80 FR 8096 - Announcement of a Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 80, Issue 30 (February 13, 2015)
National Institutes of Health
Federal Register Volume 80, Issue 30 (February 13, 2015)
| Page Range | 8096-8098 | |
| FR Document | 2015-02994 |
[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)] [Notices] [Pages 8096-8098] From the Federal Register Online [www.thefederalregister.org] [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 http://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: [email protected]. 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, [email protected]. 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 http://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 http://www.grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm; http://publicaccess.nih.gov/; http://grants.nih.gov/grants/intell-property_64FR72090.pdf; and http://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) http://www.whitehouse.gov/sites/default/files/omb/memoranda/2013/m-13-13.pdf, and Executive Order No. 13,642 (May 9, 2013) http://www.thefederalregister.org/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 [email protected], 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 http://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. --------------------------------------------------------------------------- \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). --------------------------------------------------------------------------- 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\ --------------------------------------------------------------------------- \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
![8096 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices
County noise thresholds. Furthermore, consulting parties (which would NEPA documentation will be completed
any minor change in noise levels is not include MHT and may also include based on the outcome of that review.
expected to affect the character of the Advisory Council on Historic Dated: February 5, 2015.
site. Preservation (ACHP) and Native Daniel G. Wheeland, P.E.
American tribes) to establish a
Air Quality Director, Office of Research Facilities
Memorandum of Agreement (MOA) to Development and Operations, National
Traffic is expected to be the primary resolve adverse effects. Mitigation Institutes of Health.
mobile source of air emissions at or near measures identified through this [FR Doc. 2015–02993 Filed 2–12–15; 8:45 am]
the campus. Mobile air emissions for the consultation could include in-place
campus at this time are expected to BILLING CODE 4140–01–P
preservation through site avoidance,
originate from vehicles associated with protection, or easement acquisition;
visitors, commuter transportation, development and implementation of a
employee parking, commercial delivery, DEPARTMENT OF HEALTH AND
data recovery plan to retrieve and HUMAN SERVICES
and construction vehicles. Future traffic analyze the site’s resources
generated carbon monoxide (CO) implementation of innovative, National Institutes of Health
concentrations were predicted to be less alternative mitigation measures or a
than 2003 concentrations in the combination of these measures. Announcement of a Draft NIH Policy on
Selected Alternative due to projected Dissemination of NIH-Funded Clinical
vehicle emission rate reductions. Based Practicable Means To Avoid or Trial Information
on predicted values, the one and eight- Minimize Potential Environmental
hour average National Ambient Air Harm From the Selected Alternative SUMMARY: On November 19, 2014, the
Quality Standards (NAAQS) CO All practicable means to avoid or National Institutes of Health (NIH)
concentrations would not be exceeded minimize adverse environmental effects published a request for public
and no impacts are expected for any of from the Selected Action have been comments in the NIH Guide for Grants
the proposed Alternatives. identified and incorporated into the and Contracts on a draft policy to
action. The proposed Master Plan promote broad and responsible
Wastewater/Water Supply
construction will be subject to the dissemination of information on clinical
The Selected Alternative would trials funded by the NIH through
increase the amount of wastewater existing NIH pollution prevention,
waste management, and safety, security, registration and submission of summary
generated on campus with the proposal results information to ClinicalTrials.gov.
of additional development. To facilitate and emergency response policies and
procedures as well as existing See Guide notice NOT–OD–15–019 at
the construction of the improvements http://grants.nih.gov/grants/guide/
under this proposed alternative, the environmental permits. Best
management practices, spill prevention notice-files/NOT-OD-15-019.html. NIH
existing wastewater distribution system is publishing this notice in order to
would need to be relocated and and control, and stormwater
management plans will be followed to inform readers of the Federal Register
upgraded as necessary. With the about the draft policy and the
increase in demand, NIH will consult appropriately address the construction
and operation envisioned in [or opportunity to comment.
with the Washington Suburban Sanitary
‘‘described in’’—the Master Plan itself DATES: The deadline for receiving
Commission (WSSC) to ensure adequate
will not be constructed and operated] of comments on the draft policy is no later
sewer capacity is available for the
the new Master Plan and comply with than 5:00 p.m. on March 23, 2015.
campus. This consultation would also
assist WSSC in determining if and when applicable regulatory and NIH ADDRESSES: Comments may be
any of the public lines surrounding the requirements. No additional mitigation submitted by any of the following
campus need to be upgraded. All measures have been identified. methods:
sanitary sewer design would be in Pollution Prevention • Email:
accordance with the NIH Facilities clinicaltrials.disseminationpolicy@
Development Manual, ‘‘Section 8–6: Air quality permit standards will be mail.nih.gov.
Drainage Systems’’ of the 2008 National met, as will all federal, state, and local • Fax: 301–496–9839.
Institutes of Health Design requirements to protect the environment • Mail/Hand delivery/Courier: Office
Requirements for Biomedical and public health. of Clinical Research and Bioethics
Laboratories and Animal Research Conclusion Policy, Office of Science Policy,
Facilities and the WSSC requirements. National Institutes of Health, 6705
No significant impacts are expected for Based upon review and careful Rockledge Drive, Suite 750, Bethesda,
wastewater or the NIH campus water consideration, the NIH has decided to MD 20892.
supply. implement the Selected Alternative for
a long-range physical Master Plan for FOR FURTHER INFORMATION CONTACT:
Historic Resources NIH Bethesda Campus located in Office of Clinical Research and
Bethesda, Maryland. The decision Bioethics Policy, Office of Science
NIH would comply with National
accounts for potential growth of NIH Policy, National Institutes of Health,
Historic Preservation Act (NHPA)
personnel, and consequent construction 6705 Rockledge Drive, Suite 750,
Section 106 by consulting with
of space over the planning period. The Bethesda, MD 20892, 301–496–9838,
Maryland Historical Trust (MHT) on the
decision was based upon review and OCRBP-OSP@od.nih.gov.
need for particular archeological studies
tkelley on DSK3SPTVN1PROD with NOTICES
as individual Master Plan project careful consideration of the impacts SUPPLEMENTARY INFORMATION:
elements are funded, designed, and identified in the Final EIS and public Background
executed. In the event that eligible comments received throughout the
prehistoric resources are identified and NEPA process. The National Institutes of Health
adverse effects are anticipated, NIH Separate NEPA reviews, when (NIH) is dedicated to improving the
would continue Section 106 required, will be done on projects health of Americans by conducting and
consultation with the appropriate discussed in the Master Plan. Proper funding biomedical and behavioral
VerDate Sep<11>2014 21:56 Feb 12, 2015 Jkt 235001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\13FEN1.SGM 13FEN1](https://thefederalregister.org/doc/80_FR_8126/page/1.svg)
![8098 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices
purposes of this Policy, a clinical trial accord with the timelines that will be 45 CFR 74.62 and/or other authorities,
is defined as ‘‘a research study in which set forth at ClinicalTrials.gov. Generally, as appropriate.9
one or more human subjects are this means registration of the clinical Dated: January 8, 2015.
prospectively assigned to one or more trial not later than 21 days after Lawrence Tabak,
interventions (which may include enrollment of the first participant and Principal Deputy Director, National Institutes
placebo or other control) to evaluate the submission of summary results of Health.
effects of those interventions on health- information not later than one year after [FR Doc. 2015–02994 Filed 2–12–15; 8:45 am]
related biomedical or behavioral the completion date. ‘‘Completion date’’ BILLING CODE 4140–01–P
outcomes.7’’ is defined to be the date that the final
Effective Date. This Policy is effective subject was examined or received an
for: intervention for the purpose of final
• Competing grant applications that collection of data for the primary
DEPARTMENT OF THE INTERIOR
include clinical trials and are submitted outcome, whether the clinical trial Office of the Secretary
to the NIH for the [date to be concluded according to the pre-
determined] receipt date and [AAK6006201 1565A2100DD
specified protocol or was terminated. It AOR3030.999900]
subsequent receipt dates;
will be possible to delay results
• Proposals for contracts that include
clinical trials and are submitted to the submission for up to two years beyond National Environmental Policy Act:
NIH on or after [date to be determined]; the initial deadline with a certification Implementing Procedures; Additions
and that regulatory approval of the product to Categorical Exclusions for Bureau
• NIH intramural research projects is being sought. Clinical trials covered of Indian Affairs (516 DM 10)
that include clinical trials for which by the policy will be expected to submit
AGENCY: Department of the Interior.
Institutional Review Board review is the same type of registration and results
data and in the same timeframes as the ACTION:Notice of Final National
initiated after [date to be determined]. Environmental Policy Act Implementing
Responsibilities. As set forth in the trials subject to FDAAA. The specific
registration and results information to Procedures.
terms and conditions of grant and
contract awards, all NIH-funded be submitted will be made available at SUMMARY: In accordance with the
awardees and investigators conducting the ClinicalTrials.gov site. National Environmental Policy Act of
clinical trials, funded in whole or in Institutions and investigators should 1969 (NEPA) and the Council on
part by NIH, who have committed to submit information directly to Environmental Quality regulations
NIH that they will comply with NIH ClinicalTrials.gov. If the trial is subject implementing NEPA, and Department of
policies, are expected to ensure that to FDAAA, i.e., section 402(j) of the the Interior (Department) NEPA
their NIH-funded clinical trials are Public Health Service Act (42 U.S.C. implementing regulations, the Bureau of
registered and summary results, 282(j)), submissions must be made by Indian Affairs (BIA) in the Department
including adverse event information, are the Responsible Party, as defined at 42 is adding three categorical exclusions
submitted to ClinicalTrials.gov in U.S.C. 282(j)(1)(A)(ix). If an NIH-funded (CE) to the Departmental Manual 516
clinical trial is also subject to FDAAA, DM 10. The three proposed CEs pertain
7 Several terms within the NIH definition of
it needs to have only one entry in to timber harvesting on Indian lands.
clinical trial definition mean are defined as follows.
‘‘Research’’ and ‘‘human subject’’ are defined in the ClinicalTrials.gov that contains its DATES: Effective Date: The categorical
Common Rule at 45 CFR 46.102(d) and 45 CFR registration and results information. exclusions are effective February 13,
46.102(f), respectively. ‘‘Prospectively assigned’’ Investigators and funding recipients are 2015.
refers to a pre-defined process (e.g., randomization)
specified in an approved protocol that stipulates the expected to cooperate with NLM to ADDRESSES: To obtain a copy of the new
assignment of research subjects (individually or in address any data curation or quality categorical exclusions contact Mr. David
clusters) to one or more arms (e.g., intervention, control issues to facilitate timely Koch, Acting Chief Forester, Bureau of
placebo or other control) of the clinical trial. An
‘‘intervention’’ is defined as a manipulation of the
posting. Indian Affairs, 1849 C Street,
subject or subject’s environment for the purpose of In general, NIH expects to make Washington, DC 20240; email:
modifying one or more health-related biomedical or clinical trial registration and results david.koch@bia.gov.
behavioral processes and/or endpoints. Examples
include drugs/small molecules/compounds; information publicly available through FOR FURTHER INFORMATION CONTACT: Mr.
biologics; devices; procedures (e.g., surgical ClinicalTrials.gov within 30 days after David Koch, Acting Chief Forester, (202)
techniques); delivery systems (e.g., telemedicine, receipt by ClinicalTrials.gov.8 For NIH- 208–4837.
face-to-face interviews); strategies to change health-
related behavior (e.g., diet, cognitive therapy,
funded trials that are subject to section SUPPLEMENTARY INFORMATION:
exercise, development of new habits); treatment 402(j) of the Public Health Services Act
Background
strategies; prevention strategies; and, diagnostic (42 U.S.C. 282(j)), submitted
strategies. A ‘‘health-related biomedical or information will be posted in Harvesting timber on Indian lands, as
behavioral outcome’’ is defined as the pre-specified defined in 25 CFR 163.1, allows
goal(s) or condition(s) that reflect the effect of one compliance with the relevant
or more interventions on human subjects’ requirements of that section. landowners to realize value from lands
biomedical or behavioral status or quality of life. held in trust for them by the Federal
Examples include positive or negative changes to
Failure to comply with the terms and Government or subject to restrictions
physiological or biological parameters (e.g., conditions of NIH awards may provide against alienation. The National Indian
improvement of lung capacity, gene expression); a basis for enforcement actions, Forest Resources Management Act, and
positive or negative changes to psychological or including termination, consistent with
neurodevelopmental parameters (e.g., mood its implementing regulations, require
tkelley on DSK3SPTVN1PROD with NOTICES
management intervention for smokers; reading the Secretary, with the participation of
comprehension and/or information retention); 8 For clinical trials funded through SBIRs, the
the landowners, to undertake forest land
positive or negative changes to disease processes; timeframe for posting results will be consistent with
positive or negative changes to health-related the SBIR Policy Directive, which generally prohibits management activities on Indian forest
behaviors; and, positive or negative changes to the agency from posting SBIR data for at least 4
quality of life. See http://osp.od.nih.gov/office- years from completion of the study unless the 9 When the final policy is issued, NIH will also
clinical-research-and-bioethics-policy/clinical- awardee consents to an earlier release. See SBIR provide more specific procedural guidance to
research-policy/clinical-trials> Policy Directive, Sections 8(b)(2) and (4). facilitate implementation.
VerDate Sep<11>2014 21:56 Feb 12, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\13FEN1.SGM 13FEN1](https://thefederalregister.org/doc/80_FR_8126/page/3.svg)
Document Created: 2015-12-18 13:17:41
Document Modified: 2015-12-18 13:17:41
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | The deadline for receiving comments on the draft policy is no later than 5:00 p.m. on March 23, 2015. | |
| 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, [email protected] | |
| FR Citation | 80 FR 8096 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR