[Federal Register Volume 70, Number 246 (Friday, December 23, 2005)]
[Notices]
[Pages 76331-76332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-7792]


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

NUCLEAR REGULATORY COMMISSION

[Docket No. 030-04544]


Notice of Availability of Environmental Assessment and Finding of 
No Significant Impact for License Amendment for Department of Health 
and Human Services, Food and Drug Administration, Center for Devices 
and Radiological Health (FDA/CDRH) in Rockville, MD

AGENCY: Nuclear Regulatory Commission.

ACTION: Notice of availability.

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

FOR FURTHER INFORMATION CONTACT: Betsy Ullrich, Commercial and R&D 
Branch, Division of Nuclear Materials Safety, Region I, 475 Allendale 
Road, King of Prussia, Pennsylvania, 19406, telephone (610) 337-5040, 
fax (610) 337-5269; or by e-mail: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Introduction

    The U.S. Nuclear Regulatory Commission (NRC) is considering the 
issuance of a license amendment to the Department of Health and Human 
Services, Food and Drug Administration, Center for Devices and 
Radiological Health (FDA/CDRH) for Materials License No. 19-07538-01, 
to authorize release of its facility at 12709 Twinbrook Parkway, 
Rockville, Maryland for unrestricted use. NRC has prepared an 
Environmental Assessment (EA) in support of this proposed action in 
accordance with the requirements of 10 CFR Part 51. Based on the EA, 
the NRC has concluded that a Finding of No Significant Impact (FONSI) 
is appropriate.

[[Page 76332]]

II. EA Summary

    The purpose of the proposed action is to authorize the release of 
the licensee's 12709 Twinbrook Parkway, Rockville, Maryland facility 
for unrestricted use. FDA/CDRH was authorized by NRC from 1965 to use 
radioactive materials for research and development purposes at the 
site. On August 23, 2005, FDA/CDRH requested that NRC release the 
facility for unrestricted use. FDA/CDRH has conducted surveys of the 
facility and provided information to the NRC to demonstrate that the 
site meets the license termination criteria in Subpart E of 10 CFR Part 
20 for unrestricted use.
    The NRC staff has prepared an EA in support of the license 
amendment. The facility was remediated and surveyed prior to the 
licensee requesting the license amendment. The NRC staff has reviewed 
the information and final status survey submitted by FDA/CDRH. Based on 
its review, the staff has determined that there are no additional 
remediation activities necessary to complete the proposed action. 
Therefore, the staff considered the impact of the residual 
radioactivity at the facility and concluded that since the residual 
radioactivity meets the requirements in Subpart E of 10 CFR part 20, a 
Finding of No Significant Impact is appropriate.

III. Finding of No Significant Impact

    The staff has prepared the EA (summarized above) in support of the 
license amendment to terminate the license and release the facility for 
unrestricted use. The NRC staff has evaluated FDA/CDRH's request and 
the results of the surveys and has concluded that the completed action 
complies with the criteria in Subpart E of 10 CFR Part 20. The staff 
has found that the radiological environmental impacts from the action 
are bounded by the impacts evaluated by NUREG-1496, Volumes 1-3, 
``Generic Environmental Impact Statement in Support of Rulemaking on 
Radiological Criteria for License Termination of NRC-Licensed 
Facilities'' (ML042310492, ML042320379, and ML042330385). Additionally, 
no non-radiological or cumulative impacts were identified. On the basis 
of the EA, the NRC has concluded that there are no significant 
environmental impacts from the proposed action, and has determined not 
to prepare an environmental impact statement for the proposed action.

IV. Further Information

    Documents related to this action, including the application for the 
license amendment and supporting documentation, are available 
electronically at the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/adams.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 ADAMS 
accession numbers for the documents related to this Notice are: 
Environmental Assessment [ML053480176] and Final Status Survey Report, 
Food and Drug Administration, Center for Devices and Radiological 
Health, 12709 Twinbrook Parkway, Rockville, Maryland, August 22, 2005, 
Final Report [ML052380179]. Persons who do not have access to ADAMS or 
who encounter problems in accessing the documents located in ADAMS, 
should contact the NRC PDR Reference staff by telephone at (800) 397-
4209 or (301) 415-4737, or by e-mail to [email protected].
    Documents related to operations conducted under this license not 
specifically referenced in this Notice may not be electronically 
available and/or may not be publicly available. Persons who have an 
interest in reviewing these documents should submit a request to NRC 
under the Freedom of Information Act (FOIA). Instructions for 
submitting a FOIA request can be found on the NRC's Web site at http://www.nrc.gov/reading-rm/foia/foia-privacy.html.


    Dated at King of Prussia, Pennsylvania this 14th day of 
December, 2005.

    For the Nuclear Regulatory Commission
John D. Kinneman,
Chief Materials Security & Industrial Branch, Division of Nuclear 
Materials Safety. Region I.
[FR Doc. E5-7792 Filed 12-22-05; 8:45 am]
BILLING CODE 7590-01-P