[Federal Register Volume 85, Number 92 (Tuesday, May 12, 2020)]
[Notices]
[Pages 28016-28017]
[FR Doc No: 2020-10082]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1081]

Hospira Inc., et al.; Withdrawal of Approval of Seven Abbreviated
New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of seven abbreviated new drug applications (ANDAs)
from multiple applicants. The

applicants notified the Agency in writing that the drug products were
no longer marketed and requested that the approval of the applications
be withdrawn.

DATES: Approval is withdrawn as of June 11, 2020.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 065232.................  Ceftriaxone Sodium    Hospira Inc., 275
                               for Injection,        North Field Dr.,
                               Equivalent to (EQ)    Building H1, Lake
                               10 grams (g) base/    Forest, IL 60045.
                               vial.
ANDA 088697.................  Amitriptyline         Par Pharmaceutical
                               Hydrochloride (HCl)   Inc., One Ram Ridge
                               Tablets, 10           Rd., Spring Valley,
                               milligrams (mg).      NY 10977.
ANDA 088698.................  Amitriptyline HCl     Par Pharmaceutical
                               Tablets, 25 mg.       Inc.
ANDA 088699.................  Amitriptyline HCl     Do.
                               Tablets, 50 mg.
ANDA 088700.................  Amitriptyline HCl     Do.
                               Tablets, 75 mg.
ANDA 088701.................  Amitriptyline HCl     Do.
                               Tablets, 100 mg.
ANDA 088702.................  Amitriptyline HCl     Do.
                               Tablets, 150 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of June
11, 2020. Approval of each entire application is withdrawn, including
any strengths and dosage forms inadvertently missing from the table.
Introduction or delivery for introduction into interstate commerce of
products without approved new drug applications violates section 301(a)
and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a)
and (d)). Drug products that are listed in the table that are in
inventory on June 11, 2020, may continue to be dispensed until the
inventories have been depleted or the drug products have reached their
expiration dates or otherwise become violative, whichever occurs first.

    Dated: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10082 Filed 5-11-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Rules and Regulations]
[Pages 58184-58186]
[FR Doc No: 2013-22965]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2009-0140; FRL-9901-10-Region 4]

Approval and Promulgation of Implementation Plans; North
Carolina; Removal of Stage II Gasoline Vapor Recovery Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is taking final action to approve changes to the North
Carolina State Implementation Plan (SIP) submitted by the State of
North Carolina Department of Environment and Natural Resources (NC
DENR), Division of Air Quality on September 18, 2009, for the purpose
of removing Stage II vapor control requirement contingency measures for
new and upgraded gasoline dispensing facilities in the State. The
September 18, 2009, SIP revision also addresses several non-Stage II
related rule changes. However, action on the other portions for the
September 18, 2009, SIP revision is being addressed in a separate
rulemaking action. EPA has determined that North Carolina's September
18, 2009, SIP revision regarding the Stage II vapor control
requirements is approvable because it is consistent with the Clean Air
Act (CAA or Act).

DATES: Effective Date: This rule will be effective October 23, 2013.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2009-0140. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information is not publicly available, i.e., Confidential
Business Information or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Regulatory Development Section, Air Planning Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday, 8:30 to 4:30 excluding Federal
holidays.

FOR FURTHER INFORMATION CONTACT: For information regarding this action,
contact Ms. Kelly Sheckler, Regulatory Development Section, Air
Planning Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. Ms. Sheckler's telephone number is (404)
562-9222; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Final Action
III. Statutory and Executive Order Reviews

I. Background

    EPA, under the CAA Amendments of 1990, designated (pursuant to
section 107(d)(1)) and classified certain counties in North Carolina,
either in their entirety or portions thereof, as ``moderate'' ozone
nonattainment areas for the 1-hour ozone national ambient air quality
standards (NAAQS). Specifically, the Charlotte-Gastonia Area (comprised
of Gaston and Mecklenburg Counties); the Greensboro-Winston-Salem-High
Point Area (comprised of Davidson, Davis (partial), Forsyth and
Guilford Counties); and the Raleigh-Durham Area (comprised of Durham,
Granville (partial), and Wake Counties) were all designated as
``moderate'' ozone nonattainment areas for the 1-hour ozone NAAQS. The
designations were based on the Areas' 1-hour ozone design values for
the 1987-1989 three-year period. The ``moderate'' classification
triggered various statutory requirements for these Areas including the
Stage II vapor recovery requirements pursuant to section 182(b)(3) of
the CAA.

    Prior to the deadline for implementing the requirements of section
182(b)(3) of the CAA, the Charlotte-Gastonia, Greensboro-Winston-Salem-
High Point and Raleigh-Durham Areas in North Carolina attained the 1-
hour ozone NAAQS. North Carolina had implemented all measures then
required for moderate ozone nonattainment areas under the CAA, and with
three years of data (1990-1992), demonstrated compliance with the 1-
hour ozone NAAQS.
    Subsequently, NC DENR submitted to EPA 1-hour ozone maintenance
plans and requests for redesignation for the three moderate
nonattainment areas. As part of the associated 1-hour ozone maintenance
plans for these areas, North Carolina provided contingency measures
that included regulation 15A North Carolina Administrative Code (NCAC)
02D.0953 (hereafter referred to as rule .0953), entitled Vapor Return
Piping for Stage II Vapor Recovery, for all new or improved gasoline
tanks, and 15A NCAC 02D.0954 (hereafter referred to as rule .0954),
entitled Stage II Vapor Recovery. These contingency measures were never
activated as the Areas all continued to attain the 1-hour ozone NAAQS.
EPA approved the redesignation requests and the maintenance plans for
the Charlotte-Gastonia Area on July 5, 1995 (60 FR 34859), the
Greensboro-Winston-Salem-High Point Area on September 9, 1993 (58 FR
47391), and the Raleigh-Durham Area on April 18, 1994 (59 FR 18300).
    On September 18, 2009, NC DENR submitted a SIP revision to remove
Stage II vapor control contingency measure requirements from the 1-hour
maintenance plans for the Charlotte-Gastonia, Greensboro-Winston-Salem-
High Point, and Raleigh-Durham Areas. In addition, the removal of rules
.0953 and .0954 necessitated amendments of rules 15A NCAC 02D.0902(d)--
Applicability (hereafter referred to as rule .0902(d)), 15A NCAC
02D.0909--Compliance schedules for Sources in new nonattainment Areas
(hereafter referred to as rule .0909), and 15A NCAC 02D.0952--Petitions
for Alterative Controls for RACT (hereafter referred to as rule .0952)
in North Carolina's SIP.\1\ Accordingly, NC DENR's September 18, 2009,
SIP revision also changes rules .0902(d), .0909, and .0952 to remove
subparagraphs referencing the repealed Stage II rules .0953 and .0954.
---------------------------------------------------------------------------

    \1\ North Carolina's SIP revision also make changes to Rule 15A
NCAC 02Q.0102--Activities Exempted from permit requirements
regarding New Source Performance Standards and Rule 15A NCAC
02D.1110--National Emission Standards for Hazardous Air Pollutants.
EPA is not taking action in today's action to approve these changes
and these rules are not currently part of North Carolina's
federally-approved SIP.
---------------------------------------------------------------------------

    On June 7, 2013, EPA published a proposed rulemaking to approve
North Carolina's September 18, 2009, SIP revision related to Stage II.
Detailed background for today's final rulemaking can be found in EPA's
June 7, 2013, proposed rulemaking. See 78 FR 34303. The comment period
for this proposed rulemaking closed on July 8, 2013. EPA did not
receive any comments, adverse or otherwise, during the public comment
period.

II. Final Action

    EPA is taking final action to approve the SIP revision submitted by
North Carolina for the purpose of removing Stage II vapor control
contingency measure requirements for new and upgraded gasoline
dispensing facilities in the Charlotte-Gastonia, Greensboro-Winston-
Salem-High Point, and Raleigh-Durham Areas. Specifically, this action
removes Stage II rules .0953 and .0954 from the North Carolina SIP, and
amends rules .0902(d), .0909, and .0952 to reflect the removal of rules
.0953 and .0954 in the State's implementation plan. EPA has determined
that North Carolina's September 18, 2009, SIP revision related to the
State's Stage II rules is consistent with the CAA and EPA's regulations
and guidance.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 22, 2013. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not

be challenged later in proceedings to enforce its requirements. See
section 307(b)(2).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone, Reporting and recordkeeping requirements, Volatile
organic compounds.

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

    Dated: August 29, 2013.
Beverly H. Banister,
Acting Regional Administrator, Region 4.
    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart II--North Carolina

0
2. Section 52.1770(c), under Table 1, is amended by revising the
entries for ``.0902,'' ``.0909,'' ``.0952,'' ``.0953,'' and ``.0954''
to read as follows:

Sec.  52.1770  Identification of plan.

* * * * *
    (c) * * *

                                Table 1--EPA Approved North Carolina Regulations
----------------------------------------------------------------------------------------------------------------
                                             State
 State  citation       Title/subject       effective       EPA approval date               Explanation
                                              date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
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                                        .0900 Volatile Organic Compounds
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
Sect .0902.......  Applicability........     5/1/2013  9/23/2013 [Insert         This approval does not include
                                                        citation of               the start-up shutdown language
                                                        publication].             as described in Section II. A.
                                                                                a. of EPA's 3/13/2013 proposed
                                                                                rule (78 FR 15895)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
Sect .0909.......  Compliance Schedules.     5/1/2013  9/23/2013 [Insert
                                                        citation of
                                                        publication].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
Sect .0952.......  Petitions for            9/18/2009  9/23/2013 [Insert
                    Alternative Controls                citation of
                    for RACT.                           publication].
Sect .0953.......  Vapor Return Piping      9/18/2009  9/23/2013 [Insert         This rule has been repealed as
                    for Stage II Vapor                  citation of               state effective 9/18/2009.
                    Recovery.                           publication].
Sect .0954.......  Stage II Vapor           9/18/2009  9/23/2013 [Insert         This rule has been repealed as
                    Recovery.                           citation of               state effective 9/18/2009.
                                                        publication].
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                                                  * * * * * * *
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* * * * *
[FR Doc. 2013-22965 Filed 9-20-13; 8:45 am]
BILLING CODE 6560-50-P


<EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE
PETITIONS PUBLISHED IN THE FEDERAL REGISTER  (1/1/2007)>

<EPA Registration Division contact: Susan Stanton<PHONE_NUMBER>>

<Interregional Research Project No. 4 (IR-4)>

<PP 7E7270>

<	EPA has received a pesticide petition (PP 7E7270) from Interregional
Research Project No. 4 (IR-4), Rutgers University; 500 College Road
East, Suite 201 W, Princeton, NJ 08540 proposing, pursuant to section
408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C.
346a(d), to amend 40 CFR part 180.275 by establishing tolerances for
residues of Chlorothalonil in or on the raw agricultural commodities
vegetables, fruiting, group 8 at 5.0 parts per million (ppm); okra at
5.0 ppm; persimmon at 1.9 ppm; horseradish at 4.0 ppm; rhubarb at 5.0
ppm; ginseng at 3.0 ppm; yam at 5.0 ppm; lupine at 0.1 ppm; lentil at
0.1 ppm; vegetable, cucurbit, group 9 at 5.0 ppm; and Brassica, head and
stem, subgroup 5A at 5.0 ppm.  The petition also proposes that
previously approved tolerances for residues of chlorothalonil in or on
broccoli, Brussels sprouts, cabbage, cauliflower, cucumber, melon,
nonbell pepper, pumpkin, summer squash, winter squash and tomato be
deleted, since the proposed tolerances on fruiting vegetables, cucurbit
vegetables or Brassica head and stem vegetables would apply to these
commodities.  EPA has determined that the petition contains data or
information regarding the elements set forth in section 408 (d)(2) of
FDDCA; however, EPA has not fully evaluated the sufficiency of the
submitted data at this time or whether the data supports granting of the
petition. Additional data may be needed before EPA rules on the
petition.>

<A. Residue Chemistry>

<	1. Plant metabolism The metabolism of Chlorothalonil as well as the
nature of the residues in plants is adequately understood for purposes
of the proposed tolerance. Plant metabolism has been evaluated in five
diverse crops: Carrots, celery, lettuce, snap beans, and tomatoes, which
should serve to define the similar metabolism of Chlorothalonil in a
wide range of crops. The qualitative nature of residues in plants for
Chlorothalonil is adequately understood. The

residue of concern is Chlorothalonil and its metabolite, 4-hydroxy-

2,5,6-trichloroisophthalonitrile (SDS-3701). Parent metabolite CGA-

64250 is the major compound found in crops. >

<	2. Analytical method. An adequate residue analytical method (gas
chromatography) is available for enforcement purposes. The method is

listed in the Pesticide Analytical Manual (PAM) Vol. II (PAM II).>

<	3. Magnitude of residues. All samples were analyzed for residues of
Chlorothalonil, its metabolite SDS-3701, and the manufacturing impurity
HCB.

The limit of quantitation (LOQ) for Chlorothalonil in all matrices was
0.030 ppm.  The limit of quantitation for SDS-3701 and HCB were 0.030
ppm and 0.010 ppm, respectively.

i.  Peppers (Bell):

Nine field trials were conducted in New Jersey, Florida, Texas, South
Carolina, Ohio, California, and Georgia to collect data on the residues
of Chlorothalonil on bell peppers following treatment with Bravo Weather
Stik. Seven or eight applications of the test substance were made 6 to
10 days apart at a rate of 1.125 lb ai/A ± 5% each. The total rate
applied at eight of the trials was approximately 9.0 lb ai/A per trial.
In the Georgia trial, seven applications were made for a total

application rate of 8.0 lb ai/A.  In each trial, mature bell peppers
were collected from each plot 2 to 3 days following the final
application.

Samples collected 2 to 3 days following the final application contained
residues

ranging from 0.33 to 3.5 ppm. By approximately 28 days after the last
application,

residues ranged from 0.055 to 1.0 ppm Chlorothalonil. No quantifiable
residues of SDS-3701 or HCB were observed in any of the samples.  A
method suitability test was performed to validate the analysis.

ii.   Peppers (Non-Bell):

Non-bell peppers received a total of approximately 9 lb ai/A Bravo
Ultrex 82.5WG in six or eight foliar applications of approximately 1.125
lb ai/A each. (In the California trial, one of six applications was made
at approximately 3.375 lb ai/A to shorten the application period.) All
applications were made 4 to 9 days apart, and marketable non-bell
peppers were collected 2 to 3 days following the final application.

Chlorothalonil residues ranged from 0.42 to 1.8 ppm in samples collected
2 to 3 days

following the final application. In the New Jersey and 99-TX28 Texas
trials, residues had declined by approximately 14 days, from a high of
1.8 ppm and 0.64 ppm (New Jersey and Texas, respectively) to a low of
0.40 ppm and 0.18 ppm (respectively). In the California trial, 7-day
residues were <0.030 ppm, but had increased to 0.93 ppm and 1.1 ppm
approximately 1 week later.  No residues above the limit of quantitation
of 0.030 ppm for SDS-3701 or 0.010 ppm for HCB were observed in

any of the samples.  A method suitability test was performed to validate
the analysis.

iii.   Persimmon:

Persimmons were treated five times with Bravo® 720 at 1.0 lb ai/A ± 5%
per application, for a total application rate of approximately 5.0 lb
ai/A.  Samples were collected 14 and 28 days following the final
application.

Chlorothalonil residues in 14-day treated samples ranged from 0.350 to
1.05 ppm. The 28-day samples contained Chlorothalonil residues ranging
from <0.100 ppm (the LOQ) to 0.550 ppm.  No quantifiable residues of the
metabolite SDS-3701 or the manufacturing impurity HCB were observed in
the samples.  A method suitability test was performed to validate the
analysis.

iv.   Horseradish:

Three residue field trials were conducted in Maryland, New Jersey, and
Wisconsin. A total of approximately 18 lb ai/A was applied to the
treated plots in eight foliar applications of Bravo Weather Stik at a
rate of approximately 2.25 lb ai/A each. Commercially mature horseradish
was collected 12 to 15 days after the final application.

The maximum Chlorothalonil and SDS-3701 residues were 0.48 ppm and 0.29
ppm, respectively.  No quantifiable HCB residues were detected.  A
method suitability test was performed to validate the analysis.

v.    Rhubarb:

Four residue field trials were conducted in Michigan and Oregon. A total
of approximately 13.5 lb ai/A was applied to the treated plots in six
foliar applications of Bravo Weather Stik at a rate of approximately
2.25 lb ai/A each.

Mature rhubarb petioles were collected 27 to 34 days after the final
application.

No quantifiable SDS-3701 or HCB residues were detected. The maximum
Chlorothalonil residue was 3.9 ppm.

vi.   Ginseng:

Three field trails were conducted in Marathon County, WI, the major
ginseng

producing region of the U.S.  The pesticide was applied under conditions
simulating

commercial application techniques. The roots were harvested and dried
simulating

commercial practices.  The dried roots were analyzed for residues of
Chlorothalonil, HCB and SDS 3701.

The results indicate a maximum total residue of 1.76 ppm (2.27 ppm

after correction for freezer storage losses).   Method validation and
concurrent recoveries were all mostly within the acceptable (70% - 120%)
range with one recovery of Chlorothalonil at 121%. Storage stability
(SS) recoveries indicate that there could have been some degradation
during the storage period however; the SS recoveries were fairly
consistent enabling easy correction of the residue results for apparent
degradation. Therefore, the results reported in this study are
considered reliable.>

<B. Toxicological Profile>

	1. Acute toxicity.  An assessment of the toxic effects caused by
Chlorothalonil is discussed in Unit III.A. and Unit III.B. in the
Federal Register of

March 12, 2001 (66 FR 14330) (FRL-6759-4).

	2. Genotoxicty. An assessment of the toxic effects caused by
chlorothalonil is

discussed in Unit III.A. and Unit III.B. in the Federal Register of

March 12, 2001 (66 FR 14330) (FRL-6759-4).

	3. Reproductive and developmental toxicity. An assessment of the toxic
effects caused by chlorothalonil is discussed in Unit III.A. and Unit
III.B. in the Federal Register of March 12, 2001 (66 FR 14330)
(FRL-6759-4).

<	4. Subchronic toxicity. An assessment of the toxic effects caused by
chlorothalonil is discussed in Unit III.A. and Unit III.B. in the
Federal Register of

March 12, 2001 (66 FR 14330) (FRL-6759-4).>

<	5. Chronic toxicity. An assessment of the toxic effects caused by
chlorothalonil is discussed in Unit III.A. and Unit III.B. in the
Federal Register of

March 12, 2001 (66 FR 14330) (FRL-6759-4).>

<	6. Animal metabolism. The metabolism of chlorothalonil in the rat

is adequately understood.>

<	7. Metabolite toxicology. The residues of concern for tolerance

setting purposes in or on raw agricultural commodity are the parent

compound and its metabolite, 4-hydroxy-2,5,6-trichloroisophthalonitrile

(SDS-3701). The residue of concern in meat and milk is SDS-3701.>

<	8. Endocrine disruption. Chlorothalonil does not belong to a class

of chemicals known or suspected of having adverse effects on the

endocrine system. Developmental toxicity studies in rats and rabbits

and a reproduction study in rats gave no indication that chlorothalonil

might have any effects on endocrine function related to development and

reproduction. The subchronic and chronic studies also showed no evidence
of a long-term effect related to the endocrine system.>

<C. Aggregate Exposure>

<	1. Dietary exposure. Tier II/III chronic aggregate and short-term
aggregate exposure evaluations were made for Chlorothalonil using the
Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID™, version 2.16) from Exponent.  Empirically
derived processing factors were used for beans (babyfood, 0.05X),
cabbage (0.2X), carrots (babyfood, 0.005X), cherries (babyfood, 0.05X),
cherry juice (0.075X), cocoa (0.1X), coffee (0.1X), cranberry juice
(0.25X), cucumbers (cold canned, 0.2X), cucumbers (hot canned, 0.04X),
plums (0.33X), pumpkin (0.002X), squash (0.001X), tomato juice (0.25X),
and tomato paste/puree (0.02X).  All other processing factors used were
default values taken from DEEMTM version 7.87.  All consumption data for
these assessments was taken from the USDA’s Continuing Survey of Food
Intake by individuals (CSFII) with the 1994-96 consumption database and
the Supplemental CSFII children’s survey (1998) consumption database.
These exposure assessments included all current uses for Chlorothalonil
and new uses proposed by the Interregional Research Project 4 (IR4)
including fruiting vegetables (Crop Group 8), cucurbits (Crop Group 9),
persimmons, rhubarb, horseradish, ginseng, , yams, lupines, lentils, and
Brassica, head and stem subgroup 5A.

Residue data for currently registered crops were obtained from a number
of sources including field trial data and monitoring data from the
Pesticide Data Program (PDP), FoodContam (FC), and the FDA monitoring
program.  The current tolerance definition expression for Chlorothalonil
includes Chlorothalonil plus metabolite SDS3701; residue values for
Chlorothalonil in the PDP and other monitoring databases may not include
residues of SDS3701; samples that had detectable residues of
Chlorothalonil were conservatively assigned a value of 10% of the
reported Chlorothalonil residue for SDS3701 based upon the maximum ratio
of metabolite SDS 3701 to Chlorothalonil in radio-labeled plant studies
(6.5%).  Proposed tolerances were used for all proposed new IR4 uses
including fruiting vegetables (5 ppm), cucurbits  (5 ppm), persimmon
(1.9 ppm), rhubarb (5 ppm), horseradish (4 ppm), ginseng (3 ppm), yam (5
ppm), lupines (0.1 ppm), lentils (0.1 ppm), and brassica, head and
stem, subgroup 5A (5 ppm).  Percent of crop treated values were
estimated based upon economic, pest and competitive pressures.
Tolerance-level residues were assumed for all meat commodities.  For
milk and milk-derived commodities, PDP monitoring database residue
values were used.>

<	i. Food. Food Acute Exposure:  Acute dietary (food only) assessments
were not performed, since an endpoint of concern attributable to a
single oral dose has not been identified.

Food Chronic Exposure:  The Chlorothalonil chronic dietary (food only)
risk assessment was performed for all population subgroups using a
chronic reference dose of 0.003 mg/kg-bw/day, based upon a LOAEL of 0.9
mg/kg-bw/day from a chronic rat toxicity study and an uncertainty factor
of 300X (100X for intra- and inter-species variability and an additional
3X for absence of a NOAEL).  No additional FQPA safety factor was
applied.  For the purpose of the aggregate risk assessment, exposure
values were expressed in terms of margin of exposure (MOE), calculated
by dividing the 0.9 mg/kg-bw/day endpoint by the exposure for each
population subgroup.  In addition, exposures were expressed as a percent
of the chronic reference dose (%cRfD).  Chronic dietary (food only)
exposure to the U.S. population resulted in a MOE of 4,592 (6.5% of the
cRfD).  The most sensitive sub-population was children 1-2 years old,
with a MOE of 2,885 (10.4% of the cRfD).  Since the benchmark MOE for
this assessment was 300 and since EPA generally has no concern for
exposures below 100% of the cRfD, Syngenta believes that there is a
reasonable certainty that no harm will result from dietary (food)
exposure to residues arising from all current and proposed uses for
Chlorothalonil.

Cancer.  Chlorothalonil is listed as “likely” to be a human
carcinogen by all routes of exposure, however the SAP decision of
6/30/98 supports the use of a MOE approach.  The current chronic
population adjusted dose/reference dose (cPAD, cRfD) is based upon a new
chronic/carcinogenicity study that provides a lower endpoint (LOAEL =
0.9 mg/kg/day) that that used previously and is therefore protective of
all cancer and non-cancer chronic effects.>

<	ii. Drinking water. Estimated Drinking Water Concentrations (EDWCs)
for Chlorothalonil TTR were calculated using the Tier II Model, PRZM
(Pesticide Root Zone Model) / EXAMS (Exposure Analysis Modeling
Systems), to provide surface water exposure estimates.  The existing sod
farm turf use provided the highest EDWCs and was the driving crop use,
exceeding the EDWCs for all proposed new crop uses (fruiting vegetables,
cucurbits, persimmon, rhubarb, horseradish, ginseng, yams, and lentils).
 The use on sod farms consisted of six ground applications of 2.17 lbs.
a.i./A and this use was modeled using the PRZM Crop Scenarios, FL and PA
Turf.  The PRZM/EXAMS modeling provided an annual average (chronic)
surface water EDWC of 36.2 ppb (0.0362 ppm), which was input directly
into the DEEM-FCID™ software as “water, direct and indirect, all
sources” to model anticipated chronic drinking water exposures.

Acute Exposure from Drinking Water:  Acute drinking water assessments
were not performed, since an endpoint of concern attributable to a
single oral dose has not been identified.

Chronic Exposure from Drinking Water:  The chronic EDWC of 0.0362 ppm
was used to calculate the chronic drinking water exposure values for the
U.S. Population and all population subgroups.  Chronic drinking water
exposures to the U.S. Population resulted in a MOE of 1,180 (25.4% of
the cRfD).  The most sensitive sub-population was all infants <1 year,
with a MOE of 360 (83.4% of the cRfD).  Since the benchmark MOE for this
assessment was 300 and since EPA generally has no concern for exposures
below 100% of the cRfD, Syngenta believes that there is a reasonable
certainty that no harm will result from chronic drinking water exposures
to residues arising from all current and proposed uses of
Chlorothalonil.>

<	2. Non-dietary exposure. Chlorothalonil is a broad spectrum fungicide
that can be applied to ornamentals and non-residential turfgrass and can
also be formulated into paints for interior and exterior applications.
There is a potential for residential exposure to adult handlers making
applications to ornamentals and/or from using treated paint.  There is
also a potential for residential exposure to children from ingestion of
paint chips containing Chlorothalonil, although ingestion of paint chips
is considered to be episodic in nature and is generally not included in
aggregate risk so it was therefore excluded from these assessments as
well.  The Chlorothalonil non-dietary risk assessment was performed
using a short-term incidental oral and inhalation endpoint of 30.8
mg/kg-bw/day, based upon a LOAEL from a 2-generation reproductive tox
study in the rat and an uncertainty factor of 1,000X (100X for intra-
and inter-species variability and an additional 10X for absence of a
NOAEL).  No additional FQPA safety factor was applied.  For the purpose
of the aggregate risk assessment, exposure values were expressed in
terms of margin of exposure (MOE), calculated by dividing the 30.8
mg/kg-bw/day endpoint by the exposure for each population subgroup.  The
most exposed population subgroups from the non-dietary (residential)
assessments was all male and female youths and adults 13 years and
older, attributable to inhalation exposures from applications of alkyd
exterior paint with an airless sprayer, with a MOE of 1,291.  Since the
benchmark MOE for this assessment was 1,000 and since EPA generally has
no concern for non-dietary exposures above the benchmark MOE, Syngenta
believes that there is a reasonable certainty that no harm will result
from non-dietary (residential) exposures from all current uses for
Chlorothalonil.>

<D. Cumulative Effects>

<	Cumulative Exposure to Substances with a Common Mechanism of Toxicity.
 Section 408(b)(2)(D)(v) requires that, when considering whether to
establish, modify, or revoke a tolerance, the Agency consider
“available information” concerning the cumulative effects of a
particular pesticide’s residues and “other substances that have a
common mechanism of toxicity”.  Syngenta did not perform a cumulative
risk assessment as part of this tolerance action for chlorothalonil
because HED has not yet determined that there are any other chemical
substances that have a mechanism of toxicity common with that of
chlorothalonil.  For purposes of this tolerance action, EPA has assumed
that chlorothalonil does not have a common mechanism of toxicity with
any other substance(s).>

<E. Safety Determination>

<	1. U.S. population. The chronic aggregate exposure analysis (food plus
water exposures) showed that exposure from all established and proposed
uses of Chlorothalonil resulted in a MOE of 938 (32.0% of the cRfD)
which exceeds the benchmark MOE of 300.  The short-term aggregate
exposure analysis (food plus water plus non-dietary residential
exposures) showed that exposure from all established and proposed uses
of Chlorothalonil resulted in a MOE of 1,242 for adults 50 years and
older, which exceeds the benchmark MOE of 1,000.  Based on the
completeness and reliability of the toxicity data supporting these
petitions, Syngenta believes that there is a reasonable certainty that
no harm will result to the U. S. population from aggregate exposures
arising from all current and proposed uses for Chlorothalonil.>

<	2. Infants and children. The chronic aggregate exposure analysis (food
plus water exposures) showed that exposure from all established and
proposed uses of Chlorothalonil resulted in a MOE of 348 (86.1% of the
cRfD) for all infants <1 year, which exceeds the benchmark MOE of 300.
The short-term aggregate exposure analysis (food plus water plus
non-dietary residential exposures) showed that exposure from all
established and proposed uses of Chlorothalonil resulted in a MOE of
11,920 for infants <1 year, which exceeds the benchmark MOE of 1,000.
Based on the completeness and reliability of the toxicity data
supporting these petitions, Syngenta believes that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposures arising from all current and proposed uses for
Chlorothalonil.>

3. Females 13-49 Years.  The chronic aggregate exposure analysis (food
plus water exposures) showed that exposure from all established and
proposed uses of Chlorothalonil resulted in a MOE of 1106 (29.5% of the
cRfD) for females 13-49 years, which exceeds the benchmark MOE of 300.
The short-term aggregate exposure analysis (food plus water plus
non-dietary residential exposures) showed that exposure from all
established and proposed uses of Chlorothalonil resulted in a MOE of
1,245 for females 13-49 years, which exceeds the benchmark MOE of 1,000.
 Based on the completeness and reliability of the toxicity data
supporting these petitions, Syngenta believes that there is a reasonable
certainty that no harm will result to females 13-49 years from aggregate
exposures arising from all current and proposed uses for Chlorothalonil.

<F. International Tolerances>

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

B*

 sprouts, carrots, celery, cherries, cranberries, cucumbers, melons,
onions, peaches, squash, and tomatoes.  Some incompatibilities exist
between Codex MRLs and U.S. tolerances for bananas, cabbage,
cauliflower, peanuts, and sweet corn.  No questions of compatibility
exist with respect to commodities where no Codex MRLs have been
established but U.S. tolerances exist, or where Codex MRLs have been
established but U.S. tolerances do not exist.>

 PAGE

 PAGE   2


[Federal Register Volume 87, Number 137 (Tuesday, July 19, 2022)]
[Notices]
[Pages 43108-43109]
[FR Doc No: 2022-15299]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2022-0077]

Pipeline Safety: Meeting of the Liquid Pipeline Advisory
Committee

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
Transportation (DOT).

ACTION: Notice of advisory committee meeting.

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

SUMMARY: This notice announces a virtual public meeting of the Liquid
Pipeline Advisory Committee (LPAC) to discuss the interim final rule
(IFR) titled: ``Unusually Sensitive Areas for the Great Lakes, Coastal
Beaches, and Certain Coastal Waters.''

DATES: PHMSA will hold a virtual public meeting on August 17, 2022. The
LPAC will meet from 10:30 a.m. to 2:30 p.m. ET to discuss the IFR.
Members of the public who wish to attend are asked to register no later
than August 12, 2022. PHMSA requests that individuals who require
accommodations because of a disability notify Tewabe Asebe at least
five days prior to the meeting. Public comments on the proceedings of
the LPAC meeting must be submitted by September 19, 2022.

ADDRESSES: The meeting will be held virtually. The agenda and any
additional information, including information on how to participate in
the virtual meeting will be published on the meeting website at https://primis.phmsa.dot.gov/meetings/MtgHome.mtg?mtg=160. Presentations will
be available on the meeting website and on https://www.regulations.gov/
, in docket number PHMSA-2022-0077 no later than 30 days following the
meeting. You may submit comments, identified by Docket No. PHMSA-2022-
0077, by any of the following methods:
     Web: https://www.regulations.gov. This site allows the
public to enter comments on any Federal Register notice issued by any
agency. Follow the online instructions for submitting comments.
     Fax: 1<PHONE_NUMBER>.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building: Room W12-140,
Washington, DC 20590-0001.
     Hand Delivery: U.S. Department of Transportation, 1200 New
Jersey Avenue SE, West Building: Room W12-140, Washington, DC 20590-
0001, between 9:00 a.m. and 5:00 p.m. ET Monday through Friday, except
federal holidays.
     Instructions: Identify Docket No. PHMSA-2022-0077 at the
beginning of your comments. If you submit your comments by mail, submit
two copies. Internet users may submit comments at https://www.regulations.gov. If you would like confirmation that PHMSA received
your comments, please include a self-addressed stamped postcard that is
labeled ``Comments on PHMSA-2022-0077.'' The docket clerk will date
stamp the postcard prior to returning it to you via the U.S. mail.
     Note: All comments received will be posted without edits
to https://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading for more information.
Anyone can use the site to search all comments by the name of the
submitting individual or, if the comment was submitted on behalf of an
association, business, labor union, etc., the name of the signing
individual. Therefore, please review the complete U.S. Department of
Transportation Privacy Act Statement in the Federal Register (65 FR
19477) or the Privacy Notice at https://www.regulations.gov before
submitting comments.
     Privacy Act Statement: DOT may solicit comments from the
public regarding certain general notices. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov, as described in the system of records
notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.
     Confidential Business Information: Confidential Business
Information (CBI) is commercial or financial information that is both
customarily and actually treated as private by its owner. Under the
Freedom of Information Act (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments in response to this notice contain
commercial or financial information that is customarily treated as
private, that you actually treat as private, and that is relevant or
responsive to this notice, it is important that you clearly designate
the submitted comments as CBI. Pursuant to 49 CFR 190.343, you may ask
PHMSA to provide confidential treatment to information you give to the
agency by taking the following steps: (1) mark each page of the
original document submission containing CBI as ``Confidential;'' (2)
send PHMSA a copy of the original document with the CBI deleted along
with the original, unaltered document; and (3) explain why the
information you are submitting is CBI. Submissions containing CBI
should be sent to Tewabe Asebe, DOT, PHMSA, 1200 New Jersey Avenue SE,
PHP-30, Washington, DC 20590-0001. Also, submission containing CBI can
be emailed to Tewabe Asebe by encrypted email at [email protected].
Any commentary PHMSA receives that is not specifically designated as
CBI will be placed in the public docket.
     Docket: For access to the docket or to read background
documents or comments, go to https://www.regulations.gov. Follow the
online instructions for accessing the dockets. Alternatively, this
information is available by visiting DOT at 1200 New Jersey Avenue SE,
West Building: Room W12-140, Washington, DC 20590-0001, between 9:00
a.m. and 5:00 p.m. ET Monday through Friday, except federal holidays.

FOR FURTHER INFORMATION CONTACT: Tewabe Asebe, Office of Pipeline
Safety, by phone at<PHONE_NUMBER> or by email at [email protected].

SUPPLEMENTARY INFORMATION:

I. Meeting Agenda

    On August 17, 2022, the LPAC will meet to discuss the IFR titled:
``Unusually Sensitive Areas for the Great Lakes, Coastal Beaches, and
Certain Coastal Waters'' that PHMSA published in the Federal Register
on December 27, 2021, (86 FR 73173). Comments that have been submitted
on the IFR can be found on https://www.regulations.gov in Docket No.
PHMSA-2017-0152. The LPAC will review the IFR and its associated
regulatory analyses (including, but not limited to, the cost-benefit
and risk assessment analyses within the IFR and the regulatory impact
analysis; the environmental assessment; and other materials pertaining
to the IFR provided in the public docket under PHMSA-2017-0152. PHMSA
will post additional

details on the meeting website in advance of the meeting.
    In the IFR, PHMSA amended the pipeline safety regulations in 49 CFR
part 195 to explicitly state that certain coastal waters, the Great
Lakes, and coastal beaches are classified as unusually sensitive areas
for the purpose of compliance with the hazardous liquid integrity
management regulations. The amendment implemented mandates contained in
the Protecting our Infrastructure of Pipelines and Enhancing Safety
(PIPES) Act of 2016, as amended by the PIPES Act of 2020. Under the
IFR, a hazardous liquid pipeline that could affect these newly
designated areas would have been included in an operator's integrity
management program. PHMSA requested public comments with a submission
deadline of February 25, 2022. PHMSA received four comments on the IFR.
Following the meeting, PHMSA will publish a final rule that addresses
the comments received and relevant information from the LPAC meeting
report.

II. Background

    The LPAC is a statutorily mandated advisory committee that provides
PHMSA and the Secretary of Transportation with recommendations on
proposed standards for the transportation of hazardous liquids by
pipeline. The committee was established in accordance with 49 U.S.C.
60115 and the Federal Advisory Committee Act, as amended (5 U.S.C. App.
2), to review PHMSA's regulatory initiatives and determine their
technical feasibility, reasonableness, cost-effectiveness, and
practicability. The committee consists of 15 members, with membership
evenly divided among federal and state governments, regulated industry,
and the general public.

III. Public Participation

    The meeting will be open to the public. Members of the public who
wish to attend virtually must register on the meeting website and
include their names and affiliations. PHMSA will provide members of the
public with opportunities to make a statement during this meeting.
Additionally, PHMSA will record the meeting and post a record to the
public docket. PHMSA is committed to providing all participants with
equal access to this meeting. If you need an accommodation because of a
disability, please contact Tewabe Asebe by phone at<PHONE_NUMBER> or by
email at [email protected].
    PHMSA is not always able to publish a notice in the Federal
Register quickly enough to provide timely notice regarding last-minute
issues that impact a previously announced advisory committee meeting.
Therefore, individuals should check the meeting website or contact
Tewabe Asebe regarding any possible changes.
    Issued in Washington, DC, on July 13, 2022, under authority
delegated in 49 CFR 1.97.

Alan K. Mayberry,
Associate Administrator for Pipeline Safety.
[FR Doc. 2022-15299 Filed 7-18-22; 8:45 am]
BILLING CODE 4910-60-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on November 26, 2003

NOTICE OF ACTION TAKEN -- DOCKET OST 2001-9192

________________________________________________________________________
________________________________________________________

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:  AEROLINEAS de TEHUACAN, S.A. de C.V.
              Date Filed:  November 7, 2003

Relief requested:  Exemption from 49 USC section 41301 to permit the
applicant to continue to conduct passenger charter operations between
Mexico and the United States, and other passenger charters in accordance
with 14 CFR Part 212, using small equipment.

If renewal, date and citation of last action:  November 26, 2002, in
this Docket.

Applicant representative:  Lee A. Bauer,<PHONE_NUMBER>         DOT
analyst:  Allen Brown,<PHONE_NUMBER>

Responsive pleadings:  None.

	DISPOSITION

Action:  Approved
                                            Action date:  November 26,
2003

Effective dates of authority granted:  November 26, 2003, through
November 29, 2004

Basis for approval (bilateral agreement/reciprocity):  United
States-Mexico Air Transport Services Agreement of August 15, 1960, as
amended and extended (Agreement).

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

     X  Standard exemption conditions.

Special conditions/Partial grant/Denial basis/Remarks:  In the conduct
of these operations, the carrier must adhere to all applicable
provisions of the U.S.-Mexico Agreement.  In the conduct of these
operations, the carrier may only use aircraft capable of carrying no
more than 60 passengers and having a maximum payload capacity of no more
than 18,000 pounds (small equipment).  The above grant includes
authority to conduct Third and Fourth Freedom charter operations.  While
we have subjected, consistent with the provisions of the Agreement,
Mexican carriers conducting charter operations with large aircraft to
prior approval or submission of notice for their Third and Fourth
Freedom charters, we determined that any such requirement was not
necessary on public interest grounds in this case, since the carrier
will be conducting these operations solely with small aircraft.  (Other
charter operations to/from the United States under this authority,
however, are subject to prior approval under 14 CFR Part 212.)  Further,
we are continuing to allow Mexican carriers conducting passenger
charters using small equipment to make stopovers in the United States in
the conduct of such operations.

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) our action was consistent with Department
policy; (2) the applicant was qualified to perform its proposed
operations; (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:

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


[Federal Register Volume 88, Number 150 (Monday, August 7, 2023)]
[Rules and Regulations]
[Pages 52240-52241]
[FR Doc No: 2023-16852]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2023-1480]

Agency Information Collection Activities: Requests for Comments;
Clearance of Continued Approval of Information Collection: Limited
Recreational Unmanned Aircraft Operation Applications

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request Office of
Management and Budget (OMB) approval to continue information
collection. The collection involves information related to recreational
flying under the Exception for Limited Recreational Operations of
Unmanned Aircraft. The information collected will be used to recognize
Community Based Organizations (CBOs), administer an aeronautical
knowledge and safety test, establish fixed flying sites, approve
standards and limitations for Unmanned Aircraft Systems (UAS) weighing
more than 55 pounds, and designate FAA Recognized Identification Areas
(FRIAs).

DATES: Written comments should be submitted by October 6, 2023.

ADDRESSES: Please send written comments:
    By Electronic Docket: www.regulations.gov (Enter docket number into
search field).
    By mail: Alvin A Brunner, AFS-830/SPS, 800 Independence Ave. SW,
Washington, DC 20591.
    By email: [email protected].

FOR FURTHER INFORMATION CONTACT: Alvin Brunner by email at:
[email protected]; phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-0794.
    Title: Limited Recreational Unmanned Aircraft Operation
Applications.
    Form Numbers: Online collection.
    Type of Review: Continued information collection.
    Background: In 2018, Congress passed the FAA Reauthorization Act of
2018 (Pub. L. 115-254). Section 44809 of Public Law 115-254 allows a
person to operate a small unmanned aircraft (UA) without specific
certification or operating authority from the FAA if the operation
adheres to certain limitations. These limitations require the FAA to
recognize community-based organizations (CBOs), develop and administer
an aeronautical knowledge and safety test, establish fixed flying
sites, approve standards and limitations for unmanned aircraft weighing
more than 55 pounds, and designate FAA Recognized Identification Areas
(FRIAs).
    The information will be collected online, primarily through the
FAA's DroneZone website. The information

collected will be limited to only that necessary for the FAA to
complete a review of an application under the following statutory
requirements:

 Section 44809(c)(1), Operations at Fixed Sites
 Section 44809(c)(2)(a), Standards and Limitations--UA Weighing
More Than 55 Pounds
 Section 44809(c)(2)(b), Operations at Fixed Sites--UA Weighing
More Than 55 Pounds
 Section 44809(g)(1), Aeronautical Knowledge and Safety Test
 Section 44809(i), Recognition of Community-Based Organizations

    Respondents: Individuals and organizations operating under the
Exception for Limited Recreational Operations of Unmanned Aircraft who
wish to be recognized as CBOs, administer the aeronautical knowledge
and safety test, establish fixed flying sites, have standards and
limitations for unmanned aircraft weighing more than 55 pounds
approved, and establish designated FRIAs.
    Frequency: On occasion.
    Estimated Average Burden per Response: Varies depending on the type
of stakeholder application. Fixed flying site applications (including
more than 55 pound UAS and FRIA) are estimated to take 0.5 hours per
applicant. CBO recognition and more than 55 pound UAS standards and
limitations applications are estimated to take 1.0 hours per applicant.
    Estimated Total Annual Burden: Varies depending on the type of
stakeholder application. CBO recognition and more than 55 pound UAS
standards and limitations applications are not recurring, resulting in
a one-time annual burden of 1 hour per application. However, this
number can vary greatly as incomplete applications are quickly denied,
but complete application that include over 55 pound UAS can take two or
more hours. Fixed flying site applications are required to be updated/
renewed annually, resulting in a total annual burden of 0.5 hours per
year.
    The FAA estimates 25 CBO recognition/more than 55 pound UAS
standards and limitations applications in the first year, totaling 25
hours. Fixed flying site applications (including more than 55 pound UAS
and FRIA) are expected to number around 200 applications per year,
totaling 100 hours.

    Issued in Washington, DC, on August 2, 2023.
D.C. Morris,
Aviation Safety Analyst, Flight Standards Service, General Aviation and
Commercial Division.
[FR Doc. 2023-16852 Filed 8-4-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 146 (Tuesday, August 3, 2021)]
[Rules and Regulations]
[Pages 41715-41716]
[FR Doc No: 2021-16457]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2021-0500]

Safety Zone; Brandon Road Lock and Dam to Lake Michigan Including
Des Plaines River, Chicago Sanitary and Ship Canal, Chicago River, and
Calumet-Saganashkee Channel; Chicago River Between the Michigan Avenue
Bridge and Columbus Drive Bridge, Chicago, IL

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce a safety zone, on the main branch
of the Chicago River between the Michigan Avenue Bridge and the
Columbus Drive Bridge for the Chicago Ducky Derby Marine Event. During
the enforcement period, entry into, transiting, mooring, laying-up, or
anchoring within the established safety zone is prohibited unless
authorized by the Captain of the Port Lake Michigan or an on-scene
designated representative.

DATES: A segment of the regulation in 33 CFR 165.930 will be enforced
on August 5, 2021, from 11 a.m. through 2 p.m.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email Petty Officer Eric Krukar, Marine
Safety Unit Chicago, U.S. Coast Guard; telephone:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce a segment of
the safety zone listed safety zone in 33 CFR 165.930. The segment of
the safety zone to be enforced is between the Michigan Avenue Bridge
and the Columbus Drive Bridge on the main branch of the Chicago River.
This action is being taken to provide for the safety of life on
navigable waterways during the Chicago Ducky Derby Marine Event. Our
regulation for marine events within the Ninth Coast Guard District,
Sec.  165.930, specifies the Captain of the Port Lake Michigan, may
enforce this safety zone in whole, in segments, or by any

combination of segments. The Captain of the Port Lake Michigan may
suspend the enforcement of any segment of this safety zone for which
notice of enforcement had been given.
    During the enforcement periods, as reflected in Sec.  165.930 (d),
entry into, transiting, mooring, laying up, or anchoring within any
enforced segment of the safety zone is prohibited unless authorized by
the Captain of the Port Lake Michigan, or a designated representative.
This notice of enforcement is issued under authority of 33 CFR 165.930
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
advance notification of the above-specified enforcement periods of this
safety zone via Broadcast Notice to Mariners and Local Notice to
Mariners. The Captain of the Port Lake Michigan or a designated on-
scene representative may be contacted via Channel 16, VHF-FM or at
(414) 747-7182.

    Dated: July 28, 2021.
Donald P. Montoro,
Captain, U.S. Coast Guard, Captain of the Port, Lake Michigan.
[FR Doc. 2021-16457 Filed 8-2-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: April 4, 2006 (Volume 71, Number 64)]
[Notices]
[Page 16770]
[DOCID:fr04ap06-31]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

March 28, 2006.
    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER05-1319-003.
    Applicants: Pacific Gas & Electric Company.
    Description: Pacific Gas and Electric Co. submits Substitute First
Revised Sheet 102 to its Wholesale Distribution Tariff, Small Generator
Interconnection Procedures, in accordance with FERC's Order issued 10/
11/05.
    Filed Date: 03/21/2006.
    Accession Number: 20060324-0031.
    Comment Date: 5 p.m. Eastern Time on Tuesday, April 11, 2006.

    Docket Numbers: ER06-532-001.
    Applicants: Midwest Independent Transmission System Operator, Inc.
FirstEnergy Service Company.
    Description: Midwest Independent Transmission System Operator Inc &
FirstEnergy Service Co, on behalf of American Transmission Systems
Incorporated submit a revised tariff sheet in compliance with FERC's 3/
16/06 Order.
    Filed Date: 03/21/2006.
    Accession Number: 20060324-0049.
    Comment Date: 5 p.m. Eastern Time on Tuesday, April 11, 2006.

    Docket Numbers: ER06-765-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, LLC submits an unexecuted
interconnection service agreement among PJM, H-P Energy Resources, LLC,
and Monongahela Power Co.
    Filed Date: 03/21/2006.
    Accession Number: 20060324-0025.
    Comment Date: 5 p.m. Eastern Time on Tuesday, April 11, 2006.

    Docket Numbers: ER06-766-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits an executed
interconnection agreement with City Utilities of Springfield, MO and
Empire Electric District Co.
    Filed Date: 03/21/2006.
    Accession Number: 20060324-0026.
    Comment Date: 5 p.m. Eastern Time on Tuesday, April 11, 2006.

    Docket Numbers: ER06-767-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits unexecuted network
integration transmission service agreement with Oklahoma Municipal
Power Authority etc.
    Filed Date: 03/21/2006.
    Accession Number: 20060324-0027.
    Comment Date: 5 p.m. Eastern Time on Tuesday, April 11, 2006.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-4794 Filed 4-3-06; 8:45 am]

BILLING CODE 6717-01-P