Notice and Comment

Section 1601(c) of the 2002 Act provides that the regulations needed to implement Title I of the 2002 Act, including those involved here, may be promulgated without regard to the notice and comment provisions of 5 U.S.C. 553 or the Statement of Policy of the Secretary of Agriculture effective July 24, 1971, (36 FR 13804) relating to notices of proposed rulemaking and public participation in rulemaking. Because the provisions of this rule are not effective until the 2003 crop, and due to the complexity of the issues presented in the rule, it was determined that it was in the public's interest to solicit comments on the proposed rule before it became effective.

This final rule has been determined to be significant under Executive Order 12866 and has been reviewed by the Office of Management and Budget (OMB).

This final rule has a potential impact on all programs listed in the Catalog of Federal Domestic Assistance in the Agency Program Index under the Department of Agriculture, Farm Service Agency and Natural Resources Conservation Service. Other assistance programs are also impacted.

The Regulatory Flexibility Act is not applicable to this rule because the Commodity Credit Corporation (CCC) is not required by 5 U.S.C. 553 or any other law to publish a notice of proposed rulemaking for the subject matter of this rule.

The environmental impacts of this rule have been considered under the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321 et seq., the regulations of the Council on Environmental Quality (40 CFR parts 1500-1508), and regulations of the Farm Service Agency (FSA) of the Department of Agriculture (USDA) for compliance with NEPA, 7 CFR part 799. An Environmental Evaluation was completed and the proposed action has been determined not to have the potential to significantly impact the quality of the human environment and no environmental assessment or environmental impact statement is necessary. A copy of the environmental evaluation is available for inspection and review upon request.

This rule has been reviewed under Executive Order 12778. This rule preempts State laws that are inconsistent with it, however, this rule is not retroactive. Before judicial action may be brought concerning this rule, all administrative remedies must be exhausted.

This program is not subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. See the notice related to 7 CFR part 3015, subpart V, published at 48 FR 29115 (June 24, 1983).

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) does not apply to this rule because CCC was not required by 5 U.S.C. 553 or any other law to publish a notice of proposed rulemaking for the subject matter of this rule. Also, this rule contains no mandates as defined in sections 202 and 205 of UMRA.

Section 1601(c) of the 2002 Act provides that the promulgation of regulations and the administration of Title I of the 2002 Act shall be done without regard to chapter 5 of title 44 of the United States Code (the Paperwork Reduction Act). Accordingly, these regulations and the forms and other information collection activities needed to administer the provisions authorized by these regulations are not subject to review by the Office of Management and Budget under the Paperwork Reduction Act.

FSA is committed to compliance with the Government Paperwork Elimination Act (GPEA) and the Freedom to E-File Act, which require Government agencies in general and FSA in particular to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. The form that applicants will use to certify their income has been developed for on-line use. However, because of the nature of the other paperwork and documentation that may be needed to verify eligibility based on income, the use of electronic means of submission for those information collections is not feasible at this time.

The 2002 Act authorized new programs and benefits, including direct payments and counter-cyclical payments for producers of certain covered commodities and for payments and other benefits under a number of new and revised conservation programs. Section 1604 of that Act amended the 1985 Act by adding a new section, 1001D, to provide that individuals or entities shall not be eligible to receive direct payments, counter-cyclical payments, marketing loan gains or a payment under any of the conservation programs authorized under title XII of the 1985 Act, nor a payment under the conservation programs of title II of the 2002 Act, if the three-year average of the adjusted gross income of the individual, or comparable measure for an entity, exceeds $2.5 million. An exemption, though, is provided where not less than 75 percent of the average adjusted gross income is derived from farming, ranching, or forestry operations. Section 1001D also requires a commensurate reduction in the shares of payments to an entity proportional to the interest held in the entity by parties whose adjusted gross income is more than $2.5 million.

CCC published a proposed rule as to its intentions for implementing income limits on October 28, 2002 at 67 FR 65738. The Agency received 72 timely filed letters containing 129 comments. Respondents included the following: 21 individuals, 15 corporations and similar entities, 8 commodity groups and similar organizations, 7 State and Federal agencies, 4 churches, colleges and universities, 2 Certified Public Accountants, 1 financial institution, 10 farm management companies, and 4 research and environmental organizations. Comments were received from respondents in the following States: California, Colorado, Florida, Georgia, Hawaii, Iowa, Indiana, Kansas, Louisiana, Missouri, Minnesota, Mississippi, North Dakota, Nebraska, New York, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Washington, and the District of Columbia.

Specific comments received, addressed in the same sequence as the final rule, are as follows:

Comments were received from 32 respondents who were concerned about the programs to which the income limits are applied. Some respondents commented that the income limitation will adversely affect participation in conservation and environmental programs. These respondents suggested that conservation and environmental program participants be exempted from income limits. The respondents asserted an exemption was appropriate because the rule may preclude large landowners participation in these programs and thus defeat the purposes of environmental projects and initiatives, both State and Federal. It was also argued that under certain programs, such as the Wetland Reserve Program, easement payments are for reimbursing landowners for rights foregone. As such, in their opinion, these payments should not be classified as benefits and, therefore, not subject to the adjusted gross income limitation. It was also commented that the income limitation would adversely impact compliance with highly erodible land conservation and wetland conservation provisions. Several respondents commented that other programs, not referenced in the proposed rule, which have a gross revenue restriction should use the average adjusted gross income limitation instead. It was also commented that private colleges and educational institutions should be exempt from the rule altogether, as are public institutions, since the missions of the institutions are the same.

The statute provides that the average adjusted gross income limitation applies to any program authorized by title XII of the 1985 Act or titles I or II of the 2002 Act. There are no exceptions for conservation and environmental programs and, in fact, they are specifically included. Section 1604 of the 2002 Act applies to all payments and covered benefits of the programs under the titles specified. Therefore, no exceptions are made in the final rule for payments and benefits authorized by these titles.

As to the comments concerning the application of this rule to other programs not referenced in the 2002 Act, it is true that a gross revenue restriction has been applied as a requirement for eligibility for other programs not included in the proposed rule. Although the gross revenue restriction and the average adjusted gross income limitation share a similar purpose, there are significant differences, different statutory schemes, and this rule is limited to application of the test provided for in the 2002 Act. For example, although the desire for one rule for all programs is understandable, the application of a qualifying gross revenue restriction per “person” to payments under the Noninsured Crop Disaster Assistance Program (NAP) is required by the statute authorizing NAP. However, for flexibility, provision is made to apply this subpart to other programs if so provided by statute or regulation in the future.

As to the program participants to be covered by these income limits, section 1001D(a)(1) of the 2002 Act provides that “* * * the term ‘average adjusted gross income,’ with respect to an individual or entity (for purposes of this section as defined in section 1001(e)(2)(A)(ii)), means the three-year average of the adjusted gross income or comparable measure of the individual or entity over the preceding tax years, as determined by the Secretary.” Section 1001 of the 1985 Act sets forth the statutory payment limitations applicable to certain commodity and conservation program benefits. Generally, these provisions have been the same since the enactment in 1987, and provide that the total amount of specified payments that a “person” may receive is limited to specified amounts per year.

Section 1001(e)(2)(A) defines the term “person” as follows:

In determining who is a “person” for purposes of section 1001D, an “entity” is specifically defined to be the same as an “entity” as provided in section 1001(e)(2)(A)(ii) of the 1985 Act. Notably, section 1001D does not contain such a mandate to use the definitions in sections 1001(e)(2)(A)(i) and (iii). Accordingly, this final rule provides that the definition of an “entity” shall be the same for purposes of sections 1001 and 1001D of the 1985 Act. Further, in order to provide consistency in the application of both sections 1001 and 1001D, the final rule also provides that the definition of an “individual” will be the same for both purposes.

As to the respondents” suggestion that private schools be exempted from income limits, the definition of “entity” in the 1985 Act does not include States, political subdivisions, and agencies thereof (which include a public school or university), but does include charitable organizations and other nonprofit organizations (including churches and private schools). Furthermore, the 2002 Act does not exempt any charitable or nonprofit organization from the average adjusted gross income limitation. Also, this final rule does not extend the average adjusted gross income limitation to States, counties, political subdivisions, agencies thereof, or recognized Indian tribes because Governmental organizations do not have “income” similar to the other listed individuals and entities. Although a private institution may indeed serve some of the same purposes as some public institution, there is no statutory authority to treat them the same within the context of this rule. Accordingly, this comment was not adopted and this provision of the proposed rule is not changed in the final rule. However, the final rule does recognize the special nature of some activities of such charitable organizations as was set out in the proposed rule.

A respondent commented that the disqualification should include all payment methods for certain benefits, including commodity certificates issued under marketing assistance loans. The respondent believed that the use of such certificates undermines the intent of Congress to limit program payments. Under the 2002 Act, the average adjusted gross income limitation applies to loan deficiency payments and marketing loan gains, but does not include certificate transactions or to other forms in which loan benefits might otherwise be obtained (such as loan forfeitures). Accordingly, the provisions of this rule cannot be extended to include such transactions.

Other comments on this section included: the $2.5 million level is too high; the adjusted gross income limitation will force landowners to switch from share leases to cash leases and thus place the operators at substantially greater risk; and the adjusted gross income limitation is not equitable in that a test based on the assets of the potential recipient would be a more equitable test for payment eligibility. The dollar amount of the average adjusted gross income limitation and the disqualifications are provided by statute. There is no discretion to modify the amount or impose an alternative requirement for payment eligibility. Therefore, the final rule makes no changes in this provision.

Comments were received from 14 respondents on this section of the proposed rule. The comments dealt primarily with the manner in which average adjusted gross income is determined, either by tax information or comparable measure, and the definition of income from farming, ranching and forestry operations. It was commented that “comparable measure” needed to be better defined. Other concerns were that compliance with the average adjusted gross income limitation would be adversely affected if income from various sources that the respondents believed were agricultural or farm-related, but do not fit in certain taxing categories for Internal Revenue Service (IRS) purposes, would not be considered income from farming, ranching or forestry operations. One respondent commented that there are occasions when 2 or more corporations are allowed to file a single, consolidated tax return and suggested that a certification indicating the amount each entity would have paid if separate returns had been filed should be allowed to be submitted.

The term “adjusted gross income,” for IRS purposes, applies only to taxpayers who are “individuals.” As previewed in the proposed rule, this final rule provides, for individuals, that adjusted gross income be generally based on the IRS definition of that term and associated filings. Section 1001D(a)(1) of the 2002 Act takes into account the limited IRS use of this term by providing that the Secretary is to fashion a “comparable measure” for other entities. Here also, as indicated in the proposed rule, prior years' tax filings will be the starting point of reference. Due to the severe penalties associated with the filing of a false tax return, such information may be the most credible evidence available to make income determinations.

While this rule defines the adjusted gross income for the different types of program participants, it does not specify the line item on tax returns for participants from which critical information will be gathered since such references may likely change from year-to-year. However, the CCC forms that will be used to make these determinations will specify the specific lines from various IRS forms that will be used to the extent practicable. Also to the extent practicable, for information from the entity that is needed which cannot be ascertained solely from the IRS forms, CCC will specify in its forms what other information is needed.

For individuals, the adjusted gross income would generally be the amount so specified on the individual's final (including amendments) income tax return for the applicable year. Where there is a joint return filed, the adjusted gross income specified on the joint return will be used unless a certified public accountant or attorney provides a certified statement delineating the distribution of income and expenses of the individual seeking payments had such individual filed a separate return. Accordingly, it is possible that one tax return will be used by more than one individual for purpose of this rule.

For corporations, including a “sub-chapter S corporation,” the adjusted gross income will be the final taxable income plus charitable contributions. Charitable contributions are included in order to provide equitable treatment vis-a-vis individuals. For an individual, charitable deductions are deducted from adjusted gross income, along with a variety of other items, to determine the individual's taxable income. Generally, the other items deducted from an individual's adjusted gross income, such as personal exemptions and child care credits, do not have a corresponding relevancy on a corporate return.

No change is made in the final rule to response to the comment about the treatment of corporations filing a single, consolidated tax return. Certifications of average adjusted gross income are required from a payment entity and all individuals and entities with an interest in the payment entity. If one corporation is a subsidiary of another corporation, the average adjusted gross income of the parent corporation would include the average adjusted gross income of the subsidiary corporation. If the consolidated tax returns indicate the average adjusted gross income of the parent company exceeds the limitation, all subsidiaries of the parent company would also be ineligible according to this subpart.

For charitable or nonprofit organizations with income that is not subject to Federal income taxation, the comparable measure of adjusted gross income is defined in this rule to be the “unrelated business taxable income” of the entity as reported to the Internal Revenue Service less any other income CCC determines to be from non-commercial activities. Currently, that amount is specified on line 34 of Internal Revenue Service Form 990-T. Generally, this excludes receipts that are gifts, grants and contributions that are tax deductible by the donor. Effectively, the adjusted gross income for these entities is the net income from only their commercial activities.

For a limited liability company, limited partnership, limited liability partnership or similar organization, the adjusted gross income is the sum of the income from trade or business activities plus the guaranteed payments to the members as reported for the applicable tax year. Charitable contributions will be dealt with in the same manner as with other entities.

For an estate or trust, the adjusted gross income is the sum of the adjusted total income plus the charitable deductions as reported for the applicable tax year.

As indicated, individuals and entities who have average adjusted gross income in excess of $2.5 million may still be eligible for covered benefits where their average adjusted gross income from farming, ranching, and forestry is not less than 75 percent of the total. Generally, the average adjusted gross income (AGI) of the individual or entity derived from farming, ranching or forestry will be, under the rule, determined based on the amounts as reported to IRS. The amount reported on applicable forms, currently IRS form 4835 and Schedule F, represent the net income from the farming operation after deductions for the cost of production. Income derived from forestry operations, to the extent it is not reported on these forms, will be the subject of a separate certification by the individual or entity as will be the case with other special income allowed to be counted toward the 75 percent level by the provisions of this rule.

Several respondents were concerned whether income from certain sources would be considered income from farming, ranching and forestry operations. Of particular concern was the consideration of gains from the sale of assets used in the enterprise; income from the leasing of farmland; income from commercial hunting operations on the farm; proceeds from the sale of water rights; income from contract operations; and, whether income from participation in the Conservation Reserve Program, Wetlands Reserve Program, Environmental Quality Incentives Program and similar programs would be considered farm income.

By denying program benefits to those individuals and entities who have exceeded the $2.5 million threshold, Congress intended that those individuals and entities who are dependent upon farming, ranching and forestry should be accorded deferential treatment. However, taking that into account and in response to the concerns expressed by respondents, the following clarifications and revisions are made:

(1) Income of a landowner generated by selling the landowner's land (including the sale of easements and development rights) used by the landowner or others for farming, ranching, or forestry operations will be considered to be income derived from farming, ranching or forestry operations;

(2) Income generated by selling farm water rights will be considered to be income derived from farming, ranching or forestry operations;

(3) Income from sales by a retail dealership of implements used in farming, ranching or forestry will not be considered to be income derived from farming, ranching or forestry operations, but income derived from the sale of a farm's agricultural equipment otherwise subject to depreciation expense on the IRS Form 4835 or Schedule F will be considered to be such income;

(4) Income from the rental of land used for farming, ranching or forestry operations will be considered to be income derived from farming, ranching or forestry operations, regardless of whether the rental arrangement is on a cash or crop share basis;

(5) Income from agricultural or conservation program payments will be considered to be income from farming, ranching or forestry operations;

(6) Income from commercial hunting operations on farmland will be considered to be income derived from farming, ranching, or forestry operations;

(7) Income from sales at a market will only be considered to be income derived from farming, ranching or forestry operations if the commodity being sold was produced by the individual or entity or a joint operation in which the individual or entity had an interest;

(8) Income from sales as a commission broker, auctioneer or warehouse operator or similar enterprise will not be considered to be income derived from farming, ranching or forestry operations; and

(9) In integrated operations, undifferentiated income (for example, income from a forestry operation that could not be differentiated between income from the production of the tree and from the sale of a finished product) will not be considered to be income derived from farming, ranching or forestry operations.

The proposed rule provided that, for the purpose of applying the average adjusted gross income limitation and calculating the three-year average, the average shall be the adjusted gross income for the three tax years immediately preceding the applicable crop, program, or fiscal year, as determined by CCC, excluding any year in which the individual or entity did not have income or had adjusted gross income considered to be zero. Several respondents suggested the exclusion of any year an individual or entity is not required to file a tax return, rather than excluding any year the individual or entity did not have income or the adjusted gross income was zero. The proposed rule was drafted to provide that a producer would not be allowed to average a loss year with a profitable year. Based on the suggestions, the wording of the final rule has been revised to allow for averaging loss years and no-income years with others, but for ongoing operations only. In some cases, the income of new entities will be averaged with those they replace in order to assure proper application of the average. Relief can be provided from that combination to the extent it would work unfairly in a particular instance.

A total of 18 respondents provided comments on this section of the proposed rule. Some comments suggested that in addition to allowing the certification of compliance by a CPA or an attorney as provided in the proposed rule, certification from other professionals, such as farm management firms, should be allowed. One respondent commented that it would be a burdensome task for an entity with a large number of stockholders to obtain certifications of compliance with the average AGI limitation from stockholders. It was suggested that an exemption be made for corporations with more than 500 stockholders, and that the average AGI limitation be applied to the corporation, but not to the individual stockholders. There were also concerns expressed as to whether the business information provided to the local FSA offices would remain confidential. In other words, there were concerns about what safeguards and confidentiality measures would be implemented to ensure this information would remain private and not made public in some manner.

The statute requires that to comply with the average AGI limitation, an individual or entity shall provide either: (1) A certification from a “* * * certified public accountant or another third party that is acceptable to the Secretary;” or (2) information and documentation regarding the average adjusted gross income of the individual or entity through other procedures established by the Secretary. The proposed rule indicated that, in addition to a certification from a CPA, the only other acceptable certification from a third party would be from an attorney. Although others may have knowledge of the average adjusted gross income of an individual or entity, the Agency believes that limiting third party certifications to a CPA or an attorney is unlikely to create any hardship on participants and will provide a convenient and proper way of guaranteeing some expertise and training in the particular matter at issue. As to the comment about the application of the average AGI limitation to stockholders of a corporation, the statute requires a reduction in payments to an entity, general partnership or joint venture commensurate with the interest held by each individual who has an average adjusted gross income in excess of the limitation. There is no authority provided in the statute for any exemption to the requirement for a commensurate reduction when an individual who holds an interest in an entity has an average adjusted gross income in excess of the limitation. Therefore, the final rule makes no changes regarding the certification of compliance with this subpart.

With respect to confidentiality, the provisions of the final rule avoid conflict with existing regulations and procedures. All information submitted with respect to AGI matters will be treated with regard to confidentiality concerns in accordance with existing rules. Those rules take into account concerns like those expressed in the comments.

Comments were received from 4 respondents on this section of the proposed rule. It was commented that the number of levels should be lessened to 2 or 3 rather than 5 before a commensurate reduction is applied. However, it was also commented that no level of restriction for the commensurate reduction should be established.

Based upon the agency's experience in administering section 1001 relating to the maximum payments a “person” may receive, CCC has determined that business enterprises comprised of layered ownership are often established simply to maximize the receipt of government payments. The rule should allow sufficient layering to accomplish legitimate business need while affording what otherwise would be a dodge of a statutory test or endless tracing of corporate interests back to individuals. Accordingly, no changes were made in the final rule to this section on commensurate reduction.

Miscellaneous comments were received suggesting editorial and grammatical corrections and such. A few editorial changes are made from the text and structure of the proposed rule for clarity and for ease of administration. This rule also includes an addition to the “actively engaged in farming” provisions subpart C of part 1400 to address eligibility issues relating to reservist military personnel called to active duty.

The average adjusted gross income limitation not only applies to payments under the commodity and price support programs, but to all payments and benefits under the conservation and related programs. It includes, but is not limited to, direct and counter-cyclical payments, conservation reserve and environmental quality incentive program payments, loan deficiency payments and marketing loan gains.

For the 2003 through 2007 crop, program or fiscal years, individuals and entities are not eligible for payments or benefits from the above-mentioned programs if their average adjusted gross income exceeds $2.5 million for the three tax years immediately preceding the applicable crop, program or fiscal year. This requirement applies unless 75 percent or more of that average adjusted gross income amount was derived from farming, ranching or forestry operations.

The determinations necessary for compliance with the average adjusted gross income limitation will be generally based on Internal Revenue Service concepts and information included on final tax filings. Comparable measures for adjusted gross income have been developed for entities, partnerships and for organizations that do not have such a line item on tax filings, and that are non-profit, or are not required to file tax information.

By statute, under the average adjusted gross income provisions, there is a required commensurate reduction of program payments in the situations where an owner of an entity applying for benefits fails the test. Accordingly, any program payment or benefit issued to an entity, general partnership, or joint venture shall be reduced by an amount commensurate with the direct or indirect interest held by that individual or entity that is determined to have an average adjusted gross income that exceeds the limitation.

Note that those ineligible for marketing loan gains and loan deficiency payments because of the adjusted gross income restriction may still be eligible to participate to a degree in the marketing assistance loan programs. Loans may be obtained and forfeited when commodity prices decrease. An individual or entity that fails the test will still be able to use commodity certificates to repay those loans at a rate lower than the original loan rate. Benefits they realize from the reduced payment rate, essentially the same as marketing loan gains, are not subject to payment limits or the adjusted gross income restrictions.

The 2002 Act mandates that the adjusted gross income limitation apply to the 2003 through 2007 crop years. In May 2002, the Congressional Budget Office estimated that savings from the average adjusted gross income limitation will total $22 million in fiscal years 2002 through 2006.

The Cost/Benefit Assessment of the adjusted gross income limitation is available from James Baxa, Production, Emergencies, and Compliance Division, United States Department of Agriculture (USDA), 1400 Independence Ave, SW., Washington, DC 20250. Phone: (202) 720-4189. E-mail: James Baxa@wdc.usda.gov.

On July 19, 2002, the SBA published a proposed rule in the Federal Register (67 FR 47480) to establish a $15 million size standard for forest fire suppression and fuels management services under NAICS code 115310, the Support Activities for Forestry industry. The SBA proposed to establish a size standard for these activities after reviewing requests from firms in the forestry industry. These firms believe that this action is warranted in light of the increased emphasis by the Federal Government on removing biomass fuels from the Nation's forest, the dramatic increase in funding for this effort, and the Federal Government's growing reliance upon the private sector to perform fuels management tasks and to suppress forest fires.

Based on these concerns, the SBA conducted a review of this industry's size standard. In addition to reviewing patterns of Federal procurement in this industry, it collected and evaluated data on the industry's structure. This review involved comparisons of average firm size, the size distribution of firms, measures of start-up costs, and the degree of concentration of economic activity among very large firms in the industry. Based on its review of each of these evaluation factors, and the nature and patterns of Federal contracting for forest fire suppression and fuels management services, the SBA concluded that the data supported a size standard for forest fire suppression and fuels management services industry activities of $15 million in average annual receipts. The SBA did not propose a change to the $6 million size standard for all the other remaining forestry activities within the industry. (For more information on the reasons for the proposed establishment of a $15 million size standard, see the July 19, 2002, proposed rule.) After careful consideration of the comments received on the proposed rule, the SBA has decided to adopt its proposed size standard of $15 million.

The SBA received 19 comments on the proposed size standard from eight environmental and economic associations, five firms, three Federal agencies, two individuals, and one trade association. In summary, eight commenters supported the proposed size standard and 11 commenters opposed that change. Below is a summary of the major issues raised by the comments received on the proposed rule and the SBA's response.

One organization supported the proposed increase in the size standard, but claimed that the increase could be greater than $15 million due to the 2002 fire season. This commenter did not provide any supporting statistics or documentation.

The SBA does not adopt this comment. In the proposed rule, the SBA discussed the reasons for proposing the size standard at $15 million. Even though the U.S. Forest Service (USFS) and Bureau of Land Management (BLM) expended record contract dollars for the 2002 fire season, the SBA found that the firms impacted the most were those whose revenues were below $6 million before the 2002 season. Several of these firms now exceed the current size standard. The increased revenues from this past fire season support the SBA's reasons for establishing a size standard above the current $6 million level for forest fire suppression and fuels management services activities. The SBA believes that a $15 million size standard is sufficient to allow these companies to grow to a size to meet the capital requirements of forest fire suppression and fuels management services contracts. The SBA is reluctant to adopt a higher size standard than it proposed without more information on the structure of the industry that demonstrates a stronger basis for a higher size standard.

Three commenters supported the proposed size standard because of the importance it has on firms engaged in forest fire suppression and fuels management services. One commenter pointed out that the firms performing these tasks have been developed primarily for Federal Government work. The commenter contends “it is a logical extension of the effort that Federal agencies have pursued to allow companies that have been developed for Federal work to continue this work * * * The higher standard allows continued growth as well as expansion of the small business pool through subcontracting.” Another commenter added that the Federal Government's reliance on the private sector is expected to significantly increase due to the emphasis on contract use under the National Fire Plan and the effort to outsource commercial work that can be done by private concerns.

One Federal agency expressed concern about the shift in the forestry industries away from logging and into forest fire suppression and fuels management services. The commenter stated that if a firm exceeds the size standard, there is no commercial market for these types of firms, as “The Government is in the only game in town.” These firms make up a significant portion of one of its contracting offices' fire fighting resources. It also pointed out that normally small business set-aside programs are designed to help small businesses graduate and go onto bigger and more lucrative commercial contracts. In this industry, the Federal Government far exceeds the amount of work done by private landowners, or even by the states and counties.

The SBA agrees with these comments. As stated in the preamble to the proposed rule, over the last several years the Federal Government has placed greater reliance upon contractors to perform these services, resulting in a dramatic increase in contract funding for forest fire suppression and fuels management activities. This is especially true in the western part of the country where the Federal Government owns vast amounts of land. This development has significantly changed the size structure of firms engaged in these activities, and supports the need to establish a higher size standard.

Two commenters cited increased contractor costs as a basis for increasing the size standard. One commenter identified the increasing prevailing wages mandated by the U.S. Department of Labor; the increases in fuels costs for mechanical equipment, chain saws, and drip torches for igniting prescribed fires; and the use of specialty personal protective clothing and equipment as factors leading to the increased costs. Another commenter applauded the SBA's acknowledgment of the increased capital costs placed upon companies due to the Federal Government's reliance upon these firms.

The SBA agrees with these comments. As stated in the proposed rule, because of the shift in forest fire fighting and fuels management services policies by the Federal Government, many firms have had to make capital investments in equipment and specialized clothing. In addition, the SBA obtained from the National Interagency Fire Center (NIFC) information on the average fire crew labor costs for fiscal year 2002. This information shows that the Federal Government's labor costs contracted for fire crews range between $23 and $35 per hour, with an average being $30 per hour. The level of labor costs and capital investments supports the SBA's proposal for a higher size standard.

One Federal agency commented that the increase will benefit the Government by increasing the number of viable small businesses eligible for small business set-aside awards for forest fire suppression and fuels management services. This agency noted that it has witnessed a decreasing number of business bidding on fuels reduction road maintenance contracts. Many of the firms no longer qualify under the $6 million size standard. Many of these firms qualify under the higher size standard of their primary industry ( e.g. , Other Waste Collection (which includes brush removal) with a $10.5 million size standard and Site Preparation Contractors with a $12 million size standard). In addition, the agency is aware of one contractor who is already hiring fewer crews and refusing fire assignments in order to stay under the size standard.

The agency also expressed concern that it may receive little or no competition for small business set-aside projects because of the number of firms doing fire suppression work and who have also qualified to do prescribed burns are at or above the current size standard. The commenter pointed out that substantial costs are incurred in the acquisition and maintenance of equipment as well as the training and retention of quality employees. In addition, the agency has several contractors who are now running crews under State contracts, and “with the number of fire emergencies in the 2 years, these firms are near or at the current size standard.”

The agency's comments support the SBA's findings discussed in the proposed rule that due to the increased funding for fuels management services and the severe fire seasons, many firms who perform these services for the Federal Government have had a significant increase in their revenues. Without an increase to the size standard, the Federal Government may help small business to develop their abilities in forest fire suppression and fuels management services only to have them either restrict their growth or force the agency to find and develop a new group of inexperienced firms. This, coupled with the earlier comment that the Federal Government is the primary source of revenues for the industry, strongly supports increasing the current size standard.

Four commenters opposed an increase to the current size standard because they believe that there are ample small businesses to perform fuels management services. One of these commenters provided calendar year 2000 data on the number of employees in the Support Activities for Forestry industry for the State of Oregon from the U.S. Bureau of Census' County Business Patterns statistical database. These data show that firms with 99 or less employees comprise 97% of the firms in Oregon, while 60% of the firms have four employees or less. This commenter also stated that in fiscal year 2001, using the BLM and the USFS databases for contracts awarded to firms in the States of Oregon and Washington, $87 million was expended for forestry services. The average income per contractor was $156,000, with the largest contractor capturing $7.2 million. Only 16 firms captured more than $1 million in work, while 396 captured contracts totaling $100,000.

The SBA does not agree with the comment that a size standard increase is unnecessary. The information presented by one of the commenters does not accurately reflect all firms, nationwide, that are involved in forest fire suppression and fuels management services. When developing size standards, the SBA looks at industry statistics on a national level, as its size standards affect all industry firms and Federal programs. One commenter relied on a Census Bureau report for the State of Oregon that presented information only on the number of employees in the Support Activities for Forestry industry. This report did not give data on industry receipts, which is a more accurate representation of the size distribution of firms in this industry because of its seasonal nature. The SBA's reasons for using receipts instead of employees were discussed in the proposed rule. In addition, the information presented by these commenters was for the entire Support Activities for Forest industry in Oregon, which includes firms that estimate timber, provide forest pest control services, consultant on wood attributes and reforestation, plant trees, and provide land treatment services. As explained in the proposed rule, the SBA could not use the Census Bureau data it usually relies upon to evaluate industry structure. Although that database (a special tabulation of the 1997 Economic Census) provides national industry data on firms by receipts size, it does not provide firm data on specific activities within the industry. Moreover, the significant increase in spending for forest fire suppression and fuels management services occurred after the 1997 Economic Census, and thus, the data do not reflect the impact of this increased spending on the size distribution of firms in the industry.

This commenter also presented Federal contract awards limited to firms in the States of Oregon and Washington for all forestry support services. As stated in the proposed rule, the SBA obtained information from the Federal Data Procurement Center on forest fire suppression and fuels management services contract awards from fiscal years 1998—2000, which showed that the contract awards to firms increased from $29 million in fiscal year 1998 to $173 million in fiscal year 2000. During that period the percentage of Federal contract award dollars to small business for forest fire suppression decreased from 76% to 51%. During the period of 1998 through the first two quarters of fiscal year 2002, the percentage of Federal contract award dollars to small business for fuels management decreased from 100% to 75%. The SBA believes that these trends reflect the changing composition of businesses in forest fire suppression and fuels management services and the need to establish a new size standard.

Two commenters stated that the SBA's approximation for forest fire suppression firm size is unrealistically large. These commenters stated that the SBA's estimate of 20 fire crews (one crew has 20 members) for 90 days is overestimated. They pointed out that the largest firms in the Pacific Northwest have 10 crews, and that 60 days is more of a realistic fire season. One of these commenters also used a labor cost of $20.25 per hour.

The SBA does not agree with this comment. In the proposed rule, the SBA stated that it had received a request from an organization, representing forest fire suppression firms, to increase the size standard for forest fire suppression and fuels management services to 500 employees or $27.5 million. This organization justified its recommendations, in part, by stating that 20 fire crews for 90 days could generate $10.8 million.

The SBA obtained information on fire crew lists and labor and engine rates on the national fire fighting contract from NIFC for the 2002 season. The national average labor rate for fire crews was $30 per hour and the average rate for a fire engine was $1,500 per day. The average number of fire crews was four and the average number of engines was three. In addition, the 2002 fire season was unusually long, starting in April and ending in October, a 150-180 day season. Using this information the SBA calculated the potential revenues of firms engaged in forest fire suppression. With the extended fire season, the SBA recognized that the crews would not work everyday, and used a 120 estimate of days crews worked. The table below estimates the potential revenues by the number of crews.

Using these estimates, the average firm with four crews would have the potential to generate $3.5 million in revenues just from forest fire suppression activities. Add in the cost of three fire engines at $1,500 per engine, $4,500 per day, for the 120 days, $540,000, and the average firm's 2002 revenues for just fire suppression is greater than $4 million. Given that many of the firms that fight forest fires are in other industries, these firms potentially will have revenues in excess of $6 million. The SBA believes that the size standard must be set at a level above $6 million to properly take into account these higher cost activities.

Two commenters stated that increasing the size standard will cause greater market concentration in the fuels management services. Two other commenters stated that an increase would allow for “dominant industries” to out-compete small businesses.

The SBA disagrees with these comments. Federal procurement statistics show that there has been a dramatic drop in the percentage of award dollars going to small business in fuels management services. In 1998, 100% went to small businesses. However, in the first two quarters of fiscal year 2002 small business captured only 75% of the award dollars. The percentage of contract dollars going to small business will continue to decrease because of the dramatic increase in fire suppression dollars in 2002, the growth in Federal monies for fuels reduction, and because many of the fuels management firms also are forest fire suppression contractors. As discussed in the proposed rule, the SBA believes that increasing the size standard will increase competition in the industry, thereby increasing opportunities for small business.

Seven commenters stated that the problem of size growth stems from the way the Federal Government is issuing contracts, i.e. , the size of each requirement, the use of Request for Proposals and Indefinite Delivery Indefinite Quantity (IDIQ) type contracts, and the bundling of requirements. Two of these commenters recommended that Federal land management agencies issue smaller contracts that would be accessible to smaller businesses. Both claimed that the rapid growth of the largest firms in the industry is a result of the Federal Government offering increasing large contracts.

The SBA does not agree with this comment. The SBA reviewed the fiscal year 2003 procurement forecasts for the BLM and USFS and found that these agencies were structuring their requirements for specific areas and not offering large bundled contracts. All but two of the BLM's fiscal year 2003 projected solicitations and three of the USFS fiscal year 2003 projected solicitations have estimated values not to exceed $250,000. Also, this issue is not relevant to adopting or rejecting the proposed size standard. Additionally, issues concerning contract bundling relate to the structuring of individual procurements and therefore are separate from the SBA's determination of the appropriate small business size standard for a particular industry. For more information about the SBA's efforts to address the impact of contract bundling on small businesses, see its recently proposed rule on this issue (68 FR 5134, dated January 31, 2003).

One commenter stated that $15 million was not a small business. In fact, this commenter stated that $1 million is larger than any small business operation existing in her area. The commenter claimed that a $15 million business would not be a local forestry small business.

The SBA does not agree with this recommendation. Firms with revenues below $1 million are not representative of all small businesses that perform forest fire suppression and fuels management contracts. Data the SBA analyzed on firms engaged in forest fire suppression and fuels management services clearly support a size standard above the current $6 million size standard.

The SBA received five comments recommending that forest fire suppression be separated from fuels management services. All five commenters claimed that many of the small firms were well below the current size standard and are capable of doing fuels management services. Three of these commenters acknowledge that the forest fire suppression activity may have higher capital costs, start up costs, and training costs. These firms stated that the capital costs, start up costs, and training needs may be more limited for fuels management services. Two commenters claimed that combining these two activities into one industry activity may inaccurately merge businesses of two different types together. Two different commenters stated that fuels management firms are more like firms in other forestry services than they are like forest fire suppression firms. The equipment and skill levels for mechanical thinning are unrelated to fire suppression equipment.

The SBA acknowledges that some misinterpretation may have been caused by combining forest fire suppression and fuels management services into a single sub-industry description. Both are separate activities under the Support Activities for Forestry industry. Instead of listing one exemption for both forest fire suppression and fuels management services, the SBA will modify its table of small business size standards by listing two separate exceptions under Support Activities for Forestry—one for forest fire suppression and one for fuels management services.

The SBA does not agree with the comments regarding mechanical thinning, capital costs, training, and skill levels. Mechanical thinning is only one aspect of fuels management services. As stated in the definition of fuels management services in the proposed rule, this activity also involves prescribed fire, establishment of fuel breaks, as well as thinning, pruning, and piling. In addition, contracts for these services include the removal and/or disposal of biomass. The use of prescribed fire for these services requires firms experienced in controlling forest fires. Firms who perform this portion of fuels management have expended capital on fire retardant clothing, fire fighting equipment, and training. These firms also pay higher insurance premiums because of the danger in working with controlled fire. These firms, along with their fire engines, are also certified for controlling fires by the USFS. Firms that establish fuel breaks as part of their fuel management services, require capital investment in heavy equipment such as yarders, and earth moving equipment. Many times, these firms are also involved as excavation contractors and heavy equipment contractors (site preparation contractors have a $12 million size standard and heavy equipment contractors have a $28.5 million size standard). In addition, fuels management contracts may include the removal and/or disposal of the biomass (brush removal contractors have a size standard of $10.5 million size standard). Fuels management services is not limited to mechanical thinning, as suggested by some commenters. The costs, training, and equipment for various fuels management contractors may be just as high as for forest fire suppression contractors.

One commenter recommended that the SBA perform periodic reviews on the Forestry industry aside from inflationary adjustments. The SBA agrees with this comment. As stated in the proposed rule, the SBA would continue to monitor this activity in the future to determine if another increase is warranted. If the review shows that another change in the size standard is needed, the SBA will issue a proposed rule, outlining the reasons for the change.

One commenter, a contracting officer, supported the SBA's decision to establish this size standard by receipts instead of number of employees because of the great fluctuation in employment which rises and falls throughout the year due to the fire suppression season. During a severe fire season, like 2002, some firms may operate 25 20-person crews for a period of weeks or a few months. The number of employees then drops to the amount needed to conduct fuels management.

As discussed in the proposed rule, the SBA believes that using a number of employees size standard is not appropriate for forest fire suppression and fuels management services, as most firms performing these activities have fluctuating numbers of employees because of the seasonal nature of forest fire suppression. A receipts-based size standard is a more appropriate measure of a firm's operations in these activities.

Three commenters stated that the SBA's actions would be contrary to the National Fire Plan, which was developed to reduce forest fire hazards and increase preparedness for fire suppression. All three emphasized that Congress' approach was not to create larger businesses but to build new capacity in rural communities near national forests and other public lands, and that they provided authority to direct work to small and micro businesses.

The SBA does not agree with this comment. The SBA believes its actions are aligned with Congress' intent for the National Fire Plan. Because of the devastating fire seasons during the past 5 years, and the establishment of National Fire Plan, funding to firms in forest fire suppression and fuels management services has dramatically increased. With this rule and because of the National Fire Plan, the SBA is recognizing the effect this dramatic increase in funding has had, and will continue to have, on firms in this industry.

One commenter claimed that increasing the size standard would “allow firms to grow beyond the point where contractors can ensure adequate attention to worker health and safety.” This issue does not pertain to factors related to establishing a size standard. Health and safety issues are the function of the administrative contracting officer as they monitor the compliance with the clauses in the contract that regulate these issues.

One commenter stated that the SBA actions would “open the doors to the potentially damaging new industry of removing unsustainable quantities of biomass fuel from the nation's forest.” This comment deals with environmental issues and does not relate to the size of a firm in the forest fire suppression and fuels management services.

The Office of Management and Budget (OMB) has determined that the proposed rule is a significant regulatory action for purposes of Executive Order 12866. Size standards determine which businesses are eligible for Federal small business programs. This is not a major rule under the Congressional Review Act, 5 U.S.C. 800. For purposes of Executive Order 12988, the SBA has determined that this rule is drafted, to the extent practicable, in accordance with the standards set forth in that order. For purposes of Executive Order 13132, the SBA has determined that this rule does not have any federalism implications warranting the preparation of a Federalism Assessment. For the purpose of the Paperwork Reduction Act, 44 U.S.C. Ch. 35, the SBA has determined that this rule would not impose new reporting or record keeping requirements. Below is a regulatory impact analysis of this size standard change.

The SBA is chartered to aid and assist small businesses through a variety of financial, procurement, business development, and advocacy programs. To effectively assist intended beneficiaries of these programs, the SBA must establish distinct definitions of which businesses are deemed small businesses. The Small Business Act (15 U.S.C. 632(a)) delegates to the SBA Administrator the responsibility for establishing small business definitions. It also requires that small business definitions vary to reflect industry differences. The preamble of this rule explains the approach the SBA follows when analyzing a size standard for a particular industry. Based on that analysis, the SBA believes that a size standard for forest fire suppression and fuels management services is needed to better define small businesses engaged in these industry activities.

The most significant benefit to businesses obtaining small business status as a result of this rule is eligibility for Federal small business assistance programs. Under this rule, approximately 50 to 60 additional firms will obtain small business status and become eligible for these programs. These programs include the SBA's financial assistance programs and Federal procurement preference programs for small businesses, 8(a) firms, small disadvantaged businesses (SDB), and small businesses located in Historically Underutilized Business Zones (HUBZone), including the application of a HUBZone or SDB price evaluation preference or adjustment for contracts awarded through full and open competition. Through the assistance of these programs, small businesses may benefit by becoming more knowledgeable, stable, and competitive businesses.

Other Federal agencies also use the SBA size standards for a variety of regulatory and program purposes. In situations where the SBA's size standard is not appropriate for an agency's program, the agency may establish its own size standards with the approval of the SBA Administrator ( see 13 CFR 121.902).

The benefits of a size standard increase to a more appropriate level would accrue to three groups: (1) Businesses that benefit by gaining small business status from the proposed size standards and use small business assistance programs; (2) growing small businesses that may exceed the current size standards in the near future and who will retain small business status from the proposed size standards; and (3) Federal agencies that award contracts under procurement programs that require small business status.

Newly defined small businesses would benefit from the SBA's financial programs, in particular its 7(a) Guaranteed Loan program. Under this program the SBA estimates that $100,000 in new Federal loan guarantees could be made to the newly defined small businesses. Because of the size of the loan guarantees, most loans are made to small businesses well below the size standard. Thus, increasing the size standard to include 50 to 60 additional businesses will likely result in only one or two small business guaranteed loans to businesses in this industry.

The newly defined small businesses would also benefit from the SBA's Economic Injury Disaster Loan (EIDL) program. Since this program is contingent upon the occurrence and severity of a disaster, no meaningful estimate of benefits can be projected. During fiscal years 2001-02, however, no loans were made to firms in the Support Activities for Forestry industry.

Awards to small businesses for forest fire suppression and fuels management services have decreased 27% over the last three fiscal years. Small business award dollars to firms in the forestry services activities, most of which were for forest fire suppression and fuels management services, amounted to $185 million. If this rule becomes final, small business status would be restored to several firms that have lost small business status because of the rapid growth in Federal funding and contracting in this industry. The SBA estimates that firms gaining small business status could potentially obtain Federal contracts worth $50 million per year ($185 million × 27%) under the small business set-aside program, the 8(a) and HUBZone programs, or unrestricted contracts.

Federal agencies may benefit from the higher size standards if the newly defined and expanding small businesses compete for more set-aside procurements. The larger base of small businesses would likely increase competition and lower the prices on set-aside procurements. A large base of small businesses may create an incentive for Federal agencies to set aside more procurements, thus creating greater opportunities for all small businesses. Federal contractors with small business subcontracting goals may also benefit from a larger pool of small businesses by enabling them to better achieve their subcontracting goals at lower prices. No estimate of cost savings from these contracting decisions can be made since data are not available to directly measure price or competitive trends on Federal contracts.

To the extent that approximately 50 to 60 additional firms could become active in Federal Government programs, this may entail some additional administrative costs to the Federal Government associated with additional bidders for Federal small business procurement programs, additional firms seeking the SBA guaranteed lending programs, and additional firms eligible for enrollment in the SBA's PRO-Net database program. Among businesses in this group seeking the SBA assistance, there will be some additional costs associated with compliance and verification of small business status and protests of small business status. These costs are likely to generate minimal incremental costs since mechanisms are currently in place to handle these administrative requirements.

The costs to the Federal Government may be higher on some Federal contracts as a result of this rule. With greater numbers of businesses defined as small, Federal agencies may choose to set aside more contracts for competition among small businesses rather than using full and open competition. The movement from unrestricted to set-aside contracting is likely to result in competition among fewer bidders for a contract. Also, higher costs may result if additional full and open contracts are awarded to HUBZone and SDB businesses as a result of a price evaluation preference. However, the additional costs associated with fewer bidders are likely to be minor since procurements may be set aside for small businesses or under the 8(a), and HUBZone programs only if awards are expected to be made at fair and reasonable prices.

The new size standard may have distributional effects among large and small businesses. Although the actual outcome of the gains and losses among small and large businesses cannot be estimated with certainty, several trends are likely to emerge. First, a transfer of some Federal contracts to small businesses from large businesses. Large businesses may have fewer Federal contract opportunities as Federal agencies decide to set aside more Federal procurements for small businesses. Also, some Federal contracts may be awarded to HUBZone or SDB businesses instead of large businesses since those two categories of small businesses are eligible for price evaluation preferences for contracts competed on a full and open basis. Similarly, currently defined small businesses may obtain fewer Federal contracts due to the increased competition from more businesses defined as small. This transfer may be offset by a greater number of Federal procurements set aside for all small businesses. The potential transfer of contracts away from large and currently defined small businesses would be limited by the newly defined and expanding small businesses that were willing and able to sell to the Federal Government. The potential distributional impacts of these transfers cannot be estimated with any degree of precision since the data on the size of business receiving a Federal contract are limited to identifying small or other-than-small businesses.

The revision to the current size standard for forest fire suppression and fuels management services is consistent with the SBA's statutory mandate to assist small businesses. This regulatory action promotes the Administrator's objectives. One of the SBA's goals in support of the Administrator's objectives is to help individual small businesses succeed through fair and equitable access to capital and credit, Federal Government contracts, and management and technical assistance. Reviewing and modifying size standards when appropriate ensures that intended beneficiaries have access to small business programs designed to assist them. Size standards do not interfere with State, local, and tribal governments in the exercise of their government functions. In a few cases, State and local governments have voluntarily adopted the SBA's size standards for their programs to eliminate the need to establish an administrative mechanism for developing their own size standards.

Under the Regulatory Flexibility Act (RFA), this rule may have a significant impact on a substantial number of small entities. The SBA estimates that an additional 50 to 60 businesses may obtain small business status as a result of this rule. Also, small businesses may obtain an additional $50 million in Federal contracts.

The size standard may also affect small businesses participating in programs of other agencies that use the SBA size standards. As a practical matter, however, the SBA cannot estimate the impact of a size standard change on each and every Federal program that uses its size standards. In cases where an SBA size standard is not appropriate, the Small Business Act and the SBA's regulations allow Federal agencies to develop different size standards with the approval of the SBA Administrator (13 CFR 121.902). For purposes of a regulatory flexibility analysis, agencies must consult with the SBA's Office of Advocacy when developing different size standards for their programs (13 CFR 121.902(b)(4)).

Immediately below, the SBA sets forth a final regulatory flexibility analysis (FRFA) of this rule addressing the need for and objective of the rule; a description and estimate of small entities to which the rule will apply; the projected reporting, record keeping, and other compliance requirements of the rule; the relevant Federal rules which may duplicate, overlap or conflict with the rule; and alternatives to the final rule considered by the SBA that minimize the impact on small businesses.

The SBA's objective of this rule is to establish an appropriate small business definition of businesses engaged in forest fire suppression and fuels management services, and therefore, eligible for Federal small business assistance programs. The significant increase in Federal funding and the Federal Government's increased use of contractors to perform these services has altered the structure of the industry and support the need for a new size standard for these activities.

The SBA received no comments in response to the IRFA of the proposed rule.

The SBA estimates that 200 to 300 businesses are engaged in forest fire suppression and fuels management services. These businesses come from industries in the Forestry and Logging Subsector (NAICS codes 113110, 113210, 113310, and 115310). As this is an emerging industry, the SBA developed its estimate from discussions with, and information provided by the USFS, the BLM, and industry groups. From these discussions, the SBA estimates that approximately 50% of these firms are small businesses, many of which may be currently at or just below the $6 million threshold. With the adoption of this rule, 50 to 60 additional businesses will gain small business status. Although this may not represent a substantial number of small businesses, the SBA is preparing an FRFA to ensure that the impact on small businesses of higher size standards are known and have been considered. These businesses would be eligible to seek available SBA assistance provided that they meet other program requirements.

Based on the relative size of these firms and the SBA's knowledge of contracting in these areas, the SBA estimates that small business coverage will increase by 12% of total revenues in this activity. These revenue estimates were calculated from the size distributions of the parent industries in which forest fire suppression and fuels management service firms are presently classified.

A new size standard does not impose any additional reporting, record keeping or other compliance requirements on small entities for the SBA programs. A change in a size standard would not create additional costs on a business to determine whether or not it qualifies as a small business. A business needs to only examine existing information to determine its size, such as Federal tax returns, payroll records, and accounting records. Size standards determines “voluntary” access to the SBA and other Federal programs that assist small businesses, but does not impose a regulatory burden as they neither regulate nor control business behavior. In addition, this rule does not impose any new information collecting requirements from the SBA which requires approval by OMB under the Paperwork Reduction Act of 1980, 44 U.S.C. 3501-3520.

Most of the economic impact on small businesses will be positive. The most significant benefits to businesses that will obtain small business status as a result of this final rule are (1) eligibility for the Federal Government's procurement preference programs for small businesses, 8(a) firms, small disadvantaged businesses, and businesses located in Historically Underutilized Business Zones (HUBZone); and (2) eligibility for the SBA's financial assistance programs such as 7(a) business loans, 504 business loans, and EIDL assistance. The SBA estimates that firms gaining small business status could potentially obtain Federal contracts worth $50 million per year under the small business set-aside program, the 8(a) program, the HUBZone program, or unrestricted contracts. This represents approximately 27% of the $185 million in total Federal expenditures for forest fire suppression and fuels management.

As stated in the Small Business Act, 15 U.S.C. 632, and 13 CFR part 121, the SBA establishes size standards based on industry characteristics and for non-manufacturing concerns on the basis of gross receipts of a business concern over a period of 3 years. The increased emphasis by the Federal Government on removing biomass fuels from the Nation's forests, the dramatic increase in funding for this effort, and the Government's growing reliance upon the private sector to perform fuels management tasks and to suppress forest fires supports establishing a separate size standard of $15 million.

One commenter recommended a $1 million size standard, stating that $15 million was not a small business. In fact, this commenter stated that $1 million is larger than any small business operation existing in the commenter's area and that a $15 million business would not be a local forestry small business.

The SBA does not consider this alternative realistic. Firms with revenues below $1 million are not representative of all small businesses that perform forest fire suppression and fuels management services. A $1 million size standard is well below the $6 million size standard for all forestry industries, including Support Activities for Forestry. In addition, a $1 million size standard is below the base size standard for non-manufacturing industries.

By adopting the size standard at $15 million, the SBA will minimize the impact on the small businesses in these emerging activities. Increased Federal funding and requirements, the Federal Government's growing reliance on the private sector for these services, and the severe fire seasons over the last several years have caused many firms to outgrow the $6 million size standard, thus reducing small business competition for these services. The $15 million size standard will allow firms in these activities to grow to an appropriate level without losing their small business status, but not to a level where a few firms would be able to control a significant portion of Federal contracts at the expense of other small businesses.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to all McDonnell Douglas Model MD-90-30 airplanes was published in the Federal Register on February 27, 2003 (68 FR 9034). That action proposed to require replacing the lanyards on the pressure relief door for the thrust reverser with new, improved lanyards, and doing associated modifications.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's airworthiness directives system. The regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. However, for clarity and consistency in this final rule, we have retained the language of the NPRM regarding that material.

There are approximately 110 airplanes of the affected design in the worldwide fleet. The FAA estimates that 21 airplanes of U.S. registry will be affected by this AD, that it will take approximately 8 work hours per airplane to accomplish the required actions, and that the average labor rate is $60 per work hour. Required parts will be provided at no cost to the operator. Based on these figures, the cost impact of this AD on U.S. operators is estimated to be $10,080, or $480 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

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.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

The FAA has received several reports of fuel leakage from the combustion heater fuel pumps installed on Piper Models PA-34-200T, PA-34-220T, PA-44-180, and PA-44-180T airplanes.

Improper torque was applied to the mounting screws of the fuel pump filter cover. This condition was found during a quality control inspection.

Improper torquing of the mounting screws may result in sealing surface abnormalities such as nicks, gouges, or warping.

This condition, if not corrected, could result in failure of the combustion heater fuel pump and lead to fire or explosion in the cockpit.

Piper has issued Service Bulletin No. 1127, dated February 26, 2003. This Piper service bulletin includes Kelly Aerospace Service Information Letter Bulletin No. A-110A, dated March 6, 2003.

These service bulletins include procedures for:

The FAA has reviewed all available information, including the service information referenced above; and determined that:

This AD requires you to incorporate the actions in the previously-referenced service bulletin.

In preparation of this rule, we contacted type clubs and aircraft operators to obtain technical information and information on operational and economic impacts. We have included, in the rulemaking docket, a discussion of information that may have influenced this action.

On July 10, 2002, FAA published a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs FAA's AD system. This regulation now includes material that relates to special flight permits, alternative methods of compliance, and altered products. This material previously was included in each individual AD. Since this material is included in 14 CFR part 39, we will not include it in future AD actions.

Because the unsafe condition described in this document could result in fire or explosion in the cockpit, we find that notice and opportunity for public prior comment are impracticable. Therefore, good cause exists for making this amendment effective in less than 30 days.

Although this action is in the form of a final rule and was not preceded by notice and opportunity for public comment, FAA invites your comments on the rule. You may submit whatever written data, views, or arguments you choose. You need to include the rule's docket number and submit your comments to the address specified under the caption ADDRESSES. We will consider all comments received on or before the closing date specified above. We may amend this rule in light of comments received. Factual information that supports your ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether we need to take additional rulemaking action.

We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. You may view all comments we receive before and after the closing date of the rule in the Rules Docket. We will file a report in the Rules Docket that summarizes each FAA contact with the public that concerns the substantive parts of this AD.

If you want us to acknowledge the receipt of your comments, you must include a self-addressed, stamped postcard. On the postcard, write “Comments to Docket No. 2003-CE-23-AD.” We will date stamp and mail the postcard back to you.

These regulations 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, FAA has determined that this final rule does not have federalism implications under Executive Order 13132.

We have determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and 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 (otherwise, an evaluation is not required). A copy of it, if filed, may be obtained from the Rules Docket.

On May 9, 2003, the FAA issued AD 2003-10-03, Amendment 39-13148 (68 FR 26481, May 16, 2003), to require removal from service of certain HP turbine discs in RR model RB211-535E4-37, RB211-535E4-B-37, and RB211-535E4-B-75 turbofan engines, before the discs reach newly established life limits. That action was prompted by the manufacturer's inspections and analysis of HP turbine discs that have accumulated high cycles. That AD will become effective on June 20, 2003.

The FAA is revising this amendment to remove the model RB211-535E4-37 turbofan engine from the applicability. The FAA has received additional details of the engineering analysis based on field inspection data from the Civil Aviation Authority (CAA), which is the aviation authority for the U.K., and has determined that the model RB211-535E4-37 turbofan engine is not affected by machining-induced cracking within the currently published life of the HP turbine disc. This revised AD will be effective on June 20, 2003, in order to reduce the burden on operators.

This engine model is manufactured in the U.K. and is 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. Pursuant to this bilateral airworthiness agreement, the CAA has kept the FAA informed of the situation described above. The FAA has examined the findings of the CAA, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Since an unsafe condition has been identified that is likely to exist or develop on other RR model RB211-535E4-B-37 and RB211-535E4-B-75 turbofan engines of the same type design, this AD is being issued to prevent machining-induced cracking of the HP turbine disc which could cause an uncontained HP turbine disc failure and damage to the airplane. This AD requires removal from service of certain HP turbine discs before they reach newly established life limits.

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 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 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 should 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.

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 action must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2002-NE-12-AD.” The postcard will be date stamped and returned to the commenter.

This final rule does not have federalism implications, as defined in Executive Order 13132, because it would 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. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and 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.

The FAA published this direct final rule with a request for comments in the Federal Register on April 17, 2003 (68 FR 18857) [FR Doc. 03-9508]. The FAA uses the direct final rulemaking procedure for a non-controversial rule where the FAA believes that there will be no adverse public comment. This direct final rule advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on July 10, 2003. No adverse comments were received, and thus this notice confirms that this direct final rule will become effective on that date.

On April 15, 2003, the FAA proposed to amend part 71 of the Federal Aviation Regulations (14 CFR part 71) by establishing Class E2 airspace and amending Class E5 airspace at Waycross, GA, (68 FR 18173). This action provides adequate Class E2 and Class E5 airspace for IFR operations at Waycross-Ware County Airport. Designations for Class E are published in FAA Order 7400.9K, dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR part 71.1. The Class E designations listed in this document will be published subsequently in the Order.

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments objecting to the proposal were received.

This amendment to part 71 of the Federal Aviation Regulations (14 CFR part 71) establishes Class E2 airspace and amends Class E5 airspace at Waycross, GA.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Federal Register Document 03-12816, Docket No. FAA-2003-14673; Airspace Docket 03-ASO-2, published on May 23, 2003, (68 FR 28128), establishes Class E2 airspace at Elizabeth City CGAS/Regional Airport, NC. An error was discovered in the legal description, describing the Class E2 airspace area. The name of the airport should be changed from Elizabeth City CGAS/Municipal Airport to Elizabeth City CGAS/Regional Airport. This action corrects the error.

Designations for Class E airspace areas designated as surface areas are published in Paragraph 6002 of FAA Order 7400.9k, dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

As published, the final rule contains an error which incorrectly identifies the name of the airport. Accordingly, pursuant to the authority delegated to me, the legal description for the Class E2 airspace area at Elizabeth City, NC, incorporated by reference at § 71.1, 14 CFR 71.1, and published in the Federal Register on May 23, 2003, (68 FR 28128), is corrected by making the following correcting amendment.

In the Federal Register of August 4, 1978 (43 FR 34628), FDA published an advance notice of proposed rulemaking to establish a monograph for OTC skin protectant drug products, together with the recommendations of the Advisory Review Panel on OTC Topical Analgesic, Antirheumatic, Otic, Burn, and Sunburn Prevention and Treatment Drug Products (the Panel), which was the advisory review panel responsible for evaluating data on the active ingredients in this drug class (§ 330.10(a)(6) (21 CFR 330.10(a)(6))).

In the Federal Register of February 15, 1983 (48 FR 6820), FDA published the proposed regulation for OTC skin protectant drug products in the form of a tentative final monograph (TFM). In the Federal Register of October 3, 1989 (54 FR 40808), the agency published a document to amend the TFM to include OTC drug products for poison ivy, oak, and sumac and for the treatment and/or neutralization of insect bites. This final rule completes the TFMs published on February 15, 1983, and October 3, 1989, amends the final monograph for OTC skin protectant drug products used as astringents in part 347 published on October 21, 1993 (58 FR 54458), and incorporates the name change (“witch hazel”) published in the Federal Register of June 3, 1994 (59 FR 28767).

In the Federal Register of May 10, 1993 (58 FR 27636), the agency issued a final rule establishing that certain active ingredients, including some skin protectant active ingredients, in OTC drug products are not generally recognized as safe and effective or are misbranded. These skin protectant ingredients are listed in § 310.545(a)(18). This final rule adds several ingredients to that section.

On or after 12 months after date of publication in the Federal Register , and 24 months after date of publication in the Federal Register , for products with annual sales less than $25,000, except combination products containing skin protectant and sunscreen active ingredients, and for combination products containing skin protectant and sunscreen active ingredients, no OTC drug product that is subject to this final rule and that contains a nonmonograph condition may be initially introduced or initially delivered for introduction into interstate commerce unless it is the subject of an approved new drug application or abbreviated new drug application. Further, any OTC drug product subject to this final rule that is repackaged or relabeled after the effective dates of the final rule must be in compliance with the monographs regardless of the date the product was initially introduced or initially delivered for introduction into interstate commerce. Manufacturers are encouraged to comply voluntarily as soon as possible.

All “OTC Volumes” cited throughout this document refer to information on public display in the Dockets Management Branch ( see ADDRESSES ).

(Comment 1) One comment stated its continuing position that OTC drug monographs are interpretive, as opposed to substantive, regulations.

The agency addressed this issue and reaffirms its conclusions stated in paragraphs 85 through 91 of the preamble to the procedures for classification of OTC drug products (37 FR 9464 at 9471 to 9472, May 11, 1972); in paragraph 3 of the preamble to the TFM for OTC antacid drug products (38 FR 31260, November 12, 1973); and in paragraph 1 of section I of the preamble to the TFM in the present proceeding (48 FR 6820 at 6821).

(Comment 2) One comment requested that the definition of “skin protectant” be reworded to add a primary effect of skin protectants, i.e., temporary relief of the effects of harmful or annoying stimuli and to include the word “product”. The agency agrees and is revising the definition of “skin protectant” in § 347.3(d).

(Comment 3) Four comments opposed the agency's “exclusivity policy,” which limits the indications used in OTC drug product labeling to the “specific words and phrases” approved by FDA in a final OTC drug monograph.

After these comments were submitted, the agency published a final rule in the Federal Register of May 1, 1986 (51 FR 16258) changing its labeling policy (§ 330.1(c)(2) (21 CFR 330.1(c)(2))) for stating the indications for use of OTC drug products. That policy was revised and discussed in the Federal Register of March 17, 1999 (64 FR 13254 at 13270 to 13271, and 13294). The final rule in this document is subject to that new labeling policy.

(Comment 4) Three comments disagreed with the agency's position of prohibiting cosmetic claims from appearing in any portion of the labeling that is required by an OTC drug monograph and the agency's view that this type of labeling could be misleading ( see 48 FR 6820 at 6823). One comment noted its support for the distinction made by the agency between “drug” and “cosmetic” claims for the same ingredient. Two comments cited current agency regulations in § 701.3(d) (21 CFR 701.3(d)) regarding the combined label declarations of active drug ingredients and cosmetic ingredients and requested that cosmetic indications be allowed to be stated in a manner that is not false or misleading, without regard to their position on the label.

The agency has revised its labeling requirements for OTC drug products by adding § 201.66 (21 CFR 201.66) and amending § 701.3(d) since stating its position on drug-cosmetic labeling in the TFM. Section 701.3(d) now requires separate listing of the active drug ingredients and the cosmetic ingredients where a cosmetic product is also an OTC drug product. FDA does not review and approve cosmetic terminology in OTC drug monographs. Under the new OTC drug product labeling format in § 201.66, the “Drug Facts” area of a product's labeling only contains the indication(s) for the drug part of the product. Thus, manufacturers are not allowed to commingle drug and cosmetic claims within this specific area of the labeling. However, there are no specific restrictions on commingled information outside of the “Drug Facts” area of a product's labeling. The agency's position is that if commingled drug and cosmetic labeling information is confusing or misleading, the product's labeling may be misleading within the meaning of the Federal Food, Drug, and Cosmetic Act (the act) and the product misbranded under sections 502(a) or 602(a) of the act (21 U.S.C. 352(a) or 362(a)). The agency will review the labeling of affected products on a case-by-case basis.

(Comment 5) Several comments suggested that limiting the statement of identity to one term (“skin protectant”) is too restrictive, requested other equally descriptive appropriate terms, and asked for distinct statements of identity for each indication proposed in the monograph, e.g., “minor cut protectant.”

The agency does not find it necessary to have distinct statements of identity for each use of a skin protectant drug product. The statement of identity is intended to provide information on the “general pharmacological category(ies) of the drug or the principal intended action(s) of the drug” ( see § 201.61(b) (21 CFR 201.61(b))). This position is consistent with the statement of identity proposed by the agency as “external analgesic” for all drug products that provide relief of pain and itching caused by a number of conditions (48 FR 5852 at 5868, February 8, 1983) and as “analgesic (pain reliever)” for all drug products that relieve pain due to various conditions (53 FR 46204 at 46211, November 16, 1988).

The agency concurs with one comment's suggestion of adding the dosage form to the statement of identity, i.e., “skin protectant (dosage form).” The United States Pharmacopeia ( USP ) lists a number of dosage forms that might be used for OTC topical drug products (Ref. 1). From a marketplace survey (Refs. 2, 3, and 4), the agency finds that the most widely used dosage forms for OTC skin protectant drug products are lotions, creams, ointments, and gels. The examples of dosage forms listed in the statement of identity in § 347.50(a) of this final monograph are not all inclusive and depend on products' historical marketing as skin protectants.

(Comment 6) One comment questioned the agency's statement that the term “soothes” is a cosmetic claim in the context of skin protectant products (48 FR 6820 at 6828).

The agency considers claims such as “temporarily protects” and “helps relieve” to be more informative than “soothes” in conveying to consumers that a drug product provides therapeutic action. The term “soothes” may appear elsewhere in the product's labeling.

(Comment 7) Several comments contended that the indications proposed were too restrictive and omitted indications recommended by the Panel. The comments suggested additional labeling claims.

The agency agrees with some of the comments' suggestions for the indications in § 347.50(b)(2). While the agency wishes to emphasize the “protectant” function of these ingredients, they may also help provide some relief for chapped or cracked skin and lips. Therefore, the agency is allowing manufacturers to add, at their option, the words “and helps relieve” after the word “protects” in the indications in § 347.50(b)(2). The agency also agrees that the words “cold” and “wind” are informative to consumers, and possibly easier to understand than the word “windburned.” Accordingly, the agency has made this revision in an optional labeling statement.

The agency considers other suggested claims to be better represented in the agency's proposed indications.

The agency is deleting “sunburn” from the indication proposed in § 347.50(b)(1) because the agency has reexamined the data and determined that they do not support a “protection of sunburn” claim for these ingredients. The “sunburn” claim proposed in the TFM originated from the Panel when it recommended the use of “skin protectant active ingredients for symptoms of dryness: ‘For symptoms of chapping, peeling or scaling’ (optional, any or all of the following) ‘due to minor burns, sunburn, windburn, scrapes, abrasions, or cracked lips’” ( see 43 FR 34628 at 34648). The Panel also recommended that the ingredients allantoin, cocoa butter, dimethicone, glycerin, petrolatum, and shark liver oil be included in the monograph as active ingredients for symptoms of dryness. Of these ingredients, petrolatum was the only one that the Panel discussed effectiveness for sunburn (43 FR 34628 at 34639). The Panel stated that “the use of petrolatum as an emollient has been well accepted for dry skin conditions, especially with flaking skin such as sunburn, and chapping” (43 FR 34628 at 34639).

The Panel's claim was revised in the TFM to a shortened “drug” claim that stated: “For the temporary protection of minor cuts, scrapes, burns, and sunburn” ( see 48 FR 6820 at 6832). The agency did not include peeling or scaling claims in the TFM (48 FR 6820 at 6828). The Panel's reference to symptoms of dryness was not included in the TFM because the agency considers the use of skin protectants for dryness to be a cosmetic claim. The agency has now determined that it should not have included the “sunburn” claim in the TFM because the only context in which the Panel discussed it was cosmetic in nature.

The agency is also concerned that skin protectants may inappropriately be used for “sunburn” because the data indicate that it is not desirable to apply a skin protectant to sunburn that has just occurred. As the Panel noted, when petrolatum is applied to sunburn, evaporation is curtailed (43 FR 34628 at 34639). The agency is concerned that application of skin protectants, such as petrolatum and the other igredients for which the Panel recommended a dryness claim for sunburn, to sunburn that has just occurred would occlude the area and prevent evaporation from occurring or significantly reduce evaporation. Thus, there are no data in the administrative record for this rulemaking to support a “protection of sunburn” claim for these ingredients. The agency would consider including such a claim for these ingredients, however, if adequate supporting data are provided.

The agency has determined that insufficient data were submitted to include the words “to allow healing to begin” and to include uses for heat rash, burning feet, and foot discomfort in § 347.50(b)(3). The agency concludes that the expanded “uses” section in this final monograph provides manufacturers an adequate number of options for labeling OTC skin protectant drug products.

(Comment 8) One comment mentioned that no wound healing claim or Category I labeling was provided for three skin protectant ingredients: Allantoin, live yeast cell derivative (LYCD), and zinc acetate.

The Panel classified these ingredients as Category III skin protectants for wound-healing based on the lack of effectiveness data (43 FR 34628 at 34644 through 34647). Insufficient data were submitted for LYCD ( see section II. comment 25 of this document) and no additional data were submitted for allantoin or zinc acetate to support a “wound healing” use.

(Comment 9) One comment requested that compound benzoin tincture be included as a Category I topical skin protectant. The comment mentioned the conclusion of the Advisory Review Panel on OTC Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products (Cough-Cold Panel) that compound benzoin tincture was safe for use in boiling water as a steam inhalant for expectorant purposes (41 FR 38312 at 38360, September 9, 1976). The comment also cited the recommendation of the Advisory Review Panel on OTC Dentifrice and Dental Care Drug Products (Dental Panel) that compound benzoin tincture was safe and effective for use as an oral mucosal protectant (47 FR 22712 at 22746 and 22747, May 25, 1982). The comment cited acceptance of compound benzoin tincture in several pharmacopeias, experience over decades of use, and the low incidence of adverse reactions or significant side effects in the published literature. The comment cited several skin protectant uses from well-established references or current product labeling: “* * * to small cuts and to intact skin under occlusive plasters and bandages” (Ref. 5), “* * * ulcers, bedsores, cracked nipples, and fissures of the lips and anus” (Ref. 6), and “apply to the skin under adhesive dressings, to treat skin fissures and bedsores, to reduce skin sensitivity to adhesive plasters, and to prevent skin irritation in ischemic areas” (Ref. 7).

Compound benzoin tincture is included in the USP as a fixed formulation containing 10 percent benzoin, 2 percent aloe, 8 percent storax, 4 percent tolu balsam, and 74 to 80 percent ethanol (Ref. 8). The agency finds that use as a steam inhalant for expectorant purposes evaluated by the Cough-Cold Panel (41 FR 38312 at 38360) has little relevance to use as a skin protectant. Although the agency acknowledges that standard references (Refs. 5 and 6) and literature articles describe numerous uses for compound benzoin tincture, no data from controlled clinical studies were provided.

Gosselin et al. (Ref. 9) indicated that the alcohol in benzoin tincture would be responsible for major toxic effects if ingested. The Dental Panel discussed literature reports of three cases of irritation and hypersensitivity resulting from topical use of benzoin tincture (47 FR 22712 at 22746 and 22747). In addition, the published literature contains numerous other reports of allergic contact dermatitis and sensitivity attributed to compound benzoin tincture and benzoin tincture. Cullen, Tonkin, and May (Ref. 10) stated that the literature was replete with reports of cutaneous sensitivity to compound benzoin tincture and its components, citing reports following local application. Rademaker and Kirby (Ref. 11) reported two cases of bullous contact dermatitis to a skin adhesive spray and mentioned that Fisher (Ref. 12) recommends that benzoin no longer be used as a skin adhesive. Marks and Rainey (Ref. 13) and James, White, and Yanklowitz (Ref. 14) reported other cases of allergic contact dermatitis. Sixteen cases resulted when benzoin was applied to prevent friction blisters. Other authors report contact dermatitis from benzoin used as an ingredient in greasepaint makeup (Ref. 15) and as an antioxidant in food additives (Ref. 16). In addition, benzoin provokes pemphigus erythematosus (Ref. 17), complicates management of venous leg ulcers (Ref. 18), and adversely affects wound healing after circumcision in children (Ref. 19).

Based on these reports of adverse events and the availability of other monograph skin protectant ingredients, the agency concludes that compound benzoin tincture is not safe for use as a general OTC skin protectant ingredient and would be inappropriate for many of the uses included in this final monograph.

(Comment 10) One comment requested that camphorated metacresol be included as an active ingredient in the final monograph for OTC skin protectant drug products, as long as the amount of metacresol did not exceed 1.5 percent (by weight) and the amount of camphor did not exceed 3 percent. Noting that phenol (0.5 to 1.5 percent) and camphor (0.1 to 3 percent) were proposed Category I ingredients in the TFM for OTC external analgesic drug products (48 FR 5852 at 5867, February 8, 1983) and citing an agency letter (Ref. 20) agreeing that metacresol was less toxic than phenol, the comment contended that there should be no safety concern about products containing camphor and metacresol in these concentrations.

Because information has not been provided to demonstrate a skin protectant effect, camphorated metacresol is not included in this final monograph.

(Comment 11) One manufacturer submitted data and information (Refs. 21 and 22) to FDA's Miscellaneous External Panel in response to the call-for-data notice published in the Federal Register of November 16, 1973 (38 FR 31697). The data were for a drug product containing water-soluble chlorophyllins in an ointment and a solution dosage form with a label indication “to promote healing and to relieve itching and discomfort of minor wounds, burns, surface ulcers, cuts, abrasions and skin irritations.”

The Miscellaneous External Panel was disbanded before reviewing these submissions. Subsequently, because the product label contained a claim for wound healing and products with this claim had previously been included in the skin protectant rulemaking, the agency placed the submissions in the skin protectant rulemaking as a comment to the February 15, 1983, TFM, and the manufacturer submitted a more recent study on effectiveness for wound healing (Ref. 23).

The Dental Panel evaluated water-soluble chlorophyllins as oral wound healing agents in its report on OTC oral mucosal injury drug products (44 FR 63270, November 2, 1979) and concluded that water-soluble chlorophyllins were safe but that there were insufficient data available to permit final classification of effectiveness for OTC use as an oral wound healing agent (44 FR 63270 at 63286). The agency accepted the Dental Panel's classification in the TFM for OTC oral mucosal injury drug products (48 FR 33984 at 33991, July 26, 1983). No additional data were submitted and, in the final rule (51 FR 26112, July 18, 1986), the agency included water soluble chlorophyllins in the list of nonmonograph ingredients in 21 CFR 310.534.

The agency has reviewed the manufacturer's submissions (Refs. 21, 22, and 23). One submission (Ref. 21) contained information on various kinds of wounds that were treated with water-soluble chlorophyllins by health-care professionals. None were self-treatment conditions. Another (Ref. 22) contained translations of three foreign articles reporting laboratory and animal studies on water-soluble chlorophyllins that contain background information but do not support general recognition of safety and effectiveness in humans. A research report (Ref. 23) did not assess OTC uses, lacked subject and placebo controls, and questioned whether the observed effects were due to the products or the manner of caring for the wounds.

The agency concludes that the data submitted do not support effectiveness of water-soluble chlorophyllins for promoting wound healing for conditions treated with OTC skin protectant drug products.

(Comment 12) Cod liver oil was not categorized by the Panel for use as an OTC skin protectant because it was not included among the labeled ingredients in marketed products submitted to the Panel for review. In evaluating cod liver oil for use in diaper rash drug products, the agency considered the long history of clinical use as a skin protectant ingredient (55 FR 25204 at 25213, June 20, 1990).

In the rulemaking for OTC anorectal drug products, the Advisory Review Panel on OTC Hemorrhoidal Drug Products (Hemorrhoidal Panel) classified cod liver oil as Category I for use as an anorectal protectant and recommended a maximum daily dose of 10,000 I.U. (International Units equivalent to USP Units) for vitamin A and 400 I.U. for vitamin D (cholecalciferol) per 24 hours (45 FR 35576 at 35630, May 27, 1980). The Hemorrhoidal Panel stated that an extensive review of the literature on cod liver oil revealed no adverse effects when applied topically as a protectant and concluded that the effectiveness of cod liver oil, as a protectant, is due to its bland and soothing effect associated with its oily nature. In the TFM (53 FR 30756 at 30767, August 15, 1988) and final monograph (55 FR 31776 at 31780, August 3, 1990) for OTC anorectal drug products, the agency affirmed the Hemorrhoidal Panel's Category I classification and specified that cod liver oil may be used only in combination with one to three other protectant active ingredients.

The agency has surveyed the marketplace and determined that cod liver oil is marketed only in combination with other ingredients in several products with skin protectant claims (Refs. 3 and 24). One product contains 12.5 percent (Ref. 24), but in most cases the cod liver oil concentration is not provided.

Therefore, the agency is including cod liver oil as an active ingredient in skin protectant drug products in accord with § 347.20(a)(1) and (a)(2), only in combination with certain other skin protectant active ingredients, within the concentrations (5 to 13.56 percent) specified in § 347.10(e), provided that the product is labeled so that the amount of the product that is used in a 24-hour period represents a quantity that does not exceed 400 USP Units of vitamin D and 10,000 USP Units of vitamin A.

(Comment 13) In the notice of proposed rulemaking (54 FR 40808 at 40810), the agency stated that it was necessary to have publicly available chemical information for colloidal oatmeal. One manufacturer submitted a proposed standard for colloidal oatmeal, which it stated was patterned after standards for starch and psyllium (Ref. 25). The agency sent this information to the U.S. Pharmacopeial Convention (USPC) (Ref. 26). Compendial standards were proposed in the Pharmacopeial Forum of January and February 1992 (Ref. 27) and a final USP monograph became effective on November 15, 1992 (Ref. 28).

(Comment 14) One comment requested that colloidal oatmeal be included in the skin protectant monograph as a safe and effective ingredient for the claim: “For prompt temporary relief of itchy, sore, sensitive skin due to rashes, eczema/psoriasis, hemorrhoidal and genital irritations, diaper rash, chicken pox, prickly heat, hives, poison ivy/oak, and sunburn.” The comment cited references (Refs. 29 through 33) to support this claim.

The agency previously discussed poison ivy/oak claims in comment 1 of the skin protectant poison ivy, oak, and sumac notice of proposed rulemaking (54 FR 40808 at 40809 to 40811). The agency has determined the additional references cited by the comment show that colloidal oatmeal can provide temporary skin protection and relieve minor irritation and itching due to a number of conditions. Further, the agency has no adverse reaction reports on file for colloidal oatmeal. Thus, the agency is expanding the indications for colloidal oatmeal in § 347.50(b)(4) in this final monograph. In addition, manufacturers can opt to select one or more of the “due to” conditions to list in the product's labeling. However, since no data were submitted using colloidal oatmeal for chicken pox, sunburn, or hives, these indications are nonmonograph. The agency will discuss a “prickly heat” claim in the skin protectant diaper rash drug products final rule.

(Comment 15) Two comments noted that the agency's proposed directions in § 347.50 (54 FR 40808 at 40818) for the use of colloidal oatmeal as a soak in a tub do not allow for the range of use concentrations or dosage forms that have been reported in the clinical literature and requested that FDA specify a use concentration range. The comment stated that colloidal oatmeal is unusual in comparison to other barrier skin protectants because it is often intended for dispersion in water and is formulated in a variety of other dosage forms.

One comment summarized and calculated the colloidal oatmeal concentrations used in baths (Refs. 32 and 34 through 41). The comment noted that the most common concentration ranges of colloidal oatmeal are from 0.007 to 10 percent in use but added that colloidal oatmeal is present in commercial products from 1 to 100 percent. Another comment recommended changing the proposed directions in § 347.50(d)(2) from one “cupful” to “up to a cupful.”

The agency has reviewed the recommended concentrations of colloidal oatmeal reported in the literature and reference texts (Refs. 4, 29 through 32, 34 through 45, 47, 48, and 49) and has considered the range of concentrations for colloidal oatmeal used in bath additive products and in other dosage forms. Products containing colloidal oatmeal have been formulated in the following dosage forms: Lotion (1 and 10 percent colloidal oatmeal), cleansing cream (8 percent colloidal oatmeal), shampoo (5 percent colloidal oatmeal), and cleansing bars (30, 50, and 51 percent colloidal oatmeal) (Refs. 4, 46, and 47). The agency has calculated the approximate minimum and maximum concentrations of colloidal oatmeal that have been used as follows: For regular colloidal oatmeal, a range of 0.023 to 0.625 percent when used as a tub bath soak (Refs. 29, 34 through 38, and 44), a range of 0.24 to 1.2 percent when used as a foot bath soak (Refs. 30, 31, and 34), a range of 0.24 to 15 percent in aqueous solution when used in a wet pack (Refs. 30, 31, 32, 34, and 45), and a range of 3.75 to 15 percent in aqueous solution when used as a topical lotion (Refs. 30, 32, and 34); for oilated colloidal oatmeal, a range of 0.003 to 0.03 percent when used as a tub bath soak (Refs. 35 and 39 through 43).

With regard to dosage forms, the agency agrees with the comment that colloidal oatmeal as a skin protectant does not need to be dosage-form specific and can be used in a variety of “barrier type” topical dosage forms, except for “cleanser type” topical dosage forms, for which the agency has no data to support use as a skin protectant. Therefore, based on the additional information that has been submitted, the agency is revising the directions for use in § 347.50(d)(2) in this final monograph.

(Comment 16) One comment requested that colloidal oatmeal be included in the skin protectant monograph for the claim: “For prompt temporary relief of itchy, sore, sensitive skin due to * * * hemorrhoidal and genital irritations * * *.” The comment provided reports recommending use of colloidal oatmeal baths and creams for rectal itching and other conditions in the genital area (Refs. 50 through 54).

Claims for itching in the genital area (e.g., pruritus vulvae) are included in the rulemaking for OTC external analgesic drug products. A comment to that rulemaking (Ref. 55) specifically requested a claim for colloidal oatmeal for “prompt temporary relief of itchy, sore, sensitive skin due to rashes, eczema/psoriasis, hemorrhoidal and genital irritations, diaper rash, chicken pox, prickly heat, hives, poison ivy/oak, and sunburn.” Therefore, the agency will address this comment in the final rule for OTC external analgesic drug products.

The agency concludes that the comment's requested claims for relief of rectal itching and hemorrhoids are similar to the indication (21 CFR 346.50(b)(1)) for OTC anorectal drug products that include protectant active ingredients under 21 CFR 346.14, and to the definition of a protectant drug under 21 CFR 346.3(i) as a drug that provides a physical barrier, forming a protective coating over skin or mucous membranes. Since colloidal oatmeal was not reviewed during any stage of the rulemaking for OTC anorectal drug products, interested parties should provide necessary information to demonstrate that colloidal oatmeal meets the standards of an OTC anorectal protectant active ingredient and petition the agency to include colloidal oatmeal in the final monograph for OTC anorectal drug products (Ref. 56).

(Comment 17) One comment requested that colloidal oatmeal be allowed to be combined with other Category I skin protectants for the treatment of minor irritation and itching caused by insect bites and poisonous plants. The comment cited reports using an oilated colloidal oatmeal bath additive to help treat various dermatoses.

The agency has reviewed the cited studies (Refs. 34, 43, 57, 58, and 59), and finds that these reports support the combination of colloidal oatmeal with mineral oil to treat the irritation, itching, and dryness of various dry skin dermatoses. The agency is including the combination of colloidal oatmeal and mineral oil in new § 347.20(a)(4) for the uses included in new § 347.50(b)(7) of this final monograph. Nevertheless, poison ivy, oak, and sumac are not exclusively dry skin dermatoses; they are characterized by a phase of weeping, oozing exudation. The studies cited by the comment fail to demonstrate the value of adding an additional skin protectant (an oilating component) for the treatment of these conditions in the exudative phase, and also fail to specify how many of the cases of contact dermatitis were due to poisonous plants. In addition, only one case of insect bite was identified in the studies. The agency concludes that the data are insufficient to support the combination of colloidal oatmeal with other skin protectants to treat insect bites and poison ivy, oak, and sumac.

(Comment 18) One comment responded to the agency's request in the skin protectant poison ivy, oak, and sumac notice of proposed rulemaking (54 FR 40808 at 40810) to provide information and directions to support the use of colloidal oatmeal on children under 2 years of age. The comment stated that most barrier type skin protectant active ingredients have not been restricted to any age group and submitted reports of use of colloidal oatmeal in infants (Refs. 34, 45, 50, 51, and 57). The comment added that the Miscellaneous External Panel had evaluated colloidal oatmeal and placed it in Category I for relief of itching claims with no age restrictions (Ref. 61).

The agency has reviewed the reports submitted by the comment, which described the effective use of colloidal oatmeal on infants and children from 2 months to 18 years of age for various dermatoses associated with dry skin. No adverse effects were reported. The Miscellaneous External Panel (Ref. 61) at its twenty-third meeting concluded that colloidal oatmeal, at all concentrations, is safe and effective for “the symptomatic relief and treatment of itching.” Based on the Miscellaneous External Panel's evaluation and the references provided by the comment, the agency is including colloidal oatmeal in the final monograph for use on infants and children under 2 years of age in the same concentrations, dosage forms, and directions for use for adults.

(Comment 19) One comment noted that in the skin protectant poison ivy, oak, and sumac notice of proposed rulemaking the agency proposed (in § 347.50(c)(9)) a specific warning for colloidal oatmeal: “Take special care to avoid slipping when getting into and out of the tub” (54 FR 40808 at 40818). The comment agreed that a warning against slipping is proper and appropriate, but contended that the agency's warning is unnecessarily longer than the warning on its labels, “Take special care to avoid slipping.” Furthermore, the comment contended, the reference to entering and leaving the tub may lessen the consumer's perception of need for care during bathing or when bathing a child.

The agency notes that a number of authors have expressed concerns about slipping in the bath tub with oil baths in general, and with colloidal oatmeal baths in particular (Refs. 29, 40, 44, 48, 54, and 62). Two authors (Refs. 29 and 48) recommended use of a mat to reduce the possibility of slipping. Accordingly, the agency has revised the warning, which appears in § 347.50(c)(5) of the final monograph, to read: “When using this product [bullet] to avoid slipping, use mat in tub or shower.”

(Comment 20) One comment objected to the highly specific directions for colloidal oatmeal the agency proposed in § 347.50(d)(2) of the skin protectant poison ivy, oak, and sumac notice of proposed rulemaking (54 FR 40808 at 40818). The comment requested that FDA modify the directions for use to allow for other concentrations and to address the use of other dosage forms, such as ointments, lotions, and cleansing bars. The comment objected to a specified frequency of use (“once or twice daily”) because absorption of active agent seems unlikely to occur.

The agency has reviewed the literature and agrees with the comment that other directions may also provide safe and effective use concentrations. Since a bathtub, foot bath, sitz bath, or infant bath can be used to soak and a compress or wet dressing can be applied as a soak, the agency is including all of these forms of a “soak” in the final monograph. Colloidal oatmeal can also be formulated in other topical products intended for direct application (e.g., ointment, lotion), and the monograph provides directions for these products.

Frequent and prolonged exposure to water may have a drying effect. Authors have different views on recommended frequency and duration of bathing (Refs. 37, 48, and 63 through 67) depending on the condition. The Miscellaneous External Panel noted that bathing can dry the skin out and exacerbate some conditions (Ref. 68). Given the variety of conditions for which colloidal oatmeal preparations may be used, the agency agrees with the comment and is not specifying a frequency of use in the directions but is providing for a warning statement in § 347.50(c)(7) to fully inform consumers.

(Comment 21) One comment inquired whether two high-molecular weight dimethylpolysiloxanes, designated as SF96-350 and SF96-1000, were acceptable active ingredients for skin protectant use. The comment included general safety and toxicity information on silicone products, and stated that dimethicone, a proposed Category I skin protectant ingredient, belongs to the same chemical family as the dimethylpolysiloxanes.

In the notice of proposed rulemaking for OTC skin protectant diaper rash drug products, the agency stated that silicone is a general term, but it is often used to describe dimethicone (55 FR 25204 at 25218). The agency did not classify silicone per se because there are various silicone compounds and because the agency considered dimethicone, the only silicone ingredient for which data were submitted.

The agency notes that the information provided by the comment summarizes the results of chronic and acute toxicity studies and irritation studies for specific classes of silicones. However, no specific information was provided for the individual dimethylpolysiloxanes SF96-350 and SF96-1000. In addition, no information was provided to describe the chemical structure of these dimethylpolysiloxanes. The agency concludes that the data provided are inadequate to support general recognition of the safety and effectiveness of these ingredients for OTC skin protectant use in this final monograph.

(Comment 22) In the TFM for OTC skin protectant drug products, the agency discussed a submission on 2 percent glycerin and stated that the skin protectant final monograph would not be issued until these data were reviewed by the agency and interested persons provided an opportunity to comment on an agency proposal (48 FR 6820 at 6823). The submission (Ref. 69) contained data on the use of glycerin for the indications of dry skin, minor skin irritation, skin protectant, and chapping and included a double-blind study.

The agency has reviewed the data and determined that the study was inadequately controlled and failed to demonstrate that 2, 10, or 18 percent glycerin is effective for the indication “helps prevent and temporarily protects chafed, chapped, cracked, or windburned skin and lips,” as proposed by the agency for 20 to 45 percent glycerin in the TFM for OTC skin protectant drug products (48 FR 6820 at 6832). The agency's detailed comments and evaluation of the data are on file in the Dockets Management Branch (Ref. 70). The agency concludes that glycerin at concentrations other than 20 to 45 percent is nonmonograph for use in OTC skin protectant drug products.

(Comment 23) One comment requested the agency to reopen the administrative record to include the ingredient “hard fat,” as described in the “National Formulary” (NF) (Ref. 71), as a Category I skin protectant.

In the Federal Register of December 19, 1991 (56 FR 65873), the agency agreed with the petition that it would be appropriate to reopen the administrative record and include data and information on “hard fat” in the rulemaking for OTC skin protectant drug products. The agency stated that, based on its action in the rulemaking for OTC anorectal drug products (55 FR 31776), hard fat would be classified as a monograph ingredient in the final skin protectant monograph. Since no adverse comments on hard fat were received in response to this reopening of the administrative record, the agency is including hard fat in § 347.10 at concentrations of 50 to 100 percent as a single active ingredient. Hard fat is also allowed in permitted combinations in § 347.20(a)(1), (a)(2), (b), (c), and (d) of this final monograph. Products containing hard fat may be labeled for the indications in § 347.50(b)(1), (b)(2)(i), and (b)(2)(ii) and should bear the warnings in § 347.50(c)(1) through (c)(4) and the directions in § 347.50(d)(1). In a future issue of the Federal Register , the agency will address claims for hard fat in OTC skin protectant cold sore/fever blister drug products ( see proposed § 347.50(b)(2)(ii), 55 FR 3362 at 3370).

(Comment 24) One comment requested that lanolin be categorized as an active ingredient in the skin protectant monograph for use as a single ingredient or in combination, as permitted by the monograph. In support of lanolin's safety and effectiveness as a skin emollient, the comment cited animal and human test data submitted to the Miscellaneous External Panel (Ref. 72), Kligman, Grove, and Studemayer (Ref. 73), and the Advisory Review Panel on OTC Ophthalmic Drug Products' (Ophthalmic Panel) Category I classification of lanolin as an ocular emollient for the treatment of conditions involving ocular membranes (43 FR 30002 at 30044 and 30045, May 6, 1980).

The agency has considered lanolin as a protectant or emollient active ingredient in several OTC drug rulemakings. In the TFM for OTC skin protectant diaper rash drug products (55 FR 25204 at 25218 to 25219), the agency determined that the data submitted supported the use of 15.5 percent lanolin as a skin protectant active ingredient only in combination with other skin protectant active ingredients for the treatment and prevention of diaper rash.

In the final rule for OTC ophthalmic drug products (53 FR 7076 at 7090, March 4, 1988), lanolin and anhydrous lanolin were included as monograph conditions at a 1 to 10 percent concentration in combination with one or more oleaginous emollients included in the monograph. In the final rule for OTC anorectal drug products (55 FR 31776 at 31780), lanolin was included as a monograph protectant active ingredient at concentrations of 50 percent and above as a single ingredient or between 12.5 and 50 percent in combinations.

The agency has surveyed the marketplace (Refs. 3, 74, 75, and 76), and found that lanolin is being marketed as a skin protectant both as a single ingredient and in combination with other ingredients. The concentration in two single ingredient products is 37 and 50 percent. In almost all cases, the concentration of the lanolin in the combination products is not provided. Based on the agency's market survey and its previous actions in the rulemakings for OTC diaper rash, anorectal, and ophthalmic drug products, the agency is including lanolin in the final skin protectant drug products monograph as a single ingredient and in combination with certain other skin protectant active ingredients, depending on the labeled use of the product. The use concentration included in the final monograph is 12.5 to 50 percent in accord with the concentration of marketed single ingredient skin protectant drug products and the concentration used in anorectal protectant combination drug products. The use concentration of 15.5 percent proposed in § 347.10(o) for OTC diaper rash skin protectant drug products (55 FR 25204 at 25232) will be addressed in the final rule for those drug products.

(Comment 25) One comment submitted data (Refs. 77 through 89), including two clinical studies by Kaplan (Refs. 77, 78, 80, 81, and 84), in support of reclassifying LYCD from Category III to Category I as a wound healing aid. The first Kaplan study (Ref. 77) has been published (Ref. 90). The comment also submitted data included earlier in the rulemaking for OTC anorectal drug products and transcripts of meetings of the Hemorrhoidal Panel (Ref. 87).

The ingredient LYCD was reviewed by both the Hemorrhoidal Panel and the Topical Analgesic Panel. Neither panel found LYCD to be effective. The agency determined that the data were inadequate to support the use of LYCD in the final rule for OTC anorectal drug products (58 FR 46746, September 2, 1993).

The agency has reviewed the wound healing studies (Refs. 77, 78, 80, 81, and 84) submitted to this rulemaking for OTC skin protectant drug products and determined that the studies are inadequate to include LYCD as a wound healing aid in this final monograph. The agency's detailed comments and evaluations of the nonconfidential data are on file in the Dockets Management Branch (Refs. 91 and 92).

The agency also informed the company that additional information is needed on the chemical and physical characterization of LYCD before a final classification can be made and suggested the company provide information to establish a compendial monograph for the ingredient (Ref. 93). The company submitted information, both nonconfidential (Refs. 88 and 89) and confidential, but it also was not adequate. The agency's detailed comments on the information are on file in the Dockets Management Branch (Refs. 94 and 95).

(Comment 26) The agency has included in the rulemaking for OTC skin protectant drug products several submissions (Refs. 96, 97, and 98) for drug products containing mineral oil that were originally submitted to the Miscellaneous External Panel for review. One submission (Ref. 96) did not contain any data on mineral oil as an individual ingredient and the other submissions (Refs. 97 and 98) were discussed in the TFM for OTC skin protectant diaper rash drug products (55 FR 25204 at 25220 to 25221). The agency concluded that the ingredient's physical properties were sufficient, along with the Category I findings of two other panels (Hemorrhoidal and Ophthalmic Panels), to support the effectiveness of mineral oil in § 347.10(p) of the skin protectant diaper rash TFM (55 FR 25204 at 25232) for diaper rash claims proposed in § 347.50(b)(5). In this final monograph for OTC skin protectant drug products, mineral oil in the first concentration listed in § 347.10(l) (50 to 100 percent) may be labeled for the claims listed in § 347.50(b)(1) and (b)(2). In addition, mineral oil in the second concentration listed in § 347.10(1) (30 to 35 percent) when combined with colloidal oatmeal may be labeled for the claims listed in § 347.50(b)(7).

(Comment 27) One comment urged FDA to consider a single statement of identity for the ingredient petrolatum because of its multi-purpose uses in OTC drug products. The comment suggested the term “protectant.”

Petrolatum is generally recognized as safe and effective in two other OTC drug final monographs: Ophthalmic (part 349 (21 CFR part 349)) and anorectal (21 CFR part 346). The statement of identity for ophthalmic use is “lubricant” or “emollient (lubricant) eye ointment” ( see § 349.65(a)).

The agency previously considered a related issue in the proposed rulemaking for OTC anorectal drug products ( see comment 39, 53 FR 30756 at 30771) and determined that a comment's suggested statement of identity (topical protectant and lubricant) did not make it clear that such a product could be used anorectally and thus did not fully satisfy the requirements of § 201.61(b). The agency believes that the same is true of the currently suggested statement of identity “protectant.” Thus, the agency is not adopting a single statement of identity for the ingredient petrolatum and is using “skin protectant” as the statement of identity for drug products containing petrolatum included in this final monograph (part 347).

(Comment 28) One comment argued that petrolatum should be exempt from the “directions for use” proposed in § 347.50(d), citing petrolatum's long history of consumer use, efficacy, and safety and contending that petrolatum meets the requirements for such exemption under § 201.116 (21 CFR 201.116).

The agency disagrees. Section 201.116 allows for exemption from section 502(f)(1) of the act which requires adequate directions for use, if adequate directions for common uses are known to the ordinary individual. While some individuals may know that petrolatum may be applied as needed, the agency believes that not all people who use this drug would know that it can be applied on an as needed basis. Therefore, the agency is requiring the standard direction in § 347.50(d)(1) for products that contain petrolatum.

(Comment 29) One comment contended that petrolatum should be exempt from the warnings proposed in the TFM (48 FR 6820 at 6832 to 6833). The comment argued that sufficient evidence to exempt these warnings is provided by the universal use of petrolatum over many decades for a wide variety of topical indications, the clinical and marketing experience over this long period of extensive and universal use, the Panel conclusion that “large amounts of petrolatum are essentially nontoxic when ingested * * *” (43 FR 34628 at 34639), the results of a long-term chronic feeding study by Oser et al. (Ref. 99) as demonstrating safety on ingestion, and the fact that petrolatum is regulated as an approved direct food additive (under § 172.880 (21 CFR 172.880)) and is listed in the Food Chemicals Codex (Ref. 100).

Although the comment suggested a revision, it agreed in principle with the warning “Not to be applied over deep or puncture wounds, infections, or lacerations. Consult a doctor.” A second comment requested, in the interest of brevity, clarity, and conservation of scarce label space, that the warning be shortened to read: “Do not apply over deep or puncture wounds or infections.”

The agency discussed the importance of each of the proposed warnings in comments 25 through 31 of the TFM (48 FR 6820 at 6828 to 6830) and stated that these warnings are necessary for petrolatum used as a skin protectant. In comment 31 of the TFM, however, the agency proposed not to require the “For external use only warning” for all products (including those containing petrolatum) formulated as lip balms. The agency is finalizing that proposal in this document.

Combe, Inc., 1101 Westchester Ave., White Plains, NY 10604, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 5-236 for SULFODENE Medication for Dogs to Farnam Companies, Inc., 301 West Osborn, Phoenix, AZ 85013-3928. Accordingly, the agency is amending the regulations in 21 CFR 524.1376 to reflect the transfer of ownership.

Following this change of sponsorship, Combe, Inc., is no longer the sponsor of any approved application. Accordingly, § 510.600(c) is being amended to remove the entries for Combe, Inc.

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.

The temporary regulations that are the subject of this correction are under section 1502 of the Internal Revenue Code.

As published, TD 9048 contains an error which may prove to be misleading and is in need of clarification.

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. This action was taken at the request of the United States Army and is a joint military operation with the U.S. Army, U.S. Navy and U.S. Coast Guard. This temporary security zone is necessary to safeguard the MOTCO terminal and the surrounding property from sabotage or other subversive acts, accidents, criminal actions, or other causes of similar nature. This zone is also necessary to protect military operations from compromise and interference. Additionally, the threat of maritime attacks is real as evidenced by the October 2002 attack of a tank vessel off the coast of Yemen and the continuing threat to U.S. assets as described in the President's finding in Executive Order 13273 of August 21, 2002 (67 FR 56215, September 3, 2002) that the security of the U.S. is endangered by the September 11, 2001 attacks and that such disturbances continue to endanger the international relations of the United States. See also Continuation of the National Emergency with Respect to Certain Terrorist Attacks (67 FR 58317, September 13, 2002); Continuation of the National Emergency With Respect To Persons Who Commit, Threaten To Commit, Or Support Terrorism (67 FR 59447, September 20, 2002). Additionally, a Maritime Advisory was issued to: Operators of U.S. Flag and Effective U.S. controlled Vessels and other Maritime Interests, detailing the current threat of attack, MARAD 02-07 (October 10, 2002). As a result, this security zone is needed for national security reasons to protect the United States and more specifically the people, ports, waterways, and properties of the Port Chicago and Suisun Bay areas. Any delay in implementing this rule would be contrary to the public interest since immediate action is necessary to ensure the protection of all cargo vessels, their crews, the public and national security.

Furthermore, in order to protect the interests of national security, the Coast Guard is promulgating this temporary regulation to provide for the safety and security of operations in the navigable waters of the United States. As a result, the establishment and enforcement of this security zone is a function directly involved in, and necessary to military operations. Also, 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 for the same reasons outlined above.

Since the September 11, 2001 terrorist attacks on the World Trade Center in New York, the Pentagon in Arlington, Virginia and Flight 93, the Federal Bureau of Investigation (FBI) has issued several warnings concerning the potential for additional terrorist attacks within the United States. In addition, the ongoing hostilities in Afghanistan and the conflict in Iraq have made it prudent for U.S. ports to be on a higher state of alert because Al-Qaeda and other organizations have declared an ongoing intention to conduct armed attacks on U.S. interests worldwide.

In its effort to thwart terrorist activity, the Coast Guard has increased safety and security measures on U.S. ports and waterways. As part of the Diplomatic Security and Antiterrorism Act of 1986 (Pub. L. 99-399), Congress amended section 7 of the Ports and Waterways Safety Act (PWSA), 33 U.S.C. 1226, to allow the Coast Guard to take actions, including the establishment of security and safety zones, to prevent or respond to acts of terrorism against individuals, vessels, or public or commercial structures. The Coast Guard also has authority to establish security zones pursuant to the Act of June 15, 1917, as amended by the Magnuson Act of August 9, 1950 (50 U.S.C. 191 et seq. ) and implementing regulations promulgated by the President in subparts 6.01 and 6.04 of part 6 of title 33 of the Code of Federal Regulations.

In this particular rulemaking, to address the aforementioned security concerns, United States Army officials have requested that the Captain of the Port, San Francisco Bay, California establish a temporary security zone in the navigable waters of the United States surrounding the Military Ocean Terminal Concord (MOTCO), California, to safeguard vessels, cargo and crew engaged in military operations.

In this temporary rule, the Coast Guard is establishing a fixed security zone around Military Ocean Terminal Concord (MOTCO), California, encompassing the navigable waters, extending from the surface to the sea floor, bounded by the following coordinates: latitude 38°03′07″N and longitude 122°03′00″W; thence to latitude 38°03′15″N and longitude 122°03′04″W; thence to latitude 38°03′30″N and longitude 122°02′35″W; thence to latitude 38°03′50″N and longitude 122°01′15″W; thence to latitude 38°03′43″N and longitude 122°00′28″W; thence to latitude 38°03′41″N and longitude 122°00′03″W; thence to latitude 38°03′18″N and longitude 121°59′31″W, and along the shoreline back to the beginning point.

Vessels or persons violating this section will be subject to the penalties set forth in 33 U.S.C. 1232 and 50 U.S.C. 192. Pursuant to 33 U.S.C. 1232, any violation of the security zone described herein is punishable by civil penalties (not to exceed $27,500 per violation, where each day of a continuing violation is a separate violation), criminal penalties (imprisonment up to 6 years and a maximum fine of $250,000), and in rem liability against the offending vessel. Any person who violates this section, using a dangerous weapon, or who engages in conduct that causes bodily injury or fear of imminent bodily injury to any officer authorized to enforce this regulation, also faces imprisonment up to 12 years. Vessels or persons violating this section are also subject to the penalties set forth in 50 U.S.C. 192: seizure and forfeiture of the vessel to the United States, a maximum criminal fine of $10,000, and imprisonment up to 10 years, and a civil penalty of not more than $25,000 for each day of a continuing violation.

The Captain of the Port will enforce this zone and may enlist the aid and cooperation of any Federal, State, county, municipal, and private agency to assist in the enforcement of the regulation. This regulation is proposed under the authority of 33 U.S.C. 1226 in addition to the authority contained in 50 U.S.C. 191 and 33 U.S.C. 1231.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 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 Homeland Security (DHS).

Although this regulation restricts access to the zone, the effect of this regulation will not be significant because the zone will encompass only a small portion of the waterway for a short duration. Vessels and persons may be allowed to enter these zones on a case-by-case basis with permission of the Captain of the Port, or his designated representative.

The size of the zone is the minimum necessary to provide adequate protection for MOTCO, vessels engaged in operations at MOTCO, their crews, other vessels operating in the vicinity, their crews and passengers, adjoining areas, and the public. The entities most likely to be affected are commercial vessels transiting to or from Suisun Bay via the Port Chicago Reach section of the channel.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have 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 because, although the security zone will occupy a section of the navigable channel (Port Chicago Reach) adjacent to the Marine Ocean Terminal Concord (MOTCO), vessels will receive authorization to transit through the zone by the Captain of the Port or his designated representative on a case-by-case basis. Additionally, vessels engaged in recreational activities, sightseeing and commercial fishing have ample space outside of the security zone to engage in these activities. Small entities and the maritime public will be advised of this security zone via public notice to mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offer to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If the rule will 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 this rule.

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).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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 create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation because we are establishing a security zone.

A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” are available in the docket where located 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. A Final Rule, which established safety zones around fireworks displays for the Captain of the Port Portland area of responsibility, was recently published in the Federal Register (CGD13-03-008, 33 CFR 165.1315, 68 FR 13487, May 30, 2003). An amendment cannot successfully be made to 33 CFR § 165.1315 in time to ensure the safety of vessels and spectators gathering in the vicinity of this fireworks display. The Coast Guard intends to amend 33 CFR § 165.1315 using normal rule-making procedures in the near future by adding this safety zone to that regulation.

The Coast Guard is establishing a temporary safety zone regulation to allow for a safe fireworks display. It is scheduled to start on July 26, 2003 at 9:30 p.m. (PDT) and last until 10:30 p.m. (PDT). This event will result in a large number of vessels congregating near the fireworks launching area. This safety zone is needed to provide for the safety of spectators and their watercraft from the inherent safety hazards associated with fireworks displays. Without providing an adequate safety zone, the public could be exposed to falling burning debris and would likely be within the blast range should a catastrophic accident occur on the launching barge. This safety zone will be enforced by representatives of the Captain of the Port, Portland, Oregon. The Captain of the Port may be assisted by other federal and local agencies.

This rule, for safety concerns, will control vessel movements in a regulated area surrounding a fireworks launching barge. Entry into this zone would be prohibited unless authorized by the Captain of the Port, Portland or his designated representative. Coast Guard personnel would enforce this safety zone. The Captain of the Port may be assisted by other federal and local agencies.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 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 Homeland Security (DHS). We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. This expectation is based on the fact that the regulated area established by the proposed regulation will encompass less than one-half of a mile of the Willamette River for one hour in the late evening when vessel traffic is low.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have 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 a portion of the Willamette River between 9:30 p.m. (PDT) and 10:30 p.m. (PDT) on July 4, 2003. This safety zone will not have significant economic impact on a substantial number of small entities for the following reasons. This rule will be in effect for one hour at night when vessel traffic is low. Traffic will be allowed to pass through the zone with the permission of the Captain of the Port or his designated representatives on scene, if it is deemed safe to do so. Because the impacts of this rule are expected to be so minimal, the Coast Guard certifies under 5 U.S.C. 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601-612) that this 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 the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

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).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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 create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that Order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g) of the Instruction, from further environmental documentation.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B)and (d)(3), the Coast Guard finds that good cause exists for not publishing a NPRM and for making this regulation effective less than 30 days after publication in the Federal Register . Based upon the warnings from national security and intelligence personnel, this rule is urgently required to protect the plant from subversive activity, sabotage or possible terrorist attacks initiated from the waters surrounding the plants.

Delaying the effective date of the rule would be contrary to the public interest, since immediate action is needed to protect the persons at the facilities, the public and surrounding communities from the release of nuclear radiation. This security zone should have minimal impact on vessel transits due to the fact that the security zone does not block the channel.

Due to the continued warnings from national security and intelligence officials that future terrorist attacks are possible, such as those launched against New York and Washington DC on September 11, 2001, heightened security measures are necessary for the area surrounding the Limerick Generating Station. This rule will provide the Captain of the Port Philadelphia with enforcement options to deal with potential threats to the security of the plants. The Coast Guard intends to implement a permanent security zone surrounding the plants. The Coast Guard will be publishing a NPRM to establish a permanent security zone that is temporarily effective under this rule. The Coast Guard will use the effective period of this Temporary Final Rule to engage in notice and comment rulemaking to develop a permanent regulation tailored to the present and foreseeable security environment within the Captain of the Port, Philadelphia, Pennsylvania zone.

No person or vessel may enter or remain in the prescribed security zone at any time without the permission of the Captain of the Port, Philadelphia, Pennsylvania or designated representative. Federal, state, and local agencies may assist the Coast Guard in the enforcement of this rule.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 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 Homeland Security (DHS).

The primary impact of this rule will be on vessels wishing to transit the affected waterway. Although this rule restricts traffic from freely transiting portions of the Schuylkill River, that restriction affects only a limited area and will be well publicized to allow mariners to make alternative plans.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have 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 may affect the following entities, some of which may be small entities: Owners or operators of fishing vessels and recreational vessels wishing to transit the portions of the Schuylkill River.

The rule will not have a significant impact on a substantial number of small entities for the following reasons: The restrictions affect only a limited area and traffic will be allowed to transit through the zone with permission of the Coast Guard or designated representative. The opportunity to engage in recreational and charter fishing outside the geographical limits of the security zone will not be disrupted. Therefore, this regulation should have a negligible impact on recreational and charter fishing activity.

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 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).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not affect 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 Security Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to security that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(f) and (g), of Commandant Instruction M16475.lD, from further environmental documentation.

A final “Environmental Analysis Checklist” and a final “Categorical Exclusion Determination” will be available in the docket 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) and (d)(3), the Coast Guard finds that good cause exists for not publishing a NPRM and for making this regulation effective less than 30 days after publication in the Federal Register . Based upon the warnings from national security and intelligence personnel, this rule is urgently required to protect the plant from subversive activity, sabotage or possible terrorist attacks initiated from the waters surrounding the plants.

Delaying the effective date of the rule would be contrary to the public interest, since immediate action is needed to protect the persons at the facilities, the public and surrounding communities from the release of nuclear radiation. This security zone should have minimal impact on vessel transits due to the fact that the security zone does not block the channel.

Due to the continued warnings from national security and intelligence officials that future terrorist attacks are possible, such as those launched against New York and Washington, DC on September 11, 2001, heightened security measures are necessary for the area surrounding the Peach Bottom Atomic Power Station. This rule will provide the Captain of the Port Philadelphia with enforcement options to deal with potential threats to the security of the plants. The Coast Guard intends to implement a permanent security zone surrounding the plants. The Coast Guard will be publishing a NPRM to establish a permanent security zone that is temporarily effective under this rule. The Coast Guard will use the effective period of this Temporary Final Rule to engage in notice and comment rulemaking to develop a permanent regulation tailored to the present and foreseeable security environment within the Captain of the Port, Philadelphia, Pennsylvania zone.

No person or vessel may enter or remain in the prescribed security zone at any time without the permission of the Captain of the Port, Philadelphia, Pennsylvania or designated representative. Federal, state, and local agencies may assist the Coast Guard in the enforcement of this rule.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 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 Homeland Security (DHS).

The primary impact of this rule will be on vessels wishing to transit the affected waterway. Although this rule restricts traffic from freely transiting portions of the Susquehanna River, that restriction affects only a limited area and will be well publicized to allow mariners to make alternative plans.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have 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 may affect the following entities, some of which may be small entities: owners or operators of fishing vessels and recreational vessels wishing to transit the portions of the Susquehanna River.

The rule will not have a significant impact on a substantial number of small entities for the following reasons: the restrictions affect only a limited area and traffic will be allowed to transit through the zone with permission of the Coast Guard or designated representative. The opportunity to engage in recreational and charter fishing outside the geographical limits of the security zone will not be disrupted. Therefore, this regulation should have a negligible impact on recreational and charter fishing activity.

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 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).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not affect 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 Security Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to security that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(f) and (g), of Commandant Instruction M16475.lD, from further environmental documentation.

A final “Environmental Analysis Checklist” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES.

On February 19, 2003, we published a notice of proposed rulemaking (NPRM) entitled: “Security Zone, St. Thomas, U.S. Virgin Islands, in the Federal Register (68 FR 7958). We received one letter commenting on the proposed rule. No public hearing was requested and none was held.

Based on the September 11, 2001, terrorist attacks on the World Trade Center buildings in New York and the Pentagon in Arlington, Virginia, there is an increased risk that subversive activity could be launched by vessels or persons in close proximity to the Port of Charlotte Amalie, St. Thomas, U.S. Virgin Islands, against cruise ships entering, departing and moored within the Port of Charlotte Amalie. Following these attacks by well-trained and clandestine terrorists, national security and intelligence officials have warned that future terrorists attacks are likely.

The terrorist acts against the United States on September 11, 2001, have increased the need for safety and security measures on U.S. ports and waterways. In response to these terrorist acts, and in order to prevent similar occurrences, the Coast Guard is establishing security zones around all cruise ships entering, departing and moored within the Port of Charlotte Amalie. We previously published two temporary final rules entitled “Security Zones; St. Thomas, U.S. Virgin Islands.” in the Federal Register on February 1, 2002 (67 FR 4909) and on November 13, 2002 (67 FR 68760). These temporary final rules contained similar provisions as those in this rulemaking.

The security zone for a cruise ship entering port is activated when the vessel passes: St. Thomas Harbor green lighted buoy 3 in approximate position 18°19′19″ North, 64°55′40″ West when entering the port using St. Thomas Channel; red buoy 2 in approximate position 18°19′15″ North, 64°55′59″ West when entering the port using East Gregorie Channel; and red lighted buoy 4 in approximate position 18°18′16″ North, 64°57′30″ West when entering the port using West Gregorie Channel. These zones are deactivated when the cruise ship passes any of these buoys on its departure from the Port of Charlotte Amalie.

Persons and vessels are prohibited from entering into or transiting through a security zone unless authorized by the Captain of the Port (COTP), or his designated representative. Each person and vessel in a security zone must obey any direction or order of the COTP. The COTP may remove any person, vessel, article, or thing from a security zone. No person may board, or take or place any article or thing on board, any vessel in a security zone without the permission of the Captain of the Port. The Captain of the Port will notify the public of these security zones through Marine Safety Information Bulletins via facsimile and the Marine Safety Office San Juan Web site at http://www.msocaribbean.com.

We received one letter commenting on the proposed rule. This comment addressed whether or not this rule would affect the use of a “dinghy dock” adjacent to the Crown Bay Cruise Ship terminal. The originator of the comment stated that the establishment of a 50 yard security zone around cruise ships moored at the Crown Bay terminal should not impact the use of this “dinghy dock” as users would have enough sea room to use the dock and not enter the security zone. The Coast Guard agrees that this rule will not affect the use of the dock as vessels may transit to and from it without entering the 50 yard security zone. The Coast Guard will allow the continued use of this dock while cruise ships are moored at the Crown Bay terminal.

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 Homeland Security (DHS). We expect 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 DHS is unnecessary because other vessels will be able to safely navigate around the zones while in place and persons may be authorized to enter or transit the zone with the permission of the Captain of the Port.

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 would 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 the Port of Charlotte Amalie when a cruise ship is entering, departing, moored or anchored in the Port of Charlotte Amalie. This rule will not have a significant economic impact on a substantial number of small entities because other vessels will be able to safely navigate around the zones while in place and persons may be authorized to enter or transit the zone with the permission of the Captain of the Port.

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. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Lieutenant Chip Lopez at (787) 706-2444 for assistance in understanding 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 businesses. 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'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 create an environmental risk to health or safety that may disproportionately affect children.

The Coast Guard has considered the environmental impact of this rule and has determined that, under figure 2-1, paragraph (34)g, of Commandant Instruction M16475.ID, that 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. Publishing an NPRM and delaying the rule's effective date is unnecessary and contrary to public safety because immediate action is necessary to protect the public and waters of the United States. Moreover, an NPRM is unnecessary due to the limited amount of time this rule will be in effect.

For the same reasons, 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 .

The Coast Guard is establishing a temporary safety zone encompassing a 350-foot circle surrounding a barge in approximate position 25° 44.10 N, 080° 14.30 W offshore from Coral Reef Yacht Club in Miami for the Coral Reef Yacht Club 4th of July fireworks display. This rule is needed to increase safety in Miami from 9 p.m. July 4, 2003 to 10 p.m. on July 4, 2003 during the Coral Reef Yacht Club 4th of July fireworks display due to the significant number of vessels in the area for this event. The safety zone is created to provide for the safety of the spectator craft in the vicinity offshore from Coral Reef Yacht Club in Miami, FL. Vessels are prohibited from anchoring, mooring, or transiting within this zone, unless authorized by the Captain of the Port Miami. The safety zone encompasses the area offshore from Coral Reef Yacht Club in Miami, FL.

This regulation is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential cost and benefits under section 6(a)(3) of that order. The Office of Management and Budget has exempted it from review under the order. It is not significant under the regulatory policies and procedures of the Department of Homeland Security (DHS) because these regulations will only be in effect for a short period of time, and the impacts on routine navigation are expected to be minimal.

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” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominate in their field, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under section 605 (b) that this rule will not have a significant economic impact upon a substantial number of small entities because the regulations will only be in effect for 2 hours and vessels may be allowed to transit the zone with the express permission of the Captain of the Port of Miami.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule will 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 this rule.

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 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).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implication 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 create an environmental risk to health or safety that may disproportionately affect children.

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that Order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

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. Publishing an NPRM and delaying the rule's effective date is unnecessary and contrary to public safety because immediate action is necessary to protect the public and waters of the United States. Moreover, an NPRM is unnecessary due to the limited amount of time this rule will be in effect.

For the same reasons, 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 .

The Coast Guard is establishing a temporary safety zone encompassing a 1680-foot circle surrounding a barge in approximate position 27°12.55 N, 080° 15.00 W in the St. Lucie River 1200 feet from the shore of City Hall for the City of Stuart 4th of July fireworks display. This rule is needed to increase safety in Stuart, FL from 9 p.m. July 4, 2003 to 10 p.m. on July 4, 2003 during the City of Stuart 4th of July fireworks display due to the significant number of vessels in the area for this event. The safety zone is created to provide for the safety of the spectator craft in the vicinity in the St. Lucie River 1200 feet from the shore of City Hall in Stuart, FL. Vessels are prohibited from anchoring, mooring, or transiting within this zone, unless authorized by the Captain of the Port Miami. The safety zone encompasses the area in the St. Lucie River 1200 feet from the shore of City Hall in Stuart, FL.

This regulation is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential cost and benefits under section 6(a)(3) of that order. The Office of Management and Budget has exempted it from review under the order. It is not significant under the regulatory policies and procedures of the Department of Homeland Security (DHS) because these regulations will only be in effect for a short period of time, and the impacts on routine navigation are expected to be minimal.

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” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominate in their field, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under section 605 (b) that this rule will not have a significant economic impact upon a substantial number of small entities because the regulations will only be in effect for 2 hours and vessels may be allowed to transit the zone with the express permission of the Captain of the Port of Miami.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule will 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 this rule.

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 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).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implication 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 create an environmental risk to health or safety that may disproportionately affect children.

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that Order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

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. Publishing a NPRM and delaying the rule's effective date is unnecessary and contrary to public safety because immediate action is necessary to protect the public and waters of the United States. Moreover, a NPRM is unnecessary due to the limited amount of time this rule will be in effect.

For the same reasons, 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 .

The Coast Guard is establishing a temporary safety zone encompassing a 850-foot circle surrounding a barge in approximate position 26°46.06 N, 080° 02.09 W in the ICW Northwest of Peanut Island in Rivera Beach for the Rivera Beach 4th of July fireworks display. This rule is needed to increase safety in Rivera Beach from 9 p.m. July 4, 2003 to 10 p.m. on July 4, 2003 during the Rivera Beach 4th of July fireworks display due to the significant number of vessels in the area for this event. The safety zone is created to provide for the safety of the spectator craft in the vicinity in the ICW Northwest of Peanut Island in Rivera Beach, FL. Vessels are prohibited from anchoring, mooring, or transiting within this zone, unless authorized by the Captain of the Port Miami. The safety zone encompasses the area in the ICW Northwest of Peanut Island in Rivera Beach, FL.

This regulation is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential cost and benefits under section 6(a)(3) of that order. The Office of Management and Budget has exempted it from review under the order. It is not significant under the regulatory policies and procedures of the Department of Homeland Security (DHS) because these regulations will only be in effect for a short period of time, and the impacts on routine navigation are expected to be minimal.

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” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their field, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under section 605 (b) that this rule will not have a significant economic impact upon a substantial number of small entities because the regulations will only be in effect for 2 hours and vessels may be allowed to transit the zone with the express permission of the Captain of the Port of Miami.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule will 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 this rule.

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 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).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implication 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 create an environmental risk to health or safety that may disproportionately affect children.

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that Order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

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. Publishing a NPRM and delaying the rule's effective date is unnecessary and contrary to public safety because immediate action is necessary to protect the public and waters of the United States. Moreover, a NPRM is unnecessary due to the limited amount of time this rule will be in effect.

For the same reasons, 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 .

The Coast Guard is establishing a temporary safety zone encompassing a 1300-foot circle surrounding a barge in approximate position 25°45.40 N, 080° 10.24 W in Biscayne Bay in Miami for the Grand Opening of Miami One fireworks display. This rule is needed to increase safety in Miami from 9 p.m. June 5, 2003 to 10 p.m. on June 5, 2003 during the Grand Opening of Miami One fireworks display due to the significant number of vessels in the area for this event. The safety zone is created to provide for the safety of the spectator craft in the vicinity of Biscayne Bay in Miami, FL. Vessels are prohibited from anchoring, mooring, or transiting within this zone, unless authorized by the Captain of the Port Miami. The safety zone encompasses the area in Biscayne Bay in Miami, FL.

This regulation is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential cost and benefits under section 6(a)(3) of that order. The Office of Management and Budget has exempted it from review under the order. It is not significant under the regulatory policies and procedures of the Department of Homeland Security (DHS) because these regulations will only be in effect for a short period of time, and the impacts on routine navigation are expected to be minimal.

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” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominate in their field, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under section 605 (b) that this rule will not have a significant economic impact upon a substantial number of small entities because the regulations will only be in effect for 2 hours and vessels may be allowed to transit the zone with the express permission of the Captain of the Port of Miami.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule will 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 this rule.

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 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).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implication 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 create an environmental risk to health or safety that may disproportionately affect children.

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that Order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

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. Publishing a NPRM and delaying the rule's effective date is unnecessary and contrary to public safety because immediate action is necessary to protect the public and waters of the United States. Moreover, a NPRM is unnecessary due to the limited amount of time this rule will be in effect.

For the same reasons, 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 .

The Coast Guard is establishing a temporary safety zone encompassing a 850-foot circle surrounding a barge in approximate position 26° 34.36 N, 080° 02.51 W in the ICW at East Ocean Avenue in Lantana for the Town of Lantana July 4th fireworks display. This rule is needed to increase safety in Lantana from 9 p.m. July 4, 2003 to 10 p.m. on July 4, 2003 during the Town of Lantana July 4th fireworks display due to the significant number of vessels in the area for this event. The safety zone is created to provide for the safety of the spectator craft in the vicinity in the ICW at East Ocean Avenue in Lantana, FL. Vessels are prohibited from anchoring, mooring, or transiting within this zone, unless authorized by the Captain of the Port Miami. The safety zone encompasses the area in the ICW at East Ocean Avenue in Lantana, FL.

This regulation is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential cost and benefits under section 6(a)(3) of that order. The Office of Management and Budget has exempted it from review under the order. It is not significant under the regulatory policies and procedures of the Department of Homeland Security (DHS) because these regulations will only be in effect for a short period of time, and the impacts on routine navigation are expected to be minimal.

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” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominate in their field, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under section 605(b) that this rule will not have a significant economic impact upon a substantial number of small entities because the regulations will only be in effect for 2 hours and vessels may be allowed to transit the zone with the express permission of the Captain of the Port of Miami.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule will 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 this rule.

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 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).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect a taking of private property or otherwise have taking implication 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 create an environmental risk to health or safety that may disproportionately affect children.

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

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that Order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B) and (d)(3), the Coast Guard finds that good cause exists for not publishing a NPRM and for making this regulation effective less than 30 days after publication in the Federal Register . Based upon the warnings from national security and intelligence personnel, this rule is urgently required to protect the plant from subversive activity, sabotage or possible terrorist attacks initiated from the waters surrounding the plants.

Delaying the effective date of the rule would be contrary to the public interest, since immediate action is needed to protect the persons at the facilities, the public and surrounding communities from the release of nuclear radiation. This security zone should have minimal impact on vessel transits due to the fact that the security zone does not block the channel.

Due to the continued warnings from national security and intelligence officials that future terrorist attacks are possible, such as those launched against New York and Washington DC on September 11, 2001, heightened security measures are necessary for the area surrounding the Three Mile Island Generating Station. This rule will provide the Captain of the Port Philadelphia with enforcement options to deal with potential threats to the security of the plants. The Coast Guard intends to implement a permanent security zone surrounding the plants. The Coast Guard will be publishing a NPRM to establish a permanent security zone that is temporarily effective under this rule. The Coast Guard will use the effective period of this Temporary Final Rule to engage in notice and comment rulemaking to develop a permanent regulation tailored to the present and foreseeable security environment within the Captain of the Port, Philadelphia, Pennsylvania zone.

No person or vessel may enter or remain in the prescribed security zone at any time without the permission of the Captain of the Port, Philadelphia, Pennsylvania or designated representative. Federal, state, and local agencies may assist the Coast Guard in the enforcement of this rule.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 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 Homeland Security (DHS).

The primary impact of this rule will be on vessels wishing to transit the affected waterway. Although this rule restricts traffic from freely transiting portions of the Susquehanna River, that restriction affects only a limited area and will be well publicized to allow mariners to make alternative plans.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have 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 may affect the following entities, some of which may be small entities: owners or operators of fishing vessels and recreational vessels wishing to transit the portions of the Susquehanna River.

The rule will not have a significant impact on a substantial number of small entities for the following reasons: the restrictions affect only a limited area and traffic will be allowed to transit through the zone with permission of the Coast Guard or designated representative. The opportunity to engage in recreational and charter fishing outside the geographical limits of the security zone will not be disrupted. Therefore, this regulation should have a negligible impact on recreational and charter fishing activity.

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 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).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not affect 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 Security Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to security that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(f) and (g), of Commandant Instruction M16475.lD, from further environmental documentation.

A final “Environmental Analysis Checklist” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES.

On May 30, 2003, the Coast Guard is publishing a final rule establishing safety zones, in 33 CFR 165.1315, to provide for the safety of vessels in the vicinity of fireworks displays one of which is the Astoria fireworks display. The safety zone will include all waters of the Columbia River at Astoria, Oregon enclosed by the following points: North from the Oregon shoreline at 123°50′1″ West to 46°11′50″ North, thence east to 123°49′15″ West, thence south to the Oregon shoreline and finally westerly along the Oregon shoreline to the point of origin. Entry into this zone is prohibited unless authorized by the Captain of the Port or his designee. The Captain of the Port Portland will enforce this safety zone on July 4, 2003 from 9:30 p.m. (PDT) until 10:30 p.m. (PDT). The Captain of the Port may be assisted by other federal, state, or local agencies in enforcing this security zone.

On May 30, 2003, the Coast Guard is publishing a final rule establishing safety zones, in 33 CFR 165.1315, to provide for the safety of vessels in the vicinity of fireworks displays one of which is the Cedco Inc. fireworks display. The safety zone will include waters on the Coos River bounded by shoreline to the east and west and 1000 feet of water to the north and south of the launching barge which is centered at 43°23′45″ North, 124°12′50″ West. Entry into this zone is prohibited unless authorized by the Captain of the Port or his designee. The Captain of the Port Portland will enforce this safety zone on July 3, 2003 from 9:30 p.m. (PDT) until 10:30 p.m. (PDT). A rain date is scheduled for July 4. The Captain of the Port may be assisted by other Federal, state, or local agencies in enforcing this security zone.

On May 30, 2003, the Coast Guard is publishing a final rule establishing safety zones, in 33 CFR 165.1315, to provide for the safety of vessels in the vicinity of fireworks displays one of which is the Oregon Food Bank Blues fireworks display. The safety zone will include all waters on the Willamette River bounded by the Hawthorne Bridge to the north, Marquam Bridge to the south, and shoreline to the east and west. Entry into this zone is prohibited unless authorized by the Captain of the Port or his designee. The Captain of the Port Portland will enforce this safety zone on July 4, 2003 from 9:30 p.m. (PDT) until 10:30 p.m. (PDT). The Captain of the Port may be assisted by other federal, state, or local agencies in enforcing this security zone.

On May 30, 2003, the Coast Guard is publishing a final rule establishing safety zones, in 33 CFR 165.1315, to provide for the safety of vessels in the vicinity of fireworks displays one of which is the Tri-City fireworks display. The safety zone will include waters on the Columbia River bounded by shoreline to the north and south, Interstate 395 bridge to the east, and 1000 feet of water to the west of the launching barge which is centered at 46°13′38″ North, 119°08′52″ West. Entry into this zone is prohibited unless authorized by the Captain of the Port or his designee. The Captain of the Port Portland will enforce this safety zone on July 4, 2003 from 9:30 p.m. (PDT) until 10:30 p.m. (PDT). The Captain of the Port may be assisted by other federal, state, or local agencies in enforcing this security zone.

Title VIII of the Alaska National Interest Lands Conservation Act (ANILCA) (16 U.S.C. 3111-3126) requires that the Secretary of the Interior and the Secretary of Agriculture (Secretaries) implement a joint program to grant a preference for subsistence uses of fish and wildlife resources on public lands in Alaska, unless the State of Alaska enacts and implements laws of general applicability that are consistent with ANILCA and that provide for the subsistence definition, preference, and participation specified in Sections 803, 804, and 805 of ANILCA. In December 1989, the Alaska Supreme Court ruled that the rural preference in the State subsistence statute violated the Alaska Constitution and, therefore, negated State compliance with ANILCA.

The Department of the Interior and the Department of Agriculture (Departments) assumed, on July 1, 1990, responsibility for implementation of Title VIII of ANILCA on public lands. The Departments administer Title VIII through regulations at Title 50, part 100 and Title 36, part 242 of the Code of Federal Regulations (CFR). Consistent with subparts A, B, and C of these regulations, as revised January 8, 1999, (64 FR 1276), the Departments established a Federal Subsistence Board to administer the Federal Subsistence Management Program. The Board's composition includes a Chair appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture; the Alaska Regional Director, U.S. Fish and Wildlife Service; the Alaska Regional Director, National Park Service; the Alaska State Director, Bureau of Land Management; the Alaska Regional Director, Bureau of Indian Affairs; and the Alaska Regional Forester, USDA Forest Service. Through the Board, these agencies participate in the development of regulations for subparts A, B, and C, which establish the program structure and determine which Alaska residents are eligible to take specific species for subsistence uses, and the annual Subpart D regulations, which establish seasons, harvest limits, and methods and means for subsistence take of species in specific areas. Subpart D regulations for the 2003 fishing seasons, harvest limits, and methods and means were published on February 12, 2003, (68 FR 7276).

Because this rule relates to public lands managed by an agency or agencies in both the Departments of Agriculture and the Interior, identical closures and adjustments would apply to 36 CFR part 242 and 50 CFR part 100.

The Alaska Department of Fish and Game (ADF&G), under the direction of the Alaska Board of Fisheries (BOF), manages sport, commercial, personal use, and State subsistence harvest on all lands and waters throughout Alaska. However, on Federal lands and waters, the Federal Subsistence Board implements a subsistence priority for rural residents as provided by Title VIII of ANILCA. In providing this priority, the Board may, when necessary, preempt State harvest regulations for fish or wildlife on Federal lands and waters.

These adjustments are necessary because of the need to maintain the viability of salmon stocks in the Copper River based on in-season run assessments. These actions are authorized and in accordance with 50 CFR 100.19(d)-(e) and 36 CFR 242.19(d)-(e).

In December 2001, the Board adopted regulatory proposals establishing a new Federal subsistence fishery in the Chitina Subdistrict of the Copper River. This fishery is open to Federally qualified users having customary and traditional use of salmon in this Subdistrict. The State conducts a personal use fishery in this Subdistrict that is open to all Alaska residents.

Management of the fishery is based on the numbers of salmon returning to the Copper River. A larger than predicted salmon run will allow additional fishing time. A smaller than predicted run will require restrictions to achieve upriver passage and spawning escapement goals. A run that approximates the pre-season forecast will allow fishing to proceed similar to the pre-season schedule with some adjustments made to fishing time based on in-season data. Adjustments to the preseason schedule are expected as a normal function of an abundance-based management strategy. State and Federal managers, reviewing and discussing all available in-season information, will make these adjustments.

While Federal and State regulations currently differ for this Subdistrict, the Board indicated that Federal in-season management actions regarding fishing periods were expected to mirror State actions. The State established a preseason schedule of allowable fishing periods based on daily projected sonar estimates. This preseason schedule is intended to distribute the harvest throughout the salmon run and provide salmon for upriver subsistence fisheries and the spawning escapement. The salmon season is closed until the first open period scheduled for June 7, 2003, at 8 a.m. Shown below is the first anticipated fishing schedule openings for the Chitina Subdistrict of the Copper River: Saturday, June 7, 8 a.m.-Sunday, June 8, 8 p.m.

State personal use and Federal subsistence fisheries in this Subdistrict close simultaneously by regulation on September 30, 2003. No deviation from this date is anticipated.

The new fish wheel identification requirements for the Copper River parallel State regulations recently enacted by the Alaska Board of Fisheries for the Glennallen Subdistrict. Fish wheel owners are provided with the flexibility of being identified by gear registration number and a sign bearing either their name and address, or their Alaska driver's license number, or their Alaska State identification card number. This allows for improved confidentiality, while maintaining the capability needed for enforcement purposes. The fish wheel owner is responsible for the fish wheel. Retaining the requirement to display name and address for operators other than the owner is necessary for effective enforcement.

The Board finds that additional public notice and comment requirements under the Administrative Procedure Act (APA) for these adjustments are impracticable, unnecessary, and contrary to the public interest. Lack of appropriate and immediate conservation measures could seriously affect the continued viability of fish populations, adversely impact future subsistence opportunities for rural Alaskans, and would generally fail to serve the overall public interest. Therefore, the Board finds good cause pursuant to 5 U.S.C. 553(b)(3)(B) to waive additional public notice and comment procedures prior to implementation of these actions and pursuant to 5 U.S.C. 553(d)(3) to make this rule effective as indicated in the DATES section.

A Final Environmental Impact Statement (FEIS) was published on February 28, 1992, and a Record of Decision on Subsistence Management for Federal Public Lands in Alaska (ROD) was signed April 6, 1992. The final rule for Subsistence Management Regulations for Public Lands in Alaska, Subparts A, B, and C (57 FR 22940-22964, published May 29, 1992) implemented the Federal Subsistence Management Program and included a framework for an annual cycle for subsistence hunting and fishing regulations. A final rule that redefined the jurisdiction of the Federal Subsistence Management Program to include waters subject to the subsistence priority was published on January 8, 1999, (64 FR 1276.)

The intent of all Federal subsistence regulations is to accord subsistence uses of fish and wildlife on public lands a priority over the taking of fish and wildlife on such lands for other purposes, unless restriction is necessary to conserve healthy fish and wildlife populations. A Section 810 analysis was completed as part of the FEIS process. The final Section 810 analysis determination appeared in the April 6, 1992, ROD which concluded that the Federal Subsistence Management Program, under Alternative IV with an annual process for setting hunting and fishing regulations, may have some local impacts on subsistence uses, but the program is not likely to significantly restrict subsistence uses.

The adjustment and emergency closures do not contain information collection requirements subject to Office of Management and Budget (OMB) approval under the Paperwork Reduction Act of 1995.

The adjustments have been exempted from OMB review under Executive Order 12866.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ) requires preparation of flexibility analyses for rules that will have a significant effect on a substantial number of small entities, which include small businesses, organizations, or governmental jurisdictions. The exact number of businesses and the amount of trade that will result from this Federal land-related activity is unknown. The aggregate effect is an insignificant economic effect (both positive and negative) on a small number of small entities supporting subsistence activities, such as boat, fishing gear, and gasoline dealers. The number of small entities affected is unknown; but, the effects will be seasonally and geographically-limited in nature and will likely not be significant. The Departments certify that the adjustments will not have a significant economic effect on a substantial number of small entities within the meaning of the Regulatory Flexibility Act. Under the Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801 et seq. ), this rule is not a major rule. It does not have an effect on the economy of $100 million or more, will not cause a major increase in costs or prices for consumers, and does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

Title VIII of ANILCA requires the Secretaries to administer a subsistence preference on public lands. The scope of this program is limited by definition to certain public lands. Likewise, the adjustments have no potential takings of private property implications as defined by Executive Order 12630.

The Service has determined and certifies pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq. , that the adjustments will not impose a cost of $100 million or more in any given year on local or State governments or private entities. The implementation is by Federal agencies, and no cost is involved to any State or local entities or Tribal governments.

The Service has determined that the adjustments meet the applicable standards provided in Sections 3(a) and 3(b)(2) of Executive Order 12988, regarding civil justice reform.

In accordance with Executive Order 13132, the adjustments do not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. Title VIII of ANILCA precludes the State from exercising subsistence management authority over fish and wildlife resources on Federal lands. Cooperative salmon run assessment efforts with ADF&G will continue.

In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and 512 DM 2, we have evaluated possible effects on Federally recognized Indian tribes and have determined that there are no effects. The Bureau of Indian Affairs is a participating agency in this rulemaking.

On May 18, 2001, the President issued Executive Order 13211 on regulations that significantly affect energy supply, distribution, or use. This Executive Order requires agencies to prepare Statements of Energy Effects when undertaking certain actions. As these actions are not expected to significantly affect energy supply, distribution, or use, they are not significant energy actions and no Statement of Energy Effects is required.

William Knauer drafted this document under the guidance of Thomas H. Boyd, of the Office of Subsistence Management, Alaska Regional Office, U.S. Fish and Wildlife Service, Anchorage, Alaska. Taylor Brelsford, Alaska State Office, Bureau of Land Management; Rod Simmons, Alaska Regional Office, U.S. Fish and Wildlife Service; Bob Gerhard, Alaska Regional Office, National Park Service; Dr. Glenn Chen, Alaska Regional Office, Bureau of Indian Affairs; and Ken Thompson, USDA—Forest Service, provided additional guidance.

This rule is effective upon publication for good cause as permitted by the Administrative Procedure Act (5 U.S.C. 553(d)(3)). NARA believes that delaying the effective date for 30 days is unnecessary as this rule represents minor technical amendments. Moreover, as the public benefits immediately being provided with corrections to phone numbers for Presidential libraries and the regional records facilities, and a correction to the hours that the Washington National Records Center is open to the public, any delay in the effective date would be contrary to the public interest.

This rule is not a significant regulatory action for the purposes of Executive Order 12866 and has not been reviewed by the Office of Management and Budget. This rule is not a major rule as defined in 5 U.S.C. chapter 8, Congressional Review of Agency Rulemaking. As required by the Regulatory Flexibility Act, I certify that this rule will not have a significant impact on a substantial number of small entities. This regulation does not have any federalism implications.

The Debt Collection Improvement Act of 1996

In an effort to maintain the remedial impact of civil monetary penalties (CMPs) and promote compliance with law, the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990 (Pub. L. 101-410) was amended by the Debt Collection Improvement Act of 1996 (Pub. L. 104-134) to require Federal agencies to regularly adjust CMPs for inflation. As amended, the law requires each agency to make an initial inflationary adjustment for all applicable CMPs, with specified exemptions, and to make further adjustments at lease once every four years thereafter. The Debt Collection Improvement Act of 1996 further stipulates that any resulting increases in a CMP due to the calculated inflation adjustments (i) should apply only to the violations that occur after October 23, 1996, the Act's effective date, and (ii) should not exceed 10 percent of the penalty indicated.

Under the Act, the inflation adjustment for each applicable CMP is determined by increasing the maximum CMP amount per violation by the cost of living adjustment. The “cost of living” adjustment is defined as the percentage of each CMP by which the Consumer Price Index (CPI) for the month of June of the calendar year preceding the adjustment exceeds the CPI for the month of June of the calendar year in which the amount of the CMP was last set or adjusted pursuant to law. Any calculated increase under this adjustment is subject to a specific rounding formula set in the Act.

MARAD has provisions in its regulations at 46 CFR part 221 prescribing procedures for three civil penalties that it may assess under the following authorities:

1. 46 U.S.C. 31309-a general civil penalty of up to $11,000 for violation of 46 U.S.C. Chapter 313-Commercial Instruments and Maritime Liens.

2. 46 U.S.C. 31330-a penalty of up to $27,500 for violation of 46 U.S.C. 31328 or 31329, relating to requirements for trustees of mortgaged vessels and vessel interests and purchasers of documented vessels under order of a district court.

3. 46 App. U.S.C. 808-a penalty of up to $11,000 for the unlawful transfer of a documented vessel or interests therein.

MARAD is amending its regulations at 46 CFR 221.61 to adjust the maximum amount of each of these three civil monetary penalties. Each of the $11,000 maximum penalties in being increased to $12,000. The $27,500 maximum penalty is being increased to $30,000.

This final rule is exempt from review of OMB under E.O. 12866 because it is limited to the adoption of statutory language without interpretation. Additionally, this final rule is not likely to result in an annual effect on the economy of $100 million or more. It also is not considered a major rule for purposes of Congressional review under Pub. L. 104-121.

This final rule is also not significant under the Regulatory Policies and Procedures of the Department of Transportation (44 FR 11034, February 26, 1979). The costs and benefits associated with this rulemaking are so minimal that no further analysis is necessary. Because the economic impact should be minimal, further regulatory evaluation is not necessary.

The Administrative Procedure Act (5 U.S.C. 553) provides an exception to the notice and comment procedures because they are unnecessary or contrary to the public interest. MARAD finds that under 5 U.S.C. 553(b)(3)(B) good cause exists for dispensing with notice and comment since this rule only implemented statutory authority as mandated in Pub. L. 104-134, with no issues of policy discretion. Accordingly, opportunity for public comment is unnecessary.

We analyzed this final rule in accordance with the principles and criteria contained in E.O. 13132 (“Federalism”) and have determined that it does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. The regulations have no substantial effects on the States, or on the current Federal-State relationship, or on the current distribution of power and responsibilities among the various local officials. Therefore, consultation with State and local officials was not necessary.

The Maritime Administrator certifies that this final rule will not have a significant economic impact on a substantial number of small entities. Any penalties that may be assessed by MARAD will take into account the party's ability to pay and the nature, circumstances, extent and gravity of the violation committed and, with respect to the Party, the degree of culpability, and history of prior offenses, and other factors that justice may require. The aggregate impact of any enforcement action that might be taken by MARAD on violations will not have a significant economic impact on small businesses entities.

We have analyzed this Final rule for purposes of compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ) and have concluded that under the categorical exclusions provision in section 4.05 of Maritime Administrative Order (“MAO”) 600-1, “Procedures for Considering Environmental Impacts,” 50 FR 11606 (March 22, 1985), the preparation of an Environmental Assessment, and an Environmental Impact Statement, or a Finding of No Significant Impact for this rulemaking is not required. This rulemaking involves civil penalties and has no environmental impact.

This rulemaking contains no new or amended information collection or recordkeeping requirements which have been or require approval by the Office of Management and Budget.

This final rule would not impose an unfunded mandate under the Unfunded Mandates Reform Act of 1995. It would not result in costs of $100 million or more, in the aggregate, to any of the following: State, local, or Native American tribal governments, or the private sector. This final rule is the least burdensome alternative that achieves the objective of the Federal Civil Monetary Penalty Inflation Adjustment Act of 1996, as amended by the Debt Collection Improvement Act of 1996.