Public Law 99-239 approved the Compact between the United States and the Government of the Republic of the Marshall Islands and the Government of the Federated States of Micronesia, and Public Law 99-658 approved the Compact between the United States and Palau (collectively, Compacts). Under the Compacts, the majority of citizens of these newly formed states (parts of the former Trust Territories of the Pacific Islands, now called the freely associated states (FAS)) became eligible to enter, live, work, and be educated in the United States and its territories and possessions without regard to sections 212(a)(5)(A) and 212(a)(7) (A) and (B) of the Immigration and Nationality Act (Act), formerly sections 212(a) (14), (20), and (26). Section 141(a) of the Compacts. Both Compacts, at section 141(b), provide that the right of citizens of the FAS, who were admitted to the territories or possessions of the United States pursuant to the provisions of the Compacts, to establish habitual residence in a territory or possession of the United States may be subject to nondiscriminatory limitations.

The Service interprets section 141(b) of the Compacts to the effect that citizens of the FAS who enter the territories and possessions of the United States pursuant to section 141(b) of the Compacts are subject to limitations not only at the time they establish their habitual residence but for the entire duration of their habitual residence. The negotiators of the Compacts realized that while the economy of the island territories was fragile, the vast majority of the FAS citizens would actively participate in and be beneficial to it. On the other hand, there would be some who would not be gainfully employed or who would even engage in welfare fraud and thus become a burden on the territorial economy. Section 141(b) is directed at such entrants from the FAS. It is immaterial for the territorial economy whether this burden exists at the time when the FAS citizen first established his or her habitual residence in the territory or whether it occurs at a later time. The Service cannot attribute to the parties concluding the Compacts an intent that, once a citizen from the FAS first establishes his habitual residence in a territory or possession, he or she is immune from the future imposition of the limitations envisaged by section 141(b). The Service therefore reads the word “establishment” as necessarily including “maintenance,” and uses that word accordingly in this rule.

Section 643 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996, Public Law 104-208, requires the Commissioner of the Immigration and Naturalization Service to issue regulations regarding the “rights of ‘habitual residence’ in the United States” under the terms of the Compacts.

“Habitual resident” refers to an individual who is an FAS citizen who has been admitted to a territory or possession of the United States (except the Commonwealth of the Northern Mariana Islands or American Samoa as long as the Act has not been made applicable there) pursuant to section 141(a) of the Compacts, and who occupies in such territory or possession a habitual residence as that term is defined in section 461 of the Compacts, namely, a place of general abode or a principal, actual dwelling place of a continuing or lasting nature, including physical presence for a cumulative total of at least 365 days, and who is not a: (1) Full-time student under the Compact provisions; or a (2) dependent of a resident representative as described in section 152 of the Compacts. Since the term “habitual resident” requires that the person have entered the United States pursuant to section 141(a) of the Compacts, the term does not apply to FAS citizens whose presence in the territories or possessions is based on an authority other than section 141(a), such as members of the Armed Forces of the United States described in 8 CFR § 235.1(c), persons lawfully admitted for permanent residence in the United States, or persons having nonimmigrant status whose entry into the United States is based on provisions of the Compacts or the Act other than section 141(a) of the Compacts.

This regulation is intended to define the rights of and limitations on habitual residence under the Compacts. In particular, the limitations relate to grounds for the possible removal of a habitual resident from the United States. The increasing presence of citizens of the FAS in the territories and possessions of the United States requires action to ensure that the benefits to the citizens of the FAS of employment and education in the territories and possessions, and the economic benefit to the territories and possessions of their presence are maintained, while simultaneously minimizing the impact on the territories and possessions resulting from granting unlimited access of such FAS citizens.

This rule applies to habitual residents living in the territories and possessions of the United States to which the Act applies. These territories and possessions are at present Guam, the Commonwealth of Puerto Rico, and the American Virgin Islands.

This rule does not apply to FAS citizens residing in American Samoa or the Commonwealth of the Northern Mariana Islands, as long as the Act does not apply to them, or to FAS citizens residing in the fifty States or the District of Columbia.

On June 4, 1998, the Service published a proposed rule at 63 FR 30415. Written comments were to be submitted on or before August 3, 1998. The Service received three comments. The following is a discussion of the public comments and the Service's responses.

All commenters expressed concern with the proposed definition of “dependents,” in particular, limiting dependents to an unemployed spouse, parents and unmarried children under 21 years of age. In the opinion of one commenter, this ignores the realities of family life in the Pacific Islands. However, it would not be workable to include distant relatives and family friends in the definition of “dependents,” as the writers advocated. In addition, the need to minimize any increase in social service expenditures by the territory and possession governments on behalf of habitual resident dependents renders the above-noted definition necessary.

One commenter recommended that the poverty guidelines established by the Department of Health and Human Services (HHS) that are required of the family unit be made applicable to the single individual with no family. Under the proposed rule, only 40 hours of “gainful employment” each week, regardless of his or her salary, were required of such an individual. Another commenter suggested striking altogether the requirement that the financial resources of the family unit meet or exceed 100 percent of these poverty guidelines. Another suggestion involved adjusting the HHS official poverty guideline standard to reflect the actual circumstances in Guam.

The Service lacks the needed expertise in matters relating to determining poverty guidelines to make meaningful adjustments to the HHS official poverty guidelines so as to reflect the actual circumstances in Guam, the territory most affected by this rulemaking. By incorporating the requirement that a habitual resident be “self-supporting,” however, the standard becomes based on the ability to financially support oneself with regard to local conditions. Further, “self-supporting” is defined in the final rule as either: (a) Having a lawful occupation of a current and continuing nature which provides 40 hours of gainful employment each week, without regard to the actual income or size of the family (for part-time students in college or institutions of higher learning the 40-hour requirement is reduced by three hours for each college or graduate credit-hour of study); or (b) in the case of a person employed for less than 40 hours a week or not at all, having lawfully derived funds that meet or exceed 100 percent of the official poverty guidelines for Hawaii for a family unit of the appropriate size as published annually by HHS. This approach provides what the Service views as a simple, fair, and flexible standard consistent with the Compacts.

All commenters voiced concern over adequate enforcement procedures. The writers suggested implementation of a registration system financed from revenues collected from the Service operation on Guam. These commenters wrote that the Service collects more revenue via fees than it expends in fulfilling its statutory obligations on Guam. However, the Service notes that, with the exception of a $6 Inspections user fee that all arriving persons pay upon entering Guam by air, immigration fees collected by the Service within Guam are not retained by the Service but are turned over to the Treasurer of Guam, pursuant to section 30 of the Organic Act of Guam, 48 U.S.C. 1421(h). In addition, the Inspections user fee does not currently cover the Service's operational costs on Guam. Appropriated funds are used to make up the difference. Therefore, there are no surplus funds from the Inspections user fee account that can be used to finance the enforcement efforts advocated by the commenters.

The Service is aware of the difficulties in enforcing the proposed rule in an ad hoc fashion. In order to address the concerns of the commenters and to be in compliance with our own obligation to enforce the nondiscriminatory limitations on habitual residence provided for by the Compacts and Congress, the Service intends to work with the Government of Guam and the United States Department of the Interior in order to establish methods to fairly enforce the nondiscriminatory limitations on habitual residence. (The term “nondiscriminatory” is discussed in the supplementary information portion of the proposed rule. Since the Service has made no changes in how the term is used, there is no need here for further discussion.)

The Service will enforce the existing requirement that all nonimmigrants, including FAS citizens entering a United States territory, complete Service Form I-94, Arrival-Departure Record, and turn it in, as required, upon departure. See 8 CFR 235.1(f) The Service may extract information from the I-94 for possible enforcement purposes and may share this information with the Government of Guam on an as-needed basis.

The final rule, therefore, establishes the rebuttable presumption that an FAS citizen is a habitual resident if the Service has reasons to believe that the FAS citizen was admitted to a United States territory more than a year ago but failed to turn in his or her I-94 upon departure, or failed to apply for a replacement arrival-departure record. Having the correct information, as gleaned from the I-94, on a particular FAS citizen's arrival and departure is important. Without such information the Service will now know how much time the FAS citizen has previously spent within the territory, and therefore may not know whether or not the FAS citizen is a habitual resident.

This presumption approach the Service intends to use is similar to the concept employed in a parking lot in order to determine the amount a driver must pay for parking. Upon entering the lot, the driver gets a ticket and then turns it in upon leaving to determine how much to pay. If the driver loses his or her ticket, the parking lot charges the driver for the maximum amount of time, since the parking lot attendant is able to know only when the driver is leaving. The burden is always on the driver to prove the time of entry into the parking lot. In this example, the driver's entry is proven via the parking lot ticket.

The Service will apply the same concept to the situation at hand. If the Service only knows when the FAS citizen was previously admitted, the burden is on the FAS citizen to show when he or she departed. The form itself requires that it be surrendered upon departure. The presumption can be rebutted by evidence that the FAS citizen was not in the territory for a total of at least 365 days and has not established a continuing or lasting residence. If the FAS citizen can prove he or she made an entry elsewhere on a specific date, that will demonstrate that he or she was not in the territory between that date and the date of his or her next application for admission to the United States territory.

The Service notes that the definition of “habitual resident” has been modified in this context in order to conform more closely to the definition of “habitual residence” found in section 461 of the Compacts. In particular, the Service notes that for an FAS citizen to be considered a habitual resident, he or she must have a continuing or lasting residence in the United States territory after an admission, including physical presence for a cumulative total of at least 365 days. The fact that an FAS citizen may be a habitual resident does not necessarily render the FAS citizen inadmissible to the United States territory. For example, if the resident is self-supporting, he or she may not necessarily be inadmissible.

Finally, organization of the final rule is different from that of the proposed rule in order to comply with the plain-language requirements currently used by Executive Branch agencies in drafting regulations.

The Commissioner of the Immigration and Naturalization Service, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation and, by approving it, certifies that the rule will not have a significant economic impact on a substantial number of small entities. This rule affects relatively small communities, primarily on Guam. Because the rule would require that the nonimmigrant be self-supporting in order to establish and maintain habitual residence in a territory or possession of the United States, the impact of the rule on the local economies should be positive.

This rule will not result in the expenditure by State, local, and tribal governments in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

This rule is not considered by the Department of Justice, Immigration and Naturalization Service to be a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review. Accordingly, the Office of Management and Budget has waived its review process under section 6(a)(3)(A).

The regulation proposed will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient Federalism implications to warrant the preparation of a Federalism Summary Impact Statement.

This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

FAA Order 7400.9G, Airspace Designations and Reporting Points, dated September 1, 1999, and effective September 16, 1999, listed Class A, Class B, Class C, Class D, and Class E airspace areas and reporting points. Due to the length of these descriptions, the FAA requested approval from the Office of the Federal Register to incorporate the material by reference in the Federal Aviation Regulations § 71.1 (14 CFR 71.1). The Director of the Federal Register approved the incorporation by reference of FAA Order 7400.9G in § 71.1, effective September 16, 1999, through September 15, 2000. During the incorporation by reference period, the FAA processed all proposed changes of the airspace listings in FAA Order 7400.9G in full text as proposed rule documents in the Federal Register . Likewise, all amendments of these listings were published in full text as final rules in the Federal Register . This rule reflects the periodic integration of these final rule amendments into a revised edition of Airspace Designations and Reporting Points, Order 7400.9H. The Director of the Federal Register has approved the incorporation by reference of FAA Order 7400.9H in § 71.1, as of September 16, 2000, through September 15, 2001. This rule also explains the procedures the FAA will use to amend the airspace designations incorporated by reference in part 71. Sections 71.5, 71.31, 71.33, 71.41, 71.51, 71.61, 71.71, 71.79, and 71.901 are also updated to reflect the incorporation by reference of FAA Order 7400.9H.

This action amends part 71 of the Federal Aviation Regulations (14 CFR part 71) to reflect the approval by the Director of the Federal Register of the incorporation by reference of FAA Order 7400.9H, effective September 16, 2000, through September 15, 2001. During the incorporation by reference period, the FAA will continue to process all proposed changes of the airspace listings in FAA Order 7400.9H in full text as proposed rule documents in the Federal Register . Likewise, all amendments of these listings will be published in full text as final rules in the Federal Register . The FAA will periodically integrate all final rule amendments into a revised edition of the Order, and submit the revised edition to the Director of the Federal Register for approval for incorporation by reference in § 71.1.

The FAA has determined 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) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. This action neither places any new restrictions or requirements on the public, nor changes the dimensions or operating requirements of the airspace listings incorporated by reference in part 71. Consequently, notice and public procedure under 5 U.S.C. 553(b) are unnecessary. Because this action will continue to update the changes to the airspace designations, which are depicted on aeronautical charts, and to avoid any unnecessary pilot confusion, I find that good cause exists, under 5 U.S.C. 553(d), for making this amendment effective in less than 30 days.

The FAA published this direct final rule with a request for comments in the Federal Register on July 3, 2000 (65 FR 40991). 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 November 30, 2000. No adverse comments were received, and thus this notice confirms that this direct final rule will become effective on that date.

Under section 405 of the Modernization Act (Public Law 105-115), statutory provisions on guidance documents were added to the Federal Food, Drug, and Cosmetic Act (the act) in section 701(h) (21 U.S.C. 371(h)). In the Federal Register of February 14, 2000 (65 FR 7321), we (FDA) proposed changes to our existing part 10 (21 CFR part 10) regulations to clarify our procedures for the development, issuance, and use of guidance documents. Interested parties were given until May 1, 2000, to comment on the proposal.

We received 18 comments on the proposed rule, largely from trade organizations. The comments we received generally supported the policies and procedures described in the GGP's.

(Comment 1) One comment recommended that we include in this preamble a list of generally accepted principles of a good guidance document. The comment nominated several principles for inclusion on the list.

We decline to develop a list of generally accepted principles of a “good” guidance document because we believe that the procedures described in § 10.115 reflect generally accepted principles for developing, issuing, and using guidance documents. For example, a good guidance document represents our current thinking on a matter and clearly states that it does not establish legally enforceable requirements. We expect each guidance document developed, issued, and used under the rule to have the characteristics of a good guidance document.

(Comment 2) One comment suggested that we include in the definition of guidance documents those documents that describe our current policies regarding labeling and promotion.

In our proposal, we defined guidance documents to include, among other kinds of documents, those that relate to the design, production, manufacturing, and testing of regulated products and those that relate to inspection or enforcement policies. We interpret our definition to include guidance documents about product labeling and promotion. We are amending the definition in § 10.115(b)(2) to clarify our intent to include such topics as subjects for guidance documents.

(Comment 3) Several comments discussed the annual publication of the comprehensive list of guidance documents and the guidance document agenda. Some suggested that we continue to publish these lists on a semiannual basis.

Some comments stated that yearly publication of the comprehensive list is acceptable, particularly given that we maintain a current list on the Internet.

One comment stated that annual publication of the guidance document agenda would be reasonable if we include the status of each item on the list and identify the highest priority guidance documents. Another comment recommended that the agenda be posted on the Internet.

We believe that we provide adequate notice of and access to all available guidance documents through two mechanisms. We annually publish a comprehensive list of guidance documents in the Federal Register and we maintain current (i.e., updated within 30 days of the issuance of a new or newly revised guidance document or the deletion of an obsolete guidance document) lists of guidance documents on the Internet.

We also believe that we provide adequate notice of the guidance document agenda through its annual publication in the Federal Register . We will not include the status of each document on the agenda. Each document listed on the agenda is being developed; further description of document status would not be practical because it would be too difficult to differentiate the stages of guidance document development. We also do not believe it would be feasible to prioritize the documents on the agenda. Often, resources allocated to the development of a particular document are diverted to creating guidance documents regarding other areas of greater public health need. As a result, our priorities may change throughout the year and priorities stated on the agenda would not remain accurate for an extended period of time. We try to maintain a current (i.e., updated at least semiannually) guidance document agenda on the Internet.

In efforts separate from this rulemaking, we are considering ways to enhance our lists of guidance documents maintained on the Internet. For example, we are trying to make the lists easier to navigate and search. These enhancements may allow you to more efficiently find the information you seek on the comprehensive list and the agenda.

(Comment 4) One comment suggested that we include a brief statement describing each document on the comprehensive list.

We understand that much of the value of the comprehensive list lies in its ability to convey the subject matter of each document on the list. To provide this information adequately, we plan to ensure that the titles or subtitles of documents convey the subject of the document more precisely. The comprehensive list could become too cumbersome and difficult to use if we added a description of the subject of each document. Therefore, we will not include a separate statement describing each document on the comprehensive list.

(Comment 5) A comment stated that the comprehensive list should identify guidance documents that have been revised or are currently being considered for revision.

Through the lists that we publish under the procedures previously described, we already make the information requested in the comment available to the public. On the comprehensive list, we include the date of the last revision of a guidance document. This enables you to identify those guidance documents that have been revised and the date of the revision. In our guidance document agenda, we list guidance documents that are under consideration for development or revision.

(Comment 6) In § 10.115(c), we define two levels of guidance documents, Level 1 and Level 2. The two levels of guidance documents are subject to different procedures for public participation before issuance. One comment suggested that we include the designation for each document as Level 1 or Level 2 in the prospective list of guidance documents.

We decline the suggestion to include the Level 1 or Level 2 designation for all documents on the guidance document agenda. Generally, at the time we issue the agenda, we do not know the full content of the proposed documents. Thus, a determination of whether a document meets the criteria for a Level 1 designation (§ 10.115(c)(1)) would be premature.

(Comment 7) One comment suggested that we make the guidance document agenda more user-friendly by separating guidance documents on cross-cutting issues from those that are technology-specific.

The purpose of the guidance document agenda is to notify you of guidance documents we are developing so you may comment on topics for new documents and possible revisions to existing documents. We believe the guidance agenda is currently organized to disseminate this information most effectively. The documents on the agenda are organized by the issuing center or office and generally are further grouped by topic categories. By separating guidance documents according to the issuing center or office, we enable those of you who have interest in a particular issue or type of product (e.g., food products) to focus on documents that are being developed in one of the centers or offices (e.g., the Center for Food Safety and Applied Nutrition). Guidance documents that are being developed in more than one center or office will appear on the agenda for each participating center or office. Grouping documents on the agenda by subject category (e.g., electronic submissions) provides you greater ability to focus on specific areas of interest. After the effective date of the rule, we will group all guidance documents on the agenda by subject category. This format is consistent with the format of the comprehensive list of guidance documents. We believe that the format suggested in the comment could make the agenda difficult to use because you would not be able to concentrate effectively on a particular topic of interest.

(Comment 8) One comment suggested that we implement procedures to give you the opportunity to comment on designation of a document as a Level 1 or Level 2 guidance document before the decision is made.

We decline to adopt this suggestion. It is in the best interest of promoting and preserving the public health that we be able to develop guidance documents in a timely and efficient manner. If we solicited comment on the level designation for each guidance document, we would create a procedural hurdle that could significantly slow the guidance development process. This delay in the development of guidance documents would not serve us or you.

We determine whether a document is Level 1 or Level 2 based on the criteria described in § 10.115(c). If you disagree with the designation of a document (e.g., if you believe that a guidance issued as a Level 2 should have been issued as a Level 1), you may send us an explanation of your reasons for disagreeing with our determination when you comment on the guidance document. If, after issuance, you still have a disagreement, you can appeal our designation using the dispute resolution process.

(Comment 9) One comment suggested that we announce the development and issuance of Level 2 documents in the Federal Register . Another comment recommended that we receive comments on Level 2 guidance documents before we issue them as final guidance.

We decline to amend our procedures for announcing and receiving comment on Level 2 guidance documents. When we issue Level 2 documents, they are immediately posted on the Internet. Also, their issuance is announced in the comprehensive list of guidance documents that is published annually in the Federal Register and maintained on the Internet.

Under section 701(h)(1)(D) of the act, we must solicit public comments “upon implementation” of guidance documents that describe existing practices or minor changes in agency policy. We believe the provisions of § 10.115(g)(4) are consistent with the act and describe adequate provisions for developing and issuing Level 2 guidance documents.

(Comment 10) Under § 10.115(g)(1)(v), we may issue a second draft of a guidance document and solicit comment on the document after providing an opportunity for comment on the first draft. One comment stated that two situations usually merit this procedure: When the first draft guidance on a medical or scientific topic is highly controversial and when the first draft guidance is in conflict with other widely recognized sources of scholarly guidance (e.g., International Conference on Harmonization guidance, pharmacopeial standards).

We agree that it may be appropriate for us to issue a second draft of a guidance document in the two situations described in the comment. In addition, it may also be appropriate for us to issue a second draft guidance in other circumstances. For example, if we revise a document for clarification, we may want to issue a second draft guidance document to receive comment on whether our revisions made the document easier to understand.

(Comment 11) One comment suggested that we allow the public to request the deletion of guidance documents that are no longer useful.

Under § 10.115(f), you can suggest that a document on the comprehensive list of guidance documents or on the guidance document agenda be revised or withdrawn if you find that the document is no longer relevant or accurate. We amended the final rule to explicitly state that you can suggest that a guidance be withdrawn (§ 10.115(f)(4)).

(Comment 12) Many comments urged us to include a provision in the regulation requiring us to provide written responses to public comments or suggestions for revising guidance documents. One comment stated that we should respond to each suggestion for a revision to an existing guidance document within 90 days. Other comments stated that we should explain to the public why we changed, or why we did not change, a guidance document between the draft and final stages. Some comments recommended that we provide general responses to comments grouped by topic. Others suggested that we be required to issue a written response when certain criteria are met (e.g., when a majority of the comments on a guidance document concern the same issue).

We believe that it is in the public interest to have an efficient process for developing guidance documents. The guidance document development process would be hampered if we were required to respond to each comment. When comments received are very significant or cause us to revise a guidance, we often discuss those comments in the notice of availability (NOA) for the final guidance or in the final guidance document. We intend to continue this practice. However, making a firm commitment to provide a written response to all comments when issuing a final guidance would unnecessarily delay the issuance of the document.

(Comment 13) Two comments suggested that we be required to respond to your proposals for draft guidance documents.

We agree with this comment. When you have taken the time to develop a guidance document and submit it to us for review, you should receive, at a minimum, an acknowledgment of receipt of the document. Therefore, we are now accepting guidance document submissions at the Dockets Management Branch. If you submit a document to us, you should designate it as a “Guidance Document Submission,” include the name of the center or office with oversight over the subject matter covered by the guidance document, and submit the document to the Dockets Management Branch (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

The Dockets Management Branch will ensure that the document is assigned a public docket number and it is sent to the appropriate office or center. All proposed guidance documents will be available through the public docket. We will send you a written acknowledgment that we have received your document, and to the extent feasible, we also will inform you of our actions regarding the document you have submitted. These changes to the final rule are included in revised § 10.115(f)(3).

(Comment 14) We received many comments on early collaboration and meetings to discuss guidance documents as they are being developed. Generally, the comments were very supportive of our efforts to facilitate early interaction with you. Some comments suggested that we issue a clear policy about the procedures for collaboration and early meetings. One suggested that we provide a means for industry to recommend a particular collaborative approach for a guidance document under development. Another comment recommended that we provide opportunities for you to engage in “real time dialogues” with us before we begin to write a draft or final guidance. The comment noted a number of avenues for this type of collaboration, including joint task forces, public and private meetings, advisory committee meetings, and e-mail correspondence. Other comments stated that certain agency components had refused to meet about a guidance document before that document was issued in draft. One comment specifically requested that we use more mandatory language regarding preproposal collaboration with you.

We agree that early collaboration (i.e., input from you in the early stage of developing the approach we will take in a new or revised guidance document) can be a very valuable tool in developing regulatory guidance. We have created several mechanisms to encourage early input, including the following:

• We provide an opportunity to suggest new or revised guidance.

• We publish an agenda of the guidance documents that we are working on and request your comments on the agenda.

• We notify you when we issue draft guidance documents and request your comments on the drafts.

• We may hold meetings or workshops even before we develop a draft document.

We encourage your involvement in our development of guidance documents. Often, we develop guidance documents based on your suggestions. We solicit your comments on draft guidance documents because our views are not yet finalized and we want your input on the contents of the final guidance.

We understand that you would like to meet with us more regarding the development of guidance documents. Our policies on meeting with the public on guidance development are evolving. In efforts separate from this rulemaking, we are exploring ways to increase this interaction within the confines of applicable statutes and regulations, and are considering our need to provide all interested parties access to the process, our interest in issuing documents in a timely manner, and our resource constraints. We welcome your suggestions in this area.

(Comment 15) One comment proposed establishing a mechanism in § 10.115(g) whereby companies can fund a market research initiative that would permit us, through questionnaires, focus groups, and other techniques, to obtain input on proposed policies directly from patients, doctors, and other stakeholders.

We welcome input from patients, doctors, and other stakeholders. We believe that the procedures described in § 10.115, especially our increased use of the Internet to disseminate information, provide adequate avenues for patient, doctor, and stakeholder involvement in the development of our policies. We decline at this time to establish a funded market research initiative because administering such a program would divert personnel resources from other public health priorities.

(Comment 16) One comment suggested that we consider interactive techniques, such as town hall meetings, that may encourage industry input on setting priorities for the development of guidance documents listed on the agenda.

We welcome industry input on prioritizing our development of guidance documents. We believe that the procedures described in the GGP's on the guidance document agenda, especially our increased use of the Internet to disseminate the agenda and our request for comments on the agenda, provide adequate avenues for industry and others to assist us in prioritizing guidance documents. Furthermore, the agenda is only one of several mechanisms we use to solicit input on prioritizing the guidance documents we are developing. For example, we may participate in public meetings and public hearings and may raise guidance document issues at advisory committee meetings. At this time, we decline to change the GGP's in the manner suggested but will continue to consider avenues for encouraging input at all stages of guidance development.

(Comment 17) One comment suggested that any proposed guidance documents submitted to advisory committees be made public in a manner that provides sufficient time for review before the meeting.

We agree that proposed guidance documents submitted to advisory committees should be made public as soon as practicable to allow for a review of those materials. We are working to ensure that this information is made available in a timely manner.

(Comment 18) We received several comments on the legal effect of guidance documents. A number of comments referred to the statement in the proposed regulation that we are willing to discuss an alternative approach with you to ensure that it complies with the relevant statutes and regulations (§ 10.115(c)(3)). The comments stated that if a guidance document is not binding, the discussion of alternative approaches should not be required.

The comments misinterpreted the intent of the statement in § 10.115(c)(3). If you take an alternative approach, you are not required to discuss that approach with us. Instead, we are offering our assistance to make sure that any alternative approach you take meets the appropriate statutory or regulatory requirements. Discussing alternative approaches may help you understand our interpretation of the applicable statutes and regulations and may further our understanding of the merits of your approach.

(Comment 19) Two comments suggested that compliance with a guidance document should provide a company with a safe harbor from FDA enforcement action. The comments recommended that we change the regulation to require us to amend, or at least publish a proposal to amend, a guidance document before initiating an enforcement action against a company that acted in accordance with a guidance. The comments also noted that if we do not provide a safe harbor from enforcement, at a minimum, a company's action in accordance with a guidance document should be evidence of the company's intent to comply with our regulations.

Section 701(h)(1)(B) of the act provides that guidance documents “shall not be binding on the Secretary.” Creating a “safe harbor” in a guidance document that would preclude us from taking action would impermissibly bind us. In issuing enforcement-related guidance documents, we express our current thinking regarding regulatory matters and believe this provides useful information. However, you always remain independently responsible for complying with applicable statutes and regulations. Whether you have complied with the law is determined from the facts of each case.

(Comment 20) We received two comments suggesting that we clarify to our staff that FDA may not cite failure to follow a guidance document in any observation on Form FDA 483 (List of Inspectional Observations).

We agree with this comment. Guidance documents are not binding. An enforcement action may be taken only when we find a violation of statutory or regulatory requirements. If a guidance document contains a reference to a regulatory or statutory requirement, then enforcement action may be taken if the regulation or statutory requirement is violated. Of course, enforcement action may be taken if a requirement in a regulation or statute is violated whether or not there is a reference to the requirements in any guidance document. We discuss this issue in the GGP training we provide employees under § 10.115(l)(1).

(Comment 21) We received one comment on how we should interpret a draft guidance document during the time that it is out for comment, before the document has been finalized. The comment suggested that we maintain three categories of guidance documents: Draft, approvable, and approved.

We believe the provisions of § 10.115(g) sufficiently describe both the process for issuing draft Level 1 guidance documents for comment and the process of implementing Level 1 guidance documents without comment when prior public participation is not feasible or appropriate. We do not believe that adding more categories will improve the process; instead, it could confuse the users of the documents. Early in the process of developing the GGP's, comments strongly urged the agency to streamline and simplify the nomenclature for guidance documents. We have done so. If you are concerned about FDA's thinking on an issue that is reflected only in a draft guidance, you should contact the appropriate office within FDA to discuss the issue.

While a draft Level 1 guidance document is out for comment, you may be concerned that the guidance will change based on comments received. Because a guidance document represents the agency's current thinking on a subject but it is not ever binding on FDA or outside parties, you should not rely on any guidance document, draft or final. If you have questions about compliance with statutory or regulatory requirements, you can discuss those issues with an FDA employee.

(Comment 22) We received two comments suggesting that the designation as Level 1 or Level 2 be a standard element of each guidance document.

We believe that the comment misinterpreted the significance of the Level 1 or Level 2 designation. The designation of a guidance as Level 1 or Level 2 is only relevant when a guidance document or revision to a guidance document is being developed. The designation is used to indicate whether the proposed document or revision is significant enough to warrant public comment before implementation. If the Level 1 or Level 2 determination remains with the document as a standard element, it may be confusing. For example, if we make a very minor revision to a guidance document that contains highly significant issues, this revision would warrant a Level 2 determination for the purposes of receiving comments. Affected parties should not assume that the document contains issues that are less significant because of the Level 2 designation, but rather that the change being made is not significant.

(Comment 23) One comment suggested that we require as an element in each guidance document a statement that explains why the document is needed.

Guidance documents should be issued only when a need for guidance exists. In each document, we generally include a background section that states the reason for its issuance. We will continue to do this in the future. However, although we acknowledge the utility of stating the need for each guidance, we do not believe the statement should be required. The advice we provide in a guidance document represents our current thinking, regardless of whether we adequately explain the need for the guidance. Therefore, we decline to make this information a required element in our guidance documents.

(Comment 24) One comment suggested that statements of nonbinding effect be prominently displayed on all guidance documents.

We agree with the comment. It is critical that all parties understand that guidance documents do not bind us or you. We are amending the regulation at § 10.115(i)(1)(iv) to require that a statement of the guidance document's nonbinding effect be displayed on prominently each document. In the future, this statement will be placed immediately below the title of the guidance document on the first page of text and it will be in prominent (e.g., bold or italic) print.

(Comment 25) In the proposed rule, we stated that we would not seek public input prior to implementing a Level 1 guidance document if we determine that prior public participation is not feasible or appropriate (proposed § 10.115(g)(2)). Several comments discussed this exception to the prior public participation requirement. Two comments stated that we should use the exception only in rare and extraordinary circumstances. Other comments suggested that we only use this exception in cases where there is a real, demonstrated public health emergency, not just a theoretical emergency. Another comment stated that when we use these procedures, we should provide a statement of our reasons for not soliciting prior public participation.

Under section 701(h)(1)(C) of the act, we must ensure public participation prior to the implementation of guidance documents unless we determine that such prior public participation is not feasible or appropriate. As discussed in the preamble to the proposed rule, § 10.115(g)(2) reflects the standard stated in the statute (65 FR 7321 at 7324). We anticipate that this exception will generally be used when: (1) There are public health reasons for the immediate implementation of the guidance document; (2) there is a statutory requirement, executive order, or court order that requires immediate implementation; or (3) the guidance document presents a less burdensome policy that is consistent with public health. We agree that we should explain why a document is being issued without prior public participation when we issue the document. Generally, this explanation is included in the NOA for the guidance document. We will continue to follow this procedure in the future.

(Comment 26) One comment suggested that we adopt a 30-day grace period for Level 1 guidance documents issued without prior public participation.

A grace period would not be needed for a guidance document because guidance is not binding on us or you. We do not enforce guidance documents; we enforce applicable statutory and regulatory requirements.

We are committed to ensuring that you have the opportunity to participate in guidance document development as much as possible. Therefore, we will issue a Level 1 guidance document without prior public participation only if it is not feasible or appropriate to solicit your comments (e.g., a public health emergency or a court order requires the issuance of the guidance and we need to make the document available to the public as quickly as possible). A delay in implementation would not be appropriate in such circumstances.

(Comment 27) One comment noted that there are times when a Level 2 guidance document may become controversial and suggested that we adopt procedures whereby a Level 2 document could be withdrawn, redesignated as a Level 1 document, and reissued in draft for public comment.

We believe that the GGP's implicitly provide us with the ability to act as the comment describes. If our initial determination to issue a guidance document or amended guidance document using Level 2 procedures proves to be an incorrect decision because the document is highly controversial when issued, we may withdraw the guidance document and reissue it as a draft guidance document following Level 1 procedures (i.e., publish an NOA in the Federal Register for the draft guidance document and solicit comments on the draft). We do not believe the rule should be amended to reflect these procedures.

(Comment 28) Two comments suggested that we use the Internet to the greatest extent possible to disseminate guidance documents. Several comments specifically requested that we allow submission of comments on guidance documents through e-mail.

We use the Internet as our primary means of disseminating guidance documents. In most cases, newly issued or revised guidance documents are available on the Internet at the same time they are available through other means (e.g., through the Dockets Management Branch). We are developing new ways to use Internet technology to enhance our ability to disseminate information to the public. In particular, we are developing a system for providing access to all documents on the Internet and facilitating e-mail submission of comments on guidance documents.

(Comment 29) One comment suggested that we publish a new guidance document within 30 days of changing our current thinking on a given subject. This comment also urged us to amend the regulations to clarify that the information in a guidance document may be relied on to be currently acceptable to FDA.

We agree that guidance documents should reflect our current thinking on a given subject. We try to ensure that our documents are current. However, we allocate our limited resources to the areas of greatest public health need. Although GGP's help to ensure a greater level of public participation in guidance development, following these procedures often means that it takes longer to issue guidance documents. Therefore, we will not commit ourselves to issuing guidance documents within a specific timeframe. We need flexibility to allocate our resources as we see fit, for example, to an area that presents more significant public health issues.

In response to the second part of the comment, § 10.115(d)(3) of the final rule clearly states that guidance documents represent the agency's current thinking on the subject of the document, and that FDA employees may depart from guidance documents only with appropriate justification and supervisory concurrence.

(Comment 30) One comment stated that if we depart from a guidance document on multiple occasions, we should consider revising the document. A similar comment noted that when a change in policy allows deviation from a guidance document, we should amend the document to indicate the existence of limited exceptions.

As discussed previously, guidance documents should represent our current thinking on the matters discussed in the documents. Our consistent deviation from a guidance document might suggest that we should revise it. Furthermore, we should amend guidance documents to clarify any changes in our interpretation of a guidance document. As resources allow, we will continue to update and revise guidance documents to reflect our current thinking.

(Comment 31) One comment suggested that we provide written justification for deviating from a guidance document.

As discussed in the preamble to the proposed rule (65 FR 7321 at 7327), we agree that our employees should not deviate from guidance without appropriate justification and supervisory concurrence. However, because guidance documents are not legally binding, we do not believe that we should provide written notice stating the reasons for such deviations. If we are asked to explain why we are deviating from a guidance document, we will do so.

(Comment 32) One comment suggested that we consolidate guidance documents addressing identical topics, those covering one topic that applies to several premarketing application types, and those containing identical premarketing application elements for similar product lines. This comment also noted that some currently available guidance documents are obsolete, redundant, or no longer appropriate.

We consolidate similar guidance documents when feasible and appropriate. Our primary concern is to issue documents that represent our current thinking on a particular matter. On balance, the benefit of having consolidated guidance documents is often outweighed by the burden of reissuing the documents. Furthermore, consolidated documents may be too cumbersome to be user-friendly.

We agree that documents that are obsolete, redundant, or no longer appropriate should be revised or withdrawn so they do not create confusion. During the past few years, we have tried to eliminate or revise documents when appropriate, given our resource constraints. We will continue this practice. Section 10.115(f) provides you with an opportunity to suggest documents that should be eliminated or revised.

(Comment 33) One comment noted that we should not use guidance documents as a replacement for notice-and-comment rulemaking.

We agree with this comment and believe that in certain circumstances regulations should be issued, while in other circumstances issuance of a guidance document is more appropriate. We carefully consider whether a document that contains binding requirements should be issued. This decision ultimately determines whether it is more appropriate for us to issue regulations or guidance on a given subject.

(Comment 34) We received several comments on our dispute resolution process. One comment suggested that we establish a systematic review process for external auditors to examine the decisions of our staff and to determine whether the application of a guidance document was appropriate. One comment encouraged us to develop an appeals process to address complaints about our development and use of guidance documents, stating that this appeals process is required by the Modernization Act. Other comments suggested that we describe the normal appeals process for disputes about the content of a guidance document in this final rule.

We appreciate the importance of providing effective mechanisms for dispute resolution and recognize that guidance documents need to be developed, issued, and used in a manner that is consistent with GGP's. However, we believe that an evaluation of our current dispute resolution system by an external auditor is unnecessary. We are required under section 405 of the Modernization Act to ensure that an effective appeals mechanism is in place to address complaints about our development and use of guidance documents. We believe that we have such a mechanism in place.

If you believe that an FDA staff member did not follow the GGP's, including any situation where you believe a staff member treated a guidance document as binding, under § 10.115(o) you can raise the issue with that staff member's supervisor. If the issue cannot be resolved, you can continue raising it through the chain of command. These procedures complement our dispute resolution regulation in § 10.75 (internal review of decisions). You can also use the procedures in § 10.75 to appeal a decision on the GGP's. We are amending the final rule to provide another means for raising an issue about our implementation of the GGP's. Under amended § 10.115(o), you can contact the ombudsman of the center or office with which you have a dispute and seek the ombudsman's assistance in resolving the issue. Finally, if you feel that you are not making progress or if you are unable to resolve the issue at the center or office level, you can request that our Chief Mediator and Ombudsman become involved. Each center and office has made or will make available its own guidance documents on specific procedures for resolving disputes.

You may also petition us under § 10.30 (citizen petitions) and request that we formally resolve your issue.

(Comment 35) One comment suggested that we explicitly state that guidance documents apply to all parties who work in the area addressed by the document. The comment stated that historically, we have not applied guidance documents uniformly to work undertaken by different individuals.

In each document, we generally include an introductory section that states the intended audience of the guidance document (e.g., applicants, reviewers). The guidance document applies to all members of the intended audience. If you believe that an FDA staff member is not interpreting the document appropriately, you can follow the dispute resolution procedures described previously and in § 10.115(o).

(Comment 36) One comment suggested that we post the names and titles of the supervisors for each center/office on our Internet home page (www.fda.gov).

We agree that information about the individuals to contact regarding the resolution of a dispute should be readily available. This information is currently on the Internet for all of the centers and offices. You can find the organizational charts at the following Internet addresses:

(Comment 37) In § 10.115(l)(2), we state that our centers and offices will monitor the development and issuance of guidance documents to ensure that GGP's are being followed. One comment suggested that we consider using a center ombudsman (e.g., the new ombudsman in the Center for Devices and Radiological Health) to perform this monitoring function.

We agree that it is important to ensure that guidance documents are developed and issued consistently by all centers and offices. Therefore, each center and office will designate one or more persons to monitor the development and issuance of its guidance documents. The center or office can designate the ombudsman and/or other individuals to perform this function.

As discussed previously, under § 10.115(o) you may seek the assistance of a center or office ombudsman or the Office of the Chief Mediator and Ombudsman if you believe that someone at FDA is not following the GGP's.

(Comment 38) One comment said that if we are serious about ensuring that our employees do not develop policy through speeches and other informal mechanisms, we should update and enforce internal written procedures on this subject. Another comment suggested that we state that our employees may not make statements at advisory committee meetings as a means to communicate new regulatory expectations.

We stated in the proposed regulation at § 10.115(e) that we may not use documents and other means of communication that are excluded from the definition of guidance document to informally communicate new or different regulatory expectations to the public for the first time. We are maintaining this language in the final rule. Part of our GGP training for employees includes the understanding that policy is not to be communicated initially to a broad audience through speeches. Statements at advisory committee meetings often depend on the context of the statement. If, for example, a marketing application under consideration raises a novel issue, it may be appropriate for an FDA employee to comment on that issue as it relates to a specific application during a public advisory committee meeting. If there are questions raised by an advisory committee member that are not about a specific application, an individual employee can express a view, but this would not reflect official agency policy.

(Comment 39) One comment suggested that we examine our processes for training, evaluation, and related internal guidance to ensure that our directives to staff reinforce the appropriate use of guidance documents.

Section 701(h)(1)(B) of the act requires us to provide training for employees on how to develop and use guidance documents. We train employees about guidance documents in new employee orientation and/or as part of continuing employee education and training programs. Internal procedural documents are examined before they are issued to ensure that they are consistent with our GGP policies.

(Comment 40) Several comments recommended that there be better internal coordination among centers in the development, issuance, and use of guidance documents. In particular, one comment suggested that FDA ensure closer communication among centers, clarify the role of each center in oversight, and communicate clearly the enforcing center's expectation of a firm's responsibility for following a guidance document.

One comment referred to the “enforcing” center. We note that guidance is not enforceable. It is not binding on you or us.

In section 123 of the Modernization Act, Congress directed us to minimize differences in the review and approval of products required to have approved biologics license applications under section 351 of the Public Health Service Act (42 U.S.C. 262) and products required to have approved new drug applications under section 505(b)(1) of the act (21 U.S.C. 355(b)(1)). We have made a concerted effort to minimize those differences and otherwise streamline the regulation of products that may involve dual jurisdiction of our centers. As part of this effort, we have issued numerous joint guidance documents.

We also have several checks within the guidance document development process that help to ensure that there is communication among centers on multicenter topics. For example, Level 1 guidance documents that describe new legal interpretations or significant changes in our policy are reviewed by the Office of the Chief Counsel and the Office of Policy before issuance. These offices are aware of cross-cutting issues and can ensure appropriate coordination.

(Comment 41) A comment suggested that we define the minimum levels of approval authority for sign-off on guidance documents.

We understand that having the appropriate level of clearance on guidance documents is important for purposes of quality control and to achieve the greatest level of consistency across the agency. However, we believe that we should maintain flexibility by providing discretion to the various centers and offices to determine their appropriate levels of clearance. Therefore, we decline the suggestion to mandate minimum levels of approval authority for guidance documents.

(Comment 42) One comment suggested that we clarify the status of advisory opinions and determine whether they are guidance documents.

We issue advisory opinions under § 10.85. We anticipate modifying § 10.85 and explaining the effect of § 10.115 on previously issued advisory opinions in a separate rulemaking effort. As such, the comment is outside the scope of this rulemaking.

(Comment 43) Two comments suggested that we clarify the status of guidelines. One recommended that we designate them as Level 1 guidance.

Our ability to issue guidelines was described in § 10.90(b). In the conforming amendments to the proposed rule, we proposed to delete all references to guidelines in § 10.90(b) and replace the provision with the statement that guidance documents will be developed, issued, and used according to the requirements at § 10.115. On further consideration, we have decided not to include a provision on guidance documents in § 10.90(b) because it is not necessary to state that guidance documents will be regulated under § 10.115. Therefore, we are removing and reserving § 10.90(b).

As described in the preamble to the proposed rule, all guidelines are now treated as guidance documents (65 FR 7321 at 7326). Because we no longer issue guidelines, we need not determine whether they would warrant a Level 1 or Level 2 determination. If any documents previously issued as guidelines are amended, we will follow the same procedures used for amending guidance documents (i.e., we will determine whether modifying the document meets the criteria for a Level 1 or Level 2 change).

(Comment 44) One comment asked whether we ensure that all broadly disseminated letters are posted on the Internet and whether we have procedures in place for quality control of this process.

We currently post all broadly disseminated letters on the Internet, including “Dear Doctor” letters, and letters that are broadly circulated but do not provide the agency's current thinking on a regulatory issue. All broadly disseminated letters that fall under the definition of guidance documents are issued under the procedures described in this rule. Each center and office has personnel who determine whether a broadly disseminated letter meets the criteria for a guidance document and should be issued as such.

(Comment 45) One comment asked whether we post on the Internet letters containing information about public health alerts.

In § 10.115(b)(3), we clarify that guidance documents do not include general information documents provided to consumers or health professionals. Public health alerts fall within this category of documents. While public health alerts are not guidance documents, and the comment is beyond the scope of this rulemaking, we do post such information on the Internet, as appropriate.

(Comment 46) One comment questioned whether we have a mechanism in place for receiving and evaluating suggestions for novel or more efficient procedures. The same comment suggested that we create a data base that contains all correspondence issued to a company. The comment also requested that we post on the Internet all of our speeches and the preamble to the September 29, 1978, current good manufacturing practices (CGMP's) regulation.

These comments are beyond the scope of this rulemaking.

In addition to amending the final rule as described previously in response to comments, we are making one revision that will improve our ability to participate in international negotiations on guidance documents. As described in § 10.115(i)(1) and (i)(2), a guidance document must: (1) Include the term “guidance,” (2) identify the center(s) or office(s) issuing the document, (3) identify the activity to which and the people to whom the document applies, (4) include a statement of the document's nonbinding effect, (5) include the date of issuance, (6) note if it is a revision to a previously issued guidance, and (7) contain the word “draft” if the document is a draft guidance. Furthermore, guidance documents must not include mandatory language such as “must” or “required” unless we use those words to describe a statutory or regulatory requirement.

In accordance with our mission, we actively participate in international efforts to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements (section 903(b)(3) of the act 21 U.S.C. 393(b)(3)). Through these efforts, we frequently negotiate guidance documents with representatives of other countries. For example, our participation in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has allowed us to work with representatives of regulatory authorities from Europe, Japan, and the United States and experts from the pharmaceutical industry in the three regions to develop numerous guidance documents on the regulation of human drug and biological products.

When draft documents are negotiated with representatives of other countries, we seek public comment on the resulting documents. We believe it is important to publish draft documents for comment at the same time as other countries so we may review the public comments and resume negotiations in a timely manner. However, other countries do not follow our GGP's; therefore internationally negotiated draft documents often do not comply with all of the provisions of § 10.115(i)(1) and (i)(2). For example, documents negotiated through ICH do not include the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research as issuing offices. Differences in language and use of certain terms often result in wording that implies the draft documents establish mandatory requirements. Therefore, to facilitate the development and issuance of draft documents resulting from international negotiations, we have modified the final rule to state that when issuing “draft” guidances that are the product of international negotiations, we need not apply the provisions of § 10.115(i)(1) and (i)(2). However, we recognize and the final rule provides that final guidances that are the product of international negotiations must comply with all of the provisions of § 10.115(i). We anticipate that this amendment will provide many advantages, including our ability to: (1) Provide more time for public comment on draft guidance documents that are the result of international negotiations, (2) receive more public comments on these draft documents, (3) negotiate based on issues raised in public comments more effectively, and (4) resume international negotiations in a timely manner.

We refer to guidelines issued under former § 10.90(b) throughout our regulations. Because we are revising our administrative regulations by deleting guidelines and adding guidance documents issued under § 10.115, we are making conforming amendments to 21 CFR parts 7, 10, 14, 19, 25, 101, 107, 110, 114, 170, 310, 312, 314, 316, 500, 514, 601, 803, 814, and 860 to reflect our changes. We are also adding § 601.29, Guidance documents, to the biologics regulations, to be consistent with §§ 312.145, 314.445, and 814.20. These conforming amendments will ensure the accuracy and consistency of the regulations.

The agency has determined under 21 CFR 25.30 that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required statement would be required.

We have examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Under the Regulatory Flexibility Act, if a rule may have a significant economic impact on a substantial number of small entities, an agency must consider alternatives that would minimize the economic impact of the rule on small entities. Section 202(a) of the Unfunded Mandates Reform Act requires that agencies prepare a written assessment of anticipated costs and benefits before proposing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million in any one year (adjusted annually for inflation).

We believe that this final rule is consistent with the regulatory philosophy and principles identified in Executive Order 12866 and in these two statutes. This rule does not impose any mandates on State, local, or tribal governments. The rule will not be significant as defined by the Executive Order and will not require further analysis under the Regulatory Flexibility Act. The Unfunded Mandates Reform Act does not require us to prepare a statement of costs and benefits for the rule because the rule in any 1-year expenditure would not exceed $100 million adjusted for inflation. The current inflation-adjusted statutory threshold is $110 million.

This regulation would impose no additional reporting or recordkeeping requirements. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have concluded that the rule does not contain policies that have federalism implications as defined in the order and, consequently, a federalism summary impact statement is not required.

PDMA, as amended by the PDA, amended sections 301, 303, 503, and 801 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331, 333, 353, 381) to, among other things, establish requirements for the wholesale distribution of prescription drugs; and to prohibit, with certain exceptions, the sale or offer to sell prescription drugs that have been purchased by a hospital or other health care entity or that have been donated or supplied at a reduced price to a charitable organization.

Section 503(e)(1)(A) of the act states that each person who is engaged in the wholesale distribution of a prescription drug who is not the manufacturer or an authorized distributor of record for the drug must, before each wholesale distribution of a drug, provide to the person receiving the drug a statement, also known as a drug “pedigree,” (in such form and containing such information as the Secretary may require) identifying each prior sale, purchase, or trade of the drug, including the date of the transaction and the names and addresses of all parties to the transaction. Section 503(e)(4)(A) of the act states that, for the purposes of section 503(e), the term “authorized distributors of record” means those distributors with whom a manufacturer has established an “ongoing relationship” to distribute the manufacturer's products.

In the PDMA final rule, the agency published regulations in part 203 (21 CFR part 203) implementing these and other provisions of PDMA. Section 203.50 implements section 503(e)(1)(A) of the act and requires that, before the completion of any wholesale distribution by a wholesale distributor of a prescription drug for which the seller is not an authorized distributor of record to another wholesale distributor or retail pharmacy, the seller must provide to the purchaser a statement identifying each prior sale, purchase, or trade of the drug. The identifying statement must include the proprietary and established name of the drug, its dosage, the container size, the number of containers, lot or control numbers of the drug being distributed, the business name and address of all parties to each prior transaction involving the drug, starting with the manufacturer, and the date of each previous transaction. Section 203.3(b) defines “authorized distributor of record” as a distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's products. “Ongoing relationship” is defined in § 203.3(u) to mean an association that exists when a manufacturer and a distributor enter into a written agreement under which the distributor is authorized to distribute the manufacturer's products for a period of time or for a number of shipments. If the distributor is not authorized to distribute a manufacturer's entire product line, the agreement must identify the specific drug products that the distributor is authorized to distribute.

Thus, the PDMA final rule requires unauthorized distributors (i.e., those distributors who do not have a written authorization agreement) to provide a drug statement, or pedigree, to purchasers showing the entire prior sales history of the drug back to the first sale by the manufacturer. As discussed in the preamble to the PDMA final rule (64 FR 67720 at 67747), manufacturers and authorized distributors of record are not required to provide an identifying statement when selling a drug, although the agency encouraged them to do so voluntarily to permit unauthorized distributors to continue to be able to purchase products from them. 2

The provisions in the PDMA final rule related to wholesale distribution of prescription drugs by unauthorized distributors (i.e., §§ 203.3(u) and 203.50) were adopted from the provisions in the proposed rule published in the Federal Register of March 14, 1994 (59 FR 11842), and are essentially the same as the proposed provisions, except the definition for “ongoing relationship” in the proposed rule was revised to eliminate certain requirements. 3 The agency received two comments on the proposed definition of ongoing relationship and one comment on proposed § 203.50, and responded in detail to those comments in the preamble to the PDMA final rule (see 64 FR 67720 at 67727, 67728, and 67747).

Section 503(c)(3)(A) of the act states that no person may sell, purchase, or trade, or offer to sell, purchase, or trade, any prescription drug that was purchased by a public or private hospital or other health care entity. Section 503(c)(3)(B) of the act states several exceptions to section 503(c)(3)(A), none of which are relevant to this discussion. Section 503(c)(3) of the act also states that “[f]or purposes of this paragraph, the term ‘entity’ does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law * * *.”

Sections 203.20 of the PDMA final rule provides, with certain exceptions, that no person may sell, purchase, or trade, or offer to sell, purchase, or trade any prescription drug that was purchased by a public or private hospital or other health care entity or donated or supplied at a reduced price to a charitable institution. In § 203.3(q) of the PDMA final rule, “Health care entity” is defined as meaning any person that provides diagnostic, medical, surgical, or dental treatment, or chronic or rehabilitative care, but does not include any retail pharmacy or wholesale distributor. Under both the act and the PDMA final rule, a person could not simultaneously be a health care entity and a retail pharmacy or wholesale distributor. Thus, under the PDMA final rule, blood centers functioning as health care entities could not engage in wholesale distribution of prescription drugs, except for blood and blood components intended for transfusion, which are exempt from PDMA under § 203.1 of the PDMA final rule. Blood and blood components include whole blood, red blood cells, platelets, and cryoprecipitated antihemophilic factor, which are prepared by blood banks who collect blood from donors and separate out the components using physical or mechanical means. Blood derivatives are derived from human blood, plasma, or serum through a chemical fractionation manufacturing process. Examples of blood derivative products include albumin, antihemophilic factor, immune globulin, and alpha-1 anti-tripsin. As discussed in the preamble to the PDMA final rule in response to comments (64 FR 67720 at 67725 through 67727), blood derivative products are not blood or blood components intended for transfusion and therefore could not be distributed by health care entities, including full service blood centers that function as health care entities, after the final rule goes into effect. The agency received several comments on the proposed rule objecting to the applicability of the sales restrictions to the sale of blood derivatives by blood centers that function as health care entities, and responded in detail to those comments (see 64 FR 67720 at 67726).

After publication of the PDMA final rule, the agency received letters and petitions and had other communications with industry, industry trade associations, and members of Congress objecting to the provisions in §§ 203.3(u) and 203.50. On March 29, 2000, 4 the agency met with representatives from the wholesale drug industry and industry associations. The meeting participants discussed their concerns with both: (1) The requirement in § 203.3(u) that there be a written authorization agreement between a manufacturer and distributor for the distributor to be considered an authorized distributor of record under § 203.3(b), and (2) the requirement in § 203.50 that unauthorized distributors provide a pedigree showing all prior sales going back to the manufacturer.

The meeting participants asserted that manufacturers are unwilling to enter into written authorization agreements with the majority of smaller wholesalers. As a result, these wholesalers cannot become authorized distributors of record for the drugs they sell. The meeting participants also said that smaller wholesalers cannot obtain the required pedigree showing all prior sales of the drugs they purchase for sale because a large portion of these drugs are purchased from authorized distributors who are not required to provide a pedigree and who are unwilling to voluntarily provide them. The meeting participants asserted that authorized distributors will not voluntarily provide pedigrees when they sell drugs to unauthorized distributors because it would require them to change their warehouse and business procedures, which would entail additional effort and expense.

The meeting participants asserted that implementation of the PDMA final rule will prevent over 4,000 smaller, unauthorized distributors from distributing drugs to their customers and may put them out of business, at least with respect to their prescription drug wholesale business. They also asserted that because many of their customers are smaller retail outlets that are not served by larger distributors, implementation of the PDMA final rule may leave certain markets for prescription drugs, and ultimately consumers for prescription drugs, underserved.

In addition to the meeting discussed above and other informal communications that FDA has had with industry, industry associations, and Congress, FDA received a petition for stay of action requesting that the relevant provisions of the PDMA final rule be stayed until October 1, 2001. That petition was supported by numerous letters submitted to the docket from entities that would be considered unauthorized distributors under the PDMA final rule. The agency also received a petition for reconsideration from the Small Business Administration (SBA) requesting that FDA reconsider the PDMA final rule and suspend its effective date based on the projected severe economic impact it would have on over 4,000 small businesses. The petitions argued that the requirement for a written agreement in § 203.3(u) is unreasonable because manufacturers are not willing to enter into such agreements with the majority of smaller distributors. The petitions also asserted that authorized wholesalers are not now able and could not provide, at a reasonable cost, a pedigree to their unauthorized distributor customers that meets the requirements of § 203.50 of the PDMA final rule. The SBA petition asserted that, if the effective date of the PDMA final rule is not stayed, drug products now in the inventory of wholesalers will have to be cleared and new orders will have to cease or be severely limited to comply with the PDMA final rule's December 4, 2000, effective date, with corresponding disruptions in the distribution of drugs possible by summer 2000.

In addition to the submissions on wholesale distribution by unauthorized distributors, the agency has received several letters on, and has held several meetings to discuss, the implications of the final regulations on blood centers that distribute blood derivative products and provide health care as a service to the hospitals and patients they serve. The blood center industry asserts that the regulations and, particularly the definition of “health care entity,” will severely inhibit their ability to provide full service care to the detriment of client hospitals and the patients they serve, and may disrupt the distribution of these products to the public. The agency also received a letter from Congress on this issue.

Based on the concerns expressed by industry, industry associations, and Congress about implementing §§ 203.3(u) and 203.50 by the December 4, 2000, effective date, the agency published a document in the Federal Register of May 3, 2000 (65 FR 25639), delaying the effective date for those provisions until October 1, 2001 (the May 2000 document). In addition, the May 2000 document delayed the applicability of § 203.3(q) to wholesale distribution of blood derivatives by health care entities until October 1, 2001. The May 2000 document also reopened the administrative record and gave interested persons until July 3, 2000, to submit written comments. As stated in the May 2000 document, the purpose of delaying the effective date for these provisions was to give the agency time to obtain more information about the possible consequences of implementing them and to further evaluate the issues involved.

On May 16, 2000, the House Committee on Appropriations (the Committee) stated in its report accompanying the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill, 2001 (report 106-619) that it supported the “recent FDA action to delay the effective date for implementing certain requirements of the Prescription Drug Marketing Act until October 1, 2001 and reopen the administrative record in order to receive additional comments.” In addition, the Committee stated that it “believes the agency should thoroughly review the potential impact of the proposed provisions on the secondary wholesale pharmaceutical industry.” The Committee directed the agency to provide a report to the Committee by January 15, 2001, summarizing the comments and issues raised and agency plans to address the concerns.

In light of the complexity of the issues involved and the potentially serious economic and public health consequences that implementation of the relevant provisions of the PDMA final rule may have, the agency believes that it is appropriate to hold a public meeting to solicit information from, and the views of, interested persons, including professional groups and associations, the regulated industry, health care professionals, and consumers. This will help to develop an adequate factual basis that the agency can use to determine whether it is in the public health interest to take steps to modify or change the requirements in the PDMA final rule.

The PDMA final rule provisions discussed in this document raise many complex economic and public health issues. To promote a more useful discussion at the public hearing, FDA has developed the following list of questions, which are of specific interest. This list is not intended to be exclusive, and presentations and comments answering other questions or addressing other issues, to the extent that they are pertinent to the PDMA final rule provisions discussed in this document, are encouraged.

1. How does the PDMA final rule, as published, affect the ability of unauthorized distributors to engage in drug distribution, i.e., what specific requirements would be difficult or impossible for unauthorized distributors to meet? Why?

2. If the PDMA final rule diminished the ability of unauthorized distributors to engage in drug distribution, what effect would this have on the drug distribution system? What, if any, adverse public health consequences would result? What would be the economic costs to manufacturers, distributors (authorized and unauthorized), and consumers of drugs?

3. If the act were amended by Congress to delete the requirement for provision of a drug pedigree by unauthorized distributors, would there be an increased risk of distribution of counterfeit, expired, adulterated, misbranded, or otherwise unsuitable drugs to consumers and patients?

4. If the act were amended by Congress to require authorized distributors to provide a pedigree, what types of additional costs and burdens would they incur?

5. Could specific changes be made to the information that is required under § 203.50 to appear on a pedigree to make it more practical, from an authorized distributor's standpoint, to voluntarily provide a pedigree? Would use of a standardized government form be helpful?

6. If actual sales by a manufacturer to a distributor were used by FDA as the only criterion to determine whether an ongoing relationship exists between them (and as a result, whether the distributor is an authorized distributor of record), would it result in more distributors being authorized than if a written authorization agreement is required? What other types of criteria might be used by FDA to make this determination?

1. What distribution systems are available for blood derived products? Do these distribution systems differ from those for other types of prescription drugs? If so, how?

2. What effect would the PDMA final rule, as published, have on the distribution system for blood derived products? What, if any, adverse public health consequences would result? What would be the economic costs to manufacturers, distributors, and consumers of blood derived products?

3. If blood derived products were excluded from the sales restrictions (i.e., if such products were permitted to be sold by health care entities), would there be an increased risk of distribution of counterfeit, expired, adulterated, misbranded, or otherwise unsuitable blood derived products to consumers and patients? Why or why not?

4. Do manufacturers of blood derived products provide these products to health care entities, particularly those that are also charitable organizations, at a lower price when compared to other customers? Do manufacturers sell these products to charitable or for profit health care entities with the understanding that the products will be used for patients of the purchasing health care entity and will not be resold to other health care entities, distributors, or retail pharmacies?

The Commissioner of Food and Drugs (the Commissioner) is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). The presiding officer will be the Commissioner or her designee. The presiding officer will be accompanied by a panel of FDA employees with relevant expertise.

Persons who wish to participate in the part 15 hearing must file a written notice of participation with the Dockets Management Branch (address above) prior to October 13, 2000. To ensure timely handling, any outer envelope should be clearly marked with the Docket No. 92N-0297 and the statement “FDA PDMA Hearing.” Groups should submit two copies. The notice of participation should contain the person's name; address; telephone number; affiliation, if any; the sponsor of the presentation (e.g., the organization paying travel expenses or fees), if any; brief summary of the presentation; and approximate amount of time requested for the presentation. The agency requests that interested persons and groups having similar interests consolidate their comments and present them through a single representative. FDA will allocate the time available for the hearing among the persons who file notices of participation as described above. If time permits, FDA may allow interested persons attending the hearing who did not submit a written notice of participation in advance to make an oral presentation at the conclusion of the hearing.

After reviewing the notices of participation and accompanying information, FDA will schedule each appearance and notify each participant by telephone of the time allotted to the person and the approximate time the person's oral presentation is scheduled to begin. The hearing schedule will be available at the hearing. After the hearing, the hearing schedule will be placed on file in the Dockets Management Branch under Docket No. 92N-0297.

Under § 15.30(f), the hearing is informal, and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation.

Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (part 10, subpart C (21 CFR part 10, subpart C)). Under § 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b). The transcript of the hearing will be available on the Internet at http://www.fda.gov/ohrms/dockets and orders for copies of the transcript can be placed at the meeting or through the Freedom of Information Staff (HFI-35), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

Any handicapped persons requiring special accommodations to attend the hearing should direct those needs to the contact person listed above.

To the extent that the conditions for the hearing, as described in this document, conflict with any provisions set out in part 15, this document acts as a waiver of those provisions as specified in § 15.30(h).

Interested persons may submit to the Dockets Management Branch (address above) written notices of participation and comments for consideration at the hearing by October 13, 2000. To permit time after the hearing for all interested persons to submit data, information, or views on this subject, the administrative record of the hearing will remain open following the hearing until November 20, 2000. Persons who wish to provide additional materials for consideration should file these materials with the Dockets Management Branch (address above) by November 20, 2000. Two copies of any comments are to be submitted, except that individuals may submit one copy.

Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

As published, the removal of temporary regulations (TD 8892) contains errors that may prove to be misleading and is in need of clarification.

District Commanders and Captains of the Port (COTP) must be immediately responsive to the safety needs of the waters within their jurisdiction; therefore, District Commanders and COTPs have been delegated the authority to issue certain local regulations. Safety zones may be established for safety or environmental purposes. A safety zone may be stationary and described by fixed limits or it may be described as a zone around a vessel in motion. Security zones limit access to vessels, ports, or waterfront facilities to prevent injury or damage. Special local regulations are issued to enhance the safety of participants and spectators at regattas and other marine events. Timely publication of these regulations in the Federal Register is often precluded when a regulation responds to an emergency, or when an event occurs without sufficient advance notice. However, the affected public is informed of these regulations through Local Notices to Mariners, press releases, and other means. Moreover, actual notification is provided by Coast Guard patrol vessels enforcing the restrictions imposed by the regulation. Because mariners are notified by Coast Guard officials on-scene prior to enforcement action, Federal Register notice is not required to place the special local regulation, security zone, or safety zone in effect. However, the Coast Guard, by law, must publish in the Federal Register notice of substantive rules adopted. To meet this obligation without imposing undue expense to the public, the Coast Guard periodically publishes a list of these temporary special local regulations, security zones, and safety zones. Permanent regulations are not included in this list because they are published in their entirety in the Federal Register . Temporary regulations may also be published in their entirety if sufficient time is available to do so before they are placed in effect or terminated. The safety zones, special local regulations, drawbridge regulations and security zones listed in this notice have been exempted from review under Executive Order 12866 because of their emergency nature, or limited scope and temporary effectiveness.

The following regulations were placed in effect temporarily during the period April 1, 2000 and June 30, 2000, unless otherwise indicated.

In the Saint Lawrence Seaway Development Corporation (SLSDC) Final Rule amending the Seaway Regulations and Rules (33 CFR part 401) published in the Federal Register on August 31, 2000 (65 FR 52912), inadvertent errors were made in the amended authority citation and in the amendment to § 401.90(c)(2). In the authority citation, “49 CFR 1.50a” should have been “49 CFR 1.52(a)”. In § 401.90(c)(2) the word “reasonable” should have been “reasonably”. This correction makes those changes.

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

On April 17, 2000 (65 FR 20423), EPA proposed a limited approval and limited disapproval of the following rules that were submitted for incorporation into the California SIP.

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

Rule 4.31 and Rule 4.37 allow APCO discretion as to approval of units that are exempt from RACT emission requirements due to lack of technical or economic feasibility. Rule 4.31 allows unapprovable APCO discretion as to schedule of periodic compliance determinations. Rule 4.34 allows APCO discretion in approving the use of alternate portable analyzers.

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

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

Therefore, as authorized in sections 110(k)(3) and 301(a) of the Act, EPA is finalizing a limited approval of the submitted rules. This action incorporates the submitted rules into the California SIP, including those provisions identified as deficient. As authorized under section 110(k)(3), EPA is simultaneously finalizing a limited disapproval of the rules. As a result, sanctions will be imposed unless EPA approves subsequent SIP revisions that correct the rules deficiencies within 18 months of the effective date of this action. These sanctions will be imposed under section 179 of the Act according to 40 CFR 52.31. In addition, EPA must promulgate a federal implementation plan (FIP) under section 110(c) unless we approve subsequent SIP revisions that correct the rule deficiencies within 24 months. Note that the submitted rules have been adopted by the Tehama County Air Pollution Control District, and EPA's final limited disapproval does not prevent the local agency from enforcing them.

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

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

This rule is not subject to E.O. 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

Under Executive Order 13084, Consultation and Coordination with Indian Tribal Governments, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide to OMB, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, E.O. 13084 requires EPA to develop an effective process permitting elected and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.”

Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. Accordingly, the requirements of section 3(b) of E.O. 13084 do not apply to this rule.

Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612, Federalism and 12875, Enhancing the Intergovernmental Partnership. E.O. 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under E.O. 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in E.O. 13132, because it merely acts on a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small not-for-profit enterprises, and small governmental jurisdictions.

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

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

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

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

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

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

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

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This rule is not a “major” rule as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 20, 2000. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not originally manufactured to conform to all applicable Federal motor vehicle safety standards shall be refused admission into the United States unless NHTSA has decided that the motor vehicle is substantially similar to a motor vehicle originally manufactured for importation into and sale in the United States, certified under 49 U.S.C. 30115, and of the same model year as the model of the motor vehicle to be compared, and is capable of being readily altered to conform to all applicable Federal motor vehicle safety standards. Where there is no substantially similar U.S.-certified motor vehicle, 49 U.S.C. 30141(a)(1)(B) permits a nonconforming motor vehicle to be admitted into the United States if its safety features comply with, or are capable of being altered to comply with, all applicable Federal motor vehicle safety standards based on destructive test data or such other evidence as the Secretary of Transportation decides to be adequate.

Under 49 U.S.C. 30141(a)(1), import eligibility decisions may be made “on the initiative of the Secretary of Transportation or on petition of a manufacturer or importer registered under [49 U.S.C. 30141(c)].” The Secretary's authority to make these decisions has been delegated to NHTSA. The agency publishes notice of eligibility decisions as they are made.

Under 49 U.S.C. 30141(b)(2), a list of all vehicles for which import eligibility decisions have been made must be published annually in the Federal Register . On October 1, 1996, NHTSA added the list as an appendix to 49 CFR Part 593, the regulations that establish procedures for import eligibility decisions (61 FR 51242). As described in the notice, NHTSA took that action to ensure that the list is more widely disseminated to government personnel who oversee vehicle imports and to interested members of the public. See 61 FR 51242-43. In the notice, NHTSA expressed its intention to annually revise the list as published in the appendix to include any additional vehicles decided by the agency to be eligible for importation since the list was last published. See 61 FR 51243. The agency stated that issuance of the document announcing these revisions will fulfill the annual publication requirements of 49 U.S.C. 30141(b)(2). Ibid.

This rulemaking action was not reviewed under Executive Order 12866. NHTSA has analyzed this rulemaking action and determined that it is not “significant” within the meaning of the Department of Transportation's regulatory policies and procedures.

In accordance with the Regulatory Flexibility Act, NHTSA has evaluated the effects of this action on small entities. Based upon this evaluation, I certify that the revisions resulting from this rulemaking will not have a significant economic impact on a substantial number of small entities. Accordingly, the agency has not prepared a regulatory flexibility analysis.

Because this rulemaking does not impose any regulatory requirements, but merely furnishes information by revising the list in the Code of Federal Regulations of vehicles for which import eligibility decisions have been made, it has no economic impact.

This action has been analyzed in accordance with the principles and criteria contained in Executive Order 12612, and it has been determined that this rule does not have sufficient Federalism implications to warrant preparation of a Federalism Assessment. No State laws will be affected.

The agency has considered the environmental implications of this rule in accordance with the National Environmental Policy Act of 1969 and determined that it will not significantly affect the human environment.

In accordance with the Paperwork Reduction Act of 1980, P.L. 96-511, the agency notes that there are no information collection requirements associated with this rulemaking action.

This rule does not have any retroactive effect. It does not repeal or modify any existing Federal regulations. A petition for reconsideration or other administrative proceeding will not be a prerequisite to an action seeking judicial review of this rule. This rule does not preempt the states from adopting laws or regulations on the same subject, except that it will preempt a state regulation that is in actual conflict with the Federal regulation or makes compliance with the Federal regulation impossible or interferes with the implementation of the Federal statute.

NHTSA finds that prior notice and opportunity for comment are unnecessary under 5 U.S.C. 553(b)(3)(B) because this action does not impose any regulatory requirements, but merely revises the list of vehicles not originally manufactured to conform to the Federal motor vehicle safety standards that NHTSA has decided to be eligible for importation into the United States to include all vehicles for which such decisions have been made since October 1, 1999.

In addition, so that the list of vehicles for which import eligibility decisions have been made may be included in the next edition of 49 CFR Parts 400 to 999, which is due for revision on October 1, 2000, good cause exists to dispense with the requirement in 5 U.S.C. § 553(d) for the effective date of the rule to be delayed for at least 30 days following its publication.

On June 24, 1996, at 61 FR 32411, we published a notice that discussed in full the rulemaking history of 49 CFR part 594 and the fees authorized by the Imported Vehicle Safety Compliance Act of 1988, Public Law 100-562, since recodified as 49 U.S.C. 30141-47. The reader is referred to that notice for background information relating to this rulemaking action. Certain fees were initially established to become effective January 31, 1990, and have been in effect and occasionally modified since then.

The fees applicable in any fiscal year are to be established before the beginning of such year. On July 19, 2000, we proposed fees that would become effective on October 1, 2000, the beginning of FY 2001 (65 FR 44713). There were no comments on this notice.

The statute authorizes fees to cover the costs of the importer registration program, to cover the cost of making import eligibility determinations, and to cover the cost of processing the bonds furnished to the Customs Service. We last amended the fee schedule in 1998; it has applied in Fiscal Years 1999-2000.

The fees are based on actual time and costs associated with the tasks for which the fees are assessed and reflect the slight increase in hourly costs in the past two fiscal years attributable to the approximately 3.68 and 4.94 percent raise (including the locality adjustment for Washington, DC) in salaries of employees on the General Schedule that became effective on January 1 each year in the years 1999 and 2000.

Section 30141(a)(3) of Title 49 U.S.C. provides that RIs must pay “the annual fee the Secretary of Transportation establishes * * * to pay for the costs of carrying out the registration program for importers * * *.” This fee is payable both by new applicants and by existing RIs. In order for it to maintain its registration, at the time it submits its annual fee, each RI must also file a statement affirming that the information it previously furnished in its registration application (or as later amended) remains correct (49 CFR 592.5(e)).

In accordance with the statutory directive, we reviewed the existing fees and their bases in an attempt to establish fees which would be sufficient to recover the costs of carrying out the registration program for importers for at least the next two fiscal years. The initial component of the Registration Program Fee is the fee attributable to processing and acting upon registration applications. We will increase this fee from $290 to $345 for new applications. We will increase the fee representing the review of the annual statement from $149 to $177. The adjustments reflect our recent experience in time spent reviewing both new applications and annual statements with accompanying documentation, as well as the inflation factor attributable to Federal salary increases and locality adjustments in the past two years since the regulation was last amended.

We must also recover costs attributable to maintenance of the registration program which arise from our need to review a registrant's annual statement and to verify the continuing validity of information already submitted. These costs also include anticipated costs attributable to possible revocation or suspension of registrations.

Based upon our review of the costs associated with this program, the portion of the fee attributable to the maintenance of the registration program is approximately $239 for each RI, an increase of $38. When this $239 is added to the $345 representing the registration application component, the cost to an applicant equals $584, which is the fee we are adopting. This represents an increase of $93 from the existing fee. When the $239 is added to the $177 representing the annual statement component, the total cost to the RI is $416, which represents an increase of $66.

Section 594.6(h) recounts indirect costs that were previously estimated at $12.12 per man-hour. This will be raised $1.78, to $13.90, based on the agency costs discussed above.

Section 30141(a)(3) also requires registered importers to pay “other fees the Secretary of Transportation establishes to pay for the costs of * * * (B) making the decisions under this subchapter.” This includes decisions on whether the vehicle sought to be imported is substantially similar to a motor vehicle originally manufactured for import into and sale in the United States, and certified as meeting the FMVSS, and whether it is capable of being readily altered to meet those standards. Alternatively, where there is no substantially similar U.S. motor vehicle, the decision is whether the safety features of the vehicle comply with or are capable of being altered to comply with the FMVSS. These decisions are made in response to petitions submitted by RIs or manufacturers, or pursuant to the Administrator's initiative.

The fee for a vehicle imported under an eligibility decision made pursuant to a petition is payable in part by the petitioner and in part by other importers. The fee to be charged for each vehicle is the estimated pro rata share of the costs in making all the eligibility determinations in a fiscal year.

Inflation and the small raises under the General Schedule also must be taken into account in the computation of costs. However, we have been able to reduce our processing costs through combining several decisions in a single Federal Register notice as well as achieving efficiencies through improved word processing techniques. Accordingly, we are reducing the fee of $199 presently required to accompany a “substantially similar” petition to $175, but are increasing from $721 to $800 the fee for petitions for vehicles that are not substantially similar and that have no certified counterpart. In the event that a petitioner requests an inspection of a vehicle, the fee for such an inspection remains at $550 for each of those types of petitions.

The importer of each vehicle determined to be eligible for importation pursuant to a petition currently must pay $125 upon its importation, the same fee applicable to those whose vehicles covered by an eligibility determination on the agency's initiative (other than vehicles imported from Canada that are covered by code VSA 80-83, for which no eligibility determination fee is assessed). This fee will change due to the different costs associated with petitions. For petitions based on non-substantially similar vehicles, the fee will remain at $125. For petitions based on substantially similar vehicles, the fee will be reduced from $125 to $105. Costs associated with previous eligibility determinations on the agency's own initiative will have been recovered by October 1, 2000. We shall apply the fee of $125 per vehicle only to vehicles covered by determinations made by the agency on its own initiative on and after October 1, 2000.

Section 30141(a)(3) also requires a registered importer to pay “any other fees the Secretary of Transportation establishes * * * to pay for the costs of—(A) processing bonds provided to the Secretary of the Treasury” upon the importation of a nonconforming vehicle to ensure that the vehicle will be brought into compliance within a reasonable time or if the vehicle is not brought into compliance within such time, that it is exported, without cost to the United States, or abandoned to the United States.

The statute contemplates that we will make a reasonable determination of the cost to the United States Customs Service of processing the bond. In essence, the cost to Customs is based upon an estimate of the time that a GS- 9, Step 5 employee spends on each entry, which Customs has judged to be 20 minutes.

Because of the modest salary and locality raises in the General Schedule that were effective at the beginning of 1999 and 2000, we are increasing the current processing fee by $0.35, from $5.40 per bond to $5.75.

This fee currently requires each RI to pay $16 per vehicle to cover the cost of the agency's review of the certificate of conformity furnished to the Administrator. However, if a RI enters a vehicle with the U.S. Customs Service through the Automated Broker Interface (ABI), has an e-mail address to receive communications from NHTSA, and pays the fee by credit card, the fee is $13. Based upon an analysis of the direct and indirect costs for the review and processing of these certificates, we find that the costs continue to average $16 per vehicle for non-automated entries, and we therefore did not propose a change in this fee. We estimate that there has been a reduction in cost to the agency for automated entries of approximately $7, and we will pass this on to the RI by reducing the fee from $13 to $6 per vehicle if all the information in the ABI entry is correct. Because errors in ABI entries eliminate the time-saving advantages of electronic entry, the processing cost will remain at $16 for certificates of conformity or ABI entries containing incorrect information.

The effective date of the final rule is October 1, 2000.

This rulemaking action was not reviewed under Executive Order 12886. Further, NHTSA has determined that the action is not significant under Department of Transportation regulatory policies and procedures. Based on the level of the fees and the volume of affected vehicles, NHTSA currently anticipates that the costs of the final rule are so minimal as not to warrant preparation of a full regulatory evaluation. The action does not involve any substantial public interest or controversy. There will be no substantial effect upon State and local governments. There will be no substantial impact upon a major transportation safety program. Both the number of registered importers and determinations are estimated to be comparatively small. A regulatory evaluation analyzing the economic impact of the final rule adopted on September 29, 1989, was prepared, and is available for review in the docket.

The agency has also considered the effects of this action in relation to the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). I certify that this action will not have a substantial economic impact upon a substantial number of small entities.

The following is NHTSA's statement providing the factual basis for the certification (5 U.S.C. 605(b)). The amendment would primarily affect entities that currently modify nonconforming vehicles and which are small businesses within the meaning of the Regulatory Flexibility Act; however, the agency has no reason to believe that a substantial number of these companies cannot pay the fees proposed by this action which are only modestly increased (and in some instances decreased) from those now being paid by these entities, and which can be recouped through their customers. The cost to owners or purchasers of altering nonconforming vehicles to conform with the FMVSS may be expected to increase (or decrease) to the extent necessary to reimburse the registered importer for the fees payable to the agency for the cost of carrying out the registration program and making eligibility decisions, and to compensate Customs for its bond processing costs.

Governmental jurisdictions are not affected at all since they are generally neither importers nor purchasers of nonconforming motor vehicles.

Executive Order 13132 (64 FR 43255, August 10, 1999), revokes and replaces Executive Orders 12612 “Federalism” and 12875 “Enhancing the Intergovernmental Partnership.” E.O. 13132 requires NHTSA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” Executive Order 13132 defines the term “Policies that have federalism implications” to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, NHTSA may not issue a regulation that has federalism implication, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or NHTSA consults with State and local officials early in the process of developing the proposed regulation.

The rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government as specified in Executive Order 13132. Thus, the requirements of section 6 of the Executive Order do not apply to this rulemaking action.

NHTSA has analyzed this action for purposes of the National Environmental Policy Act. The action will not have a significant effect upon the environment because it is anticipated that the annual volume of motor vehicles imported through registered importers will not vary significantly from that existing before promulgation of the rule.

This proposed rule does not have a retroactive or preemptive effect. Judicial review of a rule based on this proposal may be obtained pursuant to 5 U.S.C. 702. That section does not require that a petition for reconsideration be filed prior to seeking judicial review.

The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the cost, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by state, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually. Because the final rule based will not have an effect of $100 million, no Unfunded Mandates assessment has been prepared.

a. Revising the introductory language in paragraph (a),

b. Revising paragraph (b),

c. Removing the year “1998” in paragraph (d) and adding in its place “2000,”

d. Revising the final sentence of paragraph (h); and

e. Revising paragraph (i) to read as follows:

The shrimp fishery of the Gulf of Mexico is managed under the Fishery Management Plan for the Shrimp Fishery of the Gulf of Mexico (FMP). The FMP was prepared by the Gulf of Mexico Fishery Management Council (Council) and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

On January 27, 1999, NMFS published a final rule (64 FR 4030) pursuant to section 305(a) of the Magnuson-Stevens Act, establishing a list of authorized fisheries and fishing gear and notification guidelines for actions to be taken by regional fishery management councils (councils) and NMFS upon receipt of a notification of the intent to fish or use a fishing gear that is not on that authorized list. The list of fisheries and gear was revised upon publication of a revised final rule effective December 1, 1999 (64 FR 67511, December 2, 1999). Under the final rule, no person or vessel may employ fishing gear or engage in a fishery not included on the list without giving 90-day advance written notice to the appropriate council.

Upon receipt of a notification of intent to participate in an unlisted fishery or use an unlisted fishing gear, a council must immediately begin consideration of the notification. If the council finds that the use of an unlisted gear or participation in an unlisted fishery would not compromise the effectiveness of conservation and management efforts, it shall recommend that NMFS amend the list of authorized fisheries and gear. If the council finds that the proposed gear or fishery will be detrimental to conservation and management efforts, it will recommend that NMFS not amend the authorized list of fisheries and gear. Instead, it will request NMFS to publish emergency or interim regulations specifically to prohibit the use of the proposed gear, and begin preparation of an amendment to the subject fishery management plan, if appropriate. Ninety days after the receipt by the Council of a notification, the individual may use the gear unless regulatory action is taken to prohibit the use of the gear.

Royal red shrimp have been a small component of the Gulf of Mexico shrimp fishery since the early 1960s. The fishery uses modified penaeid shrimp trawls at depths exceeding 100 fathoms (183 meters). Trap gear is not an authorized gear in this fishery under the provisions of the FMP. On June 16, 2000, a fisherman notified the Council of his intent to use trap gear to fish for royal red shrimp in the EEZ of the Gulf of Mexico. At its July 10-13, 2000, meeting, the Council considered the notification, and based on the information available, the Council determined that allowing trap gear in the royal red shrimp fishery posed a threat to ongoing conservation and management efforts because of a potential for gear conflicts with the existing trawl fishery.

NMFS policy guidelines for the use of emergency rules (62 FR 44421, August 21, 1997), require that an emergency situation results from recent, unforeseen events, or recently discovered circumstances; presents a serious management problem; and realizes immediate benefits from the emergency rule that outweigh the value of prior notice, opportunity for public comment, and deliberative consideration expected under the normal rulemaking process. Compliance with the NMFS policy guidelines is discussed here.

Based on its review of the June 16, 2000, notification to use trap gear in the royal red shrimp fishery, the Council voted to add options to its draft FMP Amendment 11 to prohibit the use of this gear in the subject fishery. Amendment 11 is scheduled for completion in November 2000; must be reviewed by NMFS; and, if approved, likely would not be implemented prior to April 2001. Therefore, to avoid management problems in the fishery, as identified by the Council, a prohibition on the use of trap gear must be implemented on or before September 14, 2000 (the date 90 days after receipt by the Council of notification of intent to use unauthorized gear). Consequently, the Council voted without objection to request NMFS to promulgate regulations to prohibit the use of trap gear in the royal red shrimp fishery within the EEZ of the Gulf of Mexico.

The intended effect of this emergency interim rule is to prevent gear conflict that could compromise vessel safety, and to prevent overfishing in the royal red shrimp fishery. Gear conflicts are likely to occur between the traditional trawl fishery and the proposed trap line fishery on the royal red shrimp fishing grounds. This could result in substantial damage and loss of fishing gears and an increase in cost for participants in the fishery, as well as vessel safety issues because of the depth of the fishing effort, the weight of the deployed gears, and the fact that the fishing grounds are far offshore. Additionally, the introduction of new fishing effort could result in landings exceeding maximum sustainable yield (MSY), thus overfishing the resource. Since 1993, landings from the traditional trawl fishery have ranged from 200,000 to 335,000 lb (90,719 to 151,953 kg), which is approaching the MSY of 392,000 lb (177,808 kg) for the fishery.

Prohibiting the use of trap gear in the royal red shrimp fishery is anticipated to avoid economic impacts from gear damage and loss from gear conflicts in the fishery, and maintain harvest within the MSY threshold, thus, preventing overfishing. Should landings exceed MSY, and overfishing occur, additional actions would be necessary to reduce the allowable catch for either or both gear types in the fishery. The Council concluded, and NMFS agrees, that a restriction on the landings by the traditional trawl fishery to accommodate a non-traditional fishery would be inappropriate, particularly given that the trap fishery also would result in serious gear conflicts, most likely jeopardizing the ability to obtain optimum yield from the fishery.

This emergency interim rule is being made effective for 180 days, as authorized by section 305(c) of the Magnuson-Stevens Act. It may be extended for up to an additional 180 days, provided that the public has had an opportunity to comment on it and the Council is actively preparing an FMP amendment to address the emergency on a permanent basis. Public comments on this emergency interim rule and the Council's actions will be considered in determining whether to extend this emergency interim rule.

The Assistant Administrator for Fisheries, NOAA (AA), has determined that this emergency interim rule is necessary to prevent gear conflict and overfishing in the royal red shrimp fishery. The AA has also determined that this rule is consistent with the Magnuson-Stevens Act and other applicable laws.

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

NMFS has assessed the regulatory impacts associated with this emergency interim rule.

Currently, trap gear is not on the list of authorized fishing gear (50 CFR 600.725) for the royal red shrimp fishery in the Gulf of Mexico and, therefore, is not allowed. However, consistent with the guidelines contained in 50 CFR 600.725, an individual fisherman may notify the Council of the intent to use a gear not on the list. Ninety days after such notification, the individual may use the gear unless regulatory action is taken to prohibit the use of the gear. The Council was notified on June 16, 2000, of intent to use trap gear in the royal red fishery. This emergency interim rule is designed to maintain the status quo until such time as the Council can prepare and submit to NMFS for review and approval an FMP amendment to prohibit the gear. Because the emergency interim rule is designed to prohibit the use of trap gear in the royal red shrimp fishery, namely the status quo, there are no expected economic consequences to the participants in the fishery.

If the use of trap gear in the royal red shrimp fishery in the EEZ of the Gulf of Mexico were not prohibited by September 14, 2000, the Council concluded, as explained in the SUPPLEMENTARY INFORMATION , that serious gear conflict, economic losses to fishery participants, and overfishing could occur. Accordingly, under authority set forth at 5 U.S.C. 553(b)(B), the AA finds that providing notice and the opportunity for prior public comment would be contrary to the public interest. Because it would delay the completion of regulatory action to prohibit the use of trap gear in the royal red shrimp fishery in the EEZ of the Gulf of Mexico beyond September 14, 2000. For this same reason, under 5 U.S.C. 553(d)(3), the AA finds for good cause that a delay in the effective date of this emergency interim rule would be contrary to the public interest because this emergency interim rule does not impose new or additional restrictions; rather, it maintains the status quo condition regarding allowable gear in the royal red shrimp fishery, i.e., trap gear is not allowed, no time is required to come into compliance with the rule. For this reason, under 5 U.S.C. 553(d)(3), the AA also finds good cause that a delay in the effective date of this emergency interim rule is unnecessary.

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

The President has directed Federal agencies to use plain language in their communications with the public, including regulations. To comply with this directive, we seek public comment on any ambiguity or unnecessary complexity arising from the language used in this emergency interim rule. Such comments should be sent to NMFS Southeast Regional Office (see ADDRESSES ).

This document contains corrections to the technical amendment to the final 2000 PSC allowances specified for trawl groundfish fisheries of the BSAI.

The technical amendment (65 FR 42302, July 10, 2000) to the Final 2000 Harvest Specifications for Groundfish (65 FR 8282, February 18, 2000) established PSC allowances under regulations implementing Amendment 57 to the Fishery Management Plan for the Groundfish Fishery of the Bering Sea and Aleutian Islands Area (FR 65 31105, May 16, 2000). The 2000 Pacific halibut and crab PSC limits for the BSAI trawl fisheries were reduced to the following amounts: Pacific halibut, 3,675 mt; Zone 1 red king crab, 97,000 animals; Chionoecetes (C.) opilio, 4,350,000 animals; C. bairdi Zone 1,830,000; and C. bairdi Zone 2, 2,520,000 animals.

In the technical amendment, Fisheries of the Exclusive Economic Zone Off Alaska; Prohibited Species Catch in the Bering Sea and Aleutian Islands, published on July 10, 2000 (65 FR 42302), FR Doc. 00-17269, corrections are made as follows:

1. In the document, 2000 harvest specifications; technical amendment, published on July 10, 2000 (65 FR 42302), FR Doc. 00-17269, on page 42303, mathematical errors were made in Table 7. Table 7 is corrected to read as follows:

In the second column, under the heading, “Halibut mortality (mt) BSAI,” the sixth entry, “7457” that corresponds with “Jan. 1-April 30,” is corrected to read “457” and in the last line “4,675” that corresponds with the “Grand Total” is corrected to read “4,576”.