Cooling Water Intake Structure ( CWIS) Information Data Required Rig Information Rig Name Discoverer Spirit Discoverer Deep Seas Discoverer Enterprise Rig Type Dynamically Positioned Drillship Total Installed Power Generation Capacity 52,118 HP Number of Cooling Water Intake Structures ( CWISs) 4 Brief description of each CWIS ( e. g., sea chest, simple pipe) Sea Chest  Forward Area 2.81 Square Meters P& S Aft Area 5.37 Square Meters P& S Rough dimensions of each CWIS and indicate whether onboard CWIS has an existing flange Forward Machinery Space 2each 1236mm x 569 mm Port & Starboard ( Total 4) No Flange Aft Machinery Space 2 each 1236mm x636mm & 2 each 1036mm x 536mm Port and Starboard ( 8 Total) No Flange Screen type ( e. g., strainer, wedge wire) with mesh size Sea Chest Grid ( 44 each horizontal 30mm x 6mm flat bar), Duplex Basket Strainers Total Design Specifications for Daily Maximum Water Intake Volume of each CWIS Forward: 12,682,160 gal ( 2000 Cubic Meters / Hour) Aft: 41,215,200 gal ( 6500 Cubic Meters / Hour) Total Daily Water Intake Volume of each CWIS Forward: 1,810,827 gal ( 6854 Cubic Meters) Aft: 11,833,518 gal ( 44,790 Cubic Meters Design Specs for Through Screen Velocity of each CWIS ( i. e., Q= V* A) Forward 1421.5 Meters/ Hour Aft 2423.5 Meters/ Hour List of Purposes of Cooling Water Intakes ( e. g., cool crude oil, produced water, power generators, drill pipe brakes) Thruster Motors and Drives, Heat Exchangers for Drilling Equipment, Rig Air Compressors, HVAC Systems, Main Engines, and Misc. Auxiliary Equipment. List of Purposes of Non cooling Water Intakes ( e. g., fire water, hotel loads) Water Makers, Fire Main, Ballast, Drilling Mud Pits,

Total Volume of Water Intake for Ballasting, Duration of the Ballast intake, and the Through Screen Velocity of the Ballast Intake 103,200 gal ( 3100 Cubic Meters) As needed while on location, 559 Meters/ Hour Mitigation Measures for reducing Exotic Species Migration through Ballast water Vessel carries most Ballast Water between locations, The vessel performs Ballast Water Exchange in greater than 1000Meter Water Depth. Mitigation Measures for reducing Impingement and Entrainment of Aquatic Organisms, as well as Bio fouling Prevention Measures Sea chest Grids, duplex and simplex baskets, cathodic protection and Blume anti Fouling System.

Is the Rig equipped with a Radiator Cooling System for the Main Engines? No


[Federal Register: February 15, 2008 (Volume 73, Number 32)]
[Notices]
[Page 8884-8885]
[DOCID:fr15fe08-65]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0065 (formerly Docket No. 2005D-0203)]

Guidance for Industry on Safety Testing of Drug Metabolites;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Safety Testing of
Drug Metabolites.'' This guidance provides recommendations to industry
on when and how to identify and characterize drug metabolites whose
nonclinical toxicity needs to be evaluated. It also provides
recommendations on the timing and type of nonclinical studies that
should be conducted to investigate the potential for clinical toxicity
of drug metabolites. This guidance applies to small molecule
nonbiologic drug products under development. This guidance finalizes
the draft guidance published on June 6, 2005.

DATES: Submit written or electronic comments on agency guidances at any
time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to
assist that office in processing your requests. Submit written comments
on the guidance to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. Submit electronic comments to http://www.regulations.gov. See

the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.

FOR FURTHER INFORMATION CONTACT:  Aisar Atrakchi, Center for Drug
Evaluation and Research (HFD-130), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, rm. 4384, Silver Spring, MD 20993-0002,
301-796-1036.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Safety Testing of Drug Metabolites.'' This guidance
addresses drug metabolites of small molecule nonbiologic drug products
and does not apply to some cancer products. It applies to drug
metabolites that are not adequately evaluated in standard toxicology
testing with the parent drug. This can happen if the metabolite is
present only in humans or if it is present at higher levels (referred
to in the guidance as ``disproportionate drug metabolite'') in humans
than in any of the animal toxicology test species. The guidance
provides recommendations on the timing and types of nonclinical safety

studies that should be conducted for drug metabolites that are present
at greater than 10 percent of the parent drug systemic exposure as
measured in plasma.
    A draft version of this guidance was made available for public
comment in 2005 (70 FR 32839, June 6, 2005). All of the public comments
we received have been considered and the guidance was revised as
appropriate.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on the safety testing of drug metabolites. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://www
.fda.gov/ohrms/dockets/default.htm.

    Dated: February 8, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2827 Filed 2-14-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 175 (Tuesday, September 12, 2017)]
[Proposed Rules]
[Pages 42765-42767]
[FR Doc No: 2017-19213]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2017-0332; FRL-9967-56-Region 9]

Approval of California Air Plan Revisions, Placer County and
Ventura County Air Pollution Control Districts

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Placer County Air Pollution Control District
(PCAPCD) and Ventura County Air Pollution Control District (VCAPCD)
portions of the California State Implementation Plan (SIP). These
revisions concern emissions of oxides of nitrogen (NOX) from
incinerators in the PCAPCD and previously unregulated types of fuel
burning equipment in the VCAPCD. We are proposing to approve local
rules to regulate these emission sources under the Clean Air Act (CAA
or the Act). We are taking comments on this proposal and plan to follow
with a final action.

DATES: Any comments must arrive by October 12, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2017-0332 at http://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be removed or edited from
Regulations.gov. For either manner of

submission, the EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information or other information whose disclosure
is restricted by statute. Multimedia submissions (audio, video, etc.)
must be accompanied by a written comment. The written comment is
considered the official comment and should include discussion of all
points you wish to make. The EPA will generally not consider comments
or comment contents located outside of the primary submission (i.e. on
the web, cloud, or other file sharing system). For additional
submission methods, please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section. For the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Kevin Gong, EPA Region IX, (415) 972-
3073<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rules?
II. The EPA's Evaluation and Action
    A. How is the EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. EPA Recommendations To Further Improve the Rules
    D. Public Comment and Proposed Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this proposal with the dates
that they were adopted by the local air agencies and submitted by the
California Air Resources Board.

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
                                                                                Adopted or
           Local agency                Rule No.              Rule title               amended        Submitted
----------------------------------------------------------------------------------------------------------------
PCAPCD............................             206  Incinerator Burning.........      10/13/2016      01/24/2017
VCAPCD............................           74.34  NOX Reductions from               12/13/2016       2/24/2017
                                                     Miscellaneous Sources.
----------------------------------------------------------------------------------------------------------------

    On April 17, 2017, the EPA determined that the submittal for PCAPCD
Rule 206 met the completeness criteria in 40 CFR part 51 Appendix V,
which must be met before formal EPA review. On August 2, 2017, the EPA
determined that the submittal for VCAPCD Rule 74.34 also met the
completeness criteria.

B. Are there other versions of these rules?

    We approved an earlier version of PCAPCD Rule 206 into the SIP on
November 15, 1978 (43 FR 53035) for the portions of the district
regulating the Mountain Counties Air Basin and Sacramento Valley Air
Basin. We approved another earlier version of PCAPCD Rule 206 into the
SIP on August 21, 1979 (46 FR 27115) for the portion of the district
regulating the Lake Tahoe Air Basin. There are no previous versions of
VCAPCD Rule 74.34 in the SIP.

C. What is the purpose of the submitted rules?

    NOX helps produce ground-level ozone, smog and
particulate matter, which harm human health and the environment.
Section 110(a) of the CAA requires states to submit regulations that
control NOX emissions. PCAPCD Rule 206 modernizes the
requirements and limits for incineration units in Placer County. VCAPCD
Rule 74.34 establishes emission limits and operational requirements for
sources of NOX that were previously unregulated by a
prohibitory rule (including kilns, dryers, and ovens) for Ventura
County. The EPA's technical support documents (TSDs) have more
information about these rules.

II. The EPA's Evaluation and Action

A. How is the EPA evaluating the rules?

    SIP rules must be enforceable (see CAA section 110(a)(2)), must not
interfere with applicable requirements concerning attainment and
reasonable further progress or other CAA requirements (see CAA section
110(l)), and must not modify certain SIP control requirements in
nonattainment areas without ensuring equivalent or greater emissions
reductions (see CAA section 193).
    Generally, SIP rules must require Reasonably Available Control
Technology (RACT) for each major source of NOX in ozone
nonattainment areas classified as moderate or above (see CAA sections
182(b)(2) and 182(f)). The PCAPCD regulates an ozone nonattainment area
classified as ``Severe'' for the 2008 and 1997 8-hour ozone National
Ambient Air Quality Standards (NAAQS) and the 1-hour ozone NAAQS. The
VCAPCD regulates an ozone nonattainment area classified as ``Serious''
for the 2008 and 1997 8-hour ozone NAAQS and ``Severe'' for the 1-hour
ozone NAAQS (40 CFR 81.305). Therefore, these rules must implement RACT
in their respective counties.
    Guidance and policy documents that we use to evaluate
enforceability, revision/relaxation and rule stringency requirements
for the applicable criteria pollutants include the following:

    1. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies,
and Deviations,'' EPA, May 25, 1988 (the Bluebook, revised January
11, 1990).
    2. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    3. ``NOX Emissions from Industrial/Commercial/
Institutional (ICI) Boilers,'' EPA OAQPS, March 1994, EPA-453/R-94-
022.
    4. ``NOX Emissions from Process Heaters,'' EPA OAQPS,
September 1993, EPA-453/R-93-034 1993/09.
    5. ``Standards of Performance for Commercial and Industrial
Solid Waste Incineration Units,'' 40 CFR part 60, subpart CCCC.
    6. ``Standards of Performance for Other Solid Waste Incineration
Units for Which Construction is Commenced After December 9, 2004, or
for Which Modification or Reconstruction is Commenced on or After
June 16, 2006,'' 40 CFR part 60, subpart EEEE.

B. Do the rules meet the evaluation criteria?

    VCAPCD Rule 74.34 adopts emission limits, monitoring,
recordkeeping, and reporting requirements for NOX sources
that were previously unregulated by a SIP-approved rule, resulting in
an estimated NOX reduction of 40 tons per year. PCAPCD Rule
206 updates control requirements for incinerator units in the county to
meet SIP requirements to implement RACT. For these reasons, we conclude
that these rules are consistent

with CAA requirements and relevant guidance regarding enforceability,
RACT, and SIP revisions. The TSDs have more information on our
evaluation.

C. EPA Recommendations To Further Improve the Rules

    The TSDs describe additional rule revisions that we recommend for
the next time the local agencies modify the rules.

D. Public Comment and Proposed Action

    As authorized in section 110(k)(3) of the Act, the EPA proposes to
fully approve the submitted rules because they fulfill all relevant
requirements. We will accept comments from the public on this proposal
until October 12, 2017. If we take final action to approve the
submitted rules, our final action will incorporate these rules into the
federally enforceable SIP.

III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the PCAPCD and VCAPCD rules described in Table 1 of this
preamble. The EPA has made, and will continue to make, these materials
available through www.regulations.gov and at the EPA Region IX Office
(please contact the person identified in the FOR FURTHER INFORMATION
CONTACT section of this preamble for more information).

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this proposed action merely proposes to approve state law
as meeting federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation
land or in any other area where the EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: August 30, 2017.
Alexis Strauss,
Acting Regional Administrator, Region IX.
[FR Doc. 2017-19213 Filed 9-11-17; 8:45 am]
 BILLING CODE 6560-50-P