[Federal Register Volume 74, Number 31 (Wednesday, February 18, 2009)]
[Notices]
[Pages 7603-7614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3442]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Analysis of Comments and Implementation of the NIH Public Access 
Policy

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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Background

    The National Institutes of Health (NIH) Public Access Policy 
requires investigators funded by the NIH to submit, or have submitted 
for them, an electronic version of their final, peer-reviewed 
manuscripts upon acceptance for publication to the National Library of 
Medicine's digital archive, PubMed Central, to be posted publicly 
within 12 months after the official date of publication. Congress 
required the NIH to implement this funding limitation in Division G, 
Title II, Section 218 of the Consolidated Appropriations Act of 2008 
(``Section 218''). The Policy is intended to advance science, provide 
public access to the published results of NIH-funded research, and 
improve human health.
    The current Public Access Policy is the culmination of years of 
effort and community interaction. Prior to passage of Section 218, the 
NIH undertook extraordinary public outreach concerning the issue of 
public access to the published results of NIH-funded research. These 
outreach efforts included a review of over six thousand public comments 
and the establishment of an independent advisory group to review NIH's 
implementation of a voluntary Public Access Policy. Additionally, as 
part of the process to implement Section 218 in a transparent and 
participatory manner, the NIH formally sought public input through an 
open meeting and a Request for Information (RFI) seeking public 
comment. This open meeting occurred on March 20, 2008, and was designed 
to ensure that a discussion of stakeholder issues could occur. The 
feedback from the open meeting helped define questions for an RFI, 
which was published on the NIH Web site on March 28, 2008 and in the 
Federal Register on March 31, 2008 (73 FR 16881-16895). The RFI was 
designed to seek input on the NIH Public Access Policy, as it was 
revised to incorporate Section 218, and the responses to frequently 
asked questions (FAQs) concerning it. The RFI was open for sixty days 
following publication in the Federal Register, from March 28 to May 31, 
2008.

[[Page 7604]]

Overview of Feedback

    In response to the open meeting and RFI, the NIH received 613 
unduplicated comments from a broad cross-section of the public, 
including NIH-funded investigators, members of the general public, 
patient advocates, professional organizations, and publishers. This 
report summarizes these comments.
    Most comments offered broad support for the policy as written. Many 
comments requested a reduction in the delay period before papers can be 
made publicly available on PubMed Central. In some cases, commenters 
expressed concern about the Policy, others asked for clarification, and 
still others suggested alternatives to NIH's implementation. These 
questions and concerns fall into several broad categories:
     The potential administrative burden on Program Directors/
Principal Investigators and awardee institutions.
     The details of implementing the Policy, including 
applicability, cost reimbursement, compliance monitoring and 
enforcement, and publisher support of the Policy.
     Associated issues, such as submission procedures, tracking 
submitted papers, version of the paper submitted, and managing and 
protecting copyrights.
     The accordance of the Policy Implementation with copyright 
law and the Administrative Procedures Act.
     Questions about Policy impact, such as financial impacts 
on publishers and NIH.
    The NIH also received comments describing implementation efforts by 
numerous awardee institutions and publishers. In some cases, libraries 
took the lead on educating their faculty and supporting them in 
interpreting publishing agreements and submitting manuscripts to NIH. 
In other cases, offices of sponsored research provided guidance on the 
NIH Public Access Policy disseminated to their faculty community via 
the Web, memos, seminars, and video casts. Still other institutions 
described collaborations between libraries, offices of sponsored 
research, university counsels, and technology transfer offices. Several 
universities and private groups described the development of new 
policies on scholarly communications and new publishing forms and 
addenda that their faculty could use to ensure compliance with the 
Policy.

NIH Response

    The NIH carefully considered the views expressed by publishers, 
patient advocates, scientists, university administrators, and others in 
the comments submitted. Throughout the course of its analysis, the NIH 
undertook various efforts to respond to concerns as it identified them. 
The agency aimed these actions to clarify the Public Access Policy and 
to facilitate compliance with Section 218. In May, July, and September 
of 2008, NIH updated the Public Access Web site to clarify the 
applicability, goals and anticipated impact of the policy, the 
available methods to submit papers, and planned methods to document 
compliance. In June 2008, NIH updated the NIH Manuscript Submission 
System (NIHMS), the online mechanism for submission of manuscripts to 
PubMed Central (PMC), to allow Program Directors/Principal 
Investigators (PDs/PIs) to delegate all aspects of submission tasks to 
authors, and to allow publishers who submit manuscripts to the NIHMS on 
behalf of authors to exert greater control over manuscript delay 
periods. In August, the National Library of Medicine issued a new Web 
tool to help the scientific community obtain PubMed Central Identifiers 
in bulk. In September 2008, NIH issued a Guide Notice (NOT-OD-08-119 at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-119.html) 
reminding awardees about the compliance process and providing details 
concerning NIH's monitoring plan for fiscal year 2008.
    These efforts appear to be working. The NIH estimates approximately 
80,000 papers arise from NIH funds each year, and this total serves as 
the target for the Public Access Policy. During the voluntary policy, 
from May 2005 to December 2007, the NIH was able to collect a total of 
19 percent of targeted papers, from all sources. Under the first five 
months of the Section 218 requirement (April to August 2008), this rate 
jumped to an estimated 56 percent of papers per month. While NIH 
expects to post all of the estimated 56 percent of these NIH papers, 
most of them will not be publicly available until 2009.
    These first few months show the promise of a Public Access Policy 
requirement, its implementation, and the active support from the 
academic and publishing communities. However, work still remains as 
over 40 percent of applicable papers per month remain unsubmitted.
    Implementation and process refinement will be continuing in the 
coming months. The NIH has established voluntary partnerships with many 
publishers to facilitate deposit of manuscripts and final published 
papers and expects these partnerships to continue to expand and the 
percentage of submitted papers to grow. The NIH will also continue to 
engage the community as we proceed to implement the Policy in the most 
efficient and effective manner possible.

Policy Overview

    The NIH Public Access Policy, announced in January 2008, ensures 
that the public has access to the published results of NIH-funded 
research. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html. It requires scientists to submit final peer-reviewed 
journal manuscripts that arise from NIH funds to the digital archive 
PubMed Central upon acceptance for publication. To help advance science 
and improve human health, the Policy requires that these papers be 
accessible to the public on PubMed Central no later than 12 months 
after publication.
    This Policy implements the Consolidated Appropriations Act of 2008, 
which directed the NIH to require investigators funded by the NIH to 
submit, or have submitted for them, an electronic version of their 
final, peer-reviewed manuscripts upon acceptance for publication to the 
National Library of Medicine's digital archive, PubMed Central (PMC), 
to be posted publicly within 12 months after the official date of 
publication. The Policy builds upon the experience with NIH's voluntary 
Public Access Policy, which was published in 2005 and has three aims:
    1. ARCHIVE. A central collection of NIH-funded research 
publications preserves vital published research findings for years to 
come.
    2. ADVANCE. The archive is an information resource for scientists 
to research publications and for NIH to manage better its entire 
research investment.
    3. ACCESS. The archive makes available to the public research 
publications resulting from NIH-funded research.

Policy History

    The original, voluntary Public Access Policy, implemented May 2005 
(NOT-OD-05-022, available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-022.html), encouraged but did not require investigators 
receiving NIH funding to deposit their peer-reviewed manuscripts into 
PubMed Central. It was shaped, in large part, through discussion with 
the extramural community.
    The NIH began public discussions on this topic with three town hall 
style meetings in 2004. From this feedback, the NIH developed a 
proposal for a voluntary public access policy that would make final 
peer-reviewed

[[Page 7605]]

manuscripts publicly available on PubMed Central within 6 months of 
publication. The NIH issued the proposed NIH Public Access Policy for 
comment in September 2004 (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-064.html or http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/04-21097.htm). In 
response to its request for input on the proposed policy, NIH received 
over 6,200 comments from interested parties, including grantees, 
publishers and trade organizations. After carefully considering all the 
comments received, the NIH published a final policy, NOT-OD-05-022, on 
February 3, 2005 (also published at 70 FR 6891). Though 66 percent of 
comments favored a six-month delay period, the NIH implemented a 
voluntary Public Access policy with a 12-month delay period out of 
deference to concerns from some members of the publishing community.
    Implementation of this voluntary policy was marked by continued 
engagement with multiple stakeholders in order to facilitate 
participation. The NIH staff met dozens of times and exchanged hundreds 
of letters with patient advocacy groups, awardee institutions and their 
representatives, publishers, and scientific societies regarding the 
Policy. (For a breakdown of meetings and correspondence, see slide 12 
of NIH Director Elias Zerhouni's presentation at the March 20, 2008, 
open meeting at http://publicaccess.nih.gov/comments/Overview_Context.pdf.) In collaboration with publishers, investigators, 
grantees, and others, the NIH established systems to make it easy for 
scientists to deposit their manuscripts directly and for interested 
publishers to deposit manuscripts on scientists' behalf. For example, 
the NIH Manuscript Submission System (NIHMS), a Web service built to 
support the Policy, allows publishers to submit manuscripts on behalf 
of authors in bulk. The NIH also developed new forms of PubMed Central 
Journal agreements in collaboration with publishers, which enable 
publishers to submit final, published articles to PubMed Central from 
NIH-funded authors, only and/or from authors who pay open access fees 
to the journals.
    Thus, for almost three years, the NIH asked the scientists it 
supports to deposit their NIH-funded scientific manuscripts in an NIH 
online system that would make them accessible to the public, freely and 
in perpetuity. But the compliance rate under the voluntary system 
demonstrated that it would not achieve the goals of the Public Access 
Policy. In December 2007, the Consolidated Appropriations Act of 2008 
was signed into law, directing the NIH to require submission of 
manuscripts.

Implementing the Consolidated Appropriations Act of 2008

    The Consolidated Appropriations Act of 2008 (Pub. L. 110-161), at 
Division G, Title II, Section 218, directs the NIH as follows: The 
Director of the National Institutes of Health shall require that all 
investigators funded by the NIH submit or have submitted for them to 
the National Library of Medicine's PubMed Central an electronic version 
of their final, peer-reviewed manuscripts upon acceptance for 
publication, to be made publicly available no later than 12 months 
after the official date of publication: Provided, that the NIH shall 
implement the public access policy in a manner consistent with 
copyright law.
    On January 11, 2008, NIH issued the Public Access Policy 
implementing this clear and unambiguous new statute. As described in 
the NIH Guide for Grants and Contracts (NOT-OD-08-033, available at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html), 
the Policy restates the statute and offers the following specifics:
    1. The NIH Public Access Policy applies to all peer-reviewed 
articles that arise, in whole or in part, from direct costs \1\ funded 
by NIH, or from NIH staff, that are accepted for publication on or 
after April 7, 2008.
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    \1\ ``Directly'' funded means costs that can be specifically 
identified with a particular project or activity. See NIH Grants 
Policy Statement, Rev. 12/2003.
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    2. Institutions and investigators are responsible for ensuring that 
any publishing or copyright agreements concerning submitted articles 
fully comply with this Policy.
    3. PubMed Central (PMC) is the NIH digital archive of full-text, 
peer-reviewed journal articles. Its content is publicly accessible and 
integrated with other databases (see: http://www.pubmedcentral.nih.gov/
).
    4. The final, peer-reviewed manuscript includes all graphics and 
supplemental materials that are associated with the article.
    5. Beginning May 25, 2008, anyone submitting an application, 
proposal, or progress report to the NIH must include the PMC or NIH 
Manuscript Submission reference number when citing applicable articles 
that arise from their NIH-funded research. This policy includes 
applications submitted to the NIH for the May 25, 2008 due date and 
subsequent due dates.

Compliance

    Compliance with this Policy is a statutory requirement and a term 
and condition of the grant award and cooperative agreement, in 
accordance with the NIH Grants Policy Statement. For contracts, the NIH 
includes this requirement in all R&D solicitations and awards under 
Section H, Special Contract Requirements, in accordance with the 
Uniform Contract Format.
    In addition to announcing the Policy, the NIH established a Web 
site and posted responses to frequently asked questions (FAQs) that 
provide authors, their institutions, and their publishers with guidance 
on the implementation of the policy.
    As part of the process to implement Section 218 in a transparent 
and participatory manner, the NIH formally sought public input through 
an open meeting and a Request for Information seeking public comment. 
The open meeting occurred on March 20, 2008 (NOT-OD-08-057), and was 
designed to ensure that discussion of stakeholder issues could occur. 
The feedback from the open meeting helped define questions for a 
Request for Information (RFI), conducted from March 28 to May 31 (NOT-
OD-08-060). This report summarizes comments received at the meeting and 
in response to the RFI.

Open Meeting

    The purpose of the Thursday, March 20, 2008, meeting was to seek 
comment from the public on implementation of the NIH Public Access 
Policy. The meeting was open to all, including NIH-funded researchers, 
representatives of universities and other NIH grantee organizations, 
publishers (including commercial organizations, professional societies, 
and journal editors), patients and public health advocates, and members 
of the general public. The NIH desired broad participation and 
commentary.
    In particular, the NIH was interested in input concerning the 
Public Access Policy and the effectiveness of the policy's 
implementation. Individuals, groups, and organizations were also 
invited to submit written pre-meeting comments on the NIH Policy.
    The NIH made every effort to make the meeting and pre-meeting 
comments open and transparent. Comments were made public as they were 
received. The meeting was video cast, and everyone who wished to speak 
was able to. All meeting materials, including the Guide Notice, Federal 
Register Notice, video cast, transcript, and comments are available at 
http://publicaccess.nih.gov/open_meeting_march_2008.htm.

[[Page 7606]]

Comments posted on this site are recorded as submitted and, in some 
cases, include duplicates.

Request for Information (RFI)

    The feedback from the open meeting helped define questions for a 
Request for Information (RFI), which was published on the NIH Web site 
on March 28, 2008, and in the Federal Register on March 31, 2008 (73 FR 
1681-1695) (see NOT-OD-08-060). The NIH sought information from the 
public, including all stakeholders, about the new NIH Public Access 
Policy and the frequently asked questions developed to assist 
investigators to implement it. Among other issues, the NIH particularly 
sought information about the following questions:
     Do you have recommendations for alternative implementation 
approaches to those already reflected in the NIH Public Access Policy?
     In light of the change in law that makes NIH's public 
access policy mandatory, do you have recommendations for monitoring and 
ensuring compliance with the NIH Public Access Policy?
     In addition to the information already posted on the NIH 
Web site, what additional information, training or communications 
related to the NIH Public Access Policy would be helpful to you?
    Individuals, groups, and organizations interested in responding 
were invited to do so via a Web site that would record their responses 
for each question and make those responses publicly available. All 
comments received via the Web and e-mail related to the Public Access 
Policy RFI is now available at http://publicaccess.nih.gov/comments.htm.

Methodology for Analysis

Consolidating and Categorizing Comments

    Comments were posted as they were collected, and commenters had the 
opportunity to respond to other comments. This was a deliberate effort 
on the part of NIH to encourage dialogue among stakeholders and to 
provide a more synthesized set of ideas for analysis. Individuals and 
organizations were allowed to submit multiple comments, and all 
comments were treated equally, regardless of the source. Although the 
NIH requested input on several open-ended questions at the meeting and 
in the RFI, commenters did not restrict themselves to input on these 
questions and offered a variety of opinions on other topics, either in 
addition to responding to the questions or in lieu of responding to 
them.
    Combined, the open meeting and RFI yielded 613 unduplicated 
comments. The comments include materials entered through the online 
comment service, transcriptions of in-person statements offered at the 
March 20 Open Meeting, and e-mails received at the Public Access 
comments mail box.
    Duplicates were identified by finding multiple comments from the 
same individual that contained identical content. Comments that were 
entirely off-topic (e.g., SPAM, selling products) were considered 
nonresponsive and thus not counted. If an individual submitted multiple 
responses and each submission contained new content, they were not 
marked as duplicates and were separately counted and analyzed. In 
addition, if the same comment or information (e.g., a form letter) was 
received from two or more individuals those comments were counted 
separately and not marked as duplicates.
    All unduplicated comments underwent an initial review to identify 
the topic(s) addressed and to gain a sense of the relative number of 
commenters who addressed each topic. This initial analysis helped to 
identify major themes for inclusion in this report.
    The 613 unduplicated comments covered by this report, combining 
comments from both the open meeting and the RFI, and including PDF 
comments converted to text using optical character recognition, became 
available in a single file at http://publicaccess.nih.gov/comments.htm 
in October 2008. We invite our stakeholders to use these resources to 
conduct independent analyses of these data.
    The public comments were largely supportive of the Policy. Comments 
clustered around several broad themes. We describe them below, followed 
by NIH's analysis and response where appropriate.

1. Need for the Policy

    The most common theme among comments, expressed in a large majority 
of all comments, was support for the Policy as written. When reasons 
for support were offered, the most common were as follows: (1) The 
perceived benefit to patients and their families, (2) the belief that 
the American public has a right to access papers arising from NIH 
funds, and (3) the expected potential of the policy to advance 
scientific discovery. A small minority of comments expressed general 
disagreement with the Policy and/or felt that increasing access to 
papers arising from NIH funds was unnecessary.

2. The Length of the Delay Period

    The second largest number of comments, second only to general 
support for the Policy, were comments advocating reducing the period of 
time before papers are made publicly available on PubMed Central. A 
large number of commenters argued for a shorter maximum delay period--
many suggested 6 months, many no delay period at all, and a few 
suggested 3 months. Advocates for reducing the period of time explained 
that doing so would provide greater benefits to the public and to 
science. Some further claimed, and provided examples of how, shorter 
delay periods would not harm publisher interests. A few commenters 
suggested that the maximum delay period should be greater than 12 
months. These commenters claimed that a longer delay period was needed 
to protect journals in certain disciplines.
    The NIH appreciates the concerns of all commenters concerning the 
maximum delay period between journal publications and posting on PubMed 
Central. The Consolidated Appropriations Act of 2008 specifies the 
maximum delay period at 12 months. Copyright holders may always post 
materials with a shorter delay period, at their discretion.

3. Actions Taken by Institutions to Support Implementation

    Many commenters shared their efforts to implement and promote the 
Policy. Several publishers described their efforts to support 
implementation, either by facilitating submission of papers on behalf 
of their authors, or by offering new guidance and publishing agreements 
so that their authors may understand how to comply with the Policy.
    A number of awardee institutions offered their implementation 
strategies as well. In some cases, libraries were taking the lead in 
educating their faculty and supporting them in interpreting publishing 
agreements and submitting manuscripts to the NIH. In other cases, 
offices of sponsored research described guidance on the NIH Public 
Access Policy disseminated to their faculty community via the Web, 
memos, seminars, and video casts. Still other institutions described 
collaborations between libraries, offices of sponsored research, 
university counsel, and technology transfer offices. Several 
universities and private groups also described institutional policies 
on scholarly communication and new publishing forms and addenda that 
their

[[Page 7607]]

faculty could use to ensure compliance with the Policy.
    The NIH is interested in the role institutions may play in 
supporting the Policy and appreciates the efforts of these commenters 
to both support the policy and share their strategies. In January 2008, 
the NIH published an article outlining key questions institutions may 
wish to consider as they implement the Policy (http://grants.nih.gov/grants/partners/0108Nexus.htm#investigator). Based on the comments 
submitted, it appears that the community has developed multiple 
approaches to issues described in this article, but it is too early in 
the implementation of the Policy to determine if some approaches are 
more successful than others.
    NIH employees publish several thousand peer-reviewed papers each 
year, and the NIH has to support the Policy as an investigator 
institution as well. Our approach to ensure compliance among our own 
faculty involves support from the NIH Library, a unit of the NIH Office 
of Research Services; NIH technology transfer representatives; and the 
NIH Office of Intramural Research. The NIH offers employees guidance on 
our Web site, a publishing agreement addendum, centralized negotiation 
of publishing agreements, help desk support for manuscript submission 
and policy questions, and staff training upon request. See http://publicaccess.nih.gov/nih_employee_procedures.htm for more 
information.

4. Administrative Burden for Institutions and Principal Investigators

    Some comments expressed concern that the Policy would create undue 
burdens on authors, investigators, and institutions. The comments are 
described below.

A. Negotiating Publisher Agreements

    Some comments suggested the Policy required authors and individual 
investigators to negotiate with publishers directly. They felt 
individual authors lacked the skills or bargaining power to develop an 
agreement with a publisher that met their needs under the Policy.
    Investigators are central to implementing the Policy and usually 
are the initial copyright holder of the manuscripts that fall under the 
Policy. They may need to negotiate the terms of publishing agreements 
with publishers directly. However, the NIH expects that institutions 
will support their investigators in complying with terms and conditions 
of award. The NIH Public Access Policy states ``Institutions and 
investigators are responsible for ensuring that any publishing or 
copyright agreements concerning submitted articles fully comply with 
this Policy.'' The NIH underscores the importance of institutional 
support throughout the Frequently Asked Questions (FAQ). For example, 
FAQ C4 addresses publishing agreements or publishers that may not 
support compliance with the Policy. FAQ C11, released in May 2008 in 
response to this feedback, addresses another aspect of this concern. In 
both cases, the NIH encourages authors and investigators to work with 
their institution's office of sponsored research.
    With regard to particular agreement terms, individual copyright 
arrangements can take many forms, and authors and their institutions 
should continue to manage such arrangements as they have in the past.
    Institutions and investigators may wish to develop particular 
copyright agreement terms in consultation with their own legal counsel 
or other applicable official at their institution, as appropriate. As 
an example, the kind of language that an author or institution might 
add to a copyright agreement includes the following (as described in 
FAQ C3):
    ``Journal acknowledges that Author retains the right to provide a 
copy of the final peer-reviewed manuscript to the NIH upon acceptance 
for Journal publication, for public archiving in PubMed Central as soon 
as possible but no later than 12 months after publication by Journal.''
    There are many other potential models, some of which were described 
in other comments and are available for viewing therein.

B. Ability for Investigators to Publish in the Journal of Their Choice

    A few comments expressed concern that some journals would refuse to 
allow manuscripts to be posted to PMC in accordance with the Policy, 
and authors would not be able to publish in those journals. They 
claimed this could occur despite an author's best efforts to negotiate 
with a publisher.
    The NIH agrees that author choice of publication is a very 
important issue, but if this situation were to occur, an author might 
have to find an alternate journal. Therefore, the NIH encourages 
authors to clearly communicate with and address these issues before 
they may transfer their copyright and potentially lose their ability to 
comply with the Policy. The Public Access Home page states: ``Before 
you sign a publication agreement or similar copyright transfer 
agreement, make sure that the agreement allows the paper to be 
submitted to NIH in accordance with the Public Access Policy.''
    The NIH has also engaged the publishing community in order to 
minimize copyright concerns when possible. The NIH has established 
voluntary partnerships with many publishers who agree to facilitate 
deposit of manuscripts and final published papers. The number of papers 
submitted via these agreements has grown since the Public Access Policy 
took effect. The NIH issued guidance to authors to clarify these 
various arrangements in July 2008. The guidance can be found at http://publicaccess.nih.gov/submit_process.htm. Whether because of NIH's 
direct efforts, clear communication from authors and institutions or 
because of publisher support for the Policy, NIH did not receive 
comments indicating that publishers or publishing agreements have 
actually prevented authors from complying with the Policy. To the best 
of our knowledge, this concern currently remains a hypothetical risk 
and not a manifest problem.

C. Cost Reimbursement

    Some commenters raised the issue of investigators or awardees 
needing to pay potential publishing costs and fees associated with the 
Policy (e.g., fees for posting to PubMed Central, fees to reduce delay 
periods). Some commenters suggested that the NIH should cover these 
costs, others requested clarification concerning costs, and still 
others thought the NIH would offer no financial support to either 
institutions or publishers. As such, the commenters felt that the 
Policy was an unfunded mandate that might harm author or publisher 
interests, with junior authors (new investigators and trainees) being 
especially vulnerable. However, several commenters thought any 
unrecovered costs associated with the Policy were worth the benefits, 
and one commenter even requested that the NIH stipulate that costs not 
be covered.
    As with other costs, the NIH will reimburse publication costs, 
including author fees, for 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. Generally, page charges for publication 
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,

[[Page 7608]]

whether or not they are submitted by Government-sponsored authors.

D. Compliance Burden

    Some commenters expressed concern about the time Program Directors/
Principal Investigators (PDs/PIs) and authors will need to spend to 
submit papers. A few commenters said that a simple submission system 
was critical to the success of the policy. Among those commenting on 
the potential burden of the submission process, a portion said the 
existing NIH Manuscript Submission System (NIHMS) was easy to use, a 
portion said it was complex and burdensome, and a portion were unaware 
of how it worked. Some commenters also expressed concern or offered 
suggestions related to the notification and management of PubMed 
Central Identifiers (PMCIDs), which are assigned to papers after they 
are submitted and can be used to demonstrate compliance with policy on 
applications, proposals, and reports.
    The NIH agrees with the need to have a simple manuscript submission 
process to minimize the time associated with deposit of manuscripts 
into PubMed Central. NIH has worked diligently since the adoption of 
the voluntary Public Access Policy in 2005 to develop a streamlined and 
efficient process. During the voluntary Policy, NIH found it took 
authors about 10 minutes to deposit a paper in the NIH Manuscript 
Submission System (NIHMS); the time decreased for submitters as they 
began to submit more papers and gained experience with the system.
    The NIH continues to refine the NIHMS as necessary. For example, 
starting in June 2008, NIH eliminated the need for PDs/PIs to review 
each deposit. Instead, the NIHMS now allows authors to complete all 
aspects of manuscript submission, with the idea that greater 
flexibility in delegation will minimize PD/PI burden. The NIH gives 
specific guidance on these submission processes on its Web site at 
http://publicaccess.nih.gov/submit_process.htm. This guidance also 
describes how authors can delegate some submission tasks to someone in 
the author's organization (e.g., an assistant or a librarian), or to 
their publisher, and how all aspects of submission can be delegated to 
a publisher that participates in PubMed Central.
    The NIH has developed Policy compliant alternatives to manuscript 
deposit that require less author effort. For example, as described at 
http://publicaccess.nih.gov/submit_process.htm, some publishers sign 
agreements with the NIH to submit final published articles directly to 
PubMed Central without author involvement. Since the passage of the 
2008 Consolidated Appropriations Act, the number of publishers signing 
such agreements has significantly increased.
    The NIH has also made changes to the way it reports PubMed Central 
reference numbers (PMCID), and how authors and delegates can use the 
NIHMS system. For example, as described in FAQ C9, issued May 2008, the 
PMCID is posted in PubMed as soon as an article has been successfully 
processed by PMC, which usually occurs around the time of publication. 
PMCIDs are listed in the lower right corner of the Abstract Plus view 
of PubMed (http://www.ncbi.nlm.nih.gov/PubMed/). If the paper is not 
yet publicly available on PMC, PubMed will also list the date the paper 
will become available. The NIH provides other methods of obtaining 
PMCIDs (e.g., http://www.ncbi.nlm.nih.gov/sites/pmctopmid, created in 
August 2008), as do several bibliography management software packages.

E. Collaborations With Institutional Repositories

    As a way to relieve compliance burdens on their faculty, a few 
institutions requested direct feeds from their repositories to PubMed 
Central or the NIH Manuscript Submission system.
    The NIH believes that these are worthwhile suggestions, but it is 
concerned that they raise important technical and logistical challenges 
regarding author approval, copyright permissions, quality control, and 
formats for electronic transfer. The NIH remains open to closer 
collaboration with institutional archives and will consider this issue 
as the Policy matures. National Library of Medicine representatives met 
with representatives from academic communities to discuss this issue in 
November 2008.

5. Expanding the Scope of the Public Access Policy

    Some commenters suggested the Policy be expanded in several ways 
from investigators and research funded by additional or all Federal 
research funds to papers published before April 7, 2008, or to the data 
and unpublished results associated with an award. A few comments 
suggested a specific alternative approach to expand the scope of the 
policy to exempt all works arising from NIH/Government funds from 
copyright protection.
    The NIH understands and appreciates the strongly held views of many 
commenters concerning access to works funded by the NIH and the 
Government generally. The NIH Public Access Policy implements the 
Consolidated Appropriations Act of 2008, Division G, Title II, Section 
218 (Pub. L. 110-161), a Federal statute that was passed by Congress 
and signed by the President of the United States. This statute is very 
specific--it indicates what is to be submitted and when, and when and 
where submissions are made publicly available.
    The NIH's new Access Policy took effect a few months after passage 
of the law to allow copyright holders to make arrangements to post 
directly and in accordance with copyright law. Regarding the suggestion 
that works funded through the NIH should be denied copyright 
protection, we note that works of Government employees, including NIH 
investigators, are not subject to copyright protection in the United 
States (17U.S.C. 105). The works of Government awardees, however, are 
subject to copyright protection.

6. Issues About the Policy and Its Implementation Requiring 
Clarification

    A number of issues were raised that resulted in NIH providing 
clarifications.

A. Compliance Monitoring and Enforcement

    A number of comments suggested that investigators should include 
evidence of compliance with the Policy in applications, proposals or 
reports submitted to the NIH. A few comments simply asked what is the 
process for enforcing compliance.
    It is unclear whether the commenters proposing reference within NIH 
applications, proposals, or reports were endorsing the Policy as 
implemented, as it already specifies that investigators should do so, 
or were unaware of the compliance procedure described in the January 
11, 2008 Guide notice. As is made clear therein, the NIH expects that 
investigators citing their NIH-funded papers subject to the Policy in 
NIH applications, proposals, or progress reports will include the 
PubMed Central reference number for each applicable paper.
    The NIH clarified the compliance reporting process with an update 
to the Web site in May 2008 and further clarified the compliance 
documentation and monitoring processes in a Guide Notice (OD-NOT-08-119 
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-119.html). 
FAQ C8, also part of the May 2008 release, clarifies that the Policy 
reporting requirement for applicants and PDs/PIs only applies to papers 
that are authored by them or arose from their NIH award and fall under 
the policy.

[[Page 7609]]

    Some commenters also asked about consequences for PDs/PIs and 
institutions if manuscripts are not submitted as required by the law 
and the Policy. Generally, and as specified in the NIH Guide for Grants 
and Contracts, a grantee's failure to comply with the terms and 
conditions of award may cause the NIH to take one or more enforcement 
actions, depending on the severity and duration of the noncompliance. 
The NIH will undertake any such action in accordance with applicable 
statutes, regulations, and policies. The NIH generally will afford the 
grantee an opportunity to correct the deficiencies before taking 
enforcement action unless public health or welfare concerns require 
immediate action. However, even if a grantee is taking corrective 
action, the NIH may take proactive action to protect the Federal 
Government's interests, including placing special conditions on awards 
or precluding the grantee from obtaining future awards for a specified 
period, or may take action designed to prevent future noncompliance, 
such as closer monitoring. See Enforcement Actions in the NIH Grants 
Policy Statement (11/03): http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part8.htm#_Toc54600145.

B. Preventing Copyright Violations on PMC

    The NIH received feedback on the potential copyright implications 
of posting papers to PubMed Central (PMC), which cluster into two 
themes. Some comments asked how the NIH will prevent inappropriate 
posting of materials to PMC without permission of the copyright holder 
or posting prior to expiration of the delay period specified by the 
submitter. Other comments, described below, expressed concern about the 
operation of PMC and the protections it offers copyright holders 
against inappropriate use of their works.
    The comments about inappropriate posting primarily focused on 
individuals posting content without copyright permission. The NIH 
manuscript submission system is the only way in which authors may 
deposit manuscripts to PMC. That process requires the author to confirm 
he or she has the right or permission for the specific version 
submitted to be posted to PMC after the specific delay period. 
Publishers and authors have occasionally disagreed on the terms of 
their publishing agreements. Publishers have submitted final peer-
reviewed manuscripts on behalf of their authors requesting a specific 
delay period, and in the course of approving the manuscript for 
posting, authors have selected a shorter delay period. In June 2008, 
NIH modified the NIH Manuscript Submission System to allow a publisher 
to fix the delay period when they submit a manuscript on behalf of 
their authors. Authors now have to contact NIH and their publisher if 
they wish to change the delay. We expect this more direct communication 
will result in fewer disagreements about delay periods.
    Commenters also asked how NIH safeguards privately copyrighted 
materials on PubMed Central once it is posted. NIH has eight years of 
experience in safeguarding copyrighted material on the PMC Web site, 
the host archive of the Public Access Policy. There are over 1.5 
million full-text articles on the Web site. PMC has algorithms to 
detect inappropriate use, such as bulk downloading, and sites 
responsible for inappropriate use are warned of the consequences of 
violating copyright provisions and blocked from further access.

C. Applicability of the Policy

    Some commenters asked questions or expressed confusion about the 
papers to which the Policy applies. Applicability was clarified in the 
May 2008 FAQ B1. The Policy applies to any manuscript that:
    Is peer-reviewed;
     And, is accepted for publication in a journal on or after 
April 7, 2008.
     And, arises from:
     Any direct funding \2\ from an NIH grant or cooperative 
agreement active in fiscal year 2008, or;
---------------------------------------------------------------------------

    \2\ ``Directly'' funded means costs that can be specifically 
identified with a particular project or activity. See NIH Grants 
Policy Statement, Rev. 12/2003.
---------------------------------------------------------------------------

     Any direct funding from an NIH contract signed on or after 
April 7, 2008, or;
     Any direct funding from the NIH Intramural Research 
Program, or;
     An NIH employee.
    Consistent with the NIH's long-standing interest in developing a 
full and complete database, however, authors may also submit final 
peer-reviewed manuscripts accepted before April 7, 2008, that arise 
from NIH funds, if they have appropriate copyright permission or 
authority.

D. Version Control

    The NIH received comments with questions or concerns about the 
version of the paper posted to PMC. Some commenters suggested that only 
final, published versions of articles should be posted as they felt 
final peer-reviewed manuscripts may contain scientific errors corrected 
during the copy-editing process. A few commenters expressed concern 
that the formatting processes that are part of PubMed Central may 
change the meaning of the paper.
    The NIH has been posting final peer-reviewed manuscripts on PMC for 
years and found them to offer the same scientific information as the 
final published article. The NIH obtains the permission of the author 
before each author manuscript is posted to PMC. We ask authors to 
review the specific document to be posted, and allow them to correct 
any scientific issues during the approval process and afterwards. To 
date, we are unaware of uncorrected errors in PubMed Central.
    In response to questions about the version of a paper that may be 
posted on PMC, the NIH issued FAQ D6 in May 2008. It explains that the 
NIH Public Access Policy is based on a law (Division G, Title II, 
Section 218 of Pub. L. 110-161) that requires investigators to submit 
``their final, peer-reviewed manuscripts'' to PubMed Central. The NIH 
will accept the final published article in lieu of the final peer-
reviewed manuscript, provided that the submitter has the right to 
submit this version. Some journals post final published articles 
directly to PMC. See http://publicaccess.nih.gov/submit_process_journals.htm for more information.
    Papers need to be converted into the PMC Archival format in order 
to be posted. This process does not change the meaning or the content 
of the paper. However, it does further the goals of the Public Access 
Policy and is a fundamental feature of the PMC database. Once posted to 
PubMed Central, results of NIH funded research become more prominent, 
integrated, and accessible, making it easier for all scientists to 
pursue NIH's research priority areas competitively. PubMed Central 
materials are integrated with large NIH research databases such as 
Genbank and PubChem, which helps accelerate scientific discovery. 
Finally, the Policy allows the NIH to monitor, mine, and develop its 
portfolio of taxpayer-funded research more effectively and archive its 
results in perpetuity.
    The NIH should provide guidance on copyright issues.
    Some commenters requested explicit guidance on copyright issues. 
The NIH provides an example in FAQ C3 (http://publicaccess.nih.gov/FAQ.htm#c3), which states that ``* * * Individual copyright 
arrangements can take many forms, and authors and their institutions 
should continue to manage such arrangements as they have in the past.''

[[Page 7610]]

    Institutions and investigators may wish to develop particular 
copyright agreement terms in consultation with their own legal counsel 
or other applicable official at their institution, as appropriate. As 
an example, the kind of language that an author or institution might 
add to a copyright agreement includes the following:
    ``Journal acknowledges that Author retains the right to provide a 
copy of the final peer-reviewed manuscript to the NIH upon acceptance 
for Journal publication, for public archiving in PubMed Central as soon 
as possible but no later than 12 months after publication by Journal.''

7. Requests for Additional Information About the Policy and 
Implementation Procedures.

A. NIH Should Disseminate Information About Publisher Support of the 
Policy

    Some commenters asked for a list of publishers that allow their 
authors to comply with the policy. NIH has developed and maintains two 
lists of publishers and journals. Hundreds of journals make the final 
published version of every NIH-funded article publicly available in 
PubMed Central within 12 months of publication without author 
involvement. See http://publicaccess.nih.gov/submit_process_journals.htm for a list of these journals. Some publishers will deposit 
an individual final published article in PubMed Central upon author 
request, and generally for a fee. See the list of publishers at http://publicaccess.nih.gov/select_deposit_publishers.htm. All other 
publisher policies and procedures require active author involvement to 
finalize submission, as described in Methods C and D of the Policy Web 
site (see http://publicaccess.nih.gov/submit_process.htm).

B. Frequently Asked Questions

    Some commenters specifically highlighted the Frequently Asked 
Questions as a helpful resource. A few mentioned the Public Access 
Policy Web site in its entirety as helpful. The NIH also offers 
additional resources to support training efforts, including complete 
slide presentations that may be downloaded and adopted for stakeholder 
use. These are available at http://publicaccess.nih.gov/communications.htm.

8. Implementation Alternatives

A. Administrative Procedure Act

    Some commenters felt the implementation of the Public Access Policy 
was in violation of the Administrative Procedure Act. They claimed the 
NIH should not have implemented the Policy without going through a 
notice and comment rulemaking and that the January 11 Guide Notice 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) 
was issued inappropriately.
    The NIH believes the initiation of notice and comment rulemaking to 
implement the new statute is unwarranted and contrary to the interests 
of science and the public health. The mandatory access requirement now 
adopted in NIH Public Access Policy derives from Public Law 110-161, 
Sec.  218, a Federal statute that was passed by Congress and signed by 
the President of the United States. This statutory provision is a clear 
and unambiguous directive to the NIH Director to require NIH grantees 
to provide their manuscripts to PubMed Central after the date of 
publication.
    Where, as is true in this case, a statute clearly directs an agency 
to execute a congressional objective, and Congress has not directed the 
agency to promulgate implementing regulations, an agency's 
interpretation or statement of policy or procedure regarding the 
statute does not trigger a requirement for notice and comment 
rulemaking. 5 U.S.C. 553(b)(3)(A); see also Shalala v. Guernsey Mem. 
Hosp., 514 U.S. 87, 99 (1995); American Mining Congress v. Mine Safety 
& Health Admin., 995 F.2d 1106, 1112 (D.C. Cir. 1993). Further, the 
only significant difference between the new law and the NIH's former 
voluntary public access policy is implementation of the legal directive 
to require provision of the manuscripts; there is no ``gap'' left by 
Congress that would require a rule to implement the statute. See 
Chevron, U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837, 843-44 (1984). The 
mechanics of implementing the former policy were widely understood as 
described in published agency policy and in widely accessible Internet 
resources maintained by the NIH. Furthermore, the mechanics of 
implementing the new statute are substantially the same as, and 
consistent with, the NIH's earlier policy implementation. Agency 
implementation of a plainly worded Congressional mandate--particularly 
where consistent with established agency policy--does not require a 
rulemaking proceeding. See, e.g., Gray Panthers Advocacy Cmte. v. 
Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. 1991). To the extent the NIH 
has offered, and continues to offer, interpretative policy guidance or 
procedural assistance with regard to the new law, such guidance is not 
of free-standing legal effect but rather is intended to assist grantees 
to comply with their statutory obligations. See American Mining 
Congress, 995 F.2d at 1112. The impact of the mandatory submission 
requirement arises from the statute, and rulemaking is not necessary to 
implement this statutory requirement.

B. America Competes Act

    Some commenters suggested the America Competes Act as an 
alternative to the NIH's implementation. Relying on dissemination of 
reports and abstracts as described in the America Competes Act is not 
consistent with the Consolidated Appropriations Act of 2008.

C. A ``Dark Archive'' or Linking to Publisher or Other Web Sites

    A few comments suggested that awardees should submit manuscripts to 
the NIH for internal NIH reporting and portfolio management, and public 
access could be provided by links to freely available materials on 
publisher sites. Some comments suggested that the NIH only provide 
public access via publisher sites, and not maintain an internal archive 
at all. Many comments explicitly repudiated these ``dark archive'' or 
linking approaches and argued that the policy should require deposit to 
PubMed Central. One comment suggested that the Public Access Policy 
mandate deposit to institutional archives (i.e., those maintained by 
universities), and that these repositories could submit papers to 
PubMed Central.
    The Consolidated Appropriations Act of 2008 explicitly states that 
papers should be submitted to and made publicly available on PubMed 
Central and the NIH must follow this law. PubMed Central (PMC) is the 
NIH National Library of Medicine's (NLM) digital repository of full-
text, peer-reviewed biomedical, behavioral, and clinical research 
journals. NLM and its predecessor organizations have been archiving the 
biomedical literature for over 150 years and are experienced in 
maintaining a stable archive of scientific information. PMC is 
currently used by approximately 400,000 users per day.
    There are several critical advantages to the scientific community 
for making papers publicly available on PMC. Once posted to PMC, 
results of NIH-funded research become more prominent, integrated, and 
accessible, making it easier for all scientists to pursue NIH's 
research priority areas competitively. PMC materials are integrated 
with large NIH research databases such as Genbank and PubChem, which 
helps accelerate scientific discovery. Clinicians, patients, educators, 
and students can better reap

[[Page 7611]]

the benefits of papers arising from NIH funding by accessing them on 
PMC at no charge. Finally, the Policy allows NIH to monitor, mine, and 
develop its portfolio of taxpayer-funded research more effectively, and 
archive its results in perpetuity.
    The Public Access Policy does not state that PMC will be the sole 
repository for these manuscripts and publications. The NIH has always 
pointed to journal and publisher sites from PMC and PubMed and will 
continue to do so. See http://www.ncbi.nlm.nih.gov/projects/linkout/ 
for more information. Others may also post and/or archive papers 
arising from NIH funds at other locations, subject to permission from 
copyright holders, as appropriate.

9. Copyright Issues

A. Consistency With Copyright Law

    The Consolidated Appropriations Act of 2008 requires that the NIH 
implement the policy consistent with copyright law. Some commenters 
suggested that that might not be possible.
    The NIH disagrees with commenters' suggestions that it will be 
difficult to implement the new statute in a manner that is consistent 
with copyright law. To the contrary, the effect of the new statute is 
merely that an author of a work that was funded by grants from the NIH 
must retain, from the entire ``bundle of rights'' \3\ inherent in a 
copyrightable work, a right to provide the author's manuscript to 
PubMed Central for display on its Web site. The author (or his or her 
employer) could, for instance, address this point in the agreement with 
the publisher by a simple statement that reserves, on behalf of the 
assignor, the right to provide the manuscript to PubMed Central for 
display. Such a reservation of rights by the author is clearly 
consistent with copyright law and the Consolidated Appropriations Act 
of 2008.\4\
---------------------------------------------------------------------------

    \3\ See 17 U.S.C. 106.
    \4\ Copyright in a manuscript vests initially with the author 
and remains with the author unless the rights are expressly 
assigned. 17 U.S.C. 201(a). Of course, the author may be hired to 
write the manuscript or may otherwise enter into an arrangement that 
assigns the rights to an employer, making the employer the author 
for purposes of the Copyright Act. 17 U.S.C. 201(b). Nevertheless, 
the author owns all of the rights in the manuscript, and a potential 
publisher owns no rights, unless and until they are conveyed by the 
author to the publisher. A publisher that subsequently obtains 
copyright to the work can continue to hold and enforce all of the 
rights transferred by the author, subject to the principles of the 
fair use doctrine, as are all copyrights. PubMed Central includes 
many copyrighted works, and public use of a work on PubMed Central 
is constrained by copyright, including the principles of fair use, 
just as it would be if a member of the public viewed the publication 
in a library, for example. Further, the public is alerted that the 
works they are viewing may be subject to copyright, with the 
following statement: ``This site also contains resources such as 
PubMed Central, Bookshelf, OMIM, and PubChem which incorporate 
material contributed or licensed by individuals, companies, or 
organizations that may be protected by U.S. and foreign copyright 
laws. All persons reproducing, redistributing, or making commercial 
use of this information are expected to adhere to the terms and 
conditions asserted by the copyright holder. Transmission or 
reproduction of protected items beyond that allowed by fair use 
(http://www.copyright.gov/fls/fl102.html) as defined in the 
copyright laws requires the written permission of the copyright 
owners.'' [http://www.ncbi.nlm.nih.gov/About/disclaimer.html]
---------------------------------------------------------------------------

    U.S. Copyright law anticipates the transfer of ownership rights in 
a copyright by agreement among parties or by operation of law (17 
U.S.C. 201(d)). Publishers do not own any portion of a copyright in a 
work that is not transferred to them by the author, or, if it is a work 
for hire, under an employment agreement with the employing institution. 
Similarly, the Federal Government, through OMB Circular A-110, grants 
federally funded institutions the right to retain intangible property 
(including copyright) as part of the terms and conditions of a Federal 
grant. Congress could, if it wished, require grantees to assign all 
rights to intangible property to the Federal funding agency, as indeed 
was the case for patent rights prior to the Bayh-Dole Act of 1980. 
However, in recognition of the public interest in having biomedical 
scientific publications widely accessible, Congress has required only 
that NIH-funded authors reserve the right to post works on PubMed 
Central. As one among dozens of conditions imposed on a grantee by 
Congress in return for taxpayer support of the grantee's work, the 
reservation of this small sliver of the entire bundle of rights 
inherent in the work is completely consistent with U.S. Copyright law.

B. Value of Publisher-Held Copyrights if Other Aspects of Copyright Are 
Retained by Authors

    A few comments indicated concern that posting the final peer-
reviewed manuscript to PubMed Central undermines the value of all other 
aspects of copyright that a Publisher may have obtained under the 
Policy.
    As described above, it is acceptable from a copyright perspective 
for investigators to ensure their papers can be posted to PubMed 
Central. However, the NIH Public Access Policy applies to awardees, not 
publishers. The NIH implemented the Public Access Policy prospectively 
to ensure that publishers have the ability to refuse to publish any 
paper they wish, for any reason they wish, including not obtaining all 
the rights they may prefer from authors of papers arising from NIH 
funds. The 12-month delay period and the ability of NIH awardees to 
cover publication-related costs from their awards are important aspects 
of the Policy created specifically to address concerns of some 
publishers and ensure their interests are protected.
    These comments concerning loss of value of the copyrighted work 
were not supported by data and run contrary to NIH's experience. The 
voluntary support of hundreds of journals to collect papers under the 
Policy is, perhaps, a reflection of publisher protections in the Public 
Access Policy. A significant number of journals support their authors 
by volunteering to submit manuscripts, and many more go beyond the 
policy by submitting final published articles. Hundreds even deposit 
final published articles that do not arise from NIH funds. Many of 
these journals also permit their papers to be posted to PubMed Central 
before the 12-month maximum delay period. The NIH appreciates the 
efforts of all these journals to support the Policy.

C. Section 201(E) of the Copyright Act

    One comment raised a concern that Section 201(e) of the Copyright 
Act prohibits a requirement for NIH awardees to retain a right to 
deposit in PMC. Section 201(e) of the Copyright Act states that when an 
individual author's ownership of a copyright has not previously been 
transferred voluntarily by that individual author, no action by any 
governmental body purporting to seize copyright shall take effect.
    Section 201(e) does not apply to the PMC situation for many 
reasons. First, the works at issue here are for the most part works in 
which the author has already expressly agreed how copyright will be 
handled through the employment agreement with their employing 
institution (see 201(b) works made for hire). Second, the employing 
institution will have previously accepted, as a term and condition of 
the grant, the obligation to submit a work created under the grant to 
PMC. Third, Congress did not require an involuntary transfer of rights, 
or otherwise ``seize'' rights. Rather, it required submission of the 
manuscript to PMC. One way of complying with this requirement would be 
for the author to retain the right to post, rather than transfer that 
right to a third party. Such retention by the author does not 
constitute a seizure or involuntary transfer of rights. Copyrighted 
material on PMC remains

[[Page 7612]]

fully subject to copyright, and copyright owners may fully enforce 
their rights. Fourth, to the extent that the PMC requirement can be 
read as a Government-retained interest, Congress often requires funding 
agencies to retain certain rights in the public interest in tangible 
and intangible property first produced with public funds. To read the 
patent or copyright laws as preventing such action would overturn many 
long-standing provisions of OMB Circular A-110 as well as the Federal 
Acquisition Regulation (F.A.R.) (e.g., rights in data first produced in 
its procurement contracts, rights in inventions, rights in computer 
software).

D. International Copyright Issues

    A few comments suggested that copyright concerns stem from making 
materials available on the Internet, and therefore internationally 
available. The NIH appreciates that the scientific community is truly 
global and interchange among scientists worldwide is essential for 
professional and scientific advancement. The Policy applies to all NIH-
funded investigators, including those in foreign countries. The PMC 
archive is available through the Internet, and therefore globally. 
Copyrights on works displayed in PMC are fully enforceable by the 
copyright owners in the U.S. and abroad. The NIH notes that many 
publishers post materials to their Web site, which also makes them 
globally available.
    One comment raised specific concerns about the Berne Convention and 
the World Trade Organization (WTO) TRIPS provision. The Berne 
Convention's provisions require that member countries provide 
protection for literary and artistic works, including scientific 
publications. Such protection is of course provided in the United 
States by its Copyright Act. The PMC deposition requirement does not 
undermine copyright protection of the grantee's work. Copyrights on 
works displayed in PMC are fully enforceable by the copyright owners. 
Article 2(1) of the Berne Convention is consistent with the widespread 
practice of reservation of rights in works by the funders of those 
works, which is essentially what Congress did when it required, as a 
condition of a grant award, the reservation of the right to place a 
grantee's manuscript in PMC. The concern about the Public Access Policy 
and potential conflict with Article 13 of the WTO TRIPS is unwarranted 
because the requirement does not interfere with the author's commercial 
use of the work. Article 13 directs member countries to confine 
limitations on exclusive rights to special cases that do not conflict 
with the normal exploitation of the work. But the deposition 
requirement makes no limitation on the exclusive rights attached to the 
work. It merely requires, as a reasonable and mutually agreed condition 
of the grant award, that the author or its institution reserves the 
right to display the author's manuscript on PMC. If the PMC deposition 
requirement violates TRIPS, then any Government procurement contract 
that secures rights to works made under the contract would also violate 
TRIPS. No compelling argument for that proposition has been presented 
to the NIH.

10. Evaluation and Impact

A. Costs to the NIH

    Some commenters asked about the operation and implementation costs 
of the policy. By building on an existing information technology 
infrastructure housed at the NLM, the NIH Public Access Policy is an 
exceptionally cost-effective means to accomplish its goals of 
archiving, advancing science, and enhancing accessibility. At full 
compliance, Public Access would cost the NLM $4.5 million per year 
(i.e., submission of 80,000 articles per year). Costs may decrease as a 
greater portion of journals submit papers directly to PMC. The NIH 
spent an additional $250,000 in fiscal year 2008 in policy-related 
staffing costs and contracts, the Request for Information issuance, and 
the March 20 Open Meeting. These costs will reduce once implementation 
is complete. The NIH does not have estimates on the cost of compliance 
and monitoring per grant for NIH staff. Compliance monitoring may add a 
few minutes to managing active projects for a subset of NIH extramural 
staff and, as such, cannot be assigned to a specific Public Access cost 
center.

B. Potential Impact on Publishers

    Many commenters touched on potential financial impacts of this 
Policy on publishers. Some claimed that the Policy would be harmful. A 
subset of these commenters further argued that if journals are 
adversely affected by the Policy, it would harm peer review as a whole. 
No data demonstrating harm to journals or peer review was submitted.
    Some commenters claimed the Policy would not be harmful to 
publishers. A few publishers described their experience making papers 
publicly available at 12 months or less, both on and off PubMed 
Central, without adverse financial impact.
    The NIH recognizes the enormous value and critical role that peer-
reviewed journals play in the scientific quality control process. Only 
peer-reviewed papers accepted for publication will be posted in PMC. 
This Policy is designed to preserve the critical role of journals and 
publishers in peer review, editing, and scientific quality control 
processes.
    As described in FAQ F10, released September 2008, the NIH is not 
aware that there will be a substantial impact of the policy on 
Publishers. An increasing number of journals already provide the public 
with free access to the published article immediately or within one 
year of the publication.
    The NIH Public Access Policy does not affect authors' freedom to 
choose the vehicle or venue for publishing their results. The NIH 
expects that its awardees will continue to publish the results of their 
research consistent with their professional autonomy and judgment in 
order to advance science as efficiently and comprehensively as 
possible.
    The NIH has posted thousands of papers to PubMed Central under the 
NIH Public Access Policy without evidence of harm to scientific 
publishing or to journals. Only a portion of articles published in 
scientific journals result from research funded by the NIH. Of these 
articles, only the final peer-reviewed manuscript is required to be 
posted, and it need not be made publicly available for up to 12 months 
post publication. Further, the NIH continues its practice of allowing 
publication costs, including author fees, to be reimbursed from NIH 
awards (see http://publicaccess.nih.gov/FAQ.htm#e3 for more 
information).

C. Impact on Science

    Many commenters supported the idea that the policy will support the 
advance of science. A few asked for measurement of these impacts. The 
NIH will consider exploring this issue as compliance rates rise and 
more NIH funded papers become available on PubMed Central. The NIH also 
encourages the scientific community to explore this issue 
independently.

Changes to Date

    In response to the feedback received, the NIH communications and 
procedures regarding the Public Access Policy have evolved. These 
changes are summarized chronologically below.

May 2008

    On May 2, 2008, NIH made the changes listed below to the NIH Public 
Access Policy Frequently Asked Questions (FAQs). These changes

[[Page 7613]]

provide clarifications and do not signify any changes in policy.
     Questions C7, C9, and C10 are new and reflect improvements 
to PubMed. These clarify and simplify how awardees can comply with the 
fifth specification of the NIH Public Access Policy, which states: 
``Beginning May 25, 2008, anyone submitting an application, proposal, 
or progress report to the NIH must include the PMC or NIH Manuscript 
Submission reference number when citing applicable articles that arise 
from their NIH-funded research. This policy includes applications 
submitted to the NIH for the May 25, 2008, due date and subsequent due 
dates.''
     Questions A4, B10-B12, C8, C11, D5, E4, E5, F5, and F6 
were developed based on questions received by NIH.
     NIH has responded to a number of questions about issues 
already addressed by the January 11, 2008, version of the FAQs and has 
made a number of small changes to many of these FAQ questions to 
improve their clarity. The biggest changes are in the wording of FAQs 
B1-B5.
     The January 11, 2008, FAQ uses the term ``article'' as a 
generic word for a peer-reviewed scientific publication and all its 
versions. At the March 20, 2008, Open Meeting, some stakeholders 
commented that ``article'' could be confused with the term ``final 
published article.'' Therefore, this FAQ uses the term ``paper'' 
instead of ``article.'' The Web site will be updated to reflect this 
change as well.

June 2008

    The NIH updated the NIH Manuscript Submission System (NIHMS) in two 
ways:
     Authors, and not Program Directors/Principal Investigators 
(PDs/PIs), now approve manuscripts for posting. This change reduces the 
effort for PDs/PIs who are not authors of papers that arise from their 
award. It also allows these PDs/PIs to more effectively delegate 
submission duties to the author who is most familiar with the paper. 
PDs/PIs are now notified by e-mail when a manuscript is linked to one 
of their awards via the NIHMS.
     The NIH modified the NIHMS to allow publishers to fix the 
delay period when they submit a manuscript on behalf of their authors. 
Authors now must contact the NIH and their publisher if they wish to 
change the delay. The NIH expects this direct communication to result 
in fewer disagreements about delay periods. In response to concerns 
from NIH employee authors, the NIH developed procedures its employees 
can use to ensure any manuscripts they write will be submitted in 
compliance with the Public Access Policy. These procedures are 
accessible at http://publicaccess.nih.gov/nih_employee_procedures.htm.

July 2008

    The NIH made several updates to the NIH Public Access Web page to 
clarify the submission process. The Web site explains that there are 
four methods to ensure that a manuscript is submitted to PubMed Central 
in compliance with the NIH Public Access Policy. These methods vary 
based on the version of the paper submitted, and the actions undertaken 
by the author and publisher.
    Method A: Publish in a journal that deposits all NIH-funded final 
published articles in PubMed Central (PMC) without author involvement.
    Method B: Make arrangements to have a publisher deposit a specific 
final published article in PubMed Central.
    Method C: Deposit the final peer-reviewed manuscript in PMC 
yourself via the NIH Manuscript Submission System (NIHMS).
    Method D: Complete the submission process for a final peer-reviewed 
manuscript that the publisher has deposited in the NIH Manuscript 
Submission System (NIHMS).

August 2008

    In response to questions and advice about identifying PubMed 
Central Identifiers (PMCIDs), the National Library of Medicine created 
a new utility (http://www.ncbi.nlm.nih.gov/sites/pmctopmid) that uses 
PubMed IDs (PMIDs) to look up PMCIDs, and vice versa. Users can enter 
PMIDs manually or from their PubMed clipboard. The utility will provide 
a table of PMIDs with corresponding PMCIDs. For example, an author 
could look up all his/her publications in PubMed, save them to the 
clipboard, and use the utility to see which ones have PMCIDs.

September 2008

    The Request for Information analysis indicated that a number of 
FAQs developed in support of the previous voluntary policy remained 
relevant under the new Policy requirement. Accordingly these were 
slightly modified and reposted to the FAQs. They are:
    A5. What are the benefits of posting peer-reviewed papers to PubMed 
Central?
    F7. Why should there be a public resource of published peer-
reviewed research findings of NIH-funded research?
    F8. Rather than archive manuscripts in NIH's PubMed Central, why 
not provide links to other Web sites?
    F9. Aren't scientific abstracts, which are currently freely 
available, sufficient? Why does the public need full-text articles?
    F10. Will NIH's Public Access Policy harm scientific publishing?
    F11. Will the NIH Public Access Policy harm the quality of peer 
review?
    NIH also issued a Guide Notice NOT-OD-08-119 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-119.html) informing 
PDs/PIs and Institutional Business Officials that they may receive e-
mails from NIH staff if their applications, proposals, or reports 
appear to be noncompliant with the NIH Public Access Policy. The Guide 
Notice also provides reminders about the instructions for citing 
literature in key NIH forms (e.g., the PHS398, SF424, PHS2590) and 
through eSNAP.

Current Status

    The NIH Public Access Policy requirement took effect April 7, 2008, 
during the Request for Information, and after the Open Meeting. The NIH 
made a number of improvements based on the feedback it was receiving; 
the results of these efforts appear promising. The months following 
April 7, 2008, have been marked by increased participation from both 
publishers and authors, which has led to increased collection rates for 
eligible papers.
    The NIH estimates that approximately 80,000 papers arise from NIH 
funds each year, and this total serves as the target for the Public 
Access Policy. One can gauge the progress of the implementation of the 
mandatory Policy by comparing the percentage of NIH-funded papers 
collected in the period April 2008 to August 2008 with the rate that 
was achieved under the voluntary Policy (May 2005 to December 2007).
    As described at http://publicaccess.nih.gov/submit_process.htm, 
the NIH provides four methods for submitting papers under the Policy. 
With two of these (methods A and B) publishers voluntarily submit final 
published articles directly to PubMed Central. With the other two, 
(methods C and D) authors and publishers can submit final peer-reviewed 
manuscripts to PMC via the NIH Manuscript Submission System (NIHMS). As 
Figure 1 indicates, the estimated percentage of final published 
articles submitted directly to PubMed Central (methods A and B) has 
more than doubled under the new requirement as compared to the earlier 
voluntary policy. Rates rose from 12 percent to 26 percent.

[[Page 7614]]

    The percentage of manuscripts collected via the NIH Manuscript 
Submission System (NIHMS, using methods C and D) more than quadrupled, 
from 7 percent under the voluntary policy to an estimated 30 percent 
under the requirement.
    Overall, the Public Access success rate rose from 19 percent of all 
NIH-funded papers to 56 percent of all NIH-funded papers after the 
requirement took effect. These first five months show the promise of a 
Public Access Policy requirement, though the NIH and its awardees 
remain over 40 percent short of their statutory obligation to make NIH-
funded papers available on PubMed Central. Also, while the NIH expects 
to post all 56 percent of these NIH papers, most of them will not be 
publicly available until 2009.

Future Activities

    The NIH expects to continually monitor and refine the 
communications and procedures surrounding the NIH Public Access Policy. 
These changes will be governed by advice and feedback from 
stakeholders, questions to the help desk, and paper collections rates.
    The NIH is exploring ways to enhance the utilities on PubMed and 
integrate them with bibliographic information on the eRA Commons 
Profile. For example, NLM just updated its search management tool 
(http://www.ncbi.nlm.nih.gov/sites/myncbi/). This service could 
eventually provide a way for PDs/PIs and other authors to track their 
papers that arise from NIH funds, associate them with NIH awards, and 
automatically obtain PMCIDs as they become available.
    The NIH also is exploring ways to facilitate the reporting of 
papers arising from NIH awards by NIH project number. These services 
will help investigators and their institutions monitor compliance 
policy.
    The NIH looks forward to continued interaction and advice from the 
many public access stakeholders. Comments and questions may be directed 
to PublicAccess@NIH.gov.

    Note: a full version of this report is available at http://publicaccess.nih.gov/analysis_of_comments_nih_public_access_policy.pdf.


    Dated: February 10, 2009.
Raynard S. Kington,
Acting Director, National Institutes of Health.
 [FR Doc. E9-3442 Filed 2-17-09; 8:45 am]
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