[Federal Register Volume 81, Number 227 (Friday, November 25, 2016)]
[Notices]
[Page 85303]
[FR Doc No: 2016-28286]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Sixteenth Meeting of the RTCA Tactical Operations Committee

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Sixteenth Meeting of the RTCA Tactical Operations Committee.

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SUMMARY: The FAA is issuing this notice to advise the public of the
Sixteenth Meeting of the RTCA Tactical Operations Committee.

DATES: The meeting will be held December 13, 2016, 01:00 p.m.-03:00
p.m.

ADDRESS:  The meeting will be held at: RTCA Headquarters, 1150 18th
Street NW., Suite 910, Washington, DC 20036.

FOR FURTHER INFORMATION, CONTACT:  Trin Mitra at<EMAIL_ADDRESS>or
202-330-0655, the RTCA Secretariat, 1150 18th Street NW., Suite 910,
Washington, DC 20036, or by telephone at<PHONE_NUMBER>, fax at (202)
833-9434, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for the Fifteenth Meeting of the RTCA Tactical Operations
Committee. The agenda will include the following:

Tuesday, December 13, 2016--1:00 p.m.-3:00 p.m.

1. Opening of Meeting/Introduction of TOC Members--Co-Chairs Dale
Wright and Bryan Quigley
2. Official Statement of Designated Federal Official--Elizabeth Ray
3. Approval of October 27, 2016 Meeting Summary
4. Graphical TFR Task Group--Recommendation
5. GPS Adjacent Band Compatibility Task Group--Ligado Proposal Review
Recommendation
6. Updates on Future TOC Tasks
7. Other Business
8. Adjourn

    Attendance is open to the interested public but limited to space
availability. Given limited space on-site, members of the public that
wish to participate virtually can request dial-in and online meeting
information by contacting Trin Mitra, TOC Secretary, at
<EMAIL_ADDRESS>With the approval of the chairman, members of the
public may present oral statements at the meeting. Persons wishing to
present statements or obtain information should contact the person
listed in the FOR FURTHER INFORMATION CONTACT section. Members of the
public may present a written statement to the committee at any time.
Issued in Washington, DC on November 18, 2016.

Mohannad Dawoud,
Management & Program Analyst, Partnership Contracts Branch, ANG-A17,
NextGen, Procurement Services Division, Federal Aviation
Administration.
[FR Doc. 2016-28286 Filed 11-23-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: September 23, 2009 (Volume 74, Number 183)]
[Rules and Regulations]
[Page 48412-48421]
[DOCID:fr23se09-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-2008-0574, EPA-HQ-SFUND-2009-0071, EPA-HQ-SFUND-2009-
0074, EPA-HQ-SFUND-2009-0075, EPA-HQ-SFUND-2009-0068, EPA-HQ-SFUND-
2009-0069, EPA-HQ-SFUND-2008-0579, EPA-HQ-SFUND-2009-0072, EPA-HQ-
SFUND-2009-0064, EPA-HQ-SFUND-2009-0073, EPA-HQ-SFUND-1997-0009; FRL-
8961-3]
RIN 2050-AD75

National Priorities List, Final Rule No. 47

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

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SUMMARY: The Comprehensive Environmental Response,

Compensation, and Liability Act of 1980 (``CERCLA'' or ``the Act''), as
amended, requires that the National Oil and Hazardous Substances
Pollution Contingency Plan (``NCP'') include a list of national
priorities among the known releases or threatened releases of hazardous
substances, pollutants, or contaminants throughout the United States.
The National Priorities List (``NPL'') constitutes this list. The NPL
is intended primarily to guide the Environmental Protection Agency
(``EPA'' or ``the Agency'') in determining which sites warrant further
investigation. These further investigations will allow EPA to assess
the nature and extent of public health and environmental risks
associated with the site and to determine what CERCLA-financed remedial
action(s), if any, may be appropriate. This rule adds 11 sites to the
NPL, all to the General Superfund Section.

DATES: Effective Date: The effective date for this amendment to the NCP
is October 23, 2009.

ADDRESSES: For addresses for the Headquarters and Regional dockets, as
well as further details on what these dockets contain, see section II,
``Availability of Information to the Public'' in the SUPPLEMENTARY
INFORMATION portion of this preamble.

FOR FURTHER INFORMATION CONTACT: Terry Jeng, phone:<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>Site Assessment and Remedy Decisions Branch;
Assessment and Remediation Division; Office of Superfund Remediation
and Technology Innovation (mail code 5204P); U.S. Environmental
Protection Agency; 1200 Pennsylvania Avenue, NW.; Washington, DC 20460;
or the Superfund Hotline, phone<PHONE_NUMBER> or<PHONE_NUMBER> in the
Washington, DC metropolitan area.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    A. What Are CERCLA and SARA?
    B. What Is the NCP?
    C. What Is the National Priorities List (NPL)?
    D. How Are Sites Listed on the NPL?
    E. What Happens to Sites on the NPL?
    F. Does the NPL Define the Boundaries of Sites?
    G. How Are Sites Removed From the NPL?
    H. May EPA Delete Portions of Sites From the NPL as They Are
Cleaned Up?
    I. What Is the Construction Completion List (CCL)?
    J. What Is the Sitewide Ready for Anticipated Use Measure?
II. Availability of Information to the Public
    A. May I Review the Documents Relevant to This Final Rule?
    B. What Documents Are Available for Review at the Headquarters
Docket?
    C. What Documents Are Available for Review at the Regional
Dockets?
    D. How Do I Access the Documents?
    E. How May I Obtain a Current List of NPL Sites?
III. Contents of This Final Rule
    A. Additions to the NPL
    B. Site Name Change
    C. What did EPA Do With the Public Comments It Received?
IV. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    1. What Is Executive Order 12866?
    2. Is This Final Rule Subject to Executive Order 12866 Review?
    B. Paperwork Reduction Act
    1. What Is the Paperwork Reduction Act?
    2. Does the Paperwork Reduction Act Apply to This Final Rule?
    C. Regulatory Flexibility Act
    1. What Is the Regulatory Flexibility Act?
    2. How Has EPA Complied With the Regulatory Flexibility Act?
    D. Unfunded Mandates Reform Act
    1. What Is the Unfunded Mandates Reform Act (UMRA)?
    2. Does UMRA Apply to This Final Rule?
    E. Executive Order 13132: Federalism
    1. What Is Executive Order 13132?
    2. Is Executive Order 13132 Applicable to This Final Rule?
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    1. What Is Executive Order 13175?
    2. Does Executive Order 13175 Apply to This Final Rule?
    G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    1. What Is Executive Order 13045?
    2. Does Executive Order 13045 Apply to This Final Rule?
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Usage
    Is This Rule Subject to Executive Order 13211?
    I. National Technology Transfer and Advancement Act
    1. What Is the National Technology Transfer and Advancement Act?
    2. Does the National Technology Transfer and Advancement Act
Apply to This Final Rule?
    J. Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations
    1. What Is Executive Order 12898?
    2. Does Executive Order 12898 Apply to This Final Rule?
    K. Congressional Review Act
    1. Has EPA Submitted This Rule to Congress and the Government
Accountability Office?
    2. Could the Effective Date of This Final Rule Change?
    3. What Could Cause a Change in the Effective Date of This Rule?

I. Background

A. What Are CERCLA and SARA?

    In 1980, Congress enacted the Comprehensive Environmental Response,
Compensation, and Liability Act, 42 U.S.C. 9601-9675 (``CERCLA'' or
``the Act''), in response to the dangers of uncontrolled releases or
threatened releases of hazardous substances, and releases or
substantial threats of releases into the environment of any pollutant
or contaminant that may present an imminent or substantial danger to
the public health or welfare. CERCLA was amended on October 17, 1986,
by the Superfund Amendments and Reauthorization Act (``SARA''), Public
Law 99-499, 100 Stat. 1613 et seq.

B. What Is the NCP?

    To implement CERCLA, EPA promulgated the revised National Oil and
Hazardous Substances Pollution Contingency Plan (``NCP''), 40 CFR part
300, on July 16, 1982 (47 FR 31180), pursuant to CERCLA section 105 and
Executive Order 12316 (46 FR 42237, August 20, 1981). The NCP sets
guidelines and procedures for responding to releases and threatened
releases of hazardous substances, or releases or substantial threats of
releases into the environment of any pollutant or contaminant that may
present an imminent or substantial danger to the public health or
welfare. EPA has revised the NCP on several occasions. The most recent
comprehensive revision was on March 8, 1990 (55 FR 8666).
    As required under section 105(a)(8)(A) of CERCLA, the NCP also
includes ``criteria for determining priorities among releases or
threatened releases throughout the United States for the purpose of
taking remedial action and, to the extent practicable, taking into
account the potential urgency of such action, for the purpose of taking
removal action.'' ``Removal'' actions are defined broadly and include a
wide range of actions taken to study, clean up, prevent or otherwise
address releases and threatened releases of hazardous substances,
pollutants or contaminants (42 U.S.C. 9601(23)).

C. What Is the National Priorities List (NPL)?

    The NPL is a list of national priorities among the known or
threatened releases of hazardous substances, pollutants, or
contaminants throughout the United States. The list, which is appendix
B of the NCP (40 CFR part 300), was required under section 105(a)(8)(B)
of CERCLA, as amended. Section 105(a)(8)(B) defines the NPL as a list
of ``releases'' and the highest priority ``facilities'' and

requires that the NPL be revised at least annually. The NPL is intended
primarily to guide EPA in determining which sites warrant further
investigation to assess the nature and extent of public health and
environmental risks associated with a release of hazardous substances,
pollutants or contaminants. The NPL is only of limited significance,
however, as it does not assign liability to any party or to the owner
of any specific property. Also, placing a site on the NPL does not mean
that any remedial or removal action necessarily need be taken.
    For purposes of listing, the NPL includes two sections, one of
sites that are generally evaluated and cleaned up by EPA (the ``General
Superfund Section''), and one of sites that are owned or operated by
other Federal agencies (the ``Federal Facilities Section''). With
respect to sites in the Federal Facilities Section, these sites are
generally being addressed by other Federal agencies. Under Executive
Order 12580 (52 FR 2923, January 29, 1987) and CERCLA section 120, each
Federal agency is responsible for carrying out most response actions at
facilities under its own jurisdiction, custody, or control, although
EPA is responsible for preparing a Hazard Ranking System (``HRS'')
score and determining whether the facility is placed on the NPL.

D. How Are Sites Listed on the NPL?

    There are three mechanisms for placing sites on the NPL for
possible remedial action (see 40 CFR 300.425(c) of the NCP): (1) A site
may be included on the NPL if it scores sufficiently high on the HRS,
which EPA promulgated as appendix A of the NCP (40 CFR part 300). The
HRS serves as a screening tool to evaluate the relative potential of
uncontrolled hazardous substances, pollutants or contaminants to pose a
threat to human health or the environment. On December 14, 1990 (55 FR
51532), EPA promulgated revisions to the HRS partly in response to
CERCLA section 105(c), added by SARA. The revised HRS evaluates four
pathways: ground water, surface water, soil exposure, and air. As a
matter of Agency policy, those sites that score 28.50 or greater on the
HRS are eligible for the NPL. (2) Pursuant to 42 U.S.C. 9605(a)(8)(B),
each State may designate a single site as its top priority to be listed
on the NPL, without any HRS score. This provision of CERCLA requires
that, to the extent practicable, the NPL include one facility
designated by each State as the greatest danger to public health,
welfare, or the environment among known facilities in the State. This
mechanism for listing is set out in the NCP at 40 CFR 300.425(c)(2).
(3) The third mechanism for listing, included in the NCP at 40 CFR
300.425(c)(3), allows certain sites to be listed without any HRS score,
if all of the following conditions are met:
     The Agency for Toxic Substances and Disease Registry
(ATSDR) of the U.S. Public Health Service has issued a health advisory
that recommends dissociation of individuals from the release.
     EPA determines that the release poses a significant threat
to public health.
     EPA anticipates that it will be more cost-effective to use
its remedial authority than to use its removal authority to respond to
the release.
    EPA promulgated an original NPL of 406 sites on September 8, 1983
(48 FR 40658) and generally has updated it at least annually.

E. What Happens to Sites on the NPL?

    A site may undergo remedial action financed by the Trust Fund
established under CERCLA (commonly referred to as the ``Superfund'')
only after it is placed on the NPL, as provided in the NCP at 40 CFR
300.425(b)(1). (``Remedial actions'' are those ``consistent with
permanent remedy, taken instead of or in addition to removal actions *
* *.'' 42 U.S.C. 9601(24).) However, under 40 CFR 300.425(b)(2) placing
a site on the NPL ``does not imply that monies will be expended.'' EPA
may pursue other appropriate authorities to respond to the releases,
including enforcement action under CERCLA and other laws.

F. Does the NPL Define the Boundaries of Sites?

    The NPL does not describe releases in precise geographical terms;
it would be neither feasible nor consistent with the limited purpose of
the NPL (to identify releases that are priorities for further
evaluation), for it to do so. Indeed, the precise nature and extent of
the site are typically not known at the time of listing.
    Although a CERCLA ``facility'' is broadly defined to include any
area where a hazardous substance has ``come to be located'' (CERCLA
section 101(9)), the listing process itself is not intended to define
or reflect the boundaries of such facilities or releases. Of course,
HRS data (if the HRS is used to list a site) upon which the NPL
placement was based will, to some extent, describe the release(s) at
issue. That is, the NPL site would include all releases evaluated as
part of that HRS analysis.
    When a site is listed, the approach generally used to describe the
relevant release(s) is to delineate a geographical area (usually the
area within an installation or plant boundaries) and identify the site
by reference to that area. However, the NPL site is not necessarily
coextensive with the boundaries of the installation or plant, and the
boundaries of the installation or plant are not necessarily the
``boundaries'' of the site. Rather, the site consists of all
contaminated areas within the area used to identify the site, as well
as any other location where that contamination has come to be located,
or from where that contamination came.
    In other words, while geographic terms are often used to designate
the site (e.g., the ``Jones Co. plant site'') in terms of the property
owned by a particular party, the site, properly understood, is not
limited to that property (e.g., it may extend beyond the property due
to contaminant migration), and conversely may not occupy the full
extent of the property (e.g., where there are uncontaminated parts of
the identified property, they may not be, strictly speaking, part of
the ``site''). The ``site'' is thus neither equal to, nor confined by,
the boundaries of any specific property that may give the site its
name, and the name itself should not be read to imply that this site is
coextensive with the entire area within the property boundary of the
installation or plant. In addition, the site name is merely used to
help identify the geographic location of the contamination, and is not
meant to constitute any determination of liability at a site. For
example, the name ``Jones Co. plant site,'' does not imply that the
Jones company is responsible for the contamination located on the plant
site.
    EPA regulations provide that the Remedial Investigation (``RI'')
``is a process undertaken * * * to determine the nature and extent of
the problem presented by the release'' as more information is developed
on site contamination, and which is generally performed in an
interactive fashion with the Feasibility Study (``FS'') (40 CFR 300.5).
During the RI/FS process, the release may be found to be larger or
smaller than was originally thought, as more is learned about the
source(s) and the migration of the contamination. However, the HRS
inquiry focuses on an evaluation of the threat posed and therefore the
boundaries of the release need not be exactly defined. Moreover, it
generally is impossible to discover the full extent of where the
contamination ``has come to be located'' before all necessary studies
and remedial work are completed at a site. Indeed, the known

boundaries of the contamination can be expected to change over time.
Thus, in most cases, it may be impossible to describe the boundaries of
a release with absolute certainty.
    Further, as noted above, NPL listing does not assign liability to
any party or to the owner of any specific property. Thus, if a party
does not believe it is liable for releases on discrete parcels of
property, it can submit supporting information to the Agency at any
time after it receives notice it is a potentially responsible party.
    For these reasons, the NPL need not be amended as further research
reveals more information about the location of the contamination or
release.

G. How Are Sites Removed From the NPL?

    EPA may delete sites from the NPL where no further response is
appropriate under Superfund, as explained in the NCP at 40 CFR
300.425(e). This section also provides that EPA shall consult with
states on proposed deletions and shall consider whether any of the
following criteria have been met:
    (i) Responsible parties or other persons have implemented all
appropriate response actions required;
    (ii) All appropriate Superfund-financed response has been
implemented and no further response action is required; or
    (iii) The remedial investigation has shown the release poses no
significant threat to public health or the environment, and taking of
remedial measures is not appropriate.

H. May EPA Delete Portions of Sites From the NPL as They Are Cleaned
Up?

    In November 1995, EPA initiated a new policy to delete portions of
NPL sites where cleanup is complete (60 FR 55465, November 1, 1995).
Total site cleanup may take many years, while portions of the site may
have been cleaned up and made available for productive use.

I. What Is the Construction Completion List (CCL)?

    EPA also has developed an NPL construction completion list
(``CCL'') to simplify its system of categorizing sites and to better
communicate the successful completion of cleanup activities (58 FR
12142, March 2, 1993). Inclusion of a site on the CCL has no legal
significance.
    Sites qualify for the CCL when: (1) Any necessary physical
construction is complete, whether or not final cleanup levels or other
requirements have been achieved; (2) EPA has determined that the
response action should be limited to measures that do not involve
construction (e.g., institutional controls); or (3) the site qualifies
for deletion from the NPL. For the most up-to-date information on the
CCL, see EPA's Internet site at http://www.epa.gov/superfund/cleanup/
ccl.htm.

J. What Is the Sitewide Ready for Anticipated Use Measure?

    The Sitewide Ready for Anticipated Use measure (formerly called
Sitewide Ready-for-Reuse) represents important Superfund
accomplishments and the measure reflects the high priority EPA places
on considering anticipated future land use as part of our remedy
selection process. See Guidance for Implementing the Sitewide Ready-
for-Reuse Measure, May 24, 2006, OSWER 9365.0-36. This measure applies
to final and deleted sites where construction is complete, all cleanup
goals have been achieved, and all institutional or other controls are
in place. EPA has been successful on many occasions in carrying out
remedial actions that ensure protectiveness of human health and the
environment, including current and future land users, in a manner that
allows contaminated properties to be restored to environmental and
economic vitality while ensuring protectiveness for current and future
land users. For further information, please go to http://www.epa.gov/
superfund/programs/recycle/tools/index.html.

II. Availability of Information to the Public

A. May I Review the Documents Relevant to This Final Rule?

    Yes, documents relating to the evaluation and scoring of the sites
in this final rule are contained in dockets located both at EPA
Headquarters and in the Regional offices.
    An electronic version of the public docket is available through
www.regulations.gov (see table below for Docket Identification
numbers). Although not all Docket materials may be available
electronically, you may still access any of the publicly available
Docket materials through the Docket facilities identified below in
section II D.

----------------------------------------------------------------------------------------------------------------
              Site name                   City/county, state                   FDMS Docket ID No.
----------------------------------------------------------------------------------------------------------------
B.F. Goodrich........................  Rialto, CA.............  EPA-HQ-SFUND-2008-0574
Lane Street Ground Water               Elkhart, IN............  EPA-HQ-SFUND-2009-0071
 Contamination.
Southwest Jefferson County Mining....  Jefferson County, MO...  EPA-HQ-SFUND-2009-0074
Flat Creek IMM.......................  Superior, MT...........  EPA-HQ-SFUND-2009-0075
Ore Knob Mine........................  Ashe County, NC........  EPA-HQ-SFUND-2009-0068
GMH Electronics......................  Roxboro, NC............  EPA-HQ-SFUND-2009-0069
Curtis Specialty Papers, Inc.........  Milford, NJ............  EPA-HQ-SFUND-2008-0579
Little Scioto River..................  Marion County, OH......  EPA-HQ-SFUND-2009-0072
Salford Quarry.......................  Lower Salford Township,  EPA-HQ-SFUND-1997-0009
                                        PA.
Papelera Puertorriquena, Inc.........  Utuado, PR.............  EPA-HQ-SFUND-2009-0064
Amcast Industrial Corporation........  Cedarburg, WI..........  EPA-HQ-SFUND-2009-0073
----------------------------------------------------------------------------------------------------------------

B. What Documents Are Available for Review at the Headquarters Docket?

    The Headquarters Docket for this rule contains, for each site, the
HRS score sheets, the Documentation Record describing the information
used to compute the score, pertinent information regarding statutory
requirements or EPA listing policies that affect the site, and a list
of documents referenced in the Documentation Record. For sites that
received comments during the comment period, the Headquarters Docket
also contains a Support Document that includes EPA's responses to
comments.

C. What Documents Are Available for Review at the Regional Dockets?

    The Regional Dockets contain all the information in the
Headquarters Docket, plus the actual reference documents containing the
data principally relied upon by EPA in calculating or evaluating the
HRS score for the sites located in their Region. These reference
documents are available only in the

Regional Dockets. For sites that received comments during the comment
period, the Regional Docket also contains a Support Document that
includes EPA's responses to comments.

D. How Do I Access the Documents?

    You may view the documents, by appointment only, after the
publication of this rule. The hours of operation for the Headquarters
Docket are from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding Federal holidays. Please contact the Regional Dockets for
hours.
    Following is the contact information for the EPA Headquarters:
Docket Coordinator, Headquarters; U.S. Environmental Protection Agency;
CERCLA Docket Office; 1301 Constitution Avenue, NW.; EPA West, Room
3334, Washington, DC 20004, 202/566-0276.
    The contact information for the Regional Dockets is as follows:

Joan Berggren, Region 1 (CT, ME, MA, NH, RI, VT), U.S. EPA, Superfund
Records and Information Center, Mailcode HSC, One Congress Street,
Suite 1100, Boston, MA 02114-2023; 617/918-1417.
Dennis Munhall, Region 2 (NJ, NY, PR, VI), U.S. EPA, 290 Broadway, New
York, NY 10007-1866; 212/637-4343.
Dawn Shellenberger (ASRC), Region 3 (DE, DC, MD, PA, VA, WV), U.S. EPA,
Library, 1650 Arch Street, Mailcode 3PM52, Philadelphia, PA 19103; 215/
814-5364.
Debbie Jourdan, Region 4 (AL, FL, GA, KY, MS, NC, SC, TN), U.S. EPA, 61
Forsyth Street, SW., Mailcode 9T25, Atlanta, GA 30303; 404/562-8862.
Janet Pfundheller, Region 5 (IL, IN, MI, MN, OH, WI), U.S. EPA, Records
Center, Superfund Division SMR-7J, Metcalfe Federal Building, 77 West
Jackson Boulevard, Chicago, IL 60604; 312/353-5821.
Brenda Cook, Region 6 (AR, LA, NM, OK, TX), U.S. EPA, 1445 Ross Avenue,
Suite 1200, Mailcode 6SFTS, Dallas, TX 75202-2733; 214/665-7436.
Michelle Quick, Region 7 (IA, KS, MO, NE), U.S. EPA, 901 North 5th
Street, Mailcode SUPRERNB, Kansas City, KS 66101; 913/551-7335.
Gwen Christiansen, Region 8 (CO, MT, ND, SD, UT, WY), U.S. EPA, 1595
Wynkoop Street, Mailcode 8EPR-B, Denver, CO 80202-1129; 303/312-6463.
Karen Jurist, Region 9 (AZ, CA, HI, NV, AS, GU, MP), U.S. EPA, 75
Hawthorne Street, Mailcode SFD-9-1, San Francisco, CA 94105; 415/972-
3219.
Ken Marcy, Region 10 (AK, ID, OR, WA), U.S. EPA, 1200 6th Avenue,
Mailcode ECL-112, Seattle, WA 98101; 206/463-1349.

E. How May I Obtain a Current List of NPL Sites?

    You may obtain a current list of NPL sites via the Internet at
http://www.epa.gov/superfund/ (look under the Superfund sites category)
or by contacting the Superfund Docket (see contact information above).

III. Contents of This Final Rule

A. Additions to the NPL

    This final rule adds the following 11 sites to the NPL, all to the
General Superfund Section. The sites are presented in the table below:

----------------------------------------------------------------------------------------------------------------
                State                            Site name                            City/county
----------------------------------------------------------------------------------------------------------------
CA...................................  B.F. Goodrich................  Rialto.
IN...................................  Lane Street Ground Water       Elkhart.
                                        Contamination.
MO...................................  Southwest Jefferson County     Jefferson County.
                                        Mining.
MT...................................  Flat Creek IMM...............  Superior.
NC...................................  Ore Knob Mine................  Ashe County.
NC...................................  GMH Electronics..............  Roxboro.
NJ...................................  Curtis Specialty Papers, Inc.  Milford.
OH...................................  Little Scioto River..........  Marion County.
PA...................................  Salford Quarry...............  Lower Salford Township.
PR...................................  Papelera Puertorriquena, Inc.  Utuado.
WI...................................  Amcast Industrial Corporation  Cedarburg.
----------------------------------------------------------------------------------------------------------------

B. Site Name Change

    The Curtis Specialty Papers, Inc. site in Milford, New Jersey, was
proposed to the NPL under a different name. The former name was Curtis
Papers, Inc. (see Proposed Rule at 73 FR 51393, September 3, 2008). EPA
believes the new name, Curtis Specialty Papers, Inc., more accurately
identifies the site.

C. What Did EPA Do With the Public Comments It Received?

    EPA reviewed all comments received on the sites in this rule and
responded to all relevant comments.
    Eleven sites are being finalized in this rule. EPA received adverse
comments related to the HRS scoring of two sites: B.F Goodrich and
Curtis Specialty Papers, Inc. The comments, EPA's responses to the
comments, and the impacts, if any, on the HRS scores, are presented in
support documents responding to the comments for each of the two sites.
These support documents are being placed in the Headquarters and
regional dockets concurrently with the publication of this rule.
    EPA received non-HRS comments for three sites. For two of these
sites, Papelera Puertorriquena, Inc. and Amcast Industrial Corporation,
commenters requested extensions of the comment period in order to have
more review time and discuss voluntary cleanup options (Papelera
Puertorriquena, Inc.) and in order to complete due diligence and
purchase negotiations (Amcast Industrial Corporation). EPA denied both
extension requests. There were no errors in the materials available
during the comment period in either docket, and therefore, the
commenters had adequate opportunity to comment upon the proposed
listing and the underlying record for the listings. Moreover, EPA is
finalizing the sites because EPA, Puerto Rico and Wisconsin believe
listing is the most effective way of obtaining site cleanup. This
action should not interfere with a voluntary cleanup at Papelera
Puertorriquena, Inc. EPA notes that potentially responsible parties
(PRPs) may undertake the RI/FS and/or remedial design/remedial action
stages under supervision and pursuant to appropriate agreements with
governmental authorities. PRPs may also take part in the remedy
selection process through public participation opportunities. Regarding
Amcast Industrial Corporation, where a potential developer requested
the extension in order to pursue EPA brownfields grant funding, this
arrangement would have been precluded once the site was proposed; sites
proposed to the NPL are not

eligible to be considered for brownfields funding. The mayor of
Cedarburg commented in support of listing the Amcast site, which EPA is
doing through this final rule.
    In the case of the third site, Flat Creek IMM, four commenters
supported listing but urged EPA to use local workers and implement an
Historically Underutilized Business (HUB) zone set aside. EPA
anticipates using the local work force at later stages of the Superfund
process, but cannot create a HUB zone set aside because this is the
responsibility of the Small Business Administration. Another commenter
raised several different issues regarding the site. The commenter first
provided dates and other site history details that were sometimes
inconsistent with the documentation in the HRS record, which EPA based
on materials from the Montana Department of State Lands. Regardless of
whether the commenter or the State documents are correct, the
differences have no impact on the site score since the information
presented in the Site History and Description sections of the HRS
documentation record was not used to compute the HRS score. The
commenter claimed mining activities did not contaminate the ground
water or surface drinking water. This has no bearing on the score
because neither the ground water pathway nor the surface drinking water
pathway was used in the scoring; the site was scored on the soil
exposure and surface water environmental and human food chain pathways.
The commenter next claimed the levels of lead in two dumptrucks worth
of the tailings were less than the levels in the two batteries of the
commenter's pickup. In response, although lead was identified as being
at the site, it was not used to calculate the site score, and removing
it from the record would have no impact on the score. The commenter
claimed fish still inhabit Flat Creek. This is consistent with the HRS
record, which documents a fishery to be present within Flat Creek. The
commenter also stated that most people have no contact with the
tailings located along Flat Creek. Even if true, this comment does not
affect the HRS site score because the soil exposure pathway scoring for
the site considered locations other than the tailings along Flat Creek
in computing the HRS score. In conclusion, these comments have no
impact on the HRS score or listing decision for the Flat Creek IMM
site.
    For the six remaining sites being finalized in this rule, EPA
received no comments during the comment period: Lane Street Ground
Water Contamination; Southwest Jefferson County Mining; Ore Knob Mine;
GMH Electronics; Little Scioto River; and Salford Quarry.
    All comments that were received by EPA are contained in the
Headquarters Docket and are also listed in EPA's electronic public
Docket and comment system at www.regulations.gov.

IV. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

1. What Is Executive Order 12866?
    Under Executive Order 12866 (58 FR 51735 (October 4, 1993)), the
Agency must determine whether a regulatory action is ``significant''
and therefore subject to Office of Management and Budget (OMB) review
and the requirements of the Executive Order. The Order defines
``significant regulatory action'' as one that is likely to result in a
rule that may: (1) Have an annual effect on the economy of $100 million
or more or adversely affect in a material way the economy, a sector of
the economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities; (2) create a serious inconsistency or otherwise interfere
with an action taken or planned by another agency; (3) materially alter
the budgetary impact of entitlements, grants, user fees, or loan
programs or the rights and obligations of recipients thereof; or (4)
raise novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in the Executive
Order.
2. Is This Final Rule Subject to Executive Order 12866 Review?
    No. The listing of sites on the NPL does not impose any obligations
on any entities. The listing does not set standards or a regulatory
regime and imposes no liability or costs. Any liability under CERCLA
exists irrespective of whether a site is listed. It has been determined
that this action is not a ``significant regulatory action'' under the
terms of Executive Order 12866 and is therefore not subject to OMB
review.

B. Paperwork Reduction Act

1. What Is the Paperwork Reduction Act?
    According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information that requires OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations, after initial display in the preamble of the final rules,
are listed in 40 CFR part 9.
2. Does the Paperwork Reduction Act Apply to This Final Rule?
    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
EPA has determined that the PRA does not apply because this rule does
not contain any information collection requirements that require
approval of the OMB.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements;
train personnel to be able to respond to a collection of information;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information.
    An agency may not conduct or sponsor, and a person is not required
to respond to a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

1. What Is the Regulatory Flexibility Act?
    Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.,
as amended by the Small Business Regulatory Enforcement Fairness Act
(SBREFA) of 1996) whenever an agency is required to publish a notice of
rulemaking for any proposed or final rule, it must prepare and make
available for public comment a regulatory flexibility analysis that
describes the effect of the rule on small entities (i.e., small
businesses, small organizations, and small governmental jurisdictions).
However, no regulatory flexibility analysis is required if the head of
an agency certifies the rule will not have a significant economic
impact on a substantial number of small entities. SBREFA amended the
Regulatory Flexibility Act to require Federal agencies to provide a
statement of the factual basis for certifying that a

rule will not have a significant economic impact on a substantial
number of small entities.
2. How Has EPA Complied With the Regulatory Flexibility Act?
    This rule listing sites on the NPL does not impose any obligations
on any group, including small entities. This rule also does not
establish standards or requirements that any small entity must meet,
and imposes no direct costs on any small entity. Whether an entity,
small or otherwise, is liable for response costs for a release of
hazardous substances depends on whether that entity is liable under
CERCLA 107(a). Any such liability exists regardless of whether the site
is listed on the NPL through this rulemaking. Thus, this rule does not
impose any requirements on any small entities. For the foregoing
reasons, I certify that this rule will not have a significant economic
impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act

1. What Is the Unfunded Mandates Reform Act (UMRA)?
    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures by State, local, and tribal governments, in
the aggregate, or by the private sector, of $100 million or more in any
one year. Before EPA promulgates a rule where a written statement is
needed, section 205 of the UMRA generally requires EPA to identify and
consider a reasonable number of regulatory alternatives and adopt the
least costly, most cost-effective, or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most cost-effective, or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirements that may significantly or uniquely affect small
governments, including tribal governments, it must have developed under
section 203 of the UMRA a small government agency plan. The plan must
provide for notifying potentially affected small governments, enabling
officials of affected small governments to have meaningful and timely
input in the development of EPA regulatory proposals with significant
Federal intergovernmental mandates, and informing, educating, and
advising small governments on compliance with the regulatory
requirements.
2. Does UMRA Apply to This Final Rule?
    This final rule does not contain a Federal mandate that may result
in expenditures of $100 million or more for State, local, and tribal
governments, in the aggregate, or the private sector in any one year.
Listing a site on the NPL does not itself impose any costs. Listing
does not mean that EPA necessarily will undertake remedial action. Nor
does listing require any action by a private party or determine
liability for response costs. Costs that arise out of site responses
result from site-specific decisions regarding what actions to take, not
directly from the act of placing a site on the NPL. Thus, this rule is
not subject to the requirements of section 202 and 205 of UMRA.
    This rule is also not subject to the requirements of section 203 of
UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments. As is mentioned
above, site listing does not impose any costs and would not require any
action of a small government.

E. Executive Order 13132: Federalism

1. What Is Executive Order 13132
    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.''
2. Is Executive Order 13132 Applicable to This Final Rule?
    This final rule does not have federalism implications. It will not
have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132, because it does not contain any
requirements applicable to States or other levels of government. Thus,
the requirements of the Executive Order do not apply to this final
rule.
    EPA believes, however, that this final rule may be of significant
interest to State governments. In the spirit of Executive Order 13132,
and consistent with EPA policy to promote communications between EPA
and State and local governments, EPA therefore consulted with State
officials and/or representatives of State governments early in the
process of developing the rule to permit them to have meaningful and
timely input into its development. All sites included in this final
rule were referred to EPA by States for listing. For all sites in this
rule, EPA received letters of support either from the Governor or a
State official who was delegated the authority by the Governor to speak
on their behalf regarding NPL listing decisions.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

1. What Is Executive Order 13175?
    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 6, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal government and Indian tribes.''
2. Does Executive Order 13175 Apply to This Final Rule?
    This final rule does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). Listing a site
on the NPL does not impose any costs on a tribe or require a tribe to
take remedial action. Thus, Executive Order 13175 does not apply to
this final rule.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

1. What Is Executive Order 13045?
    Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885,

April 23, 1997) applies to any rule that: (1) Is determined to be
``economically significant'' as defined under Executive Order 12866,
and (2) concerns an environmental health or safety risk that EPA has
reason to believe may have a disproportionate effect on children. If
the regulatory action meets both criteria, the Agency must evaluate the
environmental health or safety effects of the planned rule on children,
and explain why the planned regulation is preferable to other
potentially effective and reasonably feasible alternatives considered
by the Agency.
2. Does Executive Order 13045 Apply to This Final Rule?
    This rule is not subject to Executive Order 13045 because it is not
an economically significant rule as defined by Executive Order 12866,
and because the Agency does not have reason to believe the
environmental health or safety risks addressed by this section present
a disproportionate risk to children.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Usage

Is This Rule Subject to Executive Order 13211?
    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not
likely to have a significant adverse effect on the supply,
distribution, or use of energy. Further, we have concluded that this
rule is not likely to have any adverse energy impacts because proposing
a site to the NPL does not require an entity to conduct any action that
would require energy use, let alone that which would significantly
affect energy supply, distribution, or usage. Thus, Executive Order
13175 does not apply to this action.

I. National Technology Transfer and Advancement Act

1. What Is the National Technology Transfer and Advancement Act?
    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note), directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
2. Does the National Technology Transfer and Advancement Act Apply to
This Final Rule?
    No. This rulemaking does not involve technical standards.
Therefore, EPA did not consider the use of any voluntary consensus
standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

1. What Is Executive Order 12898?
    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
2. Does Executive Order 12898 Apply to This Rule?
    EPA has determined that this final rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it does not
affect the level of protection provided to human health or the
environment. As this rule does not impose any enforceable duty upon
State, tribal or local governments, this rule will neither increase nor
decrease environmental protection.

K. Congressional Review Act

1. Has EPA Submitted This Rule to Congress and the Government
Accountability Office?
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, that includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA has submitted a report containing this rule and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A ``major rule''
cannot take effect until 60 days after it is published in the Federal
Register. This rule is not a ``major rule'' as defined by 5 U.S.C.
804(2).
2. Could the Effective Date of This Final Rule Change?
    Provisions of the Congressional Review Act (CRA) or section 305 of
CERCLA may alter the effective date of this regulation.
    Under the CRA, 5 U.S.C. 801(a), before a rule can take effect the
Federal agency promulgating the rule must submit a report to each House
of the Congress and to the Comptroller General. This report must
contain a copy of the rule, a concise general statement relating to the
rule (including whether it is a major rule), a copy of the cost-benefit
analysis of the rule (if any), the agency's actions relevant to
provisions of the Regulatory Flexibility Act (affecting small
businesses) and the Unfunded Mandates Reform Act of 1995 (describing
unfunded federal requirements imposed on State and local governments
and the private sector), and any other relevant information or
requirements and any relevant Executive Orders.
    EPA has submitted a report under the CRA for this rule. The rule
will take effect, as provided by law, within 30 days of publication of
this document, since it is not a major rule. Section 804(2) defines a
major rule as any rule that the Administrator of the Office of
Information and Regulatory Affairs (OIRA) of the Office of Management
and Budget (OMB) finds has resulted in or is likely to result in: an
annual effect on the economy of $100,000,000 or more; a major increase
in costs or prices for consumers, individual industries, Federal,
State, or local government agencies, or geographic regions; or
significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of United States-based
enterprises to compete with foreign-based enterprises in domestic and
export markets. NPL listing is not a major rule because, as explained
above, the listing, itself, imposes no monetary costs on any person. It
establishes no enforceable duties, does not establish that EPA
necessarily will undertake remedial action, nor does it require any
action by any party or determine its liability for site response costs.
Costs that arise out of site responses result from site-by-site
decisions about what actions to take, not directly from the act of
listing itself. Section 801(a)(3) provides for a delay in the effective
date

of major rules after this report is submitted.
3. What Could Cause a Change in the Effective Date of This Rule?
    Under 5 U.S.C. 801(b)(1) a rule shall not take effect, or continue
in effect, if Congress enacts (and the President signs) a joint
resolution of disapproval, described under section 802.
    Another statutory provision that may affect this rule is CERCLA
section 305, which provides for a legislative veto of regulations
promulgated under CERCLA. Although INS v. Chadha, 462 U.S. 919,103 S.
Ct. 2764 (1983) and Bd. of Regents of the University of Washington v.
EPA, 86 F.3d 1214,1222 (DC Cir. 1996) cast the validity of the
legislative veto into question, EPA has transmitted a copy of this
regulation to the Secretary of the Senate and the Clerk of the House of
Representatives.
    If action by Congress under either the CRA or CERCLA section 305
calls the effective date of this regulation into question, EPA will
publish a document of clarification in the Federal Register.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous substances, Hazardous waste, Intergovernmental relations,
Natural resources, Oil pollution, Penalties, Reporting and
recordkeeping requirements, Superfund, Water pollution control, Water
supply.

    Dated: September 14, 2009.
Mathy Stanislaus,
Assistant Administrator, Office of Solid Waste and Emergency Response.

0
40 CFR part 300 is amended as follows:

PART 300--[AMENDED]

0
1. The authority citation for part 300 continues to read as follows:

    Authority:  33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR
2923, 3 CFR, 1987 Comp., p. 193.

0
2. Table 1 of Appendix B to part 300 is amended by adding the following
sites in alphabetical order to read as follows:

Appendix B to Part 300--National Priorities List

                   Table 1--General Superfund Section
------------------------------------------------------------------------
      State            Site name        City/county        Notes \a\
------------------------------------------------------------------------

                              * * * * * * *
CA...............  B.F. Goodrich...  Rialto..........

                              * * * * * * *
IN...............  Lane Street       Elkhart.........
                    Ground Water
                    Contamination.

                              * * * * * * *
MO...............  Southwest         Jefferson
                    Jefferson         County..
                    County Mining.

                              * * * * * * *
MT...............  Flat Creek IMM..  Superior........

                              * * * * * * *
NC...............  Ore Knob Mine...  Ashe County.....

                              * * * * * * *
NC...............  GMH Electronics.  Roxboro.........

                              * * * * * * *
NJ...............  Curtis Specialty  Milford.........
                    Papers, Inc.

                              * * * * * * *
OH...............  Little Scioto     Marion County...
                    River.

                              * * * * * * *
PA...............  Salford Quarry..  Lower Salford
                                      Township..

                              * * * * * * *
PR...............  Papelera          Utuado..........
                    Puertorriquena,
                    Inc.

                              * * * * * * *
WI...............  Amcast            Cedarburg.......
                    Industrial
                    Corporation.

                             * * * * * * *
------------------------------------------------------------------------
\a\ A = Based on issuance of health advisory by Agency for Toxic
  Substance and Disease Registry (HRS score need not be
  28.50).
C = Sites on Construction Completion list.
S = State top priority (HRS score need not be  28.50)
P = Sites with partial deletion(s).

[FR Doc. E9-22934 Filed 9-22-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3436-3438]
[FR Doc No: 2016-01093]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0611]

Submission and Review of Sterility Information in Premarket
Notification (510(k)) Submissions for Devices Labeled as Sterile;
Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Submission and Review of
Sterility Information in Premarket Notification (510(k)) Submissions
for Devices Labeled as Sterile.'' This guidance updates and clarifies
the information regarding sterilization processes that FDA recommends
sponsors include in 510(k)s for devices labeled as sterile. This
guidance document also provides details about the pyrogenicity
information that FDA recommends sponsors include in a 510(k)
submission.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time. The recommendations in this guidance will be implemented on
March 21, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:

     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2008-D-0611 for ``Submission and Review of Sterility Information in
Premarket Notification (510(k)) Submissions for Devices Labeled as
Sterile; Guidance for Industry and Food and Drug Administration Staff;
Availability.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Submission and Review of Sterility Information in Premarket
Notification (510(k)) Submissions for Devices Labeled as Sterile'' to
the Office of the Center Director, Guidance and Policy Development,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002.
    Alternatively, you may submit written requests for single copies of
the guidance document to the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research (CBER), Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request. The guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, FDA has received an increasing number of 510(k)s
for devices labeled as sterile that are sterilized during the
manufacturing process by methods other than the traditionally used
methods (i.e., steam, dry heat, ethylene oxide (EO), and radiation).
FDA has experience with some of the other methods and now considers
them to be established methods. However, there may be alterations to
the more recently developed methods. In addition, original, innovative
sterilization technologies are being developed and proposed. FDA
considers these to be novel methods, which carry a substantial risk of
inadequate sterility assurance. Consequently, devices sterilized using
these technologies may not comply with Good Manufacturing Practice.
Failure to assure sterility presents a serious risk to human health
because of the risk of infection. Therefore, we intend to inspect the
manufacturing facility before clearing a 510(k) for a device that is
sterilized by a novel sterilization process. We believe inspecting the
manufacturing facility for devices sterilized using these novel
sterilization technologies will help ensure the safety and
effectiveness of these devices and mitigate the risks to human health.
    This guidance document updates and clarifies the information
regarding sterilization processes that we recommend sponsors include in
510(k)s for devices labeled as sterile. This guidance document also
provides details about the pyrogenicity information that we recommend
sponsors include in a 510(k) submission. In the Federal Register of
December 12, 2008 (73 FR 75724), FDA announced the availability of the
draft of this guidance. Interested persons were invited to comment by
March 12, 2009. FDA considered the public comments received and revised
the guidance, where applicable. This

document supersedes ``Updated 510(k) Sterility Review Guidance K90-1''
dated August 30, 2002.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on submission and review of sterility
information in 510(k)s for devices labeled as sterile. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to
download an electronic copy of ``Submission and Review of Sterility
Information in Premarket Notification (510(k)) Submissions for Devices
Labeled as Sterile'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document.
Please use the document number 1615 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120; and the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073.

    Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01093 Filed 1-20-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 4 (Monday, January 7, 2013)]
[Proposed Rules]
[Pages 924-925]
[FR Doc No: 2012-31433]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[Docket No. EPA-R10-OAR-2010-0914; FRL-9764-6]

Approval and Promulgation of Air Quality Implementation Plans;
Alaska: Eagle River PM10 Nonattainment Area Limited
Maintenance Plan and Redesignation Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve the Limited Maintenance Plan (LMP)
submitted by the State of Alaska on September 29, 2010, for the Eagle
River nonattainment area (Eagle River NAA) and the State's request to
redesignate the area to attainment for the National Ambient Air Quality
Standards (NAAQS) for particulate matter with an aerodynamic diameter
less than or equal to a nominal 10 micrometers (PM10). EPA
is proposing to approve the State's request because it meets Clean Air
Act (CAA) requirements for redesignation. EPA has also published, at
the same time, a direct final rule of the same title because EPA views
this as a noncontroversial SIP revision and anticipates no adverse
comments. Any parties interested in commenting on this action should do
so at this time. If EPA receives adverse comments, EPA will withdraw
the direct final rule and will then address all public comments in a
subsequent final rule based on this proposed rule.

DATES: Comments must be received on or before February 6, 2013.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R10-
OAR-2010-0914, by any of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Mail: Justin A. Spenillo, EPA Region 10, Office of Air,
Waste and Toxics (AWT-107), 1200 Sixth Avenue, Suite 900, Seattle, WA
98101.
     Hand Delivery/Courier: EPA Region 10, 1200 Sixth Avenue,
Suite 900, Seattle, WA 98101. Attention: Justin A. Spenillo, Office of
Air, Waste and Toxics, AWT-107. Such deliveries are only accepted
during normal hours of operation, and special arrangements should be
made for deliveries of boxed information.

    Instructions: Direct your comments to Docket ID No. EPA-R10-OAR-
2010-0914. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information the disclosure of which
is restricted by statute. Do not submit information that you consider
to be CBI or otherwise protected through www.regulations.gov or email.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through www.regulations.gov your
email address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
the disclosure of which is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy. Publicly available
docket materials are available either electronically in
www.regulations.gov or in hard copy

during normal business hours at the Office of Air, Waste and Toxics,
EPA Region 10, 1200 Sixth Avenue, Seattle, WA 98101.

FOR FURTHER INFORMATION CONTACT: Justin A. Spenillo at<PHONE_NUMBER>,
<EMAIL_ADDRESS>or the above EPA, Region 10 address.

SUPPLEMENTARY INFORMATION: For further information, please see the
direct final action, of the same title, which is located in the Rules
section of this Federal Register. EPA is approving the State's SIP
revision as a direct final rule without prior proposal because EPA
views this as a noncontroversial SIP revision and anticipates no
adverse comments. A detailed rationale for the approval is set forth in
the preamble to the direct final rule. If EPA receives no adverse
comments, EPA will not take further action on this proposed rule.
    If EPA receives adverse comments, EPA will withdraw the direct
final rule and it will not take effect. EPA will address all public
comments in a subsequent final rule based on this proposed rule. EPA
will not institute a second comment period on this action. Any parties
interested in commenting on this action should do so at this time.
Please note that if we receive adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.

    Dated: December 17, 2012.
Dennis J. McLerran,
Regional Administrator, Region 10.
[FR Doc. 2012-31433 Filed 1-4-13; 8:45 am]
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[Federal Register: January 21, 2009 (Volume 74, Number 12)]
[Notices]
[Page 3588]
[DOCID:fr21ja09-70]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP09-8-000]

Tuscarora Gas Transmission Company; Notice Deferring Technical
Conference

January 12, 2009.
    On January 12, 2009, Tuscarora Gas Transmission Company (Tuscarora)
filed a request for deferral of the technical conference scheduled in
the above-captioned proceeding for January 15, 2009.\1\ Tuscarora
states that it has reached a settlement in principle with the active
parties in this proceeding, and that it anticipates filing an offer of
settlement that will resolve all of the issues in this proceeding by
February 12, 2009. Therefore, Tuscarora requests that the Commission
defer the date of the technical conference until mid-February 2009, to
allow the parties time to prepare and review the offer of settlement.
Tuscarora states that it is authorized by the active parties in this
proceeding to express their support for this request to defer both the
technical conference date and the effective date of the suspended
tariff sheets.\2\
---------------------------------------------------------------------------

    \1\ The Commission directed that a technical conference be held
to address the issues raised by Tuscarora's October 1, 2008 tariff
filing in this proceeding. Tuscarora Gas Transmission Co., 125 FERC
] 61,133 (2008). The technical conference was originally scheduled
for December 11, 2008. At the request of the active parties, the
Commission issued a notice on December 8, 2008, that postponed the
date of the technical conference to January 15, 2009.
    \2\ Given agreement in principle among the active parties,
Tuscarora agrees not to move into effect the tariff sheets
previously suspended by the Commission in this proceeding prior to
June 1, 2009. This deferral of the effectiveness of the suspended
tariff sheets will afford time for a possible settlement to be filed
and considered by the Commission.
---------------------------------------------------------------------------

    By this notice, Tuscarora's request for deferral of the dates
related to the technical conference is granted. The technical
conference scheduled for January 15, 2009, is thereby postponed until
further notice.
    For further information please contact Timothy Duggan at (202) 502-
8326 or e-mail<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
 [FR Doc. E9-1017 Filed 1-16-09; 8:45 am]

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[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)]
[Notices]
[Pages 45283-45284]
[FR Doc No: 2018-19288]

=======================================================================
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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2012-0005]

The Cadmium in General Industry Standard; Extension of the Office
of Management and Budget's (OMB) Approval of Information Collection
(Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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

SUMMARY: OSHA solicits public comments concerning the proposal to
extend OMB approval of the information collection requirements
contained in the Cadmium in General Industry Standard.

DATES: Comments must be submitted (postmarked, sent, or received) by
November 5, 2018.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2012-0005,
Occupational Safety and Health Administration, U.S. Department of
Labor, Room N-3653, 200 Constitution Avenue NW, Washington, DC 20210.
Deliveries (hand, express mail, messenger, and courier service) are
accepted during the OSHA Docket Office's normal business hours, 10:00
a.m. to 3:00 p.m., ET.
    Instructions: All submissions must include the agency name and the
OSHA docket number (OSHA-2012-0005) for the Information Collection
Request (ICR). All comments, including any personal information you
provide, are placed in the public docket without change, and may be
made available online at http://www.regulations.gov. For further
information on submitting comments, see the ``Public Participation''
heading in the section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the above address. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the website. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Christie Garner
at<PHONE_NUMBER> to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Thomas Mockler or Christie Garner,
Directorate of Standards and Guidance, OSHA, U.S. Department of Labor,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance process to provide the public with an opportunity to
comment on proposed and continuing information collection requirements
in accordance with the Paperwork Reduction Act of 1995 (PRA-95) (44
U.S.C. 3506(c)(2)(A)). This program ensures that information is in the
desired format, the reporting burden (time and costs) is minimal, the
collection instruments are clearly understood, and OSHA's estimate of
the information collection burden is accurate. The Occupational Safety
and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et seq.) authorizes
information collection by employers as necessary or appropriate for
enforcement of the OSH Act or for developing information regarding the
causes and prevention of occupational injuries, illnesses, and
accidents (see 29 U.S.C. 657). The OSH Act also requires OSHA to obtain
such information with a minimum burden upon employers, especially those
operating small businesses, and to reduce to the maximum extent
feasible unnecessary duplication of effort in obtaining said
information (see 29 U.S.C. 657).

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply--
for example, by using automated or other technological information
collection and transmission techniques.
    The information collection requirements specified in the Cadmium in
General Industry Standard protect workers from the adverse health
effects that may result from their exposure to cadmium. The major
information collection requirements of the standard include: conducting
worker exposure monitoring, notifying workers of their cadmium
exposures, implementing a written compliance program, implementing
medical surveillance of workers, providing examining physicians with
specific information, ensuring that workers receive a copy of their
medical surveillance results, maintaining workers' exposure monitoring
and medical surveillance records for specific periods, and providing
access to these records to the workers who are the subject of the
records, the worker's representative, and other designated parties.
    The agency is requesting a burden hour adjustment decrease of 2,636
(from 75,998 to 73,362 hours). The agency estimates a decrease of
exposed workers in the cross-industry sectors as well as in the
specific-industry sectors. On the other hand, the number of plants is
estimated to increase slightly in both sectors. As a result, the
operation and maintenance costs have increased from $4,799,475 to
$5,453,858, a total increase of $654,383, due to increased costs for
exposure monitoring sampling and medical exams.

III. Proposed Actions

    Type of Review: Extension of a currently approved collection.
    Title: Cadmium in General Industry (29 CFR 1910.1027).
    OMB Control Number: 1218-0185.
    Affected Public: Business or other for-profits.
    Number of Respondents: 50,679.
    Frequency: On occasion; Quarterly; Biennially; Semi-annually;
Annually.
    Average Time per Response: Varies.
    Estimated Number of Responses: 208,899.
    Estimated Total Burden Hours: 73,362.

    Estimated Cost (Operation and Maintenance): $2,312,424.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the agency name
and the OSHA docket number (Docket No. OSHA-2012-0005) for the ICR. You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify electronic comments by
your name, date, and the docket number so that the agency can attach
them to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>; TTY<PHONE_NUMBER>.
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
dates of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
website. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office. Information on
using the http://www.regulations.gov website to submit comments and
access the docket is available at the website's ``User Tips'' link.
Contact the OSHA Docket Office for information about materials not
available through the website, and for assistance in using the internet
to locate docket submissions.

V. Authority and Signature

    Loren Sweatt, Deputy Assistant Secretary of Labor for Occupational
Safety and Health, directed the preparation of this notice. The
authority for this notice is the Paperwork Reduction Act of 1995 (44
U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012 (77 FR
3912).

    Signed at Washington, DC, on August 30, 2018.
Loren Sweatt,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2018-19288 Filed 9-5-18; 8:45 am]
 BILLING CODE 4510-26-P