PESTICIDE REGISTRATION (PR) DRAFT PESTICIDE REGISTRATION (PR) NOTICE 2016-X
                                  (May 2016)

Draft Document for Public Review  -  The Environmental Protection Agency (EPA) is releasing this draft document solely for the purpose of public review and comment.  This draft document is not now, and has not yet been, formally disseminated by EPA.  This document is not being used for current Agency determinations. Please submit comments to Docket ID # EPA-HQ-OPP-2015-0814 at www.regulations.gov.
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS, AND REGISTRANTS OF PESTICIDE PRODUCTS
NOTICE TO:	Manufacturers, Producers, Formulators, and Registrants of Pesticide Products and Devices; U.S. and State Departments of Agriculture; Commodity and Grower Groups, Growers
ATTENTION:	Persons Responsible for Initial and Continuing Registration of Pesticide Products
SUBJECT:      Determination of Minor Use under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(ll)
Purpose and applicability
This PR Notice is to clarify and revise the EPA's interpretation of "minor use" under FIFRA section 2(ll) as it applies to the registration of pesticides.  Section 2(ll)(1) of FIFRA defines a minor use of a pesticide as a use on a crop grown on 300,000 acres or less in the United States.  Section 2(ll)(2) of FIFRA defines a minor use of a pesticide as one that lacks sufficient economic incentive to seek or maintain a registration in addition to meeting one of four other criteria regarding the value of the use.  To date, EPA's interpretation of an economic minor use in section 2(ll)(2) has been shaped by guidance provided in PR Notice 97-2 (PRN 97-2).  Given the importance of minor use status to be eligible for many types of registration incentives, EPA is clarifying and updating its interpretation of how economic minor use status under FIFRA section 2(ll)(2) can be determined.  The revised policy will ultimately benefit growers and other pesticide users by providing more safe and effective tools to control pest problems.
This PRN describes the revised approach to interpreting economic minor use based on the concept of the registration of a pesticide as an investment.  The registrant incurs costs associated with applying for a registration while the registration once granted allows the pesticide product to be sold, generating a stream of revenue in the future.  This approach provides several measures by which EPA can assess whether there are sufficient incentives for the registration of a pesticide use.  These measures include the net present value of returns, the benefit-cost ratio, and the internal rate of return, each of which provides insight into the magnitude of the incentive to register or maintain the registration of a pesticide.  In developing the methodology, EPA consulted with the Office of Pest Management Policy and the Office of the Chief Economist of the U.S. Department of Agriculture (USDA).
This PR Notice revises the method and criteria used by EPA for evaluating "sufficient economic incentive" under FIFRA section 2(ll)(2).  It also clarifies that minor use under FIFRA section 2(ll)(1) is based on acreage reported in the USDA Census of Agriculture.  This PRN supersedes Section 5 of PRN 97-2 with respect to minor uses.
Designation as a minor use is intended to identify situations where registrants of potentially useful pesticide products may not apply for registration because the potential returns are low.  Based on discussions with stakeholders (see Section III.C, below) concerning the approach defined in PRN 97-2, EPA applied the methodology to two recent requests for minor use designation in order to qualify for exclusive use over data submitted to support a new registration after the original exclusive use period expired.  These two analyses, "Minor Use Determination of Fluridone on Cotton under FIFRA 2(ll)(2)" and "Minor Use Determination of Deltamethrin as a Mosquito Adulticide under FIFRA 2(ll)(2)" are available in this docket.  Based on these examples, the Agency concluded that evaluating whether a registrant has insufficient economic incentive using the standard in PRN 97-2 does not consider all relevant factors which affect the incentives of a registrant to apply to register a minor use.  If the current practice is not revised, use of that outdated approach could prevent applicants from obtaining the incentives for registration that should be available to them.  In turn, this could limit the availability of pesticides to control certain pests, because the uses do not create sufficient financial incentive for applicants to seek and then maintain registration.  Therefore, EPA believes it is important to revise the method used to determine when a potential minor use does not present a sufficient economic incentive for the registrant to pursue.
The revised method applies to agricultural uses for crops grown on more than 300,000 acres.  Such uses may be related to livestock protection, and non-agricultural uses of pesticides such as commercial and residential pest control, public health, and other uses where an estimate of acres grown is not appropriate.  Further, the approach can be applied to biopesticides and antimicrobials, whereas the criteria in PRN 97-2 only applied to conventional pesticides.
Effective Date
Effective immediately upon issuance of final policy.
BACKGROUND
Section 31 of FIFRA requires EPA to "assure coordination of minor use issues through the establishment of a minor use program within the Office of Pesticide Programs (OPP)."  OPP is responsible for "coordinating the development of minor use programs and policies..."  The Food Quality Protection Act (FQPA) of 1996 amended FIFRA and added the definition of a minor use.  The amended FIFRA section 2(ll) now defines a "minor use" as "the use of a pesticide on an animal, on a commercial agricultural crop or site, or for the protection of public health where:
      the total United States acreage for the crop is less than 300,000 acres... or
      ...the use does not provide sufficient economic incentive to support the initial registration or continuing registration of a pesticide for such use and -
     (A) there are insufficient efficacious alternative registered pesticides available for the use;
     (B) the alternatives to the pesticide use pose greater risks to the environment or human health;
     (C) the minor use pesticide plays or will play a significant part in managing pest resistance; or;
     (D) the minor use pesticide plays or will play a significant part in an integrated pest management program."
A "minor use" is defined under FIFRA section 2(ll) as meeting either of two criteria.  The first definition under FIFRA section 2(ll)(1) specifies a numeric threshold of 300,000 acres or less in the United States.  The second definition under FIFRA section 2(ll)(2) requires a finding of insufficient economic incentive to support a registration.  PRN 97-2 provided guidance for a use to be designated as an economic minor use under FIFRA section 2(ll)(2).  The standard defined in PRN 97-2 is that a use was minor under FIFRA 2(ll)(2) if gross revenues at full market potential did not cover the costs of registration.  Section B explains why this revision of that guidance better reflects economic incentives and applies to a wider variety of pesticide use sites.
Applications of Minor Use Status in Registration of Pesticides
FIFRA provides certain incentives for the registration of products that are important to growers (e.g., products which aid with resistance management, etc.) or to the environment (e.g., products which have lower risk to human health or the environment) but which may have low expected returns for the registrant.  Such uses may be important to growers but without the economic incentive to seek or maintain registrations an applicant may not apply for these uses.

The most common reason registrants request EPA to determine a pesticide use to be minor is to receive increased data protection rights:

       Extension of exclusive use of data [FIFRA section 3(c)(1)(F)(ii)]  -  For each 3 minor use registrations of a pesticide (within a specified time period), a registrant can receive one additional year of exclusive use data rights.  The registrant can gain up to 3 additional years of exclusive use by registering 9 minor uses.  To be eligible, each minor use must meet one of 4 biological criteria:
     (I) there are insufficient efficacious alternative registered pesticides available for the use;
     (II) the alternatives to the pesticide use pose greater risks to the environment or human health;
     (III) the minor use pesticide plays or will play a significant part in managing pest resistance; or;
(IV) the minor use pesticide plays or will play a significant part in an integrated pest management program.
These criteria are the same as those specified in FIFRA section 2(ll) (A-D).
 Exclusive use of data to add a minor use to an existing registration after the initial exclusive use period has expired [FIFRA section 3(c)(1)(F)(vi)]  -  A registrant can request (at the time of application for the minor use) exclusive use protection of data submitted solely for the registration of a new minor use after the initial data exclusivity period has expired.

In general, exclusive use protection of data limits competition for a period of time, providing the registrant more assurance of future revenue to recoup the costs of registering the use, and thereby encouraging applicants to apply for these types of minor uses.
Rationale for Revising Pesticide Registration Notice 97-2
The current guidance for defining minor use, PRN 97-2, listed crops exceeding the 300,000 acre threshold and specified that an applicant could demonstrate a lack of economic incentive for a registration by showing that the costs of data generation exceed gross revenue from sales at full market potential for that use.  (Appendix A contains the full text of the section of PRN 97-2.)  For the following three reasons, EPA has decided to revise the policy on determining minor use.
First, PRN 97-2 is outdated regarding the crops that would meet the definition of a minor use under FIFRA section 2(ll)(1).  Cropping patterns change over time and the list of crops grown on more than 300,000 acres provide in PRN 97-2 is no longer accurate.
Second, the method in PRN 97-2 does not accurately measure economic incentive to register pesticides.  Gross revenue will overstate the registrant's true return on the cost of registration while reliance on a single year of sales will understate the total stream of revenues.  The direction of bias is unknown.  Most importantly, it does not account for the difference in timing between costs of registration and future returns.  In 2012, OPP conducted an analysis, "Minor Use Determination of Fluridone on Cotton under FIFRA 2(ll)(2)," available in this docket comparing several methods for evaluating economic minor use in consultation with USDA.  With respect to the method in PRN 97-2, the analysis showed that gross revenues at full market potential greatly exceeded registration costs for a particular use.  However, the net present value (NPV) measures of returns to investment, considering reasonable estimates of net revenue over a five to ten year time horizon, indicated that registration of the use was only marginally profitable.  The pesticide in this case represented specifically the type of registration that FIFRA section 2(ll)(2) was designed to encourage: a registration for a biologically important use (in this case, a pest which had developed resistance to all other alternatives) that did not provide sufficient return for an applicant to incur the registration costs.  A second example, "Minor Use Determination of Deltamethrin as a Mosquito Adulticide under FIFRA 2(ll)(2)," also available in this docket, applies to a pesticide use that cannot be measured in acres of a crop.
Third, PRN 97-2 applies only to registration actions on conventional pesticides.  The notice specifically states that it does not apply to registrations of biopesticides and antimicrobials (e.g., disinfectants).  The method described in this PRN may be used to evaluate the registration incentive for all types of products registered by each of OPP's registering divisions.
Stakeholder Input
During the development of this PR Notice, EPA discussed the new approach with stakeholders, including registrants and USDA, which helped to inform its decision to employ the net present value method for determining economic minor use.  EPA first consulted with USDA about the draft method in February 2012.  In May 2012, EPA presented a draft method at a meeting of the Pesticide Program Dialogue Committee (PPDC) (http://www.epa.gov/pesticide-advisory-committees-and-regulatory-partners/pesticide-program-dialogue-committee-materials).  In June 2012, EPA met with registrants to learn more about factors that affect registration decisions.
More recently, EPA presented a draft of the PR Notice to USDA's Office of Pest Management Policy (OPMP) for review and presented the method to members of the PRIA Coalition at the PRIA 3 Quarterly Stakeholder meeting in March 2014.  Discussion with private sector stakeholders and USDA provided important insight into how registration decisions are made by pesticide producers, and indicated that the proposed EPA approach is appropriate.
GUIDANCE
Minor Use under FIFRA 2(ll)(1)
For minor uses defined under FIFRA section 2(ll)(1), EPA will rely on the most recent Census of Agriculture, conducted every five years by the USDA's National Agricultural Statistics Service (NASS), to determine if the crop is cultivated on less than 300,000 acres.  This supersedes the list of agricultural crops grown on more than 300,000 acres in PR Notice 97-2, which is no longer accurate.
Upon consultation with the USDA, EPA agreed that the Census of Agriculture is the best source of information to determine the acreage of crops grown in the U.S.  USDA and EPA also considered the annual Crop Production Summary reports but determined that the Census provided more complete data.  The Crop Production publications rely on a sampling of states.  Although the states sampled typically comprise at least 90 percent of the production area, it will undercount the number of acres in most crops.  USDA and EPA also considered whether to average reported acreage, whether across multiple Census or multiple Crop Production reports, as reliance on a single year (observation) can be problematic.  However, USDA and EPA agreed that reliance on the most recent Census provides an accurate accounting of crop acreage and the most simple and transparent source of information.
The Census is publicly available at http://www.agcensus.usda.gov/.

Minor Use under FIFRA 2(ll)(2)
Economic Theory and Methodology
Under FIFRA section 2(ll)(2), a minor use is defined as one that "does not provide sufficient economic incentive to support the . . . registration."  EPA interprets this to mean that the registrant would not obtain sufficient revenues from sales of the pesticide to justify the cost of registration.  Registration costs are incurred before a pesticide may be marketed while revenues accrue over a period of time.  This makes the registration decision similar to an investment decision in which there are initial costs followed by periodic payments.  Like many investments, the magnitude of future payments is subject to uncertainty.
To account for the difference in the timing of costs and revenue, economists typically calculate the net present value (NPV) in which investment costs are subtracted from the sum of discounted future revenue.  Discounting is appropriate because people (and firms) value money now more than the same amount of money at some future time.
The NPV of the investment (in registration) is calculated as:
NPV= t=1TNetRevt1+rt- C0
where,
   Net Revt 	=   	Net revenue (revenue from sales minus cost of production) at time t
   C0 	=   	Initial cash investment (registration costs)
    r 	=   	Discount rate
    t 	=   	Time of the cash flow (e.g., one year)
   T 	=   	Time at the end of analysis

This approach lends itself to several measures and potential ways of determining whether registration of a pesticide product provides sufficient returns including the calculated NPV, the benefit-cost ratio, and the internal rate of return (IRR).  All of the measures can be useful to characterize the value of the investment.  The NPV provides an estimate of the absolute magnitude of value.  The benefit-cost ratio, which can be calculated as BC=NPVC0+1, provides some context to the absolute value by comparing it to the magnitude of investment and can be helpful to determine how uncertainty in the future revenue stream influences the likelihood of an overall positive outcome.  Both of these measures require a predetermined discount rate (r), which can strongly influence the result; the higher the discount rate, the lower the NPV or benefit-cost ratio.  The IRR, in contrast, measures the return on the investment as an annual average percentage growth; it is calculated as the discount rate that results in NPV = 0.  This measure can be useful to compare the value of the registration investment to other potential investment opportunities based on the rate of return over time.
The cost of applying for registration can be viewed as an investment toward the eventual marketing of a registered product.  Applying for registration is the final step in the process of developing and marketing a pesticide.  The costs of applying for registration include the costs of generating data that EPA requires for registration, the registration fees, and the cost of paperwork burden from the registration process.  In terms of "economic incentive," the main question to answer is whether the investment in registration of a particular use is worthwhile to the registrant, that is, whether future returns from sales are sufficiently high to justify the cost of obtaining/maintaining a registration.
To estimate the NPV and the benefit-cost ratio, EPA is proposing to use a discount rate of seven percent.  This is the rate suggested in the EPA guidelines for economic analysis, based on OMB's estimates.  It reflects the rate of return or opportunity cost of private capital, which is the relevant measure for private sector investment, in contrast to a three percent discount used to represent the social cost of resources.
Application and Data Needs
This section describes how to conduct a quantitative analysis to estimate NPV, B/C, and IRR and is organized around four primary components:  the cost of registration (C0), the net revenues from sales of the pesticide (Net Revt), the discount rate (r), and the time horizon (T).  More detailed instructions for how an applicant should request the economic minor use designation and what information to submit are provided in Section V of this notice.
In general, EPA is balancing the need for a rigorous and informative analysis with one that is simple and transparent.  Simplicity is desirable because these uses, at least purportedly, offer low incentives to registrants; a burdensome process to demonstrate the fact would simply be an added deterrent to registration.  Transparency is needed so that stakeholders can review all decisions and help to ensure regulatory consistency.  To this end, the analysis will rely on several simplifying assumptions and set parameters, about which EPA seeks comments.  The analysis will depend largely on publicly available data and, as necessary, third-party proprietary data such as reputable market surveys.
EPA will consider qualitative information, described below, to select appropriate parameters of the analysis.  In addition, EPA will consider other, qualitative factors that the registrant considers relevant on a case-by-case basis to make a final determination as to whether the use meets the definition of minor use under FIFRA section 2(ll)(2).
Data needs for an NPV analysis include at least the following:
 costs of data generated for registration
 registration fees (i.e., PRIA fees)
 anticipated revenues from the proposed use (e.g., expected acres or sites treated, application rate, price per unit, etc.)

Examples of additional qualitative data which may be useful to the analysis are:
 information about the likelihood of pest resistance developing
 information about the life of the investment (e.g., basis for expecting fast resistance development, new competing technologies, etc.)
 firm-specific information with documentation about the targeted IRR for investments

The quantitative analysis will be based on publicly available data and/or third-party proprietary data available to EPA, but EPA will rely on applicants to submit sufficient information about the use for the Agency to conduct an appropriate analysis and make a final determination.  This section outlines how these data will be applied to the net present value analysis.
Cost of Registration (C0)
For this analysis, the initial cash investment (C0) is the cost of registration which includes: 1) the cost of generating data necessary to show the product can be used safely for the proposed use, 2) the fee for applying for registration (i.e., PRIA fees), and 3) the costs to prepare and submit the application.
The data required for registration are listed in the Code of Federal Regulations (40 CFR Part 158) and requirements may be refined (and additional data may be required) in consultation with EPA during the registration process.  Only those incremental data required to support the purported minor use should be included in the analysis. Thus, the context of registration of the purported minor use should be defined since some data, such as basic toxicity data, may support multiple uses.  If the use in question is one of many, such basic data should not be claimed to be part of the cost of registering an additional use.  EPA maintains a database of test costs for most studies listed in the CFR.  The test costs are obtained by EPA from independent laboratories and the averages of the costs are publicly available and should be used for the purpose of estimating the cost of generating the data required for registering the purported minor use.  The use of this cost information will ensure consistency and transparency.
PRIA fees are determined by the type of action (e.g., registration of a new, conventional active ingredient (a.i.) on a terrestrial food crop).  A full list of PRIA fees is available at http://www.epa.gov/opp00001/fees/.
Finally, the cost of preparing and submitting the application is estimated in the Information Collection Request (New or Amended Registration, EPA ICR Number 0277.16.  If the registration is associated with other actions, only a portion of the preparation and submission costs should be included.
The costs for research into chemical compounds and development of particular pesticides (R&D) are not included in this analysis for both theoretical and practical reasons.  Such costs are difficult to document accurately and there is no practical way to allocate R&D costs to a particular pesticide.  Further, the minor use definition is not chemical-specific, but refers to the use(s) of a registered active ingredient.  Finally, R&D expenses are `sunk' costs, i.e., costs already incurred, and, theoretically and empirically, costs incurred in the past are not relevant to today's decisions.
Net Revenues (Net Revt)
The returns to an investment in a pesticide registration are the net revenues from sales of the pesticide for the registered use.  Annual net revenues will be total sales (the unit price of the chemical times units sold) less the costs of producing and distributing the pesticide each year, which may include variable and fixed costs.
NetRevt=Pt∙qt-cqt-γt
Where NetRevt is net revenue in time t, Pt is the price of the pesticide per unit, qt is the quantity sold, c(qt) is the cost of manufacturing and distributing the pesticide and depends on the quantity sold, and γt are other costs that do not depend on the amount sold such as the registration maintenance fee, legal fees, and advertising costs.
Considering net revenue differs from the current approach, which only considers gross revenue.  Estimating net revenue over time is more appropriate, because it better reflects the returns to the registrant, but does add to the complexity and uncertainty of the analysis since these costs may not be observable.  EPA is proposing to use several simplifying assumptions to develop quantitative estimates and to use qualitative factors to interpret the results.
Gross revenue, or total sales, is calculated as Pt times qt.  Quantity (qt) could be estimated differently depending on the type of use.  In the case of agricultural pesticides, total sales could be estimated as the cost per acre for a treatment (cost per pound times the application rate in lbs per acre) multiplied by the acres treated.  Both application rate and acres treated are likely to depend on the pest being targeted.  Suggested application rates are typically provided on pesticide labels and would be public knowledge.  Market survey data may be available to registrants and EPA to make and verify estimates of acres treated.  For non-agricultural pesticides, estimates of sales might use another unit of measurement such as volume or row-foot, depending on the standard application rate.  For example, there might be an important use of a pesticide for postharvest pest control (e.g., control of pests in flour mills) that cannot be designated as a minor use through the acreage definition.  However, information on volume treated or even the number of mills treated per year could be used to estimate sales.  In the analyses conducted by EPA, the Agency estimated future sales of a pesticide using estimates of the acreage infested by its target pest and the suggested application rate and data on existing sales of ground-applied insecticides for mosquito control.  To estimate quantity, EPA will expect the applicant to identify the target pest(s), appropriate application rate(s), and a description of the extent of the pest problem (e.g., its range and/or life stage) to provide some basis for estimating use or projected use of the pesticide.
The price of a pesticide (Pt) or cost per acre may be readily and publicly available, especially in cases where the pesticide is currently on the market, which would typically be the case for registrants seeking either extension of exclusive use over data or a new exclusive use period.  Applicants may need to provide EPA with pricing data, such as web-based distributor price lists, to establish the typical or average sale price.  Pricing information for a new use (i.e., new exclusive use period) may have confidentiality claims, but when this applies to pesticides already on the market, current sales price would be appropriate.  For a new active ingredient, applicants could provide a proposed sale price of the product or identify alternative products used to control the target pest with which they will compete in order to establish a range for a reasonable sales price.
The costs of pesticide manufacturing and distribution, c(qt) + γ, are also likely to be subject to confidentiality claims.  Moreover, costs may be difficult for applicants or registrants to estimate and would be nearly impossible for EPA to verify.  Rather than ask applicants and registrants to submit data on production costs, EPA is proposing that all cases be evaluated using values for costs that range from 60 to 85 percent of gross revenue.  Qualitative information can be used to characterize which end of the range is likely.  For example, if the potential minor use accounts for a large proportion of total sales of an active ingredient relative to existing uses, the marginal cost of production is likely to be the higher percentage of revenue (85 percent) because it represents a larger movement along the marginal cost (supply) curve.  Qualitative considerations include aspects that increase the unit production cost, c(qt), such as particularly costly raw materials, or that affect fixed costs, γ, for example, the development of a new distribution channel associated with the potential minor use.
EPA welcomes comments and suggestions on the appropriate parameters to use as well as other factors that can be considered qualitatively.
Discount Rate and Time of Investment
The discount rate used in the analysis will affect the net present value of the investment; a higher discount rate will yield a lower present value of future cash flows.  EPA's Guidelines for Preparing Economic Analyses recommend using seven percent to represent the opportunity cost of private capital.  For simplicity and consistency, EPA suggests that seven percent be used for the calculation of NPV and the B/C ratio.
Theoretically, the time frame of the investment, T, is the life of the pesticide.  The useful life could be short, if for example, the target pests develop resistance or competing products are registered.  In general, data protection lasts about 10 years.  Moreover, the longer the time frame, the greater the uncertainty over important values such as future sales.  EPA suggests conducting the analysis using time horizons of five and 10 years.  As with the costs of production and marketing, qualitative information can be provided to show that an emphasis be placed on one end of the range when results are interpreted.
EMU Determination
Typically, a positive NPV indicates that an investment is worthwhile because it means that the present value (i.e., the discounted value) of future revenue is greater than the cost of registration.  The benefit-cost ratio is a similar measure which shows the benefits as a proportion of the costs, where NPV shows only the amount of total net present value.  If the benefit-cost ratio is greater than one, an investment is considered worthwhile.  Calculating the internal rate of return (IRR) gives the discount rate that will make the present value of future cash flows exactly equal to the initial cash investment (NPV = 0 and B/C = 1).  The IRR for a particular use can be compared to IRRs of other registered uses to provide another measure of the incentive to register a chemical for a particular use.
In general, if a use of a pesticide has a negative NPV, a B/C ratio < 1, and IRR that is lower than average for a particular sector, it will be considered to have insufficient economic incentive to pursue registration.  EPA is not setting a firm threshold, however, since registrants have competing uses for capital, and other market uncertainty may require a potential investment in registration to reach a higher threshold.  EPA currently has limited examples from which to set thresholds and would appreciate any feedback from stakeholders regarding the establishment of thresholds.  At this time, EPA plans to consider all three measures, using a range of plausible assumptions based on the qualitative factors identified in this section (e.g., additional investments costs, factors influencing costs of production and distribution) to make a determination of `minor use' on a case-by-case basis.  Typically, a positive but small NPV and a B/C slightly > 1 could still be considered evidence that there is insufficient economic incentive to pursue or maintain a registration.
Biological Criteria
In addition to lacking sufficient economic incentive, a pesticide use must meet one of the four criteria at FIFRA section 2(ll)(2)(A-D) to be considered an economic minor use:
  (A) there are insufficient efficacious alternative registered pesticides available for the use;
  (B) the alternatives to the pesticide use pose greater risks to the environment or human health;
  (C) the minor use pesticide plays or will play a significant part in managing pest resistance; or
  (D) the minor use pesticide plays or will play a significant part in an integrated pest management program.
While the evaluation of whether there is sufficient economic incentive to register a minor use is a relatively new initiative, EPA has a history of evaluating the value of the pesticide to the user, society, and the environment.  The same criteria are evaluated to determine if the minor uses for which the pesticide is registered help to qualify the registrant for an extension of the period of exclusive use over the data (See FIFRA section 3(c)(1)(F)(ii)).  To determine whether a use meets one the three agronomic criteria (criteria A, C, or D), OPP reviews information submitted by the registrant (e.g., comparative efficacy, role in resistance management, or integrated pest management).  The information is verified by consulting crop profiles and pest management strategic plans (often developed by USDA or university extensions), if available.  OPP also consults technical literature in scientific, peer-reviewed publications, extension service literature from land-grant universities, and publications by various USDA offices including Agricultural Research Service (ARS) and USDA Animal Plant Health and Inspection Service (APHIS).  Criterion B is evaluated in similar manner to evaluating whether a pesticide qualifies for `reduced risk' status.
IMPLEMENTATION
Process
The process as to when an applicant should submit a request for minor use designation will depend on why the designation is being sought.  For example, if an applicant seeks to extend the period of exclusive use over data under FIFRA section 3(c)(1)(F)(ii), it must list the sites that meet the criteria, including the criterion that the site be a minor use.  For crops that meet the acreage definition of minor use, the applicant should cite the most recent Census of Agriculture.  If the applicant wishes to claim an `economic' minor use for one of the listed sites, it should also include the information to substantiate that claim.
Information to be Submitted
For a use that the applicant requests a designation of minor use under the acreage definition under FIFRA section 2(ll)(1), the applicant should cite the most recent Census of Agriculture to support their claim of minor use.
For a use that the applicant requests a designation of economic minor use under FIFRA section 2(ll)(2), the applicant should include the following types of information in writing with the application.
 The type of registration action for the specific site/use.
 A list of the registration data requirements for the specific site/use.
 Information to inform future sales, which might include the target pest(s), the application rate, the extent of the pest problem.
 Information to inform the sales price of the pesticide, which might include the price of relevant competitors.
 A narrative addressing at least one of the criteria described in FIFRA section, 2(ll)(2)(A-D).  This summary should contain, at least, a brief description of how the pesticide will be used including the target pest(s) and alternatives.

Applicants may also wish to include the following to improve EPA's understanding of the incentives they face in producing and/or registering a pesticide for the specific use,
      A narrative describing any relevant factors that influence the cost of manufacturing and, therefore, the net revenue from product sales.
      A narrative describing any relevant factors that influence the fixed costs of registering and marketing the pesticide.
      A narrative describing any aspects of the market that might limit or enhance sales.
      A narrative describing any other factors which affect the economic incentive to register this use.

Expected Impact of the Revised Method
EPA expects that revising the method and criteria for determining sufficient economic incentive will have a positive net impact on pesticide registrants, users, as well as providing better pest control options.  In some cases, there may be a small burden to the applicant to provide additional information to the agency about the reasons that the proposed use lacks economic incentive or how it meets one of the biological criteria, but this burden is expected to be small since the information needed to conduct an analysis is readily available to the applicant.  EPA plans to rely on simplifying assumptions for certain parameters (e.g., projected revenues, production costs) in order to reduce the burden, maintain transparency, and provide a better method for determining economic sufficiency.
It is important to note that seeking minor use designation is not required as part of the registration process.  It is an optional designation that will be sought as a matter of obtaining certain incentives associated with minor uses.  EPA is issuing this PR Notice to clarify and revise the process for achieving such a designation in an effort to make the program incentives that are available for minor uses (e.g., exclusive use of data) more accessible to applicants.  The intent of this clarification and revision is to inform potential applicants of our new guidance that may result in more important, niche uses of pesticides being requested or maintained.  The revised policy will ultimately benefit growers and other pesticide users by providing more safe and effective tools to control pest problems.
The revised method for determining sufficient economic incentive in no way affects EPA's assessments of risks.  Regardless of whether a use is considered minor or not, the FIFRA registration requirements must be met before a pesticide can be registered and these requirements are not being changed by this guidance.
SCOPE
This PR Notice provides guidance and clarification to pesticide applicants.  While the requirements in FIFRA and agency regulations are binding on EPA and applicants, this Notice is not binding on EPA personnel, pesticide registrants and applicants, or the public.  EPA may depart from the guidance where circumstances warrant and without prior notice.  Likewise, pesticide applicants may assert that the guidance is not appropriate generally or not applicable to a specific pesticide or decision.  Registrants and applicants may propose alternatives to the guidance provided in any application to the Agency.
PAPERWORK REDUCTION ACT NOTICE
Under the PRA, "burden" means the total time, effort or financial resources expended by persons to generate, maintain, retain or disclose or provide information to or for a Federal agency.  The information in this Notice is generally a revision and clarification of information already listed in PR Notice 97-2 and is not expected to impose any additional data generation or record-keeping on the part of the registrant.  The registrant may incur additional burden from the following activities associated with this PR Notice: 1) reading and understanding this PR Notice, and 2) additional time to clarify the nature of the use and why it does not provide sufficient incentive to register.  Reading and understanding this PR Notice is not expected to be a recurring burden for applicants.  The additional time that may be needed in some cases to describe the basis for sufficient economic incentive is expected to occur as part of the section 3 registration process.  As stated above, the intent of this PR Notice is to reduce existing burden on applicants to make incentives in FIFRA for registering minor uses more accessible.
The information collection activities associated with the activities described in this PR Notice are already approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq.  The corresponding Information Collection Request (ICR) document for the Application for New and Amended Pesticide Registration has been assigned EPA ICR Number 0277.16 and is approved OMB control number 2070-0060.  The annual average reporting and recordkeeping burdens for a registration applicant respondent are estimated to range from 14 hours to 840 hours, depending upon the type of activity.  Estimates for the annual applicant respondent burden for collection of information average 194 hours per application for "Type A" activities, which include new active ingredients and new uses and 14 hours per application for "Type B" activities, which include amendments and notifications.  The burdens estimate for "Type C" reduced risk products, which are handled only by the Registration Division, is an average of 646 hours per product.  However, reduced risk products require both "Type A" and "Type C" for a total of 840 hours for both applications.
A copy of the most recent version of EPA ICR # 2070-0060 is available under Docket ID No. EPA-HQ-OPP-2011-0886 which may be accessed at www.regulations.gov.
FOR FURTHER INFORMATION
If you have questions or need further information about this notice, please contact Derek Berwald<EMAIL_ADDRESS>703-308-8115.

Authority: 7 U.S.C. 136 et seq.

Dated: ___________________

_____________________________________

Director, Office of Pesticide Programs.
 Appendix A  -  Minor Use Definition from PR Notice 97-2
Pesticide Registration (PR) Notice 97-2 (Dated April 18, 1997)

SUBJECT: New Chemical, New Use, EUP, Non-Fast Track Amendments and Inert Ingredient Registration Priorities for Conventional Pesticides

VII. MINOR USE DEFINITION
For the purpose of addressing the Food Quality Protection Act in this PR notice, the legislation defines "minor use" to mean the use of a pesticide on an animal, on a commercial agricultural crop or site, or for the protection of public health where--
(1) the total United States acreage for the crop is less than 300,000 acres, as determined by the Secretary of Agriculture; or
(2) the use does not provide sufficient economic incentive to support the initial registration or continuing registration of a pesticide for such use and --
   (A) there are insufficient efficacious alternative registered pesticides available for the use; or
   (B) the alternatives to the pesticide use pose greater risks to the environment or human health; or
   (C) the minor use pesticide plays or will play a significant part in managing pest resistance; or
   (D) the minor use pesticide plays or will play a significant part in an integrated pest management program.
The Food Quality Protection Act defines "minor use" of a pesticide on an animal, a commercial agricultural crop or site, or for public health purposes in two different ways. The first definition identifies minor use crops as those with less than 300,000 total U.S. acres. The second definition requires an economic determination that a registrant does not have the market revenues or sufficient economic incentive to support pesticide registration for a use site.
MINOR USE CROPS
A pesticide use on a crop with less than 300,000 acres of total U.S. production is a minor use. This definition applies to numerous fruits, vegetables, spices, and horticulture and nursery crops. As an alternative to listing all minor use crops, a list of crops with more than 300,000 acres of U.S. production is provided below. Pesticide uses on commercial agricultural crops that do not appear on the list will automatically be considered minor uses. Because the first definition applies only to crop uses of less than 300,000 acres, non-crop uses or sites (such as animal uses, aquatic weed control, and rights-of-ways) are not evaluated under the first definition.
Agricultural Crops Grown on More Than 300,000 Acres
Almonds 			Pecans
Apples 			Popcorn
Barley 			Potatoes
Beans, dry 		Rice
Beans, snap 		Rye
Canola 			Sod Farms
Corn (sweet & field) 	Sorghum
Cotton 			Soybeans
Cottonseed 		Sugarbeets
Grapes 			Sugarcane
Hay (alfalfa & other) 	Sunflower
Oats 			Tobacco
Oranges 			Tomatoes
Peanuts 			Turf
Wheat

MINOR USE ECONOMIC DEFINITION
A pesticide use on an agricultural crop grown on more than 300,000 acres or on a non-agricultural site may qualify as a minor use, provided the registrant can demonstrate that the use does not provide sufficient economic incentive to support registration. For purposes of this PR notice this economic determination can be made by using the equation:
(a) costs > gross revenues for 1 year for the specific site.
where:
Costs = incremental costs to register the site which are the costs of the additional data requirements to register the specific site. If registration costs are shared by more than one registrant, the costs should represent the registrant's share of the data requirement.
Revenues = registrant's gross sales which are the additional sales projected at full market potential for the specific site. EPA, in consultation with USDA, will make this determination based on the following information provided by the registrant:
Registrants that choose to submit priorities based on the economic definition for a minor use must provide the following:
1. A list of the registration data requirements and the estimated cost to generate the data for the specific site.
2. The Annual Domestic Sales or Revenues for the Specific Site: Provide the actual, annual value and quantity of domestic sales of the pesticide for the specific site. This value should be calculated as the average of the most recent 3 years.  For the registration of a new site, annual revenues should be projected on the basis of full market potential.
3. A written summary addressing at least one of the criteria described in section VII(2)(A-D).
For a minor use priority that is determined to be a minor use as a result of the economic criteria specified above, the one year time frame for completion of reviews does not begin until after the economic determination has been completed.


[Federal Register Volume 80, Number 41 (Tuesday, March 3, 2015)]
[Notices]
[Page 11428]
[FR Doc No: 2015-04370]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

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

    Docket Numbers: ER15-486-002.
    Applicants: Peninsula Power, LLC.
    Description: Tariff Amendment per 35.17(b): Peninsula Power, LLC
(FERC Electric Tariff) to be effective 1/1/2015.
    Filed Date: 2/25/15.
    Accession Number: 20150225-5223.
    Comments Due: 5 p.m. ET 3/18/15.

    Docket Numbers: ER15-1119-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): 2015-
02-25_SA 2751 GRE-OTP T-L IA Gorton Tap to be effective 2/26/2015.
    Filed Date: 2/25/15.
    Accession Number: 20150225-5194.
    Comments Due: 5 p.m. ET 3/18/15.

    Docket Numbers: ER15-1120-000.
    Applicants: Nevada Power Company.
    Description: Sec.  205(d) rate filing per 35.13(a)(2)(iii): Service
Agreement No. 14-00081 NPC and Aiya LGIA Amded and Restated to be
effective 2/13/2015.
    Filed Date: 2/25/15.
    Accession Number: 20150225-5275.
    Comments Due: 5 p.m. ET 3/18/15.

    Docket Numbers: ER15-1121-000.
    Applicants: Nevada Power Company.
    Description: Initial rate filing per 35.12 Service Agreement No.
12-00082 NPC and Moapa LGIG to be effective 2/13/2015.
    Filed Date: 2/25/15.
    Accession Number: 20150225-5278.
    Comments Due: 5 p.m. ET 3/18/15.

    Docket Numbers: ER15-1122-000.
    Applicants: Nevada Power Company.
    Description: Initial rate filing per 35.12 Service Agreement No.
14-00076 NPC and Playa LGIA to be effective 2/13/2015.
    Filed Date: 2/25/15.
    Accession Number: 20150225-5283.
    Comments Due: 5 p.m. ET 3/18/15.

    Take notice that the Commission received the following PURPA
210(m)(3) filings:

    Docket Numbers: QM15-2-000.
    Applicants: Northern States Power Company, a Minnesota corporation.
    Description: Application for Relief from Obligation to Purchase
Output of Twin Cities Hydro Plant of Northern States Power Company, a
Minnesota corporation.
    Filed Date: 2/18/15.
    Accession Number: 20150218-5126.
    Comments Due: 5 p.m. ET 3/24/15.

    Docket Numbers: QM15-2-000.
    Applicants: Northern States Power Company, a Minnesota corporation.
    Description: Amendment to February 18, 2015 Application for Relief
from Obligation to Purchase Output of Twin Cities Hydro Plant of
Northern States Power Company, a Minnesota corporation.
    Filed Date: 2/24/15.
    Accession Number: 20150224-5264.
    Comments Due: 5 p.m. ET 3/24/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 25, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-04370 Filed 3-2-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 236 (Monday, December 11, 2023)]
[Notices]
[Pages 85892-85894]
[FR Doc No: 2023-27044]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2022-E-2095 and FDA-2022-E-2096]

Determination of Regulatory Review Period for Purposes of Patent
Extension; WELIREG

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for WELIREG and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of patents which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by February 9, 2024.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by June 10, 2024. See ``Petitions''
in the SUPPLEMENTARY INFORMATION section for more information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 9, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to

the docket unchanged. Because your comment will be made public, you are
solely responsible for ensuring that your comment does not include any
confidential information that you or a third party may not wish to be
posted, such as medical information, your or anyone else's Social
Security number, or confidential business information, such as a
manufacturing process. Please note that if you include your name,
contact information, or other information that identifies you in the
body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2022-E-2095 and FDA-2022-E-2096 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; WELIREG.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product WELIREG
(belzutifan). WELIREG is indicated for the treatment of adult patients
with von Hippel-Lindau disease who require therapy for associated renal
cell carcinoma, central nervous system hemangioblastomas, or pancreatic
neuroendocrine tumors, not requiring immediate surgery. Subsequent to
this approval, the USPTO received patent term restoration applications
for WELIREG (U.S. Patent Nos. 9,908,845; 9,969,689) from Peloton
Therapeutics, Inc, and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated September 13, 2022, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of WELIREG represented the first permitted commercial
marketing or use of the product. Thereafter, the USPTO requested that
FDA determine the product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
WELIREG is 1,752 days. Of this time, 1,541 days occurred during the
testing phase of the regulatory review period, while 211 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
October 28, 2016. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on
October 28, 2016.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: January 15,
2021. FDA has verified the applicant's claim that the new drug
application (NDA) for WELIREG (NDA 215383) was initially submitted on
January 15, 2021.
    3. The date the application was approved: August 13, 2021. FDA has

verified the applicant's claim that NDA 215383 was approved on August
13, 2021.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 342 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: December 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27044 Filed 12-8-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 116 (Monday, June 17, 2019)]
[Rules and Regulations]
[Page 27956]
[FR Doc No: 2019-12729]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2019-0321]

Multiple Safety Zones; Fireworks Displays in the Captain of the
Port New York Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce a safety zone within the Captain
of the Port New York Zone on the specified dates and times. This action
is necessary to ensure the safety of vessels, spectators and
participants from hazards associated with fireworks displays. During
the enforcement periods, no person or vessel may enter the safety zone
without permission of the Captain of the Port (COTP).

DATES: The regulation for the safety zone described in 33 CFR 165.160
will be enforced on the date and times listed in the table below.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice
of enforcement, call or email Petty Officer First Class Ronald Sampert
U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety
zones listed in 33 CFR 165.160 on the specified date and time as
indicated in Table 1 below. This regulation was published in the
Federal Register on November 9, 2011 (76 FR 69614).

                                 Table 1
------------------------------------------------------------------------

------------------------------------------------------------------------
1. City of Poughkeepsie Independence      Launch site: A barge
 Day, Poughkeepsie, NY, Hudson River      located in approximate
 Safety Zone, 33 CFR 165.160(5.13).       position 41[deg]42'24.50'' N,
                                          073[deg]56'44.16'' W (NAD
                                          1983), approximately 420 yards
                                          north of the Mid Hudson
                                          Bridge. This Safety Zone is a
                                          300-yard radius from the
                                          barge.
                                          Date: July 4, 2019.
                                          Time: 9:00 p.m.-10:00
                                          p.m.
2. Breezy Point Co-Op Inc., Rockaway      Launch site: A barge
 Inlet Safety Zone, 33 CFR 165.160(2.9).  located in approximate
                                          position 40[deg]34'19.1'' N,
                                          073[deg]54'43.5'' W (NAD
                                          1983). 1200 yards south of
                                          Point Breeze. This Safety Zone
                                          is a 360-yard radius from the
                                          barge.
                                          Date: July 5, 2019.
                                          Rain Date: July 6,
                                          2019.
                                          Time: 9:00 p.m.-10:00
                                          p.m.
3. Peekskill Celebration, Peekskill       Launch site: A barge
 Bay, Hudson River Safety Zone, 33 CFR    located in approximate
 165.160(5.10).                           position 41[deg]17'16'' N,
                                          073[deg]56'18'' W (NAD 1983),
                                          approximately 670 yards north
                                          of Travis Point. This Safety
                                          Zone is a 360-yard radius from
                                          the barge.
                                          Date: August 3, 2019.
                                          Time: 9:30 p.m.-10:30
                                          p.m.
------------------------------------------------------------------------

    Under the provisions of 33 CFR 165.160, vessels may not enter the
safety zones unless given permission from the COTP or a designated
representative. Spectator vessels may transit outside the safety zones
but may not anchor, block, loiter in, or impede the transit of other
vessels. The Coast Guard may be assisted by other Federal, State, or
local law enforcement agencies in enforcing this regulation.
    This notice of enforcement is issued under authority of 33 CFR
165.160(a) and 5 U.S.C. 552(a). In addition to this notice of
enforcement in the Federal Register, the Coast Guard will provide
mariners with advanced notification of enforcement periods via the
Local Notice to Mariners and marine information broadcasts.
    If the COTP determines that a safety zone need not be enforced for
the full duration stated in this notice of enforcement, a Broadcast
Notice to Mariners may be used to grant general permission to enter the
safety zone.

    Dated: May 15, 2019.
J.P. Tama,
Captain, U.S. Coast Guard, Captain of the Port New York.
[FR Doc. 2019-12729 Filed 6-14-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 101 (Tuesday, May 27, 2014)]
[Proposed Rules]
[Page 30056]
[FR Doc No: 2014-12095]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2004-N-0258 (Formerly Docket No. 2004N-0456)]
RIN 0910-AF23

Food Labeling: Serving Sizes of Foods That Can Reasonably Be
Consumed at One-Eating Occasion; Dual-Column Labeling; Updating,
Modifying, and Establishing Certain Reference Amounts Customarily
Consumed; Serving Size for Breath Mints; and Technical Amendments;
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
extending the comment period for the proposed rule that appeared in the
Federal Register of March 3, 2014. In the proposed rule, FDA requested
comments on FDA's regulations for serving sizes for the Nutrition Facts
Label. We are taking this action in response to requests for an
extension to allow interested persons additional time to submit
comments.

DATES: FDA is extending the comment period on the proposed rule
published on March 3, 2014 (79 FR 11990). Submit either electronic or
written comments by August 1, 2014.

ADDRESSES: You may submit comments by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency
name, Docket No. FDA-2004-N-0258, and RIN 0910-AF23 for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Request for Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Cherisa Henderson, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 3, 2014 (79 FR 11990), we
published a proposed rule entitled ``Food Labeling: Serving Sizes of
Foods That Can Reasonably Be Consumed At One-Eating Occasion; Dual-
Column Labeling; Updating, Modifying, and Establishing Certain
Reference Amounts Customarily Consumed; Serving Size for Breath Mints;
and Technical Amendments'' with a 90-day comment period to request
comments on amending the definition of a single-serving container;
requiring dual-column labeling for certain containers; updating and
modifying several reference amounts customarily consumed; adding
several food products and food product categories to the reference
amounts customarily consumed per eating occasion for the general food
supply; amending the label serving size for breath mints; and making
technical amendments to various aspects of the serving size
regulations. Comments on the proposed rule will inform FDA's rulemaking
to amend the regulations for serving sizes for the Nutrition Facts
Label.
    We received multiple requests for a 90-day extension of the comment
period for the proposed rule. Each request conveyed concern that the
original 90-day comment period does not allow sufficient time to
develop a meaningful or thoughtful response to the proposed rule.
    We have considered the requests and are extending the comment
period for the proposed rule for 60 days, until August 1, 2014. We
believe that a 60-day extension allows adequate time for interested
persons to submit comments without significantly delaying rulemaking on
these important issues.

II. Request for Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov.

    Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12095 Filed 5-23-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Proposed Rules]
[Pages 38585-38586]
[FR Doc No: 2011-16664]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0369; Airspace Docket No. 11-AEA-07]

Proposed Establishment of Class E Airspace; Wilkes-Barre, PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish Class E Airspace at Wilkes-
Barre, PA, to accommodate new Standard Instrument Approach Procedures
at Wilkes-Barre Wyoming Valley Airport. This action would enhance the
safety and airspace management of Instrument Flight Rules (IFR)
operations at the airport.

DATES: Comments must be received on or before August 15, 2011.

ADDRESSES: Send comments on this rule to: U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001;
Telephone: 1-800-647-5527; Fax:<PHONE_NUMBER>. You must identify the
Docket Number FAA-2011-0369; Airspace Docket No. 11-AEA-07, at the
beginning of your comments. You may also submit and review received
comments through the Internet at http:[sol][sol]www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2011-0369; Airspace Docket No. 11-AEA-07) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http:[sol][sol]www.regulations.gov.
    Annotators wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2011-0369; Airspace Docket No. 11-AEA-07.'' The postcard will
be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http:[sol][sol]www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http:[sol][sol]www.faa.gov/airports--airtraffic/air--
traffic/publications/airspace--amendments/.

    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. An
informal docket may also be examined during normal business hours at
the office of the Eastern Service Center, Federal Aviation
Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia
30337.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>, to
request a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking distribution System, which describes the application
procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to establish Class E airspace at Wilkes-
Barre, PA providing the controlled airspace required to support the new
RNAV GPS standard instrument approach procedures for Wilkes-Barre
Wyoming Valley Airport. Controlled airspace extending upward from 700
feet above the surface would be established for the safety and
management of IFR operations at the airport.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order 7400.9U, dated August 18, 2010, and effective September 15,
2010, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part A, Subpart I, Section 40103. Under that
section, the FAA is charged with prescribing regulations to assign the
use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This proposed regulation is within the scope
of that authority as it would establish Class E airspace at Wilkes-
Barre Wyoming Valley Airport, Wilkes-Barre, PA.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, dated August 18, 2010, effective September 15, 2010,
is amended as follows:

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

* * * * *

AEA PA E5 Wilkes-Barre, PA [New]

Wilkes-Barre Wyoming Valley Airport
    (Lat. 41[deg]17'50'' N., long. 75[deg]51'09'' W.)

    That airspace extending upward from 700 feet above the surface
within an 11.6-mile radius of Wilkes-Barre Wyoming Valley Airport.

    Issued in College Park, Georgia, on June 27, 2011.
Barry A. Knight,
Acting Manager, Operations Support Group, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2011-16664 Filed 6-30-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 101 (Tuesday, May 26, 2020)]
[Notices]
[Pages 31490-31491]
[FR Doc No: 2020-11208]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER19-2235-002.
    Applicants: Tuscola Bay Wind, LLC.
    Description: Compliance filing: Tuscola Bay Wind, LLC, Docket No.
ER19-2235-002 to be effective 9/1/2019.
    Filed Date: 5/18/20.
    Accession Number: 20200518-5165.
    Comments Due: 5 p.m. ET 6/8/20.

    Docket Numbers: ER19-2707-002; ER10-2822-016; ER10-3158-009; ER10-
3161-009; ER10-3162-009; ER12-308-009; ER16-1238-003; ER16-1250-008;
ER17-1242-002; ER17-1392-003.
    Applicants: Poseidon Wind, LLC, Atlantic Renewable Projects II LLC,
Avangrid Arizona Renewables, LLC, Avangrid Renewables, LLC, El Cabo
Wind LLC, Dillon Wind LLC, Manzana Wind LLC, Mountain View Power
Partners III, LLC, Shiloh I Wind Project, LLC, Tule Wind LLC.
    Description: Supplement to December 19, 2019 Notice of Change in
Status of Poseidon Wind, LLC and the Avangrid Southwest MBR Sellers.
    Filed Date: 5/18/20.
    Accession Number: 20200518-5195.
    Comments Due: 5 p.m. ET 6/8/20.

    Docket Numbers: ER20-681-001.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Compliance filing: Compliance Filing Re-submittal to
be effective 2/22/2020.
    Filed Date: 5/19/20.
    Accession Number: 20200519-5132.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: ER20-1499-001.
    Applicants: Appalachian Power Company.
    Description: Tariff Amendment: OATT--AEP Texas Inc. 1-Co Rate
Update, Attach K & Misc revisions--Amend Pending to be effective 5/15/
2020.
    Filed Date: 5/19/20.
    Accession Number: 20200519-5064.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: ER20-1846-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2020-05-18_Filing to Enhance
Accreditation of Load Modifying Resources to be effective 8/16/2020.
    Filed Date: 5/18/20.
    Accession Number: 20200518-5159.
    Comments Due: 5 p.m. ET 6/8/20.

    Docket Numbers: ER20-1847-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original WMPA, Service
Agreement No. 5639; Queue No. AF1-041 to be effective 4/23/2020.
    Filed Date: 5/19/20.
    Accession Number: 20200519-5020.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: ER20-1848-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: NorthWestern Formula Rate
Revisions to Incorporate Changes File in ER20-1090 to be effective 1/
27/2020.
    Filed Date: 5/19/20.
    Accession Number: 20200519-5031.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: ER20-1849-000.
    Applicants: Hardin Wind Energy LLC.
    Description: Tariff Cancellation: Notice of Cancellation of Market-
Based Rate Tariff to be effective 7/19/2020.
    Filed Date: 5/19/20.
    Accession Number: 20200519-5037.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: ER20-1850-000.
    Applicants: Hardin Wind Energy Holdings LLC.
    Description: Tariff Cancellation: Notice of Cancellation of Market-
Based Rate Tariff to be effective 7/19/2020.

    Filed Date: 5/19/20.
    Accession Number: 20200519-5038.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: ER20-1851-000.
    Applicants: Whitetail Solar 3, LLC.
    Description: Baseline eTariff Filing: Reactive Power Compensation
to be effective 7/18/2020.
    Filed Date: 5/19/20.
    Accession Number: 20200519-5085.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: ER20-1852-000.
    Applicants: Midcontinent Independent System Operator, Inc., Ameren
Illinois Company.
    Description: Sec.  205(d) Rate Filing: 2020-05-19_SA 3498 Ameren
Illinois-BPWENA Payment Agreement to be effective 7/19/2020.
    Filed Date: 5/19/20.
    Accession Number: 20200519-5088.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: ER20-1853-000.
    Applicants: Whitehorn Solar LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authorization, Request for Related Waivers to be effective 7/19/
2020.
    Filed Date: 5/19/20.
    Accession Number: 20200519-5091.
    Comments Due: 5 p.m. ET 6/9/20.

    Docket Numbers: ER20-1854-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to Second Revised
WMPA No. 4869; Queue No. AC2-138/AD2-044 to be effective 2/22/2019.
    Filed Date: 5/19/20.
    Accession Number: 20200519-5124.
    Comments Due: 5 p.m. ET 6/9/20.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: May 19, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-11208 Filed 5-22-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 92 (Thursday, May 12, 2022)]
[Proposed Rules]
[Page 29108]
[FR Doc No: 2022-10124]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52, 75, 78, and 97

[EPA-HQ-OAR-2021-0668; FRL-8670-03-OAR]

Federal Implementation Plan Addressing Regional Ozone Transport
for the 2015 Ozone National Ambient Air Quality Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: On April 6, 2022, the Environmental Protection Agency (EPA)
proposed a rule titled, ``Federal Implementation Plan Addressing
Regional Ozone Transport for the 2015 Ozone National Ambient Air
Quality Standard.'' The EPA is extending the comment period on proposed
rule that was scheduled to close on June 6, 2022. The EPA has received
several requests for additional time to review and comment on the
proposed rule revisions.

DATES: The public comment period for the proposed ruled published in
the Federal Register on April 6, 2022 (87 FR 20036), is being extended.
Written comments must be received on or before June 21, 2022.

ADDRESSES: The EPA has established docket number EPA-HQ-OAR-2021-0668
for this action. Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e., on the web, cloud, or other file sharing system). For
additional submission methods, the full EPA public comment policy,
information about CBI or multimedia submissions and general guidance on
making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: For additional information on this
action, contact Ms. Elizabeth Selbst, Air Quality Policy Division,
Office of Air Quality Planning and Standards (C539-01), Environmental
Protection Agency, 109 TW Alexander Drive, Research Triangle Park, NC
27711; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION: After considering the requests to extend the
public comment period received from various parties, the EPA has
decided to extend the public comment period until June 21, 2022. This
extension will ensure that the public has additional time to review the
proposed rule.

Scott Mathias,
Director, Air Quality Policy Division, Office of Air Quality Planning
and Standards.
[FR Doc. 2022-10124 Filed 5-11-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: October 11, 2006 (Volume 71, Number 196)]
[Notices]
[Page 59844-59845]
[DOCID:fr11oc06-156]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54561; File No. SR-ISE-2006-54]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to ISE Stock Exchange Fees

October 2, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 6, 2006, the International Securities Exchange, LLC
(``ISE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The ISE has designated this proposal as one changing a fee
imposed by the ISE under Section 19(b)(3)(A)(ii) of the Act \3\ and
Rule 19b-4(f)(2) thereunder,\4\ which renders the proposal effective
upon filing with the Commission. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    The ISE proposes to amend its Schedule of Fees to adopt fees
related to the ISE Stock Exchange, LLC (``ISE Stock''). The text of the
proposed rule change is available on the Exchange's Web site at http://www.iseoptions.com
, at the principal office of the Exchange, and at the

Commission's Public Reference Room.

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

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

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

1. Purpose
    The ISE states that the purpose of the proposed rule change is to
adopt fees related to the trading of equity securities on ISE Stock, a
facility of the Exchange. The proposed fee schedule includes execution
fees, access fees, and regulatory fees for trading of equity
securities, as well as changes to existing language to clarify the
application of certain fees that are specific to options trading only.
With regard to the execution fees, the Exchange proposes to charge fees
based on a member's average daily shares executed, with the average
daily volume (``ADV'') calculated on a monthly basis. This fee would be
charged on a tiered basis (e.g., a member that executes 9,600,000
shares in a 20-day month would have an ADV of 480,000 shares and would
be charged as follows: $0.0025 for the first 200,000 shares ADV
(4,000,000 shares) and $0.0020 for the remaining 280,000 shares ADV
(5,600,000 shares)). Further, a member that transacts more than
3,000,000 shares on a daily basis would be charged a fee of $0.0010 per
share for all of its monthly volume instead of being charged on a
tiered basis.\5\ Additionally, in an effort to promote ISE Stock, the
Exchange proposes to waive all execution fees until December 1, 2006.
---------------------------------------------------------------------------

    \5\ The tiers are as follows:
    A.D.V. Up to 200,000 shares--$0.0025 per share.
    A.D.V. From 200,001 to 500,000 shares--$0.0020 per share.
    A.D.V. From 500,001 to 2,000,000 shares--$0.0015 per share.
    A.D.V. From 2,000,001 to 3,000,000 shares--$0.0010 per share.
    A.D.V. Over 3,000,000 shares--$0.0010 per share (applied to all
volume).
    Telephone conversation between Michou H.M. Nguyen, Special
Counsel, Division of Market Regulation, Commission, and Samir Patel,
Assistant General Counsel, Exchange, on September 27, 2006.
---------------------------------------------------------------------------

    With regard to access fees, the Exchange states that it currently
charges an Electronic Access Member (``EAM'') that trades options an
access fee of $500 per month. Access fees for these EAMs will remain
unchanged if they also trade equities on ISE Stock. For an EAM that
trades equities only, the Exchange proposes a monthly access fee of
$200. Finally, the Exchange states that it currently charges an EAM
that trades options a regulatory fee of $5,000 per year. For EAMs that
trade equities only, the Exchange proposes an annual regulatory fee of
$5,000. For EAMs that trade both equities and options, the

Exchange proposes an annual regulatory fee of $6,000.\6\
---------------------------------------------------------------------------

    \6\ The Exchange represents that there exists overlap in the
costs associated with the regulatory fee for trading options and for
trading equities. Therefore, if an EAM trades both, the EAM is only
charged $6,000 instead of $10,000. Id.
---------------------------------------------------------------------------

    The Exchange also proposes to amend (1) the Notes for the
cancellation fee to clarify that the fee is applicable to options
orders only; and (2) language to the EAM / Trade Review Terminal fee
and the Order Routing Service Connection Fee to clarify that these fees
are options fees and are applicable to EAMs that trade options.\7\ The
Exchange states that both these fees currently appear as Session/API
Fee in the current fee schedule.
---------------------------------------------------------------------------

    \7\ The Exchange represents that the Trade Review Terminal and
the related Order Routing Service are used exclusively for the
trading of options. Therefore, the Trade Review Terminal fee and the
associated Order Routing Service Connection Fee would only be
charged to EAMs trading options. Id.
---------------------------------------------------------------------------

    Finally, the Exchange also proposes to charge EAMs that trade
equity securities certain administrative fees. These would include fees
related to the registration of Form U4 as well as a CRD fee. The
Exchange states that these administrative fees currently appear under
the Legal & Regulatory section of the current fee schedule.
2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \8\ in general, and furthers the objectives of Section
6(b)(4) of the Act \9\ in particular, in that it provides for an
equitable allocation of reasonable dues, fees, and other charges among
ISE members.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

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

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

    The Exchange has not solicited nor received any written comments on
the proposed rule change.

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

    The foregoing proposed rule change has been designated as a fee
change pursuant to Section 19(b)(3)(A)(ii) of the Act \10\ and Rule
19b-4(f)(2) \11\ thereunder, because it establishes or changes a due,
fee, or other charge imposed by the Exchange. Accordingly, the proposal
will take effect upon filing with the Commission. At any time within 60
days of the filing of such proposed rule change, the Commission may
summarily abrogate such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \11\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

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

File Number SR-ISE-2006-54 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2006-54. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the ISE. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-ISE-2006-54 and should be submitted on or before
November 1, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Nancy M. Morris,
Secretary.
[FR Doc. E6-16729 Filed 10-10-06; 8:45 am]

BILLING CODE 8011-01-P