The regulations in 9 CFR part 93 (referred to below as the regulations) prohibit or restrict the importation of certain animals into the United States to prevent the introduction of communicable diseases of livestock and poultry. Subpart C-Horses, §§ 93.300 through 92.326 of the regulations, pertains to the importation of horses into the United States. Section 93.301 of the regulations contains specific provisions for the quarantine and testing of horses from regions affected with contagious equine metritis (CEM), a highly contagious bacterial venereal disease that affects breeding and fertility. Section 93.301 also identifies regions where CEM exists and regions that trade horses freely with those where CEM exists without testing for CEM. Section 93.301 prohibits, with certain exceptions, the importation of horses into the United States from those areas. The European Union-of which Spain is a Member State-is listed in § 93.301 as a region where CEM exists or may exist.

On April 3, 2000, we published in theFederal Register(65 FR 17455-17458, Docket No. 99-054-1) a proposal to amend the animal importation regulations by allowing Spanish Pure Breed horses to be imported from Spain into the United States under the same conditions that apply to thoroughbred horses from France, Germany, Ireland, and the United Kingdom. Specifically, the regulations previously provided that Spanish Pure Breed horses other than geldings, weanlings, and yearlings could be imported for permanent entry into the United States only in accordance with § 93.301(e), which requires preexport testing, Federal quarantine upon arrival, and further quarantine in a State approved to receive horses from listed regions. Under the proposal, imported Spanish Pure Breed stallions and mares that are more than 731 days old-like thoroughbred horses from France, Germany, Ireland, and the United Kingdom-that have tested negative for CEM in the country of origin and have undergone Federal quarantine upon arrival in the United States would not be subject to additional quarantine, testing, and treatment within an approved State. In addition, we proposed to add Spain's Servicio de Cria Caballar y Remonta as a breed association specifically approved by the U.S. Department of Agriculture to provide factual, current information regarding the activities of Spanish Pure Breed horses.

We solicited comments concerning our proposal for 60 days ending June 2, 2000. We received one comment by that date. The commenter, an importer of Spanish horses, expressed support for our proposal, stating that the proposed changes would help his industry. However, the commenter also asserted that our requirement that mares over 2 years old undergo Federal quarantine upon arrival in the United States was illogical and needlessly expensive, since Spanish veterinarians test and inspect the animals for CEM prior to export, and Spain is considered free of the disease.

We are making no changes to the final rule based on this comment. While we agree with the commenter that CEM presents a negligible risk in imported Spanish Pure Breed horses, with certain exceptions, all horses intended for permanent entry into the United States are also required to be detained under Federal quarantine while official tests for dourine, glanders, equine piroplasmosis, and equine infectious anemia are conducted. The animals must test negative for all of these diseases and be found by an Animal and Plant Health Inspection Service (APHIS) veterinarian to be free from any clinical evidence of disease before they can be released from quarantine. Because of the serious nature of these diseases, we believe that these requirements continue to be necessary to ensure that infected horses do not enter this country and jeopardize the health of the U.S. horse population.

CEM is difficult to diagnose and control, and infected horses of both sexes are often asymptomatic. Repeated sampling, at appropriate time intervals, constitutes the only satisfactory means of determining CEM status in horses. Therefore, we also must continue to require that all horses that have tested positive for CEM prior to importation-despite the fact that they must subsequently have been treated, tested, and found negative for the disease before being exported to the United States-undergo further quarantine, treatment, and repeated testing in a State approved to receive them upon completion of the Federal quarantine. Spanish Pure Breed horses that have tested positive for CEM prior to export and, upon treatment and retesting, been found free of the disease would still have to undergo treatment within a State approved to receive such horses. However, this action will save importers of Spanish Pure Breed horses that have tested negative to the disease prior to export and have undergone the requisite Federal quarantine the additional coststhat would be associated with further, in-State quarantine and testing.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, without change.

This is a substantive rule that relieves restrictions and, pursuant to the provisions of 5 U.S.C. 553, may be made effective less than 30 days after publication in theFederal Register. By allowing Spanish Pure Breed horses to be imported from Spain into the United States under the same conditions that apply to thoroughbred horses from certain other regions where contagious equine metritis exists or may exist, this rule will make the importation of Spanish Pure Breed horses less expensive for U.S. importers. We have determined that approximately 2 weeks are needed to ensure that APHIS personnel at ports of entry receive official notice of this change in the regulations. Therefore, the Administrator of APHIS has determined that this rule should be made effective 15 days after publication in theFederal Register.

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.

This rule amends the regulations in 9 CFR part 93 to allow Spanish Pure Breed horses to be imported from Spain into the United States under the same conditions that apply to thoroughbred horses from France, Germany, Ireland, and the United Kingdom. We are taking this action in response to a request we have received from Spain's Equine Breeding Service to relieve some of the restrictions on the importation of Spanish Pure Breed horses from Spain since the life histories and medical records of these horses can be certified by Spanish Government veterinarians.

In 1997, there were 375,218 farms in the United States keeping 2,427,277 horses of all kinds. Approximately 79,516 farms sold 325,306 horses, receiving $1.03 billion in sale revenues. Approximately 98 percent of the farms that sold horses have less than $500,000 in annual revenue and, therefore, are considered small entities by the U.S. Small Business Administration.

U.S. importers and breeders of Spanish Pure Breed horses will be affected by this rule. This rule will make it less expensive for importers to import Spanish Pure Breed horses from Spain.

There are approximately 270 domestic breeders of Spanish Pure Breed horses in the United States, most of which are likely to be small entities. In 1998, there were approximately 2,500 Spanish Pure Breed horses in the United States, and only 225 foals were registered that year.

In 1995 and 1996, 4 horses (not all of which were Spanish Pure Breed horses) were imported into the United States from Spain; there were 21 horses in 1997, 39 in 1998, and 46 in 1999. Under this rule, we estimate that the number of Spanish Pure Breed horses imported into the United States from Spain will most likely increase to an average of about 60 per year, for the next 3 to 5 years, with a maximum of 100 in any given year.

Currently, the demand for Spanish Pure Breed horses in the United States is greater than can be supplied by domestic breeders and the small number of these horses imported from Costa Rica, Mexico, and Spain. In 1997, 225 Spanish Pure Breed foals were registered in the United States, while a total of 50 were imported into the United States from all over the world, despite the high costs of shipping (approximately $5,000 per horse for air freight plus insurance against mortality, figured at 1 percent of the horse's declared value), quarantine, and testing. Because domestic Spanish Pure Breed horses are less expensive than imports, the demand for domestic Spanish Pure Breed horses should not decrease as a result of this rule. This rule will help satisfy the growing demand for the horses in the United States and make it less expensive for U.S. breeders and importers to obtain them from Spain.

We do not expect domestic breeders of Spanish Pure Breed horses to be affected by this rule, since the demand in the United States for Spanish Pure Breed horses is greater than the domestic supply and since domestic Spanish Pure Breed horses will still be less expensive than imported ones.

Under these circumstances, the Administrator of APHIS has determined that this action will not have a significant economic impact on a substantial number of small entities.

This final 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 the Paperwork Reduction Act of 1995 (44 U.S.C. 3501et seq.), the information collection or recordkeeping requirements included in this rule have been approved by the Office of Management and Budget (OMB) under OMB control number 0579-0152.

On September 7, 1995, the FAA issued AD 95-19-08, amendment 39-9370 (60 FR 48630, September 20, 1995), applicable to certain Boeing Model 727-100 and -200 series airplanes, to require replacing the attaching nutplates on certain engine nose cowls with washers and self-locking nuts. That action was prompted by reports indicating that nose cowls separated (or nearly separated) from the engines of certain airplanes following failure of the engine fan blade and subsequent vibration of the engine, which caused loosening of the attach bolts on the nose cowl of the engine. The actions required by that AD are intended to prevent the attach bolts from becoming loose, which could result in subsequent separation of the nose cowl from the engine.

Since the issuance of that AD, the FAA has transferred the supplemental type certificate data from the Seattle Aircraft Certification Office (ACO) to the Los Angeles ACO. Therefore, the FAA has determined it is necessary to issue this AD to require that all future alternative methods of compliance and adjustments of compliance time be approved by the Manager of the Los Angeles ACO.

Since unsafe condition has been identified that is likely to exist or develop on other airplanes of this same type design, this AD revises AD 95-19-08 to continue to require replacing the attaching nutplates on certain engine nose cowls with washers and self-locking nuts. This AD changes the responsible office for approval of an alternative method of compliance.

Since this AD is a minor and merely technical amendment in which the public is not particularly interested, and does not change the existing requirements, it is found that notice and opportunity for prior public comment hereon are unnecessary 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 is a minor and merely technical amendment 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 captionADDRESSES.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-249-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 underExecutive Order 13132.

The FAA has determined that notice and comment hereon are unnecessary because this is a minor and merely technical amendment in which the public is not particularly interested.

On May 23, 2000, the Federal Aviation Administration (FAA) issued AD 2000-11-06, amendment 39-11754 (65 FR 34928, June 1, 2000), which applies to all Boeing Model 767 series airplanes. That AD requires repetitive inspections to detect discrepancies of the wiring and surrounding Teflon sleeves of the fuel tank boost pumps and override/jettison pumps; replacement of the sleeves with new sleeves, for certain airplanes; and repair or replacement of the wiring and sleeves with new parts, as necessary.

That AD was prompted by reports of chafing of Teflon sleeves that surround and protect electrical wires inside conduits installed in the fuel tanks. The actions required by that AD are intended to ensure adequate protection to the fuel pump wire insulation. Such chafing of the wire insulation could eventually result in exposure of electrical conductor, permit arcing from the wire to the conduit, and create a potential for a fuel tank fire or explosion.

Since the issuance of that AD, the FAA has determined that the AD cites an incorrect date for the referenced service information. The actions in that AD are required to be accomplished under Boeing Service Bulletin 767-28A0053, Revision 1. The AD references that bulletin as being dated April 1, 1999. The correct date for the service bulletin is August 5, 1999. While the footer on each page of Revision 1 of the service bulletin shows a date of April 1, 1999, the first page of the bulletin, as well as the “Summary� and “Revision Transmittal Sheet,� show a date of August 5, 1999. The manufacturer has informed the FAA that the correct date for the bulletin is August 5, 1999.

A correction to AD 2000-11-06 is necessary. The correction will eliminate confusion for operators and ensure that operators use the correct source of service information to accomplish the actions required by the existing AD.

This document corrects the error and correctly adds the AD as an amendment to § 39.13 of the Federal Aviation Regulations (14 CFR 39.13).

The AD is reprinted in its entirety for the convenience of affected operators. The effective date of the AD remains July 6, 2000.

Since this action only clarifies the correct date for the service information referenced in the existing AD, it has no adverse economic impact and imposes no additional burden on any person. Therefore, the FAA has determined that notice and public procedures are unnecessary.

In theFederal Registerof August 12, 1987 (52 FR 30042), the agency published the final monograph for OTC antitussive drug products. The monograph included the ingredients camphor and menthol as single topical antitussives in an ointment vehicle or for steam inhalation use. Products containing camphor and menthol in combination are being considered as part of the ongoing rulemaking for OTC cough-cold combination drug products.

When the final monograph was published in 1987, the agency was not aware of safety problems occurring when products that contain camphor or menthol are added to hot water or used in a microwave oven. In theFederal Registerof July 20, 1998 (63 FR 38762), the agency discussed new information concerning 34 fire-related events (flashing occurred) resulting from antitussive drug products containing camphor and menthol (in an ointment vehicle or an alcohol-based solution) that were placed in hot water or heated in a microwave oven. As a result, the agency proposed a flammability signal word and new warning and direction statements for these products (63 FR 38762 at 38765).

The agency proposed a flammability signal word and a warning (“Keep awayfrom fire or flame�) for any product containing camphor or menthol in an ointment vehicle or for steam inhalation use. The agency also proposed a number of “do not use� warnings (e.g., near an open flame and in a microwave oven) and the following statements in the directions: “See important warnings about not using near a flame, in hot water, or in a microwave oven. Improper use may cause the mixture to splatter and cause burns.�

In response to the proposal, the agency received two comments, copies of which are on public display in the Dockets Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The agency's responses to the comments follow.

(Comment 1) One comment agreed with the proposal to require additional information to help increase appropriate use of the topical/inhalant drug products containing camphor and menthol.

(Comment 2) Two comments requested that the regulation clarify that a flammability signal word is not required on all products. The comments pointed out that the flammability signal words in 16 CFR 1500.3(b)(10) and (c)(6) state that “flammable� is any substance having a flashpoint above 20 °F and below 100 °F and that no flammability signal word is required if the flashpoint of the substance is above 150 °F. The comments added that camphor and menthol in ointment/cream products have flashpoints over 150 °F and would not need the flammability signal word or warnings, while steam inhalation products in an alcohol vehicle have a flashpoint between 20 °F and below 100 °F and would be labeled as flammable and contain the two proposed flammability warnings. One comment provided the results of flashpoint testing for its ointment, cream, and steam inhalation products (Ref. 1).

The agency has reviewed the testing results and concurs that products with a flashpoint above 150 °F would not need the flammability signal word or warnings. The agency only intended that those products that meet the criteria in 16 CFR 1500.3(b)(10) (flashpoint of 150 °F or below) be labeled with the flammability signal word and warnings. Accordingly, the agency is revising § 341.74(c)(5)(iii) (21 CFR 341.74(c)(5)(iii)) to require that the labeling contains the appropriate flammability signal word and the statement “Keep away from fire or flame� if the product meets the definition of one of the signal words (“extremely flammable,� “flammable,� “combustible�) as described in 16 CFR 1500.3(b)(10). The agency is also amending § 201.66(c)(5)(ii)(C) (21 CFR 201.66(c)(5)(ii)(C)) to include § 341.74(c)(5)(iii) as an example where a flammability warning is found in an OTC drug monograph.

(Comment 3) Two comments requested that the warnings about not using these products in certain ways be included in the “Directions,� and not the “Warnings,� section. The comments contended that the warnings relate to appropriate use of the product and belong in the directions so consumers know how to use the product correctly. The comments argued that because space limitations on small package sizes make it very difficult to fit similar information in two places (warnings and directions), the information should be consolidated in the “Directions� section.

The agency has determined that this information is more appropriate in the “Warnings� section of the labeling. Under the new OTC drug product labeling format in § 201.66(c)(5)(vi), which was issued after the proposal in the current rulemaking, the subheading “When using this product� is used to describe activities consumers should avoid while using the product. Information about not using the product near a flame or in a microwave oven belongs under this subheading. However, because of the importance of the warning information, the agency is including a short cross-reference in the “Directions� section to the location of the information in the “Warnings� section. This approach is consistent with the “choking� warning for water-soluble gums in 21 CFR 201.319 where the information about choking appears in the “Warnings� section and a cross-reference to the warning appears in the “Directions� section.

The agency proposed a two-sentence cross-reference in the “Directions� section that was repetitive of some of the information in the “Warnings� section. The agency is removing the repetitive information in the first proposed sentence (i.e., about not using near a flame, in hot water, or in a microwave oven) and shortening the sentence to refer users to the same information in the “Warnings� section. The revised directions statement now reads: “[bullet] see important warnings under ‘When using this product’ � [appears as the first statement under the heading “Directions� and is highlighted in bold type]. The agency is moving the second proposed statement about the mixture splattering and causing burns to the “Warnings� section to follow the information about not using near a flame or in a microwave oven, because the second sentence should immediately follow that information.

(Comment 4) Two comments requested that the directions provide different instructions for ointment and steam inhalation products. One comment suggested the following wording for ointment products: “Do not expose to any heat source (including stove or microwave) or place in any container in which you are heating water. Improper use may cause the mixture to splatter and cause burns.� The comment added that steam inhalation products would also include the word “flame� after “stove� and the words “except when adding to cold water in a hot steam vaporizer� after the words “heating water.�

The second comment proposed similar but revised wording for ointment products: “Do not heat. Never expose to flame, microwave, or place in any container in which you are heating water. Improper use may cause the mixture to splatter and cause burns.� The comment added that steam inhalation products should also include the words “except when adding to cold water in a hot steam vaporizer� after the words “heating water.�

As discussed in part II, comment 3 of this document, this information about not using the products in certain ways will appear in the “Warnings� section. The agency agrees that ointment, cream, and steam inhalation products could have slightly different warnings depending on the flashpoint of the products. The data provided by one comment (Ref. 1) showed that the flashpoints of an ointment product were 158 and 165 °F, while the flashpoint of a cream product was 152 °F. As discussed in part II, comment 2 of this document, other manufacturers' products might have a flashpoint of 150 °F or below and thus be required to have a flammability signal word and warnings. The agency agrees with deletion of the word “flame� from the warnings for ointment/cream products if they are not flammable or combustible. The agency also agrees with inclusion of the words “except when adding to cold water only in a hot steam vaporizer� for steam inhalation products. To increase the amount of information provided to consumers and to state the information in a clear and concise way, the agency is revising the warnings as follows:

•For any product containing camphor or menthol in a suitable ointment vehicle and that does not contain a flammability signal word as described in 16 CFR 1500.3(b)(10). “When using this product, do not • heat• microwave • add to hot water or any container where heating water. May cause splattering and result in burns.� [Information highlighted in bold type.]

•For any product containing camphor or menthol in a suitable ointment vehicle and that contains a flammability signal word as described in 16 CFR 1500.3(b)(10). “When using this product, do not • heat • microwave • use near an open flame • add to hot water or any container where heating water. May cause splattering and result in burns.� [Information highlighted in bold type.]

•For any product containing camphor or menthol for steam inhalation use. “When using this product, do not • heat • microwave • use near an open flame • add to hot water or any container where heating water except when adding to cold water only in a hot steam vaporizer. May cause splattering and result in burns.� [Information highlighted in bold type.]

There are two types of products containing camphor or menthol for steam inhalation use on the market. One is formulated to be added directly to cold water inside a hot steam vaporizer before the water is heated, and the other is formulated to be placed into the medication chamber of the vaporizer. The agency is modifying the directions in § 341.74(d)(2)(iv) and (d)(2)(v) for products containing camphor or menthol for steam inhalation use to include appropriate directions for both types of these products, as follows:

•For products formulated to be added directly to cold water inside a hot steam vaporizer. • use 1 tablespoonful of solution for each quart of water or 1/1/2/teaspoonsful of solution for each pint of water • add solution directly to cold water only in a hot steam vaporizer • follow manufacturer's directions for using vaporizer.

•For products formulated to be placed in the medication chamber of a hot steam vaporizer. • place water in the vaporizer and follow manufacturer's directions for using vaporizer • place solution in the medication chamber only.

(Comment 5) One comment stated that the proposed warning about not using an ointment product in a hot steam vaporizer is inappropriate (because these products are not used in that manner) and will lead to consumer confusion.

The agency notes that 1 of the 21 fire-related events discussed in the proposal (63 FR 38762) involved an ointment product that was added to hot water in a vaporizer. The agency believes that it is important to inform consumers about this potential problem. The portion of the warning about not adding the product to “hot water� covers both hot water in a container on the stove and hot water in a vaporizer; thus, this information should adequately inform consumers and should not cause confusion.

The following reference is on display in the Dockets Management Branch (address above) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Comment No. C200, Docket No. 76N-052T, Dockets Management Branch.

The agency concludes that the case reports raise safety concerns that could be alleviated by providing consumers with additional warnings and directions for topical/inhalant OTC antitussive drug products that contain camphor or menthol. Products that meet the definition of one of the signal words (“extremely flammable,� “flammable,� “combustible�) in 16 CFR 1500.3(b)(10) must state the signal word and “Keep away from fire or flame� in their labeling. Consumers need to be informed via warnings not to heat or microwave these products, not to add them to hot water, not to put them in any container where water is being heated (except for adding a steam inhalation product to cold water only in a hot steam vaporizer), and not to use near an open flame (if the product bears a flammability signal word). The agency has included warnings and directions with minor differences to fit the variety of products that might exist and a short cross-reference to the warnings information in the directions section. The agency has revised proposed warnings and directions in this final rule to state them in the new OTC drug labeling format required by § 201.66.

FDA has examined the impacts of this final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501et seq.). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Under the Regulatory Flexibility Act, if a rule has a significant economic impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of the rule on small entities. Section 202(a) of the Unfunded Mandates Reform Act requires that agencies prepare a written statement and economic analysis before proposing any rule that may result in an expenditure in any one year by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million (adjusted annually for inflation).

The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive Order. In addition, the final rule is not a significant regulatory action as defined by the Executive Order and so is not subject to review under the Executive Order.

The purpose of this final rule is to revise and improve the labeling (add additional warning and direction statements) for safer use of topical/inhalant products that contain camphor, menthol, or both ingredients. This revised labeling addresses the flammability of these products and alerts consumers not to heat or microwave the products, nor to use near an open flame, add to hot water, or put in any container in which water is being heated (with an exception for adding a steam inhalation product to cold water only in a hot steam vaporizer). Potential benefits include a reduction in the number of flash fires and serious burns that may occur if consumers should misuse these products.

This final rule will require relabeling of topical/inhalant products that contain camphor, menthol, or both ingredients. The agency's Drug Listing System identifies about 30 manufacturers and 80 marketers of over 100 stockkeeping units (SKU's) (individual products, packages, and sizes) of topical/inhalant antitussive drug products containing camphor, menthol, or both ingredients. There may be a few additional marketers and products that are not identified in the sources FDA reviewed.

The agency indicated in the proposal that relabeling costs of the type required by this final rule generally average about $2,000 to $3,000 per SKU. In determining this cost, the agency did not believe that manufacturers would need to increase the package size to add the additional labeling information. Almost all of these products are marketed in an outer carton, which should have adequate space for the additional information. Assuming that there are about 110 affected OTC SKU's in the marketplace, FDA estimated that the rule would impose total one-time compliance costs on industry forrelabeling of about $220,000 to $330,000. The agency did not receive any comments on these estimates.

The agency believes the actual cost could be lower for several reasons. First, most of the label changes will be made by private label small manufacturers that tend to use simpler and less expensive labeling. However, the final rule will not require any new reporting and recordkeeping activities. Therefore, no additional professional skills are needed. Second, the agency has made the compliance dates for this final rule the same as the dates for these monographed products to be in compliance with the new standardized format and standardized content requirements for the labeling of OTC drug products (§ 201.66), which are now May 16, 2002 (and May 16, 2003, for products with annual sales less than $25,000). Manufacturers will not incur any expenses determining how to state the product's labeling. All manufacturers should have ample time to use up existing labeling stocks and the relabeling costs would be mitigated. Thus, all required labeling changes can be made at the same time, thereby reducing the labeling cost of this final rule.

The agency considered but rejected several labeling alternatives: (1) A shorter or longer implementation period, and (2) an exemption from coverage for small entities. While the agency believes that consumers would benefit from having this new labeling in place as soon as possible, the agency also acknowledges that coordination of this labeling change with implementation of the new OTC “Drug Facts� labeling may significantly reduce the costs of this final rule. Both a shorter and a longer time period for this rule may cost more if firms would have to undertake two successive labeling revisions. In addition, a longer time period would unnecessarily delay the benefit of the new labeling to consumers who self-medicate with these products. The agency rejected an exemption for small entities because the new labeling information is also needed by consumers who purchase products marketed by those entities.

The agency does not believe that this final rule will have a significant economic impact on small entities, using the U.S. Small Business Administration designations for this industry (750 employees). The agency believes that any other unidentified manufacturer of these products is also a small entity. From information available to the agency, it appears that only one small entity manufactures more than three SKU's of these products. Based on the limited number of SKU's each manufacturer has to relabel, the cost for each manufacturer except one should be minimal.

Under the Unfunded Mandates Reform Act, FDA is not required to prepare a statement of costs and benefits for this final rule because this rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation.

This analysis shows that the agency has considered the burden to small entities. Thus, this economic analysis, together with other relevant sections of this document, serves as the agency's final regulatory flexibility analysis, as required under the Regulatory Flexibility Act.

FDA concludes that the labeling requirements in this final rule are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information� under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501et seq.). Rather, the labeling requirements are a “public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public� (5 CFR 1320.3(c)(2)).

The agency has determined under 21 CFR 25.31(a) 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.

On April 27, 2000, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulations; Gowanus Canal, New York, in theFederal Register(65 FR 24664). We received no comments in response to the notice of proposed rulemaking. No public hearing was requested and none was held.

The Ninth Street Bridge, at mile 1.4, across the Gowanus Canal at Brooklyn, has a vertical clearance of 5 feet at mean high water and 9 feet at mean low water. The existing operating regulations for the Ninth Street Bridge require the bridge to open on signal at all times.

The Third Street Bridge, at mile 1.8, across the Gowanus Canal at Brooklyn, has a vertical clearance of 10 feet at mean high water and 14 feet at mean low water. The existing operating regulations in 33 CFR 117.787, require the draw to open on signal at all times; except that, from May 1 through September 30, the draw shall open on signal after a six-hour advance notice is given to the New York City Highway Department's Radio (Hotline) Room.

The Carroll Street Bridge, at mile 2.0, has a vertical clearance of 3 feet at MHW and 7 feet at MLW. The existing regulations require the draw to open on signal at all times; except that, from May 1 through September 30, the draw shall open after a six-hour advance notice is given to the New York City Highway Department's Radio (Hotline) Room.

The Union Street Bridge, at mile 2.1, has a vertical clearance of 9 feet at MHW and 13 feet at MLW. The existing regulations require the draw to open on signal at all times; except that, from May 1 through September 30, the draw shall open after a six-hour advance notice is given to the New York City Highway Department's Radio (Hotline) Room.

The owner of all four bridges, the New York City Department of Transportation (NYCDOT), submitted bridge opening log data to the Coast Guard for review.

The bridge owner plans to operate these bridges with a roving crew of drawtenders. A review of the monthly breakdown of the opening data did not identify any months that had a significantly higher number of openings that would make the roving crew concept unworkable. The waterway users are all commercial vessels which operate year round. They presently provide a six-hour advance notice May 1 through September 30 at all the above bridges except the Ninth Street Bridge, which is required to open on signal.

The bridge owner has requested that all four bridges open after a two-hour advance notice is given year round. This advance notice requirement will allow the bridge owner to use a roving crew of drawtenders to operate these bridges. The Coast Guard believes this rule is reasonable based upon the fact that three of the bridges presently open after a six-hour notice May 1 through September 30, which is greater than the two-hour notice during those five months.

The Coast Guard believes that the two-hour advance notice October 1 through April 30 is reasonable because the bridges will still open on signal provided the two-hour notice is given. The commercial vessel transits on Gowanus Canal are scheduled in advance. Providing a two-hour notice for bridge openings for the additional seven months of the year, October 1 through April 30, should not prevent vessels from transiting the waterway in a timely manner.

The reduction from six-hours advance notice to two-hours advance notice during the remaining five months of the year, May 1 through September 30, should make vessel transits easier to schedule during that time period. This rule is expected to relieve the bridge owner of the burden of crewing each bridge continually, establish a consistent bridge operating schedule for the bridges listed in this rulemaking, and still meet the reasonable needs of navigation.

The Coast Guard is revising the operating regulations for the Gowanus Canal at 33 CFR 117.787 as follows:

Add operating regulations for the Ninth Street Bridge, mile 1.4, Across the Gowanus Canal to require that the draw shall open on signal, if at least a two-hour advance notice is given.

Revise the operating regulations for the Third Street Bridge, mile 1.8, across the Gowanus Canal to require that the draw shall open on signal, if at least a two-hour advance notice is given.

Revise the operating regulations for the Carroll Street, mile 2.0, across the Gowanus Canal to require that the draw shall open on signal, if at least a two-hour advance notice is given.

Revise the operating regulations for the Union Street, mile 2.1, across the Gowanus Canal to require that the draw shall open on signal, if at least a two-hour advance notice is given.

Notice for bridge openings shall be given to the NYCDOT Hotline or NYCDOT Bridge Operation Office.

The bridge owner plans to use two crews of drawtenders to operate the Gowanus Canal bridges. The use of two crews is expected to provide bridge openings in a timely manner. The Hamilton Avenue Bridge, mile 1.2, also across Gowanus Canal was not included in the roving drawtender plan because the frequency of bridge openings were considerably higher than the other bridges on this waterway.

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). This conclusion is based on the fact that three of the bridges presently open after a six-hour notice May 1 through September 30, which is greater than the proposed two-hour notice during those five months.

The Coast Guard believes that the two-hour advance notice October 1 through April 30 is reasonable because the bridges will still open on signal provided the two-hour notice is given. The commercial vessel movements on Gowanus Canal are scheduled in advance by the commercial operators. Providing two-hours notice for bridge openings for the additional seven months of the year, October 1 through April 30, should not prevent vessels from still transiting the waterway in a timely manner.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612) we considered whether this rule would have asignificant economic impact on a substantial number of small entities. “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 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 conclusion is based on the fact that three of the bridges presently open after a six-hour notice May 1 through September 30, which is greater than the proposed two-hour notice during those five months.

The Coast Guard believes that the two-hour advance notice October 1 through April 30 is reasonable because the bridges will still open on signal provided the two-hour notice is given. The commercial vessel transits on Gowanus Canal are scheduled in advance by the commercial operators. Providing two-hours notice for bridge openings for the additional seven months of the year, October 1 through April 30, when the bridge formerly opened on signal, should not prevent vessels from still transiting the waterway in a timely manner.

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'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 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 (32)(e) of Commandant Instruction M16475.1C, this rule is categorically excluded from further environmental documentation because promulgation of changes to drawbridge regulations have been found to not have a significant effect on the environment. A “Categorical Exclusion Determination� is available in the docket for inspection or copying where indicated underADDRESSES.

On April 24, 2000, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulations; Newtown Creek, Dutch Kills, English Kills and their tributaries, New York, in theFederal Register(65 FR 21683). We received no comments in response to the notice of proposed rulemaking. No public hearing was requested and none was held.

The Pulaski Bridge, at mile 0.6, across Newtown Creek between Brooklyn and Queens has a vertical clearance of 39 feet at mean high water and 43 feet at mean low water. The existing regulations require the draw to open on signal at all times.

The Greenpoint Avenue Bridge, at mile 1.3, across the Newtown Creek between Brooklyn and Queens has a vertical clearance of 26 feet at mean high water and 31 feet at mean low water. The existing regulations require the draw to open on signal at all times.

The Grand Street/Avenue Bridge, at mile 3.1 across the Newtown Creek (East Branch) between Brooklyn and Queens has a vertical clearance of 8 feet above mean high water and 12 feet at mean low water. The existing operating rules for the Grand Street/Avenue Bridge, listed at 33 CFR 117.801(e), require the bridge to open on signal unless the drawtender is at the Borden Avenue, Hunters Point Avenue or Roosevelt Island Bridges. In this event a notice to the New York City Department of Transportation (NYCDOT) Radio Hotline, or NYCDOT Bridge Operations Office shall be given, resulting in up to a one-hour delay.

The Metropolitan Avenue Bridge, at mile 3.4, across the English Kills at Brooklyn has a vertical clearance of 10 feet above mean high water and 15 feet above mean low water. The existing operating regulations require the draw to open on signal at all times.

The Borden Avenue Bridge, at mile 1.3, across the Dutch Kills has a vertical clearance of 4 feet at mean high water and 9 feet at mean low water. The existing regulations in 33 CFR 117.801(c) require the draw to open on signal if at least a one-hour advance notice is given to the drawtender at the Grand Street/Avenue Bridge, the New York City Department of Transportation Radio Hotline or NYCDOT Bridge Operations Office. In the event the drawtender is at the Roosevelt Island Bridge or the Hunters Point Avenue Bridge, up to an additional half-hour delay may occur.

The Hunters Point Avenue Bridge, at mile 1.4, over the Dutch Kills has vertical clearances of 8 feet at mean high water and 13 feet at mean low water. The existing regulations for the Hunters Point Avenue Bridge in 33 CFR 117.801(d) require the draw to open on signal if at least a one-hour advance notice is given to the drawtender at the Grand Street/Avenue Bridge, the NYCDOT Radio Hotline, or NYCDOT Bridge Operations Office. In the event the drawtender is at the Roosevelt Island Bridge or the Borden Avenue Bridge, up to an additional half-hour delay may occur.

The bridge owner, the New York City Department of Transportation (NYCDOT), submitted bridge opening log data to the Coast Guard for review. The bridge owner plans to operate these bridges with multiple crews of drawtenders. The two-hour advance notice should allow sufficient time for the crews to operate these bridges due to the close proximity of the bridges to each other. Recent yearly openings have been relatively low which will allow the bridge owner to utilize the roving crew concept and still meet the needs of navigation.

The total number of bridge openings at the above bridges from 1991 to 1999 are as follows:

The monthly distribution of openings for the above bridges were equally balanced without any specific months when opening requests were significantly greater.

This final rule should relieve the bridge owner the burden of crewing each bridge continually, and still meet the reasonable needs of navigation. A two-hour advance notice requirement for bridge openings will enable the bridge owner to utilize multiple crews of drawtenders to open these bridges for vessel traffic. The Coast Guard believes the roving drawtender concept requiring a two-hour advance notice is reasonable and should meet the needs of navigation based upon the low number of yearly openings at the bridges, the close proximity of the bridges, and the scheduling of commercial vessel transits. The bridges will still open on signal at all times provided that the advance notice is given. This rule is expected to relieve the bridge owner of the burden of crewing each bridge continually and still meet the reasonable needs of navigation.

The Coast Guard is changing the operating regulations for the Grand Street/Avenue Bridge, Borden Avenue Bridge, Hunters Point Bridge, Metropolitan Bridge, Pulaski Bridge and the Greenpoint Bridge, to require a two-hour advance notice for openings at all times.

Paragraph (a)(1) of 33 CFR 117.801 for public and state vessels used for public safety, will be removed because it is now listed at 33 CFR 117.31 under the general operating regulations for bridges.

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). This conclusion is based on the fact that the bridges will open for marine traffic butwill require mariners to provide a two-hour notice.

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. “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 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 conclusion is based on the fact that the bridges will still open on signal after a two-hour notice is given.

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'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 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 (32)(e) of Commandant Instruction M16475.1C, this rule is categorically excluded from further environmental documentation because promulgation of changes to drawbridge regulations have been found to not have a significant effect on the environment. A “Categorical Exclusion Determination� is available in the docket for inspection or copying where indicated underADDRESSES.

In 1997, the Copyright Office adopted an interim regulation which permitted correction of errors in the filing of Notices of Intent to Enforce (NIEs) restored copyrights under certain conditions, pursuant to the Uruguay Round Agreements Act. 62 FR 55736 (1997). In accordance with that regulation, a Correction Notice has been filed to correct certain information appearing on the NIE for the first work listed below, originally recorded effective August 22, 1997. The new information has been cataloged in Copyright Office records.

In a separate case, the Office has administratively amended the record for a Group NIE to reflect 45 additional titles not originally included. The effective date will be that of the original Group NIE, April 17, 1998. The Office is making this amendment to reflect a policy determination regarding the regulation permitting a single Group NIE to cover multiple works at a discounted rate where “all of the works are by the same author.� 37 CFR 201.33 (1999). Previously the Copyright Office neither indexed nor listed titles from a Group NIE that did not have complete identity of authorship with other titles. For example, if a Group NIE listed titles 1and 2 by Author A and title 3 by Coauthors A and B, the Office required an additional NIE to be filed before publishing or indexing the nonconforming title.

In response to an inquiry and reexamination of the matter, the Office has since determined that the regulation might reasonably have been interpreted to permit group filing where the works had at least one common author. The Office has, therefore, decided that when it becomes aware that it has refused to list titles from Group NIEs because the listed works did not contain total unity of authorship but had one or more common authors, the Copyright Office will amend the original NIE record to reflect the previously omitted titles and publish those titles in theFederal Registeron the next scheduled four-month publication date. If any corrections are received, the next projected publication date is December 1, 2000.

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

On October 18, 1999 (64 FR 56181), and February 4, 2000 (65 FR 5465), EPA proposed to approve the following rules into the California SIP.

We proposed to approve these rules because we determined that they complied with the relevant CAA requirements. Our proposed action contains more information on the rules and our evaluation.

EPA's proposed action provided a 30-day public comment period. During this period, we received no comments.

No comments were submitted that change our assessment that the submitted rules comply with the relevant CAA requirements. Therefore, as authorized in section 110(k)(3) of the Act, EPA is fully approving these rules into the California SIP.

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 rule 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 OMB, 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 13132, 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, because it merely acts on 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 does 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.

The final rules will not have a significant impact on a substantialnumber of small entities because SIP actions 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 action 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.

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 acts on 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.

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.

EPA believes that VCS are inapplicable to today's action because it does not require the public to perform activities conducive to the use of VCS.

The Congressional Review Act, 5 U.S.C. 801et 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 theFederal Register. A major rule cannot take effect until 60 days after it is published in theFederal Register. The rules are not “major� rules 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 October 2, 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 rules or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Federal Acquisition Circular 97-15 included an interim rule addressing contract bundling that overlaps existing coverage at NFS 1819.202-170 on contract consolidations. To conform the NFS to the FAR, NASA is eliminating its separate coverage on consolidations. Instead, NASA is supplementing FAR 7.107,Additional requirements for acquisitions involving bundling of contract requirements, to establish the following internal administrative procedures: (1) the justification and documentation mandated by the FAR for “substantial bundling� must be performed for proposed NASA bundlings of $5 million or more; (2) the measurable benefit analysis, justification, and the bundlingdocumentation for each acquisition of $5 million or more must be sent to NASA Headquarters for review; (3) the analysis, justification, and documentation requirements apply to an order from a Federal Supply Schedule contract, Governmentwide acquisition contract, or other indefinite-delivery contract if the requirements consolidated under the order meet the definition of “bundling� at FAR 2.101; and (4) proposed acquisitions identified via the agency's Master Buy Plan process must indicate if they are a bundled acquisition.

This final rule does not constitute a significant revision within the meaning of FAR 1.501 and Pub. Law 98-577 and publication for comments is not required. However, NASA will consider comments from small entities concerning the affected NFS subparts in accordance with 5 U.S.C. 610.

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

Regulations governing the scup fishery are found at 50 CFR part 648. The regulations require annual specification of a commercial quota that is allocated into three quota periods. The summer commercial quota (May through October) is distributed to the coastal states from Maine through North Carolina on a coastwide basis. The process to set the annual commercial quota and the seasonal allocation is described in § 648.120.

The total commercial quota for scup for the 2000 calendar year was set at 2,534,160 lb (1,149,476 kg)(65 FR 33486; May 24, 2000). The summer period quota was initially set at 987,055 lb (447,721 kg). As specified in § 648.120, landings in excess of the commercial quota in the 1999 summer period were deducted from the summer period allocation this year, resulting in a final summer quota allocation of 685,628 lb (310,996 kg).

Section 648.121 requires the Administrator, Northeast Region, NMFS (Regional Administrator) to monitor the commercial scup quota for each quota period and, based upon dealer reports, state data, and other available information, to determine when the commercial quota for a period has been harvested. NMFS is required to publish notification in theFederal Registeradvising that, effective upon a specific date, the scup commercial quota has been harvested, and notifying vessel and dealer permit holders that no commercial quota is available for landing scup for the remainder of the period. The Regional Administrator has determined, based upon dealer reports and other available information, that the scup commercial quota for the 2000 summer period has been harvested and no further quota is available through October 31, 2000.

The regulations at § 648.4(b) provide that Federal scup moratorium permit holders agree as a condition of the permit not to land scup in any state after NMFS has published a notification in theFederal Registerstating that the commercial quota for the period has been harvested and that no commercial quota for scup is available. Therefore, effective 0001 hours, August 1, 2000, further landings of scup by vessels holding Federal scup moratorium permits are prohibited through October 31, 2000. The Winter II period for commercial scup harvest will open on November 1, 2000. Effective 0001 hours, August 1, 2000, federally-permitted dealers are also advised that they may not purchase scup from federally-permitted vessels that land in coastal states from Maine through North Carolina for the remainder of the summer period (through October 31, 2000).

This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.

Regulations governing the spiny dogfish fishery are found at 50 CFR part 648. The regulations require annualspecification of a commercial quota that is allocated into two quota periods based upon percentages of the annual quota. The period 1 commercial quota (May through October) is distributed to the coastal states from Maine through Florida. The process to set the annual commercial quota is described in § 648.230.

The initial total commercial quota for spiny dogfish for the 2000 calendar year was set equal to 4,000,000 lb (1,814 mt) (65 FR 25887, May 4, 2000). The period 1 quota, which is equal to 57.9 percent of the annual commercial quota, was set at 2,316,000 lb (1,050 mt).

Section 648.231 requires the Regional Administrator Northeast Region, NMFS (Regional Administrator) to monitor the commercial spiny dogfish quota for each quota period and, based upon dealer reports, state data and other available information, to determine when the commercial quota has been harvested. NMFS is required to publish a notice in theFederal Registeradvising and notifying commercial vessels and dealer permit holders that, effective upon a specific date, the spiny dogfish commercial quota has been harvested and no commercial quota is available for landing spiny dogfish for the remainder of period 1. The Regional Administrator has determined, based upon dealer reports and other available information, that the spiny dogfish commercial quota for the 2000 period 1 has been harvested.

The regulations at § 648.4(b) provide that Federal spiny dogfish permit holders agree as a condition of the permit not to land spiny dogfish in any state after NMFS has published a notification in theFederal Registerstating that the commercial quota for the period has been harvested and that no commercial quota for the spiny dogfish fishery is available. The Regional Administrator has determined that period 1 for spiny dogfish no longer has commercial quota available. Therefore, effective 0001 hrs local time, August 1, 2000, further landings of spiny dogfish in coastal states from Maine through Florida by vessels holding commercial Federal fisheries permits are prohibited through October 31, 2000, 2400 hrs local time. The quota for period 2 for commercial spiny dogfish harvest will open on November 1, 2000. Effective August 1, 2000, federally permitted dealers are also advised that they may not purchase spiny dogfish from federally permitted spiny dogfish permit holders that land in coastal states from Maine through Florida for the remainder of period 1 (through October 31, 2000).

This action is required by 50 CFR part 648 and is exempt from review under Executive Order 12866.