FILE NAME:    Hexythiazox NOF 100812

Template Number P25

ATTENTION:

All commodity terms must comply with the Food and Feed Commodity
Vocabulary database (http://www.epa.gov/pesticides/foodfeed/).

All text in blue font (instructions for preparing the document), should
be removed prior to sending the document to the Federal Register Staff.
Instructional text and prompts in green font should also be removed.

GOWAN COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

(August 12, 2010)

EPA Registration Division contact: Mark Suarez, PM #13, telephone (703)
305-0120

TEMPLATE:

by amending the existing tolerances for residues of hexythiazox
(trans-5-(4-chlorophenyl)-N-cyclohexyl-4-methyl-2-oxothiazolidine-3-carb
oxamide) and its metabolites containing the
(4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety to remove the
geographical restriction for existing field corn tolerances and
establish a new tolerance for aspirated grain fractions. EPA has
determined that the petition contains data or information regarding the
elements set forth in section 408(d)(2) of the FFDCA; 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.

Plant metabolism. The nature of the residues in plants is adequately
understood for purposes of this tolerance.  Metabolism studies in fruit
crops, radish and tea have been previously reviewed by the Agency.  The
Agency has determined that the residues of concern are hexythiazox and
its metabolites containing the
(4-chlorophenyl)-4-methyl-2-oxo-3-thiazolidine moiety.  The results of a
new corn metabolism study (MRID   48081501, currently in review) are
consistent with the other plant metabolism data.

Analytical method. A practical analytical method, high pressure liquid
chromatography with a UV detector, which detects and measures residues
of hexythiazox and its metabolites as a common moiety, is available for
enforcement purposes with a limit of detection that allows monitoring of
food with residues at or above the levels set in this tolerance.

Magnitude of residues. Twenty new field trials were conducted by Gowan
Company in support of the proposed label amendments for field corn.  The
amendments include 1) removing the regional use restriction and 2)
reducing the pre-harvest interval to 30 days.  The results of these new
trials support the currently established tolerance levels of 0.02 ppm
for field corn grain and 6.0 ppm for field corn forage.  We propose to
increase the tolerance for field corn stover to 6.0 ppm.

Magnitude of the Residue in Processed Food/Feed.  Data on field corn
processed commodities support the establishment of a new tolerance of
0.5 ppm for aspirated grain fractions.

Acute toxicity. A battery of acute toxicity studies places technical
grade hexythiazox in Toxicity Category IV for acute oral LD50 (LD50 >
5,000 milligram/kilograms (mg/kg)), Category III for dermal LD50 (LD50
>5,000 mg/kg), Category III for inhalation LC50 (LC50 >2.0 mg/L),
Category III for primary eye irritation (showed mild irritation
(reddened conjunctiva)), Category IV for dermal irritation (non
irritant). Hexythiazox is a non-sensitizer.  Acute toxicological studies
place technical grade hexythiazox in Toxicology Category III.

Genotoxicty. The following genotoxicity studies were all negative: Ames
gene mutation, CHO gene mutation, CHO chromosome aberration, mouse
micronucleus and rat hepatocyte unscheduled DNA synthesis.

Reproductive and developmental toxicity.  In a developmental toxicity
study in rats, the maternal No-Adverse-Effect-Level (NOAEL) was 240
mg/kg/day and the maternal Lowest-Adverse-Effect-Level (LOAEL) was 720
mg/kg/day based on increased ovarian weights and decreased bone
ossification. In a developmental toxicity study in rabbits, the maternal
NOAEL was 1,080 mg/kg/day (HDT); the maternal LOAEL was not determined.
The developmental NOAEL was 1,080 mg/kg/day (HDT); the developmental
LOAEL was not determined.  In a 2-generation reproduction study in rats,
the parental NOAEL was 35 mg/kg/day and the parental LOAEL was 200
mg/kg/day based on decreased body weight gain, decreased food
consumption and efficiency, and increased liver, kidney and ovarian
weights. The reproductive NOAEL was 35 mg/kg/day and the reproductive
LOAEL was 200 mg/kg/day based on decreased pup bwt during lactation,
delayed hair growth and eye opening.

Subchronic toxicity. In a 1-month feeding study in dogs, the NOAEL was
1.75 mg/kg/day and the LOAEL was 12.5 mg/kg/day, based on increased
liver and adrenal weights.

Chronic toxicity. In a 1-year feeding study in dogs, the NOAEL was 2.5
mg/kg/day and the LOAEL was 12.5 mg/kg/day, based on increased alkaline
phosphatase, increased adrenal and liver weights, and liver and adrenal
lesions.   In a carcinogenicity study in mice, the NOAEL was 36
mg/kg/day and the LOAEL was 215 mg/kg/day. Effects were decreased
bodyweight in males and increased hepatocellular carcinomas and combined
adenoma/carcinomas.

In a chronic feeding/carcinogenicity study in rats, the NOAEL (systemic)
was 26 mg/kg/day and the LOAEL (systemic) was 180 mg/kg/day based on
decreased body weight gain and increased liver weights in both sexes.

A 2009 report from the Cancer Assessment Review Committee (CARC)
(September 02,2009,PC Code 128849, TXR 0055255) noted that the NOAEL of
2.5 mg/kg/day, from the one year toxicity study in dogs, used in
establishing the chronic reference dose (RfD) is approximately 65-fold
lower than the lowest dose (163 mg/kg/day) that induced tumors. Thus,
the chronic RfD of 0.025 mg/kg/day would be protective of all chronic
effects including potential carcinogenicity of hexythiazox.  The CARC
concluded that the evidence as a whole was not strong enough to warrant
the use of a linear low dose extrapolation model applied to the animal
data (Q1*) for a quantitative estimation of human risk, as had been
previously assessed in October 16, 1998, [63.FR55540].

Animal metabolism. The metabolism of hexythiazox has been studied in
goats, hens and rats. Metabolic pathways in the animal are similar to
those in plants.

Metabolic toxicology.  There are no metabolites of toxicological concern
based on a differential metabolism between plants and animals.

Endocrine disruptions.  No specific test have been conducted with
hexythiazox to determine whether the chemical may have any effect in
humans that is similar to an effect produced by a naturally ocurring
estrogen or other endocrine effects.  However, there were no significant
findings in other relevant toxicity tests, i.e., teratology and
multi-generational reproduction studies, which would suggest that
hexythiazox produces effects characteristic of the disruptions of
hormones.

Dietary Exposure from food. A dietary risk assessment for all registered
crops has been recently completed by the Agency ( March 17, 2010,
75FR12691.)

Acute Exposure.  No acute endpoint has been identified in the
toxicological studies for hexythiazox; therefore, a quantitative acute
dietary exposure assessment is unnecessary.

Chronic Exposure. A tier 1 chronic risk assessment indicates that the
proposed use results in an incremental additional dietary risk of not
more than 0.3% of the chronic Population Adjusted Dose (cPAD) for any
population The registrant has concluded that hexythiazox use in field
corn will not significantly contribute to this dietary exposure.

Cancer.   The Agency has previously determined that the chronic
reference dose is sufficient to evaluate all chronic risk of
hexythiazox, including carcinogenic potential.

Dietary Exposure from drinking water. The Agency used screening level
water exposure models in the dietary exposure analysis and risk
assessment for hexythiazox in drinking water.  Based on the Pesticide
Root Zone Model /Exposure Analysis Modeling System (PRZM/EXAMS) the
estimated drinking water concentration (EDWC) of hexythiazox for chronic
exposures for non-cancer and cancer assessments is estimated to be 4.1
parts per billion (ppb) for surface water. Since surface water residue
values greatly exceed groundwater EDWCs, surface water residues were
used in the dietary risk assessment (July 14, 2010 75FR40741).

From non-dietary exposure. HED has conducted a residential risk
assessment to support recently approved uses on turf, ornamental
landscape plantings, ornamental plants, orchids and residential fruit
trees, nut trees and caneberries. The Agency concludes that there are no
residential risks of concern associated with these uses (January 28,
2010 EPA Memo. PR Code: 128849, DP Barcode D372889.)

EPA has not determined whether hexythiazox has a common mechanism of
toxicity with other substances or how to include this pesticide in a
cumulative risk assessment.  Unlike other pesticides for which EPA has
followed a cumulative risk approach based on a common mechanism of
toxicity, hexythiazox does not share a toxic metabolite with other
substances.  For the purposes of this tolerance action, therefore, the
registrant has not assumed that hexythiazox has a common mechanism of
toxicity with other substances.  For purposes of this petition the
potential risks of hexythiazox in its aggregate exposure only will be
considered.

1. US population

Acute risk.  No adverse effect resulting from a single oral exposure to
hexythiazox has been identified, thus hexythiazox is not expected to
pose an acute risk.

Short-and intermediate term risk. EPA has concluded the combined
short-term food, water, and residential exposures result in aggregate
MOEs of 16,000 for adults and 2,000 for children. Because EPA's level of
concern for hexythiazox is a MOE of 100 or below, these MOEs are not of
concern.

Chronic risk.  EPA previously concluded that chronic exposure to
hexythiazox from food and water will utilize no more than 49% of the
cPAD for (children 1-2 years old) the population group receiving the
greatest exposure.   This assessment utilized existing tolerance values,
assumed 100% crop treated and utilized default processing factors.  The
incremental additional potential dietary exposure associated with the
proposed use will utilize no greater than 0.3%  of the cPAD.  Chronic
residential exposure to residues of hexythiazox is not expected.

Cancer risk  As discussed in the Federal Register of March 17, 2010, (75
FR 12691), EPA concluded that regulation based on the chronic reference
dose will be protective for both chronic and carcinogenic risks. There
are no chronic risks of concern.

Infants and Children Based on these risk assessments, it can be
concluded that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to hexythiazox residues.

No national or transnational maximum residue levels for hexythiazox on
field corn exist apart from those in the United States.

 PAGE  5

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[Federal Register Volume 76, Number 238 (Monday, December 12, 2011)]
[Notices]
[Page 77274]
[FR Doc No: 2011-31877]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Wednesday,
December 14, 2011 at 3 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matter also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(10) and 17 CFR 200.402(a)(10), permit consideration
of the scheduled matters at the Closed Meeting.
    Commissioner Aguilar, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting scheduled for Wednesday,
December 14, 2011 will be:
    A litigation matter.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: December 7, 2011.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-31877 Filed 12-8-11; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 123 (Thursday, June 25, 2020)]
[Notices]
[Pages 38144-38145]
[FR Doc No: 2020-13661]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1528]

Pfizer Inc., et.al.; Withdrawal of Approval of 12 Abbreviated New
Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 12 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 July 27, 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 060567............  Lidocaine Hydrochloride  Pfizer Inc., 235 East
                          (HCl); Oxytetracycline   42nd St., New York,
                          Injection, 2%; 50        NY 10017.
                          milligrams (mg)/
                          milliters (mL), and
                          2%; 125 mg/mL.
ANDA 062612............  Gentamicin Sulfate       Hospira, Inc., 275
                          Injection, Equivalent    North Field Dr.,
                          to (EQ) 10 mg base/mL.   Bldg. H1, Lake
                                                   Forest, IL 60045.
ANDA 062811............  Clindamycin Phosphate    G&W Laboratories Inc.,
                          Solution, EQ 1% base.    301 Helen St., South
                                                   Plainfield, NJ 07080.
ANDA 063333............  Cefoperazone Sodium for  Pfizer Inc.
                          Injection, EQ 1 gram
                          (gm) base/vial.

ANDA 078288............  Ondansetron HCl          Baxter Healthcare
                          Injection, EQ 2 mg       Corp., 1 Baxter
                          base/mL.                 Parkway, Deerfield,
                                                   IL 60015.
ANDA 080426............  Hydrocortisone Lotion,   Bausch Health Americas
                          0.5%.                    Inc., 400 Somerset
                                                   Corporate Blvd.,
                                                   Bridgewater, NJ
                                                   08807.
ANDA 090813............  Levetiracetam            Fresenius Kabi USA,
                          Injection, 500 mg/5 mL   LLC., Three Corporate
                          (100 mg/mL).             Dr., Lake Zurich, IL
                                                   60047.
ANDA 201751............  Articaine HCl;           Hansamed Ltd., 4761
                          Epinephrine Bitartrate   Tara Ct., West
                          Injection, 4%; EQ        Bloomfield, MI 48323.
                          0.0085 mg base/1.7 mL;
                          4%; EQ 0.005 mg base/
                          mL.
ANDA 202684............  Levonorgestrel Tablets,  Alvogen PB Research
                          0.75 mg.                 and Development LLC,
                                                   U.S. Agent for Lotus
                                                   Pharmaceutical Co.,
                                                   Ltd. Nantou Plant, 44
                                                   Whippany Rd., Suite
                                                   300, Morristown, NJ
                                                   07960.
ANDA 204796............  Capreomycin Sulfate for  Hisun Pharmaceuticals
                          Injection, EQ 1 gm       USA, Inc., U.S. Agent
                          base/vial.               for Hisun
                                                   Pharmaceutical
                                                   (Hangzhou) Co., Ltd.,
                                                   200 Crossing Blvd.,
                                                   2nd Floor,
                                                   Bridgewater, NJ
                                                   08807.
ANDA 205943............  Ethinyl Estradiol;       Lupin Pharmaceuticals,
                          Levonorgestrel           Inc., 111 South
                          Tablets, 0.02 mg, 0.15   Calvert St.,
                          mg; 0.025 mg, 0.15 mg;   Baltimore, MD 21202.
                          0.03 mg, 0.15 mg; 0.01
                          mg, N/A.
ANDA 212191............  Fluoxetine HCl Tablets,  G&W Laboratories, Inc.
                          EQ 60 mg base.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of July
27, 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 July 27, 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: June 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13661 Filed 6-24-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 135 (Thursday, July 14, 2016)]
[Notices]
[Page 45518]
[FR Doc No: 2016-16613]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4273-DR; Docket ID FEMA-2016-0001]

West Virginia; Amendment No. 5 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of West Virginia (FEMA-4273-DR), dated June 25, 2016, and
related determinations.

DATES: Effective Date: June 29, 2016.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this disaster is closed effective June 29, 2016.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-16613 Filed 7-13-16; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 130 (Monday, July 10, 2023)]
[Notices]
[Pages 43560-43561]
[FR Doc No: 2023-14492]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following Complaints
and Compliance filings in EL Dockets:

    Docket Numbers: EL23-53-000.
    Applicants: Essential Power OPP, LLC, et al. v. PJM
Interconnection, L.L.C.
    Description: Supplement to the Complaint filed March 31, 2023 of
Essential Power OPP, LLC, et al. v. PJM Interconnection, L.L.C.
    Filed Date: 6/23/23.
    Accession Number: 20230623-5194.
    Comment Date: 5 p.m. ET 7/24/23.

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

    Docket Numbers: ER10-2354-012.
    Applicants: Midway-Sunset Cogeneration Company.
    Description: Supplement to May 2, 2023, Notice of Non-Material
Change in Status of Midway-Sunset Cogeneration Company.
    Filed Date: 6/28/23.
    Accession Number: 20230628-5193.
    Comment Date: 5 p.m. ET 7/19/23.

    Docket Numbers: ER23-1894-000.
    Applicants: Pome BESS LLC.
    Description: Supplement to May 16, 2023 Pome BESS LLC tariff
filing.
    Filed Date: 6/30/23.
    Accession Number: 20230630-5416.
    Comment Date: 5 p.m. ET 7/21/23.

    Docket Numbers: ER23-2326-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to ISA, Service
Agreement No. 6705; Queue No. AE1-056 to be effective 8/1/2023.
    Filed Date: 7/3/23.
    Accession Number: 20230703-5060.
    Comment Date: 5 p.m. ET 7/24/23.

    Docket Numbers: ER23-2327-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, L.L.C. Request for Approval to
Recover Penalty Charges Assessed by the North American Electric
Reliability Corporation.
    Filed Date: 6/30/23.
    Accession Number: 20230630-5413.
    Comment Date: 5 p.m. ET 7/21/23.

    Docket Numbers: ER23-2328-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 3125R14 Basin Electric Power
Cooperative NITSA and NOA to be effective 6/1/2023.
    Filed Date: 7/3/23.
    Accession Number: 20230703-5091.
    Comment Date: 5 p.m. ET 7/24/23.

    Docket Numbers: ER23-2329-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: 1628R23 Western Farmers
Electric Cooperative NITSA NOAs to be effective 6/1/2023.
    Filed Date: 7/3/23.
    Accession Number: 20230703-5099.
    Comment Date: 5 p.m. ET 7/24/23.

    Docket Numbers: ER23-2330-000.
    Applicants: Upper Missouri G. & T. Electric Cooperative, Inc.
    Description: Sec.  205(d) Rate Filing: Administrative Filing to
Correct eTariff Records 07.03.23 to be effective 7/31/2022.
    Filed Date: 7/3/23.
    Accession Number: 20230703-5148.
    Comment Date: 5 p.m. ET 7/24/23.

    Docket Numbers: ER23-2331-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: First Revised ISA, Service
Agreement No. 5808; Queue No. AD1-039 to be effective 6/1/2023.
    Filed Date: 7/3/23.
    Accession Number: 20230703-5177.
    Comment Date: 5 p.m. ET 7/24/23.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: July 3, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-14492 Filed 7-7-23; 8:45 am]
BILLING CODE 6717-01-P


" Hunt, Tim < Tim_ Hunt@ afandpa To: Mary Kissell/ RTP/ USEPA/ US@ EPA . org> cc: Ken Hustvedt/ RTP/ USEPA/ US@ EPA Subject: Wood MACT continuous compliance 10/ 28/ 2003 10: 43 AM Mary Tom,

Based on our earlier comments and discussions on the Plywood and Composite Wood Panel MACT, AF& PA is providing you supplemental information concerning the issue of continuous compliance. We believe the issue can be resolved by providing sufficient averaging times and/ or clearance to change among compliance options. We hope this provides clarity to the issue and reiterates the importance of addressing the concerns in the final rule.

If you have any questions, please don't hesitate to call.

<< Continuous Compliance 10 28 03. doc>>

Timothy Hunt Senior Director, Air Quality Programs American Forest and Paper Association Suite 800 1111 19th St., NW Washington, DC 20036 phone: 202 463 2588 fax: 202 463 2423 Tim_ Hunt@ afandpa. org ( See attached file: Continuous Compliance 10 28 03. doc) 1 10/ 28/ 03 Importance of Providing For Continuous Compliance Obligations In the Plywood and Composite Wood Panel ( Wood) MACT It is important that EPA consider the impact of the PCWP ( Wood) MACT rule language on the ability of facilities to meet continuous compliance obligations under the Clean Air Act ( the Act). The problems can be addressed by providing sufficient averaging times and/ or clearance to change among compliance options. AF& PA submitted comments to EPA requesting longer averaging periods and/ or the ability to switch between the six add on control compliance options. These comments provide additional detail as to why these requested changes are critical to the industry.

Continuous Compliance Obligations When the MACT requirements become incorporated into a Title V permit, the responsible official at a facility must certify continuous compliance with the limitation with each semiannual compliance report. It will be difficult for a responsible official to do so under the structure of the proposed rule.

Sections 504( c) and 114( a)( 3) of the Act require that each permit contain terms and conditions that require a responsible official to identify the status of compliance and whether compliance for the covered period is continuous or intermittent. Furthermore, 40 CFR 70.6( c)( 5)( iii) and 40 CFR 71.6( c)( 5)( iii), spell out the compliance certification requirements for emission limitations, standards, or work practices in Title V permits. These provisions require the semiannual compliance certification by the responsible official include:

( c)( 5)( iii)( C) The status of compliance with the terms and conditions of the permit for the period covered by the certification, including whether compliance during the period was continuous or intermittent. The certification shall be based on the method or means designated in paragraph ( c)( 5)( iii)( B) of this section. The certification shall identify each deviation and take it into account in the compliance certification. ( Emphasis added.)

EPA further clarifies intermittent compliance in the preamble to the June 27, 2003 revisions to 40 CFR 70 and 71:

Any failure to meet the permit terms or conditions during a period when the permit required compliance would mean that compliance was not continuous, and the responsible official must identify the permit deviation ( or possible exception to compliance in the context of part 64) in the certification and certify that compliance for the permit term or condition ( that is the basis of the certification) was intermittent.

The certifications are to be based on the results of the compliance monitoring required in the permit and any other evidence available to the responsible official. Monitoring and related record keeping and reporting requirements from the PCWP MACT rule will be incorporated into the Title V permits and thus will be part of the record used to certify that compliance was continuous or intermittent. 2 EPA also set an expectation of minimum requirements to determine compliance status:

( c)( 5)( iii)( B) The identification of the method( s) or other means used by the owner or operator for determining the compliance status with each term and condition during the certification period. Such methods and other means shall include, at a minimum, the methods and means required under paragraph ( a)( 3) of this section, ( Emphasis added.)

Paragraph ( a)( 3) pertains to the monitoring and related record keeping and reporting requirements from the MACT rule that would be incorporated into the permit.

The preamble to the June 27, 2003 revisions to the compliance certification rule makes clear that EPA intended the phrase, " at a minimum," in Paragraph ( c)( 5)( iii)( B) to include consideration of evidence beyond what is specified in the permit:

Responsible officials that used any monitoring method not specified in the permit ( regardless of whether the monitoring was performed voluntarily, to comply with a State only requirement, or to track compliance with an applicable requirement that is not yet addressed by the permit), would need to identify the method( s), and take the monitoring results into account when determining the compliance status of the term or condition that is the basis of the certification ( applicable requirement). ( Emphasis added.)

Continuous compliance can be certified only when there is no evidence to the contrary and permit required conditions are met:

Absent evidence to the contrary, the responsible official for a source that is in compliance according to the monitoring results in the permit may certify `` continuous'' compliance, provided that the responsible official did not fail to monitor, or report, or collect the minimum data required by the permit...

We presume that the " evidence to the contrary" would include knowledge the facility has of any engineering or design analysis identifying that under certain operating conditions, the emission control equipment would not be able to meet the removal efficiencies specified in the permit. The draft rule would create such situations.

Continuous compliance with destruction efficiency requirements AF& PA commented to EPA that under certain production process operating conditions most emission control equipment would not be able to meet the 90 percent control efficiency requirements. For example, the 90% destruction will be difficult to maintain when VOC or HAP concentrations are low at the control device inlet ( e. g. when production process conditions are such that few HAPs or VOCs are generated). Production process conditions that generate low HAP or VOC emissions can last from a few minutes to several days. Examples of these types of conditions are given below. Despite the fact that some operating conditions result in periods of relatively low HAP generation and emissions, the structure of the current rule unfortunately would create a necessity to certify only intermittent compliance. 3 AF& PA also submitted comments offering two different approaches that would allow a facility to maintain continuous compliance with the destruction efficiency requirements in the proposed PWCP MACT. These alternatives are to provide averaging periods sufficiently long to accommodate normal production variation, or to allow facilities to switch among the six VOC/ HAPs compliance options. An additional alternative not previously discussed would be to set a lb/ hr VOC or HAP permit conditions based on 90% destruction of the maximum VOC or HAP loading to the control device rather than include the 90% destruction requirement in the permit.

Although not readily apparent, AF& PA believes that the above options for accommodating process variability are included in the floor. The data used to establish the floor are based on operating conditions during short tests that did not include process variation. The performance measured usually is representative of maximum operating rates that are expected to produce the highest concentrations of VOCs and HAPs. The floor data lack much information on control device destruction efficiency for other operating conditions. Thus the control device performance data used to set the removal requirement are primarily indicative of short term best performance rather than long term average performance.

However, there is some data in the database that do indicate the reduction in performance at low loading. These data at low load conditions illustrate the reduced level of removal representative of performance during intermittent operating conditions. These conditions should be provided for in the rule.

We can reiterate our concerns with a few examples:

A facility with a veneer dryer must decide under the draft rule which of the six control options it will use to demonstrate continuous compliance with the regulation. The facility knows that it will need to re dry about 10% of its veneer to achieve dryness specifications. Redry will be processed in the same veneer dryer used for the initial drying for about 2 hours/ day in a single run. The feed rate of the veneer being re dried will be higher than green veneer and the drying temperature reduced. HAPs and VOC emissions during re drying are expected to be very low because of reduced time exposure to heat and lower drying temperatures. The VOC emission concentration during drying of green veneer is expected to be 500 ppm as C. VOC emissions during re drying are about 10% of green veneer, and at lower concentrations, and thus would be at a concentration of less than 50 ppm in the gas stream.

The six control device options available to the mill are: > 90% removal of VOCs, HOCH, or MeOH, < 1 ppm HOCH or MeOH when inlet concentrations > 10ppm, or < 20 ppm THC C. According to the draft rule, the mill can use only one of these options.

During re drying, the concentrations of methanol and formaldehyde are expected to be less than 1 ppm, so low that the control device removal efficiency will be close to zero or negative. ( In some cases, the device will actually add HAPs to the gas stream.) Thus, neither the 90% removal control options ( i. e., > 90% removal of VOCs, HOCH, or MeOH), nor the concentration limit options (< 1 ppm HOCH or MeOH when inlet concentrations > 10ppm) are viable when processing re dry. ( Also note the AF& PA comments already identified that the concentration 4 options for < 1 ppm HOCH or MeOH when inlet concentrations > 10ppm are duplicative of the options for > 90% removal of HOCH or MeOH.)

The mill will be able to meet the 90% VOC reduction criteria when processing green veneer but will not be able to meet the destruction requirement when processing redry. Control device VOC efficiencies drop off rapidly at low VOC concentrations. When processing green veneer, even at a 90% destruction efficiency, the control device will not be able to meet the < 20 ppm VOC option. However, it would be able to meet the < 20 ppm limit when processing redry because the inlet VOC concentrations will be low.

The only solution available under the proposed rule is to develop a permit with different operating scenarios for drying green veneer and re drying veneer. Each operating scenario would use a different control device option. Use of these alternate operating scenarios would unnecessarily increase the record keeping burden on the mill and the agencies.

Other situations may not be as clear cut. For example, production slow downs could have the same impact on the ability to meet VOC destruction requirements. It would be difficult to permit production slowdowns as an alternate operating scenario. Permitting multiple dryers using the same control device would difficult to analyze and track.

Another example would be an OSB dryer that processes variable mixtures of hardwoods and softwoods. At high production rates, HAP emission concentrations would be expected to be high as a result of higher dryer inlet temperatures, and the facility could meet the 90% destruction requirements for methanol or formaldehyde. However, at low production rates, the concentration of methanol and formaldehyde would be reduced, sometimes to very low levels, and the facility would not be able to meet the 90% methanol and formaldehyde removal requirement. When running a high proportion of softwood, it could meet the 90% THC removal requirement but not the 20 ppm THC as C limit. When drying hardwoods at low production rates, it could meet the 20 ppm THC limit, but not the 90% THC removal requirement. Delineating boundaries between these operating conditions to derive identifiable operating scenarios would be very difficult, if at all possible. The only solution available to this facility under the current rule would be either to restrict the use of softwood, or specify a minimum softwood content to create emission conditions that the control device could continuously meet one or the other THC compliance options.

AF& PA believes that these problems could be avoided by simply using long averaging periods for compliance with the six control device options, or allow use of multiple compliance options under a single operating scenario.

Continuous compliance with production based limits.

For a mill to achieve continuous compliance, averaging periods also need to be specified for the production based emission limits. For example, press emissions are cyclic, with a high release each time the press opens. If no averaging period is specified, then the rule could be interpreted to apply instantaneously during a press opening. Although not generally interpreted this way, it 5 leaves open the question of continuous compliance that could easily be resolved if the rule were more specific in this instance.


[Federal Register Volume 78, Number 58 (Tuesday, March 26, 2013)]
[Notices]
[Pages 18333-18334]
[FR Doc No: 2013-06815]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP13-526-000]

Gulf South Pipeline Company, LP; Notice of Technical Conference

    Take notice that the Commission Staff will convene a technical
conference in the above-referenced proceeding on Tuesday, April 9,
2013, at 10:00 a.m. (Eastern Standard Time), in a room to be

designated at the offices of the Federal Energy Regulatory Commission,
888 First Street NE., Washington, DC 20426.
    At the technical conference, the Commission Staff and the parties
to the proceeding can discuss all of the issues raised by Gulf South's
filing. In particular, as discussed in the Order Establishing Technical
Conference \1\ in this docket, parties should be prepared to discuss
concerns regarding degradation of service, implementation of additional
service requirements, routing of nominations, implementation timing,
impact on secondary market, expansion-legacy interconnects, and
requests for additional information.
---------------------------------------------------------------------------

    \1\ Gulf South Pipeline Company, LP, 142 FERC ] 61,167 (2013).
---------------------------------------------------------------------------

    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an email to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER>
with the required accommodations.
    All interested persons are permitted to attend. For further
information please contact Vince Mareino at<PHONE_NUMBER> or email
<EMAIL_ADDRESS>
    Dated: March 19, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-06815 Filed 3-25-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 24, 2007 (Volume 72, Number 205)]
[Notices]
[Page 60365-60367]
[DOCID:fr24oc07-92]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0996; FRL-8152-7]

Pesticide Products; Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of applications to register
pesticide products containing new active ingredients not included in
any currently registered products pursuant to the provisions of section
3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended.

DATES: Comments must be received on or before November 23, 2007.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2007-0996, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's

normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays). Special arrangements should be made for
deliveries of boxed information. The Docket Facility telephone number
is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2007-0996. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket

Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov
website to view the docket index or access available documents.
Although listed in the index, some information is not publicly
available, e.g., CBI 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 in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Driss Benmhend, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
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.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

     1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Registration Applications

    EPA received applications as follows to register pesticide products
containing active ingredients not included in any previously registered
products pursuant to the provision of section 3(c)(4) of FIFRA. Notice
of receipt of these applications does not imply a decision by the
Agency on the applications.
    File Symbol: 84185-G. Applicant: Plasma Power of India, c/o OMC Ag
Consulting, 828 Tanglewood Lane, East Lansing, MI 48823. Product name:
Plasma Neem OilTM Manufacturing Use Product. Insecticide
Active ingredient: Neem Oil at 100%. Proposal classification/Use:
Agricultural Food Use. (Driss Benmhend).
    File Symbol: 84185-U. Applicant: Plasma Power of India, c/o OMC Ag
Consulting, 828 Tanglewood Lane, East Lansing, MI 48823. Product name:
Plasma Neem OilTM Biological Insecticide. Insecticide Active
ingredient: Neem Oil at 100%. Proposal classification/Use: Agricultural
Food Use. (Driss Benmhend).
    File Symbol: 83945-R. Applicant: Coeur D'Alene Fiber Fuels Inc., c/
o Steptoe and Johnson, LLP, 1330 Connecticut Ave. NW., Washington, DC
20036. Product name: Atlas Pond Renue. Algaecide Active ingredient:

Sodium Perborate Tetrahydrate at 59.8%. Proposal classification/Use:
None. (Driss Benmhend).

List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: October 11, 2007.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. E7-20965 Filed 10-23-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 85, Number 179 (Tuesday, September 15, 2020)]
[Notices]
[Pages 57219-57220]
[FR Doc No: 2020-20334]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1861]

Generic Drug User Fees; Stakeholder Meetings on Generic Drug User
Fee Amendments of 2017 Reauthorization; Request for Notification of
Stakeholder Intention To Participate

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice; request for notification of participation.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing
this notice to request that public stakeholders, including patient and
consumer advocacy groups, healthcare professionals, and scientific and
academic experts notify FDA of their intent to participate in periodic
consultation meetings on the reauthorization of the Generic Drug User
Fee Amendments of 2017 (GDUFA). At the end of September 2022, new
legislation will be required for FDA to continue collecting generic
drug user fees for subsequent fiscal years for the generic drug
program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires
that FDA consult with a range of stakeholders in developing
recommendations for the next GDUFA program. The FD&C Act also requires
that FDA hold continued discussions with patient and consumer advocacy
groups at least monthly during FDA's negotiations with the regulated
industry. The purpose of this request for notification is to ensure
continuity and progress in these monthly discussions by establishing
consistent stakeholder representation.

DATES: Submit notification of intention to participate in these series
of meetings by October 8, 2020. Stakeholder meetings will be held
monthly, and it is anticipated that they will commence in October 2020.

ADDRESSES: The meetings will take place virtually and will be held by
webcast only. Submit notification of intention to participate in
monthly stakeholder meetings by email to<EMAIL_ADDRESS>
See the SUPPLEMENTARY INFORMATION section for registration date and
information.

FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Tiana Barnes, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6196, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is requesting that public stakeholders, including patient and
consumer advocacy groups, healthcare professionals, and scientific and
academic experts, notify the Agency of their intent to participate in
periodic stakeholder consultation meetings on the reauthorization of
GDUFA. GDUFA authorizes FDA to collect user fees from the regulated
industry for the current program (GDUFA II). At the end of September
2022, new legislation will be required for FDA to continue collecting
user fees for subsequent fiscal years for the generic drug program.
Without new legislation, FDA will no longer be able to collect user
fees for future fiscal years to fund human generic drug activities.
Section 744C(f) (21 U.S.C. 379j-43(f)) of the FD&C Act requires that
FDA consult with a range of stakeholders in developing recommendations
for the next GDUFA program, including representatives from patient and
consumer groups, healthcare professionals, and scientific and academic
experts. FDA initiated this process by holding a public meeting on July
21, 2020, at which stakeholders and other members of the public were
given an opportunity to present their views on reauthorization (85 FR
38378). The FD&C Act further requires that FDA continue meeting with
these stakeholders at least once every month during negotiations with
the regulated industry to continue discussions of stakeholder views on
the reauthorization. It is anticipated that these monthly stakeholder
consultation meetings will commence in October 2020.
    FDA is issuing this Federal Register notice to request that
stakeholder representatives from patient and consumer groups,
healthcare professional associations, as well as scientific and
academic experts notify FDA of their intent to participate in periodic
stakeholder consultation meetings on GDUFA reauthorization. FDA
believes that consistent stakeholder representation at these meetings
will be important to ensure progress in these discussions. If you wish
to participate in the stakeholder consultation meetings, please
designate one or more representatives from your organization who will
commit to attending these meetings and preparing for the discussions as
needed. Stakeholders who identify themselves through this notice will
be included in all stakeholder discussions while FDA negotiates with
the regulated industry. Stakeholders who decide to participate in these
monthly meetings at a later time may still participate in remaining
monthly meetings by notifying FDA (see ADDRESSES). These stakeholder
discussions will satisfy the consultation requirement in section
744C(f)(3) (21 U.S.C. 379j-43(f)(3)) of the FD&C Act.

II. Notification of Intent To Participate in Periodic Stakeholder
Consultation Meetings

    If you intend to participate in continued periodic stakeholder
consultation meetings regarding GDUFA reauthorization, please provide
notification by email to<EMAIL_ADDRESS>by October 8,
2020. Your email should contain complete contact information, including
name, title, affiliation, address, email address, phone number, and
notice of any special accommodations required because of disability.
Stakeholders will receive confirmation and additional information about
the first meeting after FDA receives this notification. Information
concerning GDUFA, including the text of the law, the GDUFA II
Commitment Letter, key Federal Register documents, GDUFA-related
guidances, performance reports, and financial reports may be found on
the FDA website at https://www.fda.gov/gdufa.

    Dated: September 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20334 Filed 9-14-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: August 23, 2010 (Volume 75, Number 162)]
[Proposed Rules]
[Page 51698-51701]
[DOCID:fr23au10-21]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0803; Directorate Identifier 2010-NM-124-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Model A310 Series Airplanes; and
Model A300 B4-600, A300 B4-600R, A300 F4-600R Series Airplanes, and
Model A300 C4-605R Variant F Airplanes (Collectively Called A300-600
Series Airplanes)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as: The ball screw nut assemblies of the first 70 Trimmable
Horizontal Stabilizer Actuators (THSA) manufactured by Goodrich were
fitted with an upper attachment gimbal having a thickness of 58 mm
(2.28 in), which is different from the design of the final production
standard. The gimbal installed on the subsequent THSAs (final
production standard) is more robust, having a thickness of 70mm (2.76
in). During the fatigue life demonstration of the THSA upper attachment
primary load path elements, only a gimbal having a thickness of 70mm
(2.76 in) was used. Thereafter, no additional justification work to
demonstrate the robustness of the upper attachment fitted with a gimbal
of 58 mm was accomplished. In case of failure of this gimbal, the THSA
upper attachment primary load path would be lost and the THSA upper
attachment secondary load path would engage. Because the upper
attachment secondary load path will only withstand the loads for a
limited period of time, the condition where it would be engaged and not
detected could lead to failure of the secondary load path, which would
likely result in loss of control of the aeroplane. The proposed AD
would require actions that are intended to address the unsafe condition
described in the MCAI.

DATES: We must receive comments on this proposed AD by October 7, 2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus SAS--EAW (Airworthiness Office), 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; e-mail<EMAIL_ADDRESS>Internet http://
www.airbus.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue, SW., Renton, Washington. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
227-2125; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2010-0803;
Directorate Identifier 2010-NM-124-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2010-0092, dated May 21, 2010 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    The ball screw nut assemblies of the first 70 Trimmable
Horizontal Stabilizer Actuators (THSA) manufactured by Goodrich were
fitted with an upper attachment gimbal having a thickness of 58 mm
(2.28 in), which is different from the design of the final
production standard. The gimbal installed on the subsequent THSAs
(final production standard) is more robust, having a thickness of 70
mm (2.76 in).
    During the fatigue life demonstration of the THSA upper
attachment primary load path elements, only a gimbal having a
thickness of 70mm (2.76 in) was used. Thereafter, no additional
justification work to demonstrate the robustness of the upper
attachment fitted with a gimbal of 58 mm was accomplished.
    In case of failure of this gimbal, the THSA upper attachment
primary load path would be lost and the THSA upper attachment
secondary load path would engage.
    Because the upper attachment secondary load path will only
withstand the loads for a limited period of time, the condition
where it would be engaged and not detected could lead to failure of
the secondary load path, which would likely result in loss of
control of the aeroplane.
    As the affected ball screw nut assemblies (including the gimbal)
could have been moved from one THSA to another during maintenance
operation and because the change from the old design to the final
production standard design is not identified through a dedicated
THSA Part Number, a gimbal with thickness of 58 mm (2.28 in) can be
fitted on any A310 or A300-600 aeroplane.
    For the reasons described above, this AD requires the
identification of the THSA which have a 58 mm (2.28 in) gimbal
installed, repetitive [general visual] inspections to check whether
there is engagement of the secondary load path and, depending on
findings, associated corrective action(s).

Corrective actions include contacting Airbus for repair instructions
and doing the repair. You may obtain further information by examining
the MCAI in the AD docket.

Relevant Service Information

    Airbus has issued Mandatory Service Bulletins A300-27A6067,
Revision 01, including Appendix 01, dated May 12, 2010; and A310-
27A2104, Revision 01, including Appendix 01, dated May 12, 2010. The
actions described in this service information are intended to correct
the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a Note within the proposed AD.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 170 products of U.S. registry. We also estimate that
it would take about 2 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $28,900, or $170 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Airbus: Docket No. FAA-2010-0803; Directorate Identifier 2010-NM-
124-AD.

Comments Due Date

    (a) We must receive comments by October 7, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Airbus Model A300 B4-601, B4-603, B4-620,
B4-622, B4-605R, B4-622R, F4-605R, and F4-622R airplanes; Model A300
C4-605R Variant F airplanes; and Model A310-203, -204, -221, -222, -
304, -322, -324, and -325 airplanes; certificated in any category,
all certified models, all manufacturer serial numbers.

Subject

    (d) Air Transport Association (ATA) of America Code 27: Flight
controls.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    The ball screw nut assemblies of the first 70 Trimmable
Horizontal Stabilizer Actuators (THSA) manufactured by Goodrich were
fitted with an upper attachment gimbal having a thickness of 58 mm
(2.28 in), which is different from the design of the final
production standard. The gimbal installed on the subsequent THSAs
(final production standard) is more robust, having a thickness of
70mm (2.76 in).
    During the fatigue life demonstration of the THSA upper
attachment primary load path elements, only a gimbal having a
thickness of 70mm (2.76 in) was used. Thereafter, no additional
justification work to demonstrate the robustness of the upper
attachment fitted with a gimbal of 58 mm was accomplished.
    In case of failure of this gimbal, the THSA upper attachment
primary load path would be lost and the THSA upper attachment
secondary load path would engage.
    Because the upper attachment secondary load path will only
withstand the loads for a limited period of time, the condition
where it would be engaged and not detected could lead to failure of
the secondary load path, which would likely result in loss of
control of the aeroplane.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Actions

    (g) Within 130 flight cycles or 650 flight hours after the
effective date of this AD, whichever occurs first, measure the
thickness of the trimmable horizontal stabilizer actuators (THSA)
upper attachment gimbal, in accordance with the Accomplishment
Instructions of Airbus Mandatory Service Bulletin A300-27A6067,
Revision 01, dated May 12, 2010 (for Model A300-600 series
airplanes); or A310-27A2104, Revision 01, dated May 12, 2010 (for
Model A310 series airplanes).
    (1) If, during the measurement required by paragraph (g) of this
AD, the gimbal thickness is 58 mm (2.28 in.)  5 mm (0.20
in.), before further flight, do a general visual inspection of the
THSA upper attachment to determine if the THSA upper attachment
secondary load path is engaged, in accordance with the
Accomplishment Instructions of Airbus Mandatory Service Bulletin
A300-27A6067, Revision 01, dated May 12, 2010 (for Model A300-600
series airplanes); or A310-27A2104, Revision 01, dated May 12, 2010
(for Model A310 series airplanes). Repeat the inspection thereafter
at intervals not to exceed 130 flight cycles or 650 flight hours,
whichever occurs first, in accordance with the Accomplishment
Instructions of Airbus Mandatory Service Bulletin A300-27A6067,
Revision 01, dated May 12, 2010 (for Model A300-600 series
airplanes); or A310-27A2104, Revision 01, dated May 12, 2010 (for
Model A310 series airplanes).
    (2) If, during the measurement required by paragraph (g) of this
AD, the gimbal thickness is not 58 mm (2.28 in.)  5 mm
(0.20 in.), except for the requirements of paragraph (k) of this AD,
no further action is required of this AD.
    (h) If, during any inspection required by paragraph (g)(1) of
this AD, the THSA upper attachment secondary load path is found to
be engaged, before further flight, contact Airbus for repair
instructions and do the repair.

Actions Accomplished According to Previous Issue of Service Bulletin

    (i) Actions accomplished before the effective date of this AD in
accordance with Airbus Mandatory Service Bulletin A300-27A6067 (for
Model A300-600 series airplanes) or A310-27A2104 (for Model A310
series airplanes), both dated May 6, 2010, are considered acceptable
for compliance with the corresponding action specified in this AD.

Reporting Requirement

    (j) Submit a report of the findings (both positive and negative)
of the measurement required by paragraph (g) of this AD to Airbus,
as identified in Appendix 01 of Airbus Mandatory Service Bulletin
A300-27A6067, Revision 01, dated May 12, 2010 (for Model A300-600
series airplanes); or A310-27A2104, Revision 01, dated May 12, 2010
(for Model A310 series airplanes); at the applicable time specified
in paragraph (l)(1) or (l)(2) of this AD. The report must include
the information specified in Appendix 01 of Airbus Mandatory Service
Bulletin A300-27A6067, Revision 01, dated May 12, 2010 (for Model
A300-600 series airplanes); or A310-27A2104, Revision 01, dated May
12, 2010 (for Model A310 series airplanes).
    (1) If the measurement was done on or after the effective date
of this AD: Submit the report within 30 days after the inspection.
    (2) If the measurement was done before the effective date of
this AD: Submit the report within 30 days after the effective date
of this AD.

Parts Installation

    (k) As of the effective date of this AD, no person may install,
on any airplane, a THSA, unless it is in compliance with the
requirements of this AD.

FAA AD Differences

    Note 1:  This AD differs from the MCAI and/or service
information as follows: The MCAI does not include a reporting
requirement; however, the service bulletin recommends reporting.
Paragraph (j) of this AD specifies a reporting requirement.

Other FAA AD Provisions

    (l) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. Send information to ATTN: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 227-2125; fax<PHONE_NUMBER>. Before using any approved AMOC
on any airplane to which the AMOC applies, notify your principal
maintenance inspector (PMI) or principal avionics inspector (PAI),
as appropriate, or lacking a principal inspector, your local Flight
Standards District Office. The AMOC approval letter must
specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (m) Refer to MCAI EASA Airworthiness Directive 2010-0092, dated
May 21, 2010; Airbus Mandatory Service Bulletin A300-27A6067,
Revision 01, dated May 12, 2010; and Airbus Mandatory Service
Bulletin A310-27A2104, Revision 01, dated May 12, 2010; for related
information.

    Issued in Renton, Washington, on August 16, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-20854 Filed 8-20-10; 8:45 am]
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[Federal Register Volume 74, Number 110 (Wednesday, June 10, 2009)]
[Notices]
[Pages 27525-27526]
[FR Doc No: E9-13546]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. DI09-9-000]

Alaska Power & Telephone Company; Notice of Declaration of
Intention and Soliciting Comments, Protests, and/or Motions To
Intervene

June 3, 2009.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Declaration of Intention.
    b. Docket No: DI09-9-000.
    c. Date Filed: May 18, 2009.
    d. Applicant: Alaska Power & Telephone Company.
    e. Name of Project: Connelly Lake Hydroelectric Project.
    f. Location: The proposed Connelly Lake Hydroelectric Project will
be located on an unnamed stream, Connelly Lake, Chilkoot River, and
Chilkoot Lake, near the towns of Haines and Skagway, Haines Borough,
Alaska, affecting T. 28 S, R. 57 E, secs. 23, 24, 25, 26, 27, 34, and
35, and T. 29 S, R. 58 E, secs. 4, 9, 10, 14, 15, 22, 23, 25, 26, and
36, Copper River Meridian.
    g. Filed Pursuant to: Section 23(b)(1) of the Federal Power Act, 16
U.S.C. 817(b).
    h. Applicant Contact: Glen D. Martin, Project Manager, 193 Otto
Street, P.O. Box 3222, Port Townsend, WA 98368, telephone: (360) 385-
1733, x122; Fax:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>    i. FERC Contact: Any questions on this notice should be addressed
to Henry Ecton,<PHONE_NUMBER>, or E-mail address:
<EMAIL_ADDRESS>    j. Deadline for filing comments, protests, and/or motions: July 6,
2009.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Comments, protests, and/or interventions may be
filed electronically via the Internet in lieu of paper.
    Any questions, please contact the Secretary's Office. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
at http://www.ferc.gov under the ``e-Filing link.
    Please include the docket number (DI09-9-000) on any comments,
protests, and/or motions filed.
    k. Description of Project: The proposed Connelly Lake Hydropower
Project will include: (1) A 48-foot-high, 100-foot-wide rock-filled
dam; (2) a lake with a storage capacity of 4,700 acre-feet; (3) a
6,188-foot-long, 30-inch-diameter penstock; (4) a 40-foot-wide, 60-
foot-long metal powerhouse containing one or two turbines, with an
installed capacity of 6,200 kW; (5) a tailrace emptying into the
Chilkoot River; (6) a 14-mile-long, 34.5 kV underground and overhead
transmission line; and (7) appurtenant facilities. The proposed project
will not be connected to an interstate grid, and will not occupy any
federal lands.
    When a Declaration of Intention is filed with the Federal Energy
Regulatory Commission, the Federal Power Act requires the Commission to
investigate and determine if the interests of interstate or foreign
commerce would be affected by the project. The Commission also
determines whether or not the project: (1) Would be located on a
navigable waterway; (2) would occupy or affect public lands or
reservations of the United States; (3) would utilize surplus water or
water power from a government dam; or (4) if applicable, has involved
or would involve any construction subsequent to 1935 that may have
increased or would increase the project's head or generating capacity,
or have otherwise significantly modified the project's pre-1935 design
or operation.
    l. Locations of the Application: Copies of this filing are on file
with the Commission and are available for public inspection. This
filing may be viewed on the Web at http://www.ferc.gov using the
``eLibrary'' link, select ``Docket'' and follow the
instructions. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all

protests or other comments filed, but only those who file a motion to
intervene in accordance with the Commission's Rules may become a party
to the proceeding. Any comments, protests, or motions to intervene must
be received on or before the specified comment date for the particular
application.
    o. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTESTS'', AND/
OR ``MOTIONS TO INTERVENE'', as applicable, and the Docket Number of
the particular application to which the filing refers. A copy of any
motion to intervene must also be served upon each representative of the
Applicant specified in the particular application.
    p. Agency Comments--Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-13546 Filed 6-9-09; 8:45 am]
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