53297 Federal Register / Vol. 68, No. 175 / Wednesday, September 10, 2003 / Rules and Regulations statements, Indians, Intergovernmental relations, Forest and forest products, National forests, Natural resources, Reporting and recordkeeping requirements, Science and technology.

 Therefore, for the reasons set forth in the preamble, Part 219 of Title 36 of the Code of Federal Regulations is amended as follows:

PART 219   PLANNING Subpart A   National Forest System Land and Resource Management Planning  1. The authority citation for subpart A continues to read as follows:

Authority: 5 U. S. C. 301; and Secs. 6 and 15, 90 Stat. 2949, 2952, 2958 ( 16 U. S. C. 1604, 1613).

 2. Revise paragraph ( d) of § 219.35 to read as follows:

§ 219.35 Transition.

* * * * * ( d) The date by which site specific decisions made by the responsible official must be in conformance with the provisions of this subpart is extended from November 9, 2003, until the Department promulgates the final planning regulations published as proposed on December 6, 2002 ( 67 FR 72770). * * * * *

Dated: September 3, 2003. David P. Tenny, Deputy Under Secretary, Natural Resources and Environment. [ FR Doc. 03   22977 Filed 9   9   03; 8: 45 am]

BILLING CODE 3410   11   P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0244; FRL   7322   7]

Trifloxystrobin; Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for combined residues of trifloxystrobin in or on leaf petioles subgroup 4B; and vegetable, root, except sugar beet, subgroup 1B, except radish. Interregional Research Project Number 4 ( IR 4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA). DATES: This regulation is effective September 10, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0244, must be received on or before November 10, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   3194; e mail address: brothers. shaja@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you an are agricultural producer, food manufacturer, and pesticide manufacturer Potentially affected entities may include, but are not limited to:   Crop production ( NAICS 111)   Animal production ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0244. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings In the Federal Register of March 5, 2003 ( 68 FR 10469) ( FRL   7294   5), EPA issued a notice pursuant to section 408 of FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104   170), announcing the filing of a pesticide petition ( PP 3E6522) by IR 4, 681 U. S. Highway # 1 South, New Brunswick, NJ 08902   3390. That notice included a summary of the petition prepared by Bayer CropScience, the registrant. There were no comments received on this petition. The petition requested that 40 CFR 180.555 be amended by establishing tolerances for combined residues of the fungicide, trifloxystrobin, ( benzeneacetic acid, ( E, E) a ( methoxyimino) 2[[[[ 1[ 3 ( trifluoromethyl) phenyl] ethylidene] amino] oxy] methyl], methyl ester) and the free form of its acid metabolite CGA 321113(( E, E) methoxyimino[ 2[ 1( 3 trifluoromethylphenyl) ethylideneaminooxymethyl] phenyl] acetic acid), in or on the VerDate jul< 14> 2003 16: 36 Sep 09, 2003 Jkt 200001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 10SER1. SGM 10SER1 53298 Federal Register / Vol. 68, No. 175 / Wednesday, September 10, 2003 / Rules and Regulations following commodities: Leaf petioles subgroup 4B at 2.0 parts per million ( ppm), and vegetable, root, except sugar beet, subgroup 1B, except radish at 0.10 ppm. The petition was subsequently amended to propose the tolerance for the leaf petioles subgroup 4B at 3.5 ppm. Section 408( b)( 2)( A)( i) of the FFDCA allows EPA to establish a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is `` safe.'' Section 408( b)( 2)( A)( ii) of the FFDCA defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997) ( FRL   5754   7).

III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408( b)( 2)( D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408( b)( 2) of the FFDCA, for tolerances for combined residues of trifloxystrobin and the free form of its acid metabolite CGA 321113 on leaf petioles subgroup 4B at 3.5 ppm, and vegetable, root, except sugar beet, subgroup 1B, except radish at 0.10 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances follows.

A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by trifloxystrobin are discussed in Unit III. A. of the final rule on trifloxystrobin, which was published in the Federal Register of May 22, 2002 ( 67 FR 35915) ( FRL   7178   6).

B. Toxicological Endpoints The dose at which no adverse effects are observed ( the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern ( LOC). However, the lowest dose at which adverse effects of concern are identified ( the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor ( UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. For dietary risk assessment ( other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose ( acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF ( RfD = NOAEL/ UF). Where an additional safety factors ( SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose ( aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.

For non dietary risk assessments ( other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF ( 10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures ( margin of exposure ( MOE) = NOAEL/ exposure) is calculated and compared to the LOC.

The linear default risk methodology ( Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases ( e. g., risk is expressed as 1 x 10   6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non linear approach, a `` point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure ( MOEcancer = point of departure/ exposures) is calculated. A summary of the toxicological endpoints for trifloxystrobin used for human risk assessment is shown in Table 1 of this unit:

VerDate jul< 14> 2003 16: 36 Sep 09, 2003 Jkt 200001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 10SER1. SGM 10SER1 53299 Federal Register / Vol. 68, No. 175 / Wednesday, September 10, 2003 / Rules and Regulations TABLE 1.   SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR TRIFLOXYSTROBIN FOR USE IN HUMAN RISK ASSESSMENT Exposure Scenario Dose Used in Risk Assessment, UF * Special FQPA SF and LOC for Risk Assessment Study and Toxicological Effects Acute dietary females 13   49 only. NOAEL = 250 mg/ kg/ day UF = 100 Acute RfD = 2.5 mg/ kg/ day FQPA SF = 1X aPAD = aRfD ÷ FQPA SF = 2.5 mg/ kg/ day Developmental toxicity Rat LOAEL = 500 mg/ kg/ day, based upon increased fetal skeletal anomalies Acute dietary general population including infants and children. There were no appropriate toxicological effects attributable to a single exposure ( dose) observed in oral toxicity studies including maternal effects in developmental studies in rats and rabbits. Therefore, a dose and endpoint were not identified for this risk assessment Chronic dietary all populations. Parental NOAEL = 3.8 mg/ kg/ day UF = 100 Chronic RfD = 0.038 mg/ kg/ day FQPA SF = 1X cPAD = cRfD ÷ FQPA SF = 0.038 mg/ kg/ day 2   generation reproduction study Rat LOAEL = 55.3 mg/ kg/ day, based upon decreases in body weight, body weight gains, reduced food consumption and histopathological lesions in the liver, kidneys and spleen Short Term Oral ( 1   30 days). Intermediate Term Oral ( 1   6 months) Offspring NOAEL = 3.8 mg/ kg/ day LOC for MOE = 100 ( Residential includes the FQPA SF) 2   Generation reproduction study Rat LOAEL = 55.3 mg/ kg/ day, based upon reduced pup body weights during lactation Short Term Dermal ( 1   30 days). Intermediate term dermal ( 1   6 months) Dermal study NOAEL = 100 mg/ kg/ day LOC for MOE = 100 ( Residential includes the FQPA SF) 28   Day dermal toxicity study Rat LOAEL = 1,000 mg/ kg/ day, based upon increases in mean absolute and relative liver and kidney weights Long term dermal (> 6 months). Oral study NOAEL = 3.8 mg/ kg/ day ( dermal absorption rate = 33%) LOC for MOE = 100 ( Residential includes the FQPA SF) 2   Generation reproduction study Rat LOAEL = 55.3 mg/ kg/ day, based upon reduced pup body weights during lactation Short term inhalation ( 1   30 days). Intermediate Term Inhalation ( 1   6 months) Long Term Inhalation (> 6 months) Oral study NOAEL = 3.8 mg/ kg/ day ( inhalation absorption rate = 100%) LOC for MOE = 100 ( Residential includes the FQPA SF) 2   Generation reproduction study Rat LOAEL = 55.3 mg/ kg/ day, based upon reduced pup body weights during lactation Cancer ( oral, dermal inhalation). Trifloxystrobin is classified as `` Not Likely Human Carcinogen'' based on the lack of evidence of carcinogenicity in mouse and rat cancer studies C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established ( 40 CFR 180.555) for the residues of trifloxystrobin, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from trifloxystrobin in food as follows: i. Acute exposure. Acute dietary risk assessments are performed for a fooduse pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1   day or single exposure. In conducting this acute dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Data base ( DEEM FCID   ) which incorporates food consumption data as reported by respondents in the USDA 1994   1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessment: The acute dietary exposure analysis for trifloxystrobin is a Tier I assessment because no additional data were used to refine the analysis. One hundred percent of proposed and registered crops are assumed treated with trifloxystrobin (`` 100% CT''), and tolerance level residues were used in the analysis. ii. Chronic exposure. In conducting this acute dietary risk assessment EPA used the DEEM   software with the DEEM FCID   which incorporates food consumption data as reported by respondents in the USDA 1994   1996 and 1998 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessment: The chronic dietary exposure analysis for trifloxystrobin is a Tier I assessment because no additional data were used to refine the analysis. One hundred percent of proposed and registered crops are assumed treated with trifloxystrobin, and tolerance level residues were used in the analysis. iii. Cancer. The Agency determined that trifloxystrobin should be classified as a `` Not Likely Human Carcinogen.'' 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for trifloxystrobin in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates VerDate jul< 14> 2003 16: 36 Sep 09, 2003 Jkt 200001 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 10SER1. SGM 10SER1 53300 Federal Register / Vol. 68, No. 175 / Wednesday, September 10, 2003 / Rules and Regulations are made by reliance on simulation or modeling taking into account data on the physical characteristics of trifloxystrobin. The Agency uses the FQPA Index Reservoir Screening Tool ( FIRST) or the Pesticide Root Zone model/ Exposure Analysis Modeling System ( PRZM/ EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The screening concentration in ground water ( SCI GROW) model is used to predict pesticide concentrations in shallow ground water. For a screening level assessment for surface water EPA will use FIRST ( a Tier I model) before using PRZM/ EXAMS ( a Tier II model). The FIRST model is a subset of the PRZM/ EXAMS model that uses a specific high end runoff scenario for pesticides. FIRST and PRZM/ EXAMS incorporate an index reservoir environment, and a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. None of these models include consideration of the impact processing ( mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a screen for sorting out pesticides for which it is unlikely that drinking water concentrations would exceed human health LOC. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations ( EECs) from these models to quantify drinking water exposure and risk as a % RfD or % PAD. Instead drinking water levels of comparison ( DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to trifloxystrobin they are further discussed in the aggregate risk sections in Unit III. E. Trifloxystrobin is immobile, and degrades rapidly in soil and aquatic environments to the primary isomer, CGA 321113. EECs were calculated for total trifloxystrobin residues ( parent trifloxystrobin plus metabolites) using the FIRST model for surface water and the SCI GROW model for ground water. EPA's interim method for drinking water estimates for pesticides used in rice paddies was also used to generate surface water EECs. Surface water concentrations for total trifloxystrobin residues are 92 parts per billion ( ppb) for the peak value ( acute) and 50 ppb for the chronic value using the FIRST model for terrestrial uses ( turfgrass). To estimate surface water concentrations for use on rice, an interim rice paddy model was used. For surface water concentrations from treated rice, the acute estimate for the parent is 48 ppb, and the chronic estimate for the total parent plus degradate is 140 ppb. The rice estimate is considered to be an overestimate of the true value found in the environment due to the assumptions used in the drinking water model for rice. Further, EPA considers the turfgrass estimate to be a more realistic estimate of drinking water residues. The ground water screening concentration used for both acute and chronic assessments is 3.4 ppb. These values represent upperbound estimates of the concentrations of total residues of trifloxystrobin that might be found in surface water and ground water from uses on turfgrass at the maximum application rate. 3. From non dietary exposure. The term `` residential exposure'' is used in this document to refer to nonoccupational non dietary exposure ( e. g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Trifloxystrobin is currently registered for use on the following residential nondietary sites: Turfgrass and ornamental ( CompassTM). Postapplication exposures from various activities following lawn treatment are considered to be the most common and significant in residential settings. There is potential for dermal exposure to adults and children and oral exposure to children during postapplication activities. Four postapplication exposure scenarios resulting from lawn treatment were assessed, as follows: ( 1) Dermal exposure from pesticide residues on lawns, ( 2) incidental non dietary ingestion of pesticide residues on lawns from hand to mouth transfer, ( 3) incidental non dietary ingestion of residues from object to mouth activities ( pesticide treated turfgrass), and ( 4) incidental non dietary ingestion of soil from pesticide treated residential areas. Exposure via incidental non dietary ingestion involving plant material may occur but is considered negligible. Since the application of trifloxystrobin on turf grass and ornamental is limited to certified pest control operators, an assessment of dermal or inhalation exposure for residential handlers was not performed. The MOE for adult dermal risk from postapplication exposure is 1,300 and 800 for children. Children's risk from oral exposures range from 1,600 to 220,000. When incidental oral exposure from all possible residential sources are combined ( ingestion of residues on turfgrass from hand to mouth activities, mouthing turfgrass and eating soil), the result is an MOE of 1,100. Therefore, postapplication exposure and risk estimates for adults and children are considered to be below EPA's LOC. 4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408( b)( 2)( D)( v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider `` available information'' concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' EPA does not have, at this time, available data to determine whether trifloxystrobin has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to trifloxystrobin and any other substances and trifloxystrobin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that trifloxystrobin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/.

D. Safety Factor for Infants and Children 1. In general. Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments VerDate jul< 14> 2003 16: 36 Sep 09, 2003 Jkt 200001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 10SER1. SGM 10SER1 53301 Federal Register / Vol. 68, No. 175 / Wednesday, September 10, 2003 / Rules and Regulations either directly through use of a MOE analysis or through using uncertainty ( safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. Prenatal and postnatal sensitivity. There is no indication of increased susceptibility of rat or rabbits to trifloxystrobin. 3. Conclusion. There is a complete toxicity data base for trifloxystrobin and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X SF to protect infants and children should be reduced to 1X because: i. There is no indication of increased susceptibility of rat or rabbits to trifloxystrobin. In the developmental and reproduction toxicity studies, effects in the fetuses/ offspring were observed only at or above treatment levels which resulted in evidence of parental toxicity. ii. The Agency determined that a developmental neurotoxicity study in rats is not required. iii. Although an acute neurotoxicity study is required ( the submitted study was unacceptable), the lack of an acute neurotoxicity study does not impact EPA's ability to make an FQPA SF decision. iv. The acute and chronic dietary food exposure assessments utilize existing and proposed tolerance level residues and 100% crop treated information for all commodities. By using these screening level assessments, actual exposures/ risks will not be underestimated. v. The exposure assessments will not underestimate the potential dietary ( food and drinking water) or non dietary exposures for infants and children from the use of trifloxystrobin. vi. The dietary drinking water assessment utilizes water concentration values generated by model and associated modeling parameters which are designed to provide conservative, health protective, high end estimates of water concentrations which are not likely to be exceeded. vii. The residential postapplication assessment is based upon the residential Standard Operating Procedures ( SOPs). The assessment is based upon surrogate study data. These data are reliable and are not expected to underestimate risk to adults or children. The residential SOPs are based upon reasonable `` worstcase assumptions and are not expected to underestimate risk.

E. Aggregate Risks and Determination of Safety To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water ( EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure ( i. e., the PAD) is available for exposure through drinking water ( e. g., allowable chronic water exposure ( mg/ kg/ day) = cPAD  ( average food + residential exposure)). This allowable exposure through drinking water is used to calculate a DWLOC. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA Office of Water are used to calculate DWLOCs: 2 liter ( L)/ 70 kg ( adult male), 2L/ 60 kg ( adult female), and 1L/ 10 kg ( child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short term, intermediate term, chronic, and cancer. When EECs for surface water and ground water are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water ( when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to trifloxystrobin will occupy < 1% of the aPAD for females 13   49 years old. An acute dietary endpoint for the general population including infants and children was not identified. In addition, there is potential for acute dietary exposure to trifloxystrobin in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD for females 13   49 years old, as shown in Table 2 of this unit:

TABLE 2.   AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO TRIFLOXYSTROBIN Population Subgroup aPAD ( mg/ kg) % aPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Acute DWLOC ( ppb)

Females ( 13   49 years old) ...................................................................... 2.5 < 1 92 turf 48 rice 3.4 75,000 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to trifloxystrobin from food will utilize 14% of the cPAD for the U. S. population, 54% of the cPAD for children 1   2 years old, 10% of the cPAD for females 13   49 years old, and 10% of the cPAD for adults 50+ years old. Based on the use pattern, chronic residential exposure to residues of trifloxystrobin is not expected. In addition, there is potential for chronic dietary exposure to trifloxystrobin in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 3 of this unit:

VerDate jul< 14> 2003 16: 36 Sep 09, 2003 Jkt 200001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 10SER1. SGM 10SER1 53302 Federal Register / Vol. 68, No. 175 / Wednesday, September 10, 2003 / Rules and Regulations TABLE 3.   AGGREGATE RISK ASSESSMENT FOR CHRONIC ( NON CANCER) EXPOSURE TO TRIFLOXYSTROBIN Population Subgroup cPAD mg/ kg/ day % cPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Chronic DWLOC ( ppb)

U. S. Population ........................................................................................ 0.038 14 140 rice 50 turf 3.4 1,100 Children ( 1   2 years old) .......................................................................... 0.038 54 140 rice 50 turf 3.4 170 Females ( 13   49 years old) ...................................................................... 0.038 10 140 rice 50 turf 3.4 1,000 Adults ( 50+ years old) ............................................................................. 0.038 10 140 rice 50 turf 3.4 1,200 3. Short term risk. Short term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Trifloxystrobin is currently registered for use that could result in short term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short term exposures for trifloxystrobin. Using the exposure assumptions described in this unit for short term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 690 for the U. S. Population; 154 for children 1   2 years old; 970 for females 13   49 years old; and 950 for adults 50+ years old. These aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to food and residential uses. In addition, short term DWLOCs were calculated and compared to the EECs for chronic exposure of trifloxystrobin in ground water and surface water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect short term aggregate exposure to exceed the Agency's LOC, as shown in Table 4 of this unit:

TABLE 4.   AGGREGATE RISK ASSESSMENT FOR SHORT TERM EXPOSURE TO TRIFLOXYSTROBIN Population Subgroup Aggregate MOE ( Food + Residential Aggregate Level of Concern ( LOC) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Short Term DWLOC ( ppb)

U. S. Population ........................................................................................ 690 100 140 rice 50 turf 3.4 1,100 Children 1   2 years old ............................................................................. 154 100 140 rice 50 turf 3.4 130 Females 13   50 years old ........................................................................ 970 100 140 rice 50 turf 3.4 1,000 Adults 50+ years old ................................................................................ 950 100 140 rice 50 turf 3.4 1,200 4. Intermediate term risk. The intermediate term aggregate risk assessment estimates risks likely to result from 1 to 6 months of exposure ( 30 to 180 days) to trifloxystrobin residues from food, drinking water, and residential pesticide uses. Intermediateterm exposure to trifloxystrobin is not expected to occur based on the chemical's short soil half life ( about 2 days). Therefore, no intermediate term aggregate risk is expected. 5. Aggregate cancer risk for U. S. population. Trifloxystrobin is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to trifloxystrobin residues.

IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology ( gas chromatography method using nitrogen/ phosphorus detector) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755   5350; telephone number: ( 410) 305   2905; e mail address: residuemethods@ epa. gov.

B. International Residue Limits There are no Codex, Canadian, or Mexican maximum residue limits established for trifloxystrobin. Harmonization is thus not an issue at this time.

V. Conclusion Therefore, the tolerances are established for combined residues of trifloxystrobin, ( benzeneacetic acid, ( E, E) a( methoxyimino) 2[[[[ 1[ 3 ( trifluoromethyl) phenyl] ethylidene] amino] oxy] methyl], methyl ester) and the free form of its acid metabolite CGA 321113(( E, E) methoxyimino[ 2[ 1( 3 trifluoromethyl phenyl) ethylideneaminooxymethyl] phenyl] acetic acid) in or on leaf petioles subgroup 4B at 3.5 ppm, and vegetable, root, except sugar beet, subgroup 1B, except radish at 0.10 ppm.

VerDate jul< 14> 2003 16: 36 Sep 09, 2003 Jkt 200001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 10SER1. SGM 10SER1 53303 Federal Register / Vol. 68, No. 175 / Wednesday, September 10, 2003 / Rules and Regulations VI. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP   2003   0244 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before November 10, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603   0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305   5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP   2003   0244, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32).

VII. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408( d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104   4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104   113, section 12( d) ( 15 U. S. C. 272 note). Since VerDate jul< 14> 2003 16: 36 Sep 09, 2003 Jkt 200001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 10SER1. SGM 10SER1 53304 Federal Register / Vol. 68, No. 175 / Wednesday, September 10, 2003 / Rules and Regulations tolerances and exemptions that are established on the basis of a petition under section 408( d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

VIII. Congressional Review Act The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2).

List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: August 29, 2003. Debra Edwards, Director, Registration Division, Office of Pesticide Programs.

 Therefore, 40 CFR chapter I is amended as follows:

PART 180   [ AMENDED]

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

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

 2. Section 180.555 is amended by adding commodities to the table in paragraph ( a) to read as follows:

§ 180.555 Trifloxystrobin; tolerances for residues.

( a) * * *

Commodity Parts per million * * * * * Leaf petioles subgroup 4B ................................ 3.5 * * * * * Vegetable, root, except sugar beet, subgroup 1B, except radish ........ 0.10 * * * * *

* * * * * [ FR Doc. 03   23054 Filed 9   9   03; 8: 45 am]

BILLING CODE 6560   50   S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [ DA 03   2762, MB Docket No. 02   83, RM   10404]

Digital Television Broadcast Service; Sault Saint Marie, MI AGENCY: Federal Communications Commission. ACTION: Final rule.

SUMMARY: The Commission, at the request of Scanlan Television, Inc., substitutes DTV channel 9c for DTV channel 56 at Sault Saint Marie, Michigan. See 67 FR 20941, April 29, 2002. DTV channel 9c can be allotted to Sault Saint Marie in compliance with the principle community coverage requirements of § 73.625( a) at reference coordinates 46   03   08 N. and 84   06   38 W. with a power of 24, HAAT of 291 meters and with a DTV service population of 84 thousand. Since the community of Sault Saint Marie is located within 400 kilometers of the U. S. Canadian border, concurrence from the Canadian government has been obtained for this allotment. With this action, this proceeding is terminated. DATES: Effective October 20, 2003.

FOR FURTHER INFORMATION CONTACT: Pam Blumenthal, Media Bureau, ( 202) 418   1600.

SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's Report and Order, MB Docket No. 02   83, adopted August 28, 2003, and released September 4, 2003. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY   A257, Washington, DC. This document may also be purchased from the Commission's duplicating contractor, Qualex International, Portals II, 445 12th Street, SW., CY   B402, Washington, DC 20554, telephone 202   863   2893, facsimile 202   863   2898, or via e mail qualexint@ aol. com.

List of Subjects in 47 CFR Part 73 Digital television broadcasting, Television.

 Part 73 of Title 47 of the Code of Federal Regulations is amended as follows:

PART 73   [ AMENDED]

 1. The authority citation for Part 73 continues to read as follows:

Authority: 47 U. S. C. 154, 303, 334 and 336.

VerDate jul< 14> 2003 16: 36 Sep 09, 2003 Jkt 200001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 10SER1. SGM 10SER1


[Federal Register Volume 88, Number 237 (Tuesday, December 12, 2023)]
[Notices]
[Pages 86181-86183]
[FR Doc No: 2023-27157]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-99091; File No. SR-NYSE-2023-49]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Sections 902.02 and 902.03 of the NYSE Listed Company Manual To
Amend Its Initial Listing Fee and Certain of Its Annual Fees

December 6, 2023.
    Pursuant to section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (``Act'') and Rule 19b-4 thereunder,\2\ notice is hereby given
that on December 1, 2023, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Sections 902.02 and 902.03 of the
NYSE Listed Company Manual (the ``Manual') to amend its initial listing
fee and certain of its annual fees charged to listed issuers. The
proposed rule change is available on the Exchange's website at
www.nyse.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 self-regulatory organization
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 those statements may be examined at

the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to amend its initial listing fee and certain
of its annual fees charged to listed issuers as set forth in Sections
902.02 and 902.03 of the Manual. The proposed changes will take effect
from the beginning of the calendar year commencing on January 1, 2024.
    The Exchange currently charges a flat initial listing fee of
$295,000 the first time an issuer lists a class of common shares on the
Exchange. The Exchange proposes to increase this flat initial listing
fee by $5,000 from $295,000 to $300,000. Section 902.03 of the Manual
contains examples of how listing fees are calculated for certain
UPREITs, U.S. issuers and foreign private issuers. The Exchange
proposes to make conforming changes to these examples in Section 902.03
to reflect the new $300,000 flat initial listing fee.
    The Exchange currently charges an annual fee of $0.001215 per share
for each of the following: a primary class of common shares (including
Equity Investment Tracking Stocks); each additional class of common
shares (including tracking stock); a primary class of preferred stock
(if no class of common shares is listed); each additional class of
preferred stock (whether primary class is common or preferred shares);
and each class of warrants or rights. The Exchange proposes to change
the per share annual fee for the foregoing classes of securities from
$0.001215 per share to $0.001265 per share.
    The proposed increase in the initial listing fee and the per share
rates for annual fees reflect increases in the costs the Exchange
incurs in providing services to listed companies on an ongoing basis,
as well as increases in the costs of conducting its related regulatory
activities. As described below, the Exchange proposes to make the
aforementioned fee increases to better reflect the Exchange's costs
related to listing equity securities and the corresponding value of
such listing to companies.
    The revised annual fees will be applied in the same manner to all
issuers with listed securities in the affected categories and the
Exchange believes that the changes will not disproportionately affect
any specific category of issuers.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with section 6(b) of the Act,\3\ in general, and furthers the
objectives of section 6(b)(4) \4\ of the Act, in particular, in that it
is designed to provide for the equitable allocation of reasonable dues,
fees, and other charges. The Exchange also believes that the proposed
rule change is consistent with section 6(b)(5) of the Act,\5\ in that
it is designed to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest
and is not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(4).
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that it is not unfairly discriminatory and
represents an equitable allocation of reasonable fees to amend sections
902.02 and 902.03 to increase the initial listing fee and annual fees
for the various categories of equity securities as set forth above
because of the increased costs incurred by the Exchange since it
established the current rates.
The Proposed Changes Are Reasonable
    The Exchange believes that the proposed changes to its initial
listing fee and the annual fee schedule are reasonable. In that regard,
the Exchange notes that its general costs to support its listed
companies have increased, including due to price inflation. The
Exchange also continues to expand and improve the services it provides
to listed companies. Specifically, the Exchange has (among other
things) increased expenditure on listed companies and the value of an
NYSE listing by expanding the NYSE Institute, whose focus includes
providing thought leadership and advocacy on behalf of listed
companies.
    The Exchange operates in a highly competitive marketplace for the
listing of the various categories of securities affected by the
proposed annual fee adjustments. The Commission has repeatedly
expressed its preference for competition over regulatory intervention
in determining prices, products, and services in the securities
markets. Specifically, in Regulation NMS,\6\ the Commission highlighted
the importance of market forces in determining prices and SRO revenues
and, also, recognized that current regulation of the market system
``has been remarkably successful in promoting market competition in its
broader forms that are most important to investors and listed
companies.'' \7\
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    \6\ Securities Exchange Act Release No. 34-51808 (June 9, 2005);
70 FR 37496 (June 29, 2005) (``Regulation NMS'').
    \7\ See Regulation NMS, 70 FR at 37499.
---------------------------------------------------------------------------

    The Exchange believes that the ever-shifting market share among the
exchanges with respect to new listings and the transfer of existing
listings between competitor exchanges demonstrates that issuers can
choose different listing markets in response to fee changes.
Accordingly, competitive forces constrain exchange listing fees. Stated
otherwise, changes to exchange listing fees can have a direct effect on
the ability of an exchange to compete for new listings and retain
existing listings.
    Given this competitive environment, the adoption of the proposed
increase to the initial listing fee and annual fees for various
categories of equity securities represents a reasonable attempt to
address the Exchange's increased costs in servicing these listings
while continuing to attract and retain listings.
    The Exchange proposes to make the aforementioned fee increases in
Sections 902.02 and 902.03 to better reflect the value of such listing
to issuers.
The Proposal Is an Equitable Allocation of Fees
    The Exchange believes its proposal equitably allocates its fees
among its market participants.
    The Exchange believes that the proposed amendments to the initial
listing fee and annual fees for equity securities are equitable because
they do not change the existing framework for such fees, but simply
increase the amount of the flat initial listing fee and per unit annual
fee to reflect increased operating costs. Similarly, as the fee
structure remains effectively unchanged apart from the proposed
increases in the rates paid by all issuers, the changes to the initial
listing fee or annual fees for equity securities neither target nor
will they have a disparate impact on any particular category of issuer.
The Proposal Is Not Unfairly Discriminatory
    The Exchange believes that the proposal is not unfairly
discriminatory.

The proposed fee changes are not unfairly discriminatory among issuers
of operating company equity securities because the same fee schedule
will apply to all such issuers. Further, the Exchange operates in a
competitive environment and its fees are constrained by competition in
the marketplace. Other venues currently list all of the categories of
securities covered by the proposed fees and if a company believes that
the Exchange's fees are unreasonable it can decide either not to list
its securities or to list them on an alternative venue.
    For the foregoing reasons, the Exchange believes that the proposal
is consistent with the Act.

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. The proposed rule change is
designed to ensure that the fees charged by the Exchange accurately
reflect the services provided and benefits realized by listed
companies. The market for listing services is extremely competitive.
Each listing exchange has a different fee schedule that applies to
issuers seeking to list securities on its exchange. Issuers have the
option to list their securities on these alternative venues based on
the fees charged and the value provided by each listing. Because
issuers have a choice to list their securities on a different national
securities exchange, the Exchange does not believe that the proposed
fee changes impose a burden on competition.
Intramarket Competition
    The proposed amended fees will be charged to all listed issuers on
the same basis. The Exchange does not believe that the proposed amended
fees will have any meaningful effect on the competition among issuers
listed on the Exchange.
Intermarket Competition
    The Exchange operates in a highly competitive market in which
issuers can readily choose to list new securities on other exchanges
and transfer listings to other exchanges if they deem fee levels at
those other venues to be more favorable. Because competitors are free
to modify their own fees, and because issuers may change their chosen
listing venue, the Exchange does not believe its proposed fee change
can impose any burden on intermarket competition.

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

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

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

    The foregoing rule change is effective upon filing pursuant to
section 19(b)(3)(A) \8\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \9\ thereunder, because it establishes a due, fee, or other charge
imposed by the Exchange.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend 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. If the Commission
takes such action, the Commission shall institute proceedings under
section 19(b)(2)(B) \10\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

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 (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-NYSE-2023-49 on the subject line.

Paper Comments

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

All submissions should refer to file number SR-NYSE-2023-49. This file
number should be included on the subject line if email 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 website (https://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 website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. Do not
include personal identifiable information in submissions; you should
submit only information that you wish to make available publicly. We
may redact in part or withhold entirely from publication submitted
material that is obscene or subject to copyright protection. All
submissions should refer to file number SR-NYSE-2023-49 and should be
submitted on or before January 2, 2024.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-27157 Filed 12-11-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Notices]
[Pages 34152-34153]
[FR Doc No: 2023-11315]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0547; FRL-11006-01-OMS]

Agency Information Collection Activities; Submission to the
Office of Management and Budget for Review and Approval; Comment
Request; Performance Evaluation Studies on Wastewater Laboratories
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Performance Evaluation Studies on
Wastewater Laboratories (EPA ICR Number 0234.14, OMB Control Number
2080-0021) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. This is a
proposed extension of the ICR, which is currently approved through May
31, 2023. Public comments were previously requested via the Federal
Register on November 30, 2022 during a 60-day comment period. This
notice allows for an additional 30 days for public comments.

DATES: Comments may be submitted on or before June 26, 2023.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2013-0547, to EPA online using www.regulations.gov (our preferred
method), by email to [email protected], or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all
comments received will be included in the public docket without change
including any personal information provided, unless the comment
includes profanity, threats, information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Gregory Savitske, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address: [email protected].

SUPPLEMENTARY INFORMATION: This is a proposed extension of the ICR,
which is currently approved through May 31, 2023. An agency may not
conduct or sponsor and a person is not required to respond to a
collection of information unless it displays a currently valid OMB
control number.
    Public comments were previously requested via the Federal Register
November, 30, 2022 during a 60-day comment period (87 FR 73357). This
notice allows for an additional 30 days for public comments. Supporting
documents, which explain in detail the information that the EPA will be
collecting, are available in the public docket for this ICR. The docket
can be viewed online at www.regulations.gov or in person at the EPA
Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    Abstract: Discharge Monitoring Report-Quality Assurance (DMR-QA)
study program participation is mandatory for major and selected minor
National Pollutant Discharge Elimination System (NPDES) permit holders
in accordance with Clean Water Act Section 308. The DMR-QA study
program is designed to evaluate the analytic ability of laboratories
that perform chemical, microbiological and whole effluent toxicity
(WET) analyses required in NPDES permits for reporting results in the
Discharge Monitoring Reports (DMR). Under DMR-QA, the permit holder is
responsible for having their in-house and/or contract laboratories
analyze performance evaluation samples and submit results to
proficiency testing (PT) providers for grading. Graded results are
transmitted by either the permit holder or PT provider to the
appropriate federal or state NPDES permitting authority. Permit holders
are responsible for submitting corrective action reports to the
appropriate permitting authority.
    Form numbers: EPA Form 6400-01.
    Respondents/affected entities: Major and selected minor permit
holders under the Clean Water Act's National Pollutant Discharge
Elimination System (NPDES).
    Respondent's obligation to respond: Mandatory under Clean Water Act
section 308(a).
    Estimated number of respondents: 5,500 (total).
    Frequency of response: Annually, On occasion.
    Total estimated burden: 36,300 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $5,852,825 (per year), which includes
$3,781,470 annualized capital or operation & maintenance costs.
    Changes in the estimates: There is no change of hours in the total
estimated

respondent burden compared with the ICR currently approved by OMB. Non-
labor costs for obtaining performance evaluation samples increased.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2023-11315 Filed 5-25-23; 8:45 am]
BILLING CODE 6560-50-P


              EPA Meeting with Minnesota Pollution Control Agency
                               February 7, 2012

EPA Region 5 staff participated in the Minnesota Pollution Control Agency (MPCA) UST program's annual winter meeting. EPA Staff lead a discussion on the EPA's proposed revisions of the UST regulations.  He handed out the document "Comparison Of 1988 UST Regulations And Proposed UST Regulations" dated October 2011 which is on the EPA OUST website.

Attendees:
EPA  -  Mark Restaino, EPA Region 5

MPCA's UST Program -
Attendee Name
Office Location
Nate Blasing
Duluth Region
Jeff Brandon
Duluth Region
Stan Kalinoski
Brainerd Region
Bryan Olson
Detroit Lakes Region
Carey Mattison
Marshall Region
Kerry Tullis
Mankato Region
Zach Klaus
Rochester Region
JoAnne Henry
St. Paul
Ben Palmquist
St. Paul
Jenalee Boise
St. Paul
Derek Pemble
St. Paul
Mike Rynders
St. Paul
Shirley Smith
St. Paul
Jake Mueller
St. Paul
Robert Dullinger
St. Paul
Michael Wilson
Employed by Hennepin County


[Federal Register Volume 88, Number 41 (Thursday, March 2, 2023)]
[Notices]
[Pages 13113-13114]
[FR Doc No: 2023-04313]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG23-85-000.
    Applicants: Sweetland Wind Farm, LLC.
    Description: Sweetland Wind Farm, LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 2/24/23.
    Accession Number: 20230224-5145.
    Comment Date: 5 p.m. ET 3/17/23.

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

    Docket Numbers: ER23-495-002.
    Applicants: AES CE Solutions, LLC.
    Description: Tariff Amendment: AES CE Solutions, LLC MBR Tariff to
be effective 11/24/2022.
    Filed Date: 2/24/23.
    Accession Number: 20230224-5122.
    Comment Date: 5 p.m. ET 3/17/23.

    Docket Numbers: ER23-757-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Amendment of Amended ISA, SA No.
5422, Queue No. AC1-158 in Docket No. ER23-757 to be effective 3/1/
2023.
    Filed Date: 2/24/23.
    Accession Number: 20230224-5013.
    Comment Date: 5 p.m. ET 3/17/23.

    Docket Numbers: ER23-1173-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2023-02-24_Schedules 24 and
24A Cost Recovery to be effective 4/26/2023.
    Filed Date: 2/24/23.
    Accession Number: 20230224-5002.
    Comment Date: 5 p.m. ET 3/17/23.

    Docket Numbers: ER23-1174-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2023-02-24_SA 1756 METC-
Consumers Energy 16th Rev GIA (G479B) to be effective 2/1/2023.
    Filed Date: 2/24/23.
    Accession Number: 20230224-5003.
    Comment Date: 5 p.m. ET 3/17/23.

    Docket Numbers: ER23-1175-000.
    Applicants: Dominion Energy South Carolina, Inc.
    Description: Tariff Amendment: Jasper Provisional LGIA Notice of
Cancellation to be effective 2/7/2023.
    Filed Date: 2/24/23.
    Accession Number: 20230224-5018.
    Comment Date: 5 p.m. ET 3/17/23.

    Docket Numbers: ER23-1176-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: First Revised ISA, Service
Agreement No. 6248; QUeue No. AE2-206/AF1-078 to be effective 1/18/
2023.
    Filed Date: 2/24/23.
    Accession Number: 20230224-5077.
    Comment Date: 5 p.m. ET 3/17/23.

    Docket Numbers: ER23-1177-000.
    Applicants: Arizona Public Service Company.
    Description: Sec.  205(d) Rate Filing: Rate Schedule No. 217,
Exhibit B.PAD-LIB to be effective 4/28/2023.
    Filed Date: 2/24/23.
    Accession Number: 20230224-5082.
    Comment Date: 5 p.m. ET 3/17/23.

    Docket Numbers: ER23-1178-000.
    Applicants: Alabama Power Company, Georgia Power Company,
Mississippi Power Company.
    Description: Tariff Amendment: Alabama Power Company submits tariff
filing per 35.15: SE Solar II (Fayette Solar) LGIA Termination Filing
to be effective 2/3/2023.
    Filed Date: 2/24/23.
    Accession Number: 20230224-5093.
    Comment Date: 5 p.m. ET 3/17/23.

    Docket Numbers: ER23-1179-000.
    Applicants: HIKO Energy, LLC.
    Description: Notice of Cancellation of Market Based Rate Tariff of
HIKO Energy, LLC.
    Filed Date: 2/24/23.
    Accession Number: 20230224-5156.
    Comment Date: 5 p.m. ET 3/17/23.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211

and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on
or before 5:00 p.m. Eastern time on the specified comment date.
Protests may be considered, but intervention is necessary to become a
party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 24, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-04313 Filed 3-1-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 142 (Tuesday, July 24, 2018)]
[Notices]
[Pages 35006-35007]
[FR Doc No: 2018-15777]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2647]

Inborn Errors of Metabolism That Use Dietary Management:
Considerations for Optimizing and Standardizing Diet in Clinical Trials
for Drug Product Development; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Inborn
Errors of Metabolism That Use Dietary Management: Considerations for
Optimizing and Standardizing Diet in Clinical Trials for Drug Product
Development.'' This draft guidance describes FDA's current
recommendations regarding how to optimize and standardize dietary
management in clinical trials for the development of drugs treating
inborn errors of metabolism (IEM) for which dietary management is a key
component of patients' metabolic control. Optimizing dietary management
in these patients before entry into and during the clinical trial(s) is
essential to providing an accurate evaluation of the efficacy of new
drug products.

DATES: Submit either electronic or written comments on the draft
guidance by September 24, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

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 No.
FDA-2018-D-2647 for ``Inborn Errors of Metabolism That Use Dietary
Management: Considerations for Optimizing and Standardizing Diet in
Clinical Trials for Drug Product Development; Draft Guidance for
Industry; Availability.'' Received comments 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.
     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 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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or Office
of Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Dina Zand, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5239, Silver Spring, MD 20993,<PHONE_NUMBER>; or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Inborn Errors of Metabolism That Use Dietary Management:
Considerations for Optimizing and Standardizing Diet in Clinical Trials
for Drug Product Development.'' This draft guidance describes FDA's
current recommendations regarding how to optimize and standardize
dietary management in clinical trials for the development of drugs
treating IEM for which dietary management is a key component of
patients' metabolic control. Optimizing dietary management in these
patients before entry into and during the clinical trial(s) is
essential to providing an accurate evaluation of the efficacy of new
drug products.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on how sponsors
can optimize and standardize dietary management for clinical trials in
the development of drugs for inborn errors of metabolism that use
dietary management. It does not establish any rights for any person and
is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: July 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-15777 Filed 7-23-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Rules and Regulations]
[Pages 27511-27513]
[FR Doc No: 2018-12659]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0535]
RIN 1625-AA00

Safety Zone; Lewis River, Ridgefield, WA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of the Lewis River near Ridgefield, WA. This action is
necessary

to provide for the safety of life on these navigable waters during a
fireworks display on June 30, 2018. This regulation prohibits persons
and vessels from being in the safety zone unless authorized by the
Captain of the Port Columbia River or a designated representative.

DATES: This rule is effective from 9:15 p.m. to 11:45 p.m. on June 30,
2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0535 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LCDR Laura Springer, Waterways Management Division,
Marine Safety Unit Portland, Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    Pekin Ferry will be conducting a fireworks display from 10:15 p.m.
to 10:45 p.m. on June 30, 2018, to commemorate Independence Day. The
fireworks are to be launched from a barge in the Lewis River in the
vicinity of Pekin Ferry in Ridgefield, WA. Hazards from firework
displays include accidental discharge of fireworks, dangerous
projectiles, and falling hot embers or other debris. The Captain of the
Port Columbia River (COTP) has determined that potential hazards
associated with the fireworks to be used in this display will be a
safety concern for anyone within a 450-yard radius of the barge.
    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it would be impracticable to complete
a notice-and-comment rulemaking by the date of the fireworks display,
June 30, 2018.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because an enforcement regulation is
needed on June 30, 2018, to respond to the potential safety hazards
associated with the fireworks display.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Columbia River (COTP) has determined that
potential hazards associated with the fireworks display on June 30,
2018, will be a safety concern for anyone within a 450-yard radius of
the launch site. This rule is needed to protect personnel, vessels, and
the marine environment in the navigable waters within the safety zone
before, during, and after the scheduled event.

IV. Discussion of the Rule

    This rule establishes a safety zone from 9:15 p.m. until 11:45 p.m.
on June 30, 2018. The safety zone will cover all navigable waters of
the Lewis River within 450 yards of a barge located at 45[deg]52'07''
N, 122[deg]43'53'' W, in vicinity of Pekin Ferry in Ridgefield, WA. The
duration of the zone is intended to ensure the safety of vessels and
these navigable waters an hour before, during, and an hour after the
scheduled 10:15 p.m. to 10:45 p.m. fireworks display. No vessel or
person will be permitted to enter the safety zone without obtaining
permission from the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. Vessel traffic
will be able to safely transit around this safety zone which will
impact a small designated area of the Lewis River for approximately 2
and \1/2\ hours when vessel traffic is normally low. Moreover, the
Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine
channel 16 about the zone, and the rule allows vessels to seek
permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by

employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The
Coast Guard will not retaliate against small entities that question or
complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This rule involves
a safety zone lasting approximately 2 and \1/2\ hours that will
prohibit entry within 450 yards of a fireworks barge. It is
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A
Record of Environmental Consideration supporting this determination is
available in the docket where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T13-0535 to read as follows:

Sec.  165.T13-0535   Safety Zone; Lewis River, Ridgefield, WA.

    (a) Safety zone. The following area is designated a safety zone:
Waters of the Lewis River, within a 450-yard radius of the fireworks
barge located at 45[deg]52'07'' N, 122[deg]43'53'' W in vicinity of
Pekin Ferry in Ridgefield, WA.
    (b) Regulations. In accordance with Sec.  165.23, no person may
enter or remain in this safety zone unless authorized by the Captain of
the Port Columbia River or his designated representative. Also in
accordance with Sec.  165.23, no person may bring into, or allow to
remain in this safety zone any vehicle, vessel, or object unless
authorized by the Captain of the Port Columbia River or his designated
representative.
    (c) Enforcement period. This section will be enforced from 9:15
p.m. to 11:45 p.m. on June 30, 2018.

    Dated: June 6, 2018.
D.F. Berliner,
Captain, U.S. Coast Guard, Acting Captain of the Port, Sector Columbia
River.
[FR Doc. 2018-12659 Filed 6-12-18; 8:45 am]
 BILLING CODE 9110-04-P