On March 22, 2000, we published in the Federal Register (65 FR 15216-15218, Docket No. 00-016-1) an interim rule that prohibits, until further notice, the importation of the following tortoises into the United States: All species and subspecies of leopard tortoise ( Geochelone pardalis ), African spurred tortoise ( Geochelone sulcata ), and Bell's hingeback tortoise ( Kinixys belliana ). The interim rule also prohibits the interstate movement of all species and subspecies of these land tortoises. These prohibitions were established in order to prevent the spread of exotic ticks known to be vectors of heartwater disease, an acute infectious disease of ruminants.

We solicited comments on our interim rule for 60 days, ending May 22, 2000. We received 53 comments by that date. They were from tortoise breeders and owners, representatives of the reptile industry, animal advocacy groups, and other interested individuals. Many commenters supported the prohibition on importation of these tortoises, but most expressed concerns about the effect of prohibiting the interstate movement of these tortoises. Because of the prohibition, these tortoises may not be moved interstate for sale, health care, or adoption. In addition, many domestic tortoise breeders who must move their tortoises interstate prior to exporting them can no longer export these tortoises.

Therefore, based on these comments, we are taking immediate action to amend the regulations at 9 CFR part 74 to allow the interstate movement of leopard tortoise, African spurred tortoise, and Bell's hingeback tortoise if the tortoises are accompanied by a health certificate signed by a Federal or accredited veterinarian stating that the tortoises have been examined by that veterinarian and found free of ticks. The certification will help ensure that the interstate movement of these tortoises will pose no risk of spreading exotic ticks. This action is warranted to enable the export, interstate commerce, health care, and adoption of these types of tortoises while providing protection against the spread of exotic ticks known to be vectors of heartwater disease.

In the future, we will publish another document in the Federal Register that addresses all of the issues raised by the commenters.

The Administrator of the Animal and Plant Health Inspection Service has determined that there is good cause for publishing this interim rule without prior opportunity for public comment. As a result of an interim rule published and effective on March 22, 2000, the importation and interstate movement of leopard tortoise, African spurred tortoise, and Bell's hingeback tortoise has been prohibited. While this action has been effective in preventing the spread of exotic ticks known to be vectors of heartwater disease, it has also resulted in increased health risks for some tortoises that may not be moved interstate for health care or adoption and resulted in financial burdens for owners who have not been able to move to their tortoises interstate sale or for export. The latter problem may also put some tortoises at risk if owners are unable to provide adequate care for those tortoises. This interim rule will allow the interstate movement of leopard tortoise, African spurred tortoise, and Bell's hingeback tortoise if the tortoises are accompanied by a health certificate signed by a Federal or accredited veterinarian stating that the tortoises have been examined by that veterinarian and found free of ticks. Immediate action is warranted to enable the export, interstate commerce, health care, and adoption of leopard tortoise, African spurred tortoise, and Bell's hingeback tortoise.

Because prior notice and other public procedures with respect to this action are impracticable and contrary to the public interest under these conditions, we find good cause under 5 U.S.C. 553 to make this action effective less than 30 days after publication. We will consider comments that are received within 60 days of publication of this rule in the Federal Register . After the comment period closes, we will publish another document in the Federal Register . The document will include a discussion of any comments we receive and any amendments we are making to the rule as a result of the comments.

This rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

We are allowing the interstate movement of certain land tortoises if they are accompanied by a health certificate signed by a Federal or accredited veterinarian stating that the tortoises have been examined by that veterinarian and found free of ticks. This action is warranted to enable the export, interstate commerce, health care, and adoption of these types of tortoises.

The United States accounts for about 80 percent of the world's live reptile trade. In 1998, a total of 1,921,272 reptiles were imported, valued at approximately $6.37 million. Of these, turtles, including tortoises, accounted for about 26.5 percent of imports. Three states, California (48 percent), Florida (33.2 percent), and Louisiana (11.7 percent), accounted for nearly 93 percent of turtle imports.

The United States exports about 9 million live reptiles annually. Red-eared slider turtles make up about 85 percent of these exports every year. South Korea, Japan, and European countries are the major importers of U.S. turtles. However, Canada appears to be the major importer of leopard tortoise, African spurred tortoise, and Bell's hingeback tortoise. In 1995, the United States exported to Canada 32 leopard tortoises, 527 African spurred tortoises, and 2,332 Bell's hingeback tortoises. During the same year, U.S. imports of these species were 2,683, 1,223 and 952, respectively.

In 1996, between 1.5 million and 2.5 million households in the United States owned various reptiles as pets. Of these, about 534,000 households, or about 35 percent, owned a total of 950,000 turtles, including tortoises. Overall, turtles represented about 27 percent of the total reptile pet population. The prices paid for turtles ranged between $25 and $750, depending on species, size, and age. Between 1993 and 1996, the average price in the United States for a leopard tortoise was $190, for an African spurred tortoise $578, and for a Bell's hingeback tortoise $35.

This rule will positively affect individuals involved in the interstate movement of leopard tortoises, African spurred tortoises, and Bell's hingeback tortoises. This rule will require persons wishing to move these tortoises interstate to acquire a health certificate from a Federal or accredited veterinarian. This will cost about $16 to $25 dollars per health certificate. These costs are small when compared to the potential losses in revenue and animals that may result from continuing to prohibit the interstate movement of these species of tortoises. Another benefit for U.S. exporters of these tortoises is that a health certificate will help ensure the acceptability of these animals in international markets and prevent the spread of exotic ticks known to be vectors of heartwater disease.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.)

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

In accordance with section 3507(j) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the information collection and recordkeeping requirements included in this interim rule have been submitted for emergency approval to the Office of Management and Budget (OMB). OMB has assigned control number 0579-0156 to the information collection and recordkeeping requirements.

We plan to request continuation of that approval for 3 years. Please send written comments on the 3-year approval request to the following addresses: (1) Docket No. 00-016-2, Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue, SW., Washington, DC 20250. Please state that your comments refer to Docket No. 00-016-2 and send your comments within 60 days of publication of this rule.

This interim rule requires that, prior to interstate movement of certain land tortoises, a Federal or accredited veterinarian must sign a health certificate stating that the tortoises have been examined by that veterinarian and found free of ticks. The health certificate must accompany the tortoises during interstate movement. This certification will help ensure that the interstate movement of these tortoises will pose no risk of spreading exotic ticks. We are soliciting comments from the public concerning our information collection and recordkeeping requirements. These comments will help us:

(1) Evaluate whether the information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the information collection, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g. , permitting electronic submission of responses).

Estimate of burden: Public reporting burden for this collection of information is estimated to average 0.083 hours per response.

Respondents: Tortoise breeders and owners, and members of tortoise adoption organizations, in the United States.

Estimated annual number of respondents: 150.

Estimated annual number of responses per respondent: 6.

Estimated annual number of responses: 900.

Estimated total annual burden on respondents: 75 hours.

Copies of this information collection can be obtained from Ms. Cheryl Groves, APHIS' Information Collection Coordinator, at (301) 734-5086.

On November 24, 1999, the FAA issued AD 99-25-07, amendment 39-11450 (64 FR 68620, December 8, 1999), which is applicable to certain BFGoodrich main brake assemblies having part number (P/N) 2-1598 or P/N 2-1600 as installed on Airbus Model A319 and A320 series airplanes. That AD requires a one-time inspection of the wear indicator pins to determine the level of wear of the main brake assemblies of the main landing gear (MLG), and corrective actions, if necessary. That AD also requires modification of the main brake assemblies of the MLG to shorten the wear indicator pins, and change P/N 2-1598 to P/N 2-1598-1 or change P/N 2-1600 to P/N 2-1600-1. In addition, that AD requires incorporation of specified wear limits into the maintenance inspection program.

Since the issuance of AD 99-25-07, the FAA has received reports from several operators of severe oxidation on the carbon heat sinks used on BFGoodrich main brake assemblies, P/N 2-1598-1 and P/N 2-1600-1, installed on Airbus Model A319 and A320 series airplanes. Those reports indicate that the accomplishment of AD 99-25-07 did not adequately address the problem of oxidation on the main brake assemblies in time to correct the identified unsafe condition. Investigation has revealed that deterioration of the BFGoodrich main brake assemblies was caused by thermal oxidation of the carbon material on the heat sinks used in the main brake assemblies, P/N 2-1598-1 and P/N 2-1600-1, due to exposure to elevated temperatures for prolonged periods of time.

Further investigation revealed that the oxidation inhibitor process used by BFGoodrich does not completely prevent oxidation of the carbon brake material. BFGoodrich advises that the carbon brakes, which are susceptible to this oxidation condition, are used only on Airbus Model A319 and A320 series airplanes. Such oxidation first develops on the inner diameter of the rotor disk assemblies when the brake assembly is almost worn-to-limit. This condition, if not corrected, could result in deterioration of the MLG brakes, and consequent reduced braking performance.

BFGoodrich has issued Service Bulletins 2-1598-32-2 and 2-1600-32-3, both dated June 16, 2000, which describe procedures for an initial inspection to determine the length of the wear indicator pins of the MLG main brake assemblies and repetitive inspections thereafter at certain intervals. Procedures include follow-on inspections if the length of either wear indicator pin measures between 0.60 and 0.70 inches, or if the length of the pin measures between 0.20 and 0.30 inches; and corrective actions, if necessary. Follow-on inspections include inspecting the rotor disks located in the center of the heat sinks of the main brake assemblies of the MLG to detect the level of oxidation on the brake assemblies. Corrective actions include replacement of the main brake assembly with a new assembly if any oxidation exceeding the limits specified in the applicable service bulletin is detected. Following such replacement, repetitive inspections of the wear indicator pins are continued.

These airplane models are manufactured in France and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, this AD is being issued to detect and correct thermal oxidation of the main brake assemblies, which could result in deterioration of the MLG brakes, and consequent reduced braking performance. This AD requires repetitive inspections to determine the length of the wear indicator pins of each main brake assembly of the MLG; follow-on inspections; and corrective actions, if necessary. The actions are required to be accomplished in accordance with the applicable service bulletin described previously, except as discussed below.

Operators should note that the previously referenced BFGoodrich service bulletins recommend accomplishment of an initial inspection on all MLG brake assemblies to determine the length of the wear indicator pins “as soon as possible.” However, the FAA finds that a definitive compliance time is necessary. Therefore, paragraph (a) of this AD requires the accomplishment of the repetitive inspections within 10 days after the effective date of this AD, or within 500 flight cycles after replacement of any brake assembly, whichever occurs later. The FAA considers that such a compliance time represents an appropriate interval of time allowable for affected airplanes to continue to operate without compromising safety.

Operators should note that the previously referenced service bulletins include procedures for a one-time inspection on all brakes when any wear indicator pin measures between 0.60 to 0.70 inches, and another such inspection when any pin measures between 0.20 to 0.30 inches. However, the FAA has determined that it is necessary to change those wear indicator pin measurements in this AD to ensure that all brakes are inspected at appropriate intervals. Paragraph (b) of this AD requires a one-time inspection of the brake if either wear indicator pin measures between 0.31 and 0.70 inches, and paragraph (c) of this AD requires an inspection of the brake if either wear indicator pin measures 0.30 inches or less. In the event that the special detailed inspection required by paragraph (c) of this AD is accomplished prior to paragraph (b) of this AD, the inspection required by paragraph (b) of this AD is deemed unnecessary.

This is considered to be interim action. The brake manufacturer has advised that it currently is developing a modification that will positively address the unsafe condition addressed by this AD. Once this modification is developed, approved, and available, the FAA may consider additional rulemaking.

Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunity for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the AD is being requested.

• Include justification ( e.g., reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2000-NM-210-AD.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

In a notice published in the Federal Register of March 20, 1998 (63 FR 13675), FDA announced that a food additive petition (FAP 8M4584) had been filed by Edward S. Josephson, University of Rhode Island, Food Science and Nutrition Research Center, 530 Liberty Lane, West Kingston, RI 02892-1802. The petitioner proposed that the food additive regulations in part 179 Irradiation in the Production, Processing and Handling of Food (21 CFR part 179) be amended to provide for the safe use of ionizing radiation for the reduction of Salmonella in fresh shell eggs.

Under section 201(s) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(s)), a source of radiation used to treat food is defined as a food additive. The additive is not, literally, added to food. Instead, a source of radiation is used to process or treat food such that, analogous to other food processes, its use can affect the characteristics of the food. In the subject petition, the intended technical effect is a change in the microbial load of the food, specifically, a reduction in the numbers of Salmonella , a human pathogen, in or on fresh shell eggs.

The petitioner submitted published articles and other study reports containing data and information related to eggs and other kinds of food in the areas of radiation chemistry, nutrition, toxicology, and microbiology. FDA has fully considered the data and studies submitted in the petition, as well as other information in its files relevant to the safety and nutritional adequacy of eggs treated with ionizing radiation.

The effects of ionizing radiation on the characteristics of treated foods are a direct result of the chemical reactions induced by the absorbed radiation. Scientists have compiled a large body of data regarding the effects of ionizing radiation on different foods under various conditions of irradiation. Research has established that the types and amounts of products generated by radiation-induced chemical reactions (hereinafter referred to as “radiolysis products”) depend on the chemical constituents of the food and on the conditions of irradiation (e.g., temperature and presence or absence of air and moisture). Furthermore, the principles of radiation chemistry govern the extent of changes both in the nutrient levels and in the microbial load of irradiated foods. Key factors include the specific nutrient or microorganism of interest, the food, and the conditions of irradiation. (See the agency's final rule permitting the irradiation of meat (the meat final rule) in the Federal Register of December 3, 1997 (62 FR 64107) for FDA's discussion of radiation chemistry, nutrition, toxicology, and microbiology related to irradiation of foods composed primarily of water, protein, and lipids under various conditions of irradiation.)

FDA has reviewed the relevant data and information submitted in the petition regarding the radiation chemistry of fresh shell eggs, and data available in the agency's files. Fresh whole eggs are composed mainly of water (75.3 percent), protein (12.5 percent), and lipid (10.0 percent) (Ref. 1). As discussed in the meat final rule, the radiation chemistry associated with these types of compounds is well known. FDA has concluded that the concentrations and types of radiolysis products formed by the irradiation of eggs will be comparable to those products produced by the irradiation of other foods of similar composition, such as meat (Ref. 2). In addition, the petitioner's data support the conclusion that there is little change in the levels of individual fatty acids, or in the structure, digestibility, or biological value of protein, when shell eggs are treated with ionizing radiation up to 3 kiloGray (kGy) (Refs. 2 and 3). Most of the radiolysis products are either the same as, or structurally similar to, compounds found in foods that have not been irradiated, and are formed in very small amounts. In summary, an absorbed dose of 3 kGy for the irradiation of fresh shell eggs will result in only minimal changes in the macronutrients (protein, lipid, or carbohydrate), and the chemical composition of eggs will not differ in any significant manner from eggs that have not been irradiated.

The petitioner submitted studies and published reports relevant to the safety of irradiated foods, in general. In addition, a variety of irradiated foods including: Red meat, chicken, fish, and eggs, have been tested in earlier animal feeding studies and genotoxicity studies; and they were previously reviewed by FDA (see, e.g., 62 FR 64107, December 3, 1997). Included in the information considered by FDA in the review of this petition are three studies conducted specifically on irradiated eggs (Ref. 4). In the first such study, rats were fed a biscuit diet containing whole eggs irradiated at 5 kGy at a dietary level of 25 percent on a dry weight basis for 3 years (two generations). No adverse effects were observed compared to the control group fed a diet containing nonirradiated eggs. In the second study, mice and rats were fed a diet containing dried eggs irradiated at 93 kGy and irradiated pork brain. No effects were observed that were attributed to the irradiated food. In the third study, rats were fed canned eggs irradiated at 5 kGy in their diet for two generations. No effects were observed that were attributed to the irradiated diet. Taken as a whole, based on the totality of evidence from all evaluated data and studies, FDA concludes that the petitioned use of irradiation on fresh shell eggs raises no toxicity concerns (Refs. 4 and 5).

FDA also evaluated the effects of irradiation processing on micronutrients ( e.g., minerals, water-soluble vitamins, and fat-soluble vitamins). Minerals are unaffected by irradiation, but the levels of some vitamins may be reduced as a result of irradiation. For example, vitamin A levels did decrease with an increasing radiation dose. Not all vitamin loss is significant, however. The extent to which a reduction in a specific vitamin level is significant depends on the relative contribution from the food in question to the dietary intake of the vitamin and the overall sufficiency of the vitamin in the diet. Based upon data in the agency's files, FDA concludes that the intake of vitamins from other foods compensates for the vitamin loss from the irradiation of eggs (Refs. 4 and 5). For example, a fresh unirradiated egg contains approximately 95 retinol equivalents (RE) of Vitamin A (Ref. 4). In a study, shell eggs irradiated at 1.0 kGy and stored for 24 days contained approximately 72 RE's (Ref. 3). In comparison, 1 tablespoon of butter contains 108 RE's, one-half cup of bran cereal contains 258 RE's, and one-half cup of canned carrots contains 1,620 RE's of vitamin A (Ref. 4). FDA, therefore, concludes, based upon all the evidence before it, that irradiation of fresh shell eggs under the conditions set forth in the regulation below will not have an adverse impact on the nutritional adequacy of a person's diet.

Increased irradiation levels can also cause organoleptic changes in the egg. For example, data in the petition showed an increased color loss in the irradiated egg yolk and a change in the egg's viscosity as the radiation dose was increased. Thus, FDA expects that the acceptability of irradiated shell eggs, based on their color and viscosity, will limit, in a practical way, the maximum dose of irradiation applied to fresh shell eggs. Therefore, FDA has determined that there is no need to limit the irradiation level based on changes in micronutrient levels or organoleptic characteristics of the eggs.

Irradiation of fresh shell eggs at the doses requested in the petition will reduce, but not entirely eliminate, microorganisms in eggs. The stated purpose of this petition is for approval of radiation of fresh shell eggs to reduce the number of Salmonella . The data show that low dose irradiation in the range requested by the petitioner can reduce the levels of S. enteritidis in fresh shell eggs (Ref. 6). Salmonella strains, in addition to S. enteritidis , in fresh shell eggs should also be reduced by irradiation since S. enteritidis was found to have similar sensitivities to ionizing radiation as five other strains of Salmonella that were tested in various media (Ref. 7).

Based on the data and studies submitted in the petition and other information in the agency's files, FDA concludes that: (1) The proposed use of irradiation on fresh shell eggs at levels not to exceed 3.0 kGy is safe, (2) the irradiation can achieve its intended technical effect and, therefore, (3) the regulations in § 179.26 (21 CFR 179.26) should be amended as set forth below.

In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition are available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person listed above. As provided in § 171.1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection.

This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

The agency has previously considered the environmental effects of this rule as announced in the filing notice for FAP 8M4584 (63 FR 13675, March 20, 1998). No new information or comments have been received that would affect the agency's previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required.

Any person who will be adversely affected by this regulation may at any time file with the Dockets Management Branch (address above) written objections by August 21, 2000. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents are to be submitted and are to be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

The following references have been placed on display at the Dockets Management Branch (address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

Pfizer, Inc., 235 East 42d St., New York, NY 10017-5755, filed supplemental NADA 141-152 that provides for topical veterinary prescription use of Revolution TM (selamectin) in dogs and cats for the additional indication for control of intestinal hookworm ( Ancylostoma tubaeforme ) and roundworm ( Toxocara cati ) infections in cats. The supplemental NADA is approved as of June 13, 2000, and the regulations are amended in 21 CFR 524.2098 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for nonfood-producing animals qualifies for 3 years of marketing exclusivity beginning June 13, 2000, because the application contains substantial evidence of effectiveness of the drug involved or any studies of animal safety required for approval of the application and conducted or sponsored by the applicant.

The agency has determined under 21 CFR 25.33(d)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

In implementing the Secretary of State's announcement at the NATO Ministerial, May 24, 2000, in Florence, Italy, the International Traffic In Arms Regulations is being amended. Section 124.2 is amended to add a new paragraph (c) to permit U.S. companies to provide, without a license, defense services necessary to perform maintenance on and maintenance training for inventoried US-origin equipment of NATO countries, Australia and Japan, provided the maintenance and maintenance training does not result in any modification, enhancement, upgrade or other form of alteration or improvement that enhances the performance or capability of the defense article. Also, the export must not include the transfer of certain technologies; such as, design methodology, engineering analysis and manufacturing know-how. Section 125.4 is amended to add a new paragraph (c) to permit the transfer of technical data to NATO countries, Australia and Japan of technical data necessary to support offshore procurement of defense articles for use in the United States. In addition, Part 126 is amended to add, in § 126.9, a new paragraph (b) and a new § 126.14. These additions are being made to create four new comprehensive authorizations developed to limit the number of export approvals necessary to authorize the export of U.S. technology to NATO countries, Australia and Japan that will encourage government-to-government cooperative research and development, support joint ventures and teaming arrangements and facilitate a U.S. company's role in a cooperative project when covered by a government-to-government Memorandum of Understanding (MOU).

In implementing these initiatives, Part 124, 125, and 126 are being amended.

This amendment involves a foreign affairs function of the United States and therefore, is not subject to the procedures required by 5 U.S.C. 553 and 554. It is exempt from review under Executive Order 12866 but has been reviewed internally by the Department of State to ensure consistency with the purposes thereof. This rule does not require analysis under the Regulatory Flexibility Act or the Unfunded Mandates Reform Act. It has been found not to be a major rule within the meaning of the Small Business Regulatory Enforcement Act of 1966. It will not have substantial direct effects on the States, the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with § 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant application of Executive Order Nos. 12372 and 13123. However, interested parties are invited to submit written comments to the Department of State, Office of Defense Trade Controls, ATTN: Regulatory Change, NATO, Australia and Japan, 13th Floor, H1304, 2401 E Street, NW., Washington, DC 20037. Such persons must be so registered with the Department of State's Office of Defense Trade Controls (DTC) pursuant to the registration requirements of § 38 of the Arms Export Control Act.

Section 126.6 currently provides for the export of defense services when authorized by the Foreign Military Sales (FMS) Program without a license or other approval. However, companies, lacking clear guidance often sought approval of the Office of Defense Trade Controls which delayed the provision of the service or frequently also entailed seeking assurances that the foreign government believed it had already provided to the USG. Thus, this amendment to § 126.6 which clarifies the exemption on the basis of specific criteria will assist registered defense firms by making it clear when to use the exemption to provide defense services authorized by the Department of Defense in an LOA.

This amendment involves a foreign affairs function of the United States and therefore, is not subject to the procedures required by 5 U.S.C. 553 and 554. It is exempt from review under Executive Order 12866 but has been reviewed internally by the Department of State to ensure consistency with the purposes thereof. This rule does not require analysis under the Regulatory Flexibility Act or the Unfunded Mandates Reform Act. It has been found not to be a major rule within the meaning of the Small Business Regulatory Enforcement Act of 1966. It will not have substantial direct effects on the Nation, USG or any State, the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant application of Executive Order Nos. 12372 and 13123. However, interested parties are invited to submit written comments to the Department of State, Office of Defense Trade Controls, ATTN: Regulatory Change, FMS LOA Authorized Defense Services, 13th Floor, Room H1304, 2401 E Street, N.W., Washington, D.C. 20037. Such persons must be so registered with the Department of State's Office of Defense Trade Controls (ODTC) pursuant to the registration requirements of section 38 of the Arms Export Control Act.

This final rule implements section 712(c) of the National Defense Authorization Act for Fiscal Year 2000 (Pub. L. No. 106-65) which requires that a nonavailability-of-health-care statement shall be required for TRICARE/CHAMPUS cost-share of maternity care services related to outpatient prenatal, outpatient or inpatient delivery, and outpatient post-partum care subsequent to the visit which confirms the pregnancy. The nonavailability statement (NAS) requirement applies to non-enrolled TRICARE beneficiaries who live in a catchment area of a military treatment facility (MTF). Except for an emergency or when there is other primary health insurance coverage, these beneficiaries are required to obtain all maternity care from the MTF. If care is unavailable at the MTF, an NAS will be issued for the beneficiary. The Act changes the existing provisions which require an NAS for inpatient delivery but do not require an NAS for outpatient prenatal, outpatient delivery and post-partum care. The change will provide for continuity of care for maternity patients. Beneficiaries will need one NAS for the entire episode of maternity care which shall remain valid until 42 days following termination of the pregnancy. We published the interim final rule on December 23, 1999.

We provided a 60-day comment period on the interim final rule. We received no public comments, and no comments were received from other federal agencies with which we are required to coordinate.

Executive Order 12866 requires certain regulatory assessments for any significant regulatory action, defined as one which would result in an annual effect on the economy of $100 million or more, or have other substantial impacts. The Regulatory Flexibility Act (RFA) requires that each Federal agency prepare, and make available for public comment, a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This is not a significant regulatory action under Executive Order 12866 and has been reviewed by the Office of Management and Budget. In addition, this final rule will not significantly affect a substantial number of small entities. The changes set forth in the final rule are minor revisions to the existing regulation.

The final rule will not impose additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3511).

In accordance with 5 U.S.C. 553, a notice of proposed rulemaking was not published for this regulation and good cause exists for making it effective in less than 30 days after Federal Regulation publication. Publishing an NPRM and delaying its effective date would be contrary to the public interest since the scope of the activities requiring this safety zone, and other logistical details surrounding this port visit, were not finalized until a date fewer than 30 days prior to the project date. Furthermore, immediate action is necessary to provide for the safe transit of the vessel.

Although this rule is being published as a temporary final rule without prior notice, an opportunity for public comment is nevertheless desirable to ensure the rule is both reasonable and workable. Accordingly, persons wishing to comment may do so by submitting written comments to the office listed in ADDRESSES in this preamble. Those providing comments should identify the docket number for the regulation (COTP Western Alaska 00-010) and also include their name, addresses, and reason(s) for each comment presented. Based upon the comments received, the regulation may be changed.

The Coast Guard plans no public meeting. Persons may request a public meeting by writing the Marine Safety Office in Anchorage, Alaska at the address listed in ADDRESSES in this preamble.

Due to the fact that Resurrection Bay is a relatively narrow waterway, that commercial vessel traffic transits routinely through this area conducting business at the Port of Seward, and the large amount of recreational vessel traffic that utilize this waterway, the Coast Guard is establishing a 1100 yard radius safety zone to ensure the safety of 25 U.S. Marine Corps personnel that will be jumping into Resurrection Bay from a C-130 aircraft on July 20, 2000.

The Coast Guard is establishing a temporary 1100 yard safety zone around a point located at 60°02′28.7″N latitude, 149°23′02.8″W longitude in Resurrection Bay, Seward, AK. This safety zone is implemented to ensure the safety of approximately 25 U. S. Marine Corps personnel who will be jumping from a C-130 aircraft into the waters of Resurrection Bay at a time when this waterway will be extremely busy with commercial and recreational vessels. The proposed safety zone is intended to become effective at 12:30 a.m. on July 20, 2000, and terminate at 16:30 p.m. on July 20, 2000. Entry into, transit through, anchoring or remaining in this zone is prohibited unless authorized by the Captain of the Port or his authorized representative.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and does not require an assessment of potential cost and benefits under section 6(a)(3) of that order. It has not been reviewed by the Office of Management and Budget under that order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979). The Coast Guard expects the economic impact of this proposal to be so minimal that a full Regulatory Evaluation under paragraph 10(e) of the regulatory policies and procedures of DOT is unnecessary.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), the Coast Guard must consider whether this rule will have a significant economic impact on a substantial number of small entities. “Small entities” may include small businesses and not-for-profit organizations that are not dominant in their respective fields, and governmental jurisdictions with populations less than 50,000. Commercial and recreational vessel traffic will be able to transit into and out of the Port of Seward via the traffic lanes that will be open on the east and west sides of the safety zone area during the entire effective period of this regulation. For the same reasons set forth in the above Regulatory Evaluation, the Coast Guard certifies under 5 U.S.C. 605(b) that this rule is not expected to have a significant economic impact on any substantial number of entities, regardless of their size.

In accordance with section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), the Coast Guard wants to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process. If your small business or organization is affected by this rule and you have questions concerning its provisions or options for compliance, please contact Lieutenant Mark McManus, Coast Guard Marine Safety Office Anchorage, AK, at (907) 271-6762.

This rule contains no information collection requirements under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

The Coast Guard has analyzed this rule under the principles and criteria contained in Executive Order 13132 and has determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

The Coast Guard considered the environmental impact of this rule and concluded that, under Figure 2-1, paragraph 34(g) of Commandant Instruction M16475.1C, this rule is categorically excluded from further environmental documentation.

Under the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), the Coast Guard must consider whether this rule will result in an annual expenditure by state, local, and tribal governments, in the aggregate of $100 million (adjusted annually for inflation). If so, the Act requires that a reasonable number of regulatory alternatives be considered, and that from those alternatives, the least costly, most cost-effective, or least burdensome alternative that achieves the objective of the rule be selected.

No state, local, or tribal government entities will be effected by this rule, so this rule will not result in annual or aggregate costs of $100 million or more. Therefore, the Coast Guard is exempt from any further regulatory requirements under the Unfunded Mandates Act.

Pursuant to 5 U.S.C. 553, a notice of proposed rulemaking (NPRM) was not published for this regulation and good cause exists for making it effective less than 30 days after Federal Register publication. This temporary final rule establishes a safety zone around the cleanup operations being conducted after the spill of No. 6 oil from the barge Penn 460. The safety zone is needed to safeguard the public, and cleanup personnel, from the hazards associated with cleanup vessels and beach response personnel operating in the area. Any delay encountered in this regulation's effective date would be contrary to public interest since immediate action is needed to close portions of Narragansett Bay to protect the public and response personnel.

Barge Penn 460 experienced an oil spill of approximately 14,000 gallons of No. 6 oil on July 5, 2000. Due to heavy recreational traffic in vicinity of the spill, a safety zone is needed to ensure the safety of recreational traffic and response vessels and personnel. The exclusion of recreational traffic will minimize the risk of wake damage to response vessels and personnel, and will eliminate the risk of collision. Entry into this safety zone is prohibited unless authorized by the Captain of the Port (COTP), Providence, RI. A safety zone [CGD01-00-250] was previously established on Friday July 7, 2000, for this same event. This previous safety zone prohibited entry into the waters of Narragansett Bay within 500 yards of the shoreline from the base of the Coddington Cove, Middletown, Rhode Island, breakwater to the waterside end of the pier located 2,500 yards Northeast of Coddington Cove. However, the Rhode Island Department of Health and Department of Environmental Management reopened a significant portion of the area to commercial fishing at 12:00 p.m. on July 12, 2000. This new safety zone prohibits entry into the area which remains closed to commercial fishing.

This temporary final rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that order. The Office of Management and Budget has not reviewed it under that order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040; February 26, 1979). The Coast Guard expects the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10(e) of the regulatory policies and procedures of DOT is unnecessary. This safety zone prevents traffic from transiting in the immediate area of cleanup operations. This regulation will not be significant as all vessel traffic may safely pass around this safety zone, no commercial entities are located within the zone, a State of Rhode Island fisheries closure is in effect in this zone, and extensive maritime advisories will be made.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), the Coast Guard must consider whether this proposal will have a significant economic impact on a substantial number of small entities. “Small entities” may include (1) small businesses and not-for-profit organizations that are independently owned and operated and are not dominant in their fields and (2) governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) that this final rule will not have a significant economic impact on a substantial number of small entities.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule contains no collection of information requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

We have analyzed this action under E.O. 13132 and have determined that this rule does not have implications for federalism under that Order.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government's having first provided the funds to pay those costs. This rule will not impose an unfunded mandate.

This temporary rule would not effect a taking of private property or otherwise have taking implications under E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This temporary rule meets applicable standards in section 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this temporary rule under E.O. 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.

The Coast Guard has considered the environmental impact of these regulations and concluded that, under Figure 2-1, paragraph 34(g), of Commandant Instruction M16475.1C, this final rule is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” will be available in the docket for inspection or copying where indicated under ADDRESSES.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM. The sponsor of the event did not provide the Coast Guard with the final details for the event in sufficient time to publish a NPRM or a final rule 30 days in advance. The delay encountered if normal rulemaking procedures were followed would effectively cancel the event. Cancellation of this event is contrary to the public interest since the fireworks display is for the benefit of the public.

The Village of Bellport, is sponsoring a 12 minute fireworks display in Bellport Bay, Bellport, NY. The safety zone will be in effect from 8:30 p.m. until 10:00 p.m., July 22, 2000. The safety zone covers all waters of Bellport Bay within a 600 foot radius of the fireworks launching barge which will be located in Bellport Bay, Bellport, NY, in approximate position; 40°44′58″N, 072°55′43″W, (NAD 1983). This zone is required to protect the maritime community from the safety dangers associated with this fireworks display. Entry into or movement within this zone will be prohibited unless authorized by the Captain of the Port or his on-scene representative.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040, February 26, 1979). The Coast Guard expects the economic impact of this proposal to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. This safety zone involves only a portion of Bellport Bay and entry into this zone will be restricted for only 90 minutes on July 22, 2000. Although this regulation prevents traffic from transiting this section of Bellport Bay, the effect of this regulation will not be significant for several reasons: the duration of the event is limited; the event is at a late hour; all vessel traffic may safely pass around this safety zone; and extensive, advance maritime advisories will be made.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in a portion of Bellport Bay from 8:30 p.m. until 10:00 p.m. July 22, 2000. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: The duration of the event is limited; the event is at a late hour; all vessel traffic may safely pass around this safety zone; and extensive, advance maritime advisories will be made.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

We have analyzed this rule under Executive Order 13132 and have determined that this rule does not have implications for federalism under that Order.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government having first provided the funds to pay those unfunded mandate costs. This rule will not impose an unfunded mandate.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or risk to safety that may disproportionately affect children.

The Coast Guard considered the environmental impact of this rule and concluded that under figure 2-1, paragraph (34)(g), of Commandant Instruction M16475.lC, this rule is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. It was impracticable to attempt to publish a NPRM for this situation due to the inherent difficulties in scheduling marine dredging operations, and the temporary nature of this regulation.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register because the operational schedule for the drilling and blasting was not finalized until a June 21, 2000 meeting between the U.S. Coast Guard, Army Corps of Engineers and Contract Drilling and Blasting.

These regulations are needed to provide for the safety of life on navigable waters from hazards associated with drilling and blasting operations that will occur at the entrance to San Juan Harbor, Puerto Rico.

The drilling and blasting operations will be conducted to the west of the San Juan Harbor bar entrance channel, between buoys number 1 and number 4, in the approximate position of 18°28.3691′ N, 066°07.6889′ W. The drilling and blasting operations will occur outside of the navigation channel.

To further ensure the safety of life, the contractor conducting the drilling and blasting operations will, 15 minutes prior to any detonation, send two small boats outside the safety zone to advise mariners of the operation.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040, February 26, l979), The Coast Guard expects the economic impact of this proposal to be so minimal that a full Regulatory Evaluation under paragraph 10(e) of the regulatory policies and procedures of DOT is unnecessary as the operation will not significantly impede navigation and commercial activity due to the low frequency of occurrence and extremely short duration.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. The rule may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit in a portion of San Juan Harbor from July 11, 2000 to October 31, 2000. This special local regulation will not have a significant economic impact on a substantial number of small entities because this rule will be in effect sporadically, and vessel traffic can pass safely around the regulated area.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub.L. 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or government jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed under FOR FURTHER INFORMATION CONTACT for assistance in understanding and participating in this rulemaking. We also have a point of contact for commenting on actions by employees of the Coast Guard. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3520).

We have analyzed this rule under Executive Order 13132 and have determined that this rule does not have implications for federalism under that Order.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government's having first provided the funds to pay those unfunded mandate costs. This rule will not impose an unfunded mandate.

This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not concern an environmental risk to health or safety that may disproportionately affect children.

The Coast Guard has considered the environmental impact of this rule and concluded that under figure 2-1, paragraph 34(g) of Commandant Instruction M16475.1C, this rule is categorically excluded from further environmental documentation because it is establishing a temporary safety zone.

Throughout this document, “we,” “us” and “our” refer to EPA.

Table 1 lists the rules we are approving with the dates that they were adopted by the local air agency and submitted by the California Air Resources Board (CARB).

On December 19, 1996, these rule submittals were found to meet the completeness criteria in 40 CFR part 51 appendix V, which must be met before formal EPA review.

There are no previous versions of these rules in the SIP, although the VCAPCD adopted earlier versions of these rules on December 10, 1991, and CARB submitted them to us on June 19, 1992. While we can act on only the most recently submitted versions, we have reviewed materials provided with previous submittals.

Rules 74.6.1, 74.6.2, and 74.6.3 set equipment and operating requirements for cold cleaners, batch loaded vapor degreasers, and conveyorized degreasers. These requirements ensure that these sources will be operated in a way which limits VOC emissions. The TSD has more information about these rules.

Generally, SIP rules must be enforceable (see section 110(a) of the Act), must require Reasonably Available Control Technology (RACT) for major sources in nonattainment areas (see section 182(a)(2)(A)), and must not relax existing requirements (see sections 110(l) and 193). The VCAPCD regulates an ozone nonattainment area (see 40 CFR part 81), so Rules 74.6.1, 74.6.2, and 74.6.3 must fulfill RACT.

Guidance and policy documents that we used to define specific enforceability and RACT requirements include the following:

1. Portions of the proposed post-1987 ozone and carbon monoxide policy that concern RACT, 52 FR 45044, November 24, 1987.

2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations; Clarification to Appendix D of November 24, 1987 Federal Register Notice,” (Blue Book), notice of availability published in the May 25, 1988 Federal Register .

3. The Control Technique Guideline (CTG) entitled, “Control of Volatile Organic Emissions from Solvent Metal Cleaning” (November 1977; EPA-450/2-77-022)

4. The California Air Resources Board (CARB) document entitled, “Determination of Reasonably Available Control Technology and Best Available Control Technology for Organic Solvent Cleaning and Degreasing Operations'' (July 18, 1991).

We believe these rules are consistent with the relevant policy and guidance regarding enforceability, RACT, and SIP relaxations. The TSD has more information on our evaluation.

As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this, so we are finalizing the approval without proposing it in advance. However, in the Proposed Rules section of this Federal Register , we are simultaneously proposing approval of the same submitted rules. If we receive adverse comments by August 21, 2000, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on September 19, 2000. This will incorporate these rules into the federally enforceable SIP.

VOCs help produce ground-level ozone and smog, which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions. Table 2 lists some of the national milestones leading to the submittal of these local agency VOC rules.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that these rules will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because these rules approve pre-existing requirements under state law and do not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). For the same reason, these rules also do not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). These rules 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 (64 FR 43255, August 10, 1999), because they merely approve state rules implementing a federal standard, and do not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. These rules also are not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because they are not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rules in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings'' issued under the executive order. These rules do not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

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 these rules 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 rules 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).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 19, 2000. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Throughout this document, “we,” “us” and “our” refer to EPA.

On May 5, 1999 (64 FR 24119), and March 22, 2000 (65 FR 15287), respectively, EPA proposed a limited approval and limited disapproval of the following rules that were submitted for incorporation into the California SIP.

We proposed a limited approval because we determined that these rules improve the SIP and are largely consistent with the relevant CAA requirements. We simultaneously proposed a limited disapproval because some rule provisions conflict with section 110 and part D of the Act. These provisions include the following:

• Alternate Emission Control Plan (AECP) in Section 229.3 (D) and Rule 427 Section VIII C.2.d.

• Compliance schedule in Section 229.4 (A) and Rule 427 Section VIII C.1.

• Heat input language in Section 229.3 (A).

• Flow rate meter language in Section 229.3 (C).

• Group testing of engines in Rule 427 Section VIII C.2.d.

• Exemption of engines between 25 and 250 bhp in Rule 427 Section V.

Our proposed action contains more information on the basis for this rulemaking and on our evaluation of the submittals.

EPA's proposed action provided a 30-day public comment period. No comments were submitted regarding our proposed action on EDCAPCD Rule 229.

KCAPCD Rule 427: KCAPCD commented orally that EPA should not object to exempting engines between 50 and 250 bhp from NO X emission limits or testing requirements. KCAPCD argued that these engines are not likely to emit greater than 50 tons/year of NO X and are therefore not major sources subject to the RACT requirement in serious ozone nonattainment areas like Southeastern Kern County. EPA concurs with this comment and withdraws this as a basis for disapproving Rule 427 at this time. We note, however, that Southeastern Kern County may soon be reclassified as severe nonattainment and thus be subject to a 25 ton/year major source threshold. If and when that occurs, this exemption will need to be modified since engines smaller than 250 bhp are capable of emitting more than 25 tons/year NO X .

No comments were submitted that change our assessment of the rules as described in our proposed action except for the comment discussed above. Therefore, as authorized in sections 110(k)(3) and 301(a) of the Act, EPA is finalizing a limited approval of the submitted rules. This action incorporates the submitted rules into the California SIP, including those provisions identified as deficient. As authorized under section 110(k)(3), EPA is simultaneously finalizing a limited disapproval of the rules. As a result, sanctions will be imposed unless EPA approves subsequent SIP revisions that correct the rules deficiencies within 18 months of the effective date of this action. These sanctions will be imposed under section 179 of the Act according to 40 CFR 52.31. In addition, EPA must promulgate a federal implementation plan (FIP) under section 110(c) unless we approve subsequent SIP revisions that correct the rules deficiencies within 24 months. Note that the submitted rules have been adopted by the El Dorado County Air Pollution Control District and Kern County Air Pollution Control District, and EPA's final limited disapproval does not prevent the local agency from enforcing them.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.”

Executive Order 13045, entitled 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 planned rules on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

The rules are not subject to Executive Order 13045 because they do not involve decisions intended to mitigate environmental health or safety risks.

Under Executive Order 13084, Consultation and Coordination with Indian Tribal Governments, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation.

In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.” Today's rules do not significantly or uniquely affect the communities of Indian tribal governments. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to the rules.

Executive Order 13121, entitled Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612, Federalism and 12875, Enhancing the Intergovernmental Partnership. 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.” Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

The rules 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 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to the rules.

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements 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 not-for-profit enterprises, and small governmental jurisdictions.

This final rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply act on requirements that the State is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities.

EPA's disapproval of the state request under section 110 and subchapter I, part D of the Clean Air Act does not affect any existing requirements applicable to small entities. Any pre-existing federal requirements remain in place after this disapproval. Federal disapproval of the state submittal does not affect state enforceability. Moreover, EPA's disapproval of the submittal does not impose any new Federal requirements. Therefore, I certify that this action will not have a significant economic impact on a substantial number of small entities.

Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

Under Section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated annual costs to State, local, or tribal governments in the aggregate; or to private sector, of $100 million or more. Under Section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated annual costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

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 the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . The rules are not “major” rules as defined by 5 U.S.C. 804(2).

Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

The EPA believes that VCS are inapplicable to this action. Today's action does not require the public to perform activities conducive to the use of VCS.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 19, 2000. Filing a petition for reconsideration by the Administrator of the final rules does not affect the finality of the rules for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

The General Services Administration (GSA), after an analysis of additional data, has determined that the current lodging allowance for Duluth, Minnesota, does not adequately reflect the cost of lodging in this area. To provide adequate per diem reimbursement for Federal employee travel for this area, the maximum lodging allowance is changed to reflect seasonal rates.

This final rule is not required to be published in the Federal Register for notice and comment; therefore, the Regulatory Flexibility Act does not apply.

GSA has determined that this rule is not a significant regulatory action for the purposes of Executive Order 12866 of September 30, 1993.

The Paperwork Reduction Act does not apply because the rule does not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public which require the approval of the Office of Management and Budget under 44 U.S.C. 501 et seq.

This final rule is also exempt from congressional review prescribed under 5 U.S.C. 801 since it relates solely to agency management and personnel.

The Department is finalizing the rule entitled “Application Deadline for SAPT Block Grant Program,” 45 CFR Part 96, which was published as a NPRM in the Federal Register on February 4, 2000 (65 FR 5474).

When SAMHSA first implemented the SAPT Block Grant program a primary concern was affording States sufficient time to develop the increased information required to apply for a grant under this program as compared to the generally less detailed application required under the predecessor Alcohol, Drug Abuse, and Mental Health Services Block Grant program administered by the Alcohol, Drug Abuse, and Mental Health Administration. This was accomplished by affording States the opportunity to submit their applications as late as March 31, fully six months into the Federal fiscal year (FFY) for which funding is requested (See 45 CFR 96.122(d)). This relatively late receipt date results in insufficient time to administer the SAPT Block Grant program in accordance with all the governing provisions of law. This is most noted under circumstances calling for the clarification of application data and, if necessary, the conduct of hearings in a timely manner and consistent with the requirements of section 1945(e) of the Public Health Service (PHS) Act.

States are now fully aware of the application requirements and can reasonably be expected to respond to an earlier submission date. Accordingly, starting with Federal fiscal year 2001, the Department proposed to establish a new date of October 1 of the Federal fiscal year for which Block Grant funding is being requested for receipt of applications for such funding. However, if a State determines that it will not be able to submit by October 1 either the report as required at 45 CFR 96.130(e) on Synar enforcement efforts and State success in reducing youth access to tobacco products during the preceding Federal fiscal year, or the information on maintaining State expenditures (MOE) during the preceding year as required at 45 CFR 96.134(d), the State, under the proposed rule, could request an extension of the due date(s) for a limited period, not to extend past December 31 of the Federal fiscal year for which application is made. The request for the extension would need to be signed by the official with the authority to apply for the grant or the Governor, and be submitted no later than September 1 of the prior Federal fiscal year. Under the proposed rule, the extension request must indicate for which requirement the extension is requested; include an explanation of why the State is unable to comply with the due date of October 1; state the date of submission the State is requesting; and discuss whether there are steps the State can take to avoid requiring an extension in future years. Extensions for the deadlines for these requirements are to be granted in writing by the SAMHSA official with delegated authority to grant the extension. All other components of the SAPT Block Grant application not covered by the extension are due by October 1 of the Federal fiscal year for which funds are being sought.

After considering the comments on the NPRM, HHS is finalizing the rule as proposed. Below is the Department's response to the comments to the proposed rule.

The Department received comments from 9 States and one national organization, the National Association of State Alcohol and Drug.

Abuse Directors (NASADAD), during the 45-day comment period. All written comments were reviewed and taken into consideration in the preparation of the final rule. The substantive concerns raised in the public comments and the Department's responses to the comments are set out below. Similar comments are considered together.

One commenter, the national organization, indicated that the proposed change will negatively impact half of the 60 SAPT Block Grant applicants. The commenter stated that while some States may be able to complete their applications earlier than others, this may be due to the fact that their State fiscal years, data collection, and reporting systems are more consistent with the Federal fiscal year, or because they have additional staff or resources to commit to the processes of planning, collecting and analyzing data, and reporting information. However, for the other half of the States that submit their application between October 1 and March 31, the proposed rule would create a hardship. Five other commenters expressed similar concerns related to their specific States, with one State commenting that the change to advance the application date should be delayed for at least one year.

SAMHSA has engaged in a number of interactions with the States regarding the proposed change in due date for the Block Grant application as follows:

Regional Team Building Workshops: The first formal discussions of the proposed change in the application due date were held at these regional workshops. Fifty-eight of 60 Single State Agency Directors and their Staff as well as NASADAD attended at least one of this series of meetings held in San Antonio, Texas (December 8-9, 1998), Hilton Head Island, South Carolina (March 2-3, 1999), Providence, Rhode Island (April 13-14, 1999), and Juneau, Alaska (May 25-26, 1999). Some States indicated that they would not be able to comply with the new due date requirement unless they could delay reporting MOE and Synar information. As a result, SAMHSA decided to propose a 90-day extension for Synar and MOE data reporting.

State by State inquiry: In developing the proposed rule, SAMHSA queried the States in July 1999 as to their ability to meet the proposed deadline. All States responded that, while the change would pose some difficulty for some of them, they would be able to meet the deadline given the ability to receive extensions for the required Synar and MOE data. Although some States may need to make some changes in internal procedures, the Department believes the earlier application date is feasible, and the fact that we received few comments on this proposal reinforces our belief that States can adapt to the earlier due date.

NASADAD Annual Meeting: On June 5, 2000, SAMHSA staff discussed this issue with the States again at the NASADAD Leadership Forum in Reno, Nevada. The States responded that the task could be accomplished if the extensions were made available.

National Meeting: On June 22 and 23, 2000, at the Center for Substance Abuse Treatment's (CSAT) Fifth State Systems Development Program (SSDP), in Orlando, Florida, the Director of CSAT's Division of State and Community Assistance presented two workshops around Block Grant Administration issues in which most of the Single State Agency Directors participated. Again, the States responded that they can submit the application on October 1 if SAMHSA can provide the opportunity for an extension until December 31 for Synar or MOE reporting.

Two States also said that they would have difficulty because their public review and comment processes are currently (and have been since 1993) established around the March 31 deadline. It would, therefore, take time to change these long established procedures and mechanisms at the State level. The Department recognizes that these States will need to change these procedures but believes that the States and their constituent groups should be able to accommodate an October 1 deadline. Further, as we indicated in the NPRM, published in early February, States should be preparing to move toward an October 1 due date.

Commenters were concerned that the Block Grant applications and instructions have historically been received by the States from SAMHSA between May and September prior to the start of the Federal fiscal year for which they were applying. One State expressed concern but supported the rule change as long as this issue is addressed. We agree that the provision of application forms and instructions to the States so close to the next Federal fiscal year would not be appropriate with an October 1 deadline. SAMHSA has anticipated this problem, and consistent with one commenter's request that the application forms be available about six months prior to the due date, the FY 2001 Block Grant application forms and software were sent to all 60 Block Grant applicants by overnight mail on April 3, 2000. SAMHSA will continue this practice of providing sufficient lead time.

Two commenters indicated that recent changes, such as the requirement for multi-year reporting on the 16 Federal goals in the Federal fiscal year 2000 Block Grant application, have, in their view, added more work to complete the application. In turn, this increases the potential difficulty States will face in complying with the change in rule. However, the Department notes that the changes in the application simply consolidate previously existing reporting requirements into one place. These changes have been well received by most States that have discussed them with SAMHSA.

Another State indicated that the Block Grant Application System (BGAS) software distributed to the States is cumbersome and not always compatible with State software. The Department notes, however, that approximately 85 percent of States utilize the BGAS software in submitting their applications. Further, SAMHSA maintains a help desk during office hours to assist States in using the system and has provided successful on-site technical assistance to those having difficulty. SAMHSA will offer individual assistance to this commenter.

One State indicated that, although they have historically submitted their application in November, it would not have necessary MOE and Synar data available for the October due date. It should be noted that the Department has allowed for the opportunity for a State to seek an extension of the reporting date for this information until no later than December 31, which should accommodate this State's needs. With regard to the provision for an extension, a few States, and one in particular, stated a concern that the extension request provision is burdensome and unnecessary. Further, it was suggested that the due date not be changed, the due date be December 31, or that only a simple notification with the application should be required for granting an extension. We do not believe that the requirement to request an extension is unduly burdensome. States will, necessarily, have already considered their ability to submit a timely and complete application by the October 1 due date, and will be aware of the valid reasons why this is impossible. The requirement to submit an extension request is, therefore, simply a request to submit this reasoning in writing accompanied by a request for an extension. The suggestion that the due date not be changed from the current date is addressed elsewhere. The proposed alternative due date of December 31 would provide insufficient time to effectively address the needs we are addressing in this rule. Finally, the Department believes simply allowing an applicant to notify us that they will be taking until December 31 to submit an application component does not guarantee the level of attention by senior State officials which we believe essential to a process intended to assure extensions are an exception to normal practice. However, if a State wished to incorporate an extension request which fully complied with the requirements found in § 96.122(d) into its application, and it submitted that application no later than September 1 of the prior Federal fiscal year, it would be eligible for consideration as a validly submitted extension request.

Another commenter expressed concern that other required expenditure information will not be available by October 1. It should be noted, the application requires reporting on expenditures that occurred three years prior to the application submission, and it is the Department's belief that such expenditures data should be available to meet the October 1 due date.

Three commenters stated that the reporting requirements for the Block Grant application have expanded to require increased reporting which makes it more difficult to meet an October 1 due date. These changes include expansion of Synar reporting requirements, reporting on planned and actual requirements for the supplemental funding authorized by Pub. L. 104-121, the addition of Form 10 (State Use of Needs Assessment Information), and extensive treatment and prevention outcome measures. One State is concerned that the new Sections IV-A and IV-B, (Voluntary Treatment and Prevention Performance Measures), will become “required” at some point in the future. It should be noted that the reporting requirements related to Pub. L. 104-121 are minimal requirements necessary for reporting under the Block Grant, are time limited, and expire with the FFY 2001 application. Form 10 was added to correct a deficiency in reporting in previous applications and was designed to require minimal increased effort. The voluntary reporting on outcome measures is the product of agreement and extensive consensus development with the States and the national organization, NASADAD. At this time, the reporting is voluntary and the measures are being further refined through the consensus process. Although there has been an increase in the reporting of data, the Department believes that these data can be reported by the October 1 due date.

Several commenters stated that the SAPT Block Grant application is already a complex document that requires substantial involvement from both program and fiscal staff to complete. They believe the estimate provided in the NPRM of 60 additional hours required for the annual reporting burden as a result of the changed receipt date may lead to a perception that the proposed change in rule will pose no difficulties for grant applicants. Some commenters stated that they believe the 60 hours is too low an estimate. The Department recognizes the complexity of the statutorily mandated reporting required by the Block Grant application. The Department also recognizes that the change in rule will require some adjustments in current practices. However, while changing the due date for submission of the SAPT Block Grant application, the Rule does not change the basic reporting requirements. Further, the Department believes that this change is necessary to meet its responsibilities under the Block Grant program in a timely manner. The comments regarding reporting burden are more fully discussed below in the “Paperwork Reduction Act of 1995” section.

Three commenters stated that SAMHSA has limited staff to review each of the 60 Block Grant applications and that even if all applications were received on October 1 they believe it would be difficult for the SAMHSA State Project Officers to review all 60 applications in a timely manner. It should be noted that SAMHSA, with NASADAD input, has instituted a rigorous SAPT Block Grant review and approval process and a complementary tracking system that holds SAMHSA State Project Officers accountable for a timely review of all Block Grants assigned to them. SAMHSA time lines are being adjusted to accommodate the change in rule.

Two commenters recommended staggering the submission dates based on either the State fiscal year or their Synar circumstances. However, given the significant variances in State fiscal years and Synar circumstances the Department has sought to establish a process that most of the States have indicated will work for them.

Three States and NASADAD expressed concerns related to the Synar reporting requirements and processes; these are fully discussed below.

One State expressed concern regarding what it viewed as constant delays in the Federal review process due to frequent requirements for revisions of the Synar portion of the Block Grant application. The Department is aware that reporting on Synar activities requires time and resources in order to ensure that all the necessary data are included in the final report for review and analysis. However, the expressed concern is only true for States whose initial submission did not meet application requirements. In an effort to streamline the review process, SAMHSA has centralized the responsibilities for monitoring State Synar activities in the Division of State and Community System Development, System Development Branch. This change was implemented during the Federal fiscal year 2000 reviews. The Department believes that the new review process will facilitate the Synar report reviews and reduce the amount of time it takes to approve these reports. We note, however, that some States have experienced delays in funding when they have not met their negotiated Synar retailer compliance rates. The Department hopes that with the earlier application due date decisions will be made earlier in the Federal fiscal year. Further, the earlier deadline will allow SAMHSA more time to work with the States that are having Synar compliance problems, resulting in earlier funding decisions.

Another State suggested that all States be required to develop a plan that would enable them to complete their Synar reporting requirements by the required October 1 deadline, thereby making it unnecessary to institute a process for granting extensions. SAMHSA believes that, given the fact that all but three States rely on youth for the conduct of the Synar inspections, and given the fact that the summer months are the time when most youth are available to participate in the Synar inspections, many States will not be able to complete the required number of inspections, analyze the survey data and report the results back to SAMHSA by October 1. These factors will likely result in a number of States needing extensions for submitting their Synar reports. While SAMHSA is not adopting the suggested requirement, we are willing to provide assistance and work with States that may choose this approach.

Another State's comment made reference to specific circumstances for that State that seem to pose difficulties with meeting the October 1 deadline for submitting the annual Synar report. SAMHSA understands this State's concerns and is willing to provide technical assistance to the State in order to assist with adjusting the State's time lines for completing annual Synar inspections (current deadline for completing all Synar inspections is September 30), and collecting and reporting Synar information. It is SAMHSA's intent to provide assistance to all States to support the timely submission of required Synar-related materials.

The comment from NASADAD regarding Synar reporting focused on a concern about delays experienced by some States in securing SAPT Block Grant funding even when they believe they are in compliance with Synar requirements. While it is SAMHSA's desire to issue SAPT Block Grant awards as promptly as possible, if it is determined during the initial review that a Synar report is not complete, the State is asked to submit additional information to complete it. SAMHSA is only able to perform a thorough review of a State's application and make a determination of compliance with the Synar requirements after it receives a complete report from the State. In order to assure timely review, SAMHSA has implemented internal procedures designed to streamline the review process, including the development of enhanced and improved Synar plan reviews. The change to an October 1 due date for the Block Grant application should further enhance Federal review and approval of the applications. The earlier date provides SAMHSA additional time to work with the States in completing full and accurate applications in accordance with the Block Grant requirements. It also affords SAMHSA and the Department the time necessary to provide States with due process in the event that a State's application indicates possible non-compliance with Block Grant requirements.

This rule does not have cost implications for the economy of $100 million, or otherwise meet the criteria for a major rule under Executive Order 12291, and therefore does not require a regulatory impact analysis. Further, this regulation will not have a significant impact on a substantial number of small entities, and therefore does not require a regulatory flexibility analysis under the Regulatory Flexibility Act of 1980.

As was detailed earlier in the preamble, SAMHSA consulted with the States concerning the proposed change in application due date. During 1998 and 1999, SAMHSA discussed the proposed change at several regional team building workshops. As a result of these meetings, SAMHSA decided to propose a 90-day extension for Synar and MOE reporting. Also, SAMHSA staff participated in two National meetings where the States responded that the proposed task could be accomplished if extensions were made available for reporting MOE and Synar data. Further, in developing the proposed rule, SAMHSA queried all the States and the States indicated that it would not be an undue hardship on them to meet this new requirement if there can be an extension when necessary until December 31 with regard to both maintenance of effort and Synar provisions.

The primary concern set forth by the national organization, NASADAD, focused on the ability to obtain the critical information required for the SAPT Block grant application that would permit its inclusion by the proposed October 1 due date. Also, the national organization noted that while some States may be able to complete their applications earlier than others, this may be due to the fact that their State fiscal years, data collection, and reporting systems are more consistent with the Federal fiscal year, or because they have additional staff or resources to commit to the processes of planning, collecting and analyzing data, and reporting information. As a consequence of the meetings discussed in detail earlier in the preamble, and above, as well as the discussions with SAMHSA regarding such areas as making the application guidance and software available at the earliest possible date, and that guidance would be provided to the States for use in applying for extensions for MOE and Synar reporting, the Department believes that these concerns of the national organization have been addressed. Further, since Section 96.122(d) allows for an extension with regard to the MOE and Synar reporting elements of the application, we do not believe that there is a significant Federalism impact.

This proposal is not a significant regulatory action under Section 3(f) of the Executive Order 12866 and does not require an assessment of the potential costs and benefits under Section 6(a)(3) of that Order and has been exempted from review by the Office of Management and Budget under that Order.

This final rule contains information collection provisions which are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA)(44 U.S.C. 3507(d)). The title, description and respondent description of the information collections are shown in the following paragraphs with an estimate of the annual reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Title: Application Deadline for SAPT Block Grant Program.

Description: The Secretary is issuing regulations to change the receipt date of SAPT Block Grant applications starting with the Federal Fiscal Year (FY) 2001 from March 31 to October 1. All elements of the application reporting requirements will be due October 1. However, States may request an extension of time for reporting State expenditures necessary to determine compliance with the Maintenance of Effort (MOE) requirement and/or to submit required Synar information for a period up to December 31. This change will allow HHS to review Block Grant applications and make Block Grant awards to all States earlier in the fiscal year. It will also provide additional time for sufficient planning in the event of any penalty actions that may be required, while recognizing the inability of some States to report the MOE and Synar data prior to December 31.

Description of Respondents: State and tribal governments.

In response to the Secretary's invitation in the NPRM to comment on the information collection requirements, three states and the national organization included comments on the response burden associated with the SAPT Block Grant application.

Comment: Two commenters indicated that the annual application is a complex submission that requires much more time to prepare than the 60 hours indicated.

Discussion: The current burden estimate for the annual application (approved under OMB control number 0930-0080) is 655 hours per State. The 120 hours of burden shown for the first year and the 60 hours for future years reflect only additional burden associated with the change in the due date. This rule does not change those basic reporting requirements. It does add one burden hour per State annually for the purpose of sending a letter requesting an extension of the due date for reporting maintenance of effort and/or Synar. The new burden estimate assumes, conservatively, that all States will submit such a request.

Change: None.

Comment: Two States commented that the burden associated with the change in due date is much more than the estimate of one hour per State.

Discussion: The Department recognizes the complexity of the statutorily mandated reporting required by the Block Grant application. This rule changes the due date for submission of the SAPT Block Grant application, but it does not change the basic reporting requirements for the SAPT Block Grant. There will be a need for some States to adjust their work schedules in order to submit the application by the new due date. However, because of the series of meetings and discussions with the national organization and its members, over the past two years, on the plan to change the due date, States have been aware of the planned change and have been planning for the transition. The additional burden hour per State estimated for the first year is in recognition of the transition.

Change: None.

Response burden estimate: Information collection language for the current rule is approved by OMB under control number 0930-0165 (Synar reporting requirements on youth access to tobacco) and control number 0930-0163 (for all other aspects of the annual application). The Substance Abuse Prevention and Treatment Block Grant Uniform Application format for FY 2000-FY 2002 is approved by OMB under control number 0930-0080. None of the specifics of these reporting requirements are being changed. Only the due date of the Uniform Application is impacted by this final rule.

At present, approximately half of all eligible Block Grant applicants routinely submit their Uniform Application for Block Grant funds on or before September 30 of the fiscal year preceding the fiscal year for which they are applying for funds. Approximately one half of all eligible applicants submit their uniform applications between October 1 and March 31 of the fiscal year for which block grant funds are being made available.

SAMHSA recognizes that the earlier receipt date will have an impact on the applicants, particularly those that have typically submitted their Uniform Application after September 30. Since the contents of the Uniform Application are not changing, it is difficult to estimate the additional response burden and associated costs for the first year of this change of receipt date (no additional burden is estimated for this change for future years). Therefore, a nominal response burden for each applicant of one hour is provided. In addition, it is conservatively assumed that all applicants will request an extension of the MOE and Synar reporting, and one hour is estimated for preparation of such a request.

Thus, for the first year of implementation, total response burden is estimated at 120 hours. For subsequent years, the burden estimate is 60 hours.

Individuals and organizations may submit comments on these burden estimates or any other aspect of these information collection provisions, including suggestions for reducing the burden, and should direct them to: SAMHSA Reports Clearance Officer, Room 16-105, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.

The information collection provisions in this final rule have been approved under OMB control number 0930-0163. This approval expires February 28, 2001. 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.

Current Master Buy Plan (MBP) submission guidance does not address high value acquisitions from or through other government agencies and Chiles Act cooperative agreements, and any acquisition deemed to be of significant importance to the Agency regardless of its dollar value. This final rule provides that NASA field installations identify these acquisitions through the MBP process for possible Headquarters review and approval. The change to NASA's structured approach for developing a profit or fee objective (64 FR 51472-51476, September 23, 1999) mistakenly deleted NASA's policy regarding the use of the structured approach for non-profit organizations and NASA's policy not to pay profit or fee on contracts with educational institutions. This final rule corrects this error by adding the previous language as section 1815.404-471-6. Additionally, editorial corrections and miscellaneous changes are made to correct the MBP format instructions, revise Internet reference citations, and correct the instructions for completing the Customs Form 7501, Entry Summary.

NASA certifies that this rule will not have a significant economic impact on a substantial number of small business entities under the Regulatory Flexibility Act (5U.S.C. 601 et seq. ) because it does not impose any new requirements.

The Paperwork Reduction Act does not apply because the changes to the NFS do not impose any recordkeeping or information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

A proposed rule was published in the Federal Register on April 18, 2000 (65 FR 20791-92). No comments were received. This final rule adopts the proposed rule without change. NASA's Center for AeroSpace Information (CASI) serves as a repository of NASA scientific and technical information (STI). This includes information developed under NASA-sponsored research and development efforts. The NFS currently requires that copies of the final report and other progress reports under R&D contracts be submitted to CASI. The need for other progress reports no longer exists. Copies of only the final report required under an R&D contract must be submitted to CASI. Before NASA STI is made available, it is subject to a NASA Document Availability Authorization (DAA) review and release determination. Contractors cannot release final reports resulting from NASA R&D contracts until NASA has completed its Document Availability Authorization (DAA) review (NASA Form 1676).

NASA certifies that this final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) because it only affects small business entities whose R&D contracts required progress reporting.

The Paperwork Reduction Act does not apply because the changes to the NFS do not impose any new record keeping or information collection requirements which require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

Government procurement.

NASA centers have reported that interim evaluations on SBIR/STTR contracts are usually perfunctory and without substance because there is seldom anything to evaluate until contract completion. This final rule makes interim evaluations for SBIR/STTR Phase II contracts optional.

NASA certifies that this final rule will not have a significant economic impact on a substantial number of small business entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) because it only affects NASA's internal implementation of existing regulatory requirements.

The Paperwork Reduction Act does not apply because the changes to the NFS do not impose any recordkeeping or information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

The following changes to current management measures were recommended by the Pacific Fishery Management Council (Council,) in consultation with the States of Washington, Oregon, and California, at its June 27-30, 2000, meeting in Portland, OR. Pacific coast groundfish landings will be monitored throughout the year, and further adjustments to the trip limits will be made as necessary to stay within the OYs and allocations announced in the annual specifications and management measures for the groundfish fishery, published in the Federal Register (65 FR 221, January 4, 2000, as amended at 65 FR 17805, April 5, 2000; 65 FR 25881, May 4, 2000; 65 FR 31283, May 17, 2000; and 65 FR 33423, May 23, 2000). Unless otherwise specified, these changes are effective through October 31, 2000. At its September meeting, the Council will consider whether changes recommended for August through October should apply also to the November and December fishing periods. If the Council does not recommend changes at that meeting, the trip limits that have already been published for those periods (January 4, 2000, 65 FR 221; May 17, 2000, 65 FR 31283) will remain in effect.

At the June 27-30, 2000, Council meeting, the Council and its advisory entities heard testimony from commercial trawlers that the current combination of yellowtail rockfish and flatfish landings limits and gear requirements were resulting in yellowtail rockfish discard. Under year 2000 management measures, most flatfish taken with small footrope trawl (8 inches, 20 cm, or less in diameter) have no landings limits. Historically, landings for most flatfish have not been restricted because the fisheries have not achieved the acceptable biological catches for those species. To protect non-flatfish species associated with targeted flatfish on the continental shelf, the 2000 management measures encouraged use of small footrope trawls by prohibiting flatfish landings (except Dover and rex soles) taken with large footrope trawl (greater than 8 inches, 20 cm, in diameter). In May, the limits were modified to allow 400 lb (181 kg) of flatfish per trip (excluding Dover and rex soles) with large footrope trawls.

Landings of yellowtail rockfish are lower than expected for this fishery. Yellowtail rockfish may not be landed by vessels fishing with large footrope trawl, and the small footrope bottom trawl limits has been at 1,500 lb (680 kg) per month since the beginning of the year. This is a low limit for this relatively abundant species, which was set to protect overfished species that associate with yellowtail rockfish. By contrast, midwater trawl limits for yellowtail rockfish were higher, at 10,000 lb (4,536 kg) per 2-month period in January through April and at 30,000 lb (13,608 kg) per 2-month period, May through October; overfished species are not vulnerable to midwater trawl gear.

During the summer months, yellowtail rockfish tend to move away from their rockier habitats and associate more closely with flatfish. This seasonal migration, in combination with a low yellowtail rockfish small footrope trawl limit, has resulted in yellowtail rockfish discards for fishers targeting both flatfish and yellowtail rockfish. Trawlers currently use small footrope bottom trawl gear to target the more liberal flatfish limits, but may keep only 1,500 lb (680 kg) of incidentally caught yellowtail rockfish. Any incidentally caught yellowtail rockfish above the 1,500 lb (680 kg) limit is discarded. Trawlers may switch to midwater gear to directly target yellowtail, so as to achieve the 30,000 lb (13,608 kg) landings limit.

To make yellowtail rockfish and flatfish management more consistent with natural catch association patterns and to reduce discards of yellowtail rockfish taken with small footrope bottom trawl gear, the Council recommended a new “per trip” limit for yellowtail rockfish taken with small footrope bottom trawl gear equivalent to the sum of 33 percent (by weight) of all flatfish except arrowtooth flounder, plus 10 percent (by weight) of arrowtooth flounder, not to exceed 7,500 lb (3,402 kg,) per trip and not to exceed 30,000 lb (13,608 kg) per 2-month period. This limit prevents direct yellowtail targeting with small footrope bottom trawl gear by restricting all bottom trawl landings of yellowtail rockfish to vessels that also land flatfish. This change is expected to reduce yellowtail rockfish discard by making the management measures more reflective of summer groundfish catch associations while discouraging fishing patterns that would take overfished species. With these protections, the Council could justify recommending an increase in the small footrope trawl 2-month cumulative limit to the same level as the current midwater trawl limit.

In a separate action, the Council recommended increasing the arrowtooth flounder large footrope bottom trawl per trip limit from 400 lb (181 kg) to 5,000 lb (2,268 kg) to accommodate incidental catch in the deeper water fisheries for sablefish, Dover sole, and thornyheads, primarily on the continental slope. Arrowtooth flounder are not a high-value species, and this limit is not expected to increase targeted effort on that species.

Minor nearshore rockfish landings in both the limited entry fixed gear and open access fisheries have been low during the first half of 2000. The best available information at the June Council meeting indicated that limited entry fixed gear fisheries had landed 5.2 percent of the allocation for that fishery north of 40°10′ N. lat. and 13.2 percent of the allocation for that fishery south of 40°10′ N. lat. through May 31, 2000. Similarly, the best available information at that meeting also indicated that open access fisheries had landed 14.5 percent of the allocation for that fishery north of 40°10′ N. lat. and 6.4 percent of the allocation for that fishery south of 40°10′ N. lat. To allow fisheries access to these stocks without exceeding 2000 OYs, the Council recommended significant increases to the minor nearshore rockfish landings limits for these two fisheries.

North of 40°10′ N. lat. and starting with the July-August period, the limited entry minor nearshore rockfish fixed gear limit increases from 3,000 lb (1,361 kg) to 5,000 lb (2,268 kg) per 2-month period, and the sublimit for minor nearshore rockfish other than blue or black rockfish increases from 1,400 lb (635 kg) to 1,800 lb (816 kg.) South of 40°10′ N. lat. and starting with the July-August period, the limited entry minor nearshore rockfish fixed gear limit increases from 1,300 lb (590 kg) to 2,000 lb (907 kg) per 2-month period. North of 40°10′ N. lat. and starting with the July-August period, the open access minor nearshore rockfish limit would double from 1,500 lb (680 kg) to 3,000 lb (1,361 kg) per 2-month period, and the sublimit for minor nearshore rockfish other than blue or black rockfish increases from 700 lb (318 kg) to 900 lb (408 kg.) South of 40°10′ N. lat. and starting with the July-August period, the open access minor nearshore rockfish limit doubles from 800 lb (363 kg) to 1,600 lb (726 kg) per 2-month period. With the new management strategies implemented in 2000, it is difficult to predict the effect on industry. Increases in the nearshore rockfish limits increase the risk of reaching an allocation or OY before the end of the year and may result in early closures of the minor nearshore rockfish fishery in the north.

The limited entry minor shelf rockfish landings for trawl and fixed gear south of 40°10′ N. lat. were slow in January-April partly because fixed gear shelf rockfish landings were closed south of 36° N. lat. in January-February, and closed between 40°10′ N. lat. and 36° N. lat. in March-April. Shelf rockfish landings rose in May, and by the end of May the fleet had taken 5.0 percent of the limited entry minor shelf rockfish allocation. Although the overall minor shelf rockfish landings are low, the Council had concerns about shelf rockfish fisheries intercepting bocaccio, an overfished stock. Bocaccio is managed under an overfished species rebuilding plan and is caught incidentally in commercial and recreational fisheries targeting many other different species.

The best available information at the June 2000 Council meeting indicated that the recreational fisheries have exceeded the 45 mt of bocaccio estimated for recreational landings in 2000. In order to protect bocaccio from excess incidental harvest in the commercial fishery, the Council recommended decreasing the limited entry minor shelf rockfish monthly limit for both trawl and fixed gear from 1,000 lb (454 kg) to 500 lb (227 kg) per month effective August 1, 2000. (An earlier effective date would not reduce fishing mortality because most fishers would have taken the July limit of 1,000 lb (454 kg) before this notice would take effect.)

Recreational bocaccio landings occur almost exclusively in California. The State has agreed to ask its Fish and Game Commission, which sets recreational fishing policies in State waters (0-3 nm offshore), to make inseason changes that further reduce recreational fishing pressure on overfished species (bocaccio, lingcod, canary rockfish, cowcod). This may include prohibiting landings of bocaccio taken in State waters for the remainder of 2000. The Council also asked NMFS to coordinate with the State of California to implement consistent changes to recreational rockfish fishery management measures in Federal waters (3-200 nm offshore).

As with nearshore and shelf rockfish, minor slope rockfish landings south of 40°10′ N. lat. have been slow in the first half of 2000. The best available information at the June Council meeting indicated that limited entry fisheries south of 40°10′ N. lat. had landed 10.1 percent of slope rockfish set aside for those fisheries and that open access fisheries had landed only 1.0 percent of their minor slope rockfish allocation through the end of May 2000. Given these low landings rates, the Council recommended increasing cumulative landings limits to levels that would allow higher landings without jeopardizing overfished and depleted stocks. The Council recommended increasing the limited entry minor slope rockfish cumulative landings limit for both trawl and fixed gear south of 40°10′ N. lat. from 5,000 lb (2,268 kg) to 7,000 lb (3,175 kg) per 2-month period. The Council also recommended increasing the open access, minor slope rockfish cumulative landings limit south of 40°10′ N. lat. from 500 lb (227 kg) to 1,000 lb (454 kg) per 2-month period.

The best available information at the June Council meeting indicated that the open access fishery will achieve its lingcod allocation before the end of July. This fishery was closed January through April and was scheduled to be closed in November and December, following a 400 lb (181 kg) monthly cumulative limit in May through October 2000. Lingcod is an overfished species managed under a rebuilding plan. To eliminate further open access lingcod landings for the rest of the year, the Council recommended closing open access lingcod landings from August 1 through the end of the year. This closure also applies to vessels in the pink shrimp trawl fishery.

Daily trip limit sablefish landings in both the 2000 limited entry fixed gear and the open access fisheries have been relatively low through the spring months. The best available information at the June Council meeting indicated that limited entry fixed gear fisheries had landed 11.9 percent of the sablefish set aside for small daily landings and that the open access fisheries had landed 7.0 percent of their sablefish allocation, both of which are taken under the small landings limit of 300 lb (136 kg) per day. To allow fisheries access to sablefish allocations during the more active summer fishing months, the Council recommended increasing the sablefish 2-month cumulative landings limits for both limited entry and open access fisheries north of 36° N. lat. from 2,400 lb (1,089 kg) to 3,300 lb (1,497 kg.) The 300 lb (136 kg) per day landings limit would remain in effect.

At its June 2000 meeting, the Council considered season structure options for the 2000 limited entry, fixed gear regular sablefish fishery. For 2000, the Council recommended that the regular season begin on August 6, 2000, at noon l.t. and last for 9 days, ending at noon on August 15, 2000. There will be no limited entry, daily trip limit fishery for sablefish taken with fixed gear during the regular season. During the regular season, each vessel with a limited entry permit and a sablefish endorsement that is registered for use with that vessel may land up to the cumulative trip limit for the tier to which the permit is assigned. The Council recommended the following tier limits: Tier 1, 81,000 lb (36,741 kg); Tier 2, 37,000 lb (16,783 kg); Tier 3, 21,000 lb (9,525 kg). These tier limits are expected to keep the overall fleet landings from exceeding the 2065.5 mt of sablefish available to this fishery.

The pre-season and post-season closures described for this fishery at 50 CFR 660.323 (a)(2) will be in effect. The pre-season closure will begin on August 4, 2000, at noon l.t., last for 48 hours, and end when the regular season begins on August 6, 2000, at noon l.t. During the pre-season closure, sablefish taken with fixed gear in the limited entry or open access fisheries north of 36° N. lat. may not be retained or landed. Also during the pre-season closure, all fixed gear used to take and retain groundfish must be out of the water. The post-season closure will begin when the regular season ends on August 15, 2000, at noon l.t., last for 30 hours, and end on August 16, 2000, at 1800 hours l.t. No sablefish taken with fixed gear north of 36° N. lat. during the post-season closure may be retained. Sablefish taken and retained during the regular season may be possessed and landed during the post-season closure, and gear may remain in the water during the post-season closure. However, during the post-season closure, fishers may not set or pull from the water fixed gear used to take and retain groundfish.

Under 50 CFR 660.333, limited entry permits may not be transferred more than once every 12 months, and permit transfers are effective only on the first date of a major cumulative limit period. Each year, the major cumulative limit periods are defined in the annual specifications and management measures according to when the Council schedules its cumulative limit periods for the majority of the groundfish fleet. In 1999 and prior years, trawl and fixed gear landings limit periods have been the same for most species. However, the 2000 annual specifications and management measures set separate cumulative limit periods and cumulative landings limits for limited entry trawl gear and for fixed gear.

Under 50 CFR 660.333, limited entry permits may not be transferred more than once every 12 months, and permit transfers are effective only on the first date of a major cumulative limit period. Each year, the major cumulative limit periods are defined in the annual specifications and management measures according to when the Council schedules its cumulative limit periods for the majority of the groundfish fleet. In 1999 and prior years, trawl and fixed gear landings limit periods have been the same for most species. However, the 2000 annual specifications and management measures set separate cumulative limit periods and cumulative landings limits for limited entry trawl gear and for fixed gear.

In July 1999, about 20 fixed gear permit holders transferred their permits so that the transfers would be effective in time for the August 1999 regular sablefish fishery. Changes to the major cumulative landings limits periods in 2000 meant that the first start date of a major cumulative limit period after July 1, 2000, was September 1, 2000. Thus, permit holders constrained by the regulatory restriction of one transfer every 12 months who had last transferred their permits in July 1999 would have missed the August 2000 fixed gear regular sablefish season, described above. The restriction that requires that permit transfers become effective on the first date of a major cumulative limit period would have prevented these permit holders from transferring their permits until September 1, 2000. Several of these permit holders testified at the June 2000 Council meeting that without changes to these restrictions, they would not be able to participate in the primary sablefish fishery. For participants in this fishery, this opportunity is often a significant portion of their annual incomes. To ensure that these 20 permit holders have the opportunity to transfer their permits and to participate in the regular fixed gear sablefish fishery, the Council recommended at its June 2000 meeting that a major cumulative trip limit period be added at August 1, 2000, for limited entry fixed gear fisheries, for purposes of allowing permit transfers in 2000. This added major cumulative limit period start date reflects the primarily month-long cumulative limit periods for limited entry fixed gear fisheries. The regulatory restriction that limited entry permit transfers may not occur more than once every 12 months would not be altered by this change to major cumulative limit start dates.

For the reasons stated here, NMFS concurs with the Council's recommendations and announces the following changes to the 2000 annual management measures (65 FR 221, January 4, 2000, as amended at 65 FR 17805, April 5, 2000, 65 FR 25881, May 4, 2000, 65 FR 31283, May 17, 2000, and 65 FR 33423, May 23, 2000) as follows:

In Section IV, paragraph (15), under A. General Definitions and Provisions , and paragraph (2)(b)(i); under B. Limited Entry Fishery , are revised; under C. Trip Limits in the Open Access Fishery , a new paragraph (3)(a)(ii)(C) is added; and Tables 3, 4, and 5 are revised to read as follows:

NMFS manages the groundfish fisheries in the Exclusive Economic Zone (EEZ) off Alaska and the crab fisheries in the EEZ of the Bering Sea and Aleutian Islands area according to fishery management plans (FMPs) prepared by the North Pacific Fishery Management Council (Council) under the authority of the Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C., 1801 et seq . The FMPs are implemented by regulations at 50 CFR part 679. General regulations that also pertain to these fisheries appear in subpart H of 50 CFR part 600.

NMFS published a final rule in the Federal Register on August 10, 1995, (60 FR 40763) implementing the VMP and, on January 25, 1999 (64 FR 3651), published a final rule extending the program for 1 year. The VMP expired on December 31, 1999, when it was succeeded by the LLP, which became effective on January 1, 2000. This technical amendment is designed to remove obsolete regulatory text that implemented the VMP without making any substantive change in the LLP implementing regulations or other rules.

The changes implemented with this rule in each section are described as nfollows.

Paragraph (c) is removed and reserved because it is no longer effective.

Definitions of terms that were relevant only to the VMP are removed. Some defined terms that also are used in existing and currently effective regulations are revised or renumbered to remove only the parts of the definitions that were applicable to the VMP. Terms and their definitions that are removed by this action are “Lost or destroyed vessel,” “Moratorium crab species,” “Moratorium groundfish species,” “Moratorium species,” “Moratorium qualification,” “Original qualifying LOA,” “Original qualifying vessel,” and “Qualifying period.” Definitions of terms that are revised or renumbered by this action are “Catcher/processor,” “Catcher vessel,” “Directed fishing,” “Maximum LOA (MLOA),” “Person,” and “Reconstruction.”

Criteria required for a VMP permit specified at § 679.4(c) are no longer effective and are removed by this action. Paragraph (c) is reserved to maintain the designation sequence of the succeeding paragraphs. Some of these VMP permit criteria were integrated into the LLP and were referenced in the LLP qualification requirements at § 679.4(k). Hence, this action revises regulations implementing the LLP at § 679.4(k)(4) to add specified VMP qualification criteria that are included in the LLP licensing criteria previously included only by reference.

Paragraphs (d)(13) and (14) in § 679.7 are revised by substituting the term “license limitation groundfish” for the term “moratorium groundfish species.” This change is made necessary by the substitution of the LLP for the VMP. Also in paragraph (e) of this section, the heading and text are removed and the paragraph reserved. Although paragraph (e) did not explicitly expire with the VMP, its continued existence no longer is necessary and could be confusing if it were not removed.

A reference in paragraph (a)(5)(i)(A)( 1 ) of this section to catcher vessels and catcher/processors that could be exempt from the VMP is revised to reference the same exemption provided under the LLP. Although the Council originally recommended that this exemption for specific CDQ vessels be transferred to the LLP, more recently, it recommended its deletion because it is no longer necessary. Removing the CDQ exemption is beyond the scope of this action and will be included in a future proposed rule.

Because this technical amendment makes only minor, non-substantive changes to an existing rule, NMFS finds that there is good cause to waive the requirement to provide notice and an opportunity for public comment, pursuant to authority set forth at 5 U.S.C. 553(b)(B), as such procedures are unnecessary. For the same reasons, NMFS finds good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date.

Because prior notice, delayed effectiveness and opportunity for public comment are not required for this final rule by U.S.C. 553, or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq ., are inapplicable.

This final rule has been determined to be not significant for purposes of Executive Order 12866.