Department of Health and Human Services, Food and Drug Administration, Winchester Engineering and Analytical Center, 401-404 [2017-28331]
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Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Notices
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
[Notice (17–091)]
Notice of Intent To Grant Partially
Exclusive Term License Take Out This
Space
National Aeronautics and
Space Administration.
ACTION: Notice of intent to grant
partially exclusive term license.
AGENCY:
NASA hereby gives notice of
its intent to grant a partially-exclusive
term license in the United States to
practice the invention described and
claimed in U.S. Patent 6,760,487
entitled, ‘‘Estimated Spectrum Adaptive
Postfilter And The Iterative Prepost
Filtering Algorithms’’, and in U.S.
Patent 9,414,072 entitled ‘‘Improved
Performance of the JPEG Estimated
Spectrum Adaptive Postfilter (JPEG–
ESAP) for Low Bit Rates’’ to Human
Health Organization (‘‘H2O’’), having its
principal place of business in Studio
City, CA.
DATES: The prospective partiallyexclusive term license may be granted
unless NASA receives written
objections, including evidence and
argument no later than January 18, 2018,
that establish that the grant of the
license would not be consistent with the
requirements regarding the licensing of
federally owned inventions as set forth
in the Bayh-Dole Act and implementing
regulations. Competing applications
completed and received by NASA no
later than January 18, 2018 will also be
treated as objections to the grant of the
contemplated partially exclusive
license. Objections submitted in
response to this notice will not be made
available to the public for inspection
and, to the extent permitted by law, will
not be released under the Freedom of
Information Act.
ADDRESSES: Objections relating to the
prospective license may be submitted to
Patent Counsel, Bryan A. Geurts,
Goddard Space Flight Center, 8800
Greenbelt Road, M/S 140.1, Greenbelt,
MD 20771. Phone (301) 286–7351.
Facsimile (301) 286–9502.
FOR FURTHER INFORMATION CONTACT:
Enidia Santiago-Arce, Innovative
Partnerships Program Office, Goddard
Space Flight Center, 8800 Greenbelt
Road, M/S 504, Greenbelt, MD 20771.
Phone (301) 286–5810.
SUPPLEMENTARY INFORMATION: This
notice of intent to grant a partiallyexclusive term patent license is issued
in accordance with 35 U.S.C. 209(e) and
37 CFR 404.7(a)(1)(i). The patent rights
in these inventions have been assigned
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SUMMARY:
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to the United States of America as
represented by the Administrator of the
National Aeronautics and Space
Administration. The prospective
partially exclusive license will comply
with the requirements of 35 U.S.C. 209
and 37 CFR 404.7.
Information about other NASA
inventions available for licensing can be
found online at https://
technology.nasa.gov.
Mark P. Dvorscak,
Agency Counsel for Intellectual Property.
[FR Doc. 2017–28388 Filed 1–2–18; 8:45 am]
401
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
Nuclear Regulatory
Commission.
ACTION: License amendment application;
opportunity to provide comments,
request a hearing and to petition for
leave to intervene.
AGENCY:
BILLING CODE 7510–13–P
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.
SUMMARY:
NATIONAL TRANSPORTATION
SAFETY BOARD
Sunshine Act Meeting
AGENDA
9:00 a.m., Tuesday,
January 23, 2018.
PLACE: NTSB Conference Center, 429
L’Enfant Plaza SW, Washington, DC
20594.
STATUS: The one item is open to the
public.
MATTERS TO BE CONSIDERED: 5292
Aircraft Accident Report—Uncontained
Engine Failure and Subsequent Fire,
American Airlines Flight 383, Boeing
767–323, N345AN, Chicago, Illinois,
October 28, 2016.
NEWS MEDIA CONTACT: Telephone: (202)
314–6100. The press and public may
enter the NTSB Conference Center one
hour prior to the meeting for set up and
seating.
Individuals requesting specific
accommodations should contact
Rochelle McCallister at (202) 314–6305
or by email at Rochelle.McCallister@
ntsb.gov by Wednesday, January 17,
2018.
The public may view the meeting via
a live or archived webcast by accessing
a link under ‘‘News & Events’’ on the
NTSB home page at www.ntsb.gov.
Schedule updates, including weatherrelated cancellations, are also available
at www.ntsb.gov.
FOR MORE INFORMATION CONTACT: Candi
Bing at (202) 314–6403 or by email at
bingc@ntsb.gov.
FOR MEDIA INFORMATION CONTACT: Peter
Knudson at (202) 314–6100 or by email
at peter.knudson@ntsb.gov.
TIME AND DATE:
Dated: December 29, 2017.
LaSean McCray,
Alternate Federal Register Liaison Officer.
[FR Doc. 2017–28508 Filed 12–29–17; 4:15 pm]
BILLING CODE 7533–01–P
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You may submit comments
by any of the following methods:
• Federal Rulemaking website: Go to
https://www.regulations.gov and search
for Docket ID NRC–2017–0221. Address
questions about NRC dockets to Carol
Gallagher; telephone: 301–415–3463;
email: Carol.Gallagher@nrc.gov. 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;
ADDRESSES:
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Federal Register / Vol. 83, No. 2 / Wednesday, January 3, 2018 / Notices
telephone: 610–337–5399; fax number:
610–337–5269; email:
Stephen.Hammann@nrc.gov.
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 publiclyavailable information related to this
action by any of the following methods:
• Federal Rulemaking website: Go to
https://www.regulations.gov and search
for Docket ID NRC–2017–0221.
• NRC’s Agencywide Documents
Access and Management System
(ADAMS): You may obtain publiclyavailable documents online in the
ADAMS Public Documents collection at
https://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 pdr.resource@nrc.gov. 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.
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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 https://
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.
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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 § 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.
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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
https://www.nrc.gov/reading-rm/doccollections/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
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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 nonparty 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.
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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 EFiling 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 https://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
hearing.docket@nrc.gov, 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 https://
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 https://www.nrc.gov/
site-help/electronic-sub-ref-mat.html. A
filing is considered complete at the time
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403
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 EFiling 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 https://
www.nrc.gov/site-help/esubmittals.html, by email to
MSHD.Resource@nrc.gov, or by a tollfree 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
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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
OFFICE OF PERSONNEL
MANAGEMENT
Submission for Review: Disabled
Dependent Questionnaire, RI 30–10
Office of Personnel
Management.
ACTION: 30-Day notice and request for
comments.
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AGENCY:
The Retirement Services,
Office of Personnel Management (OPM)
offers the general public and other
Federal agencies the opportunity to
comment on a reinstatement with
change of an expired information
collection request (ICR), Disabled
Dependent Questionnaire, RI 30–10.
SUMMARY:
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Comments are encouraged and
will be accepted until February 2, 2018.
ADDRESSES: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503, Attention: Desk
Officer for the Office of Personnel
Management or sent via electronic mail
to oira_submission@omb.eop.gov or
faxed to (202) 395–6974.
FOR FURTHER INFORMATION CONTACT: A
copy of this ICR, with applicable
supporting documentation, may be
obtained by contacting the Retirement
Services Publications Team, Office of
Personnel Management, 1900 E Street
NW, Room 3316–L, Washington, DC
20415, Attention: Cyrus S. Benson, or
sent via electronic mail to
Cyrus.Benson@opm.gov or faxed to
(202) 606–0910 or reached via telephone
at (202) 606–4808.
SUPPLEMENTARY INFORMATION: As
required by the Paperwork Reduction
Act of 1995, (Pub. L. 104–13, 44 U.S.C.
chapter 35) as amended by the ClingerCohen Act (Pub. L. 104–106), OPM is
soliciting comments for this collection.
The information collection (OMB No.
3206–0179) was previously published in
the Federal Register on May 5, 2017, at
82 FR 21275, allowing for a 60-day
public comment period. No comments
were received for this collection. The
purpose of this notice is to allow an
additional 30 days for public comments.
The Office of Management and Budget
is particularly interested in comments
that:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
Form RI 30–10 is used to collect
sufficient information about the medical
condition and earning capacity for the
DATES:
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Office of Personnel Management to be
able to determine whether a disabled
adult child is eligible for health benefits
coverage and/or survivor annuity
payments under the Civil Service
Retirement System or the Federal
Employees Retirement System.
Analysis
Agency: Retirement Operations,
Retirement Services, Office of Personnel
Management.
Title: Disabled Dependent
Questionnaire.
OMB Number: 3206–0179.
Frequency: On occasion.
Affected Public: Individual or
Households.
Number of Respondents: 2,500.
Estimated Time per Respondent: 1
hour.
Total Burden Hours: 2,500 hours.
U.S. Office of Personnel Management.
Kathleen M. McGettigan,
Acting Director.
[FR Doc. 2017–28411 Filed 1–2–18; 8:45 am]
BILLING CODE 6325–38–P
POSTAL SERVICE
Product Change—Priority Mail Express
Negotiated Service Agreement
AGENCY:
ACTION:
Postal ServiceTM.
Notice.
The Postal Service gives
notice of filing a request with the Postal
Regulatory Commission to add a
domestic shipping services contract to
the list of Negotiated Service
Agreements in the Mail Classification
Schedule’s Competitive Products List.
SUMMARY:
Date of required notice: January
3, 2018.
DATES:
FOR FURTHER INFORMATION CONTACT:
Elizabeth A. Reed, 202–268–3179.
The
United States Postal Service® hereby
gives notice that, pursuant to 39 U.S.C.
3642 and 3632(b)(3), on December 27,
2017, it filed with the Postal Regulatory
Commission a USPS Request to Add
Priority Mail Express Contract 60 to
Competitive Product List. Documents
are available at www.prc.gov, Docket
Nos. MC2018–93, CP2018–135.
SUPPLEMENTARY INFORMATION:
Elizabeth A. Reed,
Attorney, Corporate and Postal Business Law.
[FR Doc. 2017–28355 Filed 1–2–18; 8:45 am]
BILLING CODE 7710–12–P
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[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]
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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.
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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 https://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;
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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 https://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 https://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 https://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 https://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
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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 https://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 https://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 https://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 https://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
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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
