of final author 
manuscripts; it does not affect the ability to copyright. Funding 
recipients may continue to assert copyright in works arising from NIH-
funded research, and they may assign these rights to journals as is the 
current practice. Copyright holders may enforce these copyrights as 
before. A member of the public viewing or downloading a copyrighted 
document from PMC is subject to the same rights and restrictions as 
when copying an article from the library. For example, making a copy of 
an article for personal use is generally considered to be a ``fair 
use'' under copyright law. For uses that fall outside of the fair use 
principle, permission to reproduce copyrighted

[[Page 6898]]

materials must be obtained directly from the copyright holders. PMC 
currently includes a copyright notice alerting the public to the rights 
of copyright holders and will continue to post this notice as it has 
done in the past.
    5. Bayh-Dole Act: NIH received a comment that the proposal 
undercuts the Bayh-Dole Act by interfering with technology transfer, 
because scientific publications are an important component of 
technology transfer, and the proposal weakens that component. This 
commenter also suggested the proposal undermines the Bayh-Dole 
principle that the private sector is the preferable vehicle to move 
research to the marketplace.
    The NIH Public Access Policy serves to establish a permanent 
archive of NIH-funded research publications. It is not expected to 
supersede any private sector publication activity or create competition 
with publishers. Manuscripts that are submitted by authors will be 
available to the public through PMC after the time specified by the 
author post-publication. As such, we do not believe that the Policy 
will interfere with publications as a technology transfer vehicle, or 
that it will supersede the private sector as a vehicle to move research 
to the marketplace.
    6. Patent application filing concerns: NIH received comments that 
because final manuscripts as submitted to NIH will be subject to 
Freedom of Information Act (FOIA) disclosure, they will likely be 
considered ``printed publications'' for purposes of the timing of 
filing patent applications. Commenters suggested this would be a change 
from current practice, which relies on the date of journal publication.
    The NIH Policy requests authors to submit final manuscripts after 
the peer review process has been completed. Although each research 
institution must determine the timing of the filing of any patent 
applications arising from their NIH-funded work, NIH does not believe 
that submission to PMC under the Public Access Policy will constitute a 
printed publication, nor otherwise interfere with the timing of filing 
of patent applications. The manuscripts will not have the indicia of 
``public accessibility'' that are generally relied upon as criteria by 
which prior art references have been judged. Until the interested 
public has access to the document, it would not be considered to be 
available as a printed publication within the meaning of 35 U.S.C. 
102(a) or (b). The primary journal publication constitutes the date of 
publication for patent filing purposes, as it has traditionally served.
    Courts have found it helpful to rely on distribution and indexing 
as proxies for public accessibility, and one commenter argued that the 
final manuscripts will be indexed by PMC prior to journal publication. 
However, even if indexed in preparation for posting, the publication 
itself will not be available to the public. Once final manuscripts are 
posted in the archive, indexing and search capabilities will assist 
user access.
    Other aspects of the process of scientific publication do not 
establish statutory bars to patentability. For example, processes such 
as oral presentations at scientific meetings and submission of 
manuscripts and information to peer reviewers or to a journal for 
review have not been considered to establish a publication date for 
patent purposes, because these activities have not been considered to 
result in public availability. Similarly, there is no reason to believe 
submission to NIH with the expectation of confidentiality until after 
publication will be treated differently by the U.S. Patent and 
Trademark Office.
    7. Freedom of Information Act (FOIA): Some commenters expressed 
concern that the final manuscripts would be subject to disclosure to 
the public under FOIA prior to journal publication.
    NIH believes the manuscript information is protected from release 
under FOIA by Exemption 4.\15\ In accordance with HHS FOIA regulations, 
if NIH receives a FOIA request for such a document, it will notify the 
submitter of the manuscript of the FOIA request in order to provide an 
opportunity for the manuscript submitter to object to any potential 
disclosure of the record. If the final publication is requested after 
the journal publication date but prior to the posting date on PMC, NIH 
believes that these publications are not ``agency records'' subject to 
FOIA. See 45 CFR 5.5, stating that definition of ``record'' for 
purposes of the HHS FOIA regulation does not include ``books, 
magazines, pamphlets, or other reference material in formally organized 
and officially designated HHS libraries where such materials are 
available under the rules of the particular library.''
---------------------------------------------------------------------------

    \15\ HHS FOIA Regulations, 45 CFR 5.65(b); available at: https://
www.hhs.gov/foia/45cfr5.html#Subf.
---------------------------------------------------------------------------

    8. Administrative Procedures Act (APA) rule-making: Some have 
commented that the proposed policy constitutes a rule-making under the 
Administrative Procedures Act (APA) and that NIH lacks legislative 
authority to adopt this policy because it is without rule-making power. 
They also argue that the notice and comment opportunity for the 
proposal was insufficient to meet rule-making requirements.
    NIH agrees that authority to adopt new regulations is retained by 
the Secretary, Health and Human Services, and has not been delegated to 
NIH. However, the proposed policy is not a rule-making for which APA 
notice and comment, and other procedural requirements for final agency 
actions, attach. The APA defines a ``rule'' as ``the whole or a part of 
an agency statement of general or particular applicability and future 
effect designed to implement, interpret, or prescribe law or policy 
describing the organization, procedure, or practice requirements of an 
agency.'' 5 U.S.C. 551. Exempt from the formal ``rule-making'' 
requirements of the law are matters ``relating to agency management * * 
*'' and matters concerning ``interpretative rules, general statements 
of policy, or rules of agency organization, procedure, or practice'' 5 
U.S.C. 553.
    The Policy does not require investigators to do anything other than 
what the current rules require. While funding recipients may follow the 
Policy to fulfill some of their existing reporting requirements they 
need not do so and may continue to provide hard copies of publications. 
The Policy will allow the agency to manage better its research award 
process and will also enable it to advance further its public health 
mission to support high-quality biomedical, behavioral, and clinical 
research and improve public health. In order to help it develop the 
Policy, the agency provided public notice and sought public comment on 
a draft policy. This notice and comment procedure were not undertaken 
to comply with the APA rule-making requirements; the agency does not 
believe that they apply because the Policy is not a rule.
    9. Regulatory Flexibility Act: Some commenters asserted that the 
NIH must comply with the Regulatory Flexibility Act before it 
implements the proposed policy. The Regulatory Flexibility Act (RFA), 5 
U.S.C. 601 et seq., was enacted to ensure that when adopting 
regulations, Federal agencies seek to achieve statutory goals as 
effectively and efficiently as possible without imposing unnecessary 
burdens on the public. In particular, in accordance with the RFA, 
Federal agency regulations should not disproportionately affect small 
entities. Under the RFA, Federal agencies must determine the impact of 
their regulations on small entities and consider alternatives to 
alleviate

[[Page 6899]]

burdens while achieving the agency's policy goals. By definition, the 
RFA applies when a Federal agency publishes a general notice of 
proposed rule-making under 5 U.S.C. 553(b); in other words, it is 
triggered when an agency engages in rule-making under the APA. As noted 
above, this Policy is not a rule-making. Accordingly, the RFA does not 
apply.
    10. Paperwork Reduction Act: Some commenters suggested that NIH 
must comply with the Paperwork Reduction Act (PRA) and cannot penalize 
investigators until Office of Management and Budget (OMB) clearance 
under the law is completed.
    The PRA requires OMB review before an agency undertakes a 
``collection of information,'' regardless of whether the collection is 
mandatory or voluntary. Under the regulations implementing the law, a 
``collection of information'' includes ``obtaining * * * information by 
or for an agency by means of * * * identical reporting * * * or 
disclosure requirements imposed on'' ten or more people or entities in 
any given year. 5 CFR 1320.3. While the request to provide copies of 
manuscripts or publications may not fall within this definition, even 
if the definition is met, we need not obtain any new OMB clearance 
because the Policy falls within the existing, approved information 
collection activities concerning applications, progress and final 
reporting, (OMB No. 0925-0001, Expires 9/2007 and 0925-0002, Expires 6/
2005).
    Furthermore, while some commenters focused their PRA criticism on 
the fact that the agency would be unable to penalize investigators if 
PRA review is not conducted, we note that the Policy serves as an 
alternative to compliance with existing reporting activities and, 
therefore, a discussion of any new ``penalties'' is misplaced.
    The PRA also requires that agencies ensure the public has timely 
and equitable access to agency public information. The final 
manuscripts will be submitted under confidentiality agreements and will 
be posted on PMC only with the permission of submitting authors. 
Therefore, NIH does not believe that the final manuscripts submitted by 
authors constitute ``agency public information'' within the meaning of 
the PRA until the terms of the confidentiality agreement are met and an 
author permits posting on PMC. At that time, NIH expects to ensure 
timely and equitable access. As discussed above, submission is not 
expected to constitute a ``publication'' for purposes of filing patent 
applications, nor are the documents expected to be available to the 
public under FOIA. Thus, the absence of public availability prior to 
author permission does not constitute an improperly restrictive agency 
arrangement.
    11. OMB Circular A-76: Some commenters argued that the agency must 
undertake a cost-comparison under OMB Circular A-76 to determine that 
the cost of the plan is less expensive than the cost of the present 
system of scientific publishing before implementing the Policy.
    This criticism is based on the assumption, in the words of one 
commenter, that ``NIH wants PMC to become an in-house electronic 
publisher of these final manuscripts.'' This conclusion misstates the 
Policy and NIH's goals. The NIH Policy is to maintain copies of final 
manuscripts in a permanent, public archive so that the published 
results of NIH-funded research are permanently and readily accessible 
to NIH and others. This archive will be contained in the NIH's 
existing, electronic archive for scientific publications, PMC. The PMC 
archive has provided this service for the agency and others when 
articles are voluntarily provided to it. Electronic copies of 
publications are available through PMC in the same way that hard copies 
of publications are available from the NIH's National Library of 
Medicine.
    The NIH Policy does not create any new obligations under OMB 
Circular A-76. Insofar as the activities of PMC are subject to the 
requirements of the Circular and related laws, those activities will 
continue to be reviewed and all applicable requirements will be met.
    The NIH Public Access Policy is to establish a permanent archive of 
NIH-funded research publications. It is not expected to supersede any 
private sector publication activity or create competition with 
publishers.
    12. Constitutional concerns/Executive Order (E.O.) 12630: One 
commenter suggested that the proposal implicates Executive Order 12630, 
which requires government officials to review actions that may have 
``takings'' implications and to ``be sensitive to, anticipate, and 
account for, the obligations imposed by the Just Compensation Clause of 
the Fifth Amendment in planning out and carrying out governmental 
actions * * *.''
    The purpose of E.O. 12630 is to ensure that government officials do 
not unintentionally exercise the government's power of eminent domain, 
resulting in an unanticipated or undue drain on the government 
treasury. NIH believes that its Policy is consistent with E.O. 12630 
and that no additional review is required. The private property at 
issue is the funding recipient's ability to assert copyright pursuant 
to 45 CFR 74.36. The NIH Policy does not interfere with that right, as 
authors and institutions will be voluntarily submitting copies of final 
manuscripts to NIH, and copyright may be asserted and enforced as it 
has been traditionally. Further, the same regulation that allows the 
funding recipient to assert copyright grants the government 
corresponding rights to reproduce, publish, or otherwise use the work 
for Federal purposes and to authorize others to do so. A voluntary 
request for the same use already allowed to the government by 
regulation is consistent with E.O. 12630 and does not trigger 
additional review.
    13. Information Quality Act: One commenter asked whether the 
Federal Information Quality Act (IQA), 44 U.S.C. 3516 note, applies to 
documents contained in the electronic archive of publications created 
through the NIH Public Access Policy.
    The NIH Public Access Policy calls for the centralized storage of 
NIH-funded scientific publications in PMC, an electronic archive of 
scientific publications operated by the National Library of Medicine. 
The NIH will include in its electronic archive a statement explaining 
that the views contained in the archived publications and manuscripts 
are those of the authors, and do not necessarily reflect the views of 
the government. Thus, publication in PMC does not make an article/
scientific manuscript subject to the NIH Information Quality 
Guidelines.

III. Text of Final Policy Statement

    The NIH Public Access Policy (the ``Policy'') on enhancing public 
access to archived publications resulting from NIH-funded research 
follows:
    Beginning May 2, 2005, NIH-funded investigators are requested to 
submit an electronic version of the author's final manuscript upon 
acceptance for publication, resulting from research supported, in whole 
or in part, with direct costs \16\ from NIH. The author's final 
manuscript is defined as the final version accepted for journal 
publication, and includes all modifications from the publishing peer 
review process.
---------------------------------------------------------------------------

    \16\See footnote 1.
---------------------------------------------------------------------------

    This