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. 

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 

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 

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 

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: 

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 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices 8097 

1NIH’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. 

2See 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. 

3See 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.gpo.gov/fdsys/pkg/DCPD-201300318/pdf/

DCPD-201300318.pdf. 

4Ross 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. 

5Nissen 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. 

6The 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). 

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 

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 

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 


tkelley on DSK3SPTVN1PROD with NOTICES
8098 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices 

7Several 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 http://osp.od.nih.gov/officeclinical-research-and-bioethics-policy/clinicalresearch-policy/clinical-trials> 

8For 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). 

9When the final policy is issued, NIH will also 

provide more specific procedural guidance to 

facilitate implementation. 

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 

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 

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) 

AGENCY: Department of the Interior. 

ACTION: Notice of Final National 

Environmental Policy Act Implementing 

Procedures. 

SUMMARY: 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. 

ADDRESSES: 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: 

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 


tkelley on DSK3SPTVN1PROD with NOTICES