[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Notices]
[Page 40034]
[FR Doc No: 2018-17288]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD18-13-000]

Notice of Availability of the Final Engineering Guidelines for
the Evaluation of Hydropower Projects: Chapter 12--Water Conveyance

    The staff of the Federal Energy Regulatory Commission's (FERC or
Commission) Office of Energy Projects has finalized its new Engineering
Guidelines for the Evaluation of Hydropower Projects: Chapter 12--Water
Conveyance (Guidelines), which was issued in draft form on May 17,
2018, for comment. The Guidelines revision reflects the most current
thinking and practices of the Division of Dam Safety and Inspections.
    The Guidelines can be found in Docket Number AD18-13-000. The full
text of the Guidelines can be viewed on the Commission's website at
https://www.ferc.gov/industries/hydropower/safety/guidelines/eng-guide/chap12.pdf.
    The Guidelines are intended to provide guidance to the industry.
This document does not substitute for, amend, or supersede the
Commission's regulations under the 18 CFR part 12--Safety of Water
Power Projects and Project Works. imposes no new legal obligations and
grants no additional rights.
    In response to the draft Guidelines, Commission staff received
comments from federal and state agencies, licensees whose portfolio
includes arch dams, independent consultants and inspectors, and other
interested parties. Staff reviewed and considered each comment and
modified several portions of the document in response. Staff declined
to modify the document where comments either were already adequately/
accurately addressed as written, or regarded topics that were not
relevant to the Guidelines.
    All of the information related to the Guidelines and submitted
comments can be found on the FERC website (www.ferc.gov) using the
eLibrary link. Click on the eLibrary link, click on ``Docket Search''
and in the Docket Number field enter the docket number ``AD18-13,''
excluding the last three digits. For assistance, please contact FERC
Online Support at [email protected] or toll free at (866) 208-
3676, or for TTY, contact<PHONE_NUMBER>. The eLibrary link also
provides access to formal documents issued by the Commission, such as
orders, notices, and rulemakings.

    Dated: August 7, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-17288 Filed 8-10-18; 8:45 am]
 BILLING CODE 6717-01-P


Environmental Sampling, Analysis and Results Data Standards Overview of Component Data Standards Standard No.: 1 XXX Version 1 FINAL DRAFT July 26, 2005 This standard has been produced through the Environmental Data Standards Council ( EDSC).

The Environmental Data Standards Council ( EDSC) is a partnership among EPA, States and Tribal partners to develop and agree upon data standards for environmental information collection and exchange. More information about the EDSC is available at http:// www. envdatastandards. net. Environmental Sampling, Analysis and Results Data Standard Overview of Component Data Standards Std. No.: 1 XXX Version 1   Final Draft July 26, 2006 Page 2 Foreword The Environmental Data Standards Council ( EDSC) identifies, prioritizes and pursues the creation of data standards for those areas where information exchange standards will provide the most value in achieving environmental results. The EDSC involves Tribes and Tribal Nations, state and federal agencies in the development of the standards and then provides the draft materials for general review. Business groups, non governmental organizations, and other interested parties may then provide input and comment for Council consideration and standard finalization. Draft and final standards are available at http:// www. envdatastandards. net.

1.0 INTRODUCTION The development of a Laboratory Results Data Standard was commissioned by the EDSC in January 2003. The EDSC agreed that development of a data standard to enable the sharing and integration of laboratory results data was critical for emergency response, public health assessment, environmental effects and trends analyses. A multidisciplinary team developed the draft standard. As the standard evolved it was decided that in order to adequately exchange the information the standard should follow the business processes of sampling, analysis and results. As a result, the name was changed from Laboratory Results Data Standard to the Environmental Sampling, Analysis and Results Data Standard ( ESAR). ESAR completed a technical review in February 2004. Media specific reviews in water, waste and air followed in 2004 through the spring of 2005. These reviews resulted in the development of nine supporting standards; a more generic renaming of titles for the standards and names for the data elements; and division of the primary standard into four separate component data standards: 1) ESAR Project Data Standard, 2) ESAR Monitoring Location Data Standard, 3) ESAR Field Activity Data Standard, and 4) ESAR Analysis and Results Data Standard. The EDSC envisions that this approach of using small flexible component parts will enable developers to pick and chose those elements needed and make implementation easier. The EDSC approved the suite of ESAR Draft Data Standards for public review in July of 2005.

The ESAR Draft Data Standards follow the business processes used to collect, analyze and report environmental data. The standards are meant to encompass the foundation or base amount of material needed to exchange environmental sampling, analysis, and results data. If additional data elements are required, they can be added to the standardized base. Conversely, if data elements or data groupings contained in the base are not required, they do not have to be used. The ESAR standards are designed in flexible small components that can be arranged, rearranged, used and reused as needed.

1.1 Scope This overview describes the primary and supporting data standards that may be used in the exchange of environmental sampling, analysis and results data. It explains how the components can be combined and reused.

1.2 Component and Referenced Data Standards The ESAR Draft Data Standards is a suite of supporting component standards that are based on the business processes used by collectors of environmental data for project planning, sample collection or monitoring, analysis, and reporting results. The suite is comprised of four primary standards and nine supporting components: Environmental Sampling, Analysis and Results Data Standard Overview of Component Data Standards Std. No.: 1 XXX Version 1   Final Draft July 26, 2006 Page 3 Primary Data Standards   Project   An environmental data collection effort that has a stated purpose and puts a series of samples/ results into a meaningful context. The project section provides information about the identification, contacts, dates, study areas, reasons, and quality constraints. The level of information provided for a project will be determined by parties that have to collect and manage the data.

  Monitoring Location   An identifiable location where an environmental sample, onsite measurement, and/ or observation is determined. The monitoring location section provides information about the identification, the contacts, dates, study areas, reasons, and quality constraints. There may be many monitoring locations that are utilized by a project. It is also possible that a monitoring location is not associated with any project. A monitoring location could have many field activities occurring at it over time.

  Field Activity   Field monitoring activities, include the collection of a physical sample, measurement, and/ or observation where one or more of the results will be described or quantified. The field activity section provides information about the contacts, collection method, sample identification, collection times, depth/ altitude, observation notes, sample characteristics, and batch and shipping activities. There may be many field activities at a monitoring location. A field activity may be categorized as sample collection, which may have many results produced from an original collection.

  Analysis and Results   The Analysis and Results Data Standard defines the elements required for describing analysis and results information. It provides information about the laboratory, laboratory batch receipt, laboratory sample receipt, sample preparation, laboratory analysis, and quality control data.

Supporting Data Standards   Attached Binary Object Data Standard  Describes digital items ( e. g., pictures, documents) that are attached to the transmitted data.

  Bibliographic Reference Data Standard   Library cataloging descriptors for identifying material referenced in the data transmission ( e. g., reference for a published report). Adopted from the international standard.

  Compositing Data Standard   Describes the combining of several sample results or units to produce a single entity.

  Equipment Data Standard   Describes equipment or instruments used in the field or laboratory and activities associated with calibration information.

  Measure Data Standard   Identifies the values and the associated units of measure for measuring/ recording the observation or analytical result value.

  Method Data Standard   Identifies the procedures/ processes used or references standard methodologies used to obtain the result.

  Quality Assurance and Quality Control   Identifies quantitative statistics and qualitative descriptors that are used to interpret the degree of acceptability or utility of data acquired during field or laboratory analysis.

  Representation of Date and Time Data Standard   This standard indicates a particular day within the Gregorian calendar month and specifies an instance of time in the day. It adds Coordinated Universal Time ( UTC) data elements to the existing EDSC Date data standard and is adopted from an international standard.

  Sample Handling Data Standard   Specifies the standard characteristics associated with sample preservation and treatment in the laboratory and/ or in the field. Environmental Sampling, Analysis and Results Data Standard Overview of Component Data Standards Std. No.: 1 XXX Version 1   Final Draft July 26, 2006 Page 4 Other EDSC data standards may need to be used in support of ESAR suite of data standards. The ESAR standards provide notations to reference specific standards where they may be needed. These standards include:

  Biological Taxonomy [ 1 9937 2] Data Standard   Chemical Identification [ Version 2 Draft] Data Standard   Contact Information [ 1 88433 2] Data Standard   Facility Site Identification [ 1 9936 2] Data Standard   Latitude/ Longitude [ Version 2 Draft] Data Standard 1.3 Terms and Definitions For the purposes of this document, the following terms and definitions apply:

Term Definition Field Activity Field monitoring activities, including the collection of a physical sample, measurement, and/ or observation where one or more of the results is described or quantified.

Laboratory A fixed lab, mobile or field facility equipped for testing and analysis.

Laboratory Analysis Analytical results that are generated either in the field from continuous or discrete observation / monitoring or from mobile or fixed laboratory facilities.

Project An environmental data collection effort that has a stated purpose and puts a series of samples/ results into a meaningful context.

Monitoring Location An identifiable location where an environmental sample, onsite measurement, and/ or observation is determined.

1.4 Implementation Each component standard consists of data elements and, where appropriate, groupings of data elements. The primary components describe the four major business processes and the supporting components are activities or information used multiple times within the primary components. For example:

  Many projects may be included in a set of exchanged data.

  Many monitoring locations maybe utilized by a project or monitoring locations may not have a project association.

  Many field activities may occur at a monitoring location.

  Many sample analyses may be performed during a field activity.

  Measurements can be taken at the monitoring location, in the field, in the laboratory, or in the reporting of results. In each instance, the Measure Data Standard would be used. Environmental Sampling, Analysis and Results Data Standard Overview of Component Data Standards Std. No.: 1 XXX Version 1   Final Draft July 26, 2006 Page 5 The Modular and reuse concepts are illustrated in Figure 1.

Figure 1: Relationship between ESAR Component Data Standards 1.5 Document Structure The structure of this document is briefly described below:

a. Section 2.0 ESAR Primary Data Standards, illustrates the principal data groupings contained within this standard. b. Section 3.0 ESAR Primary Data Standard Table, provides information on the high level, intermediate and elemental Measure data groupings. Where applicable, for each level of this data standard a definition, XML tag, note( s), example list of values and format are provided. The format column may include the required number of characters for the associated data element, where " A" specifies alphanumeric and " N" designates numeric. c. Section 4.0 ESAR Supporting Data Standards, illustrates the principal data groupings contained in the ESAR Supporting Data Standards. d. Data Standard Numbering: For purposes of clarity and to enhance understanding of data standard hierarchy and relationships, each data group is numerically classified from the primary to the elemental level. e. Code Metadata: Based on the business need, additional metadata may be required to sufficiently describe a code. A note regarding this additional metadata is included in the notes column for code elements. Additional metadata for codes may include:   Code List Identifier, which is a standardized reference to the context or source of the set of codes   Code List Version Identifier, which identifies the particular version of the set of codes.   Code List Version Agency Identifier, which identifies the agency responsible for maintaining the set of codes   Code List Name, which describes the corresponding name for which the code represents Primary Components Supporting Components Laboratory Data Flow Lab Data MOR Lab Data Project MOR Project Monitoring Location 1

_

Result Result Monitoring Location Monitoring Location Monitoring Location Field Activity Field Activity Field Activity Field Activity Sample Analysis Sample Analysis Sample Analysis Sample Analysis 1

_ 1

_

1

_ 1

_

Result Result 1

_ 1

_

1

_ 1

_ Bibliographic Reference Date and Time Equipment Measure Method Sample Handling Compositing Binary Object QA/ QC Other EDSC Standards Contact Facility Lat/ Long Environmental Sampling, Analysis and Results Data Standard Overview of Component Data Standards Std. No.: 1 XXX Version 1   Final Draft July 26, 2006 Page 6 2.0 ESAR PRIMARY DATA STANDARDS ESAR Primary Data Standards Figure 2   Structure of ESAR Primary Data Standards 3.0  ESAR Primary Data Standards and Data Groupings Table 1.

Environmental Sampling, Analysis and Results Primary Data Standards 1. ESAR Project  Data Standard Definition: ESAR environmental data collection effort that has a stated purpose and puts a series of samples/ results into a meaningful context.

The following data groups may be used to specify the ESAR Project:

Project Point of Contact, Project Identification, Project Duration, Project Reason, Project Data Collection Area, Project Collection Facility Site Identification, Data Collection Quality, Project Reference, Attached Binary Object, Bibliographic Reference.

2. ESAR Monitoring Location  Data Standard Definition: An ESAR identifiable location where an environmental sample, onsite measurement, and/ or observation is determined The following data groups may be used to specify the ESAR Monitoring Location:

Monitoring Location Point of Contact, Monitoring Location Identification, Geographic Monitoring Location, Monitoring Location Attached Binary Object, Monitoring Location Influences, Air Emission Release Point Identification, Air Open Path Monitoring Location, Well Identification.

3. ESAR Field Activity  Data Standard Definition: ESAR field monitoring activities, including the collection of a physical sample, measurement, and/ or observation where one or more of the results is described or quantified.

The following data groups may be used to specify the ESAR Field Activity:

Field Activity Point of Contact, Environmental Sampling, Analysis, and Results Project Monitoring Location Field Activity Analysis and Results Environmental Sampling, Analysis and Results Data Standard Overview of Component Data Standards Std. No.: 1 XXX Version 1   Final Draft July 26, 2006 Page 7 Field Activity Identification, Field Activity Date and Time, Field Activity Equipment, Field Activity Observation, Field Activity Attached Binary Object, Sample Collection Description, Sample Event Depth/ Height, Field Sample Collection Method, Field Sample Handling, Sample Batch and Shipping, Sample Chain of Custody.

4. ESAR Analysis and Results  Data Standard Definition: ESAR Analysis and Results information for a sample about the laboratory, laboratory batch receipt, laboratory sample receipt, the sample preparation, the laboratory analysis, and the quality control data.

The following data groupings may be used to specify the ESAR Data Analysis and Results:

Laboratory Identification, Laboratory Batch Receipt, Laboratory Sample Receipt, Laboratory Sample Handling, Sample Preparation, Analysis Information, Substance Identification, Analysis Results Identification, QA/ QC, Analysis Results Attached Binary Object.

4.0   ESAR Supporting Data Standards and Data Groupings Table 2 Environmental Sampling, Analysis and Results Supporting Data Standards 1. Attached Binary Object Definition: Reference documents, images, photos, GIS data layers, laboratory materials and other electronic objects attached within the data exchange, as well as information used to describe those objects.

ESAR Binary Object Exchange Characteristics ESAR Binary Object Bibliographic Reference ( reference Bibliographic Reference Information Data Standard)

2. Bibliographic Reference Definition: The descriptors used to identify and catalog an object.

ESAR Bibliographic Reference Descriptors 3. Compositing Definition: The attributes related to the combining of several samples, sub samples, results or units to produce a single entity Compositing Activity Compositing Date and Time Environmental Sampling, Analysis and Results Data Standard Overview of Component Data Standards Std. No.: 1 XXX Version 1   Final Draft July 26, 2006 Page 8 Compositing Component 4. Equipment Definition: Information needed to uniquely identify the apparatus, instrument, or equipment used for the activity.

Equipment Identification Equipment Characteristics Equipment Calibration 5. Measure Definition: Identifies the value and the associated units for measuring an observation or analytical result value.

Measure Measure QA/ QC 6. Method Definition: Identifies the procedures/ processes and references required to determine the methods used to obtain a result.

Method Identification Method Reference 7. Quality Assurance and Quality Control Definition: The quantitative statistics and qualitative descriptors that are used to interpret the degree of acceptability or utility of data to the user.

Data Quality Indicator 8. Representation of Date and Time Definition: Representation of a point in time in the Gregorian calendar and portion thereof.

Date Time 9. Sampling Handling Definition: Identifies sample handling procedures including sample treatment and/ or sample preservation.

Sample Handling Sample Preservation


[Federal Register: August 6, 2008 (Volume 73, Number 152)]
[Rules and Regulations]
[Page 45629-45634]
[DOCID:fr06au08-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0221; FRL-8367-5]

Dodine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of dodine
in or on bananas and peanuts. Agriphar S.A. c/o Ceres International LLC
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective August 6, 2008. Objections and
requests for hearings must be received on or before October 6, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0221. 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. All documents in the docket are listed in
the docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (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 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 Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Mary L. Waller, Registration Division
(7505P), 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 those
engaged in the following activities:
     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 to
provide 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. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.]

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0221 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk as required by 40 CFR part 178 on or
before October 6, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0221, 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>.

II. Petition for Tolerance

    In the Federal Register of May 9, 2007 (72 FR 26372) (FRL-8121-5),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 7F7185)
by Agriphar S.A. c/o Ceres International LLC, 1087 Heartsease Dr., West
Chester, PA 10382. The petition requested that 40 CFR 180.172 be
amended by establishing tolerances for residues of the fungicide
dodine, n-dodecylguanidine acetate, in or on bananas at 0.50 parts per
million (ppm) and on peanuts at 0.03 ppm. That notice referenced a
summary of the petition prepared by Agriphar S.A. c/o Ceres
International LLC, the registrant, which is available to the public in
the docket, http://www.regulations.gov. Comments were received on the
notice of filing. EPA's response to these comments is discussed in Unit
IV.C.
    Based upon review of the data supporting the petition, EPA has
lowered the tolerance for peanuts from 0.03 ppm to 0.013 ppm. The
reason for this change is explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for residues of dodine on bananas at 0.50 ppm and on peanuts
at

0.013 ppm. EPA's assessment of exposures and risks associated with
establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Technical dodine has moderate toxicity via the acute oral, dermal
and inhalation routes of exposure. It is a severe eye irritant and
causes severe dermal irritation; it is not a skin sensitizer. A
definitive target organ has not been identified for dodine. The most
common effects observed in subchronic and chronic oral and inhalation
studies were decreases in food consumption, body weight and/or body
weight gain. There is no evidence of neurotoxicity. Effects from dermal
exposure were limited to dermal lesions. There is no evidence of
increased susceptibility (quantitative or qualitative) in pups versus
adults based on rat and rabbit developmental studies and the rat multi-
generation reproduction study. A weight of evidence evaluation of the
carcinogenic potential of dodine was performed, and based on the
results it was concluded that there is no evidence of carcinogenicity
after exposure to dodine. All toxicological endpoints chosen for risk
assessment were based on body weight effects plus, in the case of
inhalation, reduced food consumption.
    Specific information on the studies received and the nature of the
adverse effects caused by dodine as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at http://
www.regulations.gov in document Dodine: Human Health Risk Assessment
for Proposed Use Bananas and Peanuts, pages 12 and 44 in docket ID
number EPA-HQ-OPP-2007-0221.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for dodine used for human
risk assessment can be found at http://www.regulations.gov in document
Dodine: Human Health Risk Assessment for Proposed Use Bananas and
Peanuts, page 17 in docket ID number EPA-HQ-OPP-2007-0221.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to dodine, EPA considered exposure under the petitioned-for
tolerances as well as all existing dodine tolerances in (40 CFR
180.172). EPA assessed dietary exposures from dodine in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for
dodine; therefore, a quantitative acute dietary exposure assessment is
unnecessary
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 (CSFII). As to residue levels in food, EPA assumed that
tolerance level residues were used for all crops. In terms of extent of
usage, percent crop treated information was used for pome fruit, stone
fruit, strawberry, pecan and walnut. One hundred percent crop treated
was assumed for banana and peanut crops.
    iii. Cancer. There was equivocal evidence of carcinogenicity in a
mouse carcinogenicity study. However, based on a weight of evidence
evaluation of the carcinogenic potential of dodine, the Agency
concluded that there is no evidence of carcinogenicity after exposure
to dodine. Factors bearing on this weight of the evidence determination
are described in Dodine: Human Health Risk Assessment for Proposed Use
Bananas and Peanuts, pages 20-21 in docket ID number EPA-HQ-OPP-2007-
0221. EPA principally relied on the fact that the only evidence of
cancer was a finding of statistically significant liver tumors
(primarily adenomas) in female mice at the highest dose tested and no
evidence of genotoxicity was found. There was no evidence of cancer in
male mice or rats.
    iv. Percent crop treated (PCT) information. Section 408(b)(2)(F) of
FFDCA states that the Agency may use data on the actual percent of food
treated for assessing chronic dietary risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require
registrants to submit data on PCT.
    The Agency used PCT information as follows:
    The Agency used the following PCT information for the currently
registered uses of dodine: 10% PCT for pears and quinces; 5% PCT for
apples, crabapples, loquats, cherries, walnuts and pecans; and 1% PCT
for strawberries, apricots, nectarines, peaches, and plums.

    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 years.
EPA uses an average PCT for chronic dietary risk analysis. The average
PCT figure for each existing use is derived by combining available
public and private market survey data for that use, averaging across
all observations, and rounding to the nearest 5%, except for those
situations in which the average PCT is less than one. In those cases,
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which dodine may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for dodine in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of dodine. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST), and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of dodine for chronic
exposures for non-cancer assessments are estimated to be 4.0 parts per
billion (ppb) for surface water and <0.08 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 4.0 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Dodine is not registered for any specific use patterns that would
result in residential exposure. However, a closely related chemical,
dodecylguanidine hydrochloride (DGH) is used as an antimicrobial in
household, industrial, and commercial products having residential and
non-occupational exposure potential. DGH is used as a bacteriostat in
paints and in absorbent material in disposal diapers. Dodine and DGH
have similar chemical compositions and properties and are therefore
considered bio-equivalents.
    Residential painters may have short-term dermal and inhalation
exposure as a result of using DGH treated paint. Infants < 1-year old
may have short-, intermediate, and long term dermal exposure as a
result of wearing DGH impregnated diapers. Inhalation exposure of
infants and children is expected to be negligible. Although small
children may have short-term post application oral exposure as a result
of accidental ingestion of paint chips which contain DGH, the Agency
does not believe that this would occur on a regular basis.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found dodine to share a common mechanism of toxicity
with any other substances, and dodine does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that dodine does not have
a common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see EPA's website at http://www.epa.gov/pesticides/
cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA safety
factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. There is no evidence
(quantitative or qualitative) of increased susceptibility and no
residual uncertainties with regard to prenatal and/or postnatal
toxicity following in utero exposure to rats or rabbits and prenatal
and/or postnatal exposure to rats. In a rat developmental toxicity
study, decreased body weight gain and food consumption were observed at
>= 45 milligrams/kilograms/day (mg/kg/day) in maternal animals. No
treatment-related effects were observed in fetuses up to 90 mg/kg/day.
In a rabbit developmental toxicity study, dams demonstrated decreased
food consumption at 80 mg/kg/day; however, this finding was not
considered adverse. No treatment-related effects were observed in
fetuses up to 80 mg/kg/day. In a 2-generation reproduction toxicity
study in rats, decreases in parental body weight, body weight gain and
food consumption were noted in both generations of rats at 53 mg/kg/
day. Additionally at 53 mg/kg/day, the offspring of both generations
demonstrated decreased body weight after postnatal day 4 which
continued through pre-mating.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:

    i. The toxicity database for dodine is complete.
    ii. EPA concluded that dodine is not a neurotoxic chemical and
there is no need for a developmental neurotoxicity study or additional
UFs to account for neurotoxicity. Possible neurological clinical signs
(excessive salivation and hunched posture/hypoactivity) were observed
in chronic studies in rats and mice but were not dose-related or
statistically significant. Excessive salivation in the chronic study in
dogs showed a treatment related dose response. However, the effect was
not consistent with a neurological adverse effect since it was seen
prior to dosing and was a persistent finding throughout the study. In
addition, no evidence of neuropathology was observed in the available
studies. Therefore, it was determined that there was no evidence of
neurotoxicity. Based on the weight of evidence, the Agency determined
that a developmental neurotoxicity study is not required.
    iii. There is no evidence that dodine results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on Agency recommended tolerance-level residues and health-protective
modeling assumptions. Although PCT estimates were used for crops with
existing tolerances, the use of tolerance values for residue levels
will likely overestimate actual exposures. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to dodine in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children
as well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by dodine.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single-oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
dodine is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
dodine from food and water will utilize 20% of the cPAD for (children
1-2 years of age) the population group receiving the greatest exposure.
Although dodine is not currently registered for any use patterns that
would result in residential exposure, DGH is currently registered for
uses that could result in long-term residential post-application
exposure and the Agency has determined that it is appropriate to
aggregate chronic exposure to dodine through food and water with long-
term residential post-application exposure to DGH. EPA has concluded
that the combined long-term food, water, and dermal exposure for
infants wearing diapers containing DGH treated material results in
aggregate MOEs as follows: 300 when using a 5% transfer factor and 100
when using a 30% transfer factor. The Agency believes that a transfer
factor of 30% is an overestimate of exposure in determining the amount
of DGH transferred to infants from diapers based on a transfer study
using dodine-treated paper exposed to extreme conditions. Additionally,
the Agency has requested an impregnated diaper migration study as
confirmatory data.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Although dodine is not registered for any use patterns that would
result in residential exposure, DGH is currently registered for uses
that could result in short- and intermediate-term residential exposure
and the Agency has determined that it is appropriate to aggregate
chronic exposure to dodine through food and water with short- and
intermediate-term residential exposures to DGH.
    Using the exposure assumptions described in this unit for short-
and intermediate-term exposures, EPA has concluded the short- and
intermediate-term combined food, water, and residential exposures
aggregated result in aggregate MOEs of 4,500 for adult males handling
paint and 4,600 for adult females handling paint do not exceed the
Agency's level of concern. EPA has concluded that the combined
intermediate-term food, water, and dermal exposure for infants wearing
diapers containing DGH treated material results in aggregate MOEs of
640 when using a 5% transfer factor and 120 when using a 30% transfer
factor. For the reasons stated in Unit III.E.2. the Agency believes the
risks do not exceed the Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. Based on its weight
of the evidence calculation, the Agency believes that there is no
cancer risk associated with the use of dodine.
    5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to dodine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography/mass
spectrometry/mass spectrometry) is available to enforce the tolerance
expression. The method may be requested from: Chief, Analytical
Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft.
Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits for
dodine on bananas or peanuts.

C. Response to Comments

    There was one favorable comment from Del Monte in favor of
establishing the tolerance for use of dodine on bananas in order to
control black sigatoka disease.

D. Revisions to Petitioned-For Tolerances

    The proposed tolerance of 0.03 ppm for residues of dodine on
peanuts was revised to 0.013 ppm because the tolerances were proposed
in terms of dodine free base, and the Agency recalculated the residue
results in terms of dodine using a molecular weight conversion factor
of 1.258.

V. Conclusion

    Therefore, tolerances are established for residues of dodine, n-
dodecylguanidine acetate, in or on bananas at 0.50 ppm and on peanuts
at 0.013 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: July 25, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

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

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

0
2. Section 180.172 is amended by alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec.  180.172  Dodine; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Banana.....................................................         0.50
                                * * * * *
Peanut.....................................................        0.013
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-17934 Filed 8-5-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 86, Number 11 (Tuesday, January 19, 2021)]
[Notices]
[Pages 5200-5219]
[FR Doc No: 2021-01022]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2358]

Authorizations of Emergency Use of Two Biological Products During
the COVID-19 Pandemic; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of two Emergency Use Authorizations (EUAs) (the
Authorizations) under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) for biological products for use during the COVID-19 pandemic. FDA
issued one Authorization for a biological product as requested by
Pfizer, Inc, and one Authorization for a biological product as
requested by ModernaTX, Inc. The Authorizations contain, among other
things, conditions on the emergency use of the authorized products. The
Authorizations follow the February 4, 2020, determination by the
Secretary of Health and Human Services (HHS) that there is a public
health emergency that has a significant potential to affect national
security or the health and security of U.S. citizens living abroad and
that involves a novel (new) coronavirus. The virus, now named SARS-CoV-
2, causes the illness COVID-19. On the basis of such determination, the
Secretary of HHS declared on March 27, 2020, that circumstances exist
justifying the authorization of emergency use of drugs and biological
products during the COVID-19 pandemic, pursuant to the FD&C Act,
subject to the terms of any authorization issued under that section.
The Authorizations, which include an explanation of the reasons for
issuance, are reprinted in this document.

DATES: The Authorization for Pfizer, Inc. is effective as of December
11, 2020; the Authorization for ModernaTX, Inc. is effective as of
December 18, 2020.

ADDRESSES: Submit written requests for single copies of the EUAs to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the Authorizations may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorizations.

FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4340, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the FD&C Act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product in certain
situations. With this EUA authority, FDA can help ensure that medical
countermeasures may be used in emergencies to diagnose, treat, or
prevent serious or life-threatening diseases or conditions caused by
biological, chemical, nuclear, or radiological agents when there are no
adequate, approved, and available alternatives.

II. Criteria for EUA Authorization

    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack

with a biological, chemical, radiological, or nuclear agent or agents;
(2) a determination by the Secretary of Defense that there is a
military emergency, or a significant potential for a military
emergency, involving a heightened risk to U.S. military forces,
including personnel operating under the authority of title 10 or title
50, United States Code, of attack with (i) a biological, chemical,
radiological, or nuclear agent or agents; or (ii) an agent or agents
that may cause, or are otherwise associated with, an imminently life-
threatening and specific risk to U.S. military forces; \1\ (3) a
determination by the Secretary of HHS that there is a public health
emergency, or a significant potential for a public health emergency,
that affects, or has a significant potential to affect, national
security or the health and security of U.S. citizens living abroad, and
that involves a biological, chemical, radiological, or nuclear agent or
agents, or a disease or condition that may be attributable to such
agent or agents; or (4) the identification of a material threat by the
Secretary of Homeland Security pursuant to section 319F-2 of the Public
Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect
national security or the health and security of U.S. citizens living
abroad.
---------------------------------------------------------------------------

    \1\ In the case of a determination by the Secretary of Defense,
the Secretary of HHS shall determine within 45 calendar days of such
determination, whether to make a declaration under section 564(b)(1)
of the FD&C Act, and, if appropriate, shall promptly make such a
declaration.
---------------------------------------------------------------------------

    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of a drug, device, or
biological product intended for use when the Secretary of HHS has
declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), 512, or 515 of the FD&C Act (21 U.S.C. 355,
360(k), 360b, and 360e) or section 351 of the PHS Act (42 U.S.C. 262),
or conditionally approved under section 571 of the FD&C Act (21 U.S.C.
360ccc). FDA may issue an EUA only if, after consultation with the HHS
Assistant Secretary for Preparedness and Response, the Director of the
National Institutes of Health, and the Director of the Centers for
Disease Control and Prevention (to the extent feasible and appropriate
given the applicable circumstances), FDA \2\ concludes: (1) That an
agent referred to in a declaration of emergency or threat can cause a
serious or life-threatening disease or condition; (2) that, based on
the totality of scientific evidence available to FDA, including data
from adequate and well-controlled clinical trials, if available, it is
reasonable to believe that: (A) The product may be effective in
diagnosing, treating, or preventing (i) such disease or condition; or
(ii) a serious or life-threatening disease or condition caused by a
product authorized under section 564, approved or cleared under the
FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing,
treating, or preventing such a disease or condition caused by such an
agent; and (B) the known and potential benefits of the product, when
used to diagnose, prevent, or treat such disease or condition, outweigh
the known and potential risks of the product, taking into consideration
the material threat posed by the agent or agents identified in a
declaration under section 564(b)(1)(D) of the FD&C Act, if applicable;
(3) that there is no adequate, approved, and available alternative to
the product for diagnosing, preventing, or treating such disease or
condition; (4) in the case of a determination described in section
564(b)(1)(B)(ii), that the request for emergency use is made by the
Secretary of Defense; and (5) that such other criteria as may be
prescribed by regulation are satisfied.
---------------------------------------------------------------------------

    \2\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act.

III. The Authorizations

    The Authorizations follow the February 4, 2020, determination by
the Secretary of HHS that there is a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad and that involves a novel (new)
coronavirus. The virus, now named SARS-CoV-2, causes the illness COVID-
19. Notice of the Secretary of HHS's determination was provided in the
Federal Register on February 7, 2020 (85 FR 7316). On the basis of such
determination, the Secretary of HHS declared on March 27, 2020, that
circumstances exist justifying the authorization of emergency use of
drugs and biological products during the COVID-19 pandemic, pursuant to
section 564 of the FD&C Act, subject to the terms of any authorization
issued under that section. Notice of the Secretary of HHS's declaration
was provided in the Federal Register on April 1, 2020 (85 FR 18250).
Having concluded that the criteria for issuance of the Authorizations
under section 564(c) of the FD&C Act are met, FDA issued two
authorizations for the emergency use of biological products during the
COVID-19 pandemic. On December 11, 2020, FDA issued an EUA to Pfizer,
Inc. for the Pfizer-BioNTech COVID-19 Vaccine, subject to the terms of
the Authorization. On December 18, 2020, FDA issued an EUA to
ModernaTX, Inc. for the Moderna COVID-19 Vaccine, subject to the terms
of the Authorization. The Authorizations, which are included below
after section IV. Electronic Access in their entirety (not including
the authorized versions of the fact sheets and other written
materials), provide an explanation of the reasons for issuance, as
required by section 564(h)(1) of the FD&C Act. Any subsequent
reissuances of these Authorizations can be found on FDA's web page:
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

IV. Electronic Access

    An electronic version of this document and the full text of the
Authorizations are available on the internet at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
BILLING CODE 4164-01-P

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    Dated: January 12, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-01022 Filed 1-15-21; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 80, Number 32 (Wednesday, February 18, 2015)]
[Proposed Rules]
[Pages 8571-8575]
[FR Doc No: 2015-02922]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0243; Directorate Identifier 2014-NM-114-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for all

Airbus Model A300 series airplanes; Model A300 B4-600, B4-600R, and F4-
600R series airplanes, and A300 C4-605R Variant F airplanes
(collectively called Model A300-600 series airplanes); and Model A310
series airplanes. This proposed AD was prompted by reports of cracked
aluminum support struts of the trimmable horizontal stabilizer (THS)
caused by stress corrosion. This proposed AD would require inspections
to identify the part number of each support strut, repetitive
inspections for cracking of the THS support strut ends, installation of
reinforcing clamps on strut ends, and replacement of support struts, if
necessary. We are proposing this AD to detect and correct cracked THS
support struts, which could lead to the rupture of all four support
struts making the remaining structure unable to carry limit loads,
which could result in loss of the THS and reduced control of the
airplane.

DATES: We must receive comments on this proposed AD by April 6, 2015.

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 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 W12-140, 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, Airworthiness Office--EAW, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0243; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this 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, WA 98057-3356; telephone<PHONE_NUMBER>;
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-2015-0243;
Directorate Identifier 2014-NM-114-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 Union, has issued EASA
Airworthiness Directive 2014-0164, dated July 11, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Airbus Model A300
series airplanes; Model A300 B4-600, B4-600R, and F4-600R series
airplanes, and A300 C4-605R Variant F airplanes (collectively called
Model A300-600 series airplanes); and Model A310 series airplanes. The
MCAI states:

    During scheduled maintenance, several Trimmable Horizontal
Stabilizer (THS) support struts were found cracked at the strut
ends. The THS is supported and articulated at frame (FR) 91 in the
tail cone. Lateral movement is prevented by four diagonal support
struts.
    Investigations revealed that the cracks were caused by stress
corrosion and propagated from the inside to the outside of the
strut.
    This condition, if not detected and corrected, could lead to the
rupture of all four THS support struts at FR91, which would make the
remaining structure unable to carry limit loads, potentially
resulting in loss of the Horizontal Tail Plane.
    To address this unsafe condition, EASA issued [EASA] AD 2014-
0121 [http://ad.easa.europa.eu/ad/2014-0121] to require repetitive
High Frequency Eddy Current (HFEC) inspections of the THS support
strut ends, installation of reinforcing clamps on strut ends and,
depending on findings, replacement of damaged support struts.
Installation of reinforcing clamps on strut ends is considered a
temporary solution pending introduction of a re-designed support
strut.
    Since that [EASA] AD was issued, it was discovered that the
[EASA] AD appeared to also require HFEC inspections of steel struts,
which are not prone to cracking. The unsafe condition exists only on
support struts made of aluminum, which were introduced through
Airbus modification (mod) 06101, but may also have been installed in
service as replacement parts on aeroplanes in pre-mod 06101
configuration.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2014-0121, which is superseded, and
clarifies the need for an initial identification of the support
struts installed on aeroplanes in pre-mod 06101 configuration. The
related Airbus Service Bulletins (SB) remain unchanged.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0243.

Relevant Service Information Under 1 CFR Part 51

    Airbus has issued the following service information. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI.
     Airbus Service Bulletin A300-53-0394, dated February 14,
2014. This service information describes procedures for reinforcing the
support struts of the THS at frame 91 in the fuselage tail section of
Airbus Model A300 series airplanes.
     Airbus Service Bulletin A300-53-0395, dated February 14,
2014. This service information describes procedures for inspecting for
cracking of the support struts of the THS at frame 91 in the fuselage
tail section of Airbus Model A300 series airplanes.
     Airbus Service Bulletin A300-53-6172, dated February 14,
2014. This service information describes procedures for reinforcing the
support struts of the THS at frame 91 in the fuselage tail section of
Airbus Model A300-600 series airplanes.

     Airbus Service Bulletin A300-53-6174, dated February 14,
2014. This service information describes procedures for inspecting for
cracking of the support struts of the THS at frame 91 in the fuselage
tail section of Airbus Model A300-600 series airplanes.
     Airbus Service Bulletin A310-53-2136, dated February 14,
2014. This service information describes procedures for reinforcing the
support struts of the THS at frame 91 in the fuselage tail section of
Airbus Model A310 series airplanes.
     Airbus Service Bulletin A310-53-2137, dated February 14,
2014. This service information describes procedures for inspecting for
cracking of the support struts of the THS at frame 91 in the fuselage
tail section of Airbus Model A310 series airplanes. This service
information is reasonably available; see ADDRESSES for ways to access
this service information.

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 these
same type designs.

Differences Between This Proposed AD and the MCAI or Service
Information

    Unlike the procedures described in Airbus Service Bulletin A300-53-
0395; Airbus Service Bulletin A300-53-6174; and Airbus Service Bulletin
A310-53-2137; each dated February 14, 2014; this proposed AD would not
permit further flight if cracks are detected in the aluminum support
strut ends of the trimmable horizontal stabilizer at frame 91. We have
determined that, because of the safety implications and consequences
associated with that cracking, any cracked aluminum support strut ends
of the trimmable horizontal stabilizer must be repaired or modified
before further flight. This difference has been coordinated with EASA
and Airbus.

Costs of Compliance

    We estimate that this proposed AD affects 174 airplanes of U.S.
registry.
    We also estimate that it would take about 5 work-hours per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Required parts would cost about $2,100
per product. Based on these figures, we estimate the cost of this
proposed AD on U.S. operators to be $439,350, or $2,525 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 15 work-hours and require parts costing $10,000, for a cost
of $11,275 per product. We have no way of determining the number of
aircraft that might need these actions.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this proposed AD
is 2120-0056. The paperwork cost associated with this proposed AD has
been detailed in the Costs of Compliance section of this document and
includes time for reviewing instructions, as well as completing and
reviewing the collection of information. Therefore, all reporting
associated with this proposed AD is mandatory. Comments concerning the
accuracy of this burden and suggestions for reducing the burden should
be directed to the FAA at 800 Independence Ave. SW., Washington, DC
20591, ATTN: Information Collection Clearance Officer, AES-200.

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);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

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 (AD):

Airbus: Docket No. FAA-2015-0243; Directorate Identifier 2014-NM-
114-AD.

(a) Comments Due Date

    We must receive comments by April 6, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the Airbus airplanes specified in paragraphs
(c)(1) through (c)(6) of this AD, certificated in any category, all
manufacturer serial numbers.
    (1) Airbus Model A300 B2-1A, B2-1C, B2K-3C, B2-203, B4-2C, B4-
103, and B4-203 airplanes.
    (2) Airbus Model A300 B4-601, B4-603, B4-620, and B4-622
airplanes.
    (3) Airbus Model A300 B4-605R and B4-622R airplanes.
    (4) Airbus Model A300 F4-605R and F4-622R airplanes.

    (5) Airbus Model A300 C4-605R Variant F airplanes.
    (6) Airbus Model A310-203, -204, -221, -222, -304, -322, -324,
and -325 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by reports of cracked aluminum support
struts of the trimmable horizontal stabilizer (THS) caused by stress
corrosion. We are issuing this AD to detect and correct cracked THS
support struts, which could lead to the rupture of all four support
struts making the remaining structure unable to carry limit loads,
which could result in loss of the THS and reduced control of the
airplane.

(f) Compliance

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

(g) Inspection for Part Number

    For airplanes in pre-modification 06101 configuration: Within 12
months after the effective date of this AD, do an inspection to
identify the part number (P/N) of each support strut installed on
the trimmable horizontal stabilizer (THS) at frame (FR) 91, in
accordance with the Accomplishment Instructions of the applicable
service bulletin identified in paragraphs (g)(1) through (g)(3) of
this AD. A review of airplane maintenance records is acceptable in
lieu of this inspection, provided those records can be relied upon
for that purpose and the part number can be positively identified
from that review. If no aluminum strut(s) having P/N R21449,
R21449D, R21449G, or R21449H is found during any inspection required
by this paragraph no further action is required by this AD for that
horizontal stabilizer, except for paragraph (l) of this AD.
    (1) For Airbus Model A300 series airplanes: Airbus Service
Bulletin A300-53-0395, dated February 14, 2014.
    (2) For Airbus Model A300 B4-600, B4-600R, and F4-600R series
airplanes, and A300 C4-605R Variant F airplanes (collectively called
Model A300-600 series airplanes): Airbus Service Bulletin A300-53-
6174, dated February 14, 2014.
    (3) For Airbus Model A310 series airplanes: Airbus Service
Bulletin A310-53-2137, dated February 14, 2014.

(h) Repetitive High Frequency Eddy Current (HFEC) Inspections

    For airplanes in post-modification 06101 configuration; and for
airplanes in pre-modification 06101 configuration on which one or
more aluminum support strut(s) having P/N R21449, P/N R21449D, P/N
R21449G, or P/N R21449H was found during the inspection by paragraph
(g) of this AD: Within the applicable compliance times specified in
paragraphs (h)(1), (h)(2), or (h)(3) of this AD, do an HFEC
inspection for cracking of the aluminum THS support strut ends at FR
91, in accordance with the Accomplishment Instructions of the
applicable service bulletin identified in paragraphs (g)(1) through
(g)(3) of this AD. Reinforcing clamps already installed on strut
ends must be removed before accomplishing the HFEC inspection and
re-installed after the inspection, in accordance with the
Accomplishment Instructions of the applicable service bulletin
specified in paragraphs (g)(1) through (g)(3) of this AD. Repeat the
inspection thereafter at intervals not to exceed 24 months.
    (1) For airplanes having manufacturer serial number (MSN) 0499
through MSN 0747 inclusive (post-mod 06101): Within 12 months after
the effective date of this AD.
    (2) For airplanes having MSN 0748 through MSN 0878 inclusive
(post-mod 06101): Within 18 months after the effective date of this
AD.
    (3) For airplanes having MSN 0001 through MSN 0498 inclusive
(pre-mod 06101) having one or more aluminum struts: Within 24 months
after the effective date of this AD.

(i) Installation of Reinforcing Clamps

    Concurrently with the initial HFEC inspection required by
paragraph (h) of this AD, identify struts having P/N R21449, P/N
R21449D, P/N R21449G, or P/N R21449H with no reinforcing clamps
previously installed, and before next flight, install reinforcing
clamps on each strut end, in accordance with the Accomplishment
Instructions of the applicable service bulletin specified in
paragraphs (i)(1) through (i)(3) of this AD.
    (1) For Airbus Model A300 series airplanes: Airbus Service
Bulletin A300-53-0394, dated February 14, 2014.
    (2) For Airbus Model A300 B4-600, B4-600R, and F4-600R series
airplanes, and A300 C4-605R Variant F airplanes (collectively called
Model A300-600 series airplanes): Airbus Service Bulletin A300-53-
6172, dated February 14, 2014.
    (3) For Airbus Model A310 series airplanes: Airbus Service
Bulletin A310-53-2136, dated February 14, 2014.

(j) Corrective Actions

    If, during any inspection required by paragraph (h) of this AD,
any cracking is found, before further flight, replace the affected
THS support strut(s) with serviceable struts and install clamps on
each strut end, in accordance with the Accomplishment Instructions
of the applicable service bulletin identified in paragraphs (g)(1)
through (g)(3) of this AD.

(k) Clarification

    Installation of reinforcing clamps as required by paragraph (i)
of this AD, and the replacement of support struts and/or the
installation of clamps as required by paragraph (j) of this AD, do
not constitute terminating action for the repetitive inspections
required by paragraph (h) of this AD.

(l) Reporting

    At the applicable time specified in paragraphs (l)(1) and (l)(2)
of this AD: After accomplishment of any inspection required by
paragraphs (g) and (h) of this AD, report all inspection results to
Airbus, including no findings, in accordance with the Accomplishment
Instructions of the applicable service bulletins specified in
paragraphs (g)(1) through (g)(3) of this AD, and paragraphs (i)(1)
through (i)(3) of this AD.
    (1) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after the inspection.
    (2) If the inspection was done before the effective date of this
AD: Submit the report within 30 days after the effective date of
this AD.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, 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 International Branch, send it to ATTN: Dan Rodina,
Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Airbus's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.
    (3) Reporting Requirements: A federal agency may not conduct or
sponsor, and a person is not required to respond to, nor shall a
person be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a current valid OMB Control Number. The OMB Control Number
for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 5
minutes per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.
SW., Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) European

Aviation Safety Agency Airworthiness Directive 2014-0164, dated July
11, 2014, for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2015-0243.
    (2) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAW, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com. You may view this service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on February 2, 2015.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-02922 Filed 2-17-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 45 (Wednesday, March 7, 2012)]
[Notices]
[Page 13683]
[FR Doc No: 2012-5523]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Aviation Proceedings, Agreements Filed the Week Ending February
18, 2012

    The following Agreements were filed with the Department of
Transportation under the Sections 412 and 414 of the Federal Aviation
Act, as amended (49 U.S.C. 1382 and 1384) and procedures governing
proceedings to enforce these provisions. Answers may be filed within 21
days after the filing of the application.
    Docket Number: DOT-OST-2012-0024.
    Date Filed: February 16, 2012.
    Parties: Members of the International Air Transport Association.
    Subject: PTC COMP Mail Vote 701--Resolution 011a Mileage Manual,
Non TC Member/Non IATA Carrier Sectors, Intended Effective Date 15
March 2012, for Implementation 1 April 2012 (Memo 1663).

Renee V. Wright,
Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. 2012-5523 Filed 3-6-12; 8:45 am]
BILLING CODE 4910-9X-P


[Federal Register Volume 82, Number 112 (Tuesday, June 13, 2017)]
[Notices]
[Page 27059]
[FR Doc No: 2017-12228]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2100-180]

California Department of Water Resources; Notice of Application
To Amend License and Accepted for Filing, Soliciting Comments, Motions
To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission in Project No. 2100-000 and is available for
public inspection:
    a. Application Type: Non-Capacity Amendment of License.
    b. Project No: 2100-180.
    c. Date Filed: May 17, 2017.
    d. Applicant: California Department of Water Resources (DWR).
    e. Name of Project: Feather River Hydroelectric Project.
    f. Location: On the Feather River in Butte County, California.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a--825r.
    h. Applicant Contact: Gail Kuenster, 1416 Ninth Street, P.O. Box
942836, Sacramento, CA 94236-000,<PHONE_NUMBER>;
<EMAIL_ADDRESS>    i. FERC Contact: John Aedo,<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: 15 days from the issuance date of this notice by the
Commission. The Commission strongly encourages electronic filing.
Please file comments, motions to intervene, and protests using the
Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-2100-180. Comments emailed to Commission staff are not
considered part of the Commission record.
    k. Description of Request: Flood events in February 2017 caused
extensive erosion to the service and emergency spillways at the
Oroville Dam, part of the Feather River Hydroelectric Project. The area
has been declared a federal major disaster. To protect public safety,
DWR must restore project function before the wet season returns in late
2017. The erosion at the spillways compromised two towers supporting
primary transmission lines. As part of DWR's broad emergency response
and recovery efforts, DWR proposes to permanently relocate
approximately two miles of the 230-kV transmission lines onto lands
across the Feather River from the damaged spillways outside the current
project boundary. The relocation would avoid future damage to the
transmission lines, facilitate reconstruction of the spillways, and
restore a reliable route for electricity to and from the dam's power
plant. Given the urgent need to complete the recovery effort,
Commission staff have accepted the May 17 filing as an application for
a non-capacity amendment of the project license. On June 1, 2017,
Commission staff issued a letter to DWR requesting additional
information.
    l. Locations of the Application: This filing may be viewed on the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number P-2100 in the docket number field to access the
document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and
issuances related to this or other pending projects. For assistance,
call 1-866-208-3676 or email<EMAIL_ADDRESS>for TTY, call
(202) 502-8659. A copy is also available for inspection and
reproduction at the Commission's Public Reference Room, located at 888
First Street NE., Room 2A, Washington, DC 20426, or by calling (202)
502-8371.
    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, respectively. 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 Documents: Any filing must (1) bear in all
capital letters the title COMMENTS, PROTEST, or MOTION TO INTERVENE as
applicable; (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, motions
to intervene, or protests must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). All comments,
motions to intervene, or protests should relate to project works which
are the subject of the license amendment. Agencies may obtain copies of
the application directly from the applicant. A copy of any protest or
motion to intervene must be served upon each representative of the
applicant named in the May 17 filing. If an intervener 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.

    Dated: June 7, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-12228 Filed 6-12-17; 8:45 am]
 BILLING CODE 6717-01-P