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
Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices 8099 

lands, including the approval of timber 

harvests. As a result of the need for 

Federal permits and contracts, such 

projects are Federal actions that require 

compliance with the NEPA. The BIA 

has typically conducted NEPA reviews 

of actions associated with timber 

harvesting by preparing Environmental 

Assessments (EA). The addition of CEs 

to cover these three categories of small 

actions will allow for a more efficient 

NEPA review because those EAs 

resulted in findings of no significant 

impacts which were substantiated over 

time. The three proposed CEs were 

developed based on CEs currently used 

by the United States Forest Service (FS), 

as described in FS regulations 36 CFR 

220, and adopted by the Bureau of Land 

Management (BLM), as described the 

Departmental Manual, 516 DM 11. The 

BIA relied on the experience of the FS 

and BLM and applied its expertise to 

benchmark these CEs and determined 

these are appropriate to establish as BIA 

CEs. 

Because these CEs have important 

implications for actions occurring on 

Indian lands, the BIA initiated 

consultation and requested comments 

from all federally recognized tribes. This 

consultation period began on July 23, 

2014, and concluded on September 21, 

2014. Public comments were also 

solicited through a notice placed in the 

Federal Register on November 14, 2014 

[79 FR 68287]. 

Comments on the Proposal 

The BIA received no comments from 

tribes, and no public comments. 

Conclusion 

The Department and the BIA 

determined that the actions defined in 

the CEs presented at the end of this 

notice normally do not individually or 

cumulatively have a significant effect on 

the human environment and, absent 

extraordinary circumstances, do not 

require preparation of an Environmental 

Assessment or an Environmental Impact 

Statement. This finding is based on the 

analysis of the application of similar 

CEs established and used by other 

Federal departments and agencies; and 

the professional judgment of BIA 

environmental and forestry personnel 

who conducted environmental reviews 

of similar actions that resulted in 

Findings of No Significant Impact. 

Categorical Exclusions 

The Department will add the 

following categorical exclusions to the 

Departmental Manual at 516 DM 10.5: 

H. Forestry. 

(11) Harvesting live trees not to 

exceed 70 acres, requiring no more than 

0.5 mile of temporary road construction. 

Such activities: 

(a) Shall not include even-aged 

regeneration harvests or vegetation type 

conversions. 

(b) May include incidental removal of 

trees for landings, skid trails, and road 

clearing. 

(c) May include temporary roads 

which are defined as roads authorized 

by contract, permit, lease, other written 

authorization, or emergency operation 

not intended to be part of the BIA or 

Tribal transportation systems and not 

necessary for long-term resource 

management. Temporary roads shall be 

designed to standards appropriate for 

the intended uses, considering safety, 

cost of transportation, and impacts on 

land and resources; and 

(d) Shall require the treatment of 

temporary roads constructed or used so 

as to permit the reestablishment by 

artificial or natural means, of vegetative 

cover on the roadway and areas where 

the vegetative cover was disturbed by 

the construction or use of the road, as 

necessary to minimize erosion from the 

disturbed area. Such treatment shall be 

designed to reestablish vegetative cover 

as soon as practicable, but at least 

within 10 years after the termination of 

the contract. 

Examples include, but are not limited 

to: 

(a) Removing individual trees for 

sawlogs, specialty products, or 

fuelwood. 

(b) Commercial thinning of 

overstocked stands to achieve the 

desired stocking level to increase health 

and vigor. 

(12) Salvaging dead or dying trees not 

to exceed 250 acres, requiring no more 

than 0.5 mile of temporary road 

construction. Such activities: 

(a) May include incidental removal of 

live or dead trees for landings, skid 

trails, and road clearing. 

(b) May include temporary roads 

which are defined as roads authorized 

by contract, permit, lease, other written 

authorization, or emergency operation 

not intended to be part of the BIA or 

Tribal transportation systems and not 

necessary for long-term resource 

management. Temporary roads shall be 

designed to standards appropriate for 

the intended uses, considering safety, 

cost of transportation, and impacts on 

land and resources; and 

(c) Shall require the treatment of 

temporary roads constructed or used so 

as to permit the reestablishment, by 

artificial or natural means, of vegetative 

cover on the roadway and areas where 

the vegetative cover was disturbed by 

the construction or use of the road, as 

necessary to minimize erosion from the 

disturbed area. Such treatment shall be 

designed to reestablish vegetative cover 

as soon as practicable, but at least 

within 10 years after the termination of 

the contract. 

(d) For this CE, a dying tree is defined 

as a standing tree that has been severely 

damaged by forces such as fire, wind, 

ice, insects, or disease, such that in the 

judgment of an experienced forest 

professional or someone technically 

trained for the work, the tree is likely to 

die within a few years. 

Examples include, but are not limited 

to: 

(a) Harvesting a portion of a stand 

damaged by a wind or ice event. 

(b) Harvesting fire damaged trees. 

(13) Commercial and non-commercial 

sanitation harvest of trees to control 

insects or disease not to exceed 250 

acres, requiring no more than 0.5 miles 

of temporary road construction. Such 

activities: 

(a) May include removal of infested/ 

infected trees and adjacent live 

uninfested/uninfected trees as 

determined necessary to control the 

spread of insects or disease; and 

(b) May include incidental removal of 

live or dead trees for landings, skid 

trails, and road clearing. 

(c) May include temporary roads 

which are defined as roads authorized 

by contract, permit, lease, other written 

authorization, or emergency operation 

not intended to be part of the BIA or 

tribal transportation systems and not 

necessary for long-term resource 

management. Temporary roads shall be 

designed to standards appropriate for 

the intended uses, considering safety, 

cost of transportation, and impacts on 

land and resources; and 

(d) Shall require the treatment of 

temporary roads constructed or used so 

as to permit the reestablishment, by 

artificial or natural means, of vegetative 

cover on the roadway and areas where 

the vegetative cover was disturbed by 

the construction or use of the road, as 

necessary to minimize erosion from the 

disturbed area. Such treatment shall be 

designed to reestablish vegetative cover 

as soon as practicable, but at least 

within 10 years after the termination of 

the contract. 

Examples include, but are not limited 

to: 

(a) Felling and harvesting trees 

infested with mountain pine beetles and 

immediately adjacent uninfested trees to 

control expanding spot infestations (a 

buffer); and 

(b) Removing or destroying trees 

infested or infected with a new exotic 

insect or disease, such as emerald ash 

borer, Asian longhorned beetle, or 

sudden oak death pathogen. 


tkelley on DSK3SPTVN1PROD with NOTICES
8100 Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Notices 

Dated: February 5, 2015. 

Willie R. Taylor, 

Director, Office of Environmental Policy and 

Compliance. 

[FR Doc. 2015–03039 Filed 2–12–15; 8:45 am] 

BILLING CODE 4337–A2–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

[FWS–R1–ES–2014–N247; 

FXES11130100000C4–156–FF01E00000] 

Endangered and Threatened Wildlife 

and Plants; Initiation of 5-Year Status 

Reviews of 133 Species in Hawaii, 

Oregon, Idaho, and Washington 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of initiation of reviews; 

request for information. 

SUMMARY: We, the U.S. Fish and 

Wildlife Service (Service), are initiating 

5-year status reviews for 133 species in 

Hawaii, Oregon, Idaho, and Washington 

under the Endangered Species Act of 

1973, as amended (Act). A 5-year status 

review is based on the best scientific 

and commercial data available at the 

time of the review; therefore, we are 

requesting submission of any new 

information on these species that has 

become available since the last review. 

DATES: To ensure consideration in our 

reviews, we are requesting submission 

of new information no later than April 

14, 2015. However, we will continue to 

accept new information about any listed 

species at any time. 

ADDRESSES: For the 130 species in 

Hawaii (see table below), submit 

information to: Deputy Field 

Supervisor—Programmatic, Attention: 

5-Year Review, U.S. Fish and Wildlife 

Service, Pacific Islands Fish and 

Wildlife Office, 300 Ala Moana Blvd., 

Room 3–122, Box 50088, Honolulu, HI 

96850. 

For Bradshaw’s desert-parsley and 

Howell’s spectacular thelypody, submit 

information to: Field Supervisor, 

Attention: 5-Year Review, U.S. Fish and 

Wildlife Service, Oregon Fish and 

Wildlife Office, 2600 SE 98th Avenue, 

Suite 100, Portland, OR 97266. 

Alternatively you may submit 

information on the Oregon species by 

email to: fw1or5yearreview@fws.gov. 

For MacFarlane’s four-o’-clock, 

submit information to: Field Supervisor, 

Attention: 5-Year Review, U.S. Fish and 

Wildlife Service, Idaho Fish and 

Wildlife Office, 1387 S. Vinnell Way, 

Suite 368, Boise, ID 83709. 

FOR FURTHER INFORMATION CONTACT: 

Marie Bruegmann, U.S. Fish and 

Wildlife Service, Pacific Islands Fish 

and Wildlife Office (see ADDRESSES), 

808–792–9400 (for species in Hawaii); 

Jeff Dillon, U.S. Fish and Wildlife 

Service, Oregon Fish and Wildlife 

Office, 503–231–6179 (for Bradshaw’s 

desert-parsley and Howell’s spectacular 

thelypody); or Kim Garner, Idaho Fish 

and Wildlife Office, 208–378–5243 (for 

MacFarlane’s four-o’-clock). Individuals 

who are hearing impaired or speech 

impaired may call the Federal Relay 

Service at 800–877–8339 for TTY 

assistance. 

SUPPLEMENTARY INFORMATION: 

Why do we conduct 5-year reviews? 

Under the Act (16 U.S.C. 1531 et seq.), 

we maintain Lists of Endangered and 

Threatened Wildlife and Plants (which 

we collectively refer to as the List) in 

the Code of Federal Regulations (CFR) at 

50 CFR 17.11 (for animals) and 17.12 

(for plants). Section 4(c)(2) of the Act 

requires us to review each listed 

species’ status at least once every 5 

years to determine whether it should be 

removed from the List; or be changed in 

status from endangered to threatened, or 

from threatened to endangered. Our 

regulations at 50 CFR 424.21 require 

that we publish a notice in the Federal 

Register announcing those species 

under active review. 

What information do we consider in the 

review? 

A 5-year review considers all new 

information available at the time of the 

review. In conducting these reviews, we 

consider the best scientific and 

commercial data that has become 

available since the listing determination 

or most recent status review, such as: 

(A) Species biology, including but not 

limited to population trends, 

distribution, abundance, demographics, 

and genetics; 

(B) Habitat conditions, including but 

not limited to amount, distribution, and 

suitability; 

(C) Conservation measures that have 

been implemented that benefit the 

species; 

(D) Threat status and trends in 

relation to the five listing factors (as 

defined in section 4(a)(1) of the Act); 

and 

(E) Other new information, data, or 

corrections, including but not limited 

to, taxonomic or nomenclatural changes, 

identification of erroneous information 

contained in the List, and improved 

analytical methods. 

Any new information will be 

considered during the 5-year review and 

will also be useful in evaluating the 

ongoing recovery programs for these 

species. 

What species are under review? 

This notice announces our active 

review of the 133 species listed in the 

table below. 

SPECIES FOR WHICH WE ARE INITIATING A 5-YEAR STATUS REVIEW

Common name Scientific name Status Where listed Final listing rule 

ANIMALS 

Millerbird, Nihoa ................................ Acrocephalus familiaris kingi ............. Endangered ...... U.S.A. (HI) ........ 32 FR 4001; 03/11/1967. 

Wolf spider, Kauai cave .................... Adelocosa anops ............................... Endangered ...... U.S.A. (HI) ........ 65 FR 2348; 01/14/2000. 

Duck, Laysan .................................... Anas laysanensis .............................. Endangered ...... U.S.A. (HI) ........ 32 FR 4001; 03/11/1967. 

Pomace fly [unnamed] ...................... Drosophila musaphilia ....................... Endangered ...... U.S.A. (HI) ........ 71 FR 26835; 05/09/2006. 

Fly, Hawaiian picture-wing ................ Drosophila sharpi .............................. Endangered ...... U.S.A. (HI) ........ 75 FR 18960; 04/13/2010. 

Newcomb’s snail ............................... Erinna newcombi ............................... Threatened ....... U.S.A. (HI) ........ 65 FR 4162; 01/26/2000. 

Nukupu‘u (honeycreeper) .................. Hemignathus lucidus ......................... Endangered ...... U.S.A. (HI) ........ 35 FR 16047; 10/13/1970. 

‘Akialoa, Kauai .................................. Hemignathus procerus ...................... Endangered ...... U.S.A. (HI) ........ 32 FR 4001; 03/11/1967. 

Akekee .............................................. Loxops caeruleirostris ....................... Endangered ...... U.S.A. (HI) ........ 75 FR 18960; 04/13/2010. 

‘O‘o, Kauai ......................................... Moho braccatus ................................. Endangered ...... U.S.A. (HI) ........ 32 FR 4001; 03/11/1967. 

Thrush, large Kauai ........................... Myadestes myadestinus .................... Endangered ...... U.S.A. (HI) ........ 35 FR 16047; 10/13/1970. 

Thrush, small Kauai .......................... Myadestes palmeri ............................ Endangered ...... U.S.A. (HI) ........ 32 FR 4001; 03/11/1967. 

‘Akikiki ............................................... Oreomystis bairdi .............................. Endangered ...... U.S.A. (HI) ........ 75 FR 18960; 04/13/2010. 

Amphipod, Kauai cave ...................... Spelaeorchestia koloana ................... Endangered ...... U.S.A. (HI) ........ 65 FR 2348; 01/14/2000. 

Finch, Laysan .................................... Telespyza cantans ............................ Endangered ...... U.S.A. (HI) ........ 32 FR 4001; 03/11/1967. 


tkelley on DSK3SPTVN1PROD with NOTICES