11060 Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Mary Rupp, Secretary of the Board, 

Telephone: 703–518–6304. 

Mary Rupp, 

Secretary of the Board. 

[FR Doc. 07–1175 Filed 3–8–07; 3:15 pm] 

BILLING CODE 7535–01–M 

NUCLEAR REGULATORY 

COMMISSION 

[Docket No. 030–36585] 

Issuance of Environmental 

Assessment and Finding of No 

Significant Impact to Byproduct 

Materials License 53–27775–01 for 

Covance Clinical Research Unit, Inc., 

Honolulu, HI 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Issuance of environmental 

assessment and finding of no significant 

impact for license amendment. 

FOR FURTHER INFORMATION CONTACT: 

Rachel S. Browder, M.S., Health 

Physicist, Nuclear Materials Licensing 

Branch, Division of Nuclear Materials 

Safety, Region IV, U.S. Nuclear 

Regulatory Commission, Arlington, 

Texas 76011. Telephone: (817) 276–

6552; fax number: (817) 860–8188; or by 

e-mail: rsb3@nrc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

The U.S. Nuclear Regulatory 

Commission (NRC) is considering the 

issuance of an amendment to NRC 

Byproduct Materials License No. 53–

27775–01, which was originally issued 

on July 13, 2004, pursuant to 10 CFR 

part 30. This license is held by Covance 

Clinical Research Unit, Inc., (Licensee), 

and authorizes the possession and use 

of carbon-14 in pre-packaged capsules at 

the Licensee’s laboratory located at 401 

Kamakee Street, in Honolulu, Hawaii 

(the facility), a commercial area of 

Honolulu. The facility in which all 

licensed radioactive materials were kept 

and used is a room approximately 7′ x 

12.5′ with a ceiling height of 8.5′, and 

contains a sink and ventilation hood. 

By letter dated October 10, 2006, the 

Licensee stated that use of carbon-14 

had been discontinued at their facility, 

and accordingly requested that the 

facility be released for unrestricted use, 

and that the NRC license be terminated. 

The NRC has prepared an 

Environmental Assessment (EA) in 

support of the proposed action in 

accordance with the requirements of 

Title 10, Code of Federal Regulations 

(CFR), Part 51 (10 CFR part 51). Based 

on the EA, the NRC has concluded that 

a Finding of No Significant Impact 

(FONSI) is appropriate with respect to 

the proposed action. The amendment 

will be issued to the Licensee following 

the publication of this FONSI and EA in 

the Federal Register. 

II. Environmental Assessment 

Identification of Proposed Action: The 

proposed action is to approve the 

Licensee’s October 10, 2006, license 

amendment request to release the 

facility for unrestricted use and 

terminate the license. Licensed 

activities at the facility were limited to 

conducting research trials, in which a 

pre-packaged, pharmaceutical capsule 

with approximately 100 microcuries 

(μCi) of tagged carbon-14 was given to 

each trial subject. The licensee 

conducted three separate research trials 

under the license, with the final trial 

being conducted in February 2006. Each 

trial consisted of approximately eight to 

nine subjects. Upon completion of each 

trial, the facility (where the subjects 

remained during each trial) was 

surveyed and documented to contain 

less than background levels of radiation. 

The subjects remained at the facility 

until approximately 80–90% of the 

excretion was collected. The uptake, 

excretion and distribution of the 

pharmaceutical in the respective 

subjects were observed and measured. 

The samples were collected by the 

licensee and analyzed by a liquid 

scintillation counter, and subsequently 

disposed of in the sanitary sewerage. 

The total activity of carbon-14 ordered 

by the licensee was 5,089 μCi, of which 

2,494 μCi was used during the Phase 

one trials. The remainder of the 

radioactive material was either returned 

to the sponsor or transferred to a 

licensed recipient. 

Based on the use of the radioactive 

materials in accordance with 10 CFR 

30.36(g), the Licensee was not required 

to submit a decommissioning plan to 

the NRC since any decommissioning 

activities and procedures implemented 

were consistent with those approved for 

routine operations. 

The Need for the Proposed Action: 

The Licensee has ceased licensed 

activities at the facility and seeks to 

release the facility for unrestricted use 

and subsequent license termination. 

Environmental Impacts of the Proposed 

Action: The historical review of licensed 

activities conducted at the facility 

documents that the activities involved 

the use of only carbon-14 as a tagged 

pharmaceutical in a pre-packaged 

capsule. The quantity amount in each 

capsule was approximately 100 μCi and 

the last use of licensed material was 

conducted in February 2006. During the 

research trials, the Licensee disposed of 

the excretion samples into the sanitary 

sewerage in accordance with the 

regulatory requirements in 10 CFR 

20.2003. 

The licensee has requested 

termination of the license because all 

work with radioactive materials at the 

facility have been discontinued. The 

proposed release of the licensee’s 

facility for unrestricted use does not 

effect any environmental resource, since 

there are no remediation requirements 

for the facility or potential release of 

radioactive materials to the 

environment. 

The Licensee conducted a final status 

survey of the facility during August 

2006. The final status survey report was 

submitted on October 10, 2006, as part 

of the license amendment request. The 

submitted results were not statistically 

significant from background and 

therefore, the net results did not contain 

any activity above background. The 

NRC allows licensees to demonstrate 

compliance with the radiological 

criteria for unrestricted use as specified 

in 10 CFR 20.1402 by using the 

screening approach described in 

NUREG–1757, ‘‘Consolidated NMSS 

Decommissioning Guidance,’’ Volume 

2. The Licensee’s results did not contain 

any activity above background and 

therefore were below any NRC criteria 

and were in compliance with the As 

Low As Reasonably Achievable 

(ALARA) requirement of 10 CFR 

20.1402. The NRC thus finds that the 

Licensee’s final status survey results 

acceptable. 

Based on its review, the staff has 

determined that the affected 

environment and any environmental 

impacts associated with the proposed 

action are bounded by the impacts 

evaluated by the ‘‘Generic 

Environmental Impact Statement in 

Support of Rulemaking on Radiological 

Criteria for License Termination of NRCLicensed Nuclear Facilities’’ (NUREG–

1496) Volumes 1–3 (ML042310492, 

ML042320379, and ML042330385). The 

staff finds there were no significant 

environmental impacts from the use of 

radioactive material at the licensee’s 

facility. The NRC staff reviewed the 

docket file records and the final status 

survey report to identify any nonradiological hazards that may have 

impacted the environment surrounding 

the facility. No such hazards or impacts 

to the environment were identified. The 

NRC has identified no other radiological 

or non-radiological activities in the area 

that could result in cumulative 

environmental impacts. 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 47 / Monday, March 12, 2007 / Notices 11061 

The NRC staff finds that the proposed 

release of the facility for unrestricted 

use and the termination of the NRC 

license are in compliance with 10 CFR 

20.1402. Based on its review, the staff 

considered the impact of any residual 

radioactivity in the laboratory and 

concluded that the proposed action will 

not have a significant effect on the 

quality of the human environment. 

Environmental Impacts of the 

Alternatives to the Proposed Action: 

Due to the largely administrative nature 

of the proposed action, its 

environmental impacts are small. 

Therefore, the only alternative the staff 

considered is the no-action alternative, 

under which the staff would deny the 

amendment request. This no-action 

alternative is not feasible because it 

conflicts with 10 CFR 30.36(d), 

requiring that decommissioning of 

byproduct material facilities be 

completed and approved by the NRC 

after licensed activities cease. The 

NRC’s analysis of the Licensee’s final 

status survey data confirmed that 

release of the facility meets the 

requirements of 10 CFR 20.1402 for 

unrestricted use. Additionally, denying 

the amendment request would result in 

no change in current environmental 

impacts. The environmental impacts of 

the proposed action and the no-action 

alternative are therefore similar, and the 

no-action alternative is accordingly not 

further considered. 

Conclusion: The NRC staff has 

concluded that the proposed action is 

consistent with the NRC’s unrestricted 

use criteria specified in 10 CFR 20.1402. 

Because the proposed action will not 

significantly impact the quality of the 

human environment, the NRC staff 

concludes that the proposed action is 

the preferred alternative. 

Agencies and Persons Contacted: NRC 

provided a draft of this EA to the State 

of Hawaii for review on January 22, 

2006. The State of Hawaii did not 

provide any comments to the draft EA. 

The NRC staff has determined that the 

proposed action is of a procedural 

nature, and will not affect listed species 

or critical habitat. Therefore, no further 

consultation is required under Section 7 

of the Endangered Species Act. The 

NRC staff has also determined that the 

proposed action is not the type of 

activity that has the potential to cause 

effects on historic properties. Therefore, 

no further consultation is required 

under Section 106 of the National 

Historic Preservation Act. 

III. Finding of No Significant Impact 

The NRC staff has prepared this EA in 

support of the proposed action. On the 

basis of this EA, the NRC finds that 

there are no significant environmental 

impacts from the proposed action, and 

that preparation of an environmental 

impact statement is not warranted. 

Accordingly, the NRC has determined 

that a Finding of No Significant Impact 

is appropriate. 

IV. Further Information 

Documents related to this action, 

including the application for 

amendment and supporting 

documentation, are available 

electronically at the NRC’s Electronic 

Reading Room at http://www.nrc.gov/ 

reading-rm.html. From this site, you can 

access the NRC’s Agencywide 

Document Access and Management 

System (ADAMS), which provides text 

and image files of NRC’s public 

documents. The documents related to 

this action are listed below, along with 

their ADAMS accession numbers. 

1. NRC, ‘‘Generic Environmental 

Impact Statement in Support of 

Rulemaking on Radiological Criteria for 

License Termination of NRC-Licensed 

Nuclear Facilities,’’ NUREG–1496, July 

1997 (ML042310492, ML042320379, 

and ML042330385). 

2. NRC, ‘‘Consolidated NMSS 

Decommissioning Guidance,’’ NUREG–

1757, Volume 1, Revision 1, September 

2003 (ML053260027). 

3. Title 10 Code of Federal 

Regulations, Part 20, Subpart E, 

‘‘Radiological Criteria for License 

Termination.’’

4. Title 10, Code of Federal 

Regulations, Part 51, ‘‘Environmental 

Protection Regulations for Domestic 

Licensing and Related Regulatory 

Functions.’’

5. Jacobs, Mark, Covance Clinical 

Research Unit, Inc., Decommissioning 

Report, October 10, 2006 

(ML062900229). 

6. Browder, Rachel S., 

Acknowledgment of Receipt of Final 

Status Survey, October 31, 2006 

(ML063040400). 

If you do not have access to ADAMS 

or if there are problems in accessing the 

documents located in ADAMS, contact 

the NRC Public Document Room (PDR) 

Reference staff at 1–800–397–4209, 301–

415–4737, or by e-mail to pdr@nrc.gov. 

These documents may also be viewed 

electronically on public computers 

located at the NRC’s PDR, O 1 F21, One 

White Flint North, 11555 Rockville 

Pike, Rockville, MD 20852. The PDR 

reproduction contractor will copy 

documents for a fee. 

Dated at Arlington, Texas, this 2nd day of 

March 2007. 

For the Nuclear Regulatory Commission. 

D. Blair Spitzberg, 

Chief, Fuel Cycle Decommissioning Branch, 

Division of Nuclear Materials Safety, Region 

IV. 

[FR Doc. E7–4415 Filed 3–9–07; 8:45 am] 

BILLING CODE 7590–01–P 

OFFICE OF MANAGEMENT AND 

BUDGET 

Draft 2007 Report to Congress on the 

Costs and Benefits of Federal 

Regulations 

AGENCY: Office of Management and 

Budget, Executive Office of the 

President. 

ACTION: Notice of availability and 

request for comments. 

SUMMARY: The Office of Management 

and Budget (OMB) requests comments 

on its 2007 Draft Report to Congress on 

the Costs and Benefits of Federal 

Regulations. The full Draft Report is 

available at http://www.whitehouse.gov/ 

omb/inforeg/regpolreports_congress.html, and is divided 

into four chapters. Chapter I examines 

the costs and benefits of major Federal 

regulations issued in fiscal year 2006 

and summarizes the costs and benefits 

of major regulations issued between 

September 1996 and 2006. It also 

discusses regulatory impacts on State, 

local, and tribal governments, small 

business, wages, and economic growth. 

Chapter II examines trends in regulation 

since OMB began to compile benefit and 

cost estimates records in 1981. Chapter 

III provides an update on 

implementation of the Information 

Quality Act, and Chapter IV summarizes 

agency compliance with the Unfunded 

Mandates Reform Act. 

DATES: To ensure consideration of 

comments as OMB prepares this Draft 

Report for submission to Congress, 

comments must be in writing and 

received by June 11, 2007. 

ADDRESSES: We are still experiencing 

delays in the regular mail, including 

first class and express mail. To ensure 

that your comments are received, we 

recommend that comments on this draft 

report be electronically mailed to 

OIRA_BC_RPT@omb.eop.gov, or faxed 

to (202) 395–7245. You may also submit 

comments to Mabel Echols, Office of 

Information and Regulatory Affairs, 

Office of Management and Budget, 

NEOB, Room 10201, 725 17th Street, 

NW., Washington, DC 20503. All 

comments submitted in response to this 

notice will be made available to the 

public, including by posting them on 

OMB’s Web site. For this reason, please 


pwalker on PROD1PC71 with NOTICES