55513 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations ([ 3[( 6 chloro 3 pyridinyl) methyl] 2 thiazolidinylidene] cyanamide) and metabolites retaining the thiazolidine ring intact, measured and expressed in terms of thiacloprid, per se, in or on the following commodities:

Commodity Parts per million Apple, wet pomace 0.60 Cattle, fat .............. 0.020 Cattle, kidney ........ 0.050 Cattle, liver ............ 0.15 Cattle, meat .......... 0.030 Cattle, meat byproducts ............ 0.050 Cotton, gin byproducts .................... 11.0 Cotton, undelinted seed .................. 0.020 Fruit, pome, group 11 ...................... 0.30 Goat, fat ................ 0.020 Goat, kidney ......... 0.050 Goat, liver ............. 0.15 Goat, meat ............ 0.030 Goat, meat byproducts .................... 0.050 Horse, fat .............. 0.020 Horse, kidney ........ 0.050 Horse, liver ........... 0.15 Horse, meat .......... 0.030 Horse, meat byproducts ............ 0.050 Milk ....................... 0.030 Sheep, fat ............. 0.020 Sheep, kidney ....... 0.050 Sheep, liver ........... 0.15 Sheep, meat ......... 0.030 Sheep, meat byproducts ............ 0.050 ( b) Section 18 emergency exemptions. [ Reserved] ( c) Tolerances with regional registrations. [ Reserved] ( d) Indirect or inadvertent residues. [ Reserved] [ FR Doc. 03   24371 Filed 9   25   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0301; FRL   7326   7]

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

SUMMARY: This regulation establishes tolerances for residues of fenhexamid in or on cucumber; fruit, stone, group 12, except plum, prune, fresh, postharvest; kiwifruit, postharvest; leafy greens subgroup 4A, except spinach; plum, prune, dried; plum, prune, fresh; vegetable, fruiting, group 8, except nonbell pepper. 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). EPA is also deleting certain fenhexamid tolerances that are no longer needed as a result of this action. DATES: This regulation is effective September 26, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0301, must be received on or before November 25, 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: Hoyt Jamerson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   9368; e mail address: jamerson. hoyt@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:   Industry ( NAICS 111), e. g., Crop production.   Industry ( NAICS 112), e. g., Animal production.   Industry ( NAICS 311), e. g., Food manufacturing.   Industry ( NAICS 32532), e. g., Pesticide manufacturing. 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   0301. 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. 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 May 21, 2003 ( 68 FR 27799) ( FRL   7308   4), 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 2E6463, 2E6496, 3E6532, and 3E6541) by IR   4, 681 U. S. Highway # 1 South, North Brunswick, NJ 08902   3390. That notice included a summary of the petitions prepared by Arvesta Corporation, 100 First Street, Suite 1700, San Francisco, CA 94105, the registrant. There were no comments received in response to the notice of filing. The petitions requested that 40 CFR 180.553 be amended by establishing tolerances for residues of the fungicide VerDate jul< 14> 2003 14: 38 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00081 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1 55514 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations fenhexamid, N( 2,3 dichloro 4 hydroxyphenyl) 1 methyl cyclohexane carboxamide, in or on food commodities as follows: cucumber at 2.0 parts per million ( ppm) ( PP 2E6496); fruit, stone, group 12, postharvest at 10.0 ppm ( PP 3E6541); kiwifruit, postharvest at 15.0 ppm ( PP 2E6463); leafy greens, subgroup 4A, except spinach at 30.0 ppm ( PP 3E6532); vegetable, fruiting, group 8, at 2.0 ppm ( PP2E6496). IR   4 subsequently amended PP 3E6541 to propose tolerances for fruit, stone, group 12, except plum, prune, fresh, postharvest at 10.0 ppm and separate tolerances for plum, prune, dried at 2.5 ppm and plum, prune, fresh at 1.5 ppm. IR   4 also amended PP 2E6496 to propose tolerances for vegetable, fruiting, group 8, except nonbell pepper at 2.0 ppm. EPA is deleting the established fenhexamid tolerance for fruit, stone, except plum, prune, fresh at 6.0 ppm. This tolerance is no longer needed since this action establishes a higher tolerance at 10.0 ppm to cover both pre and postharvest application to stone fruit, except plum, prune, fresh. EPA has received objections to tolerances it established for residues of fenhexamid on a variety of berry crops and pistachio ( 67 FR 19114) ( FRL   6829   9). The objections were filed by the Natural Resources Defense Council ( NRDC) and raised several issues regarding aggregate exposure estimates and the additional safety factor for the protection of infants and children. NRDC's objections raise complex legal, scientific, policy, and factual matters and EPA has initiated a public comment period on them in the Federal Register of June 19, 2002 ( 67 FR 41628) ( FRL   7167   7), which ended on October 16, 2002. Although that proceeding remains ongoing, prior to acting on this current tolerance action, EPA reviewed the fenhexamid specific objections raised by NRDC and has addressed them at relevant points throughout this preamble. 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 residues of fenhexamid on cucumber at 2.0 ppm; fruit, stone, group 12, except plum, prune, fresh, postharvest at 10.0 ppm; kiwifruit, postharvest at 15.0 ppm; leafy greens subgroup 4A, except spinach at 30.0 ppm; plum, prune, dried at 2.5 ppm; plum, prune, fresh at 1.5 ppm; vegetable, fruiting, group 8, except nonbell pepper at 2.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance 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 fenhexamid are discussed in Unit II. A. of the final rule on Fenhexamid; Pesticide Tolerance published in the Federal Register of April 13, 2000 ( 65 FR 19842) ( FRL   6553   7).

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 intra species 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 fenhexamid used for human risk assessment is shown in Table 1 of this unit:

VerDate jul< 14> 2003 14: 38 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00082 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1 55515 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations TABLE 1.   SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FENHEXAMID FOR USE IN HUMAN RISK ASSESSMENT Exposure Scenario Dose Used in Risk Assessment UF Special FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary ( General Population including infants and children) None UF = NA Acute RfD = None FQPA SF = 1X aPAD = acute RfD ÷ FQPA SF = None Not selected. No appropriate toxicological endpoint attributable to a single exposure was identified in the available toxicology studies.

Chronic Dietary ( All populations) NOAEL = 17 mg ai/ kg/ day UF = 100 Chronic RfD = 0.17 mg/ kg/ day 1X cPAD = chronic RfD ÷ FQPA SF = 0.17 mg/ kg/ day 1 Year Feeding Dog. Decreased RBC count, hemoglobin and hematocrit and increased Heinz bodies in males and females; increased adrenal weights and intracytoplasmic vacuoles in adrenal cortex in females at the LOAEL of 124 mg/ kg/ day.

Short Term ( 1   30 days) and Intermediate Term ( 1   6 months) Dermal NOAEL = 1,000 mg ai/ kg/ day Dermal absorption rate = 20% Residential MOE = Not applicable 21 Day Dermal Rabbit. In the developmental toxicity study in rabbits, decreased body weight gain and food consumption at LOAEL of 1,500 mg/ kg/ day ( dermal equivalent dose using 20% dermal absorption factor); NOAEL was 500 mg/ kg/ day ( dermal equivalent dose). Dermal exposure is not expected since there are no residential uses.

Long Term Dermal (> 6 months) None Dermal absorption rate = 20% Residential MOE = Not applicable Not selected. Long term dermal exposure is not expected since there are no residential uses.

Short Term ( 1   30 days), Intermediate Term ( 1   6 months), and Long term (> 6 months) Inhalation None Residential MOE = Not applicable Not selected. Inhalation exposure is not expected since there are no residential uses.

Cancer ( oral, dermal, inhalation) None Not applicable Fenhexamid is classified as a `` not likely'' human carcinogen based on the lack of evidence of carcinogenicity in mice and rats and the lack of genotoxicity in a battery of mutagenicity studies.

* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established ( 40 CFR 180.553) for the residues of fenhexamid, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from fenhexamid 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 one day or single exposure. An acute risk assessment was not performed. No toxicological endpoint attributable to a single ( acute) dietary exposure was identified. ii. Chronic exposure. In conducting this chronic dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database ( DEEMFCIDTM 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. An unrefined, Tier 1 chronic dietary exposure assessment was performed using tolerance level residues ( established and recommended) and 100% crop treated. DEEMTM default processing/ concentration factors were used for all processed commodities. iii. Cancer. Fenhexamid has been classified as a `` not likely'' human carcinogen. Therefore, a quantitative cancer dietary exposure assessment was not performed. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for fenhexamid in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of fenhexamid. 2. Dietary exposure from drinking water. 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 SCI GROW model is used to predict pesticide concentrations in shallow groundwater. For a screeninglevel assessment for surface water EPA will use FIRST ( a tier 1 model) before using PRZM/ EXAMS ( a tier 2 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 include 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 VerDate jul< 14> 2003 14: 38 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00083 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1 55516 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern. 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 fenhexamid they are further discussed in the aggregate risk sections in Unit III. E. Based on the FIRST and SCI GROW models the estimated environmental concentrations ( EECs) of fenhexamid for acute and chronic surface water exposures are estimated to be 28.7 parts per billion ( ppb) and 1.14 ppb, respectively. The EECs for acute and chronic ground water exposure is estimated to be 0.0007 ppb. 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). Fenhexamid is not registered for use on any sites that would result in residential exposure. 4. Cumulative effects from 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 fenhexamid 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 fenhexamid and any other substances and fenhexamid 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 fenhexamid 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 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. In the rat and the rabbit developmental toxicity studies, neither quantitative nor qualitative evidence of increased susceptibility of fetuses to in utero exposure to fenhexamid was observed. In the rat reproduction study, qualitative susceptibility was evidenced as significantly decreased pup body weights in both generations during the lactation period ( on lactation days 7, 14, and 21 in the F2 generation and lactation days 14 and 21 in the F1 generation offspring) in the presence of lesser maternal toxicity ( alterations in clinical chemistry parameters and decreased organ weights without collaborative histopathology). Considering the overall toxicity profile and the doses and endpoints selected for risk assessment for fenhexamid, the degree of concern for the effects observed in this study was characterized as low, noting that there is a clear NOAEL and well characterized dose response for the offspring effects observed and that these effects occurred in the presence of parental toxicity. No residual uncertainties were identified. The NOAEL of 17 mg/ kg/ day from the chronic dog study used to establish the chronic Reference Dose ( cRfD) for the General Population ( no aRfD was established for any population subgroup) is lower than the NOAEL of 38.2 mg/ kg/ day in the reproduction study in which the offspring effects of concern were observed ( LOAEL = 406 mg/ kg/ day). 3. Conclusion. There is a complete toxicity data base for fenhexamid and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X Safety Factor to protect infants and children should be reduced to 1X for the following reasons:   There are no residual uncertainties for pre and/ or post natal toxicities via the oral route since the doses selected for overall risk assessments would address the concerns for the developmental and offspring toxicities seen in the above mentioned studies.   There are no residual uncertainties for pre and/ or post natal toxicities via the dermal route since the dose/ endpoint/ study/ species of concern was used for dermal risk assessment.   The toxicology data base is complete.   Developmental neurotoxicity studies are not required for fenhexamid based on the following weight of theevidence considerations:   Lack of evidence of abnormalities in the development of the fetal nervous system in the pre/ post natal studies.   Neither brain weight nor histopathological examination of the nervous system was affected in the subchronic and chronic studies.   Decreased body temperatures observed in male rats in the acute neurotoxicity study were not considered to be toxicologically significant.   The dietary ( food) exposure assessment utilizes existing and proposed tolerance level residues and assumes 100% of crops treated with fenhexamid. The assessment is based on reliable data and is not expected to underestimate exposure/ risk.   Conservative assumptions are used in the drinking water models. The drinking water exposure assessment is not expected to underestimate exposure/ risk.   Fenhexamid is not registered for use sites that would result in residential exposure.

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 VerDate jul< 14> 2003 14: 38 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00084 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1 55517 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations 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 groundwater are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water ( when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP 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, OPP 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. An acute risk assessment was not performed. No toxicological endpoint attributable to a single ( acute) dietary exposure was identified. Therefore, acute risk from exposure to fenhexamid is not expected. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to fenhexamid from food will utilize 9.9 % of the cPAD for the U. S. population, 19.6 % of the cPAD for all infants < 1 year, 21.8% of the cPAD for children 1 to 2 years, the population subgroup at greatest exposure, and 8.8% of the cPAD for females 13 to 50 years old. There are no residential uses for fenhexamid that result in chronic residential exposure to fenhexamid. However, there is potential for chronic dietary exposure to fenhexamid 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 2 of this unit:

TABLE 2.   AGGREGATE RISK ASSESSMENT FOR CHRONIC ( NON CANCER) EXPOSURE TO FENHEXAMID Population Subgroup cPAD mg/ kg/ day % cPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Chronic DWLOC ( ppb)

U. S. population 0.17 9.9 1.14 0.0007 5,363 All infants < 1 year 0.17 19.6 1.14 0.0007 1,367 Children 1 to 2 years 0.17 21.8 1.14 0.0007 1,330 Females 13   50 years 0.17 8.8 1.14 0.0007 4,980 3. Short term and intermediate term risk. Short term and intermediate term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). In its objections to a separate fenhexamid tolerance action, NRDC claims that residential short term and intermediateterm risk assessments are data gaps for fenhexamid. EPA did not conduct shortterm and intermediate term risk assessments for fenhexamid since the pesticide is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of risk from chronic exposure to residues in food and water, which do not exceed the Agency's level of concern. 4. Aggregate cancer risk for U. S. population. EPA has classified fenhexamid as a `` not likely'' human carcinogen. The Agency concludes that pesticidal uses of fenhexamid do not pose a cancer risk to humans. 5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to fenhexamid residues.

IV. Other Considerations A. Analytical Enforcement Methodology Bayer AG Method 00362 has previously undergone a successful method trial and method validation, and is the enforcement method for all the fenhexamid established tolerances. 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; email address: residuemethods@ epa. gov.

V. Conclusion Therefore, the tolerance is established for residues of fenhexamid, N 2,3 dichloro 4 hydroxyphenyl) 1 methyl cyclohexanecarboxamide, in or on cucumber at 2.0 ppm; fruit, stone, group 12, except plume, prune, fresh, postharvest at 10.0 ppm; kiwifruit, postharvest at 15.0 ppm; leafy greens subgroup 4A, except spinach at 30.0 ppm; plum, prune, dried at 2.5 ppm; plum, prune, fresh at 1.5 ppm; vegetable, fruiting group 8, except nonbell pepper at 2.0 ppm.

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.

VerDate jul< 14> 2003 14: 38 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00085 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1 55518 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations 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   0301 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 25, 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   0301, 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 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 VerDate jul< 14> 2003 14: 38 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00086 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1 55519 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations 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: September 10, 2003. Debra Edwards, Director, Registration Division, Office of Pesticide Programs.

 Therefore, 40 CFR part 180 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 180.553 is amended as follows: a. By revising the commodities plum, prune, dried and plum, prune, fresh in the table in paragraph ( a). b. By removing the commodity fruit, stone, except plum, prune, fresh in the table in paragraph ( a). c. By alphabetically adding commodities in the table in paragraph ( a).

§ 180.553 Fenhexamid; tolerances for residues.

( a) * * *

Commodity Parts per million * * * * *

Cucumber 2.0 Fruit, stone, group 12, except plum, prune, fresh, postharvest 10.0 * * * * *

Kiwifruit, postharvest 15.0 * * * * *

Leafy greens, subgroup 4A, except spinach 30.0 * * * * *

Plum, prune, dried 2.5 Plum, prune, fresh 1.5 * * * * *

Vegetable, fruiting, group 8, except nonbell pepper 2.0 * * * * *

[ FR Doc. 03   24013 Filed 9   25   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0146; FRL   7320   8]

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

SUMMARY: This regulation establishes a tolerance for residues of chlorfenapyr [ 4 bromo 2( 4 chlorophenyl) 1 ( ethoxymethyl) 5( trifluoromethyl) 1Hpyrrole 3 carbonitrile] in or on vegetables, fruiting, group 8. BASF Agro Research, now BASF Corporation requested this tolerance 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 26, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0146, must be received on or before November 25, 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: Ann Sibold, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   6502; e mail address: sibold. ann@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you grow fruiting vegetables in commercial greenhouses, consume vegetables that were raised in commercial greenhouses, or provide pest control services to commercial greenhouses. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS 111)   Pesticide manufacturing ( NAICS 32532)   Other food crops grown under cover ( NAICS 111419)   Entomological services, agricultural; insect control for crops ( NAICS 115112)   Agricultural production or harvesting crews ( NAICS 115115) This listing is not intended to be exhaustive, but rather provides a guide VerDate jul< 14> 2003 14: 38 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00087 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1


[Federal Register: January 11, 2010 (Volume 75, Number 6)]
[Notices]
[Page 1395]
[DOCID:fr11ja10-55]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0606]

General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee; Amendment of Notice

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing an
amendment to the notice of a meeting of the General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee. This meeting
was announced in the Federal Register of November 17, 2009 (74 FR
59194). The amendment is being made to reflect a change in the Contact
Person and Procedure portions of the document, and to provide notice of
the availability of a docket for public comment. There are no other
changes.

FOR FURTHER INFORMATION CONTACT:  Margaret McCabe-Janicki, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., White Oak 66, rm. 1535, Silver Spring, MD 20993,
301-796-7029, or FDA Advisory Committee Information Line, 1-800-741-
8138<PHONE_NUMBER> in the Washington, DC area), code<PHONE_NUMBER>. Please
call the Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION:  In FR Doc. E9-27491, appearing on page
59194, in the Federal Register of Tuesday, November 17, 2009, the
following corrections are made:
    1. On page 59194, in the second column, under Contact Person, the
first six lines ``Peter L. Hudson, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., White
Oak 66, rm. 3618, Silver Spring, MD 20993,<PHONE_NUMBER> or FDA
Advisory'' are removed and replaced with ``Margaret McCabe-Janicki,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Avenue., White Oak 66, rm. 1535,
Silver Spring, MD 20993,<PHONE_NUMBER>, or FDA Advisory''.
    2. On page 59194, in the third column, a Comments portion is added
before the Agenda portion of the document to read: ``Comments: FDA is
opening a docket for public comment on this document. The docket number
is FDA-2009-N-0606. The docket will open for public comment on January
11, 2010. The docket will close on March 19, 2010. Interested persons
may submit electronic or written comments regarding this document.
Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management, Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.''
    3. On pages 59194 and 59195, beginning on page 59194 in the third
column, under Procedure, the year ``2009'' is changed to read ``2010''
everywhere that it appears.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: January 5, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-172 Filed 1-8-10; 8:45 am]
BILLING CODE 4160-01-S


Nathalie Simon/DC/USEPA/US

06/10/2008 11:41 AM

To

"King, Heidi R."<EMAIL_ADDRESS>Lydia Wegman/RTP/USEPA/US@EPA

cc

"Art Fraas"<EMAIL_ADDRESS>Brian Heninger/DC/USEPA/US@EPA, Charles Fulcher/RTP/USEPA/US@EPA, Kathy Kaufman/RTP/USEPA/US@EPA, Neal Fann/RTP/USEPA/US@EPA, Ron Evans/RTP/USEPA/US@EPA, Tricia Crabtree/RTP/USEPA/US@EPA

Subject

Re: Could we have a meeting tomorrow to discuss our response to your requests on the lead RIA?

Thanks.

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

Sent from my BlackBerry Wireless Handheld

----- Original Message -----

From: "King, Heidi R."<EMAIL_ADDRESS> Sent: 06/10/2008 11:36 AM AST

To: Lydia Wegman; Nathalie Simon

Cc: "Fraas, Arthur G."<EMAIL_ADDRESS>Brian Heninger; Charles Fulcher; Kathy Kaufman; Neal Fann; Ron Evans; Tricia Crabtree

Subject: RE: Could we have a meeting tomorrow to discuss our response to your requests on the lead RIA?

Confirming noon today -- we'll dial in to 4407

Thanks,

heidi

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Tuesday, June 10, 2008 11:35 AM

To<EMAIL_ADDRESS> Cc: Fraas, Arthur G<EMAIL_ADDRESS> <EMAIL_ADDRESS>King, Heidi R.;

<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> Subject: Re: Could we have a meeting tomorrow to discuss our response to

your requests on the lead RIA?

I haven't yet heard back from Heidi.  If we have the meeting at noon,

we'll use 4407.

             Nathalie

             Simon/DC/USEPA/U

             S                                                       To

                                      "King, Heidi R."

             06/10/2008 11:28<EMAIL_ADDRESS>

             AM                       Lydia Wegman/RTP/USEPA/US@EPA,

                                      "Art Fraas"

<EMAIL_ADDRESS>

                                                                     cc

                                      Ron Evans/RTP/USEPA/US@EPA, Kathy

                                      Kaufman/RTP/USEPA/US@EPA, Tricia

                                      Crabtree/RTP/USEPA/US@EPA, Neal

                                      Fann/RTP/USEPA/US@EPA, Brian

                                      Heninger/DC/USEPA/US@EPA, Charles

                                      Fulcher/RTP/USEPA/US@EPA

                                                                Subject

                                      Re: Could we have a meeting

                                      tomorrow to discuss our response

                                      to your requests on the lead RIA?

                                      (Document link: Lydia Wegman)

Has the noon meeting time been confirmed? If so, has a call-in number

been established?

Thanks!

Nathalie

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

Sent from my BlackBerry Wireless Handheld

----- Original Message -----

From: "King, Heidi R."<EMAIL_ADDRESS> Sent: 06/10/2008 09:57 AM AST

To: Lydia Wegman; "Fraas, Arthur G."<EMAIL_ADDRESS> Cc: Ron Evans; Kathy Kaufman; Tricia Crabtree; Neal Fann; Nathalie

Simon; Brian Heninger; Charles Fulcher

Subject: RE: Could we have a meeting tomorrow to discuss our response to

your requests on the lead RIA?

Thanks, Lydia,

Noon seems to work; I'll confirm shortly

heidi

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Monday, June 09, 2008 5:15 PM

To: Fraas, Arthur G.; King, Heidi R.

Cc: Ron Evans; Kathy Kaufman; Tricia Crabtree; Neal Fann; Nathalie

Simon; Brian Heninger; Charles Fulcher

Subject: Could we have a meeting tomorrow to discuss our response to

your requests on the lead RIA?

Art and Heidi,

I've had a couple of e-mail exchanges with Ron today about what we think

we can do to respond to the issues we discussed this morning.  I believe

we can get you a draft of the memo with the results of the additional

C-R functions this week, and hopefully by Wednesday or Thursday AM.  We

can make the deletions you requested.  Ron is concerned about our

ability to make quickly the baseline changes and the changes in the

presentation of benefits that you requested and it is those issues that

we need to discuss.  .

My calendar is kind of busy tomorrow.  The best times for me would be

noon or 12:30, with 10:30 being a second best time. If there's another

time that works best for you, I'll try to juggle my schedule.  Please

let me know when you might be available.  Thanks a lot.


[Federal Register Volume 78, Number 213 (Monday, November 4, 2013)]
[Notices]
[Pages 66009-66010]
[FR Doc No: 2013-26283]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-0775]

Determination That INVEGA (Paliperidone) Extended-Release Tablet,
12 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined that
INVEGA (paliperidone) extended-release tablet, 12 milligrams (mg), was
not withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for paliperidone extended-release tablet, 12 mg,
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Linda Jong, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    INVEGA (paliperidone) extended-release tablet, 12 mg, is the
subject of NDA 21-999, held by Janssen Pharmaceuticals, Inc., and
initially approved on December 19, 2006. INVEGA extended-release
tablets are indicated for the treatment of schizophrenia and the
treatment of schizoaffective disorder as monotherapy and as an adjunct
to mood stabilizers and/or antidepressants.
    Janssen Pharmaceuticals, Inc., has never marketed INVEGA
(paliperidone) extended-release tablet, 12 mg. In previous instances
(see, e.g., 72 FR 9763, 61 FR 25497), the Agency has determined that,
for purposes of Sec. Sec.  314.161 and 314.162, never marketing an
approved drug product is equivalent to withdrawing the drug from sale.
The other strengths of INVEGA (paliperidone) that are approved under
NDA 21-999 are being marketed.
    Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated
June 25, 2013 (Docket No. FDA-2013-P-0775), under 21 CFR 10.30,
requesting that the Agency determine whether

INVEGA (paliperidone) extended-release tablet, 12 mg, was discontinued
for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that INVEGA (paliperidone) extended-release tablet,
12 mg, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
INVEGA (paliperidone) extended-release tablet, 12 mg, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of INVEGA (paliperidone)
extended-release tablet, 12 mg, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events to determine whether INVEGA (paliperidone) extended-
release tablet, 12 mg, was withdrawn for reasons of safety or
effectiveness. We have reviewed the available information and
determined that the product was not withdrawn from sale for reasons of
safety or effectiveness.
    Accordingly, the Agency will continue to list INVEGA (paliperidone)
extended-release tablet, 12 mg, in the ``Discontinued Drug Product
List'' section of the Orange Book. The ``Discontinued Drug Product
List'' delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to INVEGA (paliperidone) extended-
release tablet, 12 mg, may be approved by the Agency as long as they
meet all other legal and regulatory requirements for the approval of
ANDAs. If FDA determines that labeling for this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.

    Dated: October 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26283 Filed 11-1-13; 8:45 am]
BILLING CODE 4160-01-P