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Code · REGISTER · 2007-02-06 · Food and Drug Administration, HHS · Rules and Regulations

Rules and Regulations. Final rule

4,600 words·~21 min read·/register/2007/02/06/07-495

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 3410-02-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 529 New Animal Drugs; Hydrogen Peroxide AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration
(FDA)is amending the animal drug regulations to reflect approval of a new animal drug application
(NADA)filed by Eka Chemicals, Inc. The NADA provides for immersion use of hydrogen peroxide solution for control of mortality in certain freshwater-reared finfish species in several life stages due to various fungal and bacterial diseases. DATES: This rule is effective February 6, 2007. FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: *joan.gotthardt@fda.gov* . SUPPLEMENTARY INFORMATION: Eka Chemicals, Inc., 1775 West Oak Commons Ct., Marietta, GA 30062-2254, filed NADA 141-255 for 35% PEROX-AID (hydrogen peroxide) for control of mortality in freshwater-reared finfish eggs due to saprolegniasis, for control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with *Flavobacterium branchiophilum* , and for control of mortality in freshwater-reared coolwater finfish and channel catfish due to external columnaris disease associated with *Flavobacterium columnare* ( *Flexibacter columnaris* ). The NADA is approved as of January 11, 2007, and the regulations are amended in part 529 (21 CFR part 529) by adding § 529.1150 to reflect the approval. The basis of approval is discussed in the freedom of information summary. In addition, Eka Chemicals, Inc., has not been previously listed in the animal drug regulations as a sponsor of an approved application. At this time, 21 CFR 510.600(c) is being amended to add entries for this firm. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Under section 573(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2), this approval qualifies for 7 years of exclusive marketing rights beginning January 11, 2007, because the new animal drug has been declared a designated new animal drug by FDA under section 573(a) of the act. The agency has carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 529 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and 529 are amended as follows: PART 510—NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as follows: Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e. 2. In § 510.600, in the table in paragraph (c)(1) alphabetically add an entry for “Eka Chemicals, Inc.”; and in the table in paragraph (c)(2) numerically add an entry for “061088” to read as follows: § 510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.
(c)* * *
(1)* * * Firm name and address Drug labeler code * * * * * Eka Chemicals, Inc., 1775 West Oak Commons Ct., Marietta, GA 30062-2254 061088 * * * * *
(2)* * * Drug labeler code Firm name and address * * * * * 061088 Eka Chemicals, Inc., 1775 West Oak Commons Ct., Marietta, GA 30062-2254 * * * * * PART 529—OTHER DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 529 continues to read as follows: Authority: 21 U.S.C. 360b. 4. Add § 529.1150 to read as follows: § 529.1150 Hydrogen peroxide.
(a)*Specifications* . Each milliliter of solution contains 396.1 milligrams
(mg)hydrogen peroxide (a 35% w/w solution).
(b)*Sponsor* . See No. 061088 in § 510.600(c) of this chapter.
(c)*Conditions of use in finfish* —(1) *Amount* —(i) Freshwater-reared finfish eggs: 500 to 1,000 mg per liter (/L) of culture water for 15 minutes in a continuous flow system once per day on consecutive or alternate days until hatch for all coldwater and coolwater species of freshwater-reared finfish eggs or 750 to 1,000 mg/L for 15 minutes in a continuous flow system once per day on consecutive or alternate days until hatch for all warmwater species of freshwater-reared finfish eggs.
(ii)Freshwater-reared salmonids: 100 mg/L for 30 minutes or 50 to 100 mg/L for 60 minutes once per day on alternate days for three treatments in a continuous flow water supply or as a static bath.
(iii)Coolwater species of freshwater-reared finfish fingerlings and adults (except northern pike & paddlefish) and channel catfish fingerlings and adults: 50 to 75 mg/L for 60 minutes once per day on alternate days for three treatments in continuous flow water supply or as a static bath. Coolwater species of freshwater-reared finfish fry (except northern pike, pallid sturgeon & paddlefish) and channel catfish fry: 50 mg/L for 60 minutes once per day on alternate days for three treatments in continuous flow water supply or as a static bath.
(2)*Indications for use* . For control of mortality in freshwater-reared finfish eggs due to saprolegniasis; for control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with *Flavobacterium branchiophilum* ; and for control of mortality in freshwater-reared coolwater finfish and channel catfish due to external columnaris disease associated with *Flavobacterium columnare* ( *Flexibacter columnaris* ).
(3)*Limitations* . Initial bioassay on a small number is recommended before treating the entire group. Eggs: Some strains of rainbow trout eggs are sensitive to hydrogen peroxide treatment at a time during incubation concurrent with blastopore formation through closure, about 70 to 140 Daily Temperature Units, °C. Consider withholding treatment or using an alternate therapeutant during that sensitive time to reduce egg mortalities due to drug toxicity. Finfish: Use with caution on walleye. Preharvest withdrawal time: zero days. Dated: January 26, 2007. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. E7-1848 Filed 2-5-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943 [TX-056-FOR] Texas Abandoned Mine Land Reclamation Plan AGENCY: Office of Surface Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. SUMMARY: We, the Office of Surface Mining Reclamation and Enforcement (OSM), are approving an amendment to the Texas abandoned mine land reclamation plan (Texas plan) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). The Railroad Commission of Texas (RCT or Commission) proposed to assume responsibility of the abandoned mine land reclamation
(AML)emergency program in Texas. The Commission also proposed to revise the Texas plan by updating portions to reflect its current practices and by removing references to its old regulations (Texas Coal Mining Regulations (TCMR)) and replacing them with references to its recodified regulations (16 Texas Administrative Code (TAC)). DATES: *Effective Date:* February 6, 2007. FOR FURTHER INFORMATION CONTACT: Michael C. Wolfrom, Director, Tulsa Field Office. Telephone:
(918)581-6430. E-mail address: *mwolfrom@osmre.gov.* SUPPLEMENTARY INFORMATION: I. Background on the Texas Plan II. Submission of the Amendment III. OSM's Findings IV. Summary and Disposition of Comments V. OSM's Decision VI. Procedural Determinations I. Background on the Texas Plan The Abandoned Mine Land Reclamation Program was established by Title IV of the Act (30 U.S.C. 1201 *et seq.* ) in response to concerns over extensive environmental damage caused by past coal mining activities. The program is funded by a reclamation fee collected on each ton of coal that is produced. The money collected is used to finance the reclamation of abandoned coal mines and for other authorized activities. Section 405 of the Act allows States and Indian Tribes to assume exclusive responsibility for reclamation activity within the State or on Indian lands if they develop and submit to the Secretary of the Interior (Secretary) for approval, a program (often referred to as a plan) for the reclamation of abandoned coal mines. On the basis of these criteria, the Secretary approved the Texas plan on June 23, 1980. You can find background information on the Texas plan, including the Secretary's findings, the disposition of comments, and the approval of the plan in the June 23, 1980, **Federal Register** (45 FR 41937). You can find later actions concerning the Texas plan and amendments to the plan at 30 CFR 943.25. II. Submission of the Amendment By letter dated October 11, 2006 (Administrative Record No. TAML-661), Texas sent us an amendment to its plan under SMCRA (30 U.S.C. 1201 *et seq.* ) at its own initiative. Texas proposed to assume the AML emergency program, update portions of its plan to reflect its current practices, and remove references to its old regulations
(TCMR)and replace them with references to its recodified regulations (16 TAC). We announced receipt of the proposed amendment in the November 13, 2006, **Federal Register** (71 FR 66150). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the amendment. We did not hold a public hearing or meeting because no one requested one. The public comment period ended on December 13, 2006. We did not receive any public comments. III. OSM's Findings Following are the findings we made concerning the amendment under SMCRA and the Federal regulations at 30 CFR 884.14 and 884.15. We are approving the amendment. A. AML Emergency Program Demonstration Section 410 of SMCRA authorizes the Secretary to use funds under the AML program to abate or control emergency situations in which adverse effects of past coal mining pose an immediate danger to the public health, safety, or general welfare. In a **Federal Register** notice dated September 29, 1982 (47 FR 42729), we invited states to amend their AML plans for the purpose of undertaking emergency reclamation programs on our behalf and published guidelines outlining three requirements for State assumption of the AML emergency program. For us to grant emergency authority to the State agency, the agency must demonstrate that it has the following:
(1)Statutory authority to undertake emergencies,
(2)technical capability to design and supervise the emergency work, and
(3)administrative mechanisms to respond quickly to emergencies either directly or through contractors. 1. Statutory Authority The Commission has had statutory authority under the Texas Surface Coal Mining and Reclamation Act (TSCMRA) section 134.141 to administer an emergency response program since approval of the Texas plan on June 23, 1980. In order to implement this authority, Texas' regulations at 16 TAC 134.143 and 134.144 provide for right of entry on any land where an emergency exists. In a letter dated February 27, 1979, the Governor of Texas designated the Commission as the State agency responsible for the AML program in Texas. The Attorney General of Texas issued an official opinion on March 20, 1980, stating that the Commission is authorized under State law to conduct a State reclamation program in accordance with the requirements of Title IV of the Federal Surface Mining Control and Reclamation Act of 1977, the regulations adopted pursuant thereto, and the State Reclamation Plan. Title IV of SMCRA covers both the regular AML program and the emergency reclamation program. 2. Technical Capability The Commission has demonstrated through past performance that it has the technical capability to implement an AML emergency program. In its October 11, 2006, submission of the amendment, the Commission included the following statement in its section of the Texas plan titled, “Staffing,” to demonstrate the Commission's technical capability to design and supervise the emergency work. The Surface Mining and Reclamation Division's Abandoned Mine Land Reclamation Program staff has * * * demonstrated experience in developing and managing AML Projects. Areas of expertise include realty (rights of entry, appraisal and liens), environmental assessment, engineering design, construction and contract management and revegetation and erosion control. The Division's Administration and Records Section also provides administrative support. The Commission's Finance and Accounting Division provides purchasing and contracting support and legal support is provided by the Commission's Office of General Counsel. Texas has conducted an AML program since 1980. We have found that the Texas AML program is run in a cost efficient and professional manner. Texas has conducted project design and construction work with a high degree of competence and success. Projects are thoroughly analyzed and conducted in compliance with all National Environmental Policy Act
(NEPA)requirements. Construction monitoring, post-construction monitoring, and maintenance processes ensure the projects meet contract specifications, project objectives, and program goals. Over the years, Texas has designed and inspected AML emergency projects for us. Technical capabilities used for these emergency reclamation projects are the same as those used for normal, high priority reclamation projects. We have found that Texas has developed and refined the in-house investigation, design, and project administration abilities necessary to administer an AML program and an AML emergency response program. 3. Administrative Mechanisms During a review of Texas' revised purchasing and procurement procedures at section 884.13(d)(3) of the Texas plan, we found that the Texas Building and Procurement Commission
(TBPC)has delegated the authority to make emergency purchases to all state agencies, including the Commission. The TBPC has made the decision to declare an emergency purchase the sole responsibility of the agencies and encourages the agencies to obtain at least three informal bids, whenever possible, on all emergency purchases. Emergency purchases exceeding $25,000 must be posted in the Electronic State Business Daily and are subject to pre-payment audit by the TBPC. Texas' contracting method will allow the Commission adequate flexibility to address emergency conditions. Other administrative processes required to implement the emergency program are the same as those already in place for the Texas AML program. In accordance with section 405 of SMCRA and 30 CFR 884.15, Texas has submitted an amendment to its AML plan, and we have determined, pursuant to 30 CFR 884.14, the following: 1. The public has been given adequate notice and opportunity to comment on the amendment, and the record does not reflect major unresolved controversies. 2. Views of other Federal agencies have been solicited and considered. 3. The State has the legal authority, policies, and administrative structure necessary to implement the amendment. 4. The proposed plan amendment meets all requirements of the Federal AML program regulations at 30 CFR Chapter VII, Subchapter R. 5. The State has an approved State Regulatory Program. 6. The amendment is in compliance with all applicable State and Federal laws and regulations. We find that the proposed Texas plan amendment allowing the State to assume responsibility for an AML emergency response reclamation program on our behalf is in compliance with SMCRA and meets the requirements of the Federal regulations. Therefore, we are approving Texas' assumption of the AML emergency program. B. Revisions to Texas' AML Plan Texas updated its AML plan to
(1)ensure that it has the administrative mechanisms to quickly respond to AML emergencies either directly or through contractors and
(2)reflect current state practices. The following table lists the sections of the AML plan that Texas revised. Plan Section Topic 30 CFR 884.13(c)(6) Rights of Entry—A description of the policies and procedures to be followed by the Commission regarding right of entry on lands for the purpose of performing AML program activities. 30 CFR 884.13(d)(2) Staffing—A description of the administrative and management structure to be used in conducting the reclamation program, including the incorporation of an organizational chart in the Texas plan. 30 CFR 884.13(d)(3) Purchasing and Procurement—A description of the policies and procedures to be followed by the Commission regarding purchasing and procurement for the AML program. We find that the requirements of the revised Texas AML plan meet the requirements of the Federal regulations at 30 CFR 884.13(a) through (e). Therefore, we are approving them. IV. Summary and Disposition of Comments Public Comments We asked for public comments on the amendment, but did not receive any. Federal Agency Comments On October 25, 2006, and November 7, 2006, under 30 CFR 884.14(a)(2) and 884.15(a), we requested comments on the amendment from various Federal agencies with an actual or potential interest in the Texas plan (Administrative Record No. TAML-661.1). No comments were received. V. OSM's Decision Based on the above findings, we approve the amendment Texas sent us on October 11, 2006. To implement this decision, we are amending the Federal regulations at 30 CFR part 943, which codify decisions concerning the Texas plan. We find that good cause exists under 5 U.S.C. 553(d)(3) to make this final rule effective immediately. Section 405 of SMCRA requires that the State's plan demonstrate that the State has the capability of carrying out the provisions of the Act and meeting its purposes. Making this rule effective immediately will expedite that process. SMCRA requires consistency of State and Federal standards. VI. Procedural Determinations Executive Order 12630—Takings This rule does not have takings implications. This determination is based on the analysis performed for the counterpart Federal regulations. Executive Order 12866—Regulatory Planning and Review This rule is exempted from review by the Office of Management and Budget
(OMB)under Executive Order 12866. Executive Order 12988—Civil Justice Reform The Department of the Interior has conducted the reviews required by section 3 of Executive Order 12988 and has determined that this rule meets the applicable standards of subsections
(a)and
(b)of that section. However, these standards are not applicable to the actual language of State and Tribal abandoned mine land reclamation plans and plan amendments because each program is drafted and promulgated by a specific State or Tribe, not by OSM. Decisions on proposed abandoned mine land reclamation plans and plan amendments submitted by a State or Tribe are based solely on a determination of whether the submittal meets the requirements of Title IV of SMCRA (30 U.S.C. 1231-1243) and 30 CFR part 884 of the Federal regulations. Executive Order 13132—Federalism This rule does not have Federalism implications. SMCRA delineates the roles of the Federal and State governments with regard to the regulation of abandoned mine reclamation programs. One of the purposes of SMCRA is to “establish a nationwide program to protect society and the environment from the adverse effects of surface coal mining operations.” Section 405(d) of SMCRA requires State abandoned mine land reclamation programs to be in compliance with the procedures, guidelines, and requirements established under SMCRA. Executive Order 13175—Consultation and Coordination With Indian Tribal Governments In accordance with Executive Order 13175, we have evaluated the potential effects of this rule on Federally-recognized Indian tribes and have determined that the rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. This determination is based on the fact that the Texas plan does not provide for reclamation and restoration of land and water resources adversely affected by past coal mining on Indian lands. Therefore, the Texas plan has no effect on federally-recognized Indian tribes. Executive Order 13211—Regulations That Significantly Affect the Supply, Distribution, or Use of Energy On May 18, 2001, the President issued Executive Order 13211 which requires agencies to prepare a Statement of Energy Effects for a rule that is
(1)considered significant under Executive Order 12866, and
(2)likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not expected to have a significant adverse effect on the supply, distribution, or use of energy, a Statement of Energy Effects is not required. National Environmental Policy Act This rule does not require an environmental impact statement because agency decisions on proposed State and Tribal abandoned mine land reclamation plans and plan amendments are categorically excluded from compliance with the National Environmental Policy Act (42 U.S.C. 4332) by the Manual of the Department of the Interior (516 DM 13.5 (B)(29)). Paperwork Reduction Act This rule does not contain information collection requirements that require approval by OMB under the Paperwork Reduction Act (44 U.S.C. 3507 *et seq.* ). Regulatory Flexibility Act The Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). The State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the counterpart Federal regulations. Small Business Regulatory Enforcement Fairness Act This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:
(a)Does not have an annual effect on the economy of $100 million;
(b)Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and
(c)Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulation was not considered a major rule. Unfunded Mandates This rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of $100 million or more in any given year. This determination is based upon the fact that the State submittal, which is the subject of this rule, is based upon counterpart Federal regulations for which an analysis was prepared and a determination made that the Federal regulations did not impose an unfunded mandate. List of Subjects in 30 CFR Part 943 Intergovernmental relations, Surface mining, Underground mining. Dated: January 30, 2007. Brent Wahlquist, Acting Director, Office of Surface Mining Reclamation and Enforcement. For the reasons set out in the preamble, 30 CFR part 943 is amended as set forth below: PART 943—TEXAS 1. The authority citation for part 943 continues to read as follows: Authority: 30 U.S.C. 1201 *et seq.* 2. Section 943.25 is amended in the table by adding a new entry in chronological order by “Date of final publication” to read as follows: § 943.25 Approval of Texas abandoned mine land reclamation plan amendments. Original amendment submission date Date of final publication Citation/description * * * * * * * 10/11/2006 2/6/2007 Emergency response reclamation program; AML Plan sections 884.13(c)(6), (d)(2) and (d)(3). [FR Doc. E7-1857 Filed 2-5-07; 8:45 am] BILLING CODE 4310-05-P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Parts 100, 117 and 165 [USCG-2006-26697] Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations and Drawbridge Operation Regulations AGENCY: Coast Guard, DHS. ACTION: Notice of temporary rules issued. SUMMARY: This document provides required notice of substantive rules issued by the Coast Guard and temporarily effective between January 1, 2006 and September 30, 2006 that were not published in the **Federal Register** . This quarterly notice lists temporary local regulations, temporary drawbridge operation regulations, security zones, and safety zones, all of limited duration and for which timely publication in the **Federal Register** was not possible. DATES: This document lists temporary Coast Guard rules that became effective and were terminated between January 1, 2006 and September 30, 2006. ADDRESSES: The Docket Management Facility maintains the public docket for this notice. Documents indicated in this notice will be available for inspection or copying at the Docket Management Facility, U.S. Department of Transportation, Room PL-401, 400 Seventh Street SW., Washington, DC 20593-0001 between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. You may electronically access the public docket for this notice on the Internet at *http://dms.dot.gov.* FOR FURTHER INFORMATION CONTACT: For questions on this notice contact Ms. Lesley Mose, Office of Regulations and Administrative Law, telephone
(202)372-3866. For questions on viewing, or on submitting material to the docket, contact Ms. Angie Ames, Docket Operations, telephone 202-366-5115. SUPPLEMENTARY INFORMATION: Coast Guard District Commanders and Captains of the Port
(COTP)must be immediately responsive to the safety and security needs 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 prevent injury or damage to vessels, ports, or waterfront facilities and may also describe a zone around a vessel in motion. Special local regulations are issued to enhance the safety of participants and spectators at regattas and other marine events. Drawbridge operation regulations authorize changes to drawbridge schedules to accommodate bridge repairs, seasonal vessel traffic, and local public events. Timely publication of these rules in the **Federal Register** is often precluded when a rule responds to an emergency, or when an event occurs without sufficient advance notice. The affected public is, however, informed of these rules 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 rule. Because **Federal Register** publication was not possible before the beginning of the effective period, mariners were personally notified of the contents of these special local regulations, drawbridge operation regulations, security zones, and safety zones by Coast Guard officials on-scene prior to any enforcement action. 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 on the public, the Coast Guard periodically publishes a list of these temporary special local regulations, security zones, safety zones and drawbridge operation regulations. Permanent rules are not included in this list because they are published in their entirety in the **Federal Register** . Temporary rules are also 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, security zones and drawbridge operation regulations listed in this notice have been exempted from review under Executive Order 12866, Regulatory Planning and Review, because of their emergency nature, or limited scope and temporary effectiveness. The following rules were placed in effect temporarily during the period from January 1, 2006 through September 30, 2006 unless otherwise indicated. Dated: December 19, 2006. S.G. Venckus, Chief, Office of Regulations and Administrative Law. BILLING CODE 4910-15-P ER06FE07.017 ER06FE07.018 ER06FE07.019 ER06FE07.020 ER06FE07.021 ER06FE07.022 ER06FE07.023 [FR Doc. 07-495 Filed 2-5-07; 8:45 am]
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