                                 DRAFT AGENDA
              Federal Insecticide, Fungicide, and Rodenticide Act
                       Scientific Advisory Panel Meeting
                          January 29-February 1, 2013

Prioritizing the Universe of Endocrine Disruptor Screening Program (EDSP) Chemicals Using Computational Toxicology Tools

Docket Number:  EPA-HQ-OPP-2012-0818				OPP Docket Tel:<PHONE_NUMBER>

                  Please note that all times are approximate
                      (See note at the end of the Agenda)

Tuesday, January 29, 2013

9:00 A.M.	Opening of Meeting and Administrative Procedures  -  Sharlene Matten, Ph.D., Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M. 	Introduction and Identification of Panel Members  -  Daniel Schlenk, Ph.D., Chair, FIFRA Scientific Advisory Panel

9:15 A.M.	Opening Remarks  -  Steve Bradbury, Ph.D. Director, Office of Pesticide Programs, EPA

9:25 A.M. 	Overview of EDSP21 Work Plan, Universe of Chemicals and Prioritization Scheme  -
            	Mary Manibusan, Director, Exposure Assessment Coordination and Policy Division, Office of Science Coordination and Policy, EPA

10:00 A.M.	Break

10:15 A.M.	Physico-Chemical Properties to Exclude Chemicals from EDSP Screening  -
	Ray Kent, Ph.D., Health Effects Division, Office of Pesticide Programs, EPA

11:00 A.M.	Estrogen Adverse Outcome Pathway and Estrogen Receptor Expert System  -
	Patricia Schmieder, Ph.D. and Rick Kolanczyk, Mid-Continent Ecology Division, National Health and Environmental Effects Research Laboratory Office of Research and Development, EPA

12:15 P.M.	Lunch

1:15 P.M.	Performance of High Through Put (HTP) ER Binding and Transcriptional Activation Assay  -
            Richard Judson, Ph.D., National Center for Computational Toxicology, Office of Research and Development, EPA, and Susan Laws, Ph.D., Reproductive Toxicology Division, National Health and Environmental Effects Research Laboratory, Office of Research and Development, EPA

2:45 P.M. 	Break

3:00 P.M.	Analysis of ER Expert Training Set (ES Trset) and HTP Assay Data  -  Michael Hornung, Ph.D. Mid-Continent Ecology Division, National Health and Environmental Effects Research Laboratory, Office of Research and Development, EPA

4:00 P.M.	Category Based Approach and Strategic Testing to Cover Unknowns  -
            Patricia Schmieder, Ph.D., Mid-Continent Ecology Division, National Health and Environmental Effects Research Laboratory, Office of Research and Development, EPA

5:00 P.M.	Summary  -  Vicki Dellarco, Ph.D., Office of Pesticide Programs, EPA

5:30 P.M.	Adjournment

Wednesday, January 30, 2013
9:00 A.M.	Opening of Meeting and Administrative Procedures  -  Sharlene Matten, Ph.D., Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M.	Introduction and Identification of Panel Members  -  Daniel Schlenk, Ph.D., Chair, FIFRA Scientific Advisory Panel

9:10 A.M.	Follow-up from Previous Day's Meeting  -  Mary Manibusan, Director, Exposure Assessment Coordination and Policy Division, Office of Science Coordination and Policy, EPA

9:20 A.M.	Public Comments

10:30 A.M.	Break

10:45 A.M.	Public Comments (continued)

12:00 P.M.	Lunch

1:00 P.M.	Panel Discussion of Charge Questions
      Question 1. Overall Prioritization Approach (Section 2.2; also see Section 9)
      1.1 Please comment on appropriateness of the overall conceptual approach for prioritizing the EDSP chemical inventory (note: subsequent charge questions address issues associated with specific components of the prioritization approach). In your comments, please address:
         The extent to which EPA's description of the process transparently captures and describes the key technical steps of the prioritization scheme and whether there are other scientific considerations the agency should incorporate into its EDSP prioritization scheme; the robustness of the scientific support for the overall approach and, in particular, the logical sequence of filters, and whether changes to the approach could set priorities more efficiently and effectively.

      Question 2. Physicochemical Properties (Section 2.2.2)
      Not every chemical necessarily needs to undergo EDSP screening and testing. Decisions of whether to screen a chemical for endocrine interaction are made in part based on information about a chemical's inherent properties (e.g., pKa values, molecular weight, reactivity/stability, corrosivity, known functional groups, and charged species). EPA may use this information to identify untestable chemicals or those that are unlikely to pose systemic effects (e.g., endocrine perturbation). Application of filters based on physiochemical properties enables EPA to reduce the chemical universe that would need further evaluation (as illustrated in the white paper, from ~10,000 chemicals to ~5000 or less).
      2.1 Please comment on the proposed exclusion criteria for each physicochemical property as appropriate for identifying chemicals that are untestable and/or unable to elicit systemic toxicity. Please include a discussion of the extent to which varying the range of exclusion criterion can influence confidence in identifying chemicals that are untestable and/or unable to elicit systemic effects (i.e., those substances that are unlikely to trigger the molecular initiating event). Please include in your comments:
         Whether there are additional chemical characteristics that should be considered (e.g., volatility),
         Whether there are additional data sources for each parameter identified (e.g., chemaxon for pKa values, EpiSuite for half-life values, etc.), and how to consider multiple data sources in a weight of evidence approach.
         Whether the exclusion criteria cut offs and the confidence that application of the exclusion criteria will reasonably identify those substances that are untestable and/or unable to trigger the molecular initiating event of the ER pathway. Also please discuss options for evaluating cases where uncertainty in a chemical's specific parameter range overlaps a p-chem filter cut off. Please consider in your comments the following exclusion criteria:
         pKa values <2 or >11.5;
         hydrolysis half-life of <40 days and
         charged species of 99% or greater at pH 7

2:45 P.M.	Break

3:00 P.M.	Question 3. ER Expert System Development (Section 3)
      The ER ES was originally built based on a training set (TrSet) of chemicals using in vitro assays specifically optimized to measure a well defined endpoint as indicated by ER binding and gene activation and to cover the domain of applicability (in the case of ESv1 food use pesticidal inert ingredients and antimicrobial active ingredients). This ES was the subject of a 2009 FIFRA SAP review. Since that review additional work has been done and additional TrSet data have been generated to cover pesticide non-food use inert ingredients (i.e., ESv2). In addition, an analysis has determined that the ESv2 can cover ~70 percent of the EDSP Chemical Universe that includes SDWA chemicals and fragrances.
      3.1 Please comment on the approach used to build ESv2 through chemical testing and effect-based category and read across methods to provide a scientifically defensible approach to predict ER binding potential for a larger number of chemical groups, particularly with regard to defining new groups from within the Mixed Organics and Mixed Phenols. Please indicate any considerations unique to ESv2 that indicate the approach used to develop ESv1 (SAP, 2009a) needs to be modified.
      3.2 Building from the ESv1 training set, please comment on the level of scientific confidence that a chemical is unlikely to initiate the ER AOP, if the in vitro assay TrSet data shows no activity. Please comment on the extent to which the level of confidence may vary by chemical category.
      Question 4. HTP ER Binding and ER Transactivation Data (Sections 4-6)
      The agency is proposing to use the HTP data to expand the ER expert system (i.e., ESv3). Therefore, it is important to understand how the HTP data are generated and interpreted for the intended use. As endorsed by the 2010 SAP on Integrated Approaches to Testing and Assessment Strategy: Use of New Computational and Molecular Tools, in evaluating computational tools, the agency will consider internationally accepted science principles including the OECD QSAR validation principles of "Clear, Defined Biological Endpoint, Mechanistic Interpretation, Unambiguous Algorithm, Goodness of Fit and Domain of Applicability." These principles are consistent with and complement the recommendations of the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) and considered flexible to be broadly applicable to predictive models or computational tools which may be based on HTP or other in vitro data. The principles particularly applicable to this charge question are: a well defined endpoint and mechanistic interpretation. A "well defined endpoint" is intended to ensure clarity in the endpoint data used to build predictive models, chemical categories, or read-across. Any predictions made from the data will inherently contain all uncertainties and limitations in the data measurement and interpretation. The intent of "mechanistic interpretation" is to ensure a mechanistic association between the attributes of a chemical and its interaction with the biological system resulting in the measured endpoint, to the degree possible. The following questions relate to the transparency of the HTP techniques (e.g., how the data are processed and interpreted and the extent of reliability and consistency within an assay and among HTP assays).
      4.1 Given the importance of a well defined endpoint to determining if/how endpoint data are appropriately used, the panel is asked to comment on:
         Whether the assays are sufficiently described so that others can reconstruct the assay conditions and data analysis and to what extent additional information would be useful?
         Whether EPA has described sufficiently the important experimental conditions that affect the assay measurements, and whether EPA has sufficiently discussed their potential impact on assay results and interpretation of the results?
         Whether the chemical library (e.g., purity and analysis), chemical exposure (e.g., solvents used, chemical dilutions), and plates and plate layouts provides information necessary for data interpretation?
         The adequacy of test concentrations (maximum and minimum concentration tested) and cutoffs, and whether the concentration cutoffs affected some assays results more than others, especially in the context of false negatives.
      4.2 With respect to data interpretation, please comment on the approach for defining an active chemical (i.e., to initiate the ER AOP) and an inactive chemical (i.e., unlikely to initiate the ER AOP) compound and whether the method of data interpretation is adequately described and if the rationale for the approach is sufficiently presented. Please include in your comments:
         The adequacy of the approach to generate the data plots; how and what parameters are calculated, etc.
         How the background data were used to establish the control level,
         Whether the process for identifying assay interference is adequately described,
         Adequacy of data normalization, outlier identification, curve fitting, background subtractions, and all other data processing and calculation techniques, and appropriateness of the statistical analyses.
      4.3 Would you recommend other considerations or approaches to analyzing the HTP data?

5:30 P.M.  	Adjournment

Thursday, January 31, 2013

9:00 A.M.	Opening of Meeting and Administrative Procedures  -  Sharlene Matten, Ph.D., Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M.	Introduction and Identification of Panel Members  -  Daniel Schlenk, Ph.D., Chair, FIFRA Scientific Advisory Panel

9:10 A.M.	Follow-up from Previous Day's Meeting  -  Mary Manibusan, Director, Exposure Assessment Coordination and Policy Division, Office of Science Coordination and Policy, EPA

9:20 A.M.	Question 5. Performance Evaluation of the HTP ER Binding and Transcriptional Activation Assays Against a Set of Reference Chemicals (Section 6)
      An important aspect of the Agency's Proposed Chemical Prioritization Approach for the EDSP is to minimize the occurrence of false negatives and to have confidence that all potentially active chemicals (i.e., those that can trigger the MIE) are identified. Therefore, the performance of each of the computational toxicology components of the prioritization process is being evaluated. The performance of each HTP assay has been evaluated using a set of well-documented reference chemicals that represent a diversity of chemical classes and range of potencies. Additional performance metrics have also been evaluated that take into account a number of parameters that are unique to HTP technology.
         5.1 Please comment on the selection of reference chemicals and whether they are sufficient to assess the performance of each HTP assay for ER agonists. How well do the reference chemicals represent the range of potencies needed to establish the reliability and relevance of these assays for use in EDSP chemical prioritization for the inert ingredients, fragrances, and SDWA chemicals?
         5.2 Please comment on whether the Agency's evaluation of the performance of the HTP ER binding and activation assays has considered and accurately assessed all relevant aspects of the assays. For example, have signal-to-noise ratios, background subtraction and interferences been adequately characterized when describing the strengths and limitations of the assay?
         5.3 Based on analyses in sections 5 and 6, please comment on the comparative performance of the 8 HTP assays for detecting ER reference agonists (e.g., do some assays perform differently, and if so to what extent?) Was sufficiently detailed information provided explaining the likely reasons for assay differences, when they are observed (e.g., cutoffs, assay interferences, background differences)?
10:30 A.M.	Break

10:45 A.M.	Question 6. Analysis of ER Expert Training Set and HTP in vitro Assay Data (Section 7)
      To better understand assay responses to a chemical and whether it has the potential to activate the ER-mediated pathway, the agency compared a set of chemicals evaluated with the ER HTP in vitro assays with data on the same set of chemicals included as part of the in vitro training set data used to build the ER ESv1/2 (ES TrSet).
         6.1 Please comment on the agency's assessment of how HTP in vitro assays performed with respect to expectations of performance for chemicals within chemical categories when compared with the in vitro training set data used to build the ESv1/2.
         6.2 Please comment on EPA's approach to comparing the ES TrSet data with the HTP data and the interpretations regarding discordant results between the two assay approaches. Please recommend other considerations or approaches to conducting this comparative analysis?
         6.3 Given that there may be varying occurrences of false negatives and false positives based on different sources of training set data, please include in your comments options for addressing these uncertainties for different categories in the context of building ESv3?

12:00 P.M. 	Lunch

1:00 P.M.	Question 7. Category-Based Approach and Strategic Testing to Expand the ES applicability domain with additional in vitro data (Section 8)
      Section 8 describes a category base strategy (as used to build the original ESv1) to expand coverage training set data for the entire EDSP inventory (i.e., the OECD principle that addresses the "domain of application"). The approach described in Section 8 is considered relevant to any in vitro assay data that is applicable for measuring a well-defined end point within an AOP under study (in this case, an ER-mediated pathway).
         7.1 Please comment on the adequacy and efficiency of the category based approach to select chemicals for testing to expand the training sets in terms of covering the ~1700 chemicals not covered in the domain of ESv2.
         7.2 Based on the HTP assay performance (analysis of reference chemicals and comparative analysis with the ES TrSet), please comment on the adequacy of the HTP data for advancing the ER expert system's rules to cover the additional groups of chemicals in ESv3.
         7.3 To the extent there are differences between the ES TrSet and HTP data in detecting the ability of chemicals to initiate the ER AOP, especially in the context of minimizing `false negatives' for low potency compounds, please comment on the strengths and limitations of combining data from the different assays to generate training set data for building the structure based rules within the ESv3. What are the strengths and limitations of using training set data from assays that have the same or similar degree of sensitivity?

2:30 P.M.	Break

2:45 P.M.	Question 8. In Vitro Testing and Computer Based Simulations: Addressing Active Metabolites (Note: This question is looking toward the future and there is no proposal presented in the white paper. Discussion of the issue of active metabolites in examples are presented in Section 7.4.3)
      In the context of building a category rule-based approach, it is important to understand if the biological activity is attributed to the parent compound or a metabolite. It is also important to understand if a metabolite of an `inactive' parent compound may be able to trigger the ER MEI. The agency would like to take advantage of the growing knowledge of assays systems as well as existing metabolic profiles, computation techniques for predicting metabolites and understanding of ER-binding structure activity relationships to address this area of uncertainty.
         8.1 Please provide any initial thoughts on how varying empirical and/or computational techniques could be employed to account for metabolites that may trigger the ER MIE.
      Question 9. Use of the AOP and Category-Based Testing Strategies for Other Endocrine Pathways (Chapter 9)
      The agency plans to implement an EDSP chemical prioritization scheme that will use both exposure and effect based metrics. The current paper focused on development of an effect-based approach using the ER pathway and relevant in vitro assays. This prioritization methodology draws on several fundamental concepts generally applicable to the development of computational methods. These concepts include understanding inherent chemical properties as well as chemical structure and bioactivity relationships, use of the AOP concept and category-based read across methods to guide the development and application of in vitro testing using lower or higher throughput methods and computer-based simulations.
         9.1 Please comment on whether the principles and concepts used to develop the ER expert system are generally applicable for any category-based prioritization system for other molecular initiating events (e.g., other AOPs for perturbing estrogen, androgen receptor, and thyroid hormone systems)?
         9.2 What lessons have been learned from the development of the ER focused prioritization model that will facilitate more efficient and effective development of an effect-based prioritization model for the androgen pathway.
         9.3 What will be the challenges in developing a prioritization using in vitro methods and computer based simulations for the thyroid hormone system?

5:30 P.M.	Adjournment

Friday, February 1, 2013

9:00 A.M.	Opening of Meeting and Administrative Procedures  -  Sharlene Matten, Ph.D., Designated Federal Official, Office of Science Coordination and Policy, EPA

9:05 A.M.	Introduction and Identification of Panel Members  -  Daniel Schlenk, Ph.D., Chair, FIFRA Scientific Advisory Panel

9:10 A.M.	Follow-up from Previous Day's Meeting  -  Mary Manibusan, Director, Exposure Assessment Coordination and Policy Division, Office of Science Coordination and Policy, EPA

9:25 A.M.	Discussion of Charge Questions Continued (if needed)

10:30 A.M.	Break

10:45 A.M.	Discussion of Charge Questions Continued (if needed)

12:30 P.M.	Adjournment

Please be advised that agenda times are approximate; when the discussion for one topic is completed, discussions for the next topic will begin.  For further information, please contact the Designated Federal Official for this meeting, Dr. Sharlene Matten, telephone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>, or email<EMAIL_ADDRESS>


[Federal Register Volume 87, Number 211 (Wednesday, November 2, 2022)]
[Notices]
[Pages 66170-66172]
[FR Doc No: 2022-23840]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC23-14-000.
    Applicants: San Diego Gas & Electric Company, AES Energy Storage,
LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of San Diego Gas & Electric Company, et al.
    Filed Date: 10/26/22.
    Accession Number: 20221026-5236.
    Comment Date: 5 p.m. ET 11/16/22

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

    Docket Numbers: EL23-7-000.
    Applicants: Generate Capital, PBC.
    Description: Petition for Declaratory Order of [Generate Capital,
PBC].
    Filed Date: 10/25/22.
    Accession Number: 20221025-5205.
    Comment Date: 5 p.m. ET 11/25/22.

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

    Docket Numbers: ER10-1291-024; ER10-2346-012; ER10-2353-012; ER10-
2357-011; ER10-2361-012; ER10-2368-010; ER10-2369-010; ER10-2381-012;
ER10-2382-011; ER10-2383-012; ER10-2384-010; ER10-2385-012; ER10-2812-
017; ER10-2843-016; ER11-2206-013; ER11-2207-013; ER11-2209-013; ER11-
2210-013; ER11-2211-013; ER11-2855-027; ER11-2856-027; ER11-2857-027;
ER11-3727-019; ER11-4351-014; ER12-21-025; ER12-1238-010; ER12-1239-
010; ER12-1711-019; ER13-1150-011; ER13-1151-011; ER13-1991-023; ER13-
1992-023; ER14-2820-010; ER14-2821-010; ER16-853-005; ER16-855-005;
ER16-856-005; ER16-857-005; ER16-858-005; ER16-860-005; ER16-861-005;
ER18-814-004; ER19-672-004; ER19-843-004; ER19-844-003; ER19-1061-004;
ER19-1062-003; ER19-1063-004; ER19-1200-006; ER20-486-004; ER20-2014-
001; ER21-1923-002; ER21-1947-002; ER21-2128-001; ER21-2129-001; ER22-
529-002.
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WHAM8 SOLAR, LLC, NedPower Mount Storm LLC, Black Rock Wind Force, LLC,
Rattlesnake Flat, LLC, Golden Fields Solar III, LLC, Clearway Power
Marketing LLC, Solar Borrego I LLC, Solar Avra Valley LLC, Solar Alpine
LLC, Solar Roadrunner LLC, Solar Blythe LLC, Marsh Landing LLC,
Carlsbad Energy Center LLC, Iron Springs Solar, LLC, Granite Mountain
Solar West, LLC, Granite Mountain Solar East , LLC, Escalante Solar
III, LLC, Escalante Solar II, LLC, Escalante Solar I, LLC, Enterprise
Solar, LLC, Spring Canyon Energy III LLC, Spring Canyon Energy II LLC,
Desert Sunlight 300, LLC, Desert Sunlight 250, LLC, Alta Wind XI, LLC,
Alta Wind X, LLC, High Plains Ranch II, LLC, Crofton Bluffs Wind, LLC,
Broken Bow Wind, LLC, Agua Caliente Solar, LLC, Pinnacle Wind, LLC, El
Segundo Energy Center LLC, Sun City Project LLC, Sand Drag LLC, Avenal
Park LLC, Alta Wind I, LLC, Alta Wind III, LLC, Alta Wind II, LLC, Alta
Wind IV, LLC, Alta Wind V, LLC, GenConn Middletown LLC, GenConn Devon
LLC, Elkhorn Ridge Wind, LLC, Mountain Wind Power, LLC, Mountain Wind
Power II LLC, San Juan Mesa Wind Project, LLC, Walnut Creek Energy,
LLC, Taloga Wind, L.L.C, Laredo Ridge Wind, LLC, Wildorado Wind, LLC,
Sleeping Bear, LLC, Lookout WindPower LLC, Forward WindPower LLC,
GenConn Energy LLC.
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al.
    Filed Date: 10/26/22.
    Accession Number: 20221026-5235.
    Comment Date: 5 p.m. ET 11/16/22.

    Docket Numbers: ER10-1451-007; ER10-1467-008; ER10-1468-008; ER10-
1469-008; ER10-1473-007;

ER10-1474-007; ER10-2687-007; ER10-2688-010; ER10-2689-010; ER10-2728-
009; ER12-273-003; ER10-1478-009.
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Company, LLC, Green Valley Hydro, LLC, West Penn Power Company, Potomac
Edison Company, Monongahela Power Company, Metropolitan Edison Company,
Pennsylvania Power Company, Cleveland Electric Illuminating Company,
Toledo Edison Company, Ohio Edison Company, Jersey Central Power &
Light.
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Light Company, et al.
    Filed Date: 10/25/22.
    Accession Number: 20221025-5208.
    Comment Date: 5 p.m. ET 11/15/22.

    Docket Numbers: ER10-1801-007; ER10-1805-008; ER10-2370-006.
    Applicants: NSTAR Electric Company, Public Service Company of New
Hampshire, The Connecticut Light and Power Company.
    Description: Notice of Change in Status of The Connecticut Light
and Power Company, et al.
    Filed Date: 10/27/22.
    Accession Number: 20221027-5056.
    Comment Date: 5 p.m. ET 11/17/22.

    Docket Numbers: ER22-728-002.
    Applicants: Pegasus Wind, LLC.
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    Accession Number: 20221026-5199.
    Comment Date: 5 p.m. ET 11/16/22.

    Docket Numbers: ER22-2838-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Tariff Amendment: 4011SO Panhandle Solar & Ponderosa
Wind II & OG&E SNUFCA to be effective 11/12/2022.
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    Comment Date: 5 p.m. ET 11/17/22.

    Docket Numbers: ER23-200-000.
    Applicants: Daggett Solar Power 1 LLC.
    Description: Baseline eTariff Filing: Baseline New Filing to be
effective 12/26/2022.
    Filed Date: 10/26/22.
    Accession Number: 20221026-5206.
    Comment Date: 5 p.m. ET 11/16/22.

    Docket Numbers: ER23-201-000
    Applicants: Southwest Power Pool, Inc.
    Description: Petition for Waiver of Tariff Provisions of Southwest
Power Pool, Inc.
    Filed Date: 10/26/22.
    Accession Number: 20221026-5208.
    Comment Date: 5 p.m. ET 11/16/22.

    Docket Numbers: ER23-202-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amended ISA, Service
Agreement No. 5849; Queue No. AE2-131 to be effective 10/28/2020.
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    Accession Number: 20221026-5211.
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    Docket Numbers: ER23-203-000.
    Applicants: Daggett Solar Power 2 LLC.
    Description: Baseline eTariff Filing: Baseline New Filing to be
effective 12/26/2022.
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    Accession Number: 20221026-5212.
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to be effective 1/1/2023.
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    Accession Number: 20221027-5048.
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effective 1/27/2023.
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    Accession Number: 20221027-5052.
    Comment Date: 5 p.m. ET 11/17/22.

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NOA to be effective 1/1/2023.
    Filed Date: 10/27/22.
    Accession Number: 20221027-5057.
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    Description: Compliance filing: Order 676-J Attach Q--2nd
Compliance Filing to be effective 12/31/9998.
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    Accession Number: 20221027-5069.
    Comment Date: 5 p.m. ET 11/17/22.

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effective 1/27/2023.
    Filed Date: 10/27/22.
    Accession Number: 20221027-5071.
    Comment Date: 5 p.m. ET 11/17/22.

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Energy Agency NITSA and NOA to be effective 1/1/2023.
    Filed Date: 10/27/22.
    Accession Number: 20221027-5075.
    Comment Date: 5 p.m. ET 11/17/22.

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Agreement No. 5823; Queue No. AC2-103 to be effective 10/12/2020.
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    Accession Number: 20221027-5082.
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Duke Energy Carolinas, LLC.
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tariff filing per 35: Order 676-J Compliance Filing to be effective 12/
31/9998.
    Filed Date: 10/27/22.
    Accession Number: 20221027-5083.
    Comment Date: 5 p.m. ET 11/17/22.

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    Filed Date: 10/27/22.
    Accession Number: 20221027-5087.
    Comment Date: 5 p.m. ET 11/17/22.

    Docket Numbers: ER23-215-000.
    Applicants: Duke Energy Florida, LLC.
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Cancellation to be effective 12/27/2022.
    Filed Date: 10/27/22.
    Accession Number: 20221027-5110.
    Comment Date: 5 p.m. ET 11/17/22.

    Docket Numbers: ER23-216-000.
    Applicants: West Line Solar, LLC.
    Description: Sec.  205(d) Rate Filing: West Line Solar, LLC Shared
Facilities Agreement to be effective 10/28/2022.

    Filed Date: 10/27/22.
    Accession Number: 20221027-5111.
    Comment Date: 5 p.m. ET 11/17/22.

    Docket Numbers: ER23-217-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2022-10-27_Attachment X
Appendix 10 Model Review Changes to be effective 12/27/2022.
    Filed Date: 10/27/22.
    Accession Number: 20221027-5113.
    Comment Date: 5 p.m. ET 11/17/22.

    Docket Numbers: ER23-218-000.
    Applicants: New York Independent System Operator, Inc., LS Power
Grid New York Corporation I
    Description: Sec.  205(d) Rate Filing: New York Independent System
Operator, Inc. submits tariff filing per 35.13(a)(2)(iii): Section 205
filing of LSPGNY proposed depreciation rate updates in Formula Rate to
be effective 12/27/2022.
    Filed Date: 10/27/22.
    Accession Number: 20221027-5123.
    Comment Date: 5 p.m. ET 11/17/22.

    Docket Numbers: ER23-219-000.
    Applicants: PacifiCorp.
    Description: Compliance filing: Second Compliance Filing for Order
No. 676-J to be effective N/A.
    Filed Date: 10/27/22.
    Accession Number: 20221027-5128.
    Comment Date: 5 p.m. ET 11/17/22.

    Docket Numbers: ER23-220-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Compliance Filing for Order No. 676-J of Puget Sound
Energy, Inc.
    Filed Date: 10/25/22.
    Accession Number: 20221025-5210.
    Comment Date: 5 p.m. ET 11/15/22.

    Docket Numbers: ER23-221-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Sec.  205(d) Rate Filing: NCMPA1 RS No. 318 Amendment
(2023 Confirmation) to be effective 1/1/2023.
    Filed Date: 10/27/22.
    Accession Number: 20221027-5139.
    Comment Date: 5 p.m. ET 11/17/22.

    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>.

    Dated: October 27, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-23840 Filed 11-1-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: July 27, 2010 (Volume 75, Number 143)]
[Notices]
[Page 43957-43958]
[DOCID:fr27jy10-65]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13635-000]

City of Gloversville; Notice of Application Accepted for Filing
and Soliciting Comments, Motions To Intervene, Protests,
Recommendations, and Terms and Conditions

July 20, 2010.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Conduit Exemption.
    b. Project No.: 13635-000.
    c. Date filed: November 30, 2009 and supplemented March 18 and July
6, 2010.
    d. Applicant: City of Gloversville.
    e. Name of Project: Rice Reservoir Project.
    f. Location: The project is located near the town of Gloversville
in Fulton County, New York.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791a-825r.
    h. Applicant Contact: Mr. Steven Doret, Mill Road Engineering, 23
Mill Road, Westborough, MA 01581-2901,<PHONE_NUMBER>.
    i. FERC Contact: Anthony DeLuca,<PHONE_NUMBER>62,
<EMAIL_ADDRESS>    j. Status of Environmental Analysis: This application is ready for
environmental analysis at this time, and the Commission is requesting
comments, reply comments, recommendations, terms and conditions, and
prescriptions.
    k. Deadline for filing responsive documents: Due to the small size
and location of the proposed project in a closed system, as well as the
resource agency consultation letters filed with the application, the
60-day timeframe specified in 18 CFR 4.43(b) for filing all comments,
motions to intervene, protests, recommendations, terms and conditions,
and prescriptions is shortened to 30 days from the issuance date of
this notice. All reply comments filed in response to comments submitted
by any resource agency, Indian tribe, or person, must be filed with the
Commission within 45 days from the issuance date of this notice.
    Comments, protests, and interventions may be filed electronically
via the Internet in lieu of paper; see 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the ``e-Filing''
link. The Commission strongly encourages electronic filings.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    l. Description of Project: The City of Gloversville (Gloversville)
requests Commission approval for exemption for small conduit
hydroelectric facility. This proposal consists of adding a Turgo style
25 kilowatt hydraulic turbine/generator at the discharge end of the
Rice Reservoir discharge block. The primary purpose of the conduit is
supply of processed water to the Gloversville Potable Water Treatment
Plant. The hydraulic capacity of the generator will be 2.79 cubic feet
per second and the generator will have an estimated average annual
generation of 192,000 kWh.
    m. This filing is available for review and reproduction at the
Commission in the Public Reference Room, Room 2A, 888 First Street,
NE., Washington, DC 20426. The filing may also be viewed on the Web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number, here P-13635, in the docket number field to access the
document. For assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is
also available for review and reproduction at the address in item h.
above.
    n. Development Application--Any qualified applicant desiring to
file a competing application must submit to the Commission, on or
before the specified deadline date for the particular application, a
competing development application, or a notice of intent to file such
an application. Submission of a timely notice of intent allows an
interested person to file the competing development application no
later than 120 days after the specified deadline date for the
particular application. Applications for preliminary permits will not
be accepted in response to this notice.
    o. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit a competing development application. A notice of intent must be
served on the applicant(s) named in this public notice.
    p. Protests or Motions To Intervene--Anyone may submit a protest or
a motion to intervene in accordance with the requirements of Rules of
Practice and Procedure, 18 CFR 385.210, 385.211, and 385.214. In
determining the appropriate action to take, the Commission will
consider all protests 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 protests or motions to intervene must be
received on or before the specified deadline date for the particular
application.
    q. All filings must: (1) Bear in all capital letters the title
``PROTEST,'' ``MOTION TO INTERVENE,'' ``NOTICE OF INTENT TO FILE
COMPETING APPLICATION,'' ``COMPETING APPLICATION,'' ``COMMENTS,''
``REPLY COMMENTS,'' ``RECOMMENDATIONS,'' ``TERMS AND CONDITIONS,'' or
``PRESCRIPTIONS''; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. All comments,
recommendations, terms and conditions or prescriptions must set forth
their evidentiary basis and otherwise comply with the requirements of
18 CFR 4.34(b). Agencies may obtain copies of the application directly
from the applicant. Any of these documents must be filed by providing
the original and eight copies to: The Secretary,

Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. An additional copy must be sent to Director,
Division of Hydropower Administration and Compliance, Office of Energy
Projects, Federal Energy Regulatory Commission, at the above address. A
copy of any protest or motion to intervene must be served upon each
representative of the applicant specified in the particular
application. A copy of all other filings in reference to this
application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-18286 Filed 7-26-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 6, 2010 (Volume 75, Number 193)]
[Notices]
[Page 61771]
[DOCID:fr06oc10-115]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2009-0168]

Notice of Public Availability of Navigation and Vessel Inspection
Circular (NVIC) 2-10, ``Guidance for Implementation and Enforcement of
the Salvage and Marine Firefighting Regulations for Vessel Response
Plans''

AGENCY: Coast Guard, DHS.

ACTION: Notice of availability.

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SUMMARY: The Coast Guard announces the availability of NVIC 2-10,
Guidance for Implementation and Enforcement of the Salvage and Marine
Firefighting Regulations for Vessel Response Plans. The guidance
contained in the NVIC provides details regarding the application and
enforcement of the final rule, ``Salvage and Marine Firefighting
Requirements; Vessel Response Plans for Oil,'' as published in the
Federal Register on December 31, 2008 (73 CFR 80618). Regulators and
industry have a need for further guidance in order to facilitate a
better understanding of, and compliance with, the final rule. An
electronic copy of NVIC 2-10 can be downloaded at http://www.uscg.mil/
hq/cg5/nvic/default.asp or by searching the docket number above at
http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or e-mail LCDR Ryan Allain, Office of Vessel Activities (CG-5431),
U.S. Coast Guard; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    We published a final rule in the Federal Register on December 31,
2008, requiring the identification of salvage and marine firefighting
services in vessel response plans (73 FR 80618). The regulation
requires appropriate salvage and marine firefighting resources to be
identified, contracted for, and capable of responding to incidents up
to and including the worst case discharge scenario. The rulemaking sets
new response planning timeframes for each of the required salvage and
marine firefighting services.
    On August 31, 2009, the Coast Guard published another final rule
concerning vessel response plans that deferred the implementation date
for the salvage and marine firefighting requirements from June 1, 2010
to February 22, 2011 (Vessel and Facility Response Plans for Oil: 2003
Removal Equipment Requirements and Alternative Technology Revisions, 74
FR 45004). As a result, pursuant to 33 CFR 155.4020(a), tank vessel
response plans incorporating salvage and firefighting changes must be
submitted by February 22, 2011.
    NVIC 2-10 provides voluntary guidance to vessel owners and
operators, salvage and marine firefighting resource providers, and
other members of the maritime industry for preparing and submitting the
necessary information to comply with the requirements contained in the
Salvage and Marine Firefighting Requirements; Vessel Response Plans for
Oil, 33 CFR part 155, subpart I. The NVIC also contains an extensive
list of frequently asked questions and job aids to assist affected
industry in submitting the required updates to their vessel response
plans.
    This notice is issued under authority of 5 U.S.C. 552, and 33 CFR
1.05-15.

    Dated: September 27, 2010.
Kevin S. Cook,
Rear Admiral, U.S. Coast Guard, Director of Prevention Policy.
[FR Doc. 2010-25071 Filed 10-5-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 247 (Wednesday, December 23, 2020)]
[Proposed Rules]
[Pages 83839-83840]
[FR Doc No: 2020-28164]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-1191 Airspace Docket No. 20-AGL-41]
RIN 2120-AA66

Proposed Revocation of VOR Federal Airway V-242 Due to the
Planned Decommissioning of the Atikokan, Ontario, Canada,
Nondirectional Radio Beacon (NDB) Navigation Aid

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to remove VHF Omnidirectional Range (VOR)
Federal airway V-242 in the northcentral United States to reflect
changes being made by NAV CANADA in Canadian airspace. The airway
removal is necessary due to the planned decommissioning of the
Atikokan, Ontario (ON), Canada, NDB navigation aid (NAVAID), which
provides navigation guidance for V-242. The Atikokan NDB is being
decommissioned as part of NAV CANADA's NAVAID Modernization Program.

DATES: Comments must be received on or before February 8, 2021.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2020-1191 Airspace Docket No. 20-AGL-41 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov. FAA Order 7400.11E, Airspace Designations and
Reporting Points, and subsequent amendments can be viewed online at
https://www.faa.gov/air_traffic/publications/. For further information,
you can contact the Rules and Regulations Group, Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591;
telephone:<PHONE_NUMBER>. The Order is also available for inspection
at the National Archives and Records Administration (NARA). For
information on the availability of FAA Order 7400.11E at NARA, email:
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would modify the route structure as necessary to
preserve the safe and efficient flow of air traffic within the National
Airspace System (NAS).

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2020-1191 Airspace Docket No. 20-AGL-41) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2020-1191 Airspace Docket No. 20-AGL-41.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during

normal business hours at the office of the Operations Support Group,
Central Service Center, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11E, Airspace
Designations and Reporting Points, dated July 21, 2020, and effective
September 15, 2020. FAA Order 7400.11E is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11E lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

Background

    NAV CANADA, which operates Canada's civil air navigation service,
is continuing to implement various changes to Canada's instrument
flight rules (IFR) navigation infrastructure as part of their NAVAID
Modernization Program to enhance the efficiency of operations by taking
advantage of performance based navigation and modern avionic
capabilities. The changes being implemented by NAV CANADA occasionally
affect parts of U.S. VOR Federal airways that extend across the U.S./
Canada border into Canadian airspace. As a result, the removal of V-242
would mirror changes that are planned to be made by NAV CANADA on the
Canadian side of the border.
    NAV CANADA is planning the decommissioning of the Atikokan, ON,
Canada, NDB as part of their NAVAID Modernization Program. With the
planned decommissioning of the Atikokan NDB, the ground-based NAVAID
coverage in the area is insufficient to enable the continuity of V-242.
As a result, V-242 would no longer be supportable and would be removed
in its entirety.
    To overcome the loss of the airway, instrument flight rules (IFR)
traffic could use adjacent ATS routes, including VOR Federal airways V-
133, V-300, and V-367, or request air traffic control (ATC) radar
vectors to fly through or circumnavigate the affected area. The
International Falls, MN, VHF Omni-directional Range/Distance Measuring
Equipment (VOR/DME) NAVAID, which is currently the first airway point
on V-242, will also remain in service and continue providing positive
course guidance and distance measuring service to aircraft within 40
nautical miles of the NAVAID. Additionally, IFR pilots equipped with
RNAV PBN capabilities would also be able to navigate point to point
using the existing fixes that will remain in place to support continued
operations though the affected area. Visual flight rules (VFR) pilots
who elect to navigate via the airways through the affected area could
also take advantage of the adjacent VOR Federal airways or ATC services
listed previously.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to remove VOR Federal airway V-242. The
planned decommissioning of the Atikokan, ON, Canada, NDB has made this
action necessary. The proposed change is outlined below.
    V-242: V-242 currently extends between the International Falls, MN,
VOR/DME and the Atikokan, ON, Canada, NDB, excluding that airspace
within Canada. The FAA proposes to remove the airway in its entirety.
    VOR Federal airways are published in paragraph 6010(a) of FAA Order
7400.11E, dated July 21, 2020, and effective September 15, 2020, which
is incorporated by reference in 14 CFR 71.1. The ATS route listed in
this document would be subsequently published in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

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

Environmental Review

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

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 6010(a) Domestic VOR Federal Airways.

* * * * *

V-242 [Removed]

* * * * *

    Issued in Washington, DC, on December 16, 2020.
George Gonzalez,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2020-28164 Filed 12-22-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 111 (Tuesday, June 10, 2014)]
[Notices]
[Pages 33197-33198]
[FR Doc No: 2014-13435]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0619]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Humanitarian Use Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
requirements for humanitarian use devices (HUDs).

DATES: Submit either electronic or written comments on the collection
of information by August 11, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medical Devices; Humanitarian Use Devices--21 CFR 814 (OMB Control
Number 0910-0332)--Extension

    This collection of information implements the HUD provision of
section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 360j(m)) and subpart H, part 814 (21 CFR part 814).
Under section 520(m) of the FD&C Act, FDA is authorized to exempt an
HUD from the effectiveness requirements of sections 514 and 515 of the
FD&C Act (21 U.S.C. 360d and 360e) provided that the device: (1) Is
used to treat or diagnose a disease or condition that affects fewer
than 4,000 individuals in the United States; (2) would not be available
to a

person with such a disease or condition unless an exemption is granted
because there is no comparable device other than another HUD approved
under this exemption that is available to treat or diagnose the disease
or condition; and (3) will not expose patients to an unreasonable or
significant risk of illness or injury with the probable benefit to
health from using the device outweighing the risk of injury or illness
from its use. This takes into account the probable risks and benefits
of currently available devices or alternative forms of treatment.
    The information collected will assist FDA in making determinations
on the following: (1) Whether to grant HUD designation of a medical
device; (2) exempt an HUD from the effectiveness requirements under
sections 514 and 515 of the FD&C Act, provided that the device meets
requirements set forth under section 520(m) of the FD&C Act; and (3)
whether to grant marketing approval(s) for the HUD. Failure to collect
this information would prevent FDA from making a determination on the
factors listed previously in this document. Further, the collected
information would also enable FDA to determine whether the holder of an
HUD is in compliance with the HUD provisions under section 520(m) of
the FD&C Act.
    The number of respondents in tables 1, 2, and 3 of this document
are an average based on data for the previous 3 years, i.e., fiscal
years 2011 through 2013. The number of annual reports submitted under
Sec.  814.126(b)(1) in table 1 reflects 32 respondents with approved
HUD applications. Likewise, under Sec.  814.126(b)(2) in table 2, the
number of recordkeepers is 247.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Activity/21 CFR Section         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Request for HUD designation--                 16               1              16              40             640
 814.102........................
Humanitarian device exemption                  7               1               7             320           2,240
 (HDE) application--814.104.....
HDE amendments and resubmitted                14               5              70              50           3,500
 HDEs--814.106..................
HDE supplements--814.108........             112               1             112              80           8,960
Notification of withdrawal of an               8               1               8               1               8
 HDE--814.116(e)(3).............
Notification of withdrawal of                  3               1               3               2               6
 institutional review board
 approval--814.124(b)...........
Periodic reports--814.126(b)(1).              32               1              32             120           3,840
���������������������������������
    Total.......................  ..............  ..............  ..............  ..............          19,194
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                      Activity/21 CFR Section                           Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers    recordkeeping       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
HDE Records--814.126(b)(2).........................................             247                1              247                2              494
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                      Activity/21 CFR Section                           Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of emergency use--814.124(a)..........................              22                1               22                1               22
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: June 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13435 Filed 6-9-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: June 22, 2007 (Volume 72, Number 120)]
[Notices]
[Page 34498-34499]
[DOCID:fr22jn07-94]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55918; File No. SR-CBOE-2007-63]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Regarding Fees for the CBOE Stock Exchange

June 18, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 8, 2007, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been substantially
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify its fees applicable to the CBOE
Stock Exchange (``CBSX''). The text of the proposed rule change is
available on the Exchange's Web site (http://www.cboe.org/legal), at

the Exchange's principal office, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The CBSX fee schedule lists the fees applicable to trading on CBSX.
The transaction fees are based on whether the executing member is
``taking'' liquidity or ``making'' liquidity in connection with the
transaction. This proposal would modify the fees in four respects: (1)
It would eliminate the liquidity taker volume tiers so that all takers
are charged a flat $0.29 per 100 shares regardless of the volume
executed by the user; (2) it would increase the default maker rebate
amount from $0.24 per 100 shares to $0.26 per 100 shares; (3) it would
increase the qualifying Remote Market-Maker rebate from $0.25 per 100
shares to $0.27 per 100 shares; and (4) on NBBO step-up trades, where
liquidity providers on CBSX step-up to the NBBO price displayed by
another market, the ``maker'' for fee purposes would be deemed to be
the side that steps-up (and the maker rebate for this step up would be
$0.20 per 100 shares), and the taker would be the order that was
flashed for a potential NBBO fill. The changes took effect on June 11,
2007.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act \3\ in general, and furthers the
objectives of Section 6(b)(4) \4\ in particular, in that it is designed
to provide for the equitable allocation of reasonable dues, fees, and
other charges among its members and other persons using its facilities.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the foregoing proposed rule change establishes or changes a
due, fee, or other charge imposed by the Exchange, it has become
effective upon filing pursuant to Section 19(b)(3)(A) of the Act \5\
and Rule 19b-4(f)(2) \6\ thereunder. At any time within 60 days of the
filing of the proposed rule change, the Commission may summarily
abrogate such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(3)(A).
    \6\ 17 CFR 19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File No. SR-CBOE-2007-63 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-CBOE-2007-63. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commissions Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference

Room. Copies of such filing also will be available for inspection and
copying at the principal office of the CBOE. All comments received will
be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CBOE-2007-63 and should be submitted on
or before July 13, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-12080 Filed 6-21-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 86, Number 99 (Tuesday, May 25, 2021)]
[Proposed Rules]
[Pages 28040-28042]
[FR Doc No: 2021-10908]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0375; Project Identifier MCAI-2020-01245-R]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Leonardo S.p.a. Model AB139 and AW139 helicopters. This
proposed AD was prompted by two events of uncommanded emergency
flotation system (EFS) deployment during flight. This proposed AD would
require replacing certain part-numbered EFS control panels and prohibit
installing them. The FAA is proposing this AD to address the unsafe
condition on these products.

DATES: The FAA must receive comments on this proposed AD by July 9,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://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: Deliver to Mail address between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Leonardo
S.p.A. Helicopters, Emanuele Bufano, Head of Airworthiness, Viale
G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone +39-0331-
225074; fax +39-0331-229046; or at https://www.leonardocompany.com/en/home. You may view this service information at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0375; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this NPRM, the European
Aviation Safety Agency (now European Union Aviation Safety Agency)
(EASA) AD, any comments received, and other information. The street
address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Ronnea Derby, Aerospace Engineer,
Denver ACO Branch, Compliance & Airworthiness Division, FAA, 26805 E
68th Ave., Mail Stop: Room 214; Denver, CO 80249; telephone (303) 342-
1093; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0375; Project Identifier
MCAI-2020-01245-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include

supporting data. The FAA will consider all comments received by the
closing date and may amend this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

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 (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM 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 NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Ronnea Derby, Aerospace Engineer, Denver ACO Branch, Compliance &
Airworthiness Division, FAA, 26805 E 68th Ave., Mail Stop: Room 214;
Denver, CO 80249; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Any commentary that the FAA receives which is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2015-0172, dated August 21, 2015
(EASA AD 2015-0172), to correct an unsafe condition for AgustaWestland
S.p.A (formerly Agusta S.p.A.), AgustaWestland Philadelphia Corporation
(formerly Agusta Aerospace Corporation) (now Leonardo S.p.a.) Model
AB139 and AW139 helicopters with an EFS installed. EASA advises of two
events of uncommanded EFS deployment during flight. Subsequent
investigation revealed that these conditions had been caused by
improper design of the EFS control panel part numbers (P/Ns)
3G9560V00556 (for use with night vision goggle) and 3G9560V00557
(standard). This condition, if not addressed, could result in reduced
control of the helicopter.
    Accordingly, EASA AD 2015-0172 requires replacing EFS control panel
P/Ns 3G9560V00556 and 3G9560V00557 with EFS control panel P/Ns
3G9560V00559 and 3G9560V00558, respectively. EASA AD 2015-0172 also
prohibits installing EFS control panel P/Ns 3G9560V00556 and
3G9560V00557 on any helicopter.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA is proposing this AD
after evaluating all known relevant information and determining that
the unsafe condition described previously is likely to exist or develop
on other helicopters of these same type designs.

Related Service Information

    The FAA reviewed AgustaWestland Bollettino Tecnico No. 139-374,
dated July 6, 2015. This service information specifies procedures for
replacing EFS control panel P/Ns 3G9560V00556 and 3G9560V00557 with EFS
control panel P/Ns 3G9560V00559 and 3G9560V00558, respectively. This
service information also notes that EFS control panel P/Ns 3G9560V00556
and 3G9560V00557 can be upgraded by following Sirio Panel Service
Bulletin 6WS-MI100135 Ed.01 and 6WS-MI100134 Ed.01.

Proposed AD Requirements in This NPRM

    This proposed AD would require replacing EFS control panel P/Ns
3G9560V00556 and 3G9560V00557 with EFS control panel P/Ns 3G9560V00559
and 3G9560V00558, respectively. This proposed AD would also prohibit
installing EFS control panel P/Ns 3G9560V00556 and 3G9560V00557 on any
helicopter.

Differences Between This Proposed AD and the EASA AD

    EASA AD 2015-0172 applies to Model AB139 and AW139 helicopters with
an EFS installed, whereas this proposed AD would apply to those model
helicopters with EFS control panel P/N 3G9560V00556 (for use with night
vision goggle) or 3G9560V00557 (standard) installed instead. EASA AD
2015-0172 specifies replacing an affected EFS control panel within a
compliance time of flight hours or months, whichever occurs first,
based on helicopter configuration, whereas this proposed AD would
require that replacement within a shorter compliance time in hours
time-in-service but the same number of months, based on helicopter
configuration instead.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect up to 133 helicopters of U.S. Registry. Labor rates are
estimated at $85 per work-hour. Based on these numbers, the FAA
estimates the following costs to comply with this proposed AD.
    Replacing an EFS control panel would take about 1 work-hour and
parts would cost about $12,342 for an estimated cost of $12,427 per
helicopter and up to $1,652,791 for the U.S. fleet.

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.
    The FAA is 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

    The FAA 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, I certify this proposed regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities

under the criteria of the Regulatory Flexibility Act.

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

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

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

Sec.  39.13   [Amended]

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

Leonardo S.p.a.: Docket No. FAA-2021-0375; Project Identifier MCAI-
2020-01245-R.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by July 9, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Leonardo S.p.a. Model AB139 and AW139
helicopters, certificated in any category, with an emergency
flotation system (EFS) control panel part number (P/N) 3G9560V00556
(for use with night vision goggle) or 3G9560V00557 (standard)
installed.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 3212, Emergency
Flotation Section.

(e) Unsafe Condition

    This AD was prompted by two events of uncommanded EFS deployment
during flight. The FAA is issuing this AD to address improper design
of certain EFS control panels. The unsafe condition, if not
addressed, could result in reduced control of the helicopter.

(f) Compliance

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

(g) Required Actions

    (1) At the following compliance time, replace EFS control panel
P/N 3G9560V00556 or 3G9560V00557 with EFS control panel P/N
3G9560V00559 or 3G9560V00558, respectively:
    (i) For helicopters with EFS P/N 3G9560F00111 or 3G9560F00113,
with Aerosekur floats with ``pyrotechnical'' inflation system P/N
3G9560V01051 installed, within 94 hours time-in-service (TIS) or 3
months after the effective date of this AD, whichever occurs first.
    (ii) For helicopters with EFS P/N 3G9560F00111 or 3G9560F00113,
with Aerosekur floats with ``SMA'' inflation system P/N 3G9560V01052
installed, within 377 hours TIS or 12 months after the effective
date of this AD, whichever occurs first.
    (iii) For helicopters with EFS P/N 3G9560F00212 with Aerosekur
floats with ``fuse disk'' inflation system P/N 3G9560V02051
installed, within 565 hours TIS or 18 months after the effective
date of this AD, whichever occurs first.
    (2) As of the effective date of this AD, do not install EFS
control panel P/N 3G9560V00556 or 3G9560V00557 on any helicopter.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (i)(1) of
this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(i) Related Information

    (1) For more information about this AD, contact Ronnea Derby,
Aerospace Engineer, Denver ACO Branch, Compliance & Airworthiness
Division, FAA, 26805 E 68th Ave., Mail Stop: Room 214; Denver, CO
80249; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Leonardo S.p.A. Helicopters, Emanuele Bufano, Head of Airworthiness,
Viale G.Agusta 520, 21017 C.Costa di Samarate (Va) Italy; telephone
+39-0331-225074; fax +39-0331-229046; or at https://www.leonardocompany.com/en/home. You may view this referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.
    (3) The subject of this AD is addressed in European Aviation
Safety Agency (now European Union Aviation Safety Agency) (EASA) AD
2015-0172, dated August 21, 2015. You may view the EASA AD at
https://www.regulations.gov in Docket No. FAA-2021-0375.

    Issued on May 18, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-10908 Filed 5-24-21; 8:45 am]
BILLING CODE 4910-13-P