Announcement of a Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information, 8096-8098 [2015-02994]

Download as PDF 8096 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices County noise thresholds. Furthermore, any minor change in noise levels is not expected to affect the character of the site. Air Quality Traffic is expected to be the primary mobile source of air emissions at or near the campus. Mobile air emissions for the campus at this time are expected to originate from vehicles associated with visitors, commuter transportation, employee parking, commercial delivery, and construction vehicles. Future traffic generated carbon monoxide (CO) concentrations were predicted to be less than 2003 concentrations in the Selected Alternative due to projected vehicle emission rate reductions. Based on predicted values, the one and eighthour average National Ambient Air Quality Standards (NAAQS) CO concentrations would not be exceeded and no impacts are expected for any of the proposed Alternatives. tkelley on DSK3SPTVN1PROD with NOTICES Wastewater/Water Supply The Selected Alternative would increase the amount of wastewater generated on campus with the proposal of additional development. To facilitate the construction of the improvements under this proposed alternative, the existing wastewater distribution system would need to be relocated and upgraded as necessary. With the increase in demand, NIH will consult with the Washington Suburban Sanitary Commission (WSSC) to ensure adequate sewer capacity is available for the campus. This consultation would also assist WSSC in determining if and when any of the public lines surrounding the campus need to be upgraded. All sanitary sewer design would be in accordance with the NIH Facilities Development Manual, ‘‘Section 8–6: Drainage Systems’’ of the 2008 National Institutes of Health Design Requirements for Biomedical Laboratories and Animal Research Facilities and the WSSC requirements. No significant impacts are expected for wastewater or the NIH campus water supply. Historic Resources NIH would comply with National Historic Preservation Act (NHPA) Section 106 by consulting with Maryland Historical Trust (MHT) on the need for particular archeological studies as individual Master Plan project elements are funded, designed, and executed. In the event that eligible prehistoric resources are identified and adverse effects are anticipated, NIH would continue Section 106 consultation with the appropriate VerDate Sep<11>2014 21:56 Feb 12, 2015 Jkt 235001 consulting parties (which would include MHT and may also include Advisory Council on Historic Preservation (ACHP) and Native American tribes) to establish a Memorandum of Agreement (MOA) to resolve adverse effects. Mitigation measures identified through this consultation could include in-place preservation through site avoidance, protection, or easement acquisition; development and implementation of a data recovery plan to retrieve and analyze the site’s resources implementation of innovative, alternative mitigation measures or a combination of these measures. Practicable Means To Avoid or Minimize Potential Environmental Harm From the Selected Alternative All practicable means to avoid or minimize adverse environmental effects from the Selected Action have been identified and incorporated into the action. The proposed Master Plan construction will be subject to the existing NIH pollution prevention, waste management, and safety, security, and emergency response policies and procedures as well as existing environmental permits. Best management practices, spill prevention and control, and stormwater management plans will be followed to appropriately address the construction and operation envisioned in [or ‘‘described in’’—the Master Plan itself will not be constructed and operated] of the new Master Plan and comply with applicable regulatory and NIH requirements. No additional mitigation measures have been identified. Pollution Prevention Air quality permit standards will be met, as will all federal, state, and local requirements to protect the environment and public health. Conclusion Based upon review and careful consideration, the NIH has decided to implement the Selected Alternative for a long-range physical Master Plan for NIH Bethesda Campus located in Bethesda, Maryland. The decision accounts for potential growth of NIH personnel, and consequent construction of space over the planning period. The decision was based upon review and careful consideration of the impacts identified in the Final EIS and public comments received throughout the NEPA process. Separate NEPA reviews, when required, will be done on projects discussed in the Master Plan. Proper PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 NEPA documentation will be completed based on the outcome of that review. Dated: February 5, 2015. Daniel G. Wheeland, P.E. Director, Office of Research Facilities Development and Operations, National Institutes of Health. [FR Doc. 2015–02993 Filed 2–12–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Announcement of a Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information On November 19, 2014, the National Institutes of Health (NIH) published a request for public comments in the NIH Guide for Grants and Contracts on a draft policy to promote broad and responsible dissemination of information on clinical trials funded by the NIH through registration and submission of summary results information to ClinicalTrials.gov. See Guide notice NOT–OD–15–019 at https://grants.nih.gov/grants/guide/ notice-files/NOT-OD-15-019.html. NIH is publishing this notice in order to inform readers of the Federal Register about the draft policy and the opportunity to comment. DATES: The deadline for receiving comments on the draft policy is no later than 5:00 p.m. on March 23, 2015. ADDRESSES: Comments may be submitted by any of the following methods: • Email: clinicaltrials.disseminationpolicy@ mail.nih.gov. • Fax: 301–496–9839. • Mail/Hand delivery/Courier: Office of Clinical Research and Bioethics Policy, Office of Science Policy, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892. FOR FURTHER INFORMATION CONTACT: Office of Clinical Research and Bioethics Policy, Office of Science Policy, National Institutes of Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, 301–496–9838, OCRBP-OSP@od.nih.gov. SUPPLEMENTARY INFORMATION: SUMMARY: Background The National Institutes of Health (NIH) is dedicated to improving the health of Americans by conducting and funding biomedical and behavioral E:\FR\FM\13FEN1.SGM 13FEN1 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices tkelley on DSK3SPTVN1PROD with NOTICES research, including clinical trials.1 A fundamental premise of all NIH-funded research is that the results of such work must be disseminated in order to contribute to the general body of scientific knowledge and, ultimately, to the public health. NIH awardees are expected to make the results and accomplishments of their activities available to the research community and to the public at large. The results of NIH funded research can be disclosed in a number of ways, including through publications, presentations at scientific meetings, sharing research tools, and depositing information into databases and materials into repositories. NIH has a number of policies that promote the dissemination of research results and guide funding recipients in disseminating their results. The NIH Data Sharing Policy, the NIH Public Access Policy, the NIH Research Tools Policy, and the NIH Genomic Data Sharing Policy are important examples of policies to ensure that research data and materials generated using NIH funds are used productively to further scientific progress and to promote public health.2 Increasing public access to information from NIH research supports the public access and data sharing directives of the Executive Office of the President (EOP Directives).3 Traditionally, scientists fulfill their obligation to contribute to the general body of knowledge through peer reviewed journal publications. However, journal publication is not always possible, and many clinical trials are not being published or published in a timely manner. A recent study found that the results of less than half of NIHfunded clinical trials had been published in a peer-reviewed biomedical journal within 30 months of 1 NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. See https://www.nih.gov/about/ mission.htm. 2 See https://www.grants.nih.gov/grants/policy/ data_sharing/data_sharing_guidance.htm; https:// publicaccess.nih.gov/; https://grants.nih.gov/grants/ intell-property_64FR72090.pdf; and https:// gds.nih.gov/03policy2.html. 3 See the Office of Science and Technology Policy’s memorandum, ‘‘Increasing Access to the Results of Federally Funded Scientific Research,’’ (February 22, 2013), the Office of Management and Budget’s memorandum, ‘‘Open Data Policy— Managing Information as an Asset,’’ M–13–13 (May 9, 2013) https://www.whitehouse.gov/sites/default/ files/omb/memoranda/2013/m-13-13.pdf, and Executive Order No. 13,642 (May 9, 2013) https:// www.gpo.gov/fdsys/pkg/DCPD-201300318/pdf/ DCPD-201300318.pdf. VerDate Sep<11>2014 21:56 Feb 12, 2015 Jkt 235001 trial completion.4 Selective publication of the results of some trials and not others—or publication of incomplete or partial findings from a particular trial— can lead to inappropriate conclusions about the usefulness of particular therapies.5 Public access to clinical trial information drives scientific progress and optimizes the return on the nation’s investment in clinical trials. It helps inform future research, improve study design, and prevent duplication of unsafe and unsuccessful trials. In addition, there is an important ethical dimension to dissemination of clinical trial results because individuals who volunteer to participate in such studies, and who may assume risks, trust that what we learn will contribute to generalizable knowledge about human health. Finally, enhancing transparency also increases public trust in clinical research. It is, therefore, important to provide other ways for clinical trial results to be disseminated and publicly available to researchers, health care providers, and patient communities. Some NIH-funded clinical trials are subject to mandatory registration and reporting of results under federal law, i.e., Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). FDAAA applies, in general, to controlled, interventional studies of Food and Drug Administration (FDA)-regulated drugs, biological products, and devices, excluding phase 1 studies of drugs and biological products and small feasibility studies of devices. Under FDAAA, a minimal set of summary information about such clinical trials must be submitted in a structured, tabular format to ClinicalTrials.gov, a freely accessible and searchable registry and results data bank operated by the National Library of Medicine (NLM), NIH. NIH is proposing to issue a policy to ensure that all NIH-funded clinical trials are registered and have summary results, including adverse event information, submitted to ClinicalTrials.gov. Compliance with this policy will be a term and condition in the Notice of Grant Award and a 4 Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross-sectional analysis. BMJ. 2012;344:d7292. 5 Nissen S, Biomarkers in Cardiovascular Medicine, The Shame of Publication Bias, JAMA Intern Med 2013 March 25; doi:10.001/ jamainternmed.2013.4074; Dwan K et al., Systematic review of the empirical evidence of study publication bias and outcome reporting bias, PLoS One 2008 Aug 28;3(8):e3081. doi: 0.1371/ journal.pone.0003081; Begg C, Berlin J, Publication bias and dissemination of clinical research, J Natl Cancer Inst 1989, Jan 18;81(2):107–15. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 8097 contract requirement in the Contract Award. This proposed policy supports the NIH mission and is essential to facilitate the translation of research results into knowledge, products, and procedures that improve human health. Request for Comments NIH encourages the public to provide comments on any aspect of the draft policy, described below. Comments should be submitted electronically to the Office of Clinical Research and Bioethics Policy (OCRBP), Office of Science Policy, NIH, via email at email at clinicaltrials.disseminationpolicy@ mail.nih.gov, mail at 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, or by fax at 301–496–9839. Submitted comments are considered public information; private or confidential information should not be submitted. Comments may be posted along with the submitter’s name and affiliation on the OCRBP Web site after the public comment period closes. Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information Purpose. The purpose of this Policy is to promote broad and responsible dissemination of information from NIHfunded clinical trials through ClinicalTrials.gov, the clinical trial registry and results databank operated by the National Library of Medicine (NLM). Disseminating this information supports the NIH mission to advance the translation of research results into knowledge, products, and procedures that improve human health. This Policy is intended to complement the statutory mandate under Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) that requires registration and submission of summary results for certain clinical trials, whether funded by NIH or by other entities, to be registered and have summary results submitted to ClincalTrials.gov.6 Scope and Applicability. This Policy applies to all NIH-funded awardees and investigators conducting clinical trials, funded in whole or in part by NIH, regardless of study phase, type of intervention, or whether they are subject to the FDAAA registration and results submission requirements set forth in Section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)). For 6 The mandate applies to certain ‘‘applicable clinical trials’’ (ACTs) of drugs (defined by section 402(j)(1)(A)(vii) of the Public Health Service Act to include biological products) and devices, including any pediatric postmarket surveillance of a device required by FDA under section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). See 42 U.S.C. 282(j). E:\FR\FM\13FEN1.SGM 13FEN1 8098 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices tkelley on DSK3SPTVN1PROD with NOTICES purposes of this Policy, a clinical trial is defined as ‘‘a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on healthrelated biomedical or behavioral outcomes.7’’ Effective Date. This Policy is effective for: • Competing grant applications that include clinical trials and are submitted to the NIH for the [date to be determined] receipt date and subsequent receipt dates; • Proposals for contracts that include clinical trials and are submitted to the NIH on or after [date to be determined]; and • NIH intramural research projects that include clinical trials for which Institutional Review Board review is initiated after [date to be determined]. Responsibilities. As set forth in the terms and conditions of grant and contract awards, all NIH-funded awardees and investigators conducting clinical trials, funded in whole or in part by NIH, who have committed to NIH that they will comply with NIH policies, are expected to ensure that their NIH-funded clinical trials are registered and summary results, including adverse event information, are submitted to ClinicalTrials.gov in 7 Several terms within the NIH definition of clinical trial definition mean are defined as follows. ‘‘Research’’ and ‘‘human subject’’ are defined in the Common Rule at 45 CFR 46.102(d) and 45 CFR 46.102(f), respectively. ‘‘Prospectively assigned’’ refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial. An ‘‘intervention’’ is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change healthrelated behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies. A ‘‘health-related biomedical or behavioral outcome’’ is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life. Examples include positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life. See https://osp.od.nih.gov/officeclinical-research-and-bioethics-policy/clinicalresearch-policy/clinical-trials> VerDate Sep<11>2014 21:56 Feb 12, 2015 Jkt 235001 accord with the timelines that will be set forth at ClinicalTrials.gov. Generally, this means registration of the clinical trial not later than 21 days after enrollment of the first participant and submission of summary results information not later than one year after the completion date. ‘‘Completion date’’ is defined to be the date that the final subject was examined or received an intervention for the purpose of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated. It will be possible to delay results submission for up to two years beyond the initial deadline with a certification that regulatory approval of the product is being sought. Clinical trials covered by the policy will be expected to submit the same type of registration and results data and in the same timeframes as the trials subject to FDAAA. The specific registration and results information to be submitted will be made available at the ClinicalTrials.gov site. Institutions and investigators should submit information directly to ClinicalTrials.gov. If the trial is subject to FDAAA, i.e., section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), submissions must be made by the Responsible Party, as defined at 42 U.S.C. 282(j)(1)(A)(ix). If an NIH-funded clinical trial is also subject to FDAAA, it needs to have only one entry in ClinicalTrials.gov that contains its registration and results information. Investigators and funding recipients are expected to cooperate with NLM to address any data curation or quality control issues to facilitate timely posting. In general, NIH expects to make clinical trial registration and results information publicly available through ClinicalTrials.gov within 30 days after receipt by ClinicalTrials.gov.8 For NIHfunded trials that are subject to section 402(j) of the Public Health Services Act (42 U.S.C. 282(j)), submitted information will be posted in compliance with the relevant requirements of that section. Failure to comply with the terms and conditions of NIH awards may provide a basis for enforcement actions, including termination, consistent with 8 For clinical trials funded through SBIRs, the timeframe for posting results will be consistent with the SBIR Policy Directive, which generally prohibits the agency from posting SBIR data for at least 4 years from completion of the study unless the awardee consents to an earlier release. See SBIR Policy Directive, Sections 8(b)(2) and (4). PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 45 CFR 74.62 and/or other authorities, as appropriate.9 Dated: January 8, 2015. Lawrence Tabak, Principal Deputy Director, National Institutes of Health. [FR Doc. 2015–02994 Filed 2–12–15; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF THE INTERIOR Office of the Secretary [AAK6006201 1565A2100DD AOR3030.999900] National Environmental Policy Act: Implementing Procedures; Additions to Categorical Exclusions for Bureau of Indian Affairs (516 DM 10) Department of the Interior. Notice of Final National Environmental Policy Act Implementing Procedures. AGENCY: ACTION: In accordance with the National Environmental Policy Act of 1969 (NEPA) and the Council on Environmental Quality regulations implementing NEPA, and Department of the Interior (Department) NEPA implementing regulations, the Bureau of Indian Affairs (BIA) in the Department is adding three categorical exclusions (CE) to the Departmental Manual 516 DM 10. The three proposed CEs pertain to timber harvesting on Indian lands. DATES: Effective Date: The categorical exclusions are effective February 13, 2015. SUMMARY: To obtain a copy of the new categorical exclusions contact Mr. David Koch, Acting Chief Forester, Bureau of Indian Affairs, 1849 C Street, Washington, DC 20240; email: david.koch@bia.gov. FOR FURTHER INFORMATION CONTACT: Mr. David Koch, Acting Chief Forester, (202) 208–4837. SUPPLEMENTARY INFORMATION: ADDRESSES: Background Harvesting timber on Indian lands, as defined in 25 CFR 163.1, allows landowners to realize value from lands held in trust for them by the Federal Government or subject to restrictions against alienation. The National Indian Forest Resources Management Act, and its implementing regulations, require the Secretary, with the participation of the landowners, to undertake forest land management activities on Indian forest 9 When the final policy is issued, NIH will also provide more specific procedural guidance to facilitate implementation. E:\FR\FM\13FEN1.SGM 13FEN1

Agencies

[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Notices]
[Pages 8096-8098]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02994]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Announcement of a Draft NIH Policy on Dissemination of NIH-Funded 
Clinical Trial Information

SUMMARY: On November 19, 2014, the National Institutes of Health (NIH) 
published a request for public comments in the NIH Guide for Grants and 
Contracts on a draft policy to promote broad and responsible 
dissemination of information on clinical trials funded by the NIH 
through registration and submission of summary results information to 
ClinicalTrials.gov. See Guide notice NOT-OD-15-019 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-019.html. NIH is 
publishing this notice in order to inform readers of the Federal 
Register about the draft policy and the opportunity to comment.

DATES: The deadline for receiving comments on the draft policy is no 
later than 5:00 p.m. on March 23, 2015.

ADDRESSES: Comments may be submitted by any of the following methods:
     Email: clinicaltrials.disseminationpolicy@mail.nih.gov.
     Fax: 301-496-9839.
     Mail/Hand delivery/Courier: Office of Clinical Research 
and Bioethics Policy, Office of Science Policy, National Institutes of 
Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892.

FOR FURTHER INFORMATION CONTACT: Office of Clinical Research and 
Bioethics Policy, Office of Science Policy, National Institutes of 
Health, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, 301-496-
9838, OCRBP-OSP@od.nih.gov.

SUPPLEMENTARY INFORMATION: 

Background

    The National Institutes of Health (NIH) is dedicated to improving 
the health of Americans by conducting and funding biomedical and 
behavioral

[[Page 8097]]

research, including clinical trials.\1\ A fundamental premise of all 
NIH-funded research is that the results of such work must be 
disseminated in order to contribute to the general body of scientific 
knowledge and, ultimately, to the public health. NIH awardees are 
expected to make the results and accomplishments of their activities 
available to the research community and to the public at large.
---------------------------------------------------------------------------

    \1\ NIH's mission is to seek fundamental knowledge about the 
nature and behavior of living systems and the application of that 
knowledge to enhance health, lengthen life, and reduce illness and 
disability. See https://www.nih.gov/about/mission.htm.
---------------------------------------------------------------------------

    The results of NIH funded research can be disclosed in a number of 
ways, including through publications, presentations at scientific 
meetings, sharing research tools, and depositing information into 
databases and materials into repositories. NIH has a number of policies 
that promote the dissemination of research results and guide funding 
recipients in disseminating their results. The NIH Data Sharing Policy, 
the NIH Public Access Policy, the NIH Research Tools Policy, and the 
NIH Genomic Data Sharing Policy are important examples of policies to 
ensure that research data and materials generated using NIH funds are 
used productively to further scientific progress and to promote public 
health.\2\ Increasing public access to information from NIH research 
supports the public access and data sharing directives of the Executive 
Office of the President (EOP Directives).\3\
---------------------------------------------------------------------------

    \2\ See https://www.grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm; https://publicaccess.nih.gov/; https://grants.nih.gov/grants/intell-property_64FR72090.pdf; and https://gds.nih.gov/03policy2.html.
    \3\ See the Office of Science and Technology Policy's 
memorandum, ``Increasing Access to the Results of Federally Funded 
Scientific Research,'' (February 22, 2013), the Office of Management 
and Budget's memorandum, ``Open Data Policy--Managing Information as 
an Asset,'' M-13-13 (May 9, 2013) https://www.whitehouse.gov/sites/default/files/omb/memoranda/2013/m-13-13.pdf, and Executive Order 
No. 13,642 (May 9, 2013) https://www.gpo.gov/fdsys/pkg/DCPD-201300318/pdf/DCPD-201300318.pdf.
---------------------------------------------------------------------------

    Traditionally, scientists fulfill their obligation to contribute to 
the general body of knowledge through peer reviewed journal 
publications. However, journal publication is not always possible, and 
many clinical trials are not being published or published in a timely 
manner. A recent study found that the results of less than half of NIH-
funded clinical trials had been published in a peer-reviewed biomedical 
journal within 30 months of trial completion.\4\ Selective publication 
of the results of some trials and not others--or publication of 
incomplete or partial findings from a particular trial--can lead to 
inappropriate conclusions about the usefulness of particular 
therapies.\5\
---------------------------------------------------------------------------

    \4\ Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. 
Publication of NIH funded trials registered in ClinicalTrials.gov: 
cross-sectional analysis. BMJ. 2012;344:d7292.
    \5\ Nissen S, Biomarkers in Cardiovascular Medicine, The Shame 
of Publication Bias, JAMA Intern Med 2013 March 25; doi:10.001/
jamainternmed.2013.4074; Dwan K et al., Systematic review of the 
empirical evidence of study publication bias and outcome reporting 
bias, PLoS One 2008 Aug 28;3(8):e3081. doi: 0.1371/
journal.pone.0003081; Begg C, Berlin J, Publication bias and 
dissemination of clinical research, J Natl Cancer Inst 1989, Jan 
18;81(2):107-15.
---------------------------------------------------------------------------

    Public access to clinical trial information drives scientific 
progress and optimizes the return on the nation's investment in 
clinical trials. It helps inform future research, improve study design, 
and prevent duplication of unsafe and unsuccessful trials. In addition, 
there is an important ethical dimension to dissemination of clinical 
trial results because individuals who volunteer to participate in such 
studies, and who may assume risks, trust that what we learn will 
contribute to generalizable knowledge about human health. Finally, 
enhancing transparency also increases public trust in clinical 
research. It is, therefore, important to provide other ways for 
clinical trial results to be disseminated and publicly available to 
researchers, health care providers, and patient communities.
    Some NIH-funded clinical trials are subject to mandatory 
registration and reporting of results under federal law, i.e., Title 
VIII of the Food and Drug Administration Amendments Act of 2007 
(FDAAA). FDAAA applies, in general, to controlled, interventional 
studies of Food and Drug Administration (FDA)-regulated drugs, 
biological products, and devices, excluding phase 1 studies of drugs 
and biological products and small feasibility studies of devices. Under 
FDAAA, a minimal set of summary information about such clinical trials 
must be submitted in a structured, tabular format to 
ClinicalTrials.gov, a freely accessible and searchable registry and 
results data bank operated by the National Library of Medicine (NLM), 
NIH.
    NIH is proposing to issue a policy to ensure that all NIH-funded 
clinical trials are registered and have summary results, including 
adverse event information, submitted to ClinicalTrials.gov. Compliance 
with this policy will be a term and condition in the Notice of Grant 
Award and a contract requirement in the Contract Award. This proposed 
policy supports the NIH mission and is essential to facilitate the 
translation of research results into knowledge, products, and 
procedures that improve human health.

Request for Comments

    NIH encourages the public to provide comments on any aspect of the 
draft policy, described below. Comments should be submitted 
electronically to the Office of Clinical Research and Bioethics Policy 
(OCRBP), Office of Science Policy, NIH, via email at email at 
clinicaltrials.disseminationpolicy@mail.nih.gov, mail at 6705 Rockledge 
Drive, Suite 750, Bethesda, MD 20892, or by fax at 301-496-9839. 
Submitted comments are considered public information; private or 
confidential information should not be submitted. Comments may be 
posted along with the submitter's name and affiliation on the OCRBP Web 
site after the public comment period closes.

Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial 
Information

    Purpose. The purpose of this Policy is to promote broad and 
responsible dissemination of information from NIH-funded clinical 
trials through ClinicalTrials.gov, the clinical trial registry and 
results databank operated by the National Library of Medicine (NLM). 
Disseminating this information supports the NIH mission to advance the 
translation of research results into knowledge, products, and 
procedures that improve human health. This Policy is intended to 
complement the statutory mandate under Title VIII of the Food and Drug 
Administration Amendments Act of 2007 (FDAAA) that requires 
registration and submission of summary results for certain clinical 
trials, whether funded by NIH or by other entities, to be registered 
and have summary results submitted to ClincalTrials.gov.\6\
---------------------------------------------------------------------------

    \6\ The mandate applies to certain ``applicable clinical 
trials'' (ACTs) of drugs (defined by section 402(j)(1)(A)(vii) of 
the Public Health Service Act to include biological products) and 
devices, including any pediatric postmarket surveillance of a device 
required by FDA under section 522 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act). See 42 U.S.C. 282(j).
---------------------------------------------------------------------------

    Scope and Applicability. This Policy applies to all NIH-funded 
awardees and investigators conducting clinical trials, funded in whole 
or in part by NIH, regardless of study phase, type of intervention, or 
whether they are subject to the FDAAA registration and results 
submission requirements set forth in Section 402(j) of the Public 
Health Service Act (42 U.S.C. 282(j)). For

[[Page 8098]]

purposes of this Policy, a clinical trial is defined as ``a research 
study in which one or more human subjects are prospectively assigned to 
one or more interventions (which may include placebo or other control) 
to evaluate the effects of those interventions on health-related 
biomedical or behavioral outcomes.\7\''
---------------------------------------------------------------------------

    \7\ Several terms within the NIH definition of clinical trial 
definition mean are defined as follows. ``Research'' and ``human 
subject'' are defined in the Common Rule at 45 CFR 46.102(d) and 45 
CFR 46.102(f), respectively. ``Prospectively assigned'' refers to a 
pre-defined process (e.g., randomization) specified in an approved 
protocol that stipulates the assignment of research subjects 
(individually or in clusters) to one or more arms (e.g., 
intervention, placebo or other control) of the clinical trial. An 
``intervention'' is defined as a manipulation of the subject or 
subject's environment for the purpose of modifying one or more 
health-related biomedical or behavioral processes and/or endpoints. 
Examples include drugs/small molecules/compounds; biologics; 
devices; procedures (e.g., surgical techniques); delivery systems 
(e.g., telemedicine, face-to-face interviews); strategies to change 
health-related behavior (e.g., diet, cognitive therapy, exercise, 
development of new habits); treatment strategies; prevention 
strategies; and, diagnostic strategies. A ``health-related 
biomedical or behavioral outcome'' is defined as the pre-specified 
goal(s) or condition(s) that reflect the effect of one or more 
interventions on human subjects' biomedical or behavioral status or 
quality of life. Examples include positive or negative changes to 
physiological or biological parameters (e.g., improvement of lung 
capacity, gene expression); positive or negative changes to 
psychological or neurodevelopmental parameters (e.g., mood 
management intervention for smokers; reading comprehension and/or 
information retention); positive or negative changes to disease 
processes; positive or negative changes to health-related behaviors; 
and, positive or negative changes to quality of life. See https://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/clinical-trials>
---------------------------------------------------------------------------

    Effective Date. This Policy is effective for:
     Competing grant applications that include clinical trials 
and are submitted to the NIH for the [date to be determined] receipt 
date and subsequent receipt dates;
     Proposals for contracts that include clinical trials and 
are submitted to the NIH on or after [date to be determined]; and
     NIH intramural research projects that include clinical 
trials for which Institutional Review Board review is initiated after 
[date to be determined].
    Responsibilities. As set forth in the terms and conditions of grant 
and contract awards, all NIH-funded awardees and investigators 
conducting clinical trials, funded in whole or in part by NIH, who have 
committed to NIH that they will comply with NIH policies, are expected 
to ensure that their NIH-funded clinical trials are registered and 
summary results, including adverse event information, are submitted to 
ClinicalTrials.gov in accord with the timelines that will be set forth 
at ClinicalTrials.gov. Generally, this means registration of the 
clinical trial not later than 21 days after enrollment of the first 
participant and submission of summary results information not later 
than one year after the completion date. ``Completion date'' is defined 
to be the date that the final subject was examined or received an 
intervention for the purpose of final collection of data for the 
primary outcome, whether the clinical trial concluded according to the 
pre-specified protocol or was terminated. It will be possible to delay 
results submission for up to two years beyond the initial deadline with 
a certification that regulatory approval of the product is being 
sought. Clinical trials covered by the policy will be expected to 
submit the same type of registration and results data and in the same 
timeframes as the trials subject to FDAAA. The specific registration 
and results information to be submitted will be made available at the 
ClinicalTrials.gov site.
    Institutions and investigators should submit information directly 
to ClinicalTrials.gov. If the trial is subject to FDAAA, i.e., section 
402(j) of the Public Health Service Act (42 U.S.C. 282(j)), submissions 
must be made by the Responsible Party, as defined at 42 U.S.C. 
282(j)(1)(A)(ix). If an NIH-funded clinical trial is also subject to 
FDAAA, it needs to have only one entry in ClinicalTrials.gov that 
contains its registration and results information. Investigators and 
funding recipients are expected to cooperate with NLM to address any 
data curation or quality control issues to facilitate timely posting.
    In general, NIH expects to make clinical trial registration and 
results information publicly available through ClinicalTrials.gov 
within 30 days after receipt by ClinicalTrials.gov.\8\ For NIH-funded 
trials that are subject to section 402(j) of the Public Health Services 
Act (42 U.S.C. 282(j)), submitted information will be posted in 
compliance with the relevant requirements of that section.
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    \8\ For clinical trials funded through SBIRs, the timeframe for 
posting results will be consistent with the SBIR Policy Directive, 
which generally prohibits the agency from posting SBIR data for at 
least 4 years from completion of the study unless the awardee 
consents to an earlier release. See SBIR Policy Directive, Sections 
8(b)(2) and (4).
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    Failure to comply with the terms and conditions of NIH awards may 
provide a basis for enforcement actions, including termination, 
consistent with 45 CFR 74.62 and/or other authorities, as 
appropriate.\9\
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    \9\ When the final policy is issued, NIH will also provide more 
specific procedural guidance to facilitate implementation.

     Dated: January 8, 2015.
Lawrence Tabak,
Principal Deputy Director, National Institutes of Health.
[FR Doc. 2015-02994 Filed 2-12-15; 8:45 am]
BILLING CODE 4140-01-P
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