52354 Federal Register / Vol. 68, No. 170 / Wednesday, September 3, 2003 / Rules and Regulations constitutes good cause under 5 U. S. C. 553( b)( B).

IV. Regulatory Assessment Requirements This final rule implements technical amendments to the Code of Federal Regulations and it does not otherwise impose or amend any requirements. As such, the Office of Management and Budget ( OMB) has determined that a technical amendment is not a `` significant regulatory action'' subject to review by OMB 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, entitled 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 the action does 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 action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408( n)( 4). 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.

V. Submission to Congress and the Comptroller General 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 21, 2003. Debra Edwards, Director, Registration Division, Office of Pesticide Programs.

 Therefore, 40 CFR part 180 is corrected 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 180.442 is amended by alphabetically adding the commodity `` sweet potato, roots'' to the table in paragraph ( b) to read as follows:

§ 180.442 Bifenthrin; tolerances for residues.

* * * * * ( b) * * *

Commodity Parts per million Expiration/ revocation date * * * * * Sweet potato, roots 0.05 12/ 31/ 03 * * * * *

* * * * *

[ FR Doc. 03   22314 Filed 9   2   03; 8: 45 a. m.]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0267; FRL   7321   3]

Lambda Cyhalothrin; Pesticide Tolerances for Emergency Exemptions AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes a time limited tolerance for combined residues of the pyrethroid lambdacyhalothrin 1: 1 mixture of ( S) a cyano 3 phenoxybenzyl( Z)( 1R, 3R) 3( 2 chloro 3,3,3 trifluoroprop 1 enyl) 2,2 dimethylcyclopropanecarboxylate and ( R) a cyano 3 phenoxybenzyl( Z) ( 1S, 3S) 3( 2 chloro 3,3,3 trifluoroprop 1 enyl) 2,2 dimethylcyclopropanecarboxylate and its epimer expressed as epimer of lambda cyhalothrin, a 1: 1 mixture of VerDate jul< 14> 2003 15: 35 Sep 02, 2003 Jkt 200001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 03SER1. SGM 03SER1 52355 Federal Register / Vol. 68, No. 170 / Wednesday, September 3, 2003 / Rules and Regulations ( S) a cyano 3 phenoxybenzyl( Z) ( 1S, 3S)  3( 2 chloro 3,3,3 trifluoroprop 1 enyl) 2,2 dimethylcyclopropanecarboxylate and ( R) a cyano 3 phenoxybenzyl( Z) ( 1R, 3R) 3( 2 chloro 3,3,3 trifluoroprop 1 enyl) 2,2 dimethylcyclopropanecarboxylate in or on clover, forage and clover, hay. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) authorizing use of the pesticide on alfalfa/ clover/ grass mixed stands. This regulation establishes a maximum permissible level for residues of lambdacyhalothrin and its epimer in these food commodities. The tolerances will expire and are revoked on December 31, 2005. DATES: This regulation is effective September 3, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0267, must be received on or before November 3, 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 VII. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number:( 703) 308   9367; e mail address: sec 18 mailbox@ 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 a Federal or State government agency involved in administration of environmental quality programs ( i. e., Departments of Agriculture, Environment, etc). Potentially affected entities may include, but are not limited to:   Federal or State Government Entity, ( NAICS 9241), i. e., Departments of Agriculture, Environment, etc. 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   0267. 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 EPA, on its own initiative, in accordance with sections 408( e) and 408( l)( 6) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a, is establishing tolerances for combined residues of the insecticide lambdacyhalothrin and its epimer, in or on clover, forage at 5.0 parts per million ( ppm) and clover, hay at 6.0 ppm. These tolerances will expire and are revoked on December 31, 2005. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations. Section 408( l)( 6) of the FFDCA requires EPA to establish a time limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408( e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i. e., without having received any petition from an outside party. 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. . . .'' Section 18 of the FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that `` emergency conditions exist which require such exemption.'' This provision was not amended by the Food Quality Protection Act of 1996 ( FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Lambda Cyhalothrin on Alfalfa/ Clover/ Grass Mixed Stands and FFDCA Tolerances The state of New York requested the use of lambda cyhalothrin to control alfalfa weevil ( Hypera postica),

VerDate jul< 14> 2003 15: 35 Sep 02, 2003 Jkt 200001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 03SER1. SGM 03SER1 52356 Federal Register / Vol. 68, No. 170 / Wednesday, September 3, 2003 / Rules and Regulations Armyworms ( Spodoptera spp.) and Potato leafhopper ( Empoasca fabae) on alfalfa/ clover/ grass mixed stands. The use of insecticides is the only practical means of controlling the three major pests that infest alfalfa/ clover/ grass mixed stands and there are no pesticides registered to control insect pests in these stands of mixed of alfalfa/ clover/ grass. Experts estimate a 35% yield loss if these mixed stands are not protected. EPA has authorized under FIFRA section 18 the use of lambdacyhalothrin on alfalfa/ clover/ grass mixed stands for control of alfalfa weevil, armyworms and potato leafhoppers in New York. After having reviewed the submissions, EPA concurs that an emergency condition exists for this State. As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of lambda cyhalothrin in or on clover, forage and clover, hay. In doing so, EPA considered the safety standard in section 408( b)( 2) of the FFDCA, and EPA decided that the necessary tolerances under section 408( l)( 6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408( l)( 6) of the FFDCA. Although these tolerances will expire and are revoked on December 31, 2005, under section 408( l)( 5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on clover, forage and clover, hay after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because these tolerances are being approved under emergency conditions, EPA has not made any decisions about whether lambda cyhalothrin meets EPA's registration requirements for use on alfalfa/ clover/ grass mixed stands or whether permanent tolerances for these uses would be appropriate. Under these circumstances, EPA does not believe that these tolerances serve as a basis for registration of lambda cyhalothrin by a State for special local needs under FIFRA section 24( c). Nor do these tolerances serve as the basis for any State other than New York to use this pesticide on these crops under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemption for lambdacyhalothrin contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety 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) . 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 lambda cyhalothrin and to make a determination on aggregate exposure, consistent with section 408( b)( 2) of the FFDCA, for time limited tolerances for the combined residues of lambda cyhalothrin and its epimer in or on clover, forage at 5.0 ppm and clover, hay at 6.0 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerances follows.

A. 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 endpoint. 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 factor 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 level of concern ( 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 lambda cyhalothrin used for human risk assessment is shown in the following Table 1:

VerDate jul< 14> 2003 15: 35 Sep 02, 2003 Jkt 200001 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 03SER1. SGM 03SER1 52357 Federal Register / Vol. 68, No. 170 / Wednesday, September 3, 2003 / Rules and Regulations TABLE 1.   SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR LAMBDA CYHALOTHRIN] FOR USE IN HUMAN RISK ASSESSMENT Exposure Scenario Dose Used in Risk Assessment UF FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary ( General population including infants and children) NOAEL = 0.5 mg/ kg/ day UF = 100 Acute RfD = 0.005 mg/ kg/ day FQPA SF = 1 aPAD = acute RfD ÷ FQPA SF = 0.005 mg/ kg/ day Chronic oral study in the dog ( lambdacyhalothrin LOAEL = LOAEL = 3.5 mg/ kg/ day based on clinical signs of neurotoxicity ( ataxia) observed from day 2, 3 to 7 hours post dosing

Chronic Dietary ( All populations NOAEL= 0.1 mg/ kg/ day UF = 100 Chronic RfD = 0.001 mg/ kg/ day FQPA SF = 1 cPAD = chronic RfD ÷ FQPA SF = 0.001 mg/ kg/ day Chronic oral study in the dog ( lambdacyhalothrin LOAEL = 0.5 based on gait abnormalities observed in 2 dogs Incidental Oral Short and Intermediate Term ( 1  30 Days and 1  6 Months) Residential Only NOAEL= 0.1 LOC for MOE = 100 ( Residential) Chronic oral study in the dog ( lambdacyhalothrin LOAEL = 0.5 based on gait abnormalities observed in 2 dogs Dermal ( All Durations;  Short Term ( 1 to 7 days)  Intermediate Term ( 1 week to several months)  Long Term ( several months to lifetime) ( Residential) dermal ( or oral) study NOAEL= 10 mg/ kg/ day LOC for MOE = 100 ( Residential) 21   Day dermal toxicity study in the rat ( lambda cyhalothrin) LOAEL = 50 mg/ kg/ day based on clinical signs of neurotoxicity ( observed from day 2) and decreased body weight and body weight gain Inhalation ( All Durations;  Short Term ( 1 to 7 days)  Intermediate Term ( 1 week to several months)  Long Term ( several months to lifetime) ( Residential) inhalation ( or oral) study NOAEL= 0.3 Environmental protection, Cut and past remainder of subjects. µ g/ L ( 0.08 mg/ kg/ day) ( inhalation absorption rate = 100%) LOC for MOE = 100 ( Residential) 21   Day Inhalation Study in Rats ( lambdacyhalothrin LOAEL = 3.3 µ g/ L ( 0.90 mg/ kg/ day) based on clinical signs of neurotoxicity, decreased body weight gains, increased incidence of punctuate foci in the cornea, slight reductions in cholesterol in females and slight changes in selected urinalysis parameters.

Cancer ( oral, dermal, inhalation Classification: Group D chemical ( not classifiable as to human carcinogenicity)

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

B. Exposure Assessment 1. Dietary exposure from food and feed uses. Currently established tolerances for residues of lambdacyhalothrin are listed under 40 CFR 180.438 and include permanent tolerances on plants ranging from 0.01 ppm on soybeans to 6.0 ppm on alfalfa, hay; corn, forage; and tomato, pomace ( dry or wet). Tolerances are also established on animal commodities ranging from 0.01 ppm in egg; poultry, meat; and poultry, meat by products to 5.0 ppm in milk, fat ( reflecting 0.2 ppm in whole milk). The Agency has recently established additional tolerances for lambda cyhalothrin on a number of commodities ranging from 0.05 ppm on sugarcane to 3.0 ppm on peanut, hay. Risk assessments were conducted by EPA to assess dietary exposures from lambda cyhalothrin 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. The Dietary Exposure Evaluation Model ( DEEM   ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989   1992 nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. A refined Tier 3 probabilistic acute dietary risk assessment was conducted for all currently registered and proposed lambda cyhalothrin food uses. For the acute dietary risk analysis the entire distribution of residue field trial data was used for not blended or partiallyblended commodities; average residue field trial data was used for blended commodities; information from cooking and processing studies were used when available; and market share data for proposed and established tolerances was used. ii. Chronic exposure. In conducting this chronic dietary risk assessment the DEEM   analysis evaluated the individual food consumption as reported by respondents in the USDA 1989   1992 nationwide CSFII and accumulated exposure to the chemical for each commodity. For the chronic dietary risk analysis the average of the residue field trials, information from cooking and processing studies, and market share data were used. iii. Cancer. The data base for carcinogenicity is considered complete, and no additional studies are required at this time. The requirements for oncogenicity studies in the rat and the mouse with lambda cyhalothrin have been satisfied by a combined chronic/ oncogenicity study in rats and an oncogenicity study in mice, both conducted with cyhalothrin. Lambdacyhalothrin has been classified as a Group D chemical ( not classifiable as to human carcinogenicity) with regards to its carcinogenic potential. iv. Anticipated residue and percent crop treated ( PCT) information. Section 408( b)( 2)( E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue VerDate jul< 14> 2003 15: 35 Sep 02, 2003 Jkt 200001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 03SER1. SGM 03SER1 52358 Federal Register / Vol. 68, No. 170 / Wednesday, September 3, 2003 / Rules and Regulations levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408( b)( 2)( E) of the FFDCA, EPA will issue a data call in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance. Section 408( b)( 2)( F) of the FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408( b)( 2)( F) of the FFDCA, EPA may require registrants to submit data on PCT. A detailed description of how the Agency used PCT information in this assessment can be found in the lambda cyhalothrin pesticide tolerance document published on September 27, 2002 ( 67 FR 60902; FRL   7200   1) in Unit III. C.( 1)( iv). The Agency believes that the three conditions listed above] have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. EPA uses a weighted average PCT for chronic dietary exposure estimates. This weighted average PCT figure is derived by averaging State level data for a period of up to 10 years, and weighting for the more robust and recent data. A weighted average of the PCT reasonably represents a person's dietary exposure over a lifetime, and is unlikely to underestimate exposure to an individual because of the fact that pesticide use patterns ( both regionally and nationally) tend to change continuously over time, such that an individual is unlikely to be exposed to more than the average PCT over a lifetime. For acute dietary exposure estimates, EPA uses an estimated maximum PCT. The exposure estimates resulting from this approach reasonably represent the highest levels to which an individual could be exposed, and are unlikely to underestimate an individual's acute dietary exposure. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which lambda cyhalothrin may be applied in a particular area. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for lambdacyhalothrin 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 lambdacyhalothrin The Agency uses the First Index Reservoir Screening Tool ( FIRST) or the Pesticide Root Zone/ 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 groundwater. For a screeninglevel assessment for surface water EPA will generally 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. While both FIRST and PRZM/ EXAMS incorporate an index reservoir environment, the PRZM/ EXAMS model includes 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 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 lambdacyhalothrin they are further discussed in the aggregate risk sections below. The compounds to be regulated in drinking water are lambda cyhalothrin and degradate XV ( parent hydroxylated in the 4 position of the phenoxy ring). Based on the FIRST, PRZM/ EXAMS and SCI GROW models the estimated environmental concentrations ( EECs) of lambda cyhalothrin and its degradate XV for acute exposures are estimated to be 0.62 parts per billion ( ppb) for surface water ( 0.51 ppb lambdacyhalothrin and 0.11 ppb degradate XV) and 0.012 ppb ( 0.006 ppb lambdacyhalothrin and 0.006 ppb degradate XV) for ground water. The EECs for chronic exposures are estimated to be 0.098 ppb for surface water ( 0.09 ppb lambda cyhalothrin and 0.008 ppb degradate XV) and 0.012 ppb for ground water ( 0.006 ppb lambda cyhalothrin and 0.006 ppb degradate XV). 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). The residential exposure/ risk assessment evaluated both proposed and existing uses for lambda cyhalothrin. Existing uses on turf, in gardens, on golf courses, and for structural pest control were qualitatively assessed, but a quantitative VerDate jul< 14> 2003 15: 35 Sep 02, 2003 Jkt 200001 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 03SER1. SGM 03SER1 52359 Federal Register / Vol. 68, No. 170 / Wednesday, September 3, 2003 / Rules and Regulations calculation was only completed for postapplication exposure on treated turf because this scenario is expected to have the highest associated exposures. This screening level tool is protective for all residential exposures, even the handler scenarios, because the dose levels for children playing on treated lawns are thought to exceed those expected for all other scenarios. For postapplication exposure, all residential MOEs were well above the Agency target MOE of 100 for the inhalation, dermal, and oral routes and therefore do not exceed EPA's level of concern ( range 700 to 14,700). Additionally, when total MOEs were aggregated, MOEs were still not of concern ( MOEs for children = 500 and for adults = 3,000). 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 lambda cyhalothrin has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, lambdacyhalothrin 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 lambda cyhalothrin 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 final rule for Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997).

C. 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. Developmental toxicity studies. In a developmental toxicity study in rats, the maternal NOAEL was 10 mg/ kg/ day and the LOAEL was 15 mg/ kg/ day based on uncoordiniated limbs, reduced body weight gain and food consumption. The developmental NOAEL was 15 mg/ kg/ day ( HDT) and the developmental LOAEL was > 15 mg/ kg/ day. In a developmental toxicity study in rabbits, the maternal NOAEL was 10 mg/ kg/ day and the LOAEL was 30 mg/ kg/ day based on reduced body weight gain and food consumption. The developmental NOAEL was 30 mg/ kg/ day ( HDT) and the developmental LOAEL was > 30 mg/ kg/ day. 3. Reproductive toxicity study. In a 3 generation reproduction study in rats, the parental/ offspring NOAEL was 1.5 mg/ kg/ day and the LOAEL was 5.0 mg/ kg/ day based on decreased parental body weight and body weight gain during premating and gestation periods and reduced pup weight and weight gain during lactation. The reproductive NOAEL was 5.0 mg/ kg/ day ( HDT) 4. Prenatal and postnatal sensitivity. There is no evidence of increased susceptibility of rat or rabbit fetuses following in utero exposure in the developmental studies with cyhalothrin and there is no evidence of increased susceptibility of young rats in the reproduction study with cyhalothrin. 5. Conclusion. Through the use of bridging data, the toxicology data base for lambda cyhalothrin is complete. The Agency has determined that the special FQPA safety factor should be reduced to 1x because as noted above, there is no evidence of increased susceptibility of rat or rabbit fetuses following in utero exposure in the developmental studies with cyhalothrin and there is no evidence of increased susceptibility of young rats in the reproduction study with cyhalothrin. The Agency concluded there are no residual uncertainties for pre and/ or postnatal exposure. The RfDs and other endpoints established for risk assessment are protective of pre/ postnatal toxicity following exposure to cyhalothrin.

D. 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 + chronic non dietary, nonoccupational 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, EPA concludes with reasonable certainty that exposures to lambda cyhalothrin 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 lambda cyhalothrin on 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 lambdacyhalothrin will occupy 41% of the aPAD for the U. S. population, 24% of the aPAD for females 13 years and older, 71% of the aPAD for all infants < 1 year old and 82% of the aPAD for children 1   6 years old. In addition, despite the potential for acute dietary exposure to lambda cyhalothrin in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of lambda cyhalothrin in surface and VerDate jul< 14> 2003 15: 35 Sep 02, 2003 Jkt 200001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 03SER1. SGM 03SER1 52360 Federal Register / Vol. 68, No. 170 / Wednesday, September 3, 2003 / Rules and Regulations ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 2:

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

U. S. Population ( total) 0.005 40.86 0.62 0.012 103 All Infants ( 1 year) 0.005 71.22 0.62 0.012 14 Children 1   6 years 0.005 82.36 0.62 0.012 9 Children 7   12 years 0.005 46.09 0.62 0.012 27 Females 13   50 0.005 23.83 0.62 0.012 114 Males 13   19 0.005 27.61 0.62 0.012 127 Males 20+ years 0.005 21.69 0.62 0.012 137 Seniors 55+ 0.005 21.85 0.62 0.012 137 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to lambda cyhalothrin from food will utilize 8.2% of the cPAD for the U. S. population, 11.7% of the cPAD for all infants < 1 year old and 21.8% of the cPAD for children 1 6 years old. Based on the use pattern, chronic residential exposure to residues of lambda cyhalothrin is not expected. In addition, despite the potential for chronic dietary exposure to lambdacyhalothrin in drinking water, after calculating DWLOCs and comparing them to conservative model estimated environmental concentrations of lambda cyhalothrin in surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

TABLE 3.   AGGREGATE RISK ASSESSMENT FOR CHRONIC ( NON CANCER) EXPOSURE TO LAMBDA CYHALOTHRIN Population Subgroup cPAD mg/ kg/ day % cPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Chronic DWLOC ( ppb)

U. S. Population ( total) 0.001 8.2 0.098 0.012 32 All Infants (< 1 year) 0.001 11.7 0.098 0.012 9 Children 1   6 years 0.001 21.8 0.098 0.012 8 Children 7   12 years 0.001 12.9 0.098 0.012 9 Females 13   50 0.001 5.7 0.098 0.012 28 Males 13   19 0.001 7.9 0.098 0.012 32 Males 20+ years 0.001 6.0 0.098 0.012 33 Seniors 55+ 0.001 5.8 0.098 0.012 33 3. Short and intermediate term risk. Aggregate risk for short and intermediate term durations of exposure includes food, drinking water, and residential exposure pathways. The residential exposure pathway includes dermal, inhalation, and incidental oral ( hand to mouth type inadvertent exposure) routes of exposure. This aggregate risk assessment included lawn post application exposure, considered the scenario with the highest potential for exposure and is a day 0 screening level assessment. Lambda cyhalothrin is currently registered for use( s) that could result in short and intermediate term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short term exposures for lambdacyhalothrin Using the exposure assumptions described in this unit for short and intermediate term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 879 for adults, 239 for children 1   6, and 302 for infants < 1 year old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short term DWLOCs were calculated and compared to the EECs for chronic exposure of lambda cyhalothrin in ground water and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 4:

VerDate jul< 14> 2003 15: 35 Sep 02, 2003 Jkt 200001 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 03SER1. SGM 03SER1 52361 Federal Register / Vol. 68, No. 170 / Wednesday, September 3, 2003 / Rules and Regulations TABLE 4.   AGGREGATE RISK ASSESSMENT FOR SHORT AND INTERMEDIATE TERM EXPOSURE TO LAMBDA CYHALOTHRIN Population Subgroup Aggregate MOE ( Food + Residential Aggregate Level of Concern ( LOC) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Short and Intermediate Term DWLOC ( ppb)

Adults 879 100 0.098 0.012 31 Child ( 1   6) 239 100 0.098 0.012 6 Infant (< 1 yr) 302 100 0.098 0.012 7 5. Aggregate cancer risk for U. S. population. Lambda cyhalothrin has been classified as a Group D chemcial ( not classifiable as to human carcinogenicity) with regards to its carcinogenic potential. 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 lambdacyhalothrin residues.

V. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology ( example   gas chromotography) 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 MRLs established for residues of lambda cyhalothrin in plant or animal commodities. Codex MRLs for cyhalothrin are established for several commodities which are unrelated to this action. Therefore, a discussion of compatibility with U. S. tolerances is not relevant at this time.

VI. Conclusion Therefore, the tolerances are established for the combined residues of lambda cyhalothrin and its epimer in or on clover, forage at 5.0 ppm and clover, hay at 6.0 ppm.

VII. 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 the 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   0267 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 3, 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 VII. A., you should also send a copy of your request to the PIRIB for its VerDate jul< 14> 2003 15: 35 Sep 02, 2003 Jkt 200001 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 03SER1. SGM 03SER1 52362 Federal Register / Vol. 68, No. 170 / Wednesday, September 3, 2003 / Rules and Regulations inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by the docket ID number OPP   2003   0267, 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: opp docket@ 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).

VIII. Regulatory Assessment Requirements This final rule establishes timelimited tolerances under section 408 of the FFDCA. 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 FIFRA section 18 exemption under section 408 of the FFDCA, such as the tolerances 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.

IX. Submission to Congress and the Comptroller General 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 22, 2003. Peter Caulkins, Acting 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 180.438 is amended by alphabetically adding commodities to the table in paragraph ( b) to read as follows:

VerDate jul< 14> 2003 15: 35 Sep 02, 2003 Jkt 200001 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 03SER1. SGM 03SER1 52363 Federal Register / Vol. 68, No. 170 / Wednesday, September 3, 2003 / Rules and Regulations § 180.438 Lambda cyhalothrin; tolerances for residues.

* * * * * ( b) * * *

Commodity Parts per million Expiration/ revocation date Clover, forage 5.0 12/ 31/ 05 Clover, hay 6.0 12/ 31/ 05 * * * * *

* * * * * [ FR Doc. 03   22315 Filed 9   2   03; 8: 45 am]

BILLING CODE 6560   50   S FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 54 [ CC Docket No. 96   45; DA 03   2690]

Certifications Required Pursuant to the Children's Internet Protection Act; Approval of FCC Forms 486 and 479 by the Office of Management and Budget AGENCY: Federal Communications Commission. ACTION: Final rule; announcement of effective date.

SUMMARY: This document announces the effective date of the amendments to our rules implementing the revised FCC Form 486 ( Receipt of Service Confirmation) and the revised FCC Form 479 ( Certification by Administrative Authority to Billed Entity of Compliance with Children's Internet Protection Act ( CIPA)) and instructions have been approved by the Office of Management and Budget ( OMB). The Order in CC Docket No. 96   45 was published in the Federal Register on August 8, 2003. DATES: The final rule amending 47 CFR Part 54, published on August 8, 2003 ( 68 FR 47253), became effective on August 14, 2003.

FOR FURTHER INFORMATION CONTACT: Jennifer Schneider, Attorney, Wireline Competition Bureau, Telecommunications Access Policy Division, ( 202) 418   7400, TTY: ( 202) 418   0484.

SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Public Notice, CC Docket No. 96   45, released August 19, 2003. The Wireline Competition Bureau announces that the revised FCC Form 486 ( Receipt of Service Confirmation) and the revised FCC Form 479 ( Certification by Administrative Authority to Billed Entity of Compliance with Children's Internet Protection Act ( CIPA)) and instructions have been approved by the Office of Management and Budget ( OMB). Accordingly, the effective date of the Order is August 14, 2003. See 68 FR 47253, August 8, 2003. On August 14, 2003, OMB approved the information collections. See OMB No. 3060   0853.

List of Subjects in 47 CFR Part 54 Reporting and recordkeeping requirement, Telecommunications, Telephone.

Federal Communications Commission. Marlene H. Dortch, Secretary. [ FR Doc. 03   22368 Filed 9   2   03; 8: 45 am]

BILLING CODE 6712   01   P DEPARTMENT OF TRANSPORTATION Research and Special Programs Administration 49 CFR Parts 172, 178, and 180 [ Docket No. RSPA   98   3554 ( HM   213)]

RIN 2137   AC90 Hazardous Materials: Requirements for Cargo Tanks AGENCY: Research and Special Programs Administration ( RSPA), DOT. ACTION: Final rule; response to appeals.

SUMMARY: On April 18, 2003, the Research and Special Programs Administration published a final rule under Docket No. RSPA   98   3554 ( HM   213) to update and clarify requirements in the Hazardous Materials Regulations applicable to construction and maintenance of cargo tank motor vehicles. In response to appeals submitted by persons affected by the April 18, 2003 final rule, this final rule amends certain requirements and makes minor editorial corrections. DATES: Effective Date: This final rule is effective October 1, 2003. Voluntary Compliance Date: Voluntary compliance is authorized as of September 3, 2003. FOR FURTHER INFORMATION CONTACT: Mr. Philip Olson, Office of Hazardous Materials Technology, RSPA, telephone ( 202) 366   4504; Ms. Susan Gorsky, Hazardous Materials Standards, RSPA, telephone ( 202) 366   8553; or Mr. Danny Shelton, Office of Enforcement and Program Delivery, Hazardous Materials Division, Federal Motor Carrier Safety Administration ( FMCSA), telephone ( 202) 366   6121. SUPPLEMENTARY INFORMATION:

I. Background On April 18, 2003, the Research and Special Programs Administration ( RSPA; we) published a final rule ( 68 FR 19258) that revised requirements in the Hazardous Materials Regulations ( HMR; 49 CFR parts 171   180) for cargo tank design, qualification, maintenance, and use. Specifically, the final rule:   Revised the definitions of `` Design Certifying Engineer'' and `` Registered Inspector'' to allow experienced persons without degrees to qualify;   Permitted cargo tank owners to recertify cargo tanks to their original specifications;   Revised minimum road clearance and bottom damage protection requirements for certain cargo tank motor vehicles;   Clarified current requirements for using the EPA Method 27 leakage test as an alternative to the HMR leak test requirements;   Revised certain requirements applicable to MC 331 and MC 338 cargo tanks for consistency with regulations applicable to the more recently adopted MC 400 series cargo tanks;   Required MC 338 cargo tanks to be equipped with a means of thermal activation for automatically closing the internal self closing stop valve in the event of a fire;   Clarified cargo tank test and inspection requirements and relaxes the leakage test requirement for cargo tanks in anhydrous ammonia service; and   Eliminated redundant or unnecessary regulations. In addition, the April 18 final rule revised the HMR to address three recommendations from the National Transportation Safety Board ( NTSB):   Consistent with Recommendation H   90   91, the April 18 final rule VerDate jul< 14> 2003 15: 35 Sep 02, 2003 Jkt 200001 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 03SER1. SGM 03SER1


[Federal Register Volume 79, Number 148 (Friday, August 1, 2014)]
[Notices]
[Pages 44965-44966]
[FR Doc No: 2014-18213]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FR A-2014-0059]

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System

    In accordance with part 235 of Title 49 Code of Federal Regulations
(CFR) and 49 U.S.C. 20502(a), this document provides the public notice
that by a document dated February 24, 2014, Norfolk Southern
Corporation (NS) and the Indiana and Ohio Railway (IORY) have jointly
petitioned the Federal Railroad Administration (FRA) seeking approval
for the discontinuance or modification of a signal system. FRA assigned
the petition Docket Number FRA-2014-0059.
    Applicants:

Norfolk Southern Corporation, Mr. Brian L. Sykes Chief Engineer-C&S
Engineering 1200 Peachtree Street NE., Atlanta, GA 30309.

Indiana and Ohio Railway Mr. Charles McBride Senior Vice President Ohio
Valley Region 2856 Cypress Way Cincinnati, OH 45212.

    NS and IORY seek approval of the proposed discontinuance of a
traffic control system (TCS) in Cincinnati, OH, on the IORY Oasis
Subdivision, IORY

Midland Subdivision, NS New Castle District, NS Cincinnati District,
and the following tracks connecting these lines:
     NS Cincinnati District from Red Bank, Milepost (MP) CV
111.9, to Clare, MP CV 110.7; NS Connecting Track from Red Bank, MP CV
111.9, to Valley, MP CF 7.5; IORY Oasis Subdivision from Valley, MP CF
7.5, to Mill, MP CF 16.4; NS New Castle District from Mill, MP CF 16.4
to Vaughn, MP CF 17.2; NS Connecting Track from Mill, MP CF 16.4, to
Control Point (CP) 248, MP CJ 248.4; IORY Connecting Track, from
Oakley, MP CF 10.1, to East Norwood, MP 10.9; IORY Connecting Track,
from Ridge, MP CF 10.6, to Penn, MP C 10.3; IORY Midland Sub, from East
Norwood, MP 10.9, to NA Tower, MP 7.5.
    The reason for the proposed changes is a TCS is no longer desirable
to handle current train operations. The movement of through freight
trains has been mostly eliminated from these lines for several years
and, today, consists of a few local shifter movements per day.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's Docket Operations Facility, 1200 New Jersey Avenue
SE., W12-140, Washington, DC 20590. The Docket Operations Facility is
open from 9 a.m. to 5 p.m., Monday through Friday, except Federal
Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by September 15, 2014 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
See http://www.regulations.gov/#!privacyNotice for the privacy notice
of regulations.gov or interested parties may review DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

    Issued in Washington, DC, on July 17, 2014.
Ron Hynes,
Director, Office of Safety Assurance and Compliance.
[FR Doc. 2014-18213 Filed 7-31-14; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 85, Number 24 (Wednesday, February 5, 2020)]
[Notices]
[Pages 6562-6565]
[FR Doc No: 2020-02236]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5973]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Health Care Providers' Understanding of Opioid
Analgesic Abuse Deterrent Formulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on research entitled ``Health Care Providers'
Understanding of Opioid Analgesic Abuse Deterrent Formulations.'' This
research consists of a survey examining the health care providers'
current perceptions, understanding, and behaviors related to opioid
analgesic abuse deterrent formulations (ADFs) and a study exploring the
effectiveness of different terminology and descriptions for these
products.

DATES: Submit either electronic or written comments on the collection
of information by April 6, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 6, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 6, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-5973 for ``Agency Information on Collection Activities;
Proposed Collection; Comment Request; Health Care Providers'
Understanding of Opioid Analgesic Abuse Deterrent Formulations.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    For copies of the questionnaire contact: Office of Communications
(OCOMM) Research Team<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Health Care Providers' Understanding of Opioid Analgesic Abuse
Deterrent Formulations

OMB Control Number 0910-NEW

I. Background

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA-regulated products in
carrying out the provisions of the FD&C Act.
    Prescription opioids play a significant role in the opioid misuse
and abuse epidemic in the United States. Opioid analgesics with
properties designed to deter abuse, commonly known as ADFs, may play a
role in helping to curb this epidemic. Currently available ADFs have
been demonstrated to deter some forms of abuse (injection, snorting,
or, in some cases, chewing and swallowing). FDA's own research and
other evidence suggests considerable variability in health care
providers' (HCPs) knowledge of and attitudes toward prescription opioid
products and practices (Ref. 1), including understanding of ADFs. ADF
prescription practices may present opportunities for HCPs to reduce
opioid abuse. Conducting a comprehensive evaluation of opioid
prescribers' knowledge, attitudes, perceptions, experiences, and
behaviors related to ADFs will help to inform FDA's approaches to ADFs.
    Given the significance and far-reaching nature of the opioid
crisis, along with FDA concerns about potential misunderstanding among
HCPs about ADF terminology and capabilities, FDA determined that
systematic research was necessary to provide the detailed and
comprehensive

evidence on which to base the Agency's ADF-related policy, regulatory,
and communication decisions, including potential alternative language
that may be necessary to describe and explain these products. This work
aligns with Priority 1 of the FDA's Strategic Policy Roadmap (https://www.fda.gov/about-fda/reports/healthy-innovation-safer-families-fdas-2018-strategic-policy-roadmap), and the Department of Health and Human
Services (HHS) and the White House have similarly placed high
priorities on addressing the epidemic of misuse and abuse of opioid
drugs harming U.S. families.
    The study's purpose is to explore and assess the ADF-related
knowledge, attitudes, and behaviors among opioid prescribers
(physicians, nurse practitioners and physician assistants) and
dispensers/pharmacists, including the related terms addiction and abuse
deterrence, and to explore possible alternative language for describing
these products. Phase 1 consists of focus groups (OMB approval under
control number 0910-0695). The research described in this notice
represents Phases 2 and 3 of the overall project.
    Phase 2 will consist of a survey based on the Phase 1 focus group
findings related to: (1) Health care provider understanding of
addiction, abuse, and abuse deterrent formulations; (2) attitudes
toward, perceptions about, and experiences with abuse-deterrent opioid
analgesics and abuse deterrence, including prescribing decisions and
practices, potential barriers to using ADFs, the quality and
understandability of the ADF nomenclature, and the underlying reasons
for these perceptions; and (3) HCPs' ideas for minimizing confusion
about ADFs, the kinds of ADF training needed, and suggested language/
terms they believe would best convey the concept of abuse deterrence to
HCPs. The objective of the survey will be to determine the prevalence
of HCP knowledge, attitudes, behaviors and perceptions identified
through the qualitative discussion occurring in the Phase 1 focus
groups and to uncover any subgroup differences among opioid prescribers
and dispensers. We will conduct one pretest, averaging not longer than
20 minutes, to pilot the main survey procedures among the target HCP
populations. The main survey will also average 20 minutes.
    Phase 3 will build on findings from the Phase 1 focus groups and
Phase 2 survey and will consist of an experimental study examining
variations in descriptive terminology for abuse deterrent formulation
products. We will conduct two pretests, each averaging not longer than
20 minutes, to test the experimental manipulations and pilot the main
study procedures. The main study procedure will also average 20 minutes
in length. Participants will be randomly assigned to read one
description of an abuse deterrent formulation prescription drug product
and then complete a questionnaire that assesses their comprehension and
perceptions of the information, including terminology. We will test up
to four variations in wording, including the description of ADF
included in FDA's guidance ``Abuse Deterrent Opioids--Evaluation and
Labeling'' (Ref. 2).
    For all phases of this research, we will recruit adult health care
professional volunteers 18 years of age or older. We will exclude
individuals who work for HHS or work in the health care, marketing, or
pharmaceutical industries. The sample will consist of 10 percent
pharmacists, at least half of whom dispense ADF opioids. The other 90
percent will be prescribers who, at the time they are recruited, spend
at least 50 percent of their time seeing patients and who have
prescribed opioids to at least five different patients in the last 30
days, with at least half of the opioids they prescribe being for
chronic non-cancer pain. The prescriber sample will be segmented to
include 70 percent primary care providers (i.e., those practicing in
family practice, or internal or general medicine) and 30 percent a mix
of specialists practicing in a variety of fields such as rheumatology,
neurology, anesthesiology, pain management, emergency medicine,
surgery, orthopedics, and physical medicine and rehabilitation. In each
of these groups, 60 to 70 percent will consist of physicians, 15
percent nurse practitioners, and 15 percent physician assistants. A
minimum of 30 percent must have experience prescribing an ADF opioid.
    We will use soft quotas to ensure that our sample includes a
diversity of participants, including related to age, race/ethnicity,
gender, years and location of practice, and opioid prescribing levels.
We will also exclude pretest participants from the main studies, and
participants will not be able to participate in more than one phase of
the project. With the sample sizes described below, we will have
sufficient power to detect primarily small-sized effects for Phases 2
and 3.
    FDA estimates the burden of this collection of information as
follows:

                                                    Table 1--Estimated Annual Reporting Burden 1 2 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  Number of       Number of
                   Activity                      respondents    responses per   Total annual          Average burden per response           Total hours
                                                     \3\         respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Phase 2
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest screener.............................             470               1             470  0.17 (10 minutes)........................           79.90
Pretest......................................             235               1             235  0.33 (20 minutes)........................           77.55
Survey screener..............................           2,120               1           2,120  0.17 (10 minutes)........................          360.40
Survey.......................................           1,060               1           1,060  0.33 (20 minutes)........................          349.80
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Phase 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretests screener............................             732               1             732  0.17 (10 minutes)........................          124.44
Pretests.....................................             366               1             366  0.33 (20 minutes)........................          120.78
Main study screener..........................           2,120               1           2,120  0.17 (10 minutes)........................          360.40
Main study...................................           1,060               1           1,060  0.33 (20 minutes)........................          349.80
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................        1,823.07
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Includes total burden for project phases 2 and 3.
\3\ Includes 10 percent overage.

\4\ With online surveys, several participants may be in the process of completing the survey at the time that the total target sample is reached. Those
  participants will be allowed to complete the survey, which can result in the number of valid completes exceeding the target number. With this in mind,
  we have included an additional 10 percent over our target number of valid completes to account for some overage.

II. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

    1. Hwang, C.S., L.W. Turner, S.P. Kruszewski, et al. ``Primary
Care Physicians' Knowledge and Attitudes Regarding Prescription
Opioid Abuse and Diversion.'' The Clinical Journal of Pain, 32(4),
279-284, 2016.
    2. * FDA (2015). ``Abuse Deterrent Opioids--Evaluation and
Labeling: Guidance for Industry.'' Available from https://www.fda.gov/downloads/Drugs/Guidances/UCM334743.pdf.

    Dated: January 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02236 Filed 2-4-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 86 (Thursday, May 3, 2012)]
[Proposed Rules]
[Pages 26231-26232]
[FR Doc No: 2012-10619]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2011-0520; FRL-9667-2]

40 CFR Part 147

State of Tennessee; Underground Injection Control (UIC) Program
Primacy

AGENCY: U.S. Environmental Protection Agency (EPA).

ACTION: Notice of public comment period and of public hearing.

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SUMMARY: The purpose of this notice is to announce that: 1 the EPA has
received a complete application from the State of Tennessee requesting
approval of its Underground Injection Control program; 2 the EPA has
determined the application contains all the required elements; 3 the
application is available for inspection and copying at the address
appearing below; 4 public comments are requested; and (5) a public
hearing will be held.

DATES: Requests for a public hearing and/or to present oral testimony
must be received by May 31, 2012; if determined to be warranted, the
Public Hearing will be held on June 7, 2012 at 1:00 p.m. Requests to
testify may be mailed to Fred McManus, Chief, Ground Water and SDWA
Enforcement Section, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW., Atlanta, Georgia 30303. If it is determined that a
hearing is warranted, it will be held on the 17th Floor Conference Room
B, L&C Tower, 401 Church Street, Nashville, Tennessee 37243. Comments
will be accepted until June 14, 2012. The EPA will determine by June 4,
2012, whether there is sufficient interest to warrant a public hearing.
Contact Nancy H. Marsh to determine if a hearing is warranted (see the
FOR FURTHER INFORMATION CONTACT section).

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2011-0520, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: State of Tennessee; Underground Injection Control
(UIC) Program Primacy, U.S. Environmental Protection Agency, Mailcode:
2822T, 1200 Pennsylvania Ave. NW., Washington, DC 20460. Hand Delivery:
Water Docket, EPA Docket Center (EPA/DC) EPA West, Room 3334, 1301
Constitution Ave. NW., Washington, DC. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2011-
0520. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means the EPA will not know your identity or contact information unless
you provide it in the body of your comment. If you send an email
comment directly to the EPA without going through www.regulations.gov,
your email address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, the EPA
recommends that you include your name and other contact information in
the body of your comment and with any disk or CD-ROM you submit. If the
EPA cannot read your comment due to technical difficulties and cannot
contact you for clarification, the EPA may not be able to consider your
comment. Electronic files should avoid the use of special characters,
any form of encryption, and be free of any defects or viruses. For
additional information about the EPA's public docket, visit the EPA
Docket Center homepage at http://www.epa.gov/epahome/dockets.htm of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the following locations:

U.S. Environmental Protection Agency, Region 4, Library, 9th Floor, 61
Forsyth Street SW., Atlanta, Georgia 30303. The Library is open from

9:00 a.m.-4:00 p.m. Monday through Friday, excluding legal holidays.
The telephone number for the Library is<PHONE_NUMBER>.
Tennessee Department of Environment and Conservation, 6th Floor, 401
Church Street, Nashville, Tennessee 32743, The Library is open from
9:00 a.m.-4:00 p.m. Monday through Friday, excluding legal holidays.
The telephone number for the Library is<PHONE_NUMBER>.
State of Tennessee; Underground Injection Control (UIC) Program Primacy
Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m.-4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the OW Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Nancy H. Marsh, Safe Drinking Water
Branch, U.S. Environmental Protection Agency, Region 4, 61 Forsyth
Street SW., Atlanta, Georgia 30303; telephone number:<PHONE_NUMBER>. Fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>Comments
should also be sent to this address.

SUPPLEMENTARY INFORMATION: The State of Tennessee has submitted an
application to regulate Class I, II, III, IV and V injection wells in
the State. The application was determined to be complete because it
included all of the requirements of 40 CFR Sec.  145.22(a): a letter
from the Governor requesting program approval; a complete description
of the State Underground Injection Control program; a statement of
legal authority; a memorandum of agreement between the State of
Tennessee and the EPA, Region 4; copies of all applicable rules and
forms; and a showing of the State's public participation process prior
to program submission.

    Dated: April 19, 2012.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. 2012-10619 Filed 5-2-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 232 (Wednesday, December 2, 2020)]
[Notices]
[Page 77469]
[FR Doc No: 2020-26571]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-N-1119; FDA-2010-N-0622; FDA-2011-N-0016; FDA-
2009-N-0501; and FDA-2019-N-6098]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
information collections that have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. 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.

        Table 1--List of Information Collections Approved by OMB
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                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Food Canning Establishment Registration,       0910-0037      10/31/2023
 Process Filing and Recordkeeping for
 Acidified and Thermally Processed Low-
 Acid Foods.............................
Color Additive Certification Requests          0910-0216      10/31/2023
 and Recordkeeping......................
Recordkeeping and Records Access               0910-0560      10/31/2023
 Requirements for Food Facilities.......
Reporting and Recordkeeping Requirements       0910-0643      10/31/2023
 for Reportable Food....................
Focus Groups as Used by the Food and           0910-0497      11/30/2023
 Drug Administration....................
------------------------------------------------------------------------

    Dated: November 25, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26571 Filed 12-1-20; 8:45 am]
BILLING CODE 4164-01-P