[Federal Register: August 5, 2009 (Volume 74, Number 149)]
[Proposed Rules]
[Page 39002-39003]
[DOCID:fr05au09-33]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2009-0349; Airspace Docket No. 09-ANM-6]

Proposed Modification of Class E Airspace; Pueblo, CO

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This action proposes to modify Class E airspace at Pueblo
Memorial Airport, CO. Additional controlled airspace is necessary to
facilitate vectoring of Instrument Flight Rules (IFR) traffic from en
route airspace to Pueblo Memorial Airport, CO. The FAA is proposing
this action to enhance the safety and management of aircraft operations
at Pueblo Memorial Airport, CO.

DATES: Comments must be received on or before September 21, 2009.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC, 20590.
Telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2009-
0349; Airspace Docket No. 09-ANM-6, at the beginning of your comments.
You may also submit comments through the Internet at http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue, SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

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 (FAA Docket No.
FAA 2009-0349 and Airspace Docket No. 09-ANM-6) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2009-0349 and Airspace Docket No. 09-ANM-6''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. 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/airports_airtraffic/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 a.m. and 5 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Area, Operations Support Group, 1601 Lind Avenue, SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRM's should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by modifying Class E airspace at Pueblo
Memorial Airport, CO. Additional controlled airspace extending upward
700 feet or more above the surface is necessary to accommodate en route
IFR aircraft at Pueblo Memorial Airport, Pueblo, CO. This action would
enhance the safety and management of aircraft operations at the
airport.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.9S, signed October 3, 2008, and effective October 31,
2008, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in this Order.
    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. Therefore, this proposed regulation:
(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.
    The FAAs authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority for 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 the
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 establishes additional controlled airspace at Pueblo Memorial
Airport, CO.

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of the FAA Order
7400.9S, Airspace Designations and Reporting Points, signed October 3,
2008, and effective October 31, 2008 is amended as follows:

Paragraph 6005. Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

ANM CO E5 Pueblo, CO [Modified]

Pueblo Memorial Airport, CO
    (Lat. 38[deg]17'21'' N., long. 104[deg]29'48'' W.)

    That airspace extending upward from 700 feet above the surface
within 21.8-mile radius of the Pueblo Memorial Airport, and within
the 28.8-mile radius of Pueblo Memorial Airport clockwise between
the 070[deg] and 133[deg] bearing from the airport; that airspace
extending upward from 1,200 feet above the surface bounded on the
north by lat. 38[deg]30'00'' N., on the east by V-169, on the south
by V-210, on the west by a line from lat. 37[deg]38'00'' N., long.
105[deg]00'02'' W.; to lat. 38[deg]09'25'' N., long. 105[deg]08'06''
W.; to lat. 38[deg]05'51'' N., long. 105[deg]30'49'' W.; to lat.
38[deg]10'00'' N., long. 105[deg]33'02'' W.; to lat. 38[deg]30'00''
N., long. 105[deg]33'02'' W.; that airspace extending upward from
13,700 feet MSL bounded by a line beginning at lat. 38[deg]09'25''
N., long. 105[deg]08'06'' W.; to lat. 37[deg]38'00'' N., long.
105[deg]00'02'' W.; to lat. 37[deg]34'00'' N., long. 105[deg]12'02''
W.; to lat. 38[deg]05'51'' N., long. 105[deg]30'49'' W.; thence to
point of beginning, excluding that airspace within Federal airways
and the Colorado Springs, CO, Class E airspace area.
* * * * *

    Issued in Seattle, Washington, on July 27, 2009.
H. Steve Karnes,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. E9-18736 Filed 8-4-09; 8:45 am]

BILLING CODE 4910-13-P


Table 7. Summary of Respondent Burden and Cost of Reporting Technical Year person Management Clerical Respondents hours person hours person hours Total Hours Total Cost $ a First 109 2,744 137 274 3,156 140,467 Second 4 1,612 81 161 1,854 82,519 Third 111 21,970 1,099 2,197 25,266 1,124,655 Three Year Total 224 26,326 1,316 2,633 30,275 1,347,641 Annual Average 75 8,775 439 878 10,092 449,214 a Costs are based on March 1999 Bureau of Labor Statistics, Employment Cost Trends total compensation index which includes wages, salaries and benefits. All costs are estimated using the following hourly rates: technical at $ 45, management at $ 67 and clerical at $ 28.

Table 8. Summary of Annual Burden and Cost for the Federal Government Technical Year person Management Clerical Respondents hours person hours person hours Total Hours Total Cost $ a First 109 1,040 52 104 1,196 53,238 1,196 Second 4 160 8 16 184 8,190 184 Third 111 200 10 20 230 10,238 230 Three Year Total 224 1,400 70 140 1,610 71,667 1,610 0 Annual Average 75 467 23 47 537 23,889 537 a Costs are based on March 1999 Bureau of Labor Statistics, Employment Cost Trends total compensation index which includes wages, salaries and benefits. All costs are estimated using the following hourly rates: technical at $ 45, management at $ 67 and clerical at $ 28.


[Federal Register Volume 84, Number 104 (Thursday, May 30, 2019)]
[Notices]
[Page 25120]
[FR Doc No: 2019-11277]

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DEPARTMENT OF TRANSPORTATION

Department of Transportation Advisory Committee on Human
Trafficking; Notice of Public Meeting

AGENCY: Office of the Secretary of Transportation, Department of
Transportation.

ACTION: Notice of public meeting.

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SUMMARY: This notice announces a meeting of the Department of
Transportation Advisory Committee on Human Trafficking.

DATES: The meeting will be held on June 17, 2019, from 2:00 p.m. to
5:00 p.m. EDT.

ADDRESSES: The meeting will be held via teleconference. Any person
requesting accessibility accommodations should contact the Official
listed in the next section.

FOR FURTHER INFORMATION CONTACT: Nicole L. Bambas, Senior Advisor,
Office of International Transportation and Trade, U.S. Department of
Transportation, at<EMAIL_ADDRESS>or<PHONE_NUMBER>. Also visit
the ACHT internet website at https://www.transportation.gov/stophumantrafficking/acht.

SUPPLEMENTARY INFORMATION:

I. Background

    The Advisory Committee on Human Trafficking (ACHT) was created in
accordance with Section 5 of the Combating Human Trafficking in
Commercial Vehicles Act (Pub. L. 115-99) to make recommendations to the
Secretary of Transportation on actions the Department can take to help
combat human trafficking, and to develop recommended best practices for
States and State and local transportation stakeholders in combatting
human trafficking.

II. Agenda

    At the June 17, 2019, meeting, the agenda will cover the following
topics:

 Welcome
 Review of the ACHT Process
 Overview of the ACHT Final Report
 Public Comment
 Motion to Approve Final ACHT Report
 Closing

    A final agenda will be posted on the ACHT internet website at
https://www.transportation.gov/stophumantrafficking/acht at least one
week in advance of the meeting.

III. Public Participation

    The meeting will be open to the public. Members of the public who
wish to participate in the teleconference are asked to register via
email by submitting their name and affiliation to<EMAIL_ADDRESS>by June 3, 2019. The US Department of Transportation is committed to
providing equal access to this meeting for all participants. If you
need alternative formats or services because of a disability, please
contact Nicole Bambas at<PHONE_NUMBER> or via email at
<EMAIL_ADDRESS>with your request by close of business on June 3,
2019.
    There will be 30 minutes allotted for oral comments from members of
the public joining the meeting. To accommodate as many speakers as
possible, the time for each commenter may be limited. Individuals
wishing to reserve speaking time during the meeting must submit a
request at the time of registration, as well as the name, address, and
organizational affiliation of the proposed speaker. If the number of
registrants requesting to make statements is greater than can be
reasonably accommodated during the meeting, the Office of the Secretary
may conduct a lottery to determine the speakers. Speakers are requested
to submit a written copy of their prepared remarks by 5:00 p.m. EDT on
June 3, 2019, for inclusion in the meeting records and for circulation
to ACHT members. All prepared remarks submitted on time will be
accepted and considered as part of the record.
    Persons who wish to submit written comments for consideration by
ACHT during the meeting must submit them no later than 5:00 p.m. EDT on
June 3, 2019, to ensure transmission to ACHT members prior to the
meeting. Comments received after that date and time will be distributed
to the members but may not be reviewed prior to the meeting.
    Copies of the meeting minutes will be available on the ACHT
internet website at https://www.transportation.gov/stophumantrafficking/acht.

    Dated: May 20, 2019.
Joel Szabat,
Assistant Secretary, Aviation and International Affairs.
[FR Doc. 2019-11277 Filed 5-29-19; 8:45 am]
BILLING CODE 4910-9X-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on April 25, 2005

NOTICE OF ACTION TAKEN -- DOCKET OST-2005-20657

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  Air Dolomiti S.p.A. LARE						Date Filed:  March 14, 2005

Relief requested:   Exemption from 49 U.S.C. § 41301 and blanket
statement of authorization pursuant to 14 CFR Part 212 of the
Department’s regulations to display the designator code of US Airways,
Inc. on all flights operated by Air Dolomiti on behalf of Deutsche
Lufthansa AG (Lufthansa German Airlines) within Europe.

If renewal, date and citation of last action:  New authority

Applicant representatives:  David Heffernan<PHONE_NUMBER>

DOT Analyst:  Shelita A. Smith<PHONE_NUMBER>

Responsive pleadings:  None filed

DISPOSITION

Action:  Approved							Action date:  April 25, 2005

Effective dates of exemption granted:  April 25, 2005 – April 25, 2007

Effective dates of statement of authorization granted:  April 25, 2005
– Indefinite subject to code-share conditions attached.

Basis for approval (bilateral agreement/reciprocity):  The U.S.-Italy
Air Transport Agreement

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

X  Standard exemption conditions (attached)		X  Code share-conditions
(attached)

Special conditions/Partial grant/Denial basis/Remarks: Air Dolomiti also
requested a waiver to the extent necessary from the Department’s
requirement that it be substantially owned and effectively controlled by
homeland nationals.  Air Dolomiti stated that it is wholly owned by
Lufthansa German Airlines, a foreign air carrier of Germany.  In support
of its waiver request, Air Dolomiti stated that it is licensed by the
Government of Italy and operates as a separate company under the
regulatory jurisdiction of the Italian aviation authorities.  Air
Dolomiti further stated  that three of its six directors are Italian
citizens and all of its key management personnel, with the exception of
one its five vice presidents, are Italian citizens.  In spite of the
fact that we are unable to find that Air Dolomiti is substantially owned
and effectively

controlled by homeland nationals, we find it appropriate to waive our
ownership and control requirements.  The carrier is properly licensed by
the Government of Italy to perform the proposed services, and there is
no evidence on the record which would suggest that the ownership of Air
Dolomiti would be inimical to U.S. aviation policy or interests.

The code-share operations authorized here are subject to the following
conditions:

(a)  The statement of authorizations will remain in effect only as long
as (i) Air Dolomiti and/or US Airways continue to hold the necessary
underlying authority to operate the code-share services at issue, and
(ii) the code-share agreement providing for the code-share operations
remains in effect.

(b)  Air Dolomiti and/or US Airways must promptly notify the Department
(Office of International Aviation) if the code-share agreement providing
for the code-share operations is no longer effective or the carriers
decide to cease operating any or all of the approved code-share
services.  Such notices should be filed in Docket OST-2005-20657.

(c)  Air Dolomiti and/or US Airways must notify the Department no later
than 30 days before they begin any new code-share service under the
code-share services authorized here.  Such notice shall identify the
market(s) to be served and the date on which the service will begin.
Such notices should be filed in Docket OST-2005-20657.

(d)  The code-sharing operations conducted under this authority must
comply with 14 CFR Part 257 and with any amendments to the
Department’s regulations concerning code-share arrangements that may
be adopted.  Notwithstanding any provisions in the contract between the
carriers, our approval here is expressly conditioned upon the
requirements that the subject foreign air transportation be sold in the
name of the carrier holding out such service in computer reservation
systems and elsewhere; that the carrier selling such transportation
(i.e., the carrier shown on the ticket) accept responsibility for the
entirety of the code-share journey for all obligations established in
its contract of carriage with the passenger; and that the passenger
liability of the operating carrier be unaffected.  Further, the
operating carrier shall not permit the code of its U.S. carrier
code-sharing partner to be carried on any flight that enters, departs or
transits the airspace of any area for whose airspace the Federal
Aviation Administration has issued a flight prohibition.

(e)  The authority granted here is specifically conditioned so that
neither carrier shall give any force or effect to any contractual
provisions between themselves that are contrary to these conditions.

(f)  We may amend, modify, or revoke the authority granted at any time
without hearing at our discretion.

Action taken by:  Paul L. Gretch, Director

		   Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant is

qualified to perform the proposed operations; (2) our action was
consistent with Department policy; (3) grant of the authority was
consistent with the public interest; and (4) grant of the authority
would not constitute a major regulatory action under the Energy Policy
and Conservation Act of 1975.  To the extent not
granted/deferred/dismissed, we denied

all requests in the referenced Docket.  We may amend, modify, or revoke
the authority granted in this Notice at any time without hearing at our
discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

												05/2004

  Air Dolomiti incorporated by reference information provided March 15,
2002, in Docket OST-2002-11856, containing its request to conduct
certain intra-European code-share operations with United Air Lines, Inc.
(United), and reconfirmed February 19, 2004, in the context of its
exemption renewal application in the same docket.

  We expect this notification to be received within 10 days of such
non-effectiveness or of such decision.


[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Page 31874]
[FR Doc No: 2019-14137]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3208]

DHL Laboratories Inc.; Withdrawal of Approval of a New Drug
Application for Dextrose 5% Injection in Plastic Container, 5 Grams/100
Milliliters

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of new drug application (NDA) 019971 for Dextrose 5% Injection in
Plastic Container, 5 grams (g)/100 milliliters (mL), held by DHL
Laboratories Inc., 155 Medical Science Dr., Union, SC 23979. The basis
for the withdrawal is that the holder of the NDA has repeatedly failed
to file required annual reports for the NDA.

DATES: Approval is withdrawn as of July 3, 2019.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holder of an approved application to
market a new drug for human use is required to submit annual reports to
FDA concerning its approved application in accordance with Sec.  314.81
(21 CFR 314.81).
    In the Federal Register of August 29, 2018 (83 FR 44056), FDA
published a notice offering an opportunity for a hearing (NOOH) on a
proposal to withdraw approval of NDA 019971 because DHL Laboratories
Inc. had failed to submit required annual reports for the NDA. DHL
Laboratories Inc. did not respond to the NOOH. Failure to file a
written notice of participation and request for hearing as required by
Sec.  314.200 (21 CFR 314.200) constitutes an election by the holder of
the NDA not to make use of the opportunity for a hearing concerning the
proposal to withdraw approval of the NDA and a waiver of any
contentions concerning the legal status of the drug product. FDA is
withdrawing approval of NDA 019971 for Dextrose 5% Injection in Plastic
Container, 5 g/100 mL.
    FDA finds that DHL Laboratories Inc. has repeatedly failed to
submit reports required by Sec.  314.81. In addition, under Sec.
314.200, FDA finds DHL Laboratories Inc. has waived any contentions
concerning the legal status of the drug product. Therefore, under these
findings, approval of NDA 019971, and all amendments and supplements
thereto, is hereby withdrawn as of July 3, 2019.

    Dated: June 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14137 Filed 7-2-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 44 (Tuesday, March 6, 2018)]
[Rules and Regulations]
[Pages 9440-9442]
[FR Doc No: 2018-04534]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0080; FRL-9973-39]

Lipochitooligosaccharide (LCO) SP104; Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for lipochitooligosaccharide (LCO) SP104 in or on all
food commodities when used in accordance with label directions and good
agricultural practices. Monsanto Company submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA) requesting an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of LCO SP104 under FFDCA.

DATES: This regulation is effective March 6, 2018. Objections and
requests for hearings must be received on or before May 7, 2018, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0080, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0080 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
May 7, 2018. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0080, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting

or visiting the docket, along with more information about dockets
generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of June 8, 2017 (82 FR 26641) (FRL-9961-
14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 6F8520) by Monsanto Company, 1300 I (Eye) St. NW, Suite
450 East, Washington, DC 20005. The petition requested that 40 CFR 180
be amended by establishing an exemption from the requirement of a
tolerance for residues of the plant growth regulator LCO SP104 in or on
raw agricultural commodities and processed foods. That document
referenced a summary of the petition prepared by the petitioner,
Monsanto Company, which is available in the docket via http://www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance or tolerance exemption and
to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue. . . .'' Additionally, FFDCA section 408(b)(2)(D)
requires that EPA consider ``available information concerning the
cumulative effects of [a particular pesticide's] . . . residues and
other substances that have a common mechanism of toxicity.'' FFDCA
section 408(b)(2)(C) provides that EPA shall apply an additional
tenfold (10X) margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the database on toxicity and exposure unless EPA
determines based on reliable data that a different margin of safety
will be safe for infants and children. This additional margin of safety
is commonly referred to as the Food Quality Protection Act Safety
Factor (FQPA SF). In applying this provision, EPA either retains the
default value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    EPA evaluated the available toxicity and exposure data on LCO SP104
and considered their validity, completeness, and reliability, as well
as the relationship of this information to human risk. EPA also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
    Lipochitooligosaccharides (LCOs) are signaling molecules produced
by bacteria, which are involved in the initiation of plant-microbe
endosymbiosis (the scenario when a microbe colonizes a plant) in an
estimated 70-80% of terrestrial plants. As a pesticide, LCO SP104, a
synthetically produced LCO, is intended for use as a plant growth
regulator (PGR) to increase growth and decrease stress in growing
crops. Typical of a PGR, LCO SP104 should be applied at low
concentrations because use at high concentrations can result in
detrimental effects to the plant. LCO SP104 is structurally similar to
naturally occurring LCOs. Humans are exposed to naturally occurring
LCOs as they are present in the roots of food crops and in the bacteria
and fungi that are associated with the roots of these crops. Molecules
identical to LCO breakdown products (such as chitin) are also present
in insects, crustaceans, fungi, bacteria, and humans, and are regularly
consumed by humans as part of a normal diet.
    Based on the data submitted in support of this petition (summarized
in Unit II. B., below) and the comprehensive risk assessment conducted
by the Agency (included in the Docket for this action), EPA concludes
that there is a reasonable certainty of no harm from aggregate
exposures to LCO SP104, including the consumption of food treated with
this active ingredient in accordance with label directions and good
agricultural practices. EPA has made this determination because
available toxicology data indicate that the active ingredient is not
acutely toxic and, based upon a weight of the evidence (WOE) approach,
it has been determined not to be a developmental toxicant, a mutagen,
or toxic via repeat oral exposure (i.e. not subchronically toxic via
the oral route). As such the Agency has not identified any endpoints of
concern for LC SP104 and has conducted a qualitative assessment of
exposure. The Agency has determined that residues of LCO SP104 in
drinking water are not expected when products are used according to
label instructions. The active ingredient is applied at low
concentrations, is very soluble in water, and will dissociate within
minutes once applied. Non-occupational exposures are not expected since
LCO SP104 is not intended for residential use. A full explanation of
the data upon which EPA relied and its risk assessment based on those
data can be found within the January 22, 2018, document entitled
``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for
Lipochitooligosaccharide (LCO) SP104.'' This document, as well as other
relevant information, is available in the docket for this action as
described under ADDRESSES.
    Based upon its evaluation, EPA concludes that LCO SP104 is of low
acute toxicity and no toxicological endpoints have been identified for
this compound. Therefore, EPA concludes that there is a reasonable
certainty that no harm will result to the U.S. population, including
infants and children, from aggregate exposure to residues of LCO SP104.
Therefore, EPA is establishing an exemption from the requirement of a
tolerance for residues of LCO SP104.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes due
to the lack of concern about safety for LCO SP104 at any exposure
level.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to EPA. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning

Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). This action does not contain any information collections subject
to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
et seq., nor does it require any special considerations under Executive
Order 12898, entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations'' (59 FR
7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this action, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA has determined that this
action will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, EPA has determined that
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (UMRA) (2
U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: February 23, 2018.
Richard Keigwin, Jr.,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1353 to subpart D to read as follows:

Sec.  180.1353  Lipochitooligosaccharide (LCO) SP104; exemption from
the requirement of a tolerance.

    Residues of the biochemical pesticide Lipochitooligosaccharide
(LCO) SP104 (which has been used in accordance with label directions
and good agricultural practices) are exempt from the requirement of a
tolerance in or on all food commodities.

[FR Doc. 2018-04534 Filed 3-5-18; 8:45 am]
BILLING CODE 6560-50-P