[Federal Register Volume 83, Number 2 (Wednesday, January 3, 2018)]
[Notices]
[Pages 401-404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28331]


=======================================================================
-----------------------------------------------------------------------

NUCLEAR REGULATORY COMMISSION

[Docket No. 30-4675; NRC-2017-0221]


Department of Health and Human Services, Food and Drug 
Administration, Winchester Engineering and Analytical Center

AGENCY: Nuclear Regulatory Commission.

ACTION: License amendment application; opportunity to provide comments, 
request a hearing and to petition for leave to intervene.

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

SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) has received a 
license amendment application from the Department of Health and Human 
Services, Food and Drug Administration (FDA) for the Winchester 
Engineering and Analytical Center located in Winchester, MA. The 
license authorizes the use of radioactive byproduct material for 
research and development. The licensee is requesting a partial site 
release for construction of a new 3-story building directly behind the 
existing main lab building.

DATES: Submit comments by February 2, 2018. Comments received after 
this date will be considered if it is practical to do so, but the 
Commission is able to ensure consideration only for comments received 
before this date. A request for a hearing or petition for leave to 
intervene must be filed by March 5, 2018.

ADDRESSES: You may submit comments by any of the following methods:
     Federal Rulemaking website: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0221. Address 
questions about NRC dockets to Carol Gallagher; telephone: 301-415-
3463; email: [email protected]. For technical questions, contact 
the individual listed in the FOR FURTHER INFORMATION CONTACT section of 
this document.
     Mail comments to: May Ma, Office of Administration, Mail 
Stop: OWFN-2-A13, U.S. Nuclear Regulatory Commission, Washington, DC 
20555-0001.
    For additional direction on obtaining information and submitting 
comments, see ``Obtaining Information and Submitting Comments'' in the 
SUPPLEMENTARY INFORMATION section of this document.

FOR FURTHER INFORMATION CONTACT: Stephen Hammann, Division of Nuclear 
Materials Safety, Region I, U.S. Nuclear Regulatory Commission, 2100 
Renaissance Boulevard, Suite 100, King of Prussia, Pennsylvania 19406;

[[Page 402]]

telephone: 610-337-5399; fax number: 610-337-5269; email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Obtaining Information and Submitting Comments

A. Obtaining Information

    Please refer to Docket ID NRC-2017-0221 when contacting the NRC 
about the availability of information for this action. You may obtain 
publicly-available information related to this action by any of the 
following methods:
     Federal Rulemaking website: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0221.
     NRC's Agencywide Documents Access and Management System 
(ADAMS): You may obtain publicly-available documents online in the 
ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``ADAMS Public Documents'' and 
then select ``Begin Web-based ADAMS Search.'' For problems with ADAMS, 
please contact the NRC's Public Document Room (PDR) reference staff at 
1-800-397-4209, 301-415-4737, or by email to [email protected]. The 
Decommissioning Plan is available in ADAMS under Accession No. 
ML17215A952.
     NRC's PDR: You may examine and purchase copies of public 
documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 
Rockville Pike, Rockville, Maryland 20852.

B. Submitting Comments

    Please include Docket ID NRC-2017-0221 in your comment submission.
    The NRC cautions you not to include identifying or contact 
information that you do not want to be publicly disclosed in your 
comment submission. The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into 
ADAMS. The NRC does not routinely edit comment submissions to remove 
identifying or contact information.
    If you are requesting or aggregating comments from other persons 
for submission to the NRC, then you should inform those persons not to 
include identifying or contact information that they do not want to be 
publicly disclosed in their comment submission. Your request should 
state that the NRC does not routinely edit comment submissions to 
remove such information before making the comment submissions available 
to the public or entering the comment into ADAMS.

II. Introduction

    The NRC has received, by letters dated November 25, 2016, (ADAMS 
Accession No. ML16347A523) and July 21, 2017, (ADAMS Accession Nos. 
ML17215A952 and ML17215A953) an application to amend Materials License 
No. 20-08361-01 and a decommissioning plan, respectively. The amendment 
provides for a partial site release. The decommissioning plan includes 
the radiological survey and subsequent excavation, decontamination, and 
proper disposal of licensed radioactive material identified within a 
designated area of the site. Specifically, the approval of the 
decommissioning plan would allow FDA to begin remediation activities in 
the specified area of the Winchester Engineering and Analytical Center 
to confirm that the specified area would meet the requirements for 
release for unrestricted use as specified in section 14.02 of title 10 
of the Code of Federal Regulations (10 CFR). Materials License No. 20-
08361-01 currently authorizes use of radioactive material for research 
and development as defined in 10 CFR 30.4 and 10 CFR 70.4.
    An NRC administrative completeness review found the application 
acceptable for a technical review (ADAMS Accession No. ML17215A953). 
Prior to approving the proposed action, the NRC will need to make the 
findings required by the Atomic Energy Act of 1954 as amended (the 
Act), and the NRC's regulations. The NRC's findings will be documented 
in a safety evaluation report and an environmental assessment. The 
environmental assessment will be the subject of a subsequent notice in 
the Federal Register.

III. Notice and Solicitation of Comments

    In accordance with 10 CFR 20.1405, the Commission is providing 
notice and soliciting comments from local and State governments in the 
vicinity of the site and any Federally-recognized Indian Tribe that 
could be affected by the decommissioning. This notice and solicitation 
of comments is published pursuant to Sec.  20.1405, which provides for 
publication in the Federal Register and in a forum, such as local 
newspapers, letters to State or local organizations, or other 
appropriate forum, that is readily accessible to individuals in the 
vicinity of the site. Comments should be provided within 30 days of the 
date of this notice.

IV. Opportunity To Request a Hearing and Petition for Leave To 
Intervene

    Within 60 days after the date of publication of this notice, any 
persons (petitioner) whose interest may be affected by this action may 
file a request for a hearing and petition for leave to intervene 
(petition) with respect to the action. Petitions shall be filed in 
accordance with the Commission's ``Agency Rules of Practice and 
Procedure'' in 10 CFR part 2. Interested persons should consult a 
current copy of 10 CFR 2.309. The NRC's regulations are accessible 
electronically from the NRC Library on the NRC's website at http://www.nrc.gov/reading-rm/doc-collections/cfr/. Alternatively, a copy of 
the regulations is available at the NRC's Public Document Room, located 
at One White Flint North, Room O1-F21, 11555 Rockville Pike (first 
floor), Rockville, Maryland 20852. If a petition is filed, the 
Commission or a presiding officer will rule on the petition and, if 
appropriate, a notice of a hearing will be issued.
    As required by 10 CFR 2.309(d) the petition should specifically 
explain the reasons why intervention should be permitted with 
particular reference to the following general requirements for 
standing: (1) The name, address, and telephone number of the 
petitioner; (2) the nature of the petitioner's right under the Act to 
be made a party to the proceeding; (3) the nature and extent of the 
petitioner's property, financial, or other interest in the proceeding; 
and (4) the possible effect of any decision or order which may be 
entered in the proceeding on the petitioner's interest.
    In accordance with 10 CFR 2.309(f), the petition must also set 
forth the specific contentions which the petitioner seeks to have 
litigated in the proceeding. Each contention must consist of a specific 
statement of the issue of law or fact to be raised or controverted. In 
addition, the petitioner must provide a brief explanation of the bases 
for the contention and a concise statement of the alleged facts or 
expert opinion which support the contention and on which the petitioner 
intends to rely in proving the contention at the hearing. The 
petitioner must also provide references to the specific sources and 
documents on which the petitioner intends to rely to support its 
position on the issue. The petition must include sufficient information 
to show that a genuine dispute exists with the applicant or licensee on 
a material issue of law or fact. Contentions must be limited to matters 
within the scope of the proceeding. The contention must be one which, 
if proven, would entitle the

[[Page 403]]

petitioner to relief. A petitioner who fails to satisfy the 
requirements at 10 CFR 2.309(f) with respect to at least one contention 
will not be permitted to participate as a party.
    Those permitted to intervene become parties to the proceeding, 
subject to any limitations in the order granting leave to intervene. 
Parties have the opportunity to participate fully in the conduct of the 
hearing with respect to resolution of that party's admitted 
contentions, including the opportunity to present evidence, consistent 
with the NRC's regulations, policies, and procedures.
    Petitions must be filed no later than 60 days from the date of 
publication of this notice. Petitions and motions for leave to file new 
or amended contentions that are filed after the deadline will not be 
entertained absent a determination by the presiding officer that the 
filing demonstrates good cause by satisfying the three factors in 10 
CFR 2.309(c)(1)(i) through (iii). The petition must be filed in 
accordance with the filing instructions in the ``Electronic Submissions 
(E-Filing)'' section of this document.
    A State, local governmental body, Federally-recognized Indian 
Tribe, or agency thereof, may submit a petition to the Commission to 
participate as a party under 10 CFR 2.309(h)(1). The petition should 
state the nature and extent of the petitioner's interest in the 
proceeding. The petition should be submitted to the Commission no later 
than 60 days from the date of publication of this notice. The petition 
must be filed in accordance with the filing instructions in the 
``Electronic Submissions (E-Filing)'' section of this document, and 
should meet the requirements for petitions set forth in this section. 
Alternatively, a State, local governmental body, Federally-recognized 
Indian Tribe, or agency thereof may participate as a non-party under 10 
CFR 2.315(c).
    If a hearing is granted, any person who is not a party to the 
proceeding and is not affiliated with or represented by a party may, at 
the discretion of the presiding officer, be permitted to make a limited 
appearance pursuant to the provisions of 10 CFR 2.315(a). A person 
making a limited appearance may make an oral or written statement of 
his or her position on the issues but may not otherwise participate in 
the proceeding. A limited appearance may be made at any session of the 
hearing or at any prehearing conference, subject to the limits and 
conditions as may be imposed by the presiding officer. Details 
regarding the opportunity to make a limited appearance will be provided 
by the presiding officer if such sessions are scheduled.

V. Electronic Submissions (E-Filing).

    All documents filed in NRC adjudicatory proceedings, including a 
request for hearing and petition for leave to intervene (petition), any 
motion or other document filed in the proceeding prior to the 
submission of a request for hearing or petition to intervene, and 
documents filed by interested governmental entities that request to 
participate under 10 CFR 2.315(c), must be filed in accordance with the 
NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 
46562, August 3, 2012). The E-Filing process requires participants to 
submit and serve all adjudicatory documents over the internet, or in 
some cases to mail copies on electronic storage media. Detailed 
guidance on making electronic submissions may be found in the Guidance 
for Electronic Submissions to the NRC and on the NRC website at http://www.nrc.gov/site-help/e-submittals.html. Participants may not submit 
paper copies of their filings unless they seek an exemption in 
accordance with the procedures described below.
    To comply with the procedural requirements of E-Filing, at least 10 
days prior to the filing deadline, the participant should contact the 
Office of the Secretary by email at [email protected], or by 
telephone at 301-415-1677, to (1) request a digital identification (ID) 
certificate, which allows the participant (or its counsel or 
representative) to digitally sign submissions and access the E-Filing 
system for any proceeding in which it is participating; and (2) advise 
the Secretary that the participant will be submitting a petition or 
other adjudicatory document (even in instances in which the 
participant, or its counsel or representative, already holds an NRC-
issued digital ID certificate). Based upon this information, the 
Secretary will establish an electronic docket for the hearing in this 
proceeding if the Secretary has not already established an electronic 
docket.
    Information about applying for a digital ID certificate is 
available on the NRC's public website at http://www.nrc.gov/site-help/e-submittals/getting-started.html. Once a participant has obtained a 
digital ID certificate and a docket has been created, the participant 
can then submit adjudicatory documents. Submissions must be in Portable 
Document Format (PDF). Additional guidance on PDF submissions is 
available on the NRC's public website at http://www.nrc.gov/site-help/electronic-sub-ref-mat.html. A filing is considered complete at the 
time the document is submitted through the NRC's E-Filing system. To be 
timely, an electronic filing must be submitted to the E-Filing system 
no later than 11:59 p.m. Eastern Time on the due date. Upon receipt of 
a transmission, the E-Filing system time-stamps the document and sends 
the submitter an email notice confirming receipt of the document. The 
E-Filing system also distributes an email notice that provides access 
to the document to the NRC's Office of the General Counsel and any 
others who have advised the Office of the Secretary that they wish to 
participate in the proceeding, so that the filer need not serve the 
document on those participants separately. Therefore, applicants and 
other participants (or their counsel or representative) must apply for 
and receive a digital ID certificate before adjudicatory documents are 
filed so that they can obtain access to the documents via the E-Filing 
system.
    A person filing electronically using the NRC's adjudicatory E-
Filing system may seek assistance by contacting the NRC's Electronic 
Filing Help Desk through the ``Contact Us'' link located on the NRC's 
public website at http://www.nrc.gov/site-help/e-submittals.html, by 
email to [email protected], or by a toll-free call at 1-866-672-
7640. The NRC Electronic Filing Help Desk is available between 9 a.m. 
and 6 p.m., Eastern Time, Monday through Friday, excluding government 
holidays.
    Participants who believe that they have a good cause for not 
submitting documents electronically must file an exemption request, in 
accordance with 10 CFR 2.302(g), with their initial paper filing 
stating why there is good cause for not filing electronically and 
requesting authorization to continue to submit documents in paper 
format. Such filings must be submitted by: (1) First class mail 
addressed to the Office of the Secretary of the Commission, U.S. 
Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: 
Rulemaking and Adjudications Staff; or (2) courier, express mail, or 
expedited delivery service to the Office of the Secretary, 11555 
Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and 
Adjudications Staff. Participants filing adjudicatory documents in this 
manner are responsible for serving the document on all other 
participants. Filing is considered complete by first-class mail as of 
the time of deposit in the mail, or by courier, express mail, or 
expedited delivery service upon depositing the document with the 
provider of the service. A presiding officer, having

[[Page 404]]

granted an exemption request from using E-Filing, may require a 
participant or party to use E-Filing if the presiding officer 
subsequently determines that the reason for granting the exemption from 
use of E-Filing no longer exists.
    Documents submitted in adjudicatory proceedings will appear in the 
NRC's electronic hearing docket which is available to the public at 
https://adams.nrc.gov/ehd, unless excluded pursuant to an order of the 
Commission or the presiding officer. If you do not have an NRC-issued 
digital ID certificate as described above, click cancel when the link 
requests certificates and you will be automatically directed to the 
NRC's electronic hearing dockets where you will be able to access any 
publicly available documents in a particular hearing docket. 
Participants are requested not to include personal privacy information, 
such as social security numbers, home addresses, or personal phone 
numbers in their filings, unless an NRC regulation or other law 
requires submission of such information. For example, in some 
instances, individuals provide home addresses in order to demonstrate 
proximity to a facility or site. With respect to copyrighted works, 
except for limited excerpts that serve the purpose of the adjudicatory 
filings and would constitute a Fair Use application, participants are 
requested not to include copyrighted materials in their submission.

    Dated at King of Prussia, Pennsylvania, this 17th day of 
November 2017.
    For the Nuclear Regulatory Commission.
Raymond J. Powell,
Chief, Decommissioning, ISFSI, and Reactor Health Physics Branch, 
Division of Nuclear Materials Safety, Region I.
[FR Doc. 2017-28331 Filed 1-2-18; 8:45 am]
BILLING CODE 7590-01-P