 KeystoneCEV_EPA3reanalysis_TSD_final.pdf:  Technical Support Document describing EPA Region 3's reanalysis of model receptor near the Keystone Generating Station from the original modeling analysis submitted by Pennsylvania that had a modeled design value concentration above the accepted value of the NAAQS (196.4 ug/m[3]). Supporting analysis including EPA's modeling files are included as a separate part of the docket and are available upon request.

IndianaPA_Part75_EmissionAnalysis_TSD_final.pdf:  Technical Support Document describing EPA Region 3's analysis of Indiana, PA nonattainment SIP source Part 75 reported information including SO2 emissions and boiler heat inputs.  Supporting analyses using R (input/output/figures/tables and scripts) are included as a separate part of the docket and are available upon request.

IndianaPA_RRE_TSD_final.pdf:  Technical Support Document describing EPA Region 3's analysis of Indiana, PA nonattainment SIP's hourly varying modeled emission rates for Seward (supplemental modeling analysis) and Keystone (original SIP submittal).  These sources' modeled hourly varying emissions were part of Pennsylvania's Randomly Reassigned Emission rates used to support Seward and Keystone's long-term emission limits included in Pennsylvania's SIP to demonstrate compliance with the 1-hour SO2 NAAQS.  Supporting analyses using R (input/output/figures/tables and scripts) are included as a separate part of the docket and are available upon request.


SECTION F

	TOLERANCE PROPOSAL

Tolerances are proposed for combined residues of spiromesifen: 2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate, its enol metabolite (4-hydroxy- 3-(2,4,6-trimethylphenyl)-1-oxaspiro [4.4 ] non-3-en-2-one) and its metabolites containing the 4-hydroxymethyl moiety (4-hydroxy-3-[4-(hydroxymethyl)- 2,6-dimethyl phenyl]-1-oxaspiro[4.4]non-3-en-2-one) and its conjugates, calculated as parent compound equivalents, on the following commodities from crops grown as rotational crops:

Rotational Crop

Commodity	Plant-Back

Interval	Proposed Tolerance (Ppm)

vegetable , bulb, (Crop Group 3-07)

	30

	0.09


interest requirements of Section 17A of the Act \93\ applicable to
clearing agencies as required under Rule 17Ad-22(d)(8).\94\
---------------------------------------------------------------------------

    \93\ 15 U.S.C. 78q-1.
    \94\ 17 CFR 240.17Ad-22(d)(8).
---------------------------------------------------------------------------

Amendments to the Technology Committee Charter
    OCC is proposing amendments to its TC Charter to require that the
Committee meet regularly, and no less than once annually, with OCC's
CSO and to provide that the CSO is authorized to communicate with
directly with [sic] the Chair of the TC in between meetings of the
Committee. OCC also proposes to amend the TC Charter to provide that
the TC shall make such reports to the Board as deemed necessary or
advisable. The proposed amendments are designed to strengthen the
autonomy and independence of the CSO role at OCC and to promote
effective communication between the CSO and the TC and between TC and
the Board and are in line with requirements in other Committee
Charters. OCC therefore believes the proposed amendments are designed
to protect investors and the public interest in accordance with Section
17A(b)(3)(F) of the Act \95\ and are clear and transparent to fulfill
the public interest requirements in the Act applicable to clearing
agencies and to support the objectives of owners and participants
consistent with Rule 17Ad-22(d)(8).\96\
---------------------------------------------------------------------------

    \95\ 15 U.S.C. 78q-1(b)(3)(F).
    \96\ 17 CFR 240.17Ad-22(d)(8).
---------------------------------------------------------------------------

Amendment No. 1 to Amended and Restated Stockholders Agreement
    OCC also proposes to adopt Amendment No. 1 to Amended and Restated
Stockholders Agreement in order to provide for Board action in the
nomination process for Member Directors, Public Directors, the
Executive Chairman and Member Vice Chairman in conformance with the
process set forth in the GNC Charter. The proposed change would ensure
an appropriate level of Board oversight and participation in the
nomination process and provide consistency between the processes
described in the GNC Charter and Amended and Restated Stockholders
Agreement thereby ensuring that OCC's governance

arrangements are clear and transparent to fulfill the public interest
requirements of Section 17A of the Act \97\ applicable to clearing
agencies as required under Rule 17Ad-22(d)(8).\98\
---------------------------------------------------------------------------

    \97\ 15 U.S.C. 78q-1.
    \98\ 17 CFR 240.17Ad-22(d)(8).
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    OCC does not believe that the proposed rule change would have any
impact or impose any burden on competition.\99\ The proposed changes to
OCC's By-Laws, the Board Charter, and the Committee Charters would
promote the effectiveness of OCC's Board and Board Committees'
oversight on OCC's business, risk management, and operational processes
and provide more clarity and transparency with respect to OCC's
governance arrangements. The proposed rule change would also enhance
the descriptions of the duties and functions of the Board and its
members as well as the AC, the CPC, and the RC. The proposed rule
change also promotes more effective governance arrangements for OCC,
for example, by removing term limits for Public Directors and requiring
the Chair of the AC and the CPC to be Public Directors. As a result,
OCC does not believe that the proposed changes would have any impact
between or among clearing agencies, Clearing Members, or other market
participants. The proposed modifications to OCC's governance
arrangements would not unfairly inhibit access to OCC's services or
disadvantage or favor any particular user in relationship to another
user because they relate to the governance structure of OCC, which
affects all users, and do not relate directly to any particular service
or particular use of OCC's facilities.
---------------------------------------------------------------------------

    \99\ 15 U.S.C. 78q-1(b)(3)(I).
---------------------------------------------------------------------------

    For the foregoing reasons, OCC believes that the proposed rule
change is in the public interest, would be consistent with the
requirements of the Act applicable to clearing agencies, and would not
have any impact or impose a burden on competition.

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received from Members, Participants, or Others

    Written comments on the proposed rule change were not and are not
intended to be solicited with respect to the proposed rule change and
none have been received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
(A) by order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change
should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-OCC-2016-002 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-OCC-2016-002. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549 on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of OCC and on OCC's
Web site at http://www.theocc.com/components/docs/legal/rules_and_bylaws/sr_occ_16_002.pdf. All comments received will be
posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-OCC-2016-002 and should be submitted on
or before August 24, 2016.
---------------------------------------------------------------------------

    \100\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\100\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-18320 Filed 8-2-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)]
[Notices]
[Pages 32307-32308]
[FR Doc No: 2018-14866]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0205]

Chemistry, Manufacturing, and Control Information for Human Gene
Therapy Investigational New Drug Applications; Draft Guidance for
Industry; 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 a draft guidance for industry entitled ``Chemistry,
Manufacturing, and Control (CMC) Information for Human Gene Therapy
Investigational New Drug Applications (INDs); Draft Guidance for
Industry.'' The draft guidance document provides sponsors of a human
gene therapy IND with recommendations regarding CMC information
required to assure product safety, identity, quality, purity, and
strength (including potency) of the investigational product. The draft
guidance applies to human gene therapy products and to combination
products that contain a human gene therapy in combination with a drug
or device.
    The draft guidance, when finalized, is intended to supersede the
document entitled ``Guidance for FDA Reviewers and Sponsors: Content
and Review of Chemistry, Manufacturing, and Control (CMC) Information
for Human Gene Therapy Investigational New Drug Applications (INDs),''
dated April 2008 (April 2008 guidance).

DATES: Submit either electronic or written comments on the draft
guidance by October 10, 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. Since 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-2008-D-0205 for ``Chemistry, Manufacturing, and Control (CMC)
Information for Human Gene Therapy Investigational New Drug
Applications (INDs); Draft Guidance for Industry.'' 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 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 the draft guidance 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 the office in
processing your requests. The draft 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 draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Gretchen Opper, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Chemistry, Manufacturing, and Control (CMC) Information for Human
Gene Therapy Investigational New Drug Applications (INDs); Draft
Guidance for Industry.'' The draft guidance provides sponsors of a
human gene therapy IND with recommendations regarding CMC information
required to assure product safety, identity, quality, purity, and
strength (including potency) of the investigational product (21 CFR
312.23(a)(7)(i)). The draft guidance applies to human gene therapy
products and to combination products that contain a human gene therapy
in combination with a drug or device. The field of gene therapy has
progressed rapidly since FDA issued the April 2008 guidance. Therefore,
FDA is updating the guidance to provide current FDA recommendations
regarding the CMC content of a gene therapy IND. In addition, the draft
guidance is organized to follow the structure of the FDA guidance on
the Common Technical Document.
    The draft guidance, when finalized, is intended to supersede the
April 2008 guidance. Elsewhere in this issue of the Federal Register,
FDA is announcing the availability of two other draft guidances. In a
separate document, FDA is announcing the availability of a draft
document entitled ``Long Term Follow-Up After Administration of Human
Gene Therapy Products; Draft Guidance for Industry'' and the
availability of a draft document entitled ``Testing of Retroviral
Vector-Based Human Gene Therapy Products for Replication Competent
Retrovirus During Product Manufacture and Patient Follow-up; Draft
Guidance for Industry.''
    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 CMC
information for human gene therapy INDs. 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. Paperwork Reduction Act of 1995

    This draft 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 211 have been approved under
OMB control number 0910-0139; the collections of information in 21 CFR
part 312 and Form FDA 1571 have been approved under OMB control number
0910-0014; and the collections of information in 21 CFR part 1271 have
been approved under OMB control number 0910-0543.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: July 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14866 Filed 7-11-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 149 (Monday, August 4, 2014)]
[Rules and Regulations]
[Pages 45124-45125]
[FR Doc No: 2014-18363]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2014-0002]

Final Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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

SUMMARY: Base (1% annual-chance) Flood Elevations (BFEs) and modified
BFEs are made final for the communities listed below. The BFEs and
modified BFEs are the basis for the floodplain management measures that
each community is required either to adopt or to show evidence of being
already in effect in order to qualify or remain qualified for
participation in the National Flood Insurance Program (NFIP).

DATES: The date of issuance of the Flood Insurance Rate Map (FIRM)
showing BFEs and modified BFEs for each community. This date may be
obtained by contacting the office where the maps are available for
inspection as indicated in the table below.

ADDRESSES: The final BFEs for each community are available for
inspection at the office of the Chief Executive Officer of each
community. The respective addresses are listed in the table below.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the modified
BFEs for each community listed. These modified elevations have been
published in newspapers of local circulation and ninety (90) days have
elapsed since that publication. The Deputy Associate Administrator for
Mitigation has resolved any appeals resulting from this notification.
    This final rule is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the proof Flood Insurance Study and FIRM available at the
address cited below for each community.
    The BFEs and modified BFEs are made final in the communities listed
below. Elevations at selected locations in each community are shown.
    National Environmental Policy Act. This final rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Consideration. An environmental impact assessment has not been
prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This final rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This final rule meets
the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.

    Accordingly, 44 CFR part 67 is amended as follows:

PART 67--[AMENDED]

0
1. The authority citation for part 67 continues to read as follows:

    Authority: 42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  67.11  [Amended]

0
2. The tables published under the authority of Sec.  67.11 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                                      * Elevation in
                                                                     feet  (NGVD)  +
                                                                    Elevation in feet
                                                                      (NAVD)   Depth in feet
           Flooding source(s)                    elevation             above ground      Communities  affected
                                                                    [caret] Elevation
                                                                     in meters (MSL)
                                                                         Modified

----------------------------------------------------------------------------------------------------------------
                                Harrison County, Indiana, and Incorporated Areas
                                             Docket No.: FEMA-B-1229
----------------------------------------------------------------------------------------------------------------
Blue River (backwater effects from Ohio  At the Ohio River                       +431  Unincorporated areas of
 River).                                  confluence.                                   Harrison County.
                                         Approximately 530 feet                  +431
                                          downstream of State
                                          Route 462.
Blue River.............................  Approximately 1.7 miles                 +540  Unincorporated areas of
                                          downstream of Main                            Harrison County.
                                          Street.
                                         Approximately 0.5 mile                  +545
                                          downstream of Main
                                          Street.
Blue River.............................  Approximately 1,150 feet                +551  Unincorporated areas of
                                          upstream of Norfolk                           Harrison County.
                                          Southern Railway.
                                         Approximately 0.77 mile                 +554
                                          upstream of Norfolk
                                          Southern Railway.
Indian Creek Tributary 27..............  Approximately 1,940 feet                +645  Unincorporated areas of
                                          downstream of State                           Harrison County.
                                          Route 64.
                                         Approximately 0.41 mile                 +699
                                          upstream of Private
                                          Drive 5755.
Ohio River.............................  At the Meade County                     +431  Town of Mauckport, Town
                                          boundary.                                     of New Amsterdam,
                                                                                Unincorporated areas of
                                                                                Harrison County.
                                         At the Jefferson County                 +446
                                          boundary.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.
                                                    ADDRESSES

Town of Mauckport
Maps are available for inspection at Harrison County Plan Commission, 245 Atwood Street Northeast, Suite 215,
 Corydon, IN 47112.

Town of New Amsterdam
Maps are available for inspection at Harrison County Plan Commission, 245 Atwood Street Northeast, Suite 215,
 Corydon, IN 47112.

                                     Unincorporated Areas of Harrison County
Maps are available for inspection at Harrison County Plan Commission, 245 Atwood Street Northeast, Suite 215,
 Corydon, IN 47112.
----------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: July 11, 2014.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2014-18363 Filed 8-1-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 88, Number 122 (Tuesday, June 27, 2023)]
[Proposed Rules]
[Page 41541]
[FR Doc No: 2023-13545]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2023-F-2415]

Kemin Industries, Inc.; Filing of Food Additive Petition (Animal
Use)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, submitted by Kemin Industries, Inc.,
proposing that the food additive regulations be amended to provide for
the safe use of formaldehyde as a viral mitigant for African Swine
Fever virus (ASFv) in animal food and food ingredients.

DATES: The food additive petition was filed on June 5, 2023.

ADDRESSES: For access to the docket to read background documents or
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.

FOR FURTHER INFORMATION CONTACT: Lauren Howell, Center for Veterinary
Medicine (HFV-221), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), we are giving notice that
we have filed a food additive petition (FAP 2317), submitted by Kemin
Industries, Inc., 1900 Scott Ave., Des Moines, IA 50317. The petition
proposes to amend in 21 CFR part 573--Food Additives Permitted in Feed
and Drinking Water of Animals to provide for the safe use of
formaldehyde as a viral mitigant for ASFv in animal food and food
ingredients.
    The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(r) because it is of a type that does not
individually or cumulatively have a significant effect on the human
environment. In addition, the petitioner has stated that, to their
knowledge, no extraordinary circumstances exist that may significantly
affect the quality of the human environment. If FDA determines a
categorical exclusion applies, neither an environmental assessment nor
an environmental impact statement is required. If FDA determines a
categorical exclusion does not apply, we will request an environmental
assessment and make it available for public inspection.

    Dated: June 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-13545 Filed 6-26-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 224 (Thursday, November 20, 2014)]
[Rules and Regulations]
[Pages 69037-69039]
[FR Doc No: 2014-26985]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0489; Directorate Identifier 2014-NM-048-AD;
Amendment 39-18022; AD 2014-23-06]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440)
airplanes. This AD was prompted by a report indicating that inboard and
outboard hydraulic lines of the brakes were found connected to the
incorrect ports on the swivel assembly of the main landing gear (MLG).
This AD requires modifying the MLG by installing a new bracket on the
left and right lower aft-wing planks. We are issuing this AD to prevent
incorrect installation of the brake hydraulic lines, which could cause
the brakes and the anti-skid system to operate incorrectly, and
consequent catastrophic failure of the airplane during a high-speed
rejected takeoff.

DATES: This AD becomes effective December 26, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of December 26,
2014.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0489 or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.
    For service information identified in this AD, contact contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.com. You
may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Fabio Buttitta, Aerospace Engineer,
Airframe and Mechanical Systems Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Bombardier, Inc.
Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. The NPRM
published in the Federal Register on August 4, 2014 (79 FR 45135).
    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2014-10, dated February 12, 2014 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for certain Bombardier, Inc. Model CL-600-
2B19 (Regional Jet Series 100 & 440) airplanes. The MCAI states:

    Cases of inboard and outboard hydraulic brake lines connected to
the incorrect port of the swivel assembly on the main landing gear
were found in service, including a runway overrun event. Cross-
connected brake hydraulic lines can cause the brakes and/or the
anti-skid system to operate incorrectly. During a high speed
rejected take-off, inability for the brakes to operate correctly
could be catastrophic.
    This [Canadian] AD mandates the modification to prevent
inadvertent cross-connection of the inboard and outboard hydraulic
brake lines.

    The required action in this AD includes installing a new bracket on
the left and right lower aft-wing planks of the MLG. You may examine
the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0489-0002.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM (79 FR 45135, August 4,
2014) or on the determination of the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting this AD as proposed, except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 45135, August 4, 2014) for correcting the unsafe condition;
and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 45135, August 4, 2014).

Costs of Compliance

    We estimate that this AD affects 526 airplanes of U.S. registry.
    We also estimate that it will take about 6 work-hours per product
to comply with the basic requirements of this AD. The average labor
rate is $85 per work-hour. Required parts will cost about $375 per
product. Based on these figures, we estimate the cost of this AD on
U.S. operators to be $465,510, or $885 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect 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.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0489; or in person at the
Docket Management Facility between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD docket contains this AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone 800-647-
5527) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2014-23-06 Bombardier, Inc.: Amendment 39-18022. Docket No. FAA-
2014-0489; Directorate Identifier 2014-NM-048-AD.

(a) Effective Date

    This AD becomes effective December 26, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc. Model CL-600-2B19 (Regional
Jet Series 100 & 440) airplanes, certificated in any category,
serial numbers 7003 and subsequent.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
Gear.

(e) Reason

    This AD was prompted by a report indicating that inboard and
outboard hydraulic lines of the brakes were found connected to the
incorrect ports on the swivel assembly of the main landing gear
(MLG). We are issuing this AD to prevent incorrect installation of
the brake hydraulic lines, which could cause the brakes and the
anti-skid system to operate incorrectly, and consequent catastrophic
failure of the airplane during a high-speed rejected take-off.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Modification

    Within 6,600 flight hours after the effective date of this AD,
but no later than 36 months after the effective date of this AD:
Modify the MLG by installing a new bracket on the left and right
lower aft-wing planks, in accordance with the Accomplishment
Instructions of Bombardier Service Bulletin 601R-32-110, dated
December 19, 2013.

(h) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the New York ACO, send it to ATTN: Program Manager,
Continuing Operational Safety, FAA, New York ACO, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax
516-794-5531. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office. The AMOC approval letter must
specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, New York ACO,
ANE-170, Engine and Propeller Directorate, FAA; or Transport Canada
Civil Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval
Organization (DAO). If approved by the DAO, the approval must
include the DAO-authorized signature.

(i) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2014-10, dated February
12, 2014, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0489-0002.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Bombardier Service Bulletin 601R-32-110, dated December 19,
2013.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; email<EMAIL_ADDRESS>Internet http://www.bombardier.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on November 5, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-26985 Filed 11-19-14; 8:45 am]
BILLING CODE 4910-13-P