[Federal Register: December 19, 2008 (Volume 73, Number 245)]
[Notices]
[Page 77681]
[DOCID:fr19de08-81]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER06-615-000; ER07-1257-000]

California Independent System Operator Corporation; Notice of
FERC Staff Attendance

December 15, 2008.
    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that on the following dates members of its staff will attend a
meeting of the Board of Governors of the California Independent System
Operator (CAISO). Unless otherwise noted, this meeting will be held at
the CAISO, 151 Blue Ravine Road, Folsom, CA or by teleconference. The
agenda and other documents for the meetings are available on the
CAISO's Web site, http://www.caiso.com.
    December 16-17, 2008, Board of Governors Meeting.
    Sponsored by the CAISO, this meeting is open to all market
participants, and staff's attendance is part of the Commission's
ongoing outreach efforts. This meeting may discuss matters at issue in
the above captioned dockets.
    For further information, contact Saeed Farrokhpay at
<EMAIL_ADDRESS>(916) 294-0233 or Maury Kruth at
<EMAIL_ADDRESS>(916) 294-0275.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-30227 Filed 12-18-08; 8:45 am]

BILLING CODE 6717-01-P


Technical and Analytical Support for OSHA's COVID-19 Healthcare Emergency Temporary Standard: Excel Spreadsheets Supporting the Economic Analysis. June 2021.

Attachments:
Economics Analysis June 2021 - Benefits Lowest Sensitivity
Economics Analysis June 2021 - Benefits Primary
Economics Analysis June 2021 - COVID-19 ETS Profile
Economics Analysis June 2021 - ETS Cost Spreadsheet


[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Rules and Regulations]
[Page 43255]
[FR Doc No: 2014-17603]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0062]

Safety Zone; Fleet Week Maritime Festival, Pier 66, Elliott Bay;
Seattle, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard announces that the Fleet Week Maritime
Festival's Pier 66 Safety Zone in Elliott Bay, WA will be in effect
from 8 a.m. until 8 p.m. on July 30, 2014. In addition to enforcing the
safety zone during the parade of ships and aerial demonstration, the
safety zone will only be enforced thirty minutes prior and thirty
minutes following the conclusion of the parade of ships and aerial
demonstration. This action is necessary to promote safety on navigable
waters. During the enforcement period, entry into, transit through,
mooring, or anchoring within this zone is prohibited unless authorized
by the Captain of the Port, Puget Sound or his designated
representative.

DATES: The regulations in 33 CFR 165.1330 will be in effect from 8 a.m.
until 8 p.m. on July 30, 2014.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or email LTJG Johnny Zeng, Sector Puget Sound Waterways Management
Division, Coast Guard; telephone<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The safety zone for the Fleet Week Maritime
Festival in 33 CFR 165.1330 will be in effect from 8 a.m. until 8 p.m.
on July 30, 2014. In addition to enforcing the safety zone during the
parade of ships and aerial demonstration, the safety zone will only be
enforced thirty minutes prior and thirty minutes following the
conclusion of the parade of ships and aerial demonstration.
    In accordance with the general regulations in 33 CFR Part 165,
Subpart C, no vessel operator may enter, transit, moor, or anchor
within this safety zone thirty minutes prior to the beginning, during
and thirty minutes following the conclusion of the Parade of Ships. For
the purpose of this rule, the Parade of Ships includes both the pass
and review of the ships near Pier 66 and the aerial demonstrations
immediately following the pass and review. The Captain of the Port may
be assisted by other federal, state, or local agencies as needed.
    In order to transit through this safety zone, authorization must be
granted by the Captain of the Port, Puget Sound or his designated
representative. All vessel operators desiring entry into this safety
zone may request authorization by contacting either the on-scene U.S.
Coast Guard patrol craft on VHF Ch 13 or Ch 16, or Coast Guard Sector
Puget Sound Joint Harbor Operations Center (JHOC) via telephone at
(206) 217-6002. Requests shall indicate the reason why movement within
the safety zone is necessary and the vessel's arrival and/or departure
facility name, pier and/or berth. Vessel operators granted permission
to enter this safety zone will be escorted by the on-scene patrol until
no longer within the safety zone.
    This notice is issued under authority of 33 CFR 165.1330 and 5
U.S.C. 552(a). In addition to this notice in the Federal Register, the
Coast Guard will provide the maritime community with advanced
notification of the safety zone via the Local Notice to Mariners and
marine information broadcasts. If the Captain of the Port determines
that the regulated area need not be enforced for the full duration
stated in this notice, they may use a Broadcast Notice to Mariners to
grant general permission to enter the regulated area.

    Dated: July 16, 2014.
M. W. Raymond,
Captain, U.S. Coast Guard, Captain of the Port, Puget Sound.
[FR Doc. 2014-17603 Filed 7-24-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 240 (Monday, December 15, 2014)]
[Notices]
[Pages 74079-74081]
[FR Doc No: 2014-29209]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC15-43-000.
    Applicants: Niagara Generation, LLC.
    Description: Amendment to December 1, 2014 Application of Niagara
Generation, LLC and NiGen, LLC for Expedited Approval of Intra-
Corporate Transfer Under Section 203 of the Federal Power Act.
    Filed Date: 12/4/14.
    Accession Number: 20141204-5223.
    Comments Due: 5 p.m. ET 12/22/14.

    Docket Numbers: EC15-45-000.
    Applicants: New York Transco, LLC, Consolidated Edison Company of
New York, Inc., Orange and Rockland Utilities, Inc., New York State
Electric & Gas Corporation, Rochester Gas & Electric Corporation,
Central Hudson Gas & Electric Corporation, Niagara Mohawk Power
Corporation.
    Description: Application for Approval under Section 203 of the
Federal Power Act and Request for Confidential Treatment and Waivers of
New York Transco, LLC, et. al.
    Filed Date: 12/4/14.
    Accession Number: 20141204-5225.
    Comments Due: 5 p.m. ET 12/26/14.

    Take notice that the Commission received the following exempt
wholesale generator filings:
    Docket Numbers: EG15-21-000.
    Applicants: Sierra Solar Greenworks, LLC.

    Description: Notice of Self-Certification of EWG Status of Sierra
Solar Greenworks, LLC.
    Filed Date: 12/4/14.
    Accession Number: 20141204-5036.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: EG15-22-000.
    Applicants: Rising Tree Wind Farm III LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Rising Tree Wind Farm III LLC.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5088.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: EG15-23-000.
    Applicants: NiGen, LLC.
    Description: Self-Certification of EWG of NiGen, LLC.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5203.
    Comments Due: 5 p.m. ET 12/26/14.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER10-2507-004.
    Applicants: Westar Energy, Inc.
    Description: Notice of Non-Material Change in Status of Westar
Energy, Inc.
    Filed Date: 12/4/14.
    Accession Number: 20141204-5228.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER14-1173-003.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Tariff Amendment per 35.17(b): Amendment to NCEMC SA
210 NITSA Filing to be effective 1/1/2014.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5191.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER14-2372-002.
    Applicants: California Independent System Operator Corporation.
    Description: Compliance filing per 35: 2014-12-05_OMS_Waiver to be
effective N/A.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5300.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-582-000.
    Applicants: PacifiCorp.
    Description: Tariff Withdrawal per 35.15: Termination of BPA Agmt
for Work at Hat Rock Mod 2 to be effective 2/15/2015.
    Filed Date: 12/4/14.
    Accession Number: 20141204-5186.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-583-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Amendment to BART NITSA (Oakland Connector) Filing to be effective 12/
5/2014.
    Filed Date: 12/4/14.
    Accession Number: 20141204-5206.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-584-000.
    Applicants: ISO New England Inc.
    Description: Compliance filing per 35: Filing in Response to Order
EL11-66-001--CTMEEC Sch. 21 to be effective 11/17/2014.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5084.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-585-000.
    Applicants: Mesquite Solar 1, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Mesquite Solar 1, LLC Inter-Company Shared Facilities Agreement to be
effective 12/10/2014.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5125.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-586-000.
    Applicants: Mesquite Solar 1, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Mesquite Solar 1, LLC Inter-Phase Shared Facilities Agreement to be
effective 12/10/2014.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5127.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-587-000.
    Applicants: SEP II, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): SEP II,
LLC Concurrence to Inter-Company Shared Facilities Agreement to be
effective 12/10/2014.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5137.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-588-000.
    Applicants: SEP II, LLC.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): SEP II,
LLC Concurrence to Inter-Phase Shared Facilities Agreement to be
effective 12/10/2014.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5157.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-589-000.
    Applicants: Central Maine Power Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Atlantic Wind LLC Engineering & Procurement Agreement to be effective
12/4/2014.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5159.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-590-000.
    Applicants: ITC Great Plains, LLC.
    Description: Tariff Withdrawal per 35.15: Termination of Lease
Agreement to be effective 12/31/2014.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5183.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-591-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Revisions to OA Sec 18.17 Confidentiality Provisions--Real-time
Generator Data to be effective 2/5/2015.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5188.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-592-000.
    Applicants: Duke Energy Indiana, Inc.
    Description: Request for Waiver of MISO Tariff Resource Adequacy
Requirements of Duke Energy Indiana, Inc.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5222.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-593-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Rev. to
Minimum Cap. Req. in the FAP to be effective 2/5/2015.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5238.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-594-000.
    Applicants: Central Maine Power Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Executed Interconnection Agreement with ecomaine to be effective 1/1/
2015.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5259.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-595-000.
    Applicants: Covanta Fairfax, Inc.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Application for Market-Based Rate Authorization to be effective 2/3/
2015.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5270.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-596-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii):
Revisions to OATT Schedule 12-Appendix A re: recent update to RTEP to
be effective 3/5/2015.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5288.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-597-000.
    Applicants: Hess Corporation.
    Description: Tariff Withdrawal per 35.15: Cancellation of Hess
Corporations FERC Electric Rate Schedule No 1 to be effective 12/6/
2014.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5310.
    Comments Due: 5 p.m. ET 12/26/14.

    Docket Numbers: ER15-598-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): GIA and
Distribution Service Agmt with Cameron Ridge, LLC to be effective 11/
25/2014.
    Filed Date: 12/8/14.
    Accession Number: 20141208-5005.
    Comments Due: 5 p.m. ET 12/29/14.

    Take notice that the Commission received the following public
utility holding company filings:
    Docket Numbers: PH15-2-001.
    Applicants: Consolidated Edison, Inc.
    Description: Consolidated Edison, Inc. submits FERC 65-B Material
Change in Facts of Waiver Notification.
    Filed Date: 12/4/14.
    Accession Number: 20141204-5230.
    Comments Due: 5 p.m. ET 12/26/14.

    Take notice that the Commission received the following PURPA
210(m)(3) filings:
    Docket Numbers: QM14-3-000.
    Applicants: Entergy Arkansas, Inc., Entergy Gulf States Louisiana,
L.L.C., Entergy Louisiana, LLC, Entergy Mississippi, Inc., Entergy New
Orleans, Inc., Entergy Services, Inc., Entergy Texas, Inc.
    Description: Response to Deficiency Letter of Entergy Services,
Inc., et. al. under QM14-3.
    Filed Date: 12/5/14.
    Accession Number: 20141205-5322.
    Comments Due: 5 p.m. ET 1/2/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 8, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-29209 Filed 12-12-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 135 (Friday, July 13, 2018)]
[Notices]
[Pages 32669-32670]
[FR Doc No: 2018-14971]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1156]

Q3D(R1) Elemental Impurities; International Council for
Harmonisation; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Q3D(R1)
Elemental Impurities.'' The draft guidance was prepared under the
auspices of the International Council for Harmonisation (ICH), formerly
the International Conference on Harmonisation. The draft guidance
revises the existing ICH guidance for industry ``Q3D Elemental
Impurities'' and provides an updated permitted daily exposure (PDE) for
the cadmium inhalation route of exposure. The updated PDE of 3
micrograms ([micro]g)/day is based on a modifying factor approach like
that used for calculating the PDEs for the cadmium oral and parenteral
routes of exposure. The draft guidance is intended to correct a
calculation error in the PDE for cadmium by the inhalation route of
exposure. Following deliberations within the Q3D Expert Working Group,
the revised calculation is based on a modifying factor approach that is
consistent with the oral and parenteral PDE calculations.

DATES: Submit either electronic or written comments on the draft
guidance by August 13, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2013-D-1156 for ``Q3D(R1) Elemental Impurities.'' Received comments
will be placed in the docket and, except for

those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff office
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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002, or 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 requests. The guidance may also be obtained by mail by calling
CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Tim McGovern,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, Rm. 6300, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.
    Regarding the ICH: Amanda Roache, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 1176, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, regulatory authorities and industry associations
from around the world have participated in many important initiatives
to promote international harmonization of regulatory requirements under
the ICH. FDA has participated in several ICH meetings designed to
enhance harmonization and FDA is committed to seeking scientifically
based harmonized technical procedures for pharmaceutical development.
One of the goals of harmonization is to identify and reduce differences
in technical requirements for drug development among regulatory
agencies.
    ICH was established to provide an opportunity for harmonization
initiatives to be developed with input from both regulatory and
industry representatives. FDA also seeks input from consumer
representatives and others. ICH is concerned with harmonization of
technical requirements for the registration of pharmaceutical products
for human use among regulators around the world. The six founding
members of the ICH are the European Commission; the European Federation
of Pharmaceutical Industries Associations; FDA; the Japanese Ministry
of Health, Labour, and Welfare; the Japanese Pharmaceutical
Manufacturers Association; and the Pharmaceutical Research and
Manufacturers of America. The Standing Members of the ICH Association
include Health Canada and Swissmedic. Any party eligible as a Member in
accordance with the ICH Articles of Association can apply for
membership in writing to the ICH Secretariat. The ICH Secretariat,
which coordinates the preparation of documentation, operates as an
international nonprofit organization and is funded by the Members of
the ICH Association.
    The ICH Assembly is the overarching body of the Association and
includes representatives from each of the ICH members and observers.
The Assembly is responsible for the endorsement of draft guidelines and
adoption of final guidelines. FDA publishes ICH guidelines as FDA
guidance.
    In May 2018, the ICH Assembly endorsed the draft guideline entitled
``Q3D(R1) Elemental Impurities'' and agreed that the guideline should
be made available for public comment. The draft guideline is the
product of the Quality Expert Working Group of the ICH. Comments about
this draft will be considered by FDA and the Quality Expert Working
Group.
    The draft guidance revises the existing guidance for industry ``Q3D
Elemental Impurities'' and provides an updated permitted daily exposure
(PDE) for the cadmium inhalation route of exposure. The revision was
initiated following identification of a calculation error in the
original text. The updated PDE of 3 [micro]g/day is based on a
modifying factor approach that is consistent with the method used for
calculating the PDEs for the oral and parenteral routes of exposure.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Q3D(R1)
Elemental Impurities.'' 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. This guidance is not subject to Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the document at
https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: July 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14971 Filed 7-12-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Proposed Rules]
[Pages 19987-19989]
[FR Doc No: 2018-09560]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-1187; Airspace Docket No. 17-AGL-25]
RIN 2120-AA66

Proposed Amendment of Class D and Class E Airspace and Proposed
Revocation of Class E Airspace; Jackson, MI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to modify Class D airspace, Class E
airspace designated as a surface area, and Class E airspace extending
upward from 700 feet above the surface, and remove Class E airspace
designated as an extension to Class D or Class E surface area at
Jackson County Airport-Reynolds Field, Jackson MI. The FAA is proposing
this action due to the decommissioning of the Jackson VHF
omnidirectional range (VOR) which provided navigation guidance for the
instrument procedures to this airport. The VOR is being decommissioned
as part of the VOR Minimum Operational Network (MON) Program. The name
and the geographic coordinates of the airport would also be updated to
coincide with the FAA's aeronautical database. Additionally, this
action would replace the outdated term ``Airport/Facility Directory''
with the term ``Chart Supplement'' in the associated airspace legal
descriptions.

DATES: Comments must be received on or before June 21, 2018.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2017-1187; Airspace Docket No. 17-AGL-25, at the beginning of your
comments. You may also submit comments through the internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11B, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11A at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend Class D airspace, Class E airspace designated as a
surface area, and Class E airspace extending upward from 700 feet above
the surface, and remove Class E airspace designated as an extension to
Class D or Class E surface area at Jackson County Airport-Reynolds
Field, Jackson MI to support

instrument flight rules (IFR) operations at the airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2017-1187;
Airspace Docket No. 17-AGL-25.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace
Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order 7400.11B is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11B lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 by:
    Modifying the Class D airspace at Jackson County Airport-Reynolds
Field, Jackson, MI, by updating the geographic coordinates of the
airport to coincide with the FAA's aeronautic database and replacing
the outdated term ``Airport/Facility Directory'' with the term ``Chart
Supplement'' in the airspace legal description;
    Modifying the Class E airspace designated as a surface area at
Jackson County Airport-Reynolds Field (formerly Jackson County-Reynolds
Field) by removing all airspace extensions from the 4-mile radius in
the airspace legal description, updating the name and geographic
coordinates of the airport to coincide with the FAA's aeronautical
database, and making an editorial change to the airspace legal
description replacing ``Airport/Facility Directory'' with the term
``Chart Supplement'';
    Removing the Class E airspace designated as an extension to Class D
or Class E airspace designated as a surface area at Jackson County-
Reynolds Field, MI, as it is no longer required; and
    Modifying the Class E airspace area extending upward from 700 feet
above the surface to within a 6.5-mile radius (decreased from a 7-mile
radius) of Jackson County Airport-Reynolds Field (formerly Jackson
County-Reynolds Field), removing the Jackson VOR/DME from the airspace
legal description, and updating the name and geographic coordinates to
coincide with the FAA's aeronautical database.
    Airspace reconfiguration is necessary due to the decommissioning of
the Jackson VOR, which provided navigation guidance for the instrument
procedures to this airport, as part of the VOR MON Program and to bring
the airspace in compliance with FAA Order 7400.2L, Procedures for
Handling Airspace Matters. This action would enhance safety and the
management of IFR operations at this airport.
    Class D and E airspace designations are published in paragraph
5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.11B, dated
August 3, 2017, and effective September 15, 2017, which is incorporated
by reference in 14 CFR 71.1. The Class D and E airspace designations
listed in this document will be published subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B,
Airspace Designations and Reporting

Points, dated August 3, 2017, and effective September 15, 2017, is
amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

AGL MI D Jackson, MI [Amended]

Jackson County Airport-Reynolds Field, MI
    (Lat. 42[deg]15'38'' N, long. 84[deg]27'44'' W)

    That airspace extending upward from the surface to and including
3,500 feet MSL within a 4-mile radius of Jackson County Airport-
Reynolds Field. This Class D airspace area is effective during the
specific dates and times established in advance by a Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Chart Supplement.

Paragraph 6002 Class E Airspace Areas Designated as Surface Areas.

* * * * *

AGL MI E2 Jackson, MI [Amended]

Jackson County Airport-Reynolds Field, MI
    (Lat. 42[deg]15'38'' N, long. 84[deg]27'44'' W)

    That airspace extending upward from the surface to and including
3,500 feet MSL within a 4-mile radius of Jackson County Airport-
Reynolds Field. This Class E airspace area is effective during the
specific dates and times established in advance by a Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Chart Supplement.

Paragraph 6004 Class E Airspace Designates as an Extension to Class
D and Class E Surface Areas.

* * * * *

AGL MI E4 Jackson, MI [Removed]

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL MI E5 Jackson, MI [Amended]

Jackson County Airport-Reynolds Field, MI
    (Lat. 42[deg]15'38'' N, long. 84[deg]27'44'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of the Jackson County Airport-Reynolds
Field.

    Issued in Fort Worth, Texas, on April 30, 2018.
Christopher L. Southerland,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2018-09560 Filed 5-4-18; 8:45 am]
 BILLING CODE 4910-13-P