requires States and Territories with coastal recreation waters to adopt water quality criteria for bacteria as protective of human health as the criteria published by EPA under Clean Water Act section 304( a). Section 303( i) was added to the Clean Water Act in 2000 by the BEACH Act.

At the time the BEACH Act was enacted, the current Clean Water Act section 304( a) criteria were EPA's 1986 bacteria criteria because that is EPA's only recommended bacteria criteria for protection of primary contact recreation waters. The legislative history makes it clear that Congress recognized that EPA's 1986 bacteria criteria have flaws, but also that Congress wanted States to adopt standards based on them by April 10, 2004, despite those flaws, presumably because Congress thought the 1986 bacteria criteria are better than what it characterized as " outdated" criteria used by some States. ( See H. Rep. No. 106 98, at 6 ( 1999); see generally S.

Rep. No. 106 366 ( 2000) and H. Rep. No. 106 98.)

EPA had reviewed its original studies supporting its recommended 1986 water quality criteria for bacteria and the literature on human health research conducted since EPA completed Privileged and Confidential Do Not Cite, Quote, or Release Page 68 of 97 the original studies of health effects associated with swimming in marine and freshwater, as discussed in on pages 10 13 of the Implementation Guidance for Ambient Water Quality Criteria for Bacteria ( EPA 823 B 02 003, May 2002 Draft) . Based on these reviews, EPA has confirmed that the 1986 EPA recommended water quality criteria for bacteria are protective of human health against acute gastrointestinal illness.

The epidemiological studies used to develop the criteria were themselves peer reviewed.

The marine studies were peer reviewed in the Journal of the American Public Health Association.

EPA's Office of Research and Development reviewed the freshwater studies. The Harvard School of Public Health evaluated the epidemiology test protocol for both fresh and marine studies, and the University of Pittsburgh Center for Excellence provided an independent review of the results of the epidemiology studies. Finally, the 1986 bacteria criteria were reviewed by the public when EPA published a Federal Register notice concerning the criteria ( 49 FR 21987, May 24, 1984).

While Congress directed in Clean Water Act section 303( i) that, by April 9, 2004, States and Territories adopt criteria as protective as EPA's current criteria, Congress also recognized that " EPA's 1986 criteria need to be updated to improve the scientific basis for identifying pathogens in coastal waters." S. Rep. No. 106 366, at 2. To address this concern, Congress amended Clean Water Act section 304( a) to require EPA to " publish [ within five years of enactment of the BEACH Act] new or revised water quality criteria for pathogens and pathogen indicators ( including a revised list of testing methods, as appropriate), based on the results of the studies conducted . . . for the purpose of protecting human health in coastal recreation waters."

See Clean Water Act section 304( a)( 9). Thus, while Congress recognized that the 1986 bacteria Privileged and Confidential Do Not Cite, Quote, or Release Page 69 of 97 criteria need improvement, Congress still required States and Territories to adopt water quality standards as protective of human health as the 1986 bacteria criteria. EPA is currently conducting epidemiological studies on potential health risks resulting from exposure to pathogens or pathogen indicators in coastal recreation waters, as required under this section of the Clean Water Act. Once EPA publishes these new criteria, EPA expects that States and Territories will begin to adopt water quality standards as protective of human health as the new criteria for coastal and Great Lakes recreation waters, as required by Clean Water Act section 303( i)( 1)( B).

B. Economics Some commenters noted that, if the rule imposes single sample maximums as " not to

beexceeded values, the geometric mean component of the criteria would be significantly different from the geometric mean values in most State current fecal coliform bacteria criteria for recreation. For fecal coliform criteria to protect recreational uses, most State criteria include a geometric mean value and a threshold value not to be exceeded in more than 10% of the samples.

Some commenters state that there will be a substantially large cost difference to regulated entities if the rule imposes single sample maximums for E. coli or enterococci as " not to be exceeded"

values, noting that EPA's economic analysis in the proposal does not address the cost of controlling discharges from combined sewer overflows, sanitary sewer overflows, and municipal separate storm sewer systems to meet such single sample maximums, and that EPA's cost estimates for controlling these sources in other regulatory and policy actions are not based on a single sample maximum as a never to be exceeded criterion for Clean Water Act purposes.

Today's rule does not treat single sample maximums as a requirement that may never be Privileged and Confidential Do Not Cite, Quote, or Release Page 70 of 97 exceeded in all instances. Single sample maximums are values that indicate, with a certain degree of confidence, that a waterbody may exceed the geometric mean. The State can collect additional data on a receiving water if it believes that the violation of the single sample maximum does not indicate violation of the geometric mean, as described in the preamble to today's rule.

For its economic analysis, EPA evaluated the potential controls for publicly owned treatment plants and industrial facilities likely to discharge bacteria to meet permit limits based on the single sample maximums as never to be exceeded values to provide a conservatively high estimate of cost. In reality, States and Territories have flexibility in implementing the criteria in National Pollutant Discharge Elimination System permits. EPA also assumed that none of the States covered by the rule had adopted E. coli or enterococci as the applicable water quality standard whereas several of the States in today's rule have water quality standards for E. coli or enterococci already in place for some of their coastal recreation waters. This also led to a higher estimate of cost. EPA addresses discharges of bacteria from municipal separate storm sewers,

combined sewer overflows, sanitary sewer overflows, and nonpoint sources ( e. g., agriculture) to coastal waters in existing regulations and policies, and has tallied potential control costs to comply with those regulations and policies as part of analyses for those actions. In general, the best management practices or treatment controls for wet weather discharges that are designed to meet fecal coliform standards in a waterbody are also the best management practices or treatment controls used to address E. coli and enterococci. Because of the substantial variability in bacterial indicators and the site specific effectiveness of control measures, EPA is not able to determine at this time if additional measures will ultimately be necessary to meet criteria based on the new indicators. Compliance with pathogen standards is best achieved through an adaptive Privileged and Confidential Do Not Cite, Quote, or Release Page 71 of 97 management approach based on cost effective management practices and control measures coupled with on going monitoring and revision of control plans as necessary.

C. Analytical Methods EPA received a few comments on the topic of analytical methods. One commenter expressed concern that EPA has not published EPA approved analytical methods for measuring enterococci and E. coli in effluent. EPA recognizes that it has not yet published analytical methods for measuring enterococci and E. coli in effluents. EPA published its methods for measuring enterococci and E. coli in ambient waters on July 21, 2003, and is now in the process of proposing methods for measuring these pathogen indicators in effluent. EPA has completed its inter laboratory study of method 1600 for enterococci and method 1603 for E. coli in secondary treated effluents, and has determined that the variability found in this study support publication of a proposed method for effluents. EPA is moving expeditiously to promulgate these methods.

Three commenters noted that the inter laboratory study for enterococci and E. coli methods discussed above did not address pulp and paper effluents, and that these effluents are suspected of containing E. coli and enterococci independent of fecal matter. As a result, the commenters suggest that EPA complete validation studies of enterococci and E. coli methods for pulp and paper effluents before requiring States to implement the criteria in National Pollutant Discharge Elimination System permits for pulp and paper facilities. EPA disagrees that it must complete additional validation studies before States use the criteria for permits. EPA has completed its inter laboratory validation for EPA Methods 1600 and 1603 for effluents, and is in the process of proposing these methods. In addition, EPA is currently completing its inter Privileged and Confidential Do Not Cite, Quote, or Release Page 72 of 97 laboratory validation for EPA Methods 1103.1 and 1106.1 in effluents, and intends to propose them after the validation process is completed. EPA did not specifically use pulp and paper effluent matrices in the study. EPA method validation studies typically include several representative matrices and are not intended to include every potential effluent matrix to which a method may be applicable. In addition, EPA notes that its National Pollutant Discharge Elimination System regulations do not require that compliance monitoring for National Pollutant Discharge Elimination System permits be based on EPA approved methods. 40 CFR 122.41( j)( 4)

provides that monitoring results must be conducted according to test procedures approved under 40 CFR Part 136 unless other test procedures have been specified in the permit. States implementing the criteria in National Pollutant Discharge Elimination System permits may thus specify some other analytical method that the permittee is to use for compliance monitoring. Of course, any such method must be scientifically defensible, which usually means that it has been tested and verified by some other recognized standard setting or method development body.

Permittees who believe that a particular method is not appropriate or reliable for their effluent may present documentation of this concern to the permitting authority for consideration in determining compliance monitoring requirements.

D. Effective Date Section 553 of the Administrative Procedure Act provides that a substantive rule shall be published not less than 30 days before its effective date, except under certain circumstances. EPA is promulgating today's rule with an effective date of 30 days after publication in the Federal Register in order to make the water quality criteria effective as soon as possible and available for use in assessing beach safety and for other Clean Water Act purposes. This will serve to protect Privileged and Confidential Do Not Cite, Quote, or Release Page 73 of 97 human health at coastal recreation waters.

EPA received two comments on this issue. One commenter requested that EPA delay promulgating the rule until July 2005 and another commenter suggested that EPA delay the effective date for 90 days so that a State could complete its own promulgation of water quality standards based on the 1986 bacteria criteria. EPA disagrees that it should allow more than 30 days because this would delay the time at which States and Territories will begin using today's water quality criteria to govern decisions about opening and closing beaches and for other Clean Water Act purposes. EPA understands the interest of the commenters in having their State standards serve as the effective standards for Clean Water Act purposes. If a State adopts, and EPA approves, standards satisfying Clean Water Act section 303( i) shortly after the effective date of this rule, the State criteria will immediately replace the criteria in today's rule for Clean Water Act purposes within the State, consistent with 40 CFR 131.41( d)( i). EPA does not expect that a short window during which Federal standards are in effect will unduly disrupt on going State water quality standards programs. Therefore, EPA is making the rule effective 30 days after publication in the Federal Register.

VII. Alternative Regulatory Approaches and Implementation Mechanisms States and Territories have considerable discretion in designating uses. A State or Territory may find that changes in use designations are warranted. EPA will review any new or revised use designations adopted by States or Territories for coastal recreation waters covered by this rule to determine if the standards meet the requirements of the Clean Water Act and implementing regulations. In adopting recreation uses, the States and Territories may wish to Privileged and Confidential Do Not Cite, Quote, or Release Page 74 of 97 consider additional categories of recreation uses. If States and Territories change the designated use of a waterbody consistent with Clean Water Act section 303( c) and the regulations at 40 CFR Part 131, such that they are no longer designated for swimming, bathing, surfing, or similar water contact activities, then the waterbody would not be covered by the Clean Water Act definition of " coastal recreation waters" or this rule.

EPA reminds the States and Territories that they must conduct use attainability analyses as required by 40 CFR 131.10( g) when adopting water quality standards that do not include the uses specified in Clean Water Act section 101( a)( 2) or with subcategories of the designated uses specified in Clean Water Act section 101( a)( 2) that require less stringent criteria ( see 40 CFR 131.10( j)), than those currently in effect.

VIII. Economic Analysis These water quality standards may serve as a basis for development of National Pollutant Discharge Elimination System permit limits. Many of the affected jurisdictions ( i. e., States and Territories) are the National Pollutant Discharge Elimination System permitting authorities, which retain considerable discretion in implementing standards. EPA evaluated the potential costs to National Pollutant Discharge Elimination System dischargers in affected jurisdictions associated with State and Territorial implementation of today's standards. This analysis is documented in `` Economic Analysis for Final Water Quality Standards for Coastal Recreation Waters,'' which can be found in the record for this rulemaking.

Any National Pollutant Discharge Elimination System permitted facility that discharges to waterbodies affected by this rule could potentially incur compliance costs. The types of affected Privileged and Confidential Do Not Cite, Quote, or Release Page 75 of 97 facilities may include industrial facilities and publicly owned treatment works ( POTWs) discharging sanitary wastewater to surface waters ( i. e., point sources). In addition, EPA addresses discharges of bacteria from municipal separate storm sewer systems, combined sewer overflows, and sanitary sewer overflows to coastal waters in existing regulations and policies, and has tallied potential control costs as part of the analyses for those actions. EPA expects that States and municipalities will continue to use the same types of controls to come into compliance with the revised criteria as are currently used for compliance with existing regulations and policies. Available evidence suggests that if discharges are controlled in such a way that fecal coliform criteria are met, it is likely that enterococci and E. coli criteria would also be met, and there would not be an increase in impaired waters, resulting in additional Total Maximum Daily Loads, though not enough is known about the relationship between sources, controls, and the various indicators to conclude this with any certainty at this time. EPA did not evaluate the costs of this rule to Concentrated Animal Feeding Operations because the regulations for Concentrated Animal Feeding Operations prohibit discharges except in unusual circumstances ( i. e., very large storms) and therefore those entities are unlikely to incur any additional costs as a result of today's rule. EPA did not evaluate the potential for costs to nonpoint sources, such as agricultural runoff. Finally, EPA did not attempt to quantify the potential benefits of the rule.

EPA recognizes that a State or Territory may decide to require controls for nonpoint sources ( e. g., agricultural runoff). However, it is difficult to model and evaluate the potential costs impacts of this rule to those sources because they are intermittent, highly variable, and occur under different hydrologic or climatic conditions than continuous discharges from industrial and municipal facilities, which EPA evaluates under critical low flow or drought conditions. Also, data on Privileged and Confidential Do Not Cite, Quote, or Release Page 76 of 97 instream and discharge levels of bacteria after States have implemented controls to meet current water quality standards based on fecal coliform are not available. Therefore, trying to determine which sources would not achieve standards based on E. coli or enterococci after complying with existing regulations and policies may not be possible, and would be extremely time and resource intensive. Finally, it is likely that controls needed to meet existing criteria ( assumed for the purpose of costing to be fecal coliform for all States covered by the rule) would also address water quality problems indicated by criteria for E. coli or enterococci.

A. Identifying Affected Facilities EPA identified approximately 734 point source facilities that may be affected by the rule. Of these potentially affected facilities, 306 are classified as major dischargers, and 428 are minor dischargers. EPA did not include general permit facilities in its analysis because data for such facilities are extremely limited, and flows are usually negligible. Furthermore, EPA could not determine if any of these facilities with general permits actually discharge to the affected water bodies because facility location information is not available in EPA's Permit Compliance System database.

Of the facilities located in jurisdictions included in the rule, EPA evaluated that subset of facilities with individual permits that discharge within two miles of coastal waters or the Great Lakes may be affected. EPA identified these facilities by relating facility information to the potentially affected waters using Geographic Information System software. EPA also assumed that only wastewater treatment plants or facilities with similar effluent characteristics ( i. e., facilities having the potential to discharge bacteria in the form of fecal matter) may be affected. For those Privileged and Confidential Do Not Cite, Quote, or Release Page 77 of 97 facilities for which latitude/ longitude data are not included in Permit Compliance System, EPA included only facilities for which the receiving waterbody name in Permit Compliance System indicates a coastal water ( e. g., Pacific Ocean, Lake Erie). Table 5 summarizes these potentially affected facilities by type and category.

Table 5. Potentially Affected Facilities1 Category Number of Facilities Total Major2 Minor Municipal Other3 Coastal 242 233 100 575 Great Lakes 64 75 20 159 Total 306 308 120 734 1. Facilities from States and Territories included in the rule that discharge within two miles of coastal waters or the Great Lakes.

2. No major industrial facilities are affected by the rule. However, 4 other facilities ( SIC codes 9711 and 9999) are included because their names indicate that they are wastewater treatment plants.

3. Includes the following standard industrial classifications: eating places ( 5812), drinking places ( 5813), operators of nonresidential buildings ( 6512), operators of apartment buildings ( 6513), operators of dwellings other than apartment buildings ( 6514), operators of residential mobile home sites ( 6515), hotels and motels ( 7011), recreational vehicle parks and campsites ( 7033), organization hotels and lodging houses ( 7041), physical fitness facilities ( 7991),

amusement and recreation services ( 7999), skilled nursing care facilities ( 8051), general medical and surgical hospitals ( 8062), elementary and secondary schools ( 8211), colleges, universities, and professional schools ( 8221),

civic, social, and fraternal associations ( 8641), private households ( 8811). Also includes the following SICs if the facility name suggests that they may discharge sanitary waste: operative builders ( 1531), sanitary services, not elsewhere classified ( 4959), real estate agents and managers ( 6531), business associations ( 8611), religious organizations ( 8661), services not elsewhere classified ( 8999), air and water resource and solid waste management ( 9511), national security ( 9711), and nonclassifiable establishments ( 9999). Privileged and Confidential Do Not Cite, Quote, or Release Page 78 of 97 B. Method for Estimating Potential Compliance Costs To estimate costs, EPA evaluated the 15 major municipal facilities with design flows greater than 120 mgd, thus ensuring that the facilities with the potential for the largest costs would be evaluated. For the remaining facilities, EPA evaluated a sample of facilities to represent discharger type and category.

The Permit Compliance System does not contain E. coli or enterococci effluent data for any of the sample facilities. Therefore, to evaluate potential costs associated with the E. coli criteria,

EPA assumed that 100% of the fecal coliform measured at the sample facilities is E. coli because E.

coli is a type of fecal coliform. EPA assumed that all potentially affected facilities need effluent limits that are required to meet both the applicable geometric mean and single sample maximum values promulgated in today's rule. Based on the last 3 years of data, EPA thus estimated that facilities with average monthly effluent levels exceeding a geometric mean of 126/ 100 ml, or maximum daily levels exceeding 235/ 100 ml, would most likely need treatment controls to meet potential permit limits based on today's rule.

Enterococci are fecal bacteria in the fecal streptococcus group, and their relationship to fecal coliform bacteria is uncertain. Therefore, for coastal facilities, EPA used data and information in the literature regarding the ratio of fecal coliform to enterococci in untreated sewage, and the inactivation of both of these bacteria at minimum disinfection levels, to identify the concentrations of fecal coliform ( as related to enterococci) that may indicate a need for controls. Data in the literature indicate that the ratio of fecal coliform to fecal streptococcus in untreated sewage ranges from about 4 to 28. EPA used the most conservative ( i. e., erring on the side of overestimating Privileged and Confidential Do Not Cite, Quote, or Release Page 79 of 97 costs) ratio of 4 ( i. e., fecal coliform levels are 4 times fecal streptococcus levels) to estimate the fecal coliform levels at which facilities would need treatment to comply with the enterococci criteria. A ratio of 4 translates to fecal coliform levels of 140 fecal coliform per 100 ml ( 4

35 =

140/ 100 ml); however, for consistency with the Great Lakes analysis, EPA estimated costs based on meeting a more stringent value of 126 fecal coliform per 100 ml. In addition, EPA assumed that coastal facilities with maximum fecal coliform effluent values exceeding 235 colonies per 100 ml would need treatment controls ( even though 235 / 4 = 59, which is more stringent than the single sample maximum value of 104 in the final rule).

Experiences from four facilities currently having effluent limitations to meet E. coli and enterococci criteria, as well as the current fecal coliform criteria, suggest that chlorination processes can be upgraded or adjusted to treat the levels of bacteria necessary for compliance with effluent limitations based on today's rule. Therefore, EPA estimated that optimization of existing disinfection processes would enable the sample facilities to comply with the rule. Process optimization usually involves process analysis and process modifications, and EPA's cost estimates include both capital and operating and maintenance costs.

C. Results Based on the results for the 15 facilities with flows greater than 120 mgd, and extrapolating the sample results to the remaining potentially affected facilities, EPA estimated a total annual cost of approximately $ 20 million ($ 13 million for coastal facilities, and $ 7 million for Great Lakes facilities). EPA estimates that approximately 70 major and 20 minor permittees could incur control costs as a result of permit modifications to include limits based on the criteria in today's rule. Privileged and Confidential Do Not Cite, Quote, or Release Page 80 of 97 IX. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review Under Executive Order 12866, ( 58 FR 51735, October 4, 1993) the Agency must determine whether the regulatory action is " significant" and therefore subject to Office of Management and Budget ( OMB) review and the requirements of the Executive Order. The Order defines " significant regulatory action" as one that is likely to result in a rule that may:

( 1) have an annual effect on the economy of $ 100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

( 2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

( 3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or ( 4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

Pursuant to the terms of Executive Order 12866, it has been determined that this rule is a " significant regulatory action" because the rule raises novel policy issues arising out of the BEACH Act. As such, this action was submitted to OMB for review. Changes made in response to OMB suggestions or recommendations are documented in the public record.

B. Paperwork Reduction Act Privileged and Confidential Do Not Cite, Quote, or Release Page 81 of 97 This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.). It does not include any information collection,

reporting, or record keeping requirements.

Burden means the total time, effort or financial resources expended by persons to generate,

maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information;

and transmit or otherwise disclose the information.

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. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR Part 9.

C. Regulatory Flexibility Act The Regulatory Flexibility Act ( RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 ( SBREFA), 5 U. S. C. 601 et seq., generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations and small governmental Privileged and Confidential Do Not Cite, Quote, or Release Page 82 of 97 jurisdictions.

For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: ( 1) a small business according to RFA default definitions for small business ( based on Small Business Administration size standards); ( 2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and ( 3) a small organization that is any not for profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. As discussed below, these water quality standards do not directly apply to any discharger, including small entities.

Clean Water Act section 303( i)( 2)( A) requires that if a State or Territory fails to adopt water quality criteria and standards in accordance with paragraph ( 1)( A) that are as protective of human health as the criteria for pathogen indicators for coastal recreation waters published by the Administrator, the Administrator shall promptly propose regulations for the State or Territory setting forth revised or new water quality standards for pathogen indicators described in paragraph ( 1)( A) for coastal recreation waters of the State or Territory. These State standards ( or EPApromulgated standards) are implemented through various water quality control programs including the National Pollutant Discharge Elimination System program, which limits discharges to navigable waters except in compliance with a National Pollutant Discharge Elimination System permit. The Clean Water Act requires that all National Pollutant Discharge Elimination System permits include Privileged and Confidential Do Not Cite, Quote, or Release Page 83 of 97 any limits on discharges that are necessary to meet applicable water quality standards.

In cases in which a discharger ( including a small entity) is discharging pathogens into waters subject to these standards, the permitting authority will need to determine whether the discharge is or may be discharged at a level which will cause, contribute, or have the reasonable potential to cause an exceedance of the applicable water quality standard. In making that determination, the permitting authority would need to consider the factors listed in 40 CFR 122.44( d)( 1)( ii). Whether a permitting authority will need to require a water quality based effluent limit depends on the analysis of these factors, which will vary based on the specific facts of each permit decision. Based on that analysis, if the permitting authority finds that the discharger causes, contributes to, or has the reasonable potential to cause an exceedance of the applicable water quality standard, after the application of any required technology based effluent limits, then the permitting authority will need to impose a water quality based effluent limit to meet the applicable water quality standard. ( See Clean Water Act section 301( b)( 1)( C); 40 CFR 122.44( d).) Therefore, as a practical matter,

today's rule may or may not necessitate a change in the permit, depending on the specific circumstances. While the Clean Water Act and its implementing regulations may trigger the need for new or revised discharge limits based on the water quality standards in today's rule to be placed on small entities in some cases, the standards themselves do not directly apply to any discharger,

including small entities.

Although not required by the Regulatory Flexibility Act, EPA conducted a screening analysis to evaluate the potential for today's rule to have a significant impact on a substantial number of small entities, as part of its general practice to assess and reduce burden on small entities wherever possible. The screening analysis, which is included in the docket for today's rule, supports Privileged and Confidential Do Not Cite, Quote, or Release Page 84 of 97 a conclusion that today's rule will not have a significant impact on a substantial number of small entities. EPA identified the universe of National Pollutant Discharge Elimination System permitted entities that are small in size. EPA evaluated the severity of potential economic impacts on those small entities by comparing their estimated compliance costs to revenues, sales, or household income, depending on the type of entity. EPA observed that only one small government ( a major facility) may incur annual costs that equal or exceed 1% and 3% of annual revenues. For small businesses, the impact ratio exceeds 1% for two facilities, and 3% for only one. Thus, given the few facilities for which impact ratios exceed 1% and 3%, the combined results for small governments and businesses support a conclusion that there will not be a significant impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA), P. L. 104 4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local,

and Tribal governments and the private sector. The definition of " State" for the purposes of the Unfunded Mandates Reform Act includes " a territory or possession of the United States." Under section 202 of the Unfunded Mandates Reform Act, EPA generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with " Federal mandates"

that may result in expenditures to State, local, and Tribal governments, in the aggregate, or to the private sector, of $ 100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the Unfunded Mandates Reform Act generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost effective or least burdensome alternative that achieves the objectives of the rule. Privileged and Confidential Do Not Cite, Quote, or Release Page 85 of 97 The provisions of section 205 do not apply when they are inconsistent with applicable law.

Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost effective or least burdensome alternative if the Administrator publishes with the final rule an explanation of why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments, it must have developed under section 203 of the Unfunded Mandates Reform Act a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

Today's rule contains no Federal mandates ( under the regulatory provisions of Title II of the Unfunded Mandates Reform Act) that may result in expenditures to State, local and Tribal governments, or the private sector, in the aggregate of $ 100 million or more in any one year.

Therefore, this rule is not subject to the requirements of sections 202 and 205 of the Unfunded Mandates Reform Act.

EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments. Thus, this rule is not subject to the requirements of section 203 of the Unfunded Mandates Reform Act.

E. Executive Order 13132: Federalism Executive Order 13132, entitled " Federalism" ( 64 FR 43255, August 10, 1999), requires Privileged and Confidential Do Not Cite, Quote, or Release Page 86 of 97 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 does not have Federalism implications. It will not 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, as specified in Executive Order 13132. EPA's authority and responsibility to promulgate Federal water quality standards when State standards do not meet the requirements of the Clean Water Act is well established and has been used on various occasions in the past. The final rule does not substantially affect the relationship of EPA and the States and Territories, or the distribution of power or responsibilities between EPA and the various levels of government. The final rule does not alter the States' or Territories' considerable discretion in implementing these water quality standards.

Further, this rule does not preclude the States and Territories from adopting water quality standards that meet the requirements of the Clean Water Act, either before or after promulgation of the final rule, thus eliminating the need for Federal standards. Thus, Executive Order 13132 does not apply to this rule.

Although Executive Order 13132 does not apply to this rule, in the spirit of Executive Order 13132 and consistent with EPA's policy to promote communication between EPA and State and local governments, EPA did consult with representatives of the States and Territories subject to Privileged and Confidential Do Not Cite, Quote, or Release Page 87 of 97 Clean Water Act section 303( i) in developing this rule. Prior to this rulemaking action, EPA had numerous phone calls, meetings and exchanges of written correspondence with the States to discuss EPA's concerns with the States' bacteria criteria, compliance with the BEACH Act, and the Federal rulemaking process. In June 2000, EPA and the Association of State and Interstate Water Pollution Control Administrators ( ASIWPCA) established a State/ EPA Work Group on Water Quality Standards, composed of selected senior State and EPA managers, to provide input to EPA on water quality standards issues. The group has met approximately three times per year since then,

beginning with a meeting in September 2000. At every meeting the group has discussed the scientific, programmatic, and policy aspects of bacteria criteria for both coastal and non coastal recreation waters, and has provided useful input to EPA on these topics. Members of this group,

together with other interested State participants, have also served as an ad hoc work group since 2001 to assist EPA in developing draft detailed scientific and policy guidance ( Implementation Guidance for Ambient Water Quality Criteria for Bacteria ( EPA 823 B 02 003, May 2002 Draft))

concerning adoption and implementation of EPA's recommended criteria for bacteria. Today's final rule reflects State and Territorial input, and EPA has responded to State and Territorial comment on various topics in the preamble to today's rule and in the Comment Response Document, which is part of the record for this rule.

F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments Executive Order 13175, entitled " Consultation and Coordination with Indian Tribal Governments" ( 65 FR 67249, November 6, 2000), 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." Privileged and Confidential Do Not Cite, Quote, or Release Page 88 of 97 This final rule does not have Tribal implications. It 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. There are four authorized Indian Tribes with coastal or Great Lakes waters; however, they have not yet adopted water quality standards, and therefore, have no designated coastal recreation waters within their jurisdiction. These Tribes are therefore not subject to today's rule. Thus, Executive Order 13175 does not apply to this rule.

EPA has contacted those Tribes identified as having coastal or Great Lakes waters to inform them of the potential future impact this could have on Tribal waters.

G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks Executive Order 13045: " Protection of Children from Environmental Health Risks and Safety Risks" ( 62 FR 19885, April 23, 1997) applies to any rule that: ( 1) is determined to be " economically significant" as defined under Executive Order 12866, and ( 2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the rule on children, and explain why the regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

This rule is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866, and because the Agency does not have reason to believe the Privileged and Confidential Do Not Cite, Quote, or Release Page 89 of 97 environmental health or safety risks addressed by this action present a disproportionate risk to children. As explained in section II. B of the preamble to today's rule, EPA developed the water quality criteria promulgated in today's rule based on concentrations of E. coli and enterococci from EPA sponsored epidemiological studies reflecting all reported illnesses, including those of children.

In the marine and freshwater studies, the range of the number of children under age 10 was between 15% and 25% of the total study population. Children in the age range 10 to 19 years old made up a slightly higher percentage of the study population. During the studies, information on gastroenteritis, respiratory symptoms, and other symptoms were collected for all participants,

including children. EPA designed the 1986 bacteria criteria to protect all age groups.

H. Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution, or Use This rule is not a " significant energy action" as defined in Executive Order 13211, " Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use" ( 66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply,

distribution, or use of energy. EPA estimates that compliance with the final rule will create a negligible increase in nationwide energy consumption for point source facilities discharging to coastal recreation waters in affected States. In section VIII, EPA presented its estimated incremental costs to permitted facilities as a result of the final rule. Some of these costs include energy use associated with increased maintenance of disinfection tanks. EPA estimates that the increased energy use from these activities would be about 99,000 kilowatt hours. Net production by electric power generation facilities in the United States in 2002 was 3,858,452 million kilowatt hours ( Energy Information Administration, Department of Energy,

http:// www. eia. doe. gov/ neic/ quickfacts/ quickelectric. htm). EPA estimates that the additional Privileged and Confidential Do Not Cite, Quote, or Release Page 90 of 97 energy requirements of EPA's rule are insignificant ( i. e., 0.000003% of national energy generation).

I. National Technology Transfer and Advancement Act As noted in the proposal, section 12( d) of the National Technology Transfer and Advancement Act of 1995 (" NTTAA"), Pub. L. 104 113, section 12( d) ( 15 U. S. C. 272 note)

directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e. g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

While ambient water quality criteria may be considered technical standards, EPA is not aware of any voluntary consensus standards relating to bacteria criteria to protect human health and none were brought to our attention in comments on the proposed rule. Furthermore, even if there were such voluntary consensus standards, the BEACH Act specifically directs EPA to promulgate Federal standards based on its own bacteria criteria, in accordance with Clean Water Act section 304( a), in cases where States fail to do so. Therefore, EPA is not considering the use of any voluntary consensus standards.

J. Congressional Review Act The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect,

the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to Water Quality Standards for Coastal and Great Lakes Recreation Waters page 91 of 97 Privileged and Confidential Do Not Cite, Quote, or Release Page 91 of 97 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 the rule in the Federal Register. A " major rule" cannot take effect until 60 days after it is published in the Federal Register. This action is not a " major rule" as defined by 5 U. S. C. 804( 2). This rule will be effective [ INSERT DATE 30 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER].

List of Subjects in 40 CFR Part 131 Environmental protection, Intergovernmental relations, Reporting and recordkeeping requirements,

Water pollution control.

Dated:

Michael O. Leavitt,

Administrator.

For the reasons set out in the preamble, 40 CFR part 131 is amended as follows:

PART 131 WATER QUALITY STANDARDS 1. The authority citation for part 131 continues to read as follows:

Authority: 33 U. S. C. 1251 et seq.

Subpart D  [ Amended]

2. Section 131.41 is added to Subpart D to read as follows: Privileged and Confidential Do Not Cite, Quote, or Release Page 92 of 97 § 131.41 Bacteriological criteria for those states not complying with Clean Water Act section 303( i)( 1)( A).

( a) Scope. This section is a promulgation of the Clean Water Act section 304( a) criteria for bacteria for coastal recreation waters in specific States. It is not a general promulgation of the Clean Water Act section 304( a) criteria for bacteria. This section also contains a compliance schedule provision.

( b) Definitions. ( 1) Coastal Recreation Waters are the Great Lakes and marine coastal waters ( including coastal estuaries) that are designated under section 303( c) of the Clean Water Act for use for swimming, bathing, surfing, or similar water contact activities. Coastal recreation waters do not include inland waters or waters upstream from the mouth of a river or stream having an unimpaired natural connection with the open sea.

( 2) Designated bathing beach waters are those coastal recreation waters that, during the recreation season, are heavily used ( based upon a comparison of use within the State) and may have: a lifeguard, bathhouse facilities, or public parking for beach access. States may include any other waters in this category even if the waters do not meet these criteria.

( 3) Moderate use coastal recreation waters are those coastal recreation waters that are not designated bathing beach waters but typically, during the recreation season, are used by at least half of the number of people as at typical designated bathing beach waters within the State. States may also include light use or infrequent use coastal recreation waters in this category.

( 4) Light use coastal recreation waters are those coastal recreation waters that are not designated bathing beach waters but typically, during the recreation season, are used by less than half of the number of people as at typical designated bathing beach waters within the State, but are more than Privileged and Confidential Do Not Cite, Quote, or Release Page 93 of 97 infrequently used. States may also include infrequent use coastal recreation waters in this category.

( 5) Infrequent use coastal recreation waters are those coastal recreation waters that are rarely or occasionally used.

( 6) New pathogen discharger for the purposes of this section means any building, structure, facility,

or installation from which there is or may be a discharge of pathogens, the construction of which commenced on or after [ INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION]. It does not include relocation of existing combined sewer overflow outfalls.

( 7) Existing pathogen discharger for the purposes of this section means any discharger that is not a new pathogen discharger.

( c) EPA's section 304( a) ambient water quality criteria for bacteria.

( 1) Freshwaters:

A Indicatord B Geometric Mean C Single Sample Maximum ( per 100 ml)

C1 Designated bathing beach ( 75%

confidence level) C2 Moderate use coastal recreation waters ( 82%

confidence level) C3 Light use coastal recreation waters ( 90% confidence level) C4 Infrequent use coastal recreation waters ( 95%

confidence level)

E. colie 126/ 100 mla 235b 298b 409b 575b Enterococcie 33/ 100 mlc 61b 78b 107b 151b Footnotes to table in paragraph ( c)( 1):

a. This value is for use with analytical methods 1103.1, 1603, or 1604 or any equivalent method that measures viable bacteria.

b. Calculated using the following: single sample maximum = geometric mean * 10^( confidence level factor * log standard deviation), where the confidence level factor is: 75%: 0.68; 82%: 0.94; 90%: Privileged and Confidential Do Not Cite, Quote, or Release Page 94 of 97 1.28; 95%: 1.65. The log standard deviation from EPA's epidemiological studies is 0.4.

c. This value is for use with analytical methods 1106.1 or 1600 or any equivalent method that measures viable bacteria.

d. The State will determine which of these indicators applies to its freshwater coastal recreation waters.

e. These values apply to E. coli or enterococci regardless of origin unless a sanitary survey shows that sources of the indicator bacteria are non human and an epidemiological study shows that the indicator densities are not indicative of a human health risk.

( 2) Marine waters:

A Indicator B Geometric Mean C Single Sample Maximum ( per 100 ml)

C1 Designated bathing beach ( 75%

confidence level) C2 Moderate use coastal recreation waters ( 82%

confidence level) C3 Light use coastal recreation waters ( 90% confidence level) C4 Infrequent use coastal recreation waters ( 95%

confidence level)

Enterococcic 35/ 100 mla 104b 158b 276b 501b Footnotes to table in paragraph ( c)( 2):

a. This value is for use with analytical methods 1106.1 or 1600 or any equivalent method that measures viable bacteria.

b. Calculated using the following: single sample maximum = geometric mean * 10^( confidence level factor * log standard deviation), where the confidence level factor is: 75%: 0.68; 82%: 0.94; 90%:

1.28; 95%: 1.65. The log standard deviation from EPA's epidemiological studies is 0.7.

c. These values apply to enterococci regardless of origin unless a sanitary survey shows that sources Privileged and Confidential Do Not Cite, Quote, or Release Page 95 of 97 of the indicator bacteria are non human and an epidemiological study shows that the indicator densities are not indicative of a human health risk.

( 3) As an alternative to the single sample maximum in paragraph ( c)( 1) or ( c)( 2) of this section,

States may use a site specific log standard deviation to calculate a single sample maximum for individual coastal recreation waters, but must use at least 30 samples from a single recreation season to do so.

( d) Applicability. ( 1) The criteria in paragraph ( c) of this section apply to the coastal recreation waters of the States identified in paragraph ( e) of this section and apply concurrently with any ambient recreational water criteria adopted by the State, except for those coastal recreation waters where State regulations determined by EPA to meet the requirements of Clean Water Act section 303( i) apply, in which case the State's criteria for those coastal recreation waters will apply and not the criteria in paragraph ( c) of this section.

( 2) The criteria established in this section are subject to the State's general rules of applicability in the same way and to the same extent as are other Federally adopted and State adopted numeric criteria when applied to the same use classifications.

( e) Applicability to specific jurisdictions. ( 1) The criteria in paragraph ( c)( 1) of this section apply to fresh coastal recreation waters of the following States: Illinois, Minnesota, New York, Ohio,

Pennsylvania, Wisconsin.

( 2) The criteria in paragraph ( c)( 2) of this section apply to marine coastal recreation waters of the following States: Alaska, California ( except for coastal recreation waters within the jurisdiction of Regional Board 4), Florida, Georgia, Hawaii ( except for coastal recreation waters within 300 meters of the shoreline), Louisiana, Maine ( except for SA waters and SB and SC waters with Privileged and Confidential Do Not Cite, Quote, or Release Page 96 of 97 human sources of fecal contamination), Maryland, Massachusetts, Mississippi, New York, North Carolina, Oregon, Puerto Rico ( except for waters classified by Puerto Rico as intensely used for primary contact recreation and for those waters included in § 131.40), Rhode Island, United States Virgin Islands.

( f) Schedules of compliance. ( 1) Paragraph ( f) applies to any State that does not have a regulation in effect for Clean Water Act purposes that authorizes compliance schedules for National Pollutant Discharge Elimination System permit limitations needed to meet the criteria in paragraph ( c) of this section. All dischargers shall promptly comply with any new or more restrictive water quality based effluent limitations based on the water quality criteria set forth in this section.

( 2) When a permit issued on or after [ INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION] to a new pathogen discharger as defined in paragraph ( b) of this section contains water quality based effluent limitations based on water quality criteria set forth in paragraph ( c) of this section, the permittee shall comply with such water quality based effluent limitations upon the commencement of the discharge.

( 3) Where an existing pathogen discharger reasonably believes that it will be infeasible to comply immediately with a new or more restrictive water quality based effluent limitations based on the water quality criteria set forth in paragraph ( c) of this section, the discharger may request approval from the permit issuing authority for a schedule of compliance.

( 4) A compliance schedule for an existing pathogen discharger shall require compliance with water quality based effluent limitations based on water quality criteria set forth in paragraph ( c) of this section as soon as possible, taking into account the dischargers' ability to achieve compliance with such water quality based effluent limitations. Privileged and Confidential Do Not Cite, Quote, or Release Page 97 of 97 ( 5) If the schedule of compliance for an existing pathogen discharger exceeds one year from the date of permit issuance, reissuance or modification, the schedule shall set forth interim requirements and dates for their achievement. The period between dates of completion for each requirement may not exceed one year. If the time necessary for completion of any requirement is more than one year and the requirement is not readily divisible into stages for completion, the permit shall require, at a minimum, specified dates for annual submission of progress reports on the status of interim requirements.

( 6) In no event shall the permit issuing authority approve a schedule of compliance for an existing pathogen discharge which exceeds five years from the date of permit issuance, reissuance, or modification, whichever is sooner.

( 7) If a schedule of compliance exceeds the term of a permit, interim permit limits effective during the permit shall be included in the permit and addressed in the permit's fact sheet or statement of basis. The administrative record for the permit shall reflect final permit limits and final compliance dates. Final compliance dates for final permit limits, which do not occur during the term of the permit, must occur within five years from the date of issuance, reissuance or modification of the permit which initiates the compliance schedule.


[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Page 10344]
[FR Doc No: 2023-03381]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-2842]

Determination That Dihydroergotamine Mesylate 45 Injection USP, 1
Milligram/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety
or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that D.H.E. 45 (dihydroergotamine mesylate) injection USP, 1
milligram (mg)/milliliter (mL), was not withdrawn from sale for reasons
of safety or effectiveness. This determination means that FDA will not
begin procedures to withdraw approval of abbreviated new drug
applications (ANDAs) that refer to this drug product, and it will allow
FDA to continue to approve ANDAs that refer to the product as long as
they meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Donna Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    D.H.E. 45 (dihydroergotamine mesylate) injection USP, 1 mg/mL, is
the subject of NDA 005929, held by Bausch Health US, LLC, and initially
approved on April 12, 1946. D.H.E. 45 (dihydroergotamine mesylate) is
indicated for the acute treatment of migraine headaches with or without
aura and the acute treatment of cluster headache episodes.
    In a letter dated June 13, 2022, Bausch Health US, LLC notified FDA
that D.H.E. 45 (dihydroergotamine mesylate) injection USP, 1 mg/mL, was
being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
    Baxter Healthcare Corporation submitted a citizen petition dated
November 11, 2022 (Docket No. FDA-2022-P-2842), under 21 CFR 10.30,
requesting that the Agency determine whether D.H.E. 45
(dihydroergotamine mesylate) injection USP, 1 mg/mL, was withdrawn from
sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that D.H.E. 45 (dihydroergotamine mesylate)
injection USP, 1 mg/mL, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that D.H.E. 45 (dihydroergotamine mesylate)
injection USP, 1 mg/mL, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of D.H.E. 45 (dihydroergotamine mesylate)
injection USP, 1 mg/mL, from sale. We have also independently evaluated
relevant literature and data for possible postmarketing adverse events.
We have found no information that would indicate that this drug product
was withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list D.H.E. 45
(dihydroergotamine mesylate) injection USP, 1 mg/mL, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. FDA will not begin procedures to withdraw
approval of approved ANDAs that refer to this drug product. Additional
ANDAs for this drug product may also be approved by the Agency as long
as they meet all other legal and regulatory requirements for the
approval of ANDAs. If FDA determines that labeling for this drug
product should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.

    Dated: February 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03381 Filed 2-16-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 27, 2007 (Volume 72, Number 187)]
[Notices]
[Page 54975-54977]
[DOCID:fr27se07-121]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2007-28692]

Final Decision That Certain Nonconforming Vehicles Are Eligible
for Importation

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Final decision that certain nonconforming vehicles are eligible
for importation.

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SUMMARY: This document announces a final decision by the National
Highway Traffic Safety Administration (NHTSA) that certain vehicles
that do not comply with all applicable Federal motor vehicle safety
standards, but that are certified by their original manufacturer as
complying with all applicable

Canadian motor vehicle safety standards, are eligible for importation
into the United States. The vehicles in question either (1) are
substantially similar to vehicles that were certified by their
manufacturers as complying with the U.S. safety standards and are
capable of being readily altered to conform to those standards, or (2)
have safety features that comply with, or are capable of being altered
to comply with, all U.S. safety standards.

DATES: This decision is effective on September 27, 2007.

FOR FURTHER INFORMATION CONTACT: Coleman Sachs, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable Federal motor
vehicle safety standards (FMVSS) shall be refused admission into the
United States unless NHTSA has decided, either pursuant to a petition
from the manufacturer or registered importer or on its own initiative,
(1) that the nonconforming motor vehicle is substantially similar to a
motor vehicle of the same model year that was originally manufactured
for importation into and sale in the United States and certified by its
manufacturer as complying with all applicable FMVSS, and (2) that the
nonconforming motor vehicle is capable of being readily altered to
conform to all applicable FMVSS. Where there is no substantially
similar U.S.-certified motor vehicle, 49 U.S.C. 30141(a)(1)(B) permits
a nonconforming motor vehicle to be admitted into the United States if
NHTSA decides that its safety features comply with, or are capable of
being altered to comply with, all applicable FMVSS based on destructive
test data or such other evidence as NHTSA decides to be adequate.
    On August 14, 2007, NHTSA published a notice in the Federal
Register at 72 FR 45488 announcing that it had made a tentative
decision that certain motor vehicles that do not comply with all
applicable FMVSS, but that are certified by their original manufacturer
as complying with all applicable Canadian motor vehicle safety
standards, are eligible for importation into the United States. The
notice identified these vehicles as:
    (a) All passenger cars manufactured on or after September 1, 2007,
and before September 1, 2008, that, as originally manufactured, comply
with FMVSS Nos. 110, 118, 201, 208, 213, 214, 225, and 401, and,
insofar as it is applicable, with FMVSS No. 138;
    (b) All passenger cars manufactured on or after September 1, 2008
and before September 1, 2011 that, as originally manufactured, comply
with FMVSS Nos. 110, 118, 201, 202a, 206, 208, 213, 214, 225, and 401,
and, insofar as it is applicable, with FMVSS No. 138;
    (c) All passenger cars manufactured on or after September 1, 2011
and before September 1, 2012 that, as originally manufactured, comply
with FMVSS Nos. 110, 118, 126, 201, 202a, 206, 208, 213, 214, 225, and
401, and, insofar as it is applicable, with FMVSS No. 138;
    (d) All multipurpose passenger vehicles, trucks, and buses with a
GVWR of 4,536 kg (10,000 lb) or less manufactured on or after September
1, 2007 and before September 1, 2008, that, as originally manufactured,
comply with FMVSS Nos. 110, 118, 201, 208, 213, 214, and 216, and
insofar as they are applicable, with FMVSS Nos. 138 and 225;
    (e) All multipurpose passenger vehicles, trucks, and buses with a
GVWR of 4,536 kg (10,000 lb) or less manufactured on or after September
1, 2008 and before September 1, 2011, that, as originally manufactured,
comply with FMVSS Nos. 110, 118, 201, 202a, 206, 208, 213, 214, and
216, and insofar as they are applicable, with FMVSS Nos. 138 and 225;
and
    (f) All multipurpose passenger vehicles, trucks, and buses with a
GVWR of 4,536 kg (10,000 lb) or less manufactured on or after September
1, 2011 and before September 1, 2012, that, as originally manufactured,
comply with FMVSS Nos. 110, 118, 126, 201, 202a, 206, 208, 213, 214,
and 216, and insofar as they are applicable, with FMVSS Nos. 138 and
225.
    The reader is referred to the August 14 notice for a full
discussion of the factors leading to the tentative decision. In
accordance with 49 U.S.C. 30141(b), the notice solicited public
comments on the tentative decision. No comments were submitted in
response to the notice. Accordingly, we are adopting the tentative
decision as a final decision.
    NHTSA has required Canadian-certified multipurpose passenger
vehicles, trucks, and buses with a GVWR of 4,536 kg (10,000 lb) or less
to be originally manufactured to comply with FMVSS No. 202 Head
Restraints for those vehicles to be imported under past eligibility
decisions. The tentative decision inadvertently omitted FMVSS No. 202
from the list of standards that multipurpose passenger vehicles,
trucks, and buses with a GVWR of 4,536 kg (10,000 lb) or less
manufactured on or after September 1, 2007 and before September 1, 2008
must be originally manufactured to comply with to be eligible for
importation. That standard has been restored to the list in this final
decision.
    In addition, the final decision identifies FMVSS No. 138 Tire
Pressure Monitoring Systems as a standard that passenger cars
manufactured on or after September 1, 2007 must be originally
manufactured to comply with to be eligible for importation. The
tentative decision stated that passenger cars would be required to
comply with that standard ``insofar as it is applicable.'' The only
such vehicles to which the standard would not apply are those ``with
dual wheels on an axle.'' See paragraph S2 of the standard, at 49 CFR
571.138. Since NHTSA is not aware of any passenger cars that are
manufactured with dual wheels on an axle, the agency has eliminated
this conditional language in the final decision.

Final Decision

    In consideration of the foregoing, the Administrator of NHTSA
hereby decides that:
    (a) All passenger cars manufactured on or after September 1, 2007,
and before September 1, 2008, that, as originally manufactured, comply
with FMVSS Nos. 110, 118, 138, 201, 208, 213, 214, 225, and 401;
    (b) All passenger cars manufactured on or after September 1, 2008
and before September 1, 2011 that, as originally manufactured, comply
with FMVSS Nos. 110, 118, 138, 201, 202a, 206, 208, 213, 214, 225, and
401;
    (c) All passenger cars manufactured on or after September 1, 2011
and before September 1, 2012 that, as originally manufactured, comply
with FMVSS Nos. 110, 118, 126, 138, 201, 202a, 206, 208, 213, 214, 225,
and 401;
    (d) All multipurpose passenger vehicles, trucks, and buses with a
GVWR of 4,536 kg (10,000 lb) or less manufactured on or after September
1, 2007 and before September 1, 2008, that, as originally manufactured,
comply with FMVSS Nos. 110, 118, 201, 202, 208, 213, 214, and 216, and
insofar as they are applicable, with FMVSS Nos. 138 and 225;
    (e) All multipurpose passenger vehicles, trucks, and buses with a
GVWR of 4,536 kg (10,000 lb) or less manufactured on or after September
1, 2008 and before September 1, 2011, that, as originally manufactured,
comply with FMVSS Nos. 110, 118, 201, 202a, 206, 208, 213, 214, and
216, and insofar as they are applicable, with FMVSS Nos. 138 and 225;
and

    (f) All multipurpose passenger vehicles, trucks, and buses with a
GVWR of 4,536 kg (10,000 lb) or less manufactured on or after September
1, 2011 and before September 1, 2012, that, as originally manufactured,
comply with FMVSS Nos. 110, 118, 126, 201, 202a, 206, 208, 213, 214,
and 216, and insofar as they are applicable, with FMVSS Nos. 138 and
225,

that are certified by their original manufacturer as complying with all
applicable Canadian motor vehicle safety standards, are eligible for
importation into the United States on the basis that either:
    1. They are substantially similar to vehicles of the same make,
model, and model year originally manufactured for importation into and
sale in the United States, or originally manufactured in the United
States for sale therein, and certified as complying with all applicable
FMVSS, and are capable of being readily altered to conform to all
applicable FMVSS, or
    2. They have safety features that comply with, or are capable of
being altered to comply with, all applicable FMVSS.

Vehicle Eligibility Number

    The importer of a vehicle admissible under any final decision must
indicate on the form HS-7 accompanying entry the appropriate vehicle
eligibility number indicating that the vehicle is eligible for entry.
All passenger cars admissible under this decision are eligible for
entry under vehicle eligibility number VSA-80, and all multipurpose
passenger vehicles, trucks, and buses admissible under this decision
are eligible for entry under vehicle eligibility number VSA-81.

    Authority: 49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49
CFR 593.8; delegation of authority at 49 CFR 1.50.

    Issued on: September 24, 2007.
Ronald L. Medford,
Senior Associate Administrator for Vehicle Safety.
[FR Doc. E7-19114 Filed 9-26-07; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 86, Number 44 (Tuesday, March 9, 2021)]
[Notices]
[Pages 13539-13540]
[FR Doc No: 2021-04829]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 2785-103, 10809-051, 10810-057]

Boyce Hydro Power, LLC; Notice of Termination of Licenses by
Implied Surrender and Soliciting Comments, Protests, and Motions To
Intervene

    Take notice that the following hydroelectric proceeding has been
initiated by the Commission:
    a. Type of Proceeding: Termination of Licenses by Implied
Surrender.
    b. Project Nos: P-2785-103, P-10809-051, and P-10810-057.
    c. Date Initiated: February 5, 2021.
    d. Licensee: Boyce Hydro Power, LLC (Boyce Hydro).
    e. Name of Projects: Sanford (P-2785), Secord (P-10809) and
Smallwood (P-10810) Hydroelectric Projects (Boyce Projects).
    f. Location: The projects are located on the Tittabawasee River in
Midland and Gladwin counties, Michigan.
    g. Filed Pursuant to: 18 CFR 6.4.
    h. Applicant Contact: Mr. Michael A. Swiger, Van Ness Feldman, LLP,
1050 Thomas Jefferson Street NW, Washington, DC 20007.<PHONE_NUMBER>,
<EMAIL_ADDRESS>    i. FERC Contact: Rebecca Martin,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene and protests:
June 1, 2021.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include docket numbers P-2785-103, P-10809-051, and P-10810-057.
Comments emailed to Commission staff are not considered part of the
Commission record.
    k. Description of Projects Facilities: The Boyce Projects are
located on the Tittabawassee River with the Secord Project being the
most upstream, followed by the Smallwood Project, which is located
approximately seven river miles downstream, followed by the non-
jurisdictional Edenville dam (formerly FERC Project No. 10808), which
is located approximately 13 river miles downstream of the Smallwood
Project, at the confluence of the Tittabawassee and Tobacco Rivers. The
Sanford Project is located approximately 11 river miles downstream of
Edenville Dam.
    The Secord Project was licensed on October 16, 1998. The project
works consist of: (1) The 1,100-acre reservoir, Secord Lake; (2) a 47-
foot-long intake structure; (3) an earthen dam with a 1,400-foot-long,
55-foot-high section between the left abutment and the powerhouse, a
600-foot-long section between the spillway and the right abutment; (4)
a reinforced concrete multiple arch spillway with an ogee crest and two
Taintor gates; (5) a powerhouse integral with the dam housing with one
Francis vertical-axis turbine-generator unit with installed capacity of
1,200 kilowatts (kW); and (6) appurtenant facilities.
    The Smallwood Project was licensed on October 16, 1998. The project
works consist of: (1) The 500-acre reservoir, Smallwood Lake; (2) a 52-
foot-long, 25-foot-high, and 50-foot-wide reinforced concrete hollow
gravity spillway dam at the base; (3) two 25.3-foot-wide, 10-foot-high
steel Taintor gates on top of the spillway crest; (4) a 100-foot-long,
40-foot-high right-side earth embankment; (5) a 550-foot-long, 40-foot-
high left-side earth embankment; (6) a 55-foot-long, 27-foot-wide, and
65-foot-high reinforced concrete powerhouse integral with the spillway
housing a vertical axis, open flume turbine-generator unit with
capacity of 1,200 kW; and (7) appurtenant facilities.
    On May 19, 2020, the Sanford Project, licensed on December 1, 1987,
was breached. This breach resulted in the loss of the right embankment
and fuse plug and significant erosion of the left bank. However, as
licensed, the project works consisted of: (1) A 1,526-acre reservoir;
(2) a 26-foot-high, 1,600-foot-long dam with an integrated 71-foot-long
powerhouse section, a 149-foot-long spillway section controlled by six
Taintor gates, and a 1,380-foot-long earth embankment; (3) a masonry
powerhouse housing three generating units with a total installed
capacity of 3,300 kW; (4) a 40-foot-long, 2.3-kilovolt transmission
line; and (5) appurtenant facilities.
    l. Description of Proceeding: The Commission's regulations, at 18
CFR 6.4, provide that if a licensee shall cause or suffer essential
property to be removed or destroyed, or become unfit for use, without
replacement it is deemed to be the intent of a licensee to surrender
the license, and the Commission may, and not less than 90 days after
public notice, in its discretion terminate the license by implied
surrender.
    The Commission is issuing this notice of termination by implied
surrender based on case specifics. On May 19, 2020, the floodwaters of
the Tittabawassee and Tobacco Rivers breached the Edenville Dam and the
downstream Sanford Dam. The Secord and Smallwood Dams were not
breached. The breaches and flooding caused substantial damage to the
surrounding communities, washing out major roads, destroying homes, and
forcing the evacuation of thousands of residents. The Commission's
Division of Dam Safety and Inspections issued numerous directives
relating to dam and public safety at the Boyce Projects that Boyce
Hydro failed to address. Boyce Hydro filed for bankruptcy protection on
July 31, 2020. Midland and Gladwin Counties, Michigan, acting through
their delegated authority, the Four Lakes Task Force, filed
condemnation petitions against Boyce Hydro. On December 23, 2020, and
December 28, 2020, the circuit court judges granted the petitions,
which resulted in the transfer of all properties associated with the
Secord, Sanford, Smallwood, and the non-jurisdictional Edenville
Projects to Four Lakes Task Force, retroactively, effective to July 31,
2020.

    m. Location of the Orders Issuing Licenses: These orders may be
viewed on the Commission's website at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    n. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    o. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application. The Commission
invites comments by the Four Lakes Task Force, which now owns the
project works for the three projects, as well by Michigan Department of
Environment Great Lakes and Energy, which would become the regulator of
the facilities should the Commission terminate the licenses.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described proceeding. If an agency does not
file comments within the time specified for filing comments, it will be
presumed to have no comments.
    q. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person commenting, protesting or intervening; and (4)
otherwise comply with the requirements of 18 CFR 385.2001 through
385.2005. All comments, motions to intervene, or protests must set
forth their evidentiary basis. Any filing made by an intervenor must be
accompanied by proof of service on all persons listed in the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 385.2010.

    Dated: March 3, 2021.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2021-04829 Filed 3-8-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Notices]
[Page 26537]
[FR Doc No: 2023-09134]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas & Oil Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP23-700-000.
    Applicants: ANR Pipeline Company.
    Description: Compliance filing: 2023 Operational Purchases and
Sales Report to be effective N/A.
    Filed Date: 4/24/23.
    Accession Number: 20230424-5142.
    Comment Date: 5 p.m. ET 5/8/23.

    Docket Numbers: RP23-701-000.
    Applicants: ANR Storage Company.
    Description: Compliance filing: 2023 Operational Purchases and
Sales Report to be effective N/A.
    Filed Date: 4/24/23.
    Accession Number: 20230424-5150.
    Comment Date: 5 p.m. ET 5/8/23.

    Docket Numbers: RP23-702-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) Rate Filing: Rate Schedule GSS/LSS Fuel
Retention Percentage Tracker Filing to be effective 5/1/2023.
    Filed Date: 4/24/23.
    Accession Number: 20230424-5156.
    Comment Date: 5 p.m. ET 5/8/23.

    Docket Numbers: RP23-703-000.
    Applicants: Bison Pipeline LLC.
    Description: Compliance filing: 2023 Operational Purchases and
Sales Report to be effective N/A.
    Filed Date: 4/24/23.
    Accession Number: 20230424-5159.
    Comment Date: 5 p.m. ET 5/8/23.

    Docket Numbers: RP23-704-000.
    Applicants: Blue Lake Gas Storage Company.
    Description: Compliance filing: 2023 Operational Purchases and
Sales Report to be effective N/A.
    Filed Date: 4/24/23.
    Accession Number: 20230424-5168.
    Comment Date: 5 p.m. ET 5/8/23.

    Docket Numbers: RP23-705-000.
    Applicants: Ruby Pipeline, L.L.C.
    Description: Sec.  4(d) Rate Filing: RP 2023-04-24 GT&C Revisions
to be effective 5/22/2023.
    Filed Date: 4/24/23.
    Accession Number: 20230424-5169.
    Comment Date: 5 p.m. ET 5/8/23.

    Docket Numbers: RP23-706-000.
    Applicants: Great Lakes Gas Transmission Limited Partnership.
    Description: Compliance filing: 2023 Operational Purchases and
Sales Report to be effective N/A.
    Filed Date: 4/24/23.
    Accession Number: 20230424-5179.
    Comment Date: 5 p.m. ET 5/8/23.

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

    Dated: April 25, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-09134 Filed 4-28-23; 8:45 am]
BILLING CODE 6717-01-P