Rules and Regulations. Proposed rule; correction

20,596 words·~94 min read·/register/2007/02/22/07-794·

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

BILLING CODE 3510-22-S 72 35 Thursday, February 22, 2007 Proposed Rules DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 94 [Docket No. APHIS-2006-0104] Classical Swine Fever Status of the Mexican State of Nayarit; Correction AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule; correction. SUMMARY: We are correcting an error in our proposed rule to amend the regulations for importing animals and animal products by adding the Mexican State of Nayarit to the list of regions considered free of classical swine fever (CSF).

We would also add Nayarit to the list of CSF-free regions whose exports of live swine, pork, and pork products to the United States must meet certain certification requirements to ensure their freedom from CSF. The proposed rule was published in the **Federal Register** on January 31, 2007 (72 FR 4463-4467, Docket No. APHIS 2006-0104). FOR FURTHER INFORMATION CONTACT: Dr. Chip Wells, Senior Staff Veterinarian, Regionalization Evaluation Services-Import, National Center for Import and Export, VS, APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231;

(301)734-4356. SUPPLEMENTARY INFORMATION: On January 31, 2007, we published in the **Federal Register** (72 FR 4463-4467, Docket No. APHIS-2006-0104) a proposed rule to amend the regulations for importing animals and animal products by adding the Mexican State of Nayarit to the list of regions considered free of classical swine fever (CSF). We would also add Nayarit to the list of CSF-free regions whose exports of live swine, pork, and pork products to the United States must meet certain certification requirements to ensure their freedom from CSF. In the summary of the proposed rule, and in the supplementary information under the heading “Executive Order 12866 and Regulatory Flexibility Act,” we stated that we would add Nayarit to the list of CSF-affected regions whose exports of live swine, pork, and pork products to the United States must meet certain certification requirements to ensure their freedom from CSF. This information was incorrect. We are proposing to recognize the State of Nayarit as free of this disease, so it should have read that we would add the State to the list of CSF-free regions to which those requirements apply. This document corrects these errors. Correction In FR Doc. E7-1530, published on January 31, 2007 (72 FR 4463-4467) make the following corrections: On page 4463, under Summary, third sentence, and on page 4466, first column, first full sentence, correct “CSF-affected” to read “CSF-free”. Done in Washington, DC, this 15th day of February 2007. Elizabeth E. Gaston, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7-3012 Filed 2-21-07; 8:45 am] BILLING CODE 3410-34-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-27269; Directorate Identifier 2006-NM-207-AD] RIN 2120-AA64 Airworthiness Directives; Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model ERJ 170 Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: The FAA proposes to adopt a new airworthiness directive

(AD)for certain EMBRAER Model ERJ 170 airplanes. This proposed AD would require installing updated software revisions and, as applicable, doing concurrent actions. This proposed AD results from a report of an error in the implementation procedure of the Primus Epic digital software platform, which could result in improper functioning of certain flight systems. Further, current revisions of the Primus Epic software may cause blinking of all cockpit flight displays. We are proposing this AD to prevent improper functioning of certain flight systems and blinking of cockpit flight displays, which could lead to increased pilot workload during critical phases of flight. DATES: We must receive comments on this proposed AD by March 26, 2007. ADDRESSES: Use one of the following addresses to submit comments on this proposed AD. • *DOT Docket Web site:* Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • *Government-wide rulemaking Web site:* Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • *Mail:* Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC 20590. *Fax:*

(202)493-2251. *Hand Delivery:* Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Contact Empresa Brasileira de Aeronautica S.A. (EMBRAER), P.O. Box 343—CEP 12.225, Sao Jose dos Campos—SP, Brazil, for service information identified in this proposed AD. FOR FURTHER INFORMATION CONTACT: Todd Thompson, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone

(425)227-1175; fax

(425)227-1149. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed in the ADDRESSES section. Include the docket number “FAA-2007-27269; Directorate Identifier 2006-NM-207-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments. We will post all comments we receive, without change, to *http://dms.dot.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78), or you may visit *http://dms.dot.gov.* Examining the Docket You may examine the AD docket on the Internet at *http://dms.dot.gov,* or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone

(800)647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them. Discussion The Agência Nacional de Aviação Civil (ANAC), which is the airworthiness authority for Brazil, notified us that an unsafe condition may exist on certain EMBRAER Model ERJ 170 airplanes. The ANAC advises of a reported error in the implementation procedure of the Primus Epic digital software platform, which may lead to an ineffective power-up built-in test

(PBIT)of certain fly-by-wire (FBW), autoflight, and avionics system functions, which could result in improper functioning of those systems. Further, current Primus Epic software revisions may cause blinking of all cockpit flight displays. This condition, if not corrected, could lead to increased pilot workload during critical phases of flight. Relevant Service Information EMBRAER has issued Service Bulletin 170-31-0013, Revision 01, dated January 13, 2006. The service bulletin describes procedures for installing Primus Epic software part number (P/N) PS7027709-00113 (load version 17.3). For airplanes equipped with a lightning sensor system

(LSS)and software load version 15.3 or 15.4, the installation includes doing certain wiring revisions of the LSS connector. For airplanes that have received all described software upgrades in accordance with EMBRAER Service Bulletin 170-31-0013, dated December 17, 2005, an additional action is described by Service Bulletin 170-31-0013, Revision 01. The additional action includes installing a new, upgraded loadable diagnostic information

(LDI)database. The ANAC mandated the service information and issued Brazilian airworthiness directive 2006-06-01, effective June 28, 2006, to ensure the continued airworthiness of these airplanes in Brazil. For certain airplanes, EMBRAER Service Bulletin 170-31-0013, Revision 01, specifies prior or concurrent accomplishment of certain actions specified in EMBRAER Service Bulletin 170-73-0001, dated September 13, 2005, and Revision 01, dated September 23, 2005. These actions include installing full-authority digital engine-control (FADEC) software version V5.20. FAA's Determination and Requirements of the Proposed AD These airplane models are manufactured in Brazil and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the ANAC has kept the FAA informed of the situation described above. We have examined the ANAC's findings, evaluated all pertinent information, and determined that we need to issue an AD for airplanes of this type design that are certificated for operation in the United States. Therefore, we are proposing this AD, which would require accomplishing the actions specified in the service information described previously. Clarification of Requirements The ANAC airworthiness directive 2006-06-01 does not specifically state that prior or concurrent installation of FADEC software version V5.20 is required. However, to ensure proper correction of the unsafe condition, this proposed AD would require accomplishing this concurrent action. EMBRAER Service Bulletin 170-31-0013, Revision 01, describes EMBRAER Service Bulletin 170-73-0001 as the appropriate source of service information for doing the concurrent action. This difference has been coordinated with the ANAC. Interim Action We consider this proposed AD interim action. The manufacturer is developing a modification that will further address the unsafe condition identified in this proposed AD. Once this modification is approved and available, we may consider additional rulemaking. Costs of Compliance This proposed AD would affect about 68 airplanes of U.S. registry. Software upgrades would be provided by the manufacturer at no charge to operators, and parts for wiring changes would be provided from operator stores. The following table provides the estimated costs for U.S. operators to comply with this proposed AD at an average labor rate of $80 per work hour. Estimated Costs Action Work hours Cost per airplane Fleet cost Install software Between 5 and 6 Between $400 and $480 Between $27,200 and $32,640. Revise wiring 1 $80 Up to $5,440. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration

(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **Empresa Brasileira de Aeronautica S.A. (EMBRAER):** Docket No. FAA-2007-27269; Directorate Identifier 2006-NM-207-AD. Comments Due Date

(a)The FAA must receive comments on this AD action by March 26, 2007. Affected ADs

(b)None. Applicability

(c)This AD applies to EMBRAER Model ERJ 170-100 LR, -100 STD, -100 SE, -100 SU, -200 LR, -200 STD, and -200 SU airplanes, certificated in any category; as identified in EMBRAER Service Bulletin 170-31-0013, Revision 01, dated January 13, 2006. Unsafe Condition

(d)This AD results from a report of an error in the implementation procedure of the Primus Epic digital software platform, which could result in improper functioning of certain flight systems. Further, current revisions of the Primus Epic software may possibly cause blinking of all cockpit flight displays. We are issuing this AD to prevent improper functioning of certain flight systems and blinking of cockpit flight displays, which could lead to increased pilot workload during critical phases of flight. Compliance

(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Inspection for Software Identification

(f)Within 30 days after the effective date of this AD, inspect to determine the part number (P/N) of the Primus Epic software and the upgrade version number of the full-authority digital engine-control (FADEC) software installed on the airplane. Software Installation and Concurrent Actions

(g)Within the compliance time specified in paragraph (g)(1) or (g)(2) of this AD, as applicable, install Primus Epic P/N PS7027709-00113 (load version 17.3) and do applicable wiring revisions; in accordance with the Accomplishment Instructions of EMBRAER Service Bulletin 170-31-0013, Revision 01, dated January 13, 2006.

(1)For airplanes equipped with software having P/N PS7027709-00108 (load version 15.3), P/N PS7027709-00109 (load version 15.4), or P/N PS7027709-00110 (load version 15.5): Within 30 days after the effective date of this AD.

(2)For airplanes equipped with software having P/N PS7027709-00106 (load version 17.1) or P/N PS7027709-00112 (load version 17.2.02): Within 120 days after the effective date of this AD. Concurrent Actions

(h)For airplanes which do not have FADEC software upgrade version V5.20 installed at the time of the inspection required by paragraph

(f)of this AD: Prior to or concurrently with the installation required by paragraph

(g)of this AD, install FADEC software upgrade version V5.20 as specified in EMBRAER Service Bulletin 170-73-0001, dated September 13, 2005; or Revision 01, dated September 23, 2005. Actions Accomplished According to Previous Issue of Service Bulletin

(i)Actions accomplished before the effective date of this AD according to EMBRAER Service Bulletin 170-31-0013, dated December 17, 2005, are considered acceptable for compliance with paragraph

(g)of this AD; except that, for airplanes identified in paragraph 1D., “Additional Action,” of EMBRAER Service Bulletin 170-31-0013, Revision 01, dated January 13, 2006, the additional action specified in Service Bulletin 170-31-0013, Revision 01, must be done as required by this AD. Alternative Methods of Compliance (AMOCs) (j)(1) The Manager, International Branch, ANM-116, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.

(k)Brazilian airworthiness directive 2006-06-01, effective June 28, 2006, also addresses the subject of this AD. Issued in Renton, Washington, on February 7, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-2980 Filed 2-21-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-27268; Directorate Identifier 2006-NM-190-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Model A318, A319, A320, and A321 Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: The FAA proposes to adopt a new airworthiness directive

(AD)for all Airbus Model A318, A319, A320, and A321 airplanes. This proposed AD would require revising the Airworthiness Limitations section of the Instructions for Continued Airworthiness to incorporate new limitations for fuel tank systems. This proposed AD results from fuel system reviews conducted by the manufacturer. We are proposing this AD to prevent the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane. DATES: We must receive comments on this proposed AD by March 26, 2007. ADDRESSES: Use one of the following addresses to submit comments on this proposed AD. • *DOT Docket Web site:* Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • *Government-wide rulemaking Web site:* Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • *Mail:* Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street SW., Nassif Building, room PL-401, Washington, DC 20590. • *Fax:*

(202)493-2251. • *Hand Delivery:* Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France, for service information identified in this proposed AD. FOR FURTHER INFORMATION CONTACT: Tim Dulin, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone

(425)227-2141; fax

(425)227-1149. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed in the ADDRESSES section. Include the docket number “FAA-2007-27268; Directorate Identifier 2006-NM-190-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments. We will post all comments we receive, without change, to *http://dms.dot.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78), or you may visit *http://dms.dot.gov* . Examining the Docket You may examine the AD docket on the Internet at *http://dms.dot.gov* , or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone

(800)647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them. Discussion The FAA has examined the underlying safety issues involved in fuel tank explosions on several large transport airplanes, including the adequacy of existing regulations, the service history of airplanes subject to those regulations, and existing maintenance practices for fuel tank systems. As a result of those findings, we issued a regulation titled “Transport Airplane Fuel Tank System Design Review, Flammability Reduction and Maintenance and Inspection Requirements” (66 FR 23086, May 7, 2001). In addition to new airworthiness standards for transport airplanes and new maintenance requirements, this rule included Special Federal Aviation Regulation No. 88 (“SFAR 88,” Amendment 21-78, and subsequent Amendments 21-82 and 21-83). Among other actions, SFAR 88 requires certain type design ( *i.e.* , type certificate

(JAA)has issued a regulation that is similar to SFAR 88. (The JAA is an associated body of the European Civil Aviation Conference

(ECAC)representing the civil aviation regulatory authorities of a number of European States who have agreed to co-operate in developing and implementing common safety regulatory standards and procedures.) Under this regulation, the JAA stated that all members of the ECAC that hold type certificates for transport category airplanes are required to conduct a design review against explosion risks. We have determined that the actions identified in this proposed AD are necessary to reduce the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane. The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, notified us that an unsafe condition may exist on all Airbus Model A318, A319, A320, and A321 airplanes. The EASA advises that Airbus has issued new fuel airworthiness limitations

(FALs)to address failure conditions for which an unacceptable probability of ignition risk could exist if specific tasks or practices or both are not performed in accordance with the manufacturer's requirements. The new FALs are intended to satisfy the JAA's Interim Policy of Fuel Tank Safety and SFAR 88 requirements. Relevant Service Information Airbus has issued A318/A319/A320/A321 ALS—Airworthiness Limitations Section, dated February 28, 2006, which is a repository for stand-alone documents that are approved independently from each other. The Airbus ALS comprises the following documents: • ALS Part 1—Safe Life Airworthiness Limitation Items. • ALS Part 2—Damage-Tolerant Airworthiness Limitation Items. • ALS Part 3—Certification Maintenance Requirements. • ALS Part 4—(Reserved). • ALS Part 5—Fuel Airworthiness Limitations. Airbus ALS Part 5—Fuel Airworthiness Limitations, dated February 28, 2006, refers to Airbus A318/A319/A320/A321 Fuel Airworthiness Limitations, Document 95A.1931/05, Issue 1, dated December 19, 2005 (approved by the EASA on March 14, 2006). Section 1, “Maintenance/Inspection Tasks,” of Document 95A.1931/05 describes certain FAL inspections, which are periodic inspections of certain features for latent failures that could contribute to an ignition source. Section 2, “Critical Design Configuration Control Limitations,” of Document 95A.1931/05 identifies critical design configuration control limitations (CDCCLs). A CDCCL is a limitation requirement to preserve a critical ignition source prevention feature of the fuel tank system design that is necessary to prevent the occurrence of an unsafe condition. The purpose of a CDCCL is to provide instruction to retain the critical ignition source prevention feature during configuration change that may be caused by alterations, repairs, or maintenance actions. A CDCCL is not a periodic inspection. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. The EASA mandated the service information and issued airworthiness directive 2006-0203, dated July 11, 2006, to ensure the continued airworthiness of these airplanes in the European Union. FAA's Determination and Requirements of the Proposed AD These airplane models are manufactured in France and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. As described in FAA Order 8100.14A, “Interim Procedures for Working with the European Community on Airworthiness Certification and Continued Airworthiness,” dated August 12, 2005, the EASA has kept the FAA informed of the situation described above. We have examined the EASA's findings, evaluated all pertinent information, and determined that we need to issue an AD for airplanes of this type design that are certificated for operation in the United States. Therefore, we are proposing this AD, which would require revising the Airworthiness Limitations section of the Instructions for Continued Airworthiness to incorporate new limitations for fuel tank systems. Costs of Compliance This proposed AD would affect about 720 airplanes of U.S. registry. The proposed actions would take about 2 work hours per airplane, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the proposed AD for U.S. operators is $115,200, or $160 per airplane. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration

(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **Airbus:** Docket No. FAA-2007-27268; Directorate Identifier 2006-NM-190-AD. Comments Due Date

(a)The FAA must receive comments on this AD action by March 26, 2007. Affected ADs

(b)None. Applicability

(c)This AD applies to all Airbus Model A318-111, -112, -121, and -122 airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-111, -211, -212, -214, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes; certificated in any category. Note 1: This AD requires revisions to certain operator maintenance documents to include new inspections and critical design configuration control limitations (CDCCLs). Compliance with the operator maintenance documents is required by 14 CFR 91.403(c). For airplanes that have been previously modified, altered, or repaired in the areas addressed by these inspections and CDCCLs, the operator may not be able to accomplish inspections and CDCCLs described in the revisions. In this situation, to comply with 14 CFR 91.403(c), the operator must request approval for an alternative method of compliance according to paragraph

(i)of this AD. The request should include a description of changes to the required inspections and CDCCLs that will preserve the critical ignition source prevention feature of the affected fuel system. Unsafe Condition

(d)This AD results from fuel system reviews conducted by the manufacturer. We are issuing this AD to prevent the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane. Compliance

(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Revise Airworthiness Limitations Section

(ALS)To Incorporate Fuel Maintenance and Inspection Tasks

(f)Within 3 months after the effective date of this AD, revise the ALS of the Instructions for Continued Airworthiness to incorporate Airbus A318/A319/A320/A321 ALS Part 5—Fuel Airworthiness Limitations, dated February 28, 2006, as defined in Airbus A318/A319/A320/A321 Fuel Airworthiness Limitations, Document 95A.1931/05, Issue 1, dated December 19, 2005 (approved by the European Aviation Safety Agency

(EASA)on March 14, 2006), Section 1, “Maintenance/Inspection Tasks.” For all tasks identified in Section 1 of Document 95A.1931/05, the initial compliance times start from the effective date of this AD and must be accomplished within the repetitive interval specified in Section 1 of Document 95A.1931/05. Revise ALS To Incorporate CDCCLs

(g)Within 12 months after the effective date of this AD, revise the ALS of the Instructions for Continued Airworthiness to incorporate Airbus A318/A319/A320/A321 ALS Part 5—Fuel Airworthiness Limitations, dated February 28, 2006, as defined in Airbus A318/A319/A320/A321 Fuel Airworthiness Limitations, Document 95A.1931/05, Issue 1, dated December 19, 2005 (approved by the EASA on March 14, 2006), Section 2, “Critical Design Configuration Control Limitations.” No Alternative Inspections, Inspection Intervals, or CDCCLs

(h)Except as provided by paragraph

(i)of this AD: After accomplishing the actions specified in paragraphs

(f)and

(g)of this AD, no alternative inspections, inspection intervals, or CDCCLs may be used. Alternative Methods of Compliance (AMOCs) (i)(1) The Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.

(j)EASA airworthiness directive 2006-0203, dated July 11, 2006, also addresses the subject of this AD. Issued in Renton, Washington, on February 7, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-2977 Filed 2-21-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-27302; Directorate Identifier 2006-NM-273-AD] RIN 2120-AA64 Airworthiness Directives; McDonnell Douglas DC-10-30 and DC-10-30F (KC-10A and KDC-10) Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: The FAA proposes to adopt a new airworthiness directive

(AD)for certain McDonnell Douglas DC-10-30 and DC-10-30F (KC-10A and KDC-10) airplanes. This proposed AD would require installing Teflon sleeving around the fuel pump wire harness inside the conduit in the aft supplemental fuel tank. This proposed AD results from fuel system reviews conducted by the manufacturer. We are proposing this AD to prevent the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane. DATES: We must receive comments on this proposed AD by April 9, 2007. ADDRESSES: Use one of the following addresses to submit comments on this proposed AD. • DOT Docket Web site: Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • Government-wide rulemaking Web site: Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • Mail: Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street SW., Nassif Building, room PL-401, Washington, DC 20590. • Fax:

(202)493-2251. • Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Contact Boeing Commercial Airplanes, Long Beach Division, 3855 Lakewood Boulevard, Long Beach, California 90846, Attention: Data and Service Management, Dept. C1-L5A (D800-0024), for the service information identified in this proposed AD. FOR FURTHER INFORMATION CONTACT: Samuel Lee, Aerospace Engineer, Propulsion Branch, ANM-140L, FAA, Los Angeles Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137; telephone

(562)627-5262; fax

(562)627-5210. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed in the ADDRESSES section. Include the docket number “FAA-2007-27302; Directorate Identifier 2006-NM-273-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments. We will post all comments we receive, without change, to *http://dms.dot.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78), or you may visit *http://dms.dot.gov.* Examining the Docket You may examine the AD docket on the Internet at *http://dms.dot.gov,* or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone

(800)647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them. Discussion The FAA has examined the underlying safety issues involved in fuel tank explosions on several large transport airplanes, including the adequacy of existing regulations, the service history of airplanes subject to those regulations, and existing maintenance practices for fuel tank systems. As a result of those findings, we issued a regulation titled “Transport Airplane Fuel Tank System Design Review, Flammability Reduction and Maintenance and Inspection Requirements” (66 FR 23086, May 7, 2001). In addition to new airworthiness standards for transport airplanes and new maintenance requirements, this rule included Special Federal Aviation Regulation No. 88 (“SFAR 88,” Amendment 21-78, and subsequent Amendments 21-82 and 21-83). Among other actions, SFAR 88 requires certain type design ( *i.e.* , type certificate

(TC)and supplemental type certificate (STC)) holders to substantiate that their fuel tank systems can prevent ignition sources in the fuel tanks. This requirement applies to type design holders for large turbine-powered transport airplanes and for subsequent modifications to those airplanes. It requires them to perform design reviews and to develop design changes and maintenance procedures if their designs do not meet the new fuel tank safety standards. As explained in the preamble to the rule, we intended to adopt airworthiness directives to mandate any changes found necessary to address unsafe conditions identified as a result of these reviews. In evaluating these design reviews, we have established four criteria intended to define the unsafe conditions associated with fuel tank systems that require corrective actions. The percentage of operating time during which fuel tanks are exposed to flammable conditions is one of these criteria. The other three criteria address the failure types under evaluation: Single failures, single failures in combination with a latent condition(s), and in-service failure experience. For all four criteria, the evaluations included consideration of previous actions taken that may mitigate the need for further action. We have determined that the actions identified in this proposed AD are necessary to reduce the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane. We have received a report indicating that fuel leaked from the No. 1 main fuel tank boost pump electrical conduit into the fuel shroud drain system, on a Model DC-10-30 airplane. The airplane had accumulated about 25,000 total flight hours. Investigation revealed that electrical arcing between chafed wiring and the inside of the conduit wall caused a hole in the conduit. Fuel then leaked into the conduit through the hole from the fuel tank. This condition, if not prevented, could result in the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane. Relevant Service Information We have reviewed McDonnell Douglas DC-10 Service Bulletin 24-128, dated January 19, 1984. The service bulletin describes procedures for installing Teflon sleeving around the fuel pump wire harness inside the conduit in the aft supplemental fuel tank. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. FAA's Determination and Requirements of the Proposed AD We have evaluated all pertinent information and identified an unsafe condition that is likely to exist or develop on other airplanes of this same type design. For this reason, we are proposing this proposed AD, which would require accomplishing the actions specified in the service information described previously, except as discussed under “Difference Between the Proposed AD and Service Bulletin.” Difference Between the Proposed AD and Service Bulletin The service bulletin recommends accomplishing the modification within 34,000 flight hours after installing the supplemental fuel tank. When the service bulletin was issued in 1984, we did not have a safety concern that warranted AD action. However, the service bulletin was re-evaluated as part of the SFAR 88 review activity. We determined that AD action is warranted. From that review, we also determined that the recommended compliance time should be re-examined. Boeing subsequently recommended a 60-month compliance time, which is consistent with the compliance time recommended in similar Boeing service bulletins. In developing an appropriate compliance time for this AD, we considered the typical utilization of the affected airplanes, the degree of urgency associated with the subject unsafe condition, and the time necessary to perform the modification (2 hours). In light of all of these factors, we find that a 60-month compliance time represents an appropriate interval of time for affected airplanes to continue to operate without compromising safety. Costs of Compliance There are about 5 airplanes of the affected design in the worldwide fleet. This proposed AD would affect about 5 airplanes of U.S. registry. The proposed actions would take about 2 work hours per airplane, at an average labor rate of $80 per work hour. The cost of required parts is negligible. Based on these figures, the estimated cost of the proposed AD for U.S. operators is $800, or $160 per airplane. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration

(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **McDonnell Douglas:** Docket No. FAA-2007-27302; Directorate Identifier 2006-NM-273-AD. Comments Due Date

(a)The FAA must receive comments on this AD action by April 9, 2007. Affected ADs

(b)None. Applicability

(c)This AD applies to McDonnell Douglas Model DC-10-30 and DC-10-30F (KC-10A and KDC-10) airplanes, certificated in any category; as identified McDonnell Douglas DC-10 Service Bulletin 24-128, dated January 19, 1984. Unsafe Condition

(d)This AD results from fuel system reviews conducted by the manufacturer. We are issuing this AD to prevent the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors, could result in fuel tank explosions and consequent loss of the airplane. Compliance

(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Modification

(f)Within 60 months after the effective date of this AD, install Teflon sleeving around the fuel pump wire harness inside the conduit in the aft supplemental fuel tank, in accordance with the Accomplishment Instructions of McDonnell Douglas DC-10 Service Bulletin 24-128, dated January 19, 1984. Alternative Methods of Compliance (AMOCs) (g)(1) The Manager, Los Angeles Aircraft Certification Office, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.

(2)Before using any AMOC approved in accordance with § 39.19 on any airplane to which the AMOC applies, notify the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office. Issued in Renton, Washington, on February 13, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-2975 Filed 2-21-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 352 [Docket No. 2006N-0479] RIN 0910-AF43 Insect Repellent-Sunscreen Drug Products for Over-the-Counter Human Use; Request for Information and Comments AGENCY: Food and Drug Administration, HHS. ACTION: Request for data and information. SUMMARY: The Food and Drug Administration

(FDA)is seeking information to formulate a regulatory position on insect repellent products that contain over-the-counter

(OTC)sunscreen ingredients. FDA is considering amending its monograph for OTC sunscreen drug products (the regulation that establishes conditions under which these drug products are generally recognized as safe and effective and not misbranded) to add conditions for marketing insect repellent-sunscreen drug products. The insect repellent ingredients in these products are regulated by the Environmental Protection Agency (EPA). Elsewhere in this issue of the **Federal Register** is a companion document in which EPA is also requesting information and comments on these products. The decision on what regulations, if any, to propose will be based, in part, on information and comments submitted in response to this request for data and information. DATES: Submit written or electronic comments by May 23, 2007. ADDRESSES: You may submit comments, identified by Docket No. 2006N-0479 or RIN 0910-AF43, by any of the following methods: Electronic Submissions Submit electronic comments in the following ways: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Agency Web site: *http://www.fda.gov/dockets/ecomments* . Follow the instructions for submitting comments on the agency Web site. Written Submissions Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described in the *Electronic Submissions* portion of this paragraph. *Instructions* : All submissions received must include the agency name and Docket No. and Regulatory Information Number

(RIN)for this rulemaking. All comments received will be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or comments received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Matthew R. Holman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, MS 5411, Silver Spring, MD 20993, 301-796-2090. SUPPLEMENTARY INFORMATION: I. Background A. Description of Insect Repellent-Sunscreen Drug Products FDA and EPA are seeking information to formulate a regulatory position for combination insect repellent-sunscreen drug products for use on human skin. Because sunscreen drug products are regulated by FDA and the insect repellent components of these products are separately regulated by EPA, both agencies are seeking comments to determine how these combination products should be regulated. Currently, approximately 20 combination insect repellent-sunscreen drug products are available for consumers. These products consist of one of three insect repellents (N,N-diethyl-meta-toluamide (DEET), oil of citronella, or IR3535) and a sunscreen component (one or more sunscreen ingredients). Combination insect repellent-sunscreen drug products are available in lotion, cream, and spray-on formulations and are currently marketed for use by the entire family. Due to concerns about the potential conflict in the directions for use and other labeling requirements for the insect repellent and the sunscreen components of the product, EPA postponed a regulatory decision on combination DEET/sunscreen products in its Reregistration Eligibility Decision

(RED)for DEET (December 1998) until additional information could be obtained. This document solicits opinion and comment from the public to assist both agencies in regulating these products. B. Regulatory Status of the Insect Repellent Ingredients EPA regulates insect repellents under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Three insect repellent active ingredients are currently used in combination with sunscreens: DEET, oil of citronella, and IR3535. EPA recently registered two other insect repellents, p-menthane-3,8-diol and picaridin. However, neither is currently available in combination with a sunscreen. Both DEET and oil of citronella have undergone reregistration, which entailed an evaluation and analysis of the complete database for each ingredient by EPA. IR3535, p-menthane-3,8-diol, and picaridin are registered chemicals evaluated by the registration process, which involves a similar analysis by EPA. They have not yet undergone the reregistration analysis. 1. DEET In December 1998, EPA completed its RED for DEET (Ref. 1), which includes the active ingredient N,N-diethyl-meta-toluamide and its isomers. DEET products, which are applied directly to skin and/or clothing, are available in numerous formulations (e.g., aerosol and non-aerosol sprays, creams, lotions, sticks, foams, and towelettes) and concentrations (products range from about 4 percent to 100 percent active ingredient). DEET is an insect and mite repellent labeled for use in households/domestic dwellings, on the human body and clothing, on cats, dogs, and horses, and in pet living/sleeping quarters. Based on pesticide usage information mainly for 1990 (Ref. 1), an average annual estimate of the domestic usage of DEET is 4 million pounds (active ingredient). About 30 percent of the U.S. population uses DEET annually as an insect repellent (this figure includes about 27 percent of adult males, 31 percent of adult females, and 34 percent of children). Approximately 21 percent of U.S. households use DEET annually. About 19 percent of households use DEET on household members, and about 4 percent of households that have cats and/or dogs use DEET on those pets. EPA indicated in its DEET RED (Ref. 1): The Agency is concerned about consumer use of products that combine sunscreen and DEET, since directions to reapply sunscreens generously and frequently may promote greater use of DEET than needed for pesticidal efficacy and thus pose unnecessary exposure to DEET. DEET labels currently recommend that products be used sparingly and not be reapplied too often. Sunscreen products, however, recommend frequent reapplication. No benefits attach to use of DEET more frequently than necessary to achieve its purpose. EPA did not make a regulatory decision regarding these DEET-sunscreen products at that time because it believed that it had not yet obtained adequate information. 2. Oil of Citronella In February 1997, EPA completed its RED for Oil of Citronella (Ref. 2). This decision includes a comprehensive reassessment of the required target data and the use patterns of currently registered oil of citronella products. Oil of citronella is a biochemical pesticide. It is registered as an animal repellent and as an insect repellent/feeding depressant. Oil of citronella is the volatile oil obtained from the steam distillation of freshly cut or partially dried grasses ( *Cymbopogon nardus* (Rendal) and *Cymbopogon winterianus* (Jowitt)). Two varieties of citronella oil exist commercially: “Ceylon type” (derived from *C. nardus* ) and “Java type” (derived from *C. winterianus* ). Based on pesticide survey usage information for 1991 and 1992 (Ref. 2), annual oil of citronella domestic usage ranged approximately from 33,000 to 48,000 pounds active ingredient for four sites: Domestic dwellings; ornamentals; human face, skin, and clothing; and manufacturing. The largest markets, in terms of total pounds active ingredient, for oil of citronella as an insect repellent are: Human face, skin, and clothing (56 to 74 percent); domestic dwelling [outdoor] (22 to 41 percent); and ornamentals (1.5 to 2.0 percent). The balance is used for manufacturing. In the RED (Ref. 2), EPA required all oil of citronella products with label claims for repelling mosquitoes, fleas, and ticks to have a minimum protection time of 1 hour. The directions for use must also contain the following statement pertaining to maintenance of repellent activity: “For maximum repellent effectiveness of this product, repeat applications at 1 hour intervals.” The RED allows the labeling to claim a protection time longer than 1 hour so long as it can be supported by product performance data showing an acceptable level of repellent activity. Because the principal uses of oil of citronella are dermal, special precautionary labeling related to dermal sensitization and irritation is required for all products with use directions for dermal application. EPA (Ref. 2) requires oil of citronella-sunscreen products for dermal application to bear the following precautionary statements regarding dermal sensitivity: “For external use only. Avoid contact with eyes. Discontinue if irritation or rash appears. Use on children under 6 months of age only with the advice of a physician.” These precautionary statements are consistent with the warnings and directions (regarding use on children under 6 months of age) that appear in FDA's stayed monograph for OTC sunscreen drug products (part 352 (21 CFR part 352)). 3. IR3535 The third currently registered insect repellent used in combination with a sunscreen is IR3535 (CAS number 52304-36-6). In 1997, EPA classified IR3535 as a biochemical for the following reasons (Ref. 3):

(1)It is functionally identical to naturally occurring beta-alanine,

(2)both ingredients repel insects,

(3)their basic molecular structure is identical,

(4)the end groups are not likely to contribute to toxicity, and

(5)IR3535 acts to control the target pest via a nontoxic mode of action. IR3535 is a technical grade synthetic biochemical pesticide that is produced by an integrated process. It is a liquid containing 98 percent 3-[N-Butyl-N-acetyl]-aminopropionic acid, ethyl ester as the active ingredient and 2 percent inert ingredients. 4. p-menthane-3,8-diol and KBR 3023 There are two insect repellent active ingredients that are not currently used in a combination insect repellent-sunscreen drug product. However, for the purposes of completeness, all currently registered insect repellents are discussed within this document. The first ingredient is p-menthane-3,8-diol, a biochemical pesticide that is chemically synthesized, although the natural oil can be extracted from lemon eucalyptus leaves and twigs (Ref. 4). It can be used in spray and lotion products to repel insects such as mosquitoes. The other insect repellent is KBR 3023, which contains the active ingredient picaridin. This chemical is currently formulated only for application to human skin. In December 2000, EPA registered a 15 percent pump-spray, 10 percent aerosol spray, 7 percent cream, 7 percent pump-spray, 5 percent cream, and 5 percent pump-spray (Ref. 5). C. Regulatory Status of the Sunscreen Ingredients In the **Federal Register** of May 21, 1999 (64 FR 27666), FDA issued a final monograph for OTC sunscreen drug products in part 352, establishing conditions under which these products are generally recognized as safe and effective and not misbranded. The monograph includes 16 sunscreen active ingredients in § 352.10; provides for combinations of sunscreen active ingredients in § 352.20; specifies required labeling in §§ 352.50, 352.52, and 352.60; and sets forth required testing procedures in §§ 352.70 through 352.77. Once the monograph becomes effective, any drug product (including any combination insect repellent-sunscreen drug product) that contains unsuitable inactive ingredients or active drug ingredients that do not comply with the monograph will be considered a new drug and require an approved new drug application

(NDA)before it may be legally marketed in the United States. Initially, the final monograph was to become effective on May 21, 2001, but FDA subsequently extended that date to December 31, 2002 (65 FR 36319, June 8, 2000). FDA then stayed the effective date of the monograph until further notice (66 FR 67485, December 31, 2001). FDA has delayed this effective date as it prepares an amendment to part 352 to address formulation, labeling, and testing requirements for ultraviolet A

(UVA)radiation protection and to revise some of the requirements for ultraviolet B

(UVB)radiation protection in a more comprehensive final monograph. Historically, FDA has used its enforcement discretion to allow the marketing of insect repellent-sunscreen drug products pending the issuance of the final sunscreen monograph so long as the products contained sunscreen ingredients included in the FDA rulemaking and were registered with EPA. These types of products were first marketed before the OTC drug review began in 1972, and FDA has not explicitly addressed them at any time in the rulemaking for OTC sunscreen drug products. Because they have always contained a pesticide, the combination insect repellent-sunscreen products have also historically been registered with and regulated by EPA. FDA is now interested in determining whether it should further amend that monograph to address these combination products. Once the final monograph for sunscreen drug products becomes effective, any combination product containing an unsuitable inactive ingredient or an active drug ingredient that is not included in the final monograph will be considered a new drug and need an NDA to be legally marketed, even if the product is also registered with EPA. Thus, one purpose of this document is to gather information to help FDA formulate its regulatory position toward these combination products. D. Regulatory Jurisdiction Over Insect Repellent-Sunscreen Drug Products In the **Federal Register** of December 22, 1971 (36 FR 24234), the Department of Health, Education, and Welfare

(DHEW)and EPA published a Memorandum of Agreement (the Agreement) regarding matters of mutual responsibility under the Federal Food, Drug, and Cosmetic Act (FFDCA) and the FIFRA. The Agreement was amended in the **Federal Register** of September 6, 1973 (38 FR 24233). This Agreement does not explicitly address products that combine sunscreen and insect repellent active ingredients. As noted, one purpose of this document is to solicit comments regarding the complexities of joint jurisdiction of these combination products. II. Information Requested and Specific Topics for Comment Interested persons are asked to review and comment upon all aspects of both FDA's and EPA's documents. Interested persons should submit all comments to both agencies. Both agencies have potential safety and effectiveness concerns for some of these products because of the different intervals of time required or recommended between applications of sunscreens versus insect repellents. FDA is particularly interested in receiving comments on the following topics: A. Possible Manufacturing Conflicts Because they contain ingredients regulated by EPA and FDA, all insect repellent-sunscreen drug products currently need to comply with both EPA's testing and laboratory requirements in 40 CFR part 158 and FDA's current good manufacturing practice for finished pharmaceuticals requirements in part 211 (21 CFR part 211). The products will also have to meet the testing procedures for OTC sunscreen drug products in part 352, subpart D, when that monograph becomes effective. The agencies are not aware of any specific manufacturing requirements that conflict and invite specific comment and information on this subject. 1. Are manufacturers of insect repellent-sunscreen drug products or others aware of any conflicts between the EPA and FDA manufacturing requirements for these products? If yes, is there any way to resolve the conflict(s)? 2. Approximately 20 insect repellent-sunscreen drug products are currently registered with EPA. If there is a future FDA rulemaking for all combination insect repellent-sunscreen drug products, how should these currently registered products be addressed in the sunscreen monograph? What requirements should be retained, revised, or eliminated from the sunscreen monograph? 3. Have manufacturers of currently marketed insect repellent-sunscreen drug products conducted any of the testing described in part 352, subpart D, for their combination product(s), notwithstanding that the effective date of part 352 has been stayed? If yes, what problems, if any, have they encountered? B. Possible Formulation Conflicts During completion of its DEET RED, EPA solicited information from registrants of insect repellent-sunscreen drug products on the possibility of formulation conflicts. At that time, EPA received information that suggests a potential formulation conflict is encountered when sunscreen and insect repellent are used separately (or sequentially applied) (Ref. 6). It is unclear whether this formulation issue poses a similar or related problem when these ingredients are combined into a single product. The agencies invite specific comment and information on this subject. C. Possible Labeling Conflicts Insect repellent and sunscreen products each have different labeling requirements that may conflict when both are combined and packaged in one product. The insect repellent component is subject to the labeling requirements in 40 CFR 156.10 entitled “labeling requirements and the active ingredient specific requirements.” For each registered insect repellent, these requirements are listed in the registration or reregistration documents. The sunscreen component of the product is subject to the labeling requirements in § 201.66 (21 CFR 201.66) and part 352. However, FDA has stayed these regulations for OTC sunscreen drug products until we issue a sunscreen final rule (69 FR 53801 (September 3, 2004) and 66 FR 67485). The agencies are concerned that the labeling format and some of the content requirements vary between the EPA and FDA requirements. For example, FDA uses the word “warning” on labels, while EPA uses the word “caution” and only uses the word “warning” as an indicator of toxicity level on pesticide labels. Many of the required warning section headings are also different. In addition, the application directions for the sunscreen and the insect repellent components may be significantly different. For example, the application directions for sunscreens state to “apply liberally (or generously) * * * as needed” and provide for application to more areas of the body than do the application instructions for insect repellents, which tend to restrict the frequency of application and where and how the product can be applied. EPA requirements for DEET include labeling that states: “Apply sparingly around ears.” and “Do not apply to children's hands.” The directions for some DEET products require a 6-hour interval between applications and state: “Use just enough repellent to cover exposed skin and/or clothing” and “avoid over-application of this product.” Also, a currently marketed insect repellent (DEET)-sunscreen drug product states in its labeling “frequent reapplication and saturation is unnecessary for effectiveness.” While frequent reapplication may not be necessary for the effectiveness of the DEET in this product, frequent reapplication may be necessary for the effectiveness of the sunscreen. Hence, there are many differences between the labeling required by FDA for OTC drugs and EPA for pesticides. The labeling formats, labeling content, and the order in which information is presented are quite different. FDA and EPA are exploring whether they can reconcile these differences, safeguard the public health, and still adequately meet the requirements of FFDCA and FIFRA. 1. Concerning an integrated label, can the different instructions for the two components (regarding frequency of application and where the product can be applied) be reconciled into a single direction that does not lead to improper application (i.e., incorrect location), over-application of the insect repellent, or under-application of the sunscreen? Is there labeling that would reflect the differences in reapplication intervals for DEET when combined with sunscreen ingredients? Oil of citronella when combined with sunscreen ingredients? IR3535 when combined with sunscreen ingredients? 2. The FFDCA requires that all OTC drug products list the established name of each inactive ingredient on the outside container of the retail package (see section 502(e)(1)(A)(iii) of FFDCA (21 U.S.C. 352(e)(1)(A)(iii)); also see § 201.66(c)(8)). EPA does not require a complete declaration of “inactive or inert” ingredients and normally does not require insect repellent manufacturers to list the identities of inert ingredients on product labels. However, under FIFRA, if one inert ingredient is disclosed in product labeling, then all inert ingredients must be disclosed. EPA is currently discussing, with a wide spectrum of stakeholders, how to make information concerning inert ingredients more widely available. The results of those discussions will affect combination insect repellent-sunscreen drug products as well as other pesticide products. Failure to list all of the inactive ingredients in the product's labeling, including all such ingredients in the insect repellent, would cause a combination insect repellent-sunscreen drug product to be misbranded under the FFDCA (see section 502(e)(1)(A)(iii) of FFDCA). Is there a way to label combination sunscreen-insect repellent drug products that satisfies FFDCA's requirements under section 502(e)(1)(A) of FFDCA but does not violate FIFRA? Are those ingredients that are “inert” under FIFRA also necessarily “inactive” under FFDCA? D. Safety Issues FDA is aware of only two studies examining percutaneous absorption when combining an insect repellent with a sunscreen. One study involved hairless mice (Ref. 6) and the other study involved piglets (Ref. 7). Both studies demonstrate increased absorption of the insect repellent DEET and different sunscreens when the components were combined. Thus, FDA would like more information concerning the safety of insect repellent-sunscreen drug products: 1. Is there data available to show whether increased absorption of the sunscreen ingredients(s) does or does not occur as a result of being combined with an insect repellent ingredient? If so, please provide. For example, is there any evidence that absorption increases as the particle size of titanium dioxide and zinc oxide decreases (down to a few nanometers) in insect repellent-sunscreen products? If so, is there evidence regarding the health or safety effects associated with the increased absorption? 2. Are there reports or other information relating to skin irritation resulting from use of a combination insect repellent-sunscreen drug product are manufacturers of these products or others aware of? Provide a summary of the types of events reported and, if possible, estimate an incidence of occurrence. E. Effectiveness Issues For some insect repellent-sunscreen products, FDA has effectiveness concerns because of the interval of time required or recommended between applications of the product. EPA identifies reapplication times on insect repellent labels so consumers can maintain the maximum protection against insect bites but avoid over-exposure. This reapplication time relates to the effectiveness of the insect repellent portion of the product and not to the sunscreen protection. The directions for sunscreen products, which encourage frequent reapplication of the drug, relate to the effectiveness of the sunscreen component of the product and not to the insect repellent component. The differences in directions for use for the insect repellent component and the sunscreen component need to be resolved to ensure safety and effectiveness of both components and the combination product as a whole. For example, the directions for some products containing DEET require a 6-hour interval between applications and state “use just enough repellent to cover exposed skin and/or clothing” and “avoid over-application of this product.” In contrast, the directions for sunscreen drug products in § 352.52(d)(1) and (d)(2) state to “apply liberally, generously, smoothly, or evenly * * * before sun exposure and as needed,” and “reapply as needed or after towel drying, swimming, or (select ‘sweating’ or ‘perspiring’).” Section 352.60(d) of the sunscreen monograph also states that “when the time intervals or age limitations for administration of the individual ingredients differ, the directions for the combination product may not contain any dosage that exceeds those established for any individual ingredient in the applicable OTC drug monograph(s), and may not provide for use by any age group lower than the highest minimum age limit established for any individual ingredient.” Concerns about effectiveness also stem from a study (Ref. 8) indicating that separate application of sunscreen followed by DEET resulted in a decrease in sun protection factor

(SPF)after application of the insect repellent. Thus, FDA is soliciting comment on the following questions: 1. Is there additional evidence suggesting that application of a sunscreen product followed by application of a separate insect repellent product results in a decrease in the sunscreen's SPF? Is there evidence suggesting that sequential application of the products has no adverse effect on the sunscreen? 2. Is there evidence suggesting that combining a sunscreen and insect repellent in a single formulation adversely impacts the effectiveness of the sunscreen? Is there evidence suggesting that such a combination has no adverse impact on the sunscreen component? 3. Are there effective concentrations of the insect repellent ingredients that could be used to allow for liberal application and frequent reapplication of the insect repellent-sunscreen drug products, as directed by the sunscreen directions, without jeopardizing the safety of the consumer? How does this vary by insect repellent ingredient? Would any of the insect repellent ingredients be effective at such concentrations? 4. Is there information available to show whether there are any chemical or physical incompatibilities between insect repellent and sunscreen active ingredients when used in combination products or when used separately? Are there any sunscreen ingredients that should not be used with a specific insect repellent ingredient? 5. If an insect repellent ingredient (e.g., DEET) is labeled for 6-hour intervals between applications, can the effectiveness of the sunscreen be assured if the product cannot be applied more often than every 6 hours? Is there a need for a minimal SPF to assure the effectiveness of the combination product considering the wide variation in minimal erythemal dose

(MED)between individuals and the need for reapplication due to physical stress such as toweling or rubbing of the skin? If the answer is yes, what minimal SPF value should be required, and what is the basis for that SPF value? 6. Is there information available to demonstrate that there are product performance benefits [other than the convenience of using one product instead of two] derived from the concurrent application of the insect repellent and the sunscreen (as opposed to sequential application of these products separately)? Please submit any data that you reference. 7. Oil of Citronella products are labeled to repeat applications at 1 hour intervals for maximum repellent effectiveness. Is it possible that insect repellent-sunscreen drug products can be formulated in such a way that the insect repellent reapplication intervals coincide more closely with the sunscreen reapplication intervals? Can this be done without jeopardizing the safety or effectiveness of these products? III. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on this document. Three copies of all written comments are to be submitted. Individuals submitting written comments or anyone submitting electronic comments may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document and may be accompanied by a supporting memorandum or brief. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. References The following references are on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. EPA Reregistration Eligibility Decision for DEET, 1998. 2. EPA Reregistration Eligibility Decision for Oil of Citronella, 1997. 3. EPA Biopesticide Registration Eligibility Document for IR3535, 1999. 4. EPA Biopesticide Registration Eligibility Document for p-menthane-3,8-diol, 2000. 5. EPA Decision Memorandum on KBR 3023, 2000. 6. Ross, E. A. et al., “Insect Repellent Interactions: Sunscreens Enhance DEET ( *N,N* -Diethyl- *M* -Toluamide) Absorption,” *Drug Metabolism and Disposition* , 32:783-785, 2004. 7. Gu, X. et al., “In Vitro Evaluation of Concurrent Use of Commercially Available Insect Repellent and Sunscreen Preparations,” *British Journal of Dermatology* , 152: 1263-1267, 2005. 8. Montemarano, A. D. et al., “Insect Repellents and the Efficacy of Sunscreens,” *The Lancet* , 349:1670-1671, 1997. This request for information and comment is issued under sections 201, 501, 502, 503, 505, 510, and 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 355, 360, and 371) and under authority of the Commissioner of Food and Drugs. Dated: December 5, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-2890 Filed 2-21-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-301P] 21 CFR Part 1308 Schedules of Controlled Substances: Placement of Lisdexamfetamine into Schedule II AGENCY: Drug Enforcement Administration, U.S. Department of Justice. ACTION: Notice of proposed rulemaking. SUMMARY: This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration

(DEA)to place the substance lisdexamfetamine, including its salts, isomers, and salts of isomers, into schedule II of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Assistant Secretary for Health of the Department of Health and Human Services

(DHHS)and on an evaluation of the relevant data by DEA. This scheduling of lisdexamfetamine in schedule II will not be finalized until a New Drug Application

(NDA)for a lisdexamfetamine product is approved by the Food and Drug Administration (FDA). If finalized, this action would impose the regulatory controls and criminal sanctions of schedule II on those who handle lisdexamfetamine and products containing lisdexamfetamine. DATES: Written comments must be postmarked, and electronic comments must be sent, on or before March 26, 2007. ADDRESSES: To ensure proper handling of comments, please reference “Docket No. DEA-301” on all written and electronic correspondence. Written comments sent via regular mail should be sent to the Deputy Administrator, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to the Deputy Administrator, Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301. Comments may be directly sent to DEA electronically by sending an electronic message to *dea.diversion.policy@usdoj.gov.* Comments may also be sent electronically through *http://www.regulations.gov* using the electronic comment form provided on that site. An electronic copy of this document is also available at the *http://www.regulations.gov* Web site. DEA will accept electronic comments containing MS Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file format other than those specifically listed here. FOR FURTHER INFORMATION CONTACT: Christine Sannerud, PhD, Chief, Drug and Chemical Evaluation Section, Drug Enforcement Administration, Washington, DC 20537,

(202)307-7183. SUPPLEMENTARY INFORMATION: Lisdexamfetamine is a central nervous system stimulant drug. The Food and Drug Administration

(FDA)is currently reviewing a New Drug Application

(NDA)for lisdexamfetamine. Upon approval of this pending NDA, lisdexamfetamine will be marketed as a prescription drug product for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Lisdexamfetamine is an amide ester conjugate comprised of the amino acid L-lysine covalently bound to the amino group of d-amphetamine. The chemical name of its dimesylate salt form is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenethyl]hexanamide dimethanesulfonate (CAS number 608137-32-3). Lisdexamfetamine per se is pharmacologically inactive and its effects are due to its in vivo metabolic conversion to d-amphetamine. In this regard, lisdexamfetamine acts as a prodrug. Lisdexamfetamine shares substantial pharmacological effects and abuse potential with amphetamine. Lisdexamfetamine is positively reinforcing in monkeys. It generalizes to the discriminative stimulus effects of d-amphetamine in monkeys. It produces locomotor stimulation in rats. In adults, the total amphetamine exposure resulting from 75 mg oral lisdexamfetamine is equivalent to 35 mg oral Adderall XR, an extended release amphetamine product. Peak plasma concentrations of d-amphetamine following oral ingestion of 50 and 70 mg lisdexamfetamine correspond closely to those produced by oral ingestion of 30 and 50 mg immediate-release d-amphetamine product. In controlled clinical studies, lisdexamfetamine has been found to be similar to d-amphetamine in psychoactive measures. It produces euphoria in humans typical of d-amphetamine. Lisdexamfetamine shows an adverse event profile similar to that of d-amphetamine. Some adverse effects of lisdexamfetamine include insomnia, nervousness, irritability, anorexia, weight loss, mood alterations, and increases in blood pressure and heart rate. Lisdexamfetamine has not been studied for its psychological and physical dependence potential. However, since lisdexamfetamine is a prodrug for d-amphetamine, it is expected to possess dependence potential similar to that of d-amphetamine. d-Amphetamine is known to cause both psychological and physical dependence. Some symptoms of d-amphetamine withdrawal include depression, increase in sleep and food intake, drug craving, anhedonia, irritability and poor concentration. Lisdexamfetamine is a new molecular entity and has not been marketed in the United States or other countries. Therefore, there has been no evidence of diversion, abuse, or law enforcement encounters involving lisdexamfetamine. On November 14, 2006, the Assistant Secretary for Health, DHHS, sent the Deputy Administrator of DEA a scientific and medical evaluation and a letter recommending that lisdexamfetamine be placed into schedule II of the CSA. Enclosed with the November 14, 2006 letter was a document prepared by the FDA entitled, “Basis for the Recommendation for Control of Lisdexamfetamine in Schedule II of the Controlled Substances Act.” The document contained a review of the factors which the CSA requires the Secretary to consider (21 U.S.C. 811(b)). The factors considered by the Assistant Secretary of Health and DEA with respect to lisdexamfetamine were:

(1)Its actual or relative potential for abuse;

(2)Scientific evidence of its pharmacological effects;

(3)The state of current scientific knowledge regarding the drug;

(4)Its history and current pattern of abuse;

(5)The scope, duration, and significance of abuse;

(6)What, if any, risk there is to the public health;

(7)Its psychic or physiological dependence liability; and

(8)Whether the substance is an immediate precursor of a substance already controlled under this subchapter. (21 U.S.C. 811(c)) Based on the recommendation of the Assistant Secretary for Health, received in accordance with section 201(b) of the Act (21 U.S.C. 811(b)), and the independent review of the available data by DEA, the Deputy Administrator of DEA, pursuant to sections 201(a) and 201(b) of the Act (21 U.S.C. 811(a) and 811(b)), finds that:

(1)Lisdexamfetamine has a high potential for abuse;

(2)Upon approval of the pending NDA, lisdexamfetamine will have a currently accepted medical use in treatment in the United States; and

(3)Abuse of lisdexamfetamine may lead to severe psychological or physical dependence. Based on these findings, the Deputy Administrator of DEA concludes that lisdexamfetamine, including its salts, isomers, and salts of isomers, warrants control in schedule II of the CSA, if and when an NDA for lisdexamfetamine is approved. Interested persons are invited to submit their comments, objections or requests for a hearing with regard to this proposal. Requests for a hearing should state, with particularity, the issues concerning which the person desires to be heard. All correspondence regarding this matter should be submitted to the Deputy Administrator, Drug Enforcement Administration, Washington, DC, 20537, Attention: DEA Federal Register Representative/ODL. In the event that comments, objections, or requests for a hearing raise one or more issues which the Deputy Administrator finds warrant a hearing, the Deputy Administrator shall order a public hearing by notice in the **Federal Register** , summarizing the issues to be heard and setting the time for the hearing. Requirements for Handling Lisdexamfetamine If this rule is finalized as proposed, lisdexamfetamine would be subject to CSA regulatory controls and administrative, civil and criminal sanctions applicable to the manufacture, distribution, dispensing, importing and exporting of a schedule II controlled substance, including the following: *Registration.* Any person who manufactures, distributes, dispenses, imports, exports, engages in research or conducts instructional activities with lisdexamfetamine, or who desires to manufacture, distribute, dispense, import, export, engage in instructional activities or conduct research with lisdexamfetamine, would be required to be registered to conduct such activities in accordance with Part 1301 of Title 21 of the Code of Federal Regulations. *Security.* Lisdexamfetamine would be subject to schedule II security requirements and must be manufactured, distributed and stored in accordance with §§ 1301.71, 1301.72(a), (c), and (d), 1301.73, 1301.74, 1301.75(b) and (c), 1301.76 and 1301.77 of Title 21 of the Code of Federal Regulations. *Labeling and Packaging.* All labels and labeling for commercial containers of lisdexamfetamine which are distributed after finalization of this rule would be required to comply with requirements of §§ 1302.03-1302.07 of Title 21 of the Code of Federal Regulations. *Quotas.* Quotas for lisdexamfetamine would be established pursuant to part 1303 of Title 21 of the Code of Federal Regulations. *Inventory.* Every registrant required to keep records and who possesses any quantity of lisdexamfetamine would be required to keep an inventory of all stocks of lisdexamfetamine on hand pursuant to §§ 1304.03, 1304.04 and 1304.11 of Title 21 of the Code of Federal Regulations. Every registrant who desires registration in schedule II for lisdexamfetamine would be required to conduct an inventory of all stocks of the substance on hand at the time of registration. *Records.* All registrants would be required to keep records pursuant to §§ 1304.03, 1304.04, 1304.21, 1304.22, and 1304.23 of Title 21 of the Code of Federal Regulations. *Reports.* All registrants required to submit reports to the Automation of Reports and Consolidated Order System (ARCOS) in accordance with § 1304.33 of Title 21 of the Code of Federal Regulations would be required to do so for lisdexamfetamine. *Orders for Lisdexamfetamine.* All registrants involved in the distribution of lisdexamfetamine would be required to comply with the order form requirements of part 1305 of Title 21 of the Code of Federal Regulations. *Prescriptions.* All prescriptions for lisdexamfetamine or prescriptions for products containing lisdexamfetamine would be required to be issued pursuant to 21 CFR 1306.03-1306.06 and 1306.11-1306.15. *Importation and Exportation.* All importation and exportation of lisdexamfetamine would need to be in compliance with part 1312 of Title 21 of the Code of Federal Regulations. *Criminal Liability.* Any activity with lisdexamfetamine not authorized by, or in violation of, the Controlled Substances Act or the Controlled Substances Import and Export Act occurring on or after finalization of this proposed rule would be unlawful. Regulatory Certifications Executive Order 12866 In accordance with the provisions of the CSA (21 U.S.C. 811(a)), this action is a formal rulemaking “on the record after opportunity for a hearing.” Such proceedings are conducted pursuant to the provisions of 5 U.S.C. 556 and 557 and, as such, are exempt from review by the Office of Management and Budget pursuant to Executive Order 12866, section 3(d)(1). Regulatory Flexibility Act The Deputy Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this proposed rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. Lisdexamfetamine products will be prescription drugs used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Handlers of lisdexamfetamine will also handle other controlled substances used to treat ADHD which are already subject to the regulatory requirements of the CSA. Executive Order 12988 This regulation meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform. Executive Order 13132 This rulemaking does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132. Unfunded Mandates Reform Act of 1995 This rule will not result in the expenditure by state, local and tribal governments, in the aggregate, or by the private sector, of $118,000,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995. Congressional Review Act This rule is not a major rule as defined by § 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule will not result in an annual effect on the economy of $100,000,000 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. List of Subjects in 21 CFR Part 1308 Administrative practice and procedure, Drug traffic control, Narcotics, Prescription drugs. Under the authority vested in the Attorney General by section 201(a) of the CSA (21 U.S.C. 811(a)), and delegated to the Administrator of DEA by U.S. Department of Justice regulations (28 CFR 0.100), and redelegated to the Deputy Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby proposes that 21 CFR part 1308 be amended as follows: PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES [AMENDED] 1. The authority citation for 21 CFR part 1308 continues to read as follows: Authority: 21 U.S.C. 811, 812, 871(b) unless otherwise noted. 2. Section 1308.12 is proposed to be amended by adding a new paragraph (d)(5) to read as follows: § 1308.12 Schedule II.

(d)* * *

(5)Lisdexamfetamine, its salts, isomers, and salts of its isomers 1205 Dated: February 12, 2007. Michele M. Leonhart, Deputy Administrator. [FR Doc. E7-2993 Filed 2-21-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 070209029-7029-01; I.D. 112906A] RIN 0648-AU58 Fisheries of the Exclusive Economic Zone Off Alaska; Groundfish Observer Program AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Proposed rule; request for comments. SUMMARY: NMFS issues a proposed rule to amend regulations implementing the North Pacific Groundfish Observer Program (Observer Program). This action is necessary to avoid expiration of these regulations on December 31, 2007, and ensure uninterrupted observer coverage in North Pacific groundfish fisheries. The proposed rule is intended to promote the goals and objectives of the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area and the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMPs). DATES: Written comments must be received by March 23, 2007. ADDRESSES: Send comments to Sue Salveson, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region, NMFS, Attn: Ellen Sebastian. Comments may be submitted by any of the following methods: • Mail: to P.O. Box 21668, Juneau, AK 99802; • Hand delivery to the Federal Building: 709 West 9 th Street, Room 420A, Juneau, AK, 99802; • Fax:

(907)586-7557; • E-mail: *0648-AU58obs@noaa.gov* . Include in the subject line of the email the following identifier: Observer Program Extension 0648-AU58. E-mail comments, with or without attachments, are limited to five megabytes; or • Webform at the Federal e-Rulemaking Portal: *http://www.regulations.gov* . Copies of the Environmental Assessment/Regulatory Impact Review/Initial Regulatory Flexibility Analysis (EA/RIR/IRFA) prepared for this action may be obtained from the mailing address above or by calling the Sustainable Fisheries Division, Alaska Region, NMFS, at 907-586-7228. FOR FURTHER INFORMATION CONTACT: Jason Anderson, 907-586-7228, or *jason.anderson@noaa.gov* . SUPPLEMENTARY INFORMATION: Background NMFS manages the U.S. groundfish fisheries of the Bering Sea and Aleutian Islands Management Area

(BSAI)and Gulf of Alaska

(GOA)in the Exclusive Economic Zone

(EEZ)under the FMPs. The North Pacific Fishery Management Council (Council) has prepared the FMPs pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Regulations implementing the FMPs appear at 50 CFR part 679. General regulations that pertain to U.S. fisheries appear at subpart H of 50 CFR part 600. Groundfish fisheries in the GOA and BSAI are managed under quotas set annually for groundfish species and for several other species that groundfish fishery participants are prohibited from retaining. Management programs under the FMPs allocate specific quotas among areas, seasons, gear types, processor and catcher vessel sectors, cooperatives, and individual fishermen. Annual quotas are based on NMFS stock assessments and Council recommendations. The Alaska Region NMFS is responsible for monitoring the catch of these quotas, and for closing the fisheries when quotas are reached. Stock assessments, quota monitoring, and management require an accounting for all groundfish and prohibited species catch, including discarded catch. Observer requirements for fisheries off Alaska have been in place since the mid-1970s, when the Magnuson Fishery Conservation and Management Act (re-authorized in 1996 as the Magnuson-Stevens Act) was implemented and NMFS began to monitor U.S. EEZ foreign groundfish fisheries. The Secretary of Commerce (Secretary) and the Council recognized that living marine resources cannot be effectively managed without the types of information that are either available only or most efficiently through an observer program. Therefore, when foreign vessel fisheries ended in 1991, the Council developed and the Secretary approved a domestic Observer Program that authorized the placement of observers on domestic fishing vessels and at shoreside processing plants participating in Alaskan groundfish fisheries. The domestic Observer Program was implemented through Amendment 18 to the GOA FMP and Amendment 13 to the BSAI FMP (54 FR 50386, December 6, 1989, and 55 FR 4839, February 12, 1990). Observer coverage requirements have remained mostly unchanged since approval of the program. The current Observer Program has an integral role in the management of North Pacific fisheries. The information collected by observers provides the best available scientific information for managing the fisheries and developing measures to minimize bycatch in furtherance of the purposes and national standards of the Magnuson-Stevens Act. Observers collect catch data used by managers for quota monitoring and management of groundfish and prohibited species, biological data and samples used by scientists for stock assessment analyses, information used by managers to document and reduce fishery interactions with protected resources, and information and samples used by scientists in marine ecosystem research. The Observer Program also provides information, analyses, and support in the development of proposed policy and management measures. Further, observers interact with the fishing industry on a daily basis and the Observer Program strives to promote constructive communication between the agency and interested parties. Observations are used by managers and enforcement personnel to document the effectiveness of the management programs of various entities, including NMFS, the U.S. Coast Guard, and the U.S. Fish and Wildlife Service. High quality observer data are a cornerstone of Alaska groundfish fisheries management. However, the quality and utility of observer data suffer due to the current structure of procuring and deploying observers. Under the current program, coverage levels vary with the size of the vessel or the quantity of fish processed. Vessel owners and operators choose when and where to carry observers, and fishery managers do not control when and where observers are deployed. To address these concerns, the Council directed NMFS to develop an alternate program structure. Since the early 1990's, the Council and NMFS have explored alternative program structures as part of three separate actions. However, the Council identified problems with each of these actions and none were adopted. While the Council was developing and considering options for an alternate program structure, the Council recommended, and the Secretary approved, several extensions of the Observer Program regulations. A thorough discussion of the history of the Observer Program, including past efforts to restructure and extend the Observer Program, is provided in the EA/RIR/ IRFA prepared for this action (see ADDRESSES ), and is not repeated here. In October 2002, the Council tasked its observer advisory committee

(OAC)to develop a problem statement and alternatives for restructuring the Observer Program. In April 2003, the Council adopted a suite of alternatives that contemplated restructuring the Observer Program in a stepwise approach, beginning in the GOA. However, as NMFS began evaluating these alternatives, it became apparent that certain operational and data quality issues would be difficult to resolve in a revised program under which NMFS contracted directly with observers for observer services in the GOA, but retained the current system for procuring observer services in the BSAI. From December 2003 through June 2005, the Council refined the suite of alternatives, and in June 2005 adopted the current alternatives for analysis. These alternatives include options to restructure the Observer Program for all groundfish and halibut vessels fishing in the GOA only, for halibut vessels and certain sectors fishing in both the GOA and BSAI, and for all groundfish and halibut fisheries. Shoreside and stationary floating processors were included under each alternative depending on their location and management program. In addition to the “no-action” alternative under which the Observer Program would expire, the Council also asked staff to analyze an alternative that would remove the December 31, 2007, expiration date and continue current observer coverage regulations without an expiration date. While the Council intended to adopt a preferred alternative by January 1, 2008, several issues arose during the course of analysis of the alternatives that has made this difficult. First, due to uncertainty about the applicability of overtime pay provisions of the Fair Labor Standards Act to contracted observers, staff were unable to adequately analyze observer costs under any of the restructure alternatives. Second, the Research Plan authority to assess a fee for observer coverage could not be exclusively applied to a subset of the North Pacific groundfish fisheries vessels. Therefore, all the action alternatives except Alternative 2 (extension of the current program) required new statutory authorization for fee collection from a portion of the fleet or to implement different fee mechanisms for different sectors, as were considered in the analysis. Because observer costs cannot be adequately calculated and the uncertainty that Congress would authorize fee collection, NMFS recommended that the Council adopt Alternative 2 as its preferred alternative. The Council concurred and adopted Alternative 2 at its February 2006 meeting. The Council also amended the problem statement to reflect that, while Alternative 2 does not address most of the issues in the problem statement, it ensures Observer Program viability, and the continued collection of information necessary to manage the North Pacific fisheries. While the costs of the restructuring alternatives cannot be adequately calculated at this time, the analysis prepared for this action includes restructuring alternatives to provide context to the Council's adoption of Alternative 2. Expiration of the Observer Program would result in significant costs to groundfish fishery participants. Without data collected by observers, NMFS would be forced to adopt a much more conservative approach towards managing the groundfish fisheries of the GOA and BSAI. Such an approach could lead to early fisheries closures because there would be no observer data for total allowable catch

(TAC)and prohibited species catch limit calculations. NMFS would likely rely on more population models to generate allowable biological catch and TAC recommendations. In addition, failure to maintain a groundfish observer program in the North Pacific would violate the terms of a variety of statutes, including the Endangered Species Act (ESA). The ESA requires observer coverage as a reasonable and prudent measure for certain management actions. These are non-discretionary measures under current biological opinions and are prescribed under the incidental take statements for endangered marine mammals, salmon, and seabirds. Also in June 2006, the Council decided it would consider a new amendment proposing restructuring alternatives for the Observer Program when

(1)legislative authority is established for fee-based alternatives;

(2)the cost issues described above are clarified (by statute, regulation, or guidance) to allow estimated costs associated with the fee-based alternatives; or

(3)the Council responds to changes in conditions that cannot be anticipated now. On January 12, 2007, the President signed the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act (Pub. Law No. 109-479). The reauthorized Magnuson-Stevens Act includes language that would appear to allow the Council to adopt a fee collection program as considered in the analysis. However, the exact nature of the fee program authorized by the Magnuson-Stevens Act must be determined, the Council must consider a new amendment to restructure the current Observer Program, and NMFS must undergo rulemaking to implement a new Observer Program. Therefore, implementing a fee collection and restructured Observer Program prior to the December 31, 2007, expiration date would be difficult. Additionally, the observer cost issues described above remain unresolved. Revisions to Observer Program Regulations For the reasons described above, NMFS proposes to remove the December 31, 2007, expiration date from the heading of 50 CFR 679.50 and from regulations at § 679.50(j)(1)(vi). The current Observer Program would continue until the Council recommends and the Secretary approves and implements further action to amend the program. Continuation of the current Observer Program is necessary to prevent interruption of many current management programs. Classification This proposed rule has been determined to be not significant for purposes of Executive Order 12866. NMFS prepared an IRFA as required by section 603 of the Regulatory Flexibility Act. The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. A description of the action, why it is being considered, and the objectives and legal basis for this action are contained in the preamble and are not repeated here. A copy of the IRFA is available from NMFS (see ADDRESSES ). A summary of the analysis follows. This proposed rule would extend the effective date of regulations governing the Observer Program beyond December 31, 2007, the current expiration date. Extending the Observer Program beyond December 31, 2007, is necessary for uninterrupted continuation of many of the current management programs. The entities that would be directly regulated by this proposed action are groundfish and halibut harvesters and processors of the BSAI and GOA EEZ. These entities include the halibut vessels, groundfish catcher vessels, groundfish catcher processor vessels, and shoreside processors active in these areas. It also includes organizations to which direct allocations of groundfish are made, such as the BSAI community development quota

(CDQ)groups and the American Fisheries Act

(AFA)fishing sectors. The IRFA identified the following small entities that would be impacted by this rule. Based on 2005 data, 23 of the 87 catcher/processors active in the North Pacific groundfish fisheries would be considered small entities. All five North Pacific observer provider companies and the six CDQ groups would be considered small entities. Estimates of the number of shoreside processors that are small entities include all Alaska processors that reported processing groundfish to NMFS in 2002. Due to insufficient ownership and affiliation information, it is not possible, at this time, to determine how many of the 73 shoreside processors qualify as small entities. However, at least eight shoreside processors would be considered large entities because of American Fisheries Act

(AFA)affiliations. Finally, 807 groundfish and halibut catcher vessels have gross revenues less than $4 million, and would be considered small entities. Alternative 1 is the no action alternative. Under this alternative, the current Observer Program would continue to be the only system under which groundfish observers would be provided in the BSAI and GOA groundfish fisheries. Regulations authorizing the current program expire at the end of 2007. No additional recordkeeping and reporting requirements are associated with this action. Alternative 2 is the preferred alternative, and would extend the existing program. Under this alternative, the 2007 sunset date for the existing program would be removed and the program would be extended indefinitely with no changes to the overall service delivery model until the Council took further action. Alternative 3 would restructure the Observer Program for GOA groundfish and all halibut fisheries, while BSAI groundfish fisheries would be administered under the current system. A new ex-vessel value fee program would be established to fund coverage for GOA groundfish vessels, GOA-based processors, and halibut vessels operating throughout Alaska. Regulations that divide the fleet into zero, 30 percent, and 100 percent coverage categories would no longer apply to vessels and processors in the GOA. Fishermen and processors would no longer be responsible for obtaining their own observer coverage. Rather, NMFS would determine when and where to deploy observers based on data collection and monitoring needs, and would contract directly for observers using fee proceeds and/or direct Federal funding. Alternative 4 would restructure the Observer Program for all fisheries with coverage less than 100 percent. All vessels and processors assigned to Tiers 3 and 4 would participate in the new program throughout Alaska and pay an ex-vessel value based fee. In general, this alternative would apply to all halibut vessels, all groundfish catcher vessels less than 125 ft (38.1 m) in length overall and all non-AFA shoreside processors. All vessels and processors assigned to Tiers 1 and 2 (100 percent or greater coverage) would continue to operate under the current “pay-as-you-go” system throughout Alaska. Alternative 5 would restructure the Observer Program for all groundfish and halibut fisheries off Alaska. This alternative would establish a new fee-based groundfish observer program in which NMFS has a direct contract with observer providers for all GOA and BSAI groundfish and halibut vessels. Under this alternative, vessels with 100 percent or greater coverage requirements would pay a daily observer fee and vessels with coverage requirements less than 100 percent would pay an ex-vessel value based fee. As noted in the preamble above, Alternative 1 would result in significant costs to the fleet. The impacts to small entities of the Alternatives 2 through 5, expressed as a percentage of the ex-vessel value of groundfish and halibut landed, are presented in the EA/RIR/IRFA prepared for this action and are summarized here. Current observer costs expressed as a percentage of ex-vessel landed catch value can be considered a reasonable estimate of the costs to each sector of the fleet under Alternative 2 (rollover of the existing program). In the BSAI management area for the years 2000 through 2003, these costs averaged 2.54 percent for catcher/processors, 1.49 percent for catcher vessels, and 0.89 percent for all processors, including motherships. In the GOA management area for these same years, these costs averaged 1.11 percent for catcher/processors, 1.71 percent for catcher vessels, and 0.65 percent for all processors. Although adoption of Alternative 3, 4 or 5 would require new statutory authority that currently does not exist, adoption of any of these alternatives as presented in the EA/RIR/IRFA would require selection of a low, middle, or high ex-vessel fee percentage. Estimated costs expressed as a percentage of ex-vessel value of groundfish and halibut landings for the low, middle, and high endpoint options for Alternative 3 are 0.52 percent, 0.70 percent, and 1.05 percent, respectively. Estimated costs in terms of a percent of ex-vessel value for Alternative 4 are 0.69 percent, 0.83 percent, and 1.15 percent. Finally estimated costs in terms of a percent of ex-vessel value for Alternative 5 are 0.69 percent, 0.83 percent, and 1.15 percent. The analysis did not reveal any Federal rules that duplicate, overlap, or conflict with the proposed action. List of Subjects in 50 CFR Part 679 Alaska, Fisheries, Reporting and recordkeeping requirements. Dated: February 15, 2007. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service. For the reasons set out in the preamble, NMFS proposes to amend 50 CFR part 679 as follows: PART 679—FISHERIES OF THE EXCLUSIVE ECONOMIC ZONE OFF ALASKA 1. The authority citation for part 679 continues to read as follows: Authority: 16 U.S.C. 773 *et seq.* ; 1540(f); 1801 *et seq.* ; 1851 note; 3631 *et seq.* 2. In § 679.50, paragraph (j)(1)(vi) is removed and the section heading is revised to read as follows: § 679.50 Groundfish Observer Program. [FR Doc. E7-3019 Filed 2-21-07; 8:45 am] BILLING CODE 3510-22-S 72 35 Thursday, February 22, 2007 Notices AGENCY FOR INTERNATIONAL DEVELOPMENT Board for International Food and Agricultural Development One Hundred and Fiftieth Meeting; Notice of Meeting Pursuant to the Federal Advisory Committee Act, notice is hereby given of the one hundred and fiftieth meeting of the Board for International Food and Agricultural Development (BIFAD). The meeting will be held from 8:30 a.m. to 3:45 p.m. on February 27, 2007 at the National Association of State Universities and Land Grant Colleges (NASULGC) located at 1307 New York Avenue NW., Washington, DC. The meeting is being held in NASULGC's main conference room located on the ground floor. The morning session will be opened by Mr. Peter McPherson, Chairman of the BIFAD. The first presentation to the Board will cover Transformational Development and Budget Implications for U.S. Universities. This will be followed by a presentation on Increasing the Role of Universities in African Development—New Perspectives. At mid-morning the Board will then host an open discussion to explore the strategic direction of BIFAD for 2007. At noon Mr. James R. Kunder, Acting Deputy Administrator of the U.S. Agency for International Development (USAID), will join the Board for an executive luncheon. Following the luncheon Mr. Kunder will swear-in new BIFAD members. Title XII implementation will be the focus of the afternoon business sessions. Included will be presentations and discussion on USAID's horticultural development initiative, management of the Collaborative Research Support Programs (CRSPS), and the Strategic Partnership for Agricultural Research & Education (SPARE). The meeting is free and open to the public; with the exception of the executive luncheon which is closed. Those wishing to attend the meeting or obtain additional information about BIFAD should contact Ronald S. Senykoff, the Designated Federal Officer for BIFAD. Write him in care of the U.S. Agency for International Development, Ronald Reagan Building, Office of Agriculture, Bureau for Economic Growth, Agriculture and Trade, 1300 Pennsylvania Avenue, NW., Room 2.11-085, Washington DC, 20523-2110 or telephone him at

(202)712-0218 or fax

(202)216-3010. Ronald S. Senykoff, USAID Designated Federal Officer for BIFAD, Office of Agriculture, Bureau for Economic Growth, Agriculture & Trade, U.S. Agency for International Development. [FR Doc. E7-2900 Filed 2-21-07; 8:45 am] BILLING CODE 6116-01-P DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Docket No. AMS-FV-07-0023; FV02-502] Notice of Request for Revision of a Currently Approved Information Collection AGENCY: Agricultural Marketing Service, USDA. ACTION: Notice and request for comments. SUMMARY: In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), this notice announces the Agricultural Marketing Service's

(AMS)intention to request for revision of a currently approved information collection for Fruit and Vegetable Market News. DATES: Comments must be received by April 23, 2007. ADDRESSES: Interested persons are invited to submit written comments on the internet at *http://www.regulations.gov* or to the Market News Branch, Fruit & Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., Room 2503 South, Stop 0238, Washington, DC 20250-0238. Comments should make reference to the dates and page number of this issue of the **Federal Register** and will be made available for public inspection in the above office during regular business hours. FOR FURTHER INFORMATION: Contact Terry C. Long, Chief; Fruit and Vegetable Market News Branch, Fruit and Vegetable Programs,

(202)720-2175, Fax:

(202)720-0547. SUPPLEMENTARY INFORMATION: *Title:* Fruit and Vegetable Market News. *OMB Number:* 0581-0006. *Expiration Date of Approval:* July 31, 2007. *Type of Request:* Revision of a currently approved information collection. *Abstract:* Collection and dissemination of information for fruit, vegetable and ornamental production and to facilitate trading by providing a price base used by producers, wholesalers, and retailers to market product. The Agricultural Marketing Act of 1946 (7 U.S.C. 1621 *et seq.* ), section 203(g) directs and authorizes the collection and dissemination of marketing information including adequate outlook information, on a market area basis, for the purpose of anticipating and meeting consumer requirements, aiding in the maintenance of farm income and to bring about a balance between production and utilization. The fruit and vegetable industry provides information on a voluntary basis, and is gathered through confidential telephone and face-to-face interviews by market reporters. Reporters request supplies, demand, and prices of over 330 fresh fruit, vegetable, nut ornamental, and other specialty crops. The information is collected, compiled, and disseminated by Market News in its critical role as an impartial third party. It is collected and reported in a manner which protects the confidentiality of the respondent and their operations. The fruit and vegetable market news reports are used by academia and various government agencies for regulatory and other purposes, but are primarily used by the fruit, vegetable and ornamental trade, which includes packers, processors, brokers, retailers, producers, and associated industries. Members of the fruit and vegetable industry regularly make it clear that they need and expect the Department of Agriculture will issue price and supply market reports for commodities of regional, national and international significance in order to assist in making immediate production and marketing decisions and as a guide to the amount of product in the supply channel. In addition, the Agricultural Marketing Service buys hundreds of millions of dollars of fruit and vegetable products each year for domestic feeding programs, and Market News data is a critical component of the decision making process. *Estimate of Burden:* Public reporting burden for this collection of information is estimated to average .03 hours per response. *Respondents:* Fruit, vegetable, and ornamental industry, or other for-profit businesses, individuals or households, farms. *Estimated Number of Respondents:* 18,274. *Estimated Number of Responses per Respondent:* 218. *Estimated Total Annual Burden on Respondents:* 119,512 hours. Comments are invited on:

(1)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2)the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

(4)ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record. Dated: February 15, 2007. Lloyd C. Day, Administrator, Agricultural Marketing Service. [FR Doc. E7-2944 Filed 2-21-07; 8:45 am] BILLING CODE 3410-02-P DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service [Docket No. APHIS-2006-0157] Syngenta; Availability of Petition and Environmental Assessment for Determination of Nonregulated Status for Corn Genetically Engineered for Insect Resistance AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice; reopening of comment period for draft environmental assessment. SUMMARY: We are reopening the comment period for a draft environmental assessment prepared with respect to a petition from Syngenta Seeds, Inc., seeking a determination of nonregulated status for corn rootworm-resistant corn derived from a transformation event designated as MIR604. This action will allow interested persons additional time to prepare and submit comments on the draft environmental assessment. DATES: We will consider all comments on the draft environmental assessment that are received on or before March 9, 2007. ADDRESSES: You may submit comments by either of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov* , select “Animal and Plant Health Inspection Service” from the agency drop-down menu, then click “Submit.” In the Docket ID column, select APHIS-2006-0157 to submit or view public comments and to view supporting and related materials available electronically. Information on using Regulations.gov, including instructions for accessing documents, submitting comments, and viewing the docket after the close of the comment period, is available through the site's “User Tips” link. • *Postal Mail/Commercial Delivery:* Please send four copies of your comment (an original and three copies) to Docket No. APHIS-2006-0157, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. APHIS-2006-0157. *Reading Room:* You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call

(202)690-2817 before coming. *Other Information:* Additional information about APHIS and its programs is available on the Internet at *http://www.aphis.usda.gov* . FOR FURTHER INFORMATION CONTACT: Dr. Catherine Preston, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236;

(301)734-5874, e-mail: *catherine.a.preston@aphis.usda.gov* . To obtain copies of the petition or the environmental assessment, contact Ms. Cynthia Eck at

(301)734-0667, e-mail: *cynthia.a.eck@aphis.usda.gov* . The petition and the environmental assessment are also available on the Internet at *http://www.aphis.usda.gov/brs/aphisdocs/04_36201p.pdf* and *http://www.aphis.usda.gov/brs/aphisdocs/04_36201p_ea.pdf* SUPPLEMENTARY INFORMATION: On January 10, 2007, we published in the **Federal Register** (72 FR 1212-1214, Docket No. APHIS-2006-0157) a notice advising the public that the Animal and Plant Health Inspection Service has received a petition from Syngenta Seeds, Inc., seeking a determination of nonregulated status for corn rootworm-resistant corn derived from a transformation event designated as MIR604. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. In accordance with those regulations, our notice solicited comments on whether this corn presents a plant pest risk. We also made available for public comment a draft environmental assessment for the proposed determination of nonregulated status. In our notice, we stated that we will consider comments on the petition that are received on or before March 12, 2007, and comments on the draft environmental assessment that are received on or before February 9, 2007. We are reopening the comment period for the draft environmental assessment for an additional 15 days from the date of publication of this notice. This action will allow interested persons additional time to prepare and submit comments on the draft environmental assessment. We will also consider all comments on the draft environmental assessment we receive between February 10, 2007, and the date of this notice. (Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.) Done in Washington, DC, this 16th day of February 2007. W. Ron DeHaven, Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7-3119 Filed 2-21-07; 8:45 am] BILLING CODE 3410-34-P COMMISSION ON CIVIL RIGHTS Membership of the USCCR Performance Review Board AGENCY: U.S. Commission on Civil Rights. ACTION: Notice of Membership of the USCCR Performance Review Board. SUMMARY: This notice announces the appointment of the Performance Review Board

(PRB)of the United States Commission on Civil Rights. Publication of PRB membership is required pursuant to 5 U.S.C. 4314(c)(4). The PRB provides fair and impartial review of the U.S. Commission on Civil Rights' Senior Executive Service performance appraisals and makes recommendations regarding performance ratings and performance awards to the Staff Director, U.S. Commission on Civil Rights for the FY 2006 rating year. FOR FURTHER INFORMATION CONTACT: Tyro Beatty, Director of Human Resources, U.S. Commission on Civil Rights, 624 Ninth Street, NW., Washington, DC 20425. Telephone:

(202)376-8364. USCCR Performance Review Board Members Cynthia G. Pierre, Director, Field Management Programs, EEOC. Lawrence W. Roffee, Executive Director, U.S. Access Board. David Enzel, Deputy Director, HUD Office of Appeals Policy Management. Dated: February 15, 2007. David P. Blackwood, General Counsel. [FR Doc. E7-2957 Filed 2-21-07; 8:45 am] BILLING CODE 6335-01-P DEPARTMENT OF COMMERCE International Trade Administration A-583-816 Certain Stainless Steel Butt-Weld Pipe Fittings from Taiwan: Notice of Extension of Time Limit for Preliminary Results in Antidumping Duty Administrative Review AGENCY: Import Administration, International Trade Administration, Department of Commerce. EFFECTIVE DATE: February 22, 2007. FOR FURTHER INFORMATION CONTACT: Helen Kramer or Judy Lao, AD/CVD Operations, Office 7, Import Administration, International Trade Administration, U.S. Department of Commerce, 14 th Street and Constitution, NW, Washington DC 20230; telephone:

(202)482-0405 and

(202)482-7924, respectively. SUPPLEMENTARY INFORMATION: Background On June 2, 2006, the Department of Commerce (“the Department”) published a notice of opportunity to request an administrative review of the antidumping duty order on stainless steel butt-weld pipe fittings from Taiwan for the period of review (“POR”) of June 1, 2005, through May 31, 2006. *See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation, Opportunity to Request Administrative Review* ; 71 FR 32032 (June 2, 2006). On June 22, 2006, Flowline Division of Markovitz Enterprises, Inc. (“Flowline Division”), Gerlin, Inc., Shaw Alloy Piping Products, Inc., and Taylor Forge Stainless, Inc. (collectively, “petitioners”) requested an antidumping duty administrative review for Ta Chen Stainless Pipe Co., Ltd. (“Ta Chen”), Liang Feng Stainless Steel Fitting Co., Ltd., Tru-Flow Industrial Co., Ltd., Censor International Corporation, and PFP Taiwan Co., Ltd. On June 29, 2006, Ta Chen requested an administrative review of its sales to the United States during the POR. On July 27, 2006, the Department published the notice initiating this administrative review. *See Initiation of Antidumping and Countervailing Duty Administrative Reviews and Request for Revocation In Part* , 71 FR 42626 (July 27, 2006). The preliminary results are currently due not later than March 2, 2007. Extension of Time Limits for Preliminary Results of Review Pursuant to section 751(a)(3)(A) of the Tariff Act of 1930, as amended (“the Act”), and 19 CFR § 351.213(h)(2), the Department may extend the deadline for completion of the preliminary results of a review by 120 days if it determines that it is not practicable to complete the preliminary results within 245 days after the last day of the anniversary month of the date of publication of the order for which the administrative review was requested. Due to the complexity of the issues involved and the time required to analyze Ta Chen's supplemental questionnaire responses, as well as the demands of other proceedings handled by the office administering this review, the Department has determined that it is not practicable to complete this review within the original time period. Accordingly, the Department is extending the time limit for the preliminary results by 120 days, to not later than July 2, 2007, in accordance with Section 751(a)(3)(A) of the Act. The deadline for the final results of this review will continue to be 120 days after publication of the preliminary results. This notice is published in accordance with sections 751(a)(3)(A) and 777(i) of the Act. Dated: February 13, 2007. Stephen J. Claeys, Deputy Assistant Secretary for Import Administration. [FR Doc. E7-2901 Filed 2-21-07; 8:45 am] BILLING CODE 3510-DS-S DEPARTMENT OF COMMERCE International Trade Administration Implementation of Grants to Manufacturers of Certain Worsted Wool Fabrics Established Under Title IV of the Miscellaneous Trade and Technical Corrections Act of 2004 AGENCY: Department of Commerce, International Trade Administration. ACTION: Notice Announcing the Availability of Grant Funds. SUMMARY: This Notice announces the availability of grant funds in calendar year 2007 for U.S. manufacturers of certain worsted wool fabrics. The purpose of this notice is to provide the general public with a single source of program and application information related to the worsted wool grant offerings, and it contains the information about the program required to be published in the **Federal Register** . DATES: Applications by eligible U.S. producers of certain worsted wool fabrics must be received or postmarked by 5 p.m. Eastern Daylight Standard Time on March 26, 2007. Applications received after the closing date and time will not be considered. ADDRESSES: Applications must be submitted to the Industry Assessment Division, Office of Textiles and Apparel, Room 3001, U.S. Department of Commerce, Washington, DC 20230,

(202)482-4058. FOR FURTHER INFORMATION CONTACT: Jim Bennett, Office of Textiles and Apparel, U.S. Department of Commerce,

(202)482-4058. SUPPLEMENTARY INFORMATION: *Electronic Access:* The full funding opportunity announcement for the worsted wool fabrics program is available through FedGrants at *http://www.grants.gov* . The Catalog of Federal Domestic Assistance

(CFDA)Number is 11.113, Special Projects. *Statutory Authority:* Section 4002(c)(6) of the Miscellaneous Trade and Technical Corrections Act of 2004 (Public Law 108-429, 118 Stat. 2603) (the “Act”). The Act was amended pursuant to Section 1633 of the Pension Protection Act of 2006 (Public Law 109-280), which extended the availability of grant funds through 2009 and modified the eligibility criteria. *Program Description:* Section 4002(c)(6)(A) of the Act authorizes the Secretary of Commerce to provide grants to persons (including firms, corporations, or other legal entities) who were, during calendar years 1999, 2000, and 2001, manufacturers of two categories of worsted wool fabrics. The first category are manufacturers of worsted wool fabrics, containing 85 percent or more by weight of wool, with average fiber diameters greater than 18.5 micron (Harmonized Tariff Schedule of the United States

(HTS)heading 9902.51.11); the total amount of available funds is $2,666,000, to be allocated among such manufacturers on the basis of the percentage of each manufacturers' production of worsted wool fabric included in HTS 9902.51.11. The second category are manufacturers of worsted wool fabrics, containing 85 percent or more by weight of wool, with average fiber diameters of 18.5 micron or less (HTS heading 9902.51.15, previously HTS heading 9902.51.12); the total amount of available funds is $2,666,000, to be allocated among such manufacturers on the basis of the percentage of each manufacturers' production of worsted wool fabric included in HTS 9902.51.15. *Funding Availability:* The Secretary of Commerce is authorized under section 4002(c)(6)(A) of the Act to provide grants to manufacturers of certain worsted wool fabrics. Funding for the worsted wool fabrics grant program will be provided by the Department of the Treasury from amounts in the Wool Apparel Manufacturers Trust Fund (the “Trust Fund”). The total amount of grants to manufacturers of worsted wool fabrics described in HTS 9902.51.11 shall be $2,666,000 in calendar year 2007. The total amount of grants to manufacturers of worsted wool fabrics described in HTS 9902.51.15 shall also be $2,666,000 in calendar year 2007. *Eligibility Criteria:* Eligible applicants for the worsted wool fabric program include persons (including firms, corporations, or other legal entities) who were, during calendar years 1999, 2000 and 2001, manufacturers of worsted wool fabric in the United States of the kind described in HTS 9902.51.11 or 9902.51.15. Section 1633(b)(1)(C) of the Pension Protection Act of 2006 provides that only manufacturers who weave worsted wool fabric in the United States as of the date of application shall be eligible for grant funds. Any manufacturer who becomes a successor-of-interest to a manufacturer of the worsted wool fabrics described in HTS 9902.51.11 or HTS 9902.51.15 during 1999, 2000 or 2001 because of a reorganization or otherwise, shall be eligible to apply for such grants. *Applications to Receive Allocations:* Applicants must provide:

(1)Company name, address, contact and phone number;

(2)Federal tax identification number;

(3)the name and address of each plant or location in the United States where worsted wool fabrics of the kind described in HTS 9902.51.11 or HTS 9902.51.15 was woven by the applicant in 1999, 2000 and 2001;

(4)the name and address of each plant or location in the United States where the applicant is weaving worsted wool fabrics of the kind described in HTS 9902.51.11 and or HTS 9902.51.15 as of the date of application;

(5)the quantity, in linear yards, of worsted wool fabric production described in HTS 9902.51.11 or 9902.51.15, as appropriate, woven in the United States in each of calendar years 1999, 2000 and 2001; and

(6)the value of worsted wool fabric production described in HTS 9902.51.11 or 9902.51.15, as appropriate, woven in the United States in each of calendar years 1999, 2000 and 2001. This data must indicate actual production (not estimates) of worsted wool fabric of the kind described in HTS 9902.51.11 or 9902.51.15. At the conclusion of the application, the applicant must attest that “all information contained in the application is complete and correct and no false claims, statements, or representations have been made.” Applicants should be aware that, generally, pursuant to 31 U.S.C. 3729, persons providing a false or fraudulent claims, and, pursuant to 18 U.S.C. 1001, persons making materially false statements or representations, are subject to civil or criminal penalties, respectively. Information that is marked “business confidential” will be protected from disclosure to the full extent permitted by law. *Other Application Requirements:* Complete applications must include the following forms and documents: CD-346, Applicant for Funding Assistance; CD-511, Certification Regarding Lobbying; SF-424, Application for Federal Assistance; and SF-424B, Assurances - Non-Construction Programs. The CD forms are available via Web site: **http://www.osec.doc.gov/forms/direct.htm** . The SF forms are available via web site: *http://www.grants.gov/sitemap/sitemap.jsp* (See “Applicant Information, Approved Standard Form SF-424 Forms”). This document contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA). The use of Standard Forms 269, 424, 424A, 424B, SF-LLL, and CD-346 has been approved by the Office of Management and Budget

(OMB)under the respective control numbers 0348-0039, 0348-0043, 0348-0044, 0348-0040, 0348-0046, and 0605-0001. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA unless that collection of information displays a currently valid OMB control number. *Allocation Procedures:* Section 4002(c)(6)(A) of the Act requires that each grant be allocated among eligible applicants on the basis of the percentage of each manufacturers' production of the fabric described in HTS 9902.51.11 or HTS 9902.51.15 for calendar years 1999, 2000, and 2001, compared to the production of such fabric by all manufacturers who qualify for such grants. Following the closing date of the receipt of applications, the Department shall calculate the appropriate allocation of the allotted funds among eligible applicants in accordance with the statutory procedures. Award decisions shall be final and not subject to appeal or protest. *Intergovernmental Review:* Applications under this program are not subject to Executive Order 12372, “Intergovernmental Review of Federal Programs”. *Administrative and National Policy Requirements:* Department of Commerce Pre-Award Notifications for Grants and Cooperative Agreements, which are contained in the **Federal Register** Notice of December 30, 2004 (69 FR 78389), are applicable to this solicitation. It has been determined that this notice is not significant for purposes of E.O. 12866. *Administrative Procedure/Regulatory Flexibility:* Prior notice and an opportunity for public comment are not required by the Administrative Procedure Act for rules concerning public property, loans, grants, benefits, and contracts (5 USC 553(a)(2)). Because notice and opportunity for comment are not required pursuant to 5 USC 553 or any other law, the analytical requirements of the Regulatory Flexibility Act (5 USC 601 et seq.) are inapplicable. Therefore, a regulatory flexibility analysis is not required and has not been prepared. Dated: February 15, 2007. R. Matthew Priest, Deputy Assistant Secretary for Textiles and Apparel. [FR Doc. 07-794 Filed 2-16-07; 2:26 pm]

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