Proposed Rules. Notice of proposed rulemaking (NPRM)
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/register/2007/12/04/07-5938A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 3510-22-C 72 232 Tuesday, December 4, 2007 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-0267; Directorate Identifier 2007-NM-245-AD] RIN 2120-AA64 Airworthiness Directives; Boeing Model 747-400 and 747-400D Series 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 Boeing Model 747-400 and 747-400D series airplanes. This proposed AD would require a general visual inspection of the power feeder wire bundle of the auxiliary power unit
(APU)where it crosses the hydraulic system 4 return tube to determine if parts are installed to provide separation between the wire bundle and hydraulic tube. This proposed AD would also require related investigative and corrective actions if necessary. This proposed AD results from a report that the power feeder wire bundle of the APU was found touching the hydraulic system return tube during inspection of an airplane. We are proposing this AD to prevent insufficient clearance between the wire bundle and hydraulic tube that could lead to chafing of the wire bundle, which could cause arcing and a consequent hydraulic fluid fire in an area outside of the smoke detection and fire extinguishing zone; this condition could result in an uncontrolled fire on the airplane. DATES: We must receive comments on this proposed AD by January 18, 2008. ADDRESSES: You may send comments by any of the following methods: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov.* Follow the instructions for submitting comments. • *Fax:* 202-493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. For service information identified in this AD, contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207. Examining the AD Docket You may examine the AD docket on the Internet at *http://www.regulations.gov;* or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Georgios Roussos, Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6482; fax
(425)917-6590. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2007-0267; Directorate Identifier 2007-NM-245-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments. We will post all comments we receive, without change, to *http://www.regulations.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD. Discussion We have received a report indicating that the power feeder wire bundle of the auxiliary power unit
(APU)was found touching the hydraulic system return tube during inspection of an in-production Boeing Model 747-400 series airplane. Boeing subsequently surveyed several in-service airplanes and found that most of the airplanes had less than the allowable minimum clearance between the wire bundle and hydraulic tube. The wire bundle and hydraulic tube are installed in the aft bulk cargo compartment above the ceiling lining, in an area outside of the smoke detection and fire extinguishing zone. Insufficient clearance between the wire bundle and hydraulic tube could lead to chafing of the wire bundle, which could cause arcing and a consequent hydraulic fluid fire. This condition, if not corrected, could result in an uncontrolled fire on the airplane. Relevant Service Information We have reviewed Boeing Special Attention Service Bulletin 747-24-2257, Revision 1, dated August 2, 2007. The service bulletin describes procedures for doing a general visual inspection of the power feeder wire bundle of the APU where it crosses the hydraulic system 4 return tube to determine if parts are installed to provide separation between the wire bundle and hydraulic tube. The service bulletin also describes procedures for doing related investigative actions and corrective actions if necessary. The related investigative actions include the following actions: • Measuring the clearance between the wire bundle and hydraulic tube to ensure that the clearance is a minimum of 0.5 inch, if the wire bundle is clamped directly above the hydraulic tube. • Doing a general visual inspection for damage to the wire bundle where it crosses the hydraulic tube, if two loop clamps and a spacer are installed to provide separation, if a plastic tie strap and mount and loop clamp are installed to provide separation, or if no parts are installed to provide separation. • Doing a general visual inspection for damage to the hydraulic tube where the wire bundle crosses the hydraulic tube, if the wire bundle is found damaged. The corrective actions include the following actions: • Adjusting the position of the wire bundle to maximize its separation from the hydraulic tube, if the clearance is less than 0.5 inch. • Removing any parts installed to provide separation between the wire bundle and hydraulic tube. • Repairing the damaged wire bundle. • Repairing the damaged hydraulic tube or replacing it with a new hydraulic tube. • Installing a tetrafluoroethylene sleeve on the wire bundle and attaching the wire bundle and hydraulic tube with two loop clamps and a spacer. 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 AD, which would require accomplishing the actions specified in the service information described previously. Costs of Compliance There are about 462 airplanes of the affected design in the worldwide fleet. This proposed AD would affect about 61 airplanes of U.S. registry. The proposed inspection would take about 1 work hour 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 $4,880, or $80 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): **Boeing:** Docket No. FAA-2007-0267; Directorate Identifier 2007-NM-245-AD. Comments Due Date
(a)The FAA must receive comments on this AD action by January 18, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to Boeing Model 747-400 and 747-400D series airplanes, certificated in any category; as identified in Boeing Special Attention Service Bulletin 747-24-2257, Revision 1, dated August 2, 2007. Unsafe Condition
(d)This AD results from a report that the power feeder wire bundle of the auxiliary power unit
(APU)was found touching the hydraulic system return tube during inspection of an airplane. We are issuing this AD to prevent insufficient clearance between the wire bundle and hydraulic tube that could lead to chafing of the wire bundle, which could cause arcing and a consequent hydraulic fluid fire in an area outside of the smoke detection and fire extinguishing zone; this condition could result in an uncontrolled fire on 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. Inspection and Related Investigative and Corrective Actions
(f)Within 24 months after the effective date of this AD, do a general visual inspection of the power feeder wire bundle of the APU where it crosses the hydraulic system 4 return tube to determine if parts are installed to provide separation between the wire bundle and hydraulic tube, and do all the related investigative and corrective actions as applicable, by accomplishing all of the actions specified in the Accomplishment Instructions of Boeing Special Attention Service Bulletin 747-24-2257, Revision 1, dated August 2, 2007. The related investigative and corrective actions must be accomplished before further flight after the inspection. Credit for Actions Done According to Previous Issue of Service Bulletin
(g)Actions done before the effective date of this AD in accordance with Boeing Special Attention Service Bulletin 747-24-2257, dated May 18, 2006, are acceptable for compliance with the corresponding requirements of paragraph
(f)of this AD. Alternative Methods of Compliance (AMOCs) (h)(1) The Manager, Seattle 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)To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. Issued in Renton, Washington, on November 23, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-23460 Filed 12-3-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-28246; Directorate Identifier 2007-CE-048-AD] RIN 2120-AA64 Airworthiness Directives; Cirrus Design Corporation Models SR20 and SR22 Airplanes AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Supplemental notice of proposed rulemaking (NPRM); Reopening of the comment period. SUMMARY: We are revising an earlier proposed airworthiness directive
(AD)that applies to certain Cirrus Design Corporation
(CDC)Models SR20 and SR22 airplanes. The earlier NPRM would have required you to inspect and, as necessary, adjust the aileron and rudder rigging and would have required you to modify, inspect, and, as necessary, adjust the rudder-aileron interconnect system. The earlier NPRM resulted from a jamming of the aileron and rudder controls on a Model SR20 airplane, which resulted in loss of rudder and aileron flight controls. Since issuance of the NPRM, CDC revised the service information as a result of comments received on the NPRM, and the FAA has determined the changes to the service information are necessary to address the unsafe condition. The changes in the revised service information include the addition of airplanes to the Applicability; a requirement to check rudder, aileron, and rudder-aileron interconnect rigging; a requirement to replace the attaching hardware and clamp at the end of the rudder-aileron interconnect arm; and an increase in work-hours to do the proposed actions. This proposed AD would require you to use the revised service information and would require you to report any out-of-rig condition found. Since these actions impose an additional burden over that proposed in the NPRM, we are reopening the comment period to allow the public the chance to comment on these additional actions. DATES: We must receive comments on this proposed AD by January 3, 2008. ADDRESSES: Use one of the following addresses to comment on this proposed AD: • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov.* Follow the instructions for submitting comments. • *Fax:*
(202)493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. For service information identified in this proposed AD, contact Cirrus Design Corporation, 4515 Taylor Circle, Duluth, Minnesota 55811; telephone:
(218)727-2737; Internet address: *http://www.cirrusdesign.com.* FOR FURTHER INFORMATION CONTACT: Wess Rouse, Aerospace Engineer, 2300 East Devon Avenue, Room 107, Des Plaines, Illinois 60018; telephone:
(847)294-8113; fax:
(847)294-7834. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments regarding this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include the docket number, “FAA-2007-28246; Directorate Identifier 2007-CE-048-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://www.regulations.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive concerning this proposed AD. Discussion On June 14, 2007, we issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain CDC Models SR20 and SR22 airplanes. This proposal was published in the **Federal Register** as a notice of proposed rulemaking
(NPRM)on June 21, 2007 (72 FR 34198). The NPRM proposed to require you to inspect and, as necessary, adjust the aileron and rudder rigging and would require you to modify, inspect, and, as necessary, adjust the rudder-aileron interconnect system. Comments We provided the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal and FAA's response to each comment: Comment Issue No. 1: Language in the Summary of the NPRM Implies That the Control Jamming Event Only Occurs on the Ground Mr. Gene Hudson and Ms. Bridgette Doremire state that language in the Summary of the NPRM improperly implies that the control jamming event only occurs on the ground. They contend that such language might encourage owners and operators to underestimate the risk. Hudson recommends deleting the language from the Summary. We agree that the language of the Summary could imply that the control jamming event only occurs on the ground. To eliminate this implication, we will delete the language in the Summary that implies that the control jamming event only occurs on the ground. Comment Issue No. 2: Remove Text From the Service Information That States the Control Jamming Event Has Not Been Seen on Aircraft With Flight Control Systems Rigged to Specifications Hudson and Doremire state the service information text is misleading and implies that the jamming of the flight controls will only occur if the flight controls have been improperly rigged after leaving the factory. They claim that evidence exists of airplanes being improperly rigged at the factory or of flight controls jamming in the field after aircraft are rigged at the factory. Hudson recommends deleting the text from the service information or not referencing the service information in the proposed AD if the service information includes the misleading text. We do not agree with the commenters. Although it is not known how the controls became improperly rigged, this is the reason the jamming occurred. The aileron and rudder controls have not jammed on a properly rigged airplane. The CDC has changed the rigging procedure to give more detailed instructions regarding the rigging procedure. We are not changing the proposed AD as a result of this comment. Comment Issue No. 3: Include Text in the Proposed AD That the Jamming Condition Can Occur at Positions Other Than Full Cross Control Hudson and Doremire contend that the jamming condition can occur at positions other than full cross control. The commenters claim that they have inspected several airplanes and have noted interference conditions during cross-control deflections at less than half-travel. We infer that the commenters want language in the proposed AD to reflect that the jamming condition can occur at positions other than full cross control. There has been no evidence provided to show that there is a problem until full cross-control. The airplane that we inspected showed no interference until full cross control. One of the airplanes that the commenters discussed was reviewed by representatives of the FAA, CDC, and the National Transportation Safety Board (NTSB). It was determined that the airplane's rudder was improperly rigged. The CDC has revised procedures for rudder rigging to give more detailed instructions in the manufacturer's service bulletin. We are not changing the proposed AD as a result of this comment. Comment Issue No. 4: Proposed AD Gives the False Impression That the Jamming Condition Has Been Identified on Only One Airplane Hudson and Doremire state that the proposed AD gives the impression that the jamming condition has been identified on only 1 airplane. Doremire claims to have seen the jamming condition on 12 airplanes. Hudson also states that a posting on an Internet Web site indicates that aircraft owners believe that the problem has only been found on 1 airplane. The jammed condition initially occurred on 1 airplane. However, subsequent inspections have shown improper rigging on other airplanes. We will revise the proposed AD to identify the occurrence of improper rigging on several airplanes. Comment Issue No. 5: Issue the Proposed AD as an Emergency AD and Ground Any Airplane That Has Not Incorporated the Modifications Required by the AD Hudson and Doremire contend that the urgency of the rudder-aileron interconnect problem has been understated. They want this AD action to be an Emergency AD and include the immediate grounding of any airplane that has not incorporated the modifications required by the AD. Our risk assessment shows the rudder-aileron interconnect problem warrants NPRM AD action. We are not changing the proposed AD as a result of this comment. Comment Issue No. 6: Inspect for Clamp and Bungee Clamp Interference With Adjacent Control Cables; Implement a Solution to the Control System Interference Hudson and Doremire state that there is a significant risk for flight control cable fraying with repeated clamp chafing, especially in airplanes used in flight training. Further, airplanes have potentially experienced chafing while doing normal crosswind takeoffs and landings. They recommend revising the proposed AD to require an inspection for clamp and bungee clamp interference with adjacent control cables, including a specific check for rudder, aileron, and elevator control cable fraying in the 12 inches adjacent to the forward and aft bungee clamps and the interconnect arm rudder clamp. The commenters also recommend revising the proposed AD to implement a solution to the control system interference to prevent possible contact between the moving parts of the system throughout the full range of possible control travel. We agree with the commenters that interference of the control cable mechanism should not occur. The manufacturer's service bulletin has been revised to add design changes to further increase clearances. In addition, more detailed rigging and inspection instructions have been added. Additionally, the revised service bulletin adds a redesigned clamp for the end of the interconnect arm. We are incorporating the revised service bulletin into the proposed AD. Comment Issue No. 7: Restrict Affected Aircraft From Forward and Side Slips, Power On and Off Stalls, Unusual Attitudes, Steep Turns, Slow Flight, and Any Takeoffs or Landings in Crosswind Conditions Doremire strongly recommends restricting all affected aircraft from forward slips, side slips, power on and off stalls, unusual attitudes, steep turns, slow flight, and any takeoffs or landings in crosswind conditions. The commenter states that such restrictions would prevent in-flight loss of control. The FAA disagrees with the recommendation. The restrictions that the commenter proposes will ground all CDC airplanes until incorporation of the AD actions. The data submitted so far shows that the binding of the controls has only occurred on misrigged airplanes and can be overcome by additional control forces. The risk assessment performed does not support these proposed restrictions. We are not changing the proposed AD as a result of this comment. Comment Issue No. 8: Special Flight Permit Limitations Hudson recommends removal of the interconnect bungee as a condition for the issuance of a special flight permit. We conclude that the commenter recommends the requirement of a special flight permit with the above restriction. We disagree that the restriction should be added to the AD. Evidence warranting this restriction for a special flight permit has not been shown. In the event that an aircraft has experienced a binding event, the aircraft should not be flown until the binding event is addressed/corrected. The Principal Inspector and/or Flight Standards District Office
(FSDO)may always add this restriction on a case-by-case basis when issuing a special flight permit. We are not changing the proposed AD as a result of this comment. Comment Issue No. 9: Require Incorporation of Service Bulletin No. SB 2X-27-14 R3 Within the Listed Compliance Time and Allow an Extended Compliance Time for Those Who Have Already Done Service Bulletin No. SB2X-27-14 R2 CDC comments that aircraft complying with Service Bulletin No. SB2X-27-14 R2 minimizes the probability for the locking condition and meets the primary objective of the proposed AD. They request the proposed AD allow for an extended compliance period for those who have already done Service Bulletin No. SB2X-27-14 R2. We disagree with CDC. The instructions listed in Service Bulletin No. SB2X-27-14 R2 do not include adequate rigging instructions for the rudder. Further, it is not known if the modified airplanes were rigged correctly. Also, additional improvements to the rudder/ailerons interconnect system were made that were not included in Service Bulletin No. SB2X-27-14 R2. The FAA has determined that the changes incorporated into Service Bulletin No. SB 2X-27-14 R3 are necessary to address the unsafe condition. We are not changing the proposed AD as a result of this comment. FAA's Determination and Requirements of This Proposed AD We have carefully reviewed the available data and determined that the unsafe condition referenced in this document exists or could develop on other products of the same type design; and we should take AD action to correct this unsafe condition. Certain changes described above in the comments expand the scope of the earlier NPRM. As a result, we have determined that it is necessary to reopen the comment period to provide additional opportunity for the public to comment on the proposed AD. The Supplemental NPRM Since issuance of the NPRM, CDC has issued Cirrus Service Bulletin No. SB 2X-27-14 R3, Revised: October 10, 2007. The revised service information includes instructions that add new attaching parts, including an improved bungee clamp that replaces the existing Adel clamp at the end of the rudder-aileron interconnect arm; re-orient existing cable clamps 180 degrees at the RH rudder cable; clarify security of attaching parts and orientation of bungee cord ends; change the serial number effectivity for the Model SR20 airplane; and increase work-hours necessary to do the proposed action. The FAA has determined that the changes incorporated into the service bulletin are necessary to address the unsafe condition. The added proposed AD actions following the revised service bulletin go beyond the scope of what was originally proposed in the NPRM. Therefore, we are reopening the comment period and allowing the public the chance to comment on these additional actions. Costs of Compliance We estimate that this proposed AD affects 2,435 airplanes in the U.S. registry. We estimate the following costs to do the proposed check of the rudder, aileron, and rudder-aileron interconnect rigging, and replacement of the attaching hardware for the rudder-aileron interconnect arm and RH aileron cable clamps: Labor cost Parts cost Total cost per airplane Total cost on U.S. operators 1.5 work-hours x $80 per hour = $120 $18 $138 $336,030 CDC will provide warranty credit to the extent noted in Service Bulletin SB 2X-27-14 R3, Issued: May 9, 2007, Revised: October 10, 2007. 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. Examining the AD Docket You may examine the AD docket that contains the proposed AD, the regulatory evaluation, any comments received, and other information on the Internet at *http://dms.dot.gov;* or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone
(800)647-5227) is located at the street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. 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 FAA amends § 39.13 by adding the following new AD: **Cirrus Design Corporation:** Docket No. FAA-2007-28246; Directorate Identifier 2007-CE-048-AD. Comments Due Date
(a)We must receive comments on this airworthiness directive
(AD)action by January 3, 2008. Affected ADs
(b)None. Applicability
(c)This AD applies to Model SR20 airplanes, serial numbers
(SN)1005 through 1861, and Model SR22 airplanes, SN 0002 through 2333, SN 2335 through 2419, and SN 2421 through 2437, that are certificated in any category. Unsafe Condition
(d)This AD results from an incident of jamming of the aileron and rudder controls on a Model SR20 airplane and the possibility of the occurrence on other airplanes. In addition, other Models SR20 and SR22 airplanes have been found with misrigging of the flight controls that could lead to jamming. We are issuing this AD to prevent the possibility of jamming of the rudder-aileron interconnect system, which may result in loss of rudder and aileron flight controls. Compliance
(e)To address this problem, you must do the following, unless already done: Actions Compliance Procedures
(1)Inspect/check the rudder, aileron, and rudder-aileron interconnect rigging; correct any out-of-rig condition; and replace the attaching hardware for the rudder-aileron interconnect arm. At whichever occurs first:
(i)Within the next 25 hours time-in-service
(TIS)after the effective date of this AD; or
(ii)Within the next 3 months after the effective date of this AD. Follow Cirrus Service Bulletin No. SB 2X-27-14 R3, Issued: May 9, 2007, Revised: October 10, 2007.
(2)*Only if you find an out-of-rig condition:* Report to the FAA any out-of-rig conditions discovered as a result of the inspection required by paragraph (e)(1) of this AD on the form in Figure 1 of this AD. The Office of Management and Budget
(OMB)approved the information contained in this regulation under the provisions of the Paperwork Reduction Act and assigned OMB Control Number 2120-0056. At whichever occurs later:
(i)Within 10 days after the inspection required in paragraph (e)(1) of this AD; or
(ii)Within 10 days after the effective date of this AD. Send the form (Figure 1 of this AD) to FAA, Manufacturing Inspection District Office, 6020 28th Avenue South, Room 103, Minneapolis, Minnesota, 55450-2700; telephone
(612)713-4366; facsimile
(612)713-4365. Note: Temporary revisions to the airplane maintenance manuals (AMM), SR20 AMM Temporary Revision No. 27-1 and SR22 AMM Temporary Revision No. 27-1, both dated October 10, 2007, contain information pertaining to this subject. Docket No. FAA-2007-28246 Inspection Report [Report only if you find an out-of-rig condition] 1. Inspection Performed By: 2. Telephone: 3. Aircraft Model: 4. Airplane Serial Number: 5. Aircraft Total Hours Time-in-Service: 6. Date of inspection required in paragraph (e)(1) of this AD: 7a. Do any of the aircraft logs contain entries describing flight control system maintenance, preventative maintenance, or alteration: 7b. If Yes, copy the log book entry(s) and include the date of the entry. __Yes __No 8. Inspection Results: (Report only if an out-of-rig condition is found, and describe the out-of-rig condition as accurate and detailed as possible): 9. Corrective Action Taken: Send to: Federal Aviation Administration Manufacturing Inspection District Office 6020 28th Avenue South, Room 103 Minneapolis, Minnesota 55450-2700 Telephone
(612)713-4366 Facsimile
(612)713-4365 Alternative Methods of Compliance (AMOCs)
(g)The Manager, Chicago Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Wess Rouse, Aerospace Engineer, 2300 East Devon Avenue, Room 107, Des Plaines, Illinois 60018; telephone:
(847)294-8113; fax:
(847)294-7834. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. Related Information
(h)To get copies of the service information referenced in this AD, contact Cirrus Design Corporation, 4515 Taylor Circle, Duluth, Minnesota 55811; telephone:
(218)727-2737; Internet address: *http://www.cirrusdesign.com.* To view the AD docket, go to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, or on the Internet at *http://dms.dot.gov.* The docket number is Docket No. FAA-2007-28246; Directorate Identifier 2007-CE-048-AD. Issued in Kansas City, Missouri, on November 28, 2007. Patrick R. Mullen, Acting Manager, Small Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-23456 Filed 12-3-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 210 and 211 [Docket No. 1995N-0362] Current Good Manufacturing Practice; Amendment of Certain Requirements For Finished Pharmaceuticals; Withdrawal AGENCY: Food and Drug Administration, HHS ACTION: Proposed rule; withdrawal. SUMMARY: The Food and Drug Administration
(FDA)is announcing the withdrawal of a proposed rule published in the **Federal Register** of May 3, 1996 (61 FR 20103) (the May 1996 proposed rule). The May 1996 proposed rule would have amended certain requirements of the current good manufacturing practice
(CGMP)regulations for finished pharmaceuticals. These proposed changes would have clarified certain manufacturing, quality control, and documentation requirements and would have updated the requirements for process and methods validation. In light of more recent scientific and technical advances and evolving quality systems and risk management concepts, FDA concludes that, at this time, it is appropriate to withdraw the May 1996 proposed rule and newly evaluate the issues raised in that proposal. DATES: The proposed rule is withdrawn on December 4, 2007. FOR FURTHER INFORMATION CONTACT: Mary Malarkey, Center for Biologics Evaluation and Research (HFM-600), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6190, or Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6956, or Frederick Blumenschein, Center for Drug Evaluation and Research (HFD-326), Food and Drug Administration, 11919 Rockville Pike, Rockville, MD 20852, 301-827-9022. SUPPLEMENTARY INFORMATION: I. Background In the **Federal Register** of May 3, 1996 (61 FR 20103), FDA proposed to amend certain requirements of the CGMP regulations for finished pharmaceuticals in parts 210 and 211 (21 CFR parts 210 and 211) to clarify certain manufacturing, quality control, and documentation requirements so that the regulations would more accurately reflect the prevailing CGMP. FDA received approximately 1,500 comments on the proposed rule. (See section III of this document, Comments on the May 1996 Proposed Rule). After publication of the May 1996 proposed rule, FDA began to reconsider its approach to regulation of CGMP, consistent with changes occurring in other industries and in other countries. This change in approach is summarized in the following paragraphs. In August 2002, FDA announced a significant new initiative to enhance and modernize regulation of pharmaceutical manufacturing quality, the Pharmaceutical CGMPs for the 21st Century initiative (21st Century initiative). As a part of the 21st Century initiative, FDA created a CGMP Harmonization Analysis working group to analyze internal and external CGMP requirements, including those related to quality systems. The working group performed a formal analysis of parts 210 and 211 compared with other regulations, such as the FDA Medical Device Quality System Requirements, the FDA Food Hazard Analysis and Critical Control Points requirements, and the drug GMPs of the European Union, to identify the differences and consider the value of adding or changing the current regulations in light of these more recently developed and related product manufacturing standards. Based on the working group's analysis, the agency decided that a different approach to revising the CGMP regulations was appropriate, and has decided to withdraw the proposed rule. II. New Approach to Revising FDA's CGMP Regulations The emphasis of the new approach to CGMP arising from the 21st Century Initiative will be to encourage timely detection of and response to emerging adverse trends or indications that product quality has been compromised, to provide further clarity and modernize the regulations, and to harmonize various aspects of parts 210 and 211 both internationally and with other agency regulations. 1 1 See Pharmaceutical CGMPs for the 21st Century—A Risk Based Approach; Final Report, September, 2004; available at *http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm* . The agency has determined that the current CGMP regulations (parts 210 and 211) provide a degree of flexibility that will permit the agency to continue to modernize its approach to regulation of CGMP. The agency has also concluded that, as stated in the final report on the 21st Century initiative, given this new approach to regulation of pharmaceutical CGMP, it would be preferable to revise the CGMP regulations in an incremental fashion, rather than using the comprehensive approach taken in the May 1996 proposed rule. After careful consideration, FDA concludes that at this time, it is appropriate to withdraw the May 1996 proposed rule and newly evaluate the issues raised in that proposal in the context of more recent scientific and technical advances and quality systems and risk management concepts. We plan to revise the CGMP regulations using a more incremental approach. As part of the FDA's incremental approach to revising our CGMP regulations, we are publishing a direct final rule (and a companion proposed rule) elsewhere in this issue of the **Federal Register** that will, when finalized, clarify and modernize certain provisions in parts 210 and 211. That direct final rule and proposed rule include some of the minor changes to CGMP that were originally proposed in 1996. III. Comments on the May 1996 Proposed Rule FDA received approximately 1,500 comments on the May 1996 proposed rule from 116 pharmaceutical companies, attorneys, consultants, trade associations, and generic companies. The most significant topics on which FDA received comments are summarized as follows: • Approximately 298 comments addressed the proposed new section on process validation (§ 211.220). The volume and variety of comments and suggestions indicated to FDA that the new section, as proposed, did not provide the clarification intended. • Approximately 102 comments were directed at the proposed changes to § 211.110 on sampling and testing of in-process materials and drug products, which would have added new in-process sampling and validation requirements with respect to blend uniformity. The bulk of these comments questioned the need for additional testing and sampling requirements in § 211.110, because other sections of the current rule already require scientifically sound sampling plans and representative samples. • Approximately 112 comments discussed proposed revisions to § 211.192 on the production, control, and laboratory review, and investigation of discrepancies. The May 1996 proposed rule required written procedures to be established for the review of certain records and investigation of unexplained discrepancies. Many of these comments recommended that these investigations and reviews should be used to proactively prevent (potential) future problems rather than being used only to retroactively identify manufacturing discrepancies. • A number of comments to the rule were submitted by the compressed medical gas industry, which communicated concerns regarding the applicability to the compressed medical gas industry of the proposed changes to CGMP. • Approximately 70 comments were received regarding the proposed new § 211.240 on control of chemical and physical contaminants. Many of the comments stated that the rule should be revised to better describe how contaminants will be identified and to provide allowances for threshold levels or limits of contaminants. Overall, the comments were constructive, informative, and addressed nearly every area of the May 1996 proposed rule. Although we do not plan to publish specific responses to each of these comments, we will take these comments into account as we proceed to make incremental changes to parts 210 and 211. IV. Withdrawal of the Proposed Rule For the reasons described in this document, FDA is withdrawing the proposed rule published on May 3, 1996 (61 FR 20103). Dated: November 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-23271 Filed 12-3-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 210 and 211 [Docket No. 2007N-0280] Amendment to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals; Companion Document to the Direct Final Rule AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration
(FDA)is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the **Federal Register** , which is intended to amend certain sections of the regulations as the first phase of an incremental approach to modifying the current good manufacturing practice
(CGMP)regulations for finished pharmaceuticals. DATES: Submit written or electronic comments on or before February 19, 2008. ADDRESSES: You may submit comments, identified by Docket No. 2007N-0280, 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 previously, in the ADDRESSES portion of this document under *Electronic Submissions* . *Instructions* : All submissions received must include the agency name and Docket No(s). and Regulatory Information Number
(RIN)(if a RIN number has been assigned) for this rulemaking. All comments received may 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(s), 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: Mary Malarkey, Center for Biologics Evaluation and Research (HFM-600), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6190, or Dennis Bensley, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6956, or Frederick Blumenschein, Center for Drug Evaluation and Research (HFD-326), Food and Drug Administration, 11919 Rockville Pike, Rockville, MD 20852, 301-827-9022. SUPPLEMENTARY INFORMATION: I. Background Since the development of the CGMP regulations in 1962, FDA has balanced the need for easily understood minimum standards with the need to encourage innovation and the development of improved manufacturing technologies. We strive to give manufacturers latitude to determine how to achieve the level of control necessary for CGMP compliance, recognizing that, in some instances, more direction from FDA is necessary to provide a uniform standard to the entire industry or because of the potential for harm or the narrow range of acceptable means to accomplish a particular CGMP objective. FDA periodically reassesses and revises the CGMP regulations to accommodate advances in technology that further safeguard the drug manufacturing process and the public health. As technology and scientific knowledge related to CGMP evolve, so does understanding of the material, equipment, and process variables, as well as the operational procedures and oversight methods that must be defined and controlled to achieve assurance of drug product quality. In 1996, as part of this reassessment process, FDA proposed to amend certain requirements of the CGMP regulations for finished pharmaceuticals to clarify certain manufacturing, quality control, and documentation requirements, and to ensure that the regulations more accurately encompass current industry practice (61 FR 20103, May 3, 1996) (1996 proposed rule)). Subsequently, as a part of the risk-based pharmaceutical CGMPs for the 21st century initiative, FDA created a CGMP Harmonization Analysis Working Group (CGMP Working Group) to analyze related CGMP requirements in effect in the United States and internationally, including those related to quality systems. The CGMP Working Group compared parts 210 amd 211 (21 CFR parts 210 and 211) with the GMPs of the European Union (EU), as well as other FDA regulations (e.g., the Quality Systems Regulation, 21 CFR part 820) to identify the differences and consider the value of supplementing or changing the current regulations. Based on the CGMP Working Group's analysis, we decided to take an incremental approach to modifying parts 210 and 211 (see *http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm#_Toc84065744* ). Because of this change in approach, FDA decided not to finalize the 1996 proposed rule. Therefore, elsewhere in this issue of the **Federal Register** , we are publishing a notice withdrawing the 1996 proposed rule. The amendments being proposed in this rule are intended to clarify and modernize the CGMP regulations, as well as harmonize the regulations with international GMP requirements and other FDA regulations. This proposed rule represents the first increment of modifications to parts 210 and 211. II. Additional Information This proposed rule is a companion to the direct final rule published in the final rule section of this issue of the **Federal Register** . The proposed rule and the direct final rule are substantively identical. This companion proposed rule provides the procedural framework to proceed with standard notice-and-comment rulemaking if the direct final rule receives significant adverse comment and is withdrawn. A significant adverse comment is one that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. The comment period for the companion proposed rule runs concurrently with the comment period of the direct final rule. Any comments received on this companion proposed rule will also be treated as comments on the direct final rule and vice versa. For additional information, see the corresponding direct final rule published in the final rules section of this issue of the **Federal Register** . All persons who may wish to comment should review the rationale for these amendments set out in the preamble discussion of the direct final rule. A comment recommending a rule change in addition to this rule will not be considered a significant adverse comment unless the comment states why this rule would be ineffective without the additional change. If no significant adverse comment is received in response to the direct final rule, no further action will be taken related to this companion proposed rule. Instead, we will publish a confirmation notice within 30 days after the comment period ends, and we intend the direct final rule to become effective 30 days after publication of the confirmation notice. If we receive significant adverse comments, we will withdraw the direct final rule. We will proceed to respond to all of the comments received regarding the direct final rule, treating those comments as comments to this proposed rule. The agency will address the comments in a subsequent final rule. We will not provide additional opportunity for comment. III. Analysis of Impacts A. Review Under Executive Order 12866, the Regulatory Flexibility Act, and the Unfunded Mandates Reform Act of 1995 FDA has examined the impacts of this proposed rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this proposed rule is not a significant regulatory action as defined by the Executive order, because the rule, if finalized, would generally either clarify the agency's longstanding interpretation of, or increase latitude for manufacturers in complying with, preexisting CGMP requirements. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this proposed rule, if finalized, would not impose any new regulatory obligations, the agency tentatively certifies that it would not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $122 million, using the most current
(2005)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount. The purpose of this proposed rule is to update the codified language to reflect current practice and to harmonize requirements in the CGMP regulations with requirements in other regulations. It would not impose any additional requirements; therefore, industry would not incur incremental compliance costs for these proposed changes. B. Environmental Impact It is FDA's tentative conclusion that issuing these clarifying amendments to the CGMP regulations would not have a significant impact on the human environment. Therefore, FDA believes that an environmental impact statement is not required. C. Federalism FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has tentatively concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. IV. Paperwork Reduction Act of 1995 The provisions of this proposed rule contain requirements that were submitted for review and approval to the Director of the Office of Management and Budget (OMB), as required by section 3507(d) of the Paperwork Reduction Act of 1995. The requirements were approved and assigned OMB control number 0910-0139. V. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. This comment period runs concurrently with the comment period for the direct final rule. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that any individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. List of Subjects 21 CFR Part 210 Drugs, Packaging and containers 21 CFR Part 211 Drugs, Labeling, Laboratories, Packaging and containers, Prescription drugs, Reporting and recordkeeping requirements, Warehouses. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR parts 210 and 211 be amended as follows: PART 210—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 1. The authority citation for 21 CFR part 210 continues to read as follows: Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. 2. Section 210.3 is amended by revising paragraph (b)(6) to read as follows: § 210.3 Definitions.
(b)* * *
(6)Nonfiber releasing filter means any filter, which after appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 3. The authority citation for 21 CFR part 211 continues to read as follows: Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. 4. Section 211.48 is amended by revising paragraph
(a)to read as follows: § 211.48 Plumbing.
(a)Water supplied by the plumbing system of the facility must be safe for human consumption. This water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. 5. Section 211.67 is amended by revising paragraph
(a)to read as follows: § 211.67 Equipment cleaning and maintenance.
(a)Equipment and utensils shall be cleaned, maintained, and sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. 6. Section 211.68 is amended by adding paragraph
(c)to read as follows: § 211.68 Automatic, mechanical, and electronic equipment.
(c)Such automated equipment used for performance of operations addressed by §§ 211.101(c) or (d), 211.103, 211.182, or 211.188(b)(11) can satisfy the requirements included in those sections relating to the performance of an operation by one person and checking by another person if such equipment is used in conformity with this section and one person verifies that the operations addressed in those sections are performed accurately by such equipment. 7. Section 211.72 is revised to read as follows: § 211.72 Filters. Filters for liquid filtration used in the manufacture, processing, or packing of injectable drug products intended for human use shall not release fibers into such products. Fiber-releasing filters may not be used in the manufacture, processing, or packing of these injectable drug products unless it is not possible to manufacture such drug products without the use of such filters. If use of a fiber-releasing filter is necessary, an additional nonfiber-releasing filter of 0.22 micron maximum mean porosity (0.45 micron if the manufacturing conditions so dictate) shall subsequently be used to reduce the content of particles in the injectable drug product. 8. Section 211.82 is amended by revising paragraph
(b)to read as follows: § 211.82 Receipt and storage of untested components, drug product containers, and closures.
(b)Components, drug product containers, and closures shall be stored under quarantine until they have been tested or examined, whichever is appropriate, and released. Storage within the area shall conform to the requirements of § 211.80. 9. Section 211.84 is amended by revising paragraphs (c)(1), (d)(3), and (d)(6) to read as follows: § 211.84 Testing and approval or rejection of components, drug product containers, and closures.
(c)* * *
(1)The containers of components selected shall be cleaned when necessary in a manner to prevent introduction of contaminants into the component.
(d)* * *
(3)Containers and closures shall be tested for conformity with all appropriate written specifications. In lieu of such testing by the manufacturer, a certificate of testing may be accepted from the supplier, provided that at least a visual identification is conducted on such containers/closures by the manufacturer and provided that the manufacturer establishes the reliability of the supplier's test results through appropriate validation of the supplier's test results at appropriate intervals.
(6)Each lot of a component, drug product container, or closure with potential for microbiological contamination that is objectionable in view of its intended use shall be subjected to microbiological tests before use. 10. Section 211.94 is amended by revising paragraph
(c)as follows: § 211.94 Drug product containers and closures.
(c)Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use. Such depyrogenation processes shall be validated. 11. Section 211.101 is amended by revising paragraphs
(c)and
(d)to read as follows: § 211.101 Charge-in of components.
(c)Weighing, measuring, or subdividing operations for components shall be adequately supervised. Each container of component dispensed to manufacturing shall be examined by a second person to assure that:
(1)The component was released by the quality control unit;
(2)The weight or measure is correct as stated in the batch production records;
(3)The containers are properly identified. If the weighing, measuring, or subdividing operations are performed by automated equipment under § 211.68, only one person is needed to assure paragraphs (c)(1), (c)(2), and (c)(3) of this section.
(d)Each component shall either be added to the batch by one person and verified by a second person or, if the components are added by automated equipment under § 211.68, only verified by one person. 12. Section 211.103 is revised to read as follows: § 211.103 Calculation of yield. Actual yields and percentages of theoretical yield shall be determined at the conclusion of each appropriate phase of manufacturing, processing, packaging, or holding of the drug product. Such calculations shall either be performed by one person and independently verified by a second person, or, if the yield is calculated by automated equipment under § 211.68, be independently verified by one person. 13. Section 211.110 is amended by revising paragraph
(a)introductory text and by adding paragraph (a)(6) to read as follows: § 211.110 Sampling and testing of in-process materials and drug products.
(a)To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Such control procedures shall include, but are not limited to, the following, where appropriate:
(6)Bioburden testing. 14. Section 211.113 is amended by revising paragraph
(b)to read as follows: § 211.113 Control of microbiological contamination.
(b)Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of all aseptic and sterilization processes. 15. Section 211.160 is amended by revising paragraph (b)(1) to read as follows: § 211.160 General requirements.
(b)* * *
(1)Determination of conformity to applicable written specifications for the acceptance of each lot within each shipment of components, drug product containers, closures, and labeling used in the manufacture, processing, packing, or holding of drug products. The specifications shall include a description of the sampling and testing procedures used. Samples shall be representative and adequately identified. Such procedures shall also require appropriate retesting of any component, drug product container, or closure that is subject to deterioration. 16. Section 211.182 is revised to read as follows: § 211.182 Equipment cleaning and use log. A written record of major equipment cleaning, maintenance (except routine maintenance such as lubrication and adjustments), and use shall be included in individual equipment logs that show the date, time, product, and lot number of each batch processed. If equipment is dedicated to manufacture of one product, then individual equipment logs are not required, provided that lots or batches of such product follow in numerical order and are manufactured in numerical sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use shall be part of the batch record. The persons performing and double-checking the cleaning and maintenance (or, if the cleaning and maintenance is performed using automated equipment under § 211.68, just the person verifying the cleaning and maintenance done by the automated equipment) shall date and sign or initial the log indicating that the work was performed. Entries in the log shall be in chronological order. 17. Section 211.188 is amended by revising paragraph (b)(11) to read as follows: § 211.188 Batch production and control records.
(b)* * *
(11)Identification of the persons performing and directly supervising or checking each significant step in the operation, or if a significant step in the operation is performed by automated equipment under § 211.68, the identification of the person checking the significant step performed by the automated equipment. Dated: November 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-23292 Filed 12-3-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2007-0096] RIN 1625-AA09 Drawbridge Operation Regulations; Pinellas Bayway Structure “E” (SR 679) Bridge, Gulf Intracoastal Waterway, mile 113, St. Petersburg Beach, Pinellas County, FL AGENCY: Coast Guard, DHS. ACTION: Notice of proposed rulemaking. SUMMARY: The Coast Guard proposes to change the drawbridge regulation of the Pinellas Bayway Structure “E” (SR 679) Bridge, Gulf Intracoastal Waterway, mile 113, St. Petersburg Beach, Pinellas County, Florida. This rule is needed to provide vehicular traffic relief during heavy vehicular traffic periods flowing into a nearby county park while still meeting the reasonable needs of mariners. DATES: Comments and related material must reach the Coast Guard on or before January 18, 2008. ADDRESSES: You may submit comments identified by Coast Guard docket number USCG-2007-0096 to the Docket Management Facility at the U.S. Department of Transportation. To avoid duplication, please use only one of the following methods:
(1)Online: *http://www.regulations.gov* .
(2)Mail: Docket Management Facility (M-30), U.S. Department of Transportation, West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001.
(3)Hand delivery: Room W12-140 on the Ground Floor of the West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202-366-9329.
(4)Fax: 202-493-2251. FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed rule, call Michael Lieberum, Seventh Coast Guard District, Bridge Branch, telephone number 305-415-6744. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202-366-9826. SUPPLEMENTARY INFORMATION: Public Participation and Request for Comments We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted, without change, to *http://www.regulations.gov* and will include any personal information you have provided. We have an agreement with the Department of Transportation
(DOT)to use the Docket Management Facility. Please see DOT's “Privacy Act” paragraph below. Submitting Comments If you submit a comment, please include the docket number for this rulemaking (USCG-2007-0096), indicate the specific section of this document to which each comment applies, and give the reason for each comment. We recommend that you include your name and a mailing address, an e-mail address, or a phone number in the body of your document so that we can contact you if we have questions regarding your submission. You may submit your comments and material by electronic means, mail, fax, or delivery to the Docket Management Facility at the address under ADDRESSES ; but please submit your comments and material by only one means. If you submit them by mail or delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this proposed rule in view of them. Viewing Comments and Documents To view comments, as well as documents mentioned in this preamble as being available in the docket, go to *http://www.regulations.gov* at any time, click on “Search for Dockets,” and enter the docket number for this rulemaking (USCG-2007-0096) in the Docket ID box, and click enter. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Privacy Act Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the Department of Transportation's Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477), or you may visit *http://DocketsInfo.dot.gov* . Public Meeting We do not now plan to hold a public meeting. But you may submit a request for a meeting by writing to the Bridge Branch, Seventh Coast Guard District at the address under ADDRESSES explaining why one would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the **Federal Register** . Background and Purpose The Pinellas Bayway Structure “E” (SR 679) Bridge, Gulf Intracoastal Waterway, mile 113, St. Petersburg Beach, Pinellas County, Florida, currently opens on signal; except that, from 9 a.m. to 7 p.m. the draw need only open on the hour, 20 minutes after the hour, and 40 minutes after the hour. The bridge provides vehicular access into and out of a popular county park. At the request of Florida State Representative Frishe's office, who is acting on behalf of local citizens, the Coast Guard is proposing this regulation that will require the Pinellas Bayway “E” Bridge to open on signal, except that from 7 a.m. to 9 p.m. the bridge will open on the hour and half-hour. Public vessels of the United States, tugs with tows and vessels in distress shall be allowed to pass on signal. Discussion of Proposed Rule Under this proposed rule, the draw of the Pinellas Bayway Structure “E” Bridge would be required to open on signal, except that from 7 a.m. to 9 p.m. the bridge would only need to open on the hour and half-hour. The draw would be required to open, upon proper signal, for the passage of tugs with tows, public vessels of the United States and vessels in a situation where a delay would endanger life or property. This proposed rule is expected to provide vehicular traffic relief during heavy traffic periods by allowing two openings an hour instead of the current three openings an hour. Regulatory Evaluation This proposed rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security. We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation is unnecessary, because the rule would allow for scheduled bridge openings of this drawbridge and all waterway restrictions or closure times would be published with adequate time for mariners to plan accordingly. Small Entities Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities, as the rule will allow for scheduled bridge openings. This proposed rule would affect the following entities, some of which may be small entities: The owners or operators of vessels needing to transit the Gulf Intracoastal Waterway in the vicinity of the Pinellas Bayway Structure “E” Bridge, persons intending to drive over the bridge, and nearby business owners. The revision to the opening schedule would not have a significant impact on a substantial number of small entities. Vehicle traffic and small business owners in the area may benefit from the improved traffic flow that regularly scheduled openings will offer this area. Although bridge openings would be less frequent, vessel traffic would still be able to transit the Gulf Intracoastal Waterway on the hour and half-hour between 7 a.m. until 9 p.m. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it. Assistance for Small Entities Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance please contact the Seventh Coast Guard District Bridge Branch at the address under ADDRESSES . The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. Collection of Information This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this proposed rule under that Order and have determined that it does not have implications for federalism. Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble. Taking of Private Property This proposed rule would not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. Civil Justice Reform This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Protection of Children We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children. Indian Tribal Governments This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Energy Effects We have analyzed this proposed rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Technical Standards The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards. Environment We have analyzed this proposed rule under Commandant Instruction M16475.lD which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is not likely to have a significant effect on the human environment because it simply promulgates the operating regulations or procedures for drawbridges. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule. List of Subjects in 33 CFR Part 117 Bridges. For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 117 as follows: PART 117—DRAWBRIDGE OPERATION REGULATIONS 1. The authority citation for part 117 continues to read as follows: Authority: 33 U.S.C. 499; 33 CFR 1.05-1(g); Department of Homeland Security Delegation No. 0170.1. 2. Revise § 117.287(d)(4) to read as follows: § 117.287 Gulf Intracoastal Waterway. (d)(4) Pinellas Bayway Structure “E” (SR 679) bridge, mile 113.0 at St. Petersburg Beach. The draw shall open on signal, except that from 9 a.m. to 7 p.m. the draw need open only on the hour and 30 minutes past the hour. Dated: November 21, 2007. William Lee, CAPT, USCG, Acting D7 District Commander. [FR Doc. E7-23412 Filed 12-3-07; 8:45 am] BILLING CODE 4910-15-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R07-OAR-2007-1055; FRL-8502-1] Approval and Promulgation of Implementation Plans; State of Missouri; General Conformity AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve a revision to the Missouri State Implementation Plan
(SIP)to amend the General Conformity Rule to include de minimus emission levels for Particulate Matter 2.5 (PM <sup>2.5</sup> ). This update ensures consistency with the Federal General Conformity Rule. DATES: Comments on this proposed action must be received in writing by January 3, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-OAR-2007-1055 by one of the following methods: 1. *http://www.regulations.gov* : Follow the on-line instructions for submitting comments. 2. *E-mail: shepard.barbara@epa.gov* . 3. *Mail:* Barbara Shepard, Environmental Protection Agency, Region 7, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101. 4. *Hand Delivery or Courier:* Deliver your comments to Barbara Shepard, Environmental Protection Agency, Region 7, Air Planning and Development Branch, 901 North 5th Street, Kansas City, Kansas 66101. Such deliveries are only accepted during the Regional Office's normal hours of operation. The Regional Office's official hours of business are Monday through Friday, 8 a.m. to 4:30 p.m., excluding legal holidays. Please see the direct final rule which is located in the Rules section of this **Federal Register** for detailed instructions on how to submit comments. FOR FURTHER INFORMATION CONTACT: Barbara Shepard at
(913)551-7759, or by e-mail at *shepard.barbara@epa.gov* . SUPPLEMENTARY INFORMATION: In the final rules section of the **Federal Register** , EPA is approving the state's SIP revision as a direct final rule without prior proposal because the Agency views this as a noncontroversial revision amendment and anticipates no relevant adverse comments to this action. A detailed rationale for the approval is set forth in the direct final rule. If no relevant adverse comments are received in response to this action, no further activity is contemplated in relation to this action. If EPA receives relevant adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed action. EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on part of this rule and if that part can be severed from the remainder of the rule, EPA may adopt as final those parts of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule which is located in the rules section of this **Federal Register** . Dated: November 26, 2007. William Rice, Acting Regional Administrator, Region 7. [FR Doc. E7-23483 Filed 12-3-07; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R05-OAR-2007-0717; FRL-8501-6] Approval and Promulgation of Air Quality Implementation Plans; Wisconsin; Approval of Construction Permit Waiver AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is proposing to approve revisions to the Wisconsin State Implementation Plan
(SIP)submitted by the Wisconsin Department of Natural Resources
(WDNR)on May 1, 2007. The WDNR has submitted for approval into its SIP a revision which allows the State to issue a waiver to a source allowing it to commence construction prior to a construction permit being issued, in certain cases. This provision is only allowed for minor sources which meet specific criteria, and WDNR must follow established procedures to grant a waiver. In addition, the revision also contains changes to Wisconsin's fee provisions to allow a fee to be charged for the waiver. EPA is proposing to approve this revision because it is consistent with Federal regulations governing state permit programs. DATES: Comments must be received on or before January 3, 2008. ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-OAR-2007-0717, by one of the following methods: 1. *http://www.regulations.gov:* Follow the on-line instructions for submitting comments. 2. *E-mail: blakley.pamela@epa.gov* . 3. *Fax:* (312)886-5824. 4. *Mail:* Pamela Blakley, Chief, Air Permits Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. 5. *Hand Delivery:* Pamela Blakley, Chief, Air Permits Section, Air Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such deliveries are only accepted during the Regional Office normal hours of operation, and special arrangements should be made for deliveries of boxed information. The Regional Office official hours of business are Monday through Friday, 8:30 a.m. to 4:30 p.m. excluding Federal holidays. *Instructions:* Direct your comments to Docket ID No. EPA-R05-OAR-2007-0717. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *http://www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *http://www.regulations.gov* or e-mail. The *http://www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *http://www.regulations.gov* , your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional instructions on submitting comments, go to Section I of the SUPPLEMENTARY INFORMATION section of this document. *Docket:* All documents in the docket are listed in the *http://www.regulations.gov index* . Although listed in the index, some information is not publicly available, e.g. CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in www.regulations.gov or in hard copy at the Environmental Protection Agency, Region 5, Air and Radiation Division, 77 West Jackson Boulevard, Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. We recommend that you telephone Susan Siepkowski, Environmental Engineer, at
(312)353-2654 before visiting the Region 5 office. FOR FURTHER INFORMATION CONTACT: Susan Siepkowski, Environmental Engineer, Air Permits Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604,
(312)353-2654, *siepkowski.susan@epa.gov* . SUPPLEMENTARY INFORMATION: Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows: I. What Should I Consider as I Prepare My Comments for EPA? II. What Has Wisconsin Submitted? III. Does This Submittal Comply With Federal Regulations? IV. What Action Is EPA Taking Today? V. Statutory and Executive Order Reviews. I. What Should I Consider as I Prepare My Comments for EPA? When submitting comments, remember to: 1. Identify the rulemaking by docket number and other identifying information (subject heading, **Federal Register** date and page number). 2. Follow directions—The EPA may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations
(CFR)part or section number. 3. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. 4. Describe any assumptions and provide any technical information and/or data that you used. 5. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. 6. Provide specific examples to illustrate your concerns, and suggest alternatives. 7. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. 8. Make sure to submit your comments by the comment period deadline identified. II. What Has Wisconsin Submitted? On May 1, 2007, WDNR submitted a SIP revision request to EPA for approval. The submittal requests that EPA approve the following revisions to WDNR's SIP: to renumber and amend NR 406.03, to amend NR 410.03(intro.) and to create NR 406.03(2) and NR 410.03(l)(bm). These changes would allow WDNR to issue a waiver to a source allowing it to commence construction prior to a construction permit being issued. These revisions also contain changes to Wisconsin's fee provisions to allow a fee to be charged for the waiver. The WDNR held two public hearings in August 2006 and the comment period for this rule closed on August 18, 2006. The WDNR proposed this rule revision to the Wisconsin Natural Resources Board for adoption, and the Board approved the final rule on March 22, 2007. Wisconsin Rule NR 406 contains the requirements and procedures for construction permits. The revisions to NR 406.03 require the following conditions to be satisfied before the State may grant a source a waiver:
(1)A complete construction permit application has been submitted for the source;
(2)the source and the proposed project will result in the source remaining a true minor source (no synthetic minor or netting permits);
(3)the waiver requests must demonstrate that undue hardship will result if the waiver is not granted. Undue hardship may result from adverse weather conditions, catastrophic damage of existing equipment, a substantial financial hardship that may preclude the project in its entirety, and other unique conditions;
(4)the source is not located or to be located within 10 kilometers of a Class I area. The rule further states that a waiver does not obligate the WDNR to ultimately approve the project, or relieve the source from compliance with any applicable regulation. Finally, if a waiver is granted and the source proceeds with construction, the rule specifies that it is doing so at its own risk, and the source may not operate until the permit is issued. WDNR may rescind a waiver if the owner or operator does not diligently respond to inquiries on the construction permit application or if WDNR preliminarily determines that the source will not meet the criteria for permit approval. Additional changes are being made to NR 410, Wisconsin's air permit fee rules, to include fees for waivers. NR 10.03(1)(a)(5), related to the fees for a construction permit revision, is amended to exempt the fee if the requested revision is to make the source eligible for a registration operation permit. III. Does This Submittal Comply With Federal Regulations? EPA reviewed Wisconsin's May 1, 2007, SIP revision submittal to determine completeness, in accordance with the completeness criteria set out at 40 CFR part 51, appendix V (1991), as amended by 57 FR 42216 (August 26, 1991). We found the submittal to be complete. EPA evaluated Wisconsin's waiver rule with respect to the SIP approval criteria established in EPA's June 28, 1989, rulemaking “Requirements for the Preparation, Adoption, and Submittal of Implementation Plans,” (EPA's 1989 rulemaking); Approval and Promulgation of Implementation Plans, 54 FR 27274. In addition, EPA has evaluated WDNR's rule with respect to relevant Federal rules and guidance documents, as discussed in more detail below. Section 165 of the Clean Air Act
(Act)sets forth preconstruction requirements for the Prevention of Significant Deterioration
(PSD)program. Specifically, “(a) No major emitting facility on which construction is commenced after the date of the enactment of this part, may be constructed in any area to which this part applies unless
(1)a permit has been issued for such proposed facility in accordance with this part setting forth emission limitations for such facility which conform to the requirements of this part.” However, this requirement only applies to major sources, and no such restriction is specified under the minor New Source Review
(NSR)program requirements, which are set forth in 40 CFR 51.160. In addition, EPA has made determinations which further support that construction may begin before a permit is issued for minor sources. For example, EPA's October 10, 1978, memorandum from Edward E. Reich to Thomas W. Devine in Region 1 discusses preconstruction activities allowed at a site with both PSD and non-PSD sources. This memo states that construction may begin on PSD-exempt projects before the permit is issued. Furthermore, EPA approved a rule for Idaho's permit program which allowed construction to commence prior to a permit being issued. (See 68 FR 2217, final rule.) The August 13, 2002, **Federal Register** proposed approval of Idaho's rule, Section 213, regarding construction prior to final permit issuance, states: Section 213, entitled “Pre-Permit Construction” allows construction to commence on certain non-major sources and non-major modifications prior to receiving a final permit to construct, provided certain conditions are met. EPA believes that this provision is consistent with the requirements of section 110(a)(2)(C) of the CAA and 40 CFR 51.160, including 40 CFR 51.160(b), which requires States to have legally enforceable procedures to prevent construction or modification of a source if it would violate any SIP control strategies or interfere with attainment or maintenance of the NAAQS. (See 67 FR 52666). WDNR's rule revision provides that waivers can only be granted for minor sources, and the rule complies with EPA's minor source NSR rules set forth at 40 CFR 51.160. The minor source NSR rules require a state to have a program:
(1)To determine “whether construction or modification” of a source will interfere with the SIP or attainment or maintenance of the National Ambient Air Quality Standards (NAAQS); and,
(2)that includes procedures to “prevent the construction or modification” of the source if it would interfere with the SIP or attainment or maintenance of the NAAQS. WDNR will have enforceable procedures to prevent construction or modification of a source if it would violate any SIP requirement, or interfere with attainment or maintenance of the NAAQS. Additionally, WDNR can rescind a waiver if the source does not meet the criteria in Wis. Statute 285.63(1), which contain the criteria for permit application approval, including that the source will not cause or exacerbate a violation of any NAAQS or ambient air increment, and that the source will meet all applicable emission limitations and other requirements promulgated under the chapter. Finally, the rule contains the following additional safeguards. First, granting a waiver does not obligate the WDNR to ultimately approve the proposed project, or relieve the source from compliance with any applicable regulation. Second, if a waiver is granted and the source proceeds with construction, the rule specifies that it is doing so at its own risk, and the source may not operate until the permit is issued. Based on EPA's regulations and guidance, and the reasons set forth above, we believe that WDNR's SIP revision is approvable. IV. What Action Is EPA Taking Today? EPA is proposing to approve revisions to Wisconsin SIP rules NR 406 and 410 submitted by the State on May 1, 2007. EPA also is soliciting comment on this proposed approval. V. Statutory and Executive Order Reviews Executive Order 12866: Regulatory Planning and Review Under Executive Order 12866 (58 FR 51735, September 30, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. Paperwork Reduction Act This proposed rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). Regulatory Flexibility Act This proposed action merely proposes to approve state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Unfunded Mandates Reform Act Because this rule proposes to approve pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 13132: Federalism This action also does not have Federalism implications because it does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely proposes to approve a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Act. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This proposed rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). Executive Order 13045: Protection of Children From Environmental Health and Safety Risks This proposed rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it proposes approval of a state rule implementing a Federal standard. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use Because it is not a “significant regulatory action” under Executive Order 12866 or a “significant regulatory action,” this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). National Technology Transfer Advancement Act Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), 15 U.S.C. 272, requires Federal agencies to use technical standards that are developed or adopted by voluntary consensus to carry out policy objectives, so long as such standards are not inconsistent with applicable law or otherwise impractical. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Act. Absent a prior existing requirement for the state to use voluntary consensus standards, EPA has no authority to disapprove a SIP submission for failure to use such standards, and it would thus be inconsistent with applicable law for EPA to use voluntary consensus standards in place of a program submission that otherwise satisfies the provisions of the Act. Therefore, the requirements of section 12(d) of the NTTAA do not apply. List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds. Dated: November 23, 2007. Gary Gulezian, Acting Regional Administrator, Region 5. [FR Doc. E7-23482 Filed 12-3-07; 8:45 am] BILLING CODE 6560-50-P 72 232 Tuesday, December 4, 2007 Notices DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request November 28, 2007. The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding
(a)whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b)the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used;
(c)ways to enhance the quality, utility and clarity of the information to be collected;
(d)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 should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), *OIRA_Submission@OMB.EOP.GOV* or fax
(202)395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Comments regarding these information collections are best assured of having their full effect if received within 30 days of this notification. Copies of the submission(s) may be obtained by calling
(202)720-8958. An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. Food and Nutrition Service *Title:* Issuance Reconciliation Report. *OMB Control Number:* 0584-0080. *Summary of Collection:* The Food Stamp Act of 1977 (the Act) at Section 7(d) requires State agencies to report on their Food Stamp Program issuance operations not less than monthly, through a reconciliation process. The Food and Nutrition Service (FNS), administers the Food Stamp Program in cooperation with State and local governments. States are held liable to USDA for any financial losses involved in the issuance of food stamp benefits. *Need and Use of the Information:* FNS uses form FNS-46 form, Issuance Reconciliation Report, to ensure that State agencies are responsible for preventing losses or shortages of Federal funds in the issuance of benefits. The FNS-46 report is a program management report which is used on an ongoing basis to document the reconciliation process by which State agencies compare all issuances made during the month to the record for issuance. *Description of Respondents:* State, Local, or Tribal Government. *Number of Respondents:* 54. *Frequency of Responses:* Reporting: Monthly. *Total Burden Hours:* 5,184. Ruth Brown, Departmental Information Collection Clearance Officer. [FR Doc. E7-23418 Filed 12-3-07; 8:45 am] BILLING CODE 3410-30-P DEPARTMENT OF COMMERCE Bureau of Economic Analysis Proposed Data Sharing Activity AGENCY: Bureau of Economic Analysis, Department of Commerce. ACTION: Notice and request for public comment. SUMMARY: The Bureau of Economic Analysis
(BEA)proposes to provide to the Bureau of Labor Statistics
(BLS)data collected from several surveys that it conducts on U.S. direct investment abroad, foreign direct investment in the United States, and U.S. international services transactions for statistical purposes exclusively. In accordance with the requirement of Section 524(d) of the Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA), we are providing the opportunity for public comment on this data-sharing action. The data provided to BLS will be used for two purposes:
(1)The BLS International Price Program is researching the feasibility of producing price indexes for imports and exports of services, such as financial services, film and tape rentals, and royalties and license fees. BLS will use data from BEA surveys to develop sample frames of companies that trade these services and to directly collect price information from the selected companies. BLS will also use BEA data as weighting sources for the price indexes. Should it prove feasible to produce price indexes for international services, BEA will share data collected in its direct investment and international services surveys with BLS each time BLS draws a new sample and reweights the indexes. BLS will share sample frame and revenue information that it collects with BEA, which will allow BEA to identify errors or omissions in the data collected on its surveys. This data sharing effort will improve the quality of price indexes for imported and exported services that BEA uses in compiling the National Income and Product Accounts.
(2)The BLS Division of Foreign Labor Statistics will use BEA data collected on employment, compensation, and (as available) hours worked at the foreign affiliates of U.S. multinational companies to estimate their hourly compensation costs for research comparing the levels and trends of hourly compensation costs of foreign affiliates with the average costs for establishments in the same industries and same host countries as the affiliates. DATES: Written comments must be submitted on or before February 4, 2008. ADDRESSES: Please direct all written comments on this proposed program to the Director, Bureau of Economic Analysis (BE-1), Washington, DC 20230. FOR FURTHER INFORMATION CONTACT: Requests for additional information on this proposed program should be directed to Maria Borga, Bureau of Economic Analysis (BE-50), Washington, DC 20230, by phone on
(202)606-9853, via the Internet at *Maria.Borga@bea.gov* , or by fax on
(202)606-5318. SUPPLEMENTARY INFORMATION: Background CIPSEA (Pub. L. 107-347, Title V) and the International Investment and Trade in Services Survey Act (Pub. L. 94-472, 22 United States Code (U.S.C.) 3101-3108) allow BEA and BLS to share certain business data for exclusively statistical purposes. Section 524(d) of the CIPSEA requires a **Federal Register** notice announcing the intent to share data (allowing 60 days for public comment), since BEA respondents were required by law to report the data. Section 524(d) also requires us to provide information about the terms of the agreement for data sharing. For purposes of this notice, BEA has decided to group these terms by three categories. The categories are: • Shared data. • Statistical purposes for the shared data. • Data access and confidentiality. Shared Data BEA proposes to provide BLS with data from its surveys of U.S. direct investment abroad, foreign direct investment in the United States, and U.S. international services transactions. BLS will use these data for statistical purposes exclusively. Statistical Purposes for the Shared Data Data collected in BEA's surveys of direct investment are used to develop estimates of the financing and operations of U.S. parent companies, their foreign affiliates, and U.S. affiliates of foreign companies, and estimates of transactions between parents and affiliates. Data collected in BEA's surveys of U.S. international services transactions are used to develop estimates of services transactions between U.S. persons (in a broad legal sense, including companies) and foreign persons. These estimates are published in the *Survey of Current Business* , BEA's monthly journal; in other BEA publications; and on BEA's Web site at *http://www.bea.gov/.* All data are collected under sections 3101-3108, of Title 22, U.S.C. The shared data will be used for several exclusively statistical purposes by both agencies, such as the production of price indexes for imported and exported services and the making of international comparisons between the hourly compensation costs at the foreign affiliates of U.S. multinational companies and the average costs for establishments in the same industries and same host countries as the foreign affiliates. Data Access and Confidentiality Title 22, U.S.C. 3104 protects the confidentiality of the data to be provided by BEA to BLS. The data may be seen only by persons sworn to uphold the confidentiality of the information. Access to the shared data will be restricted to specifically authorized personnel and will be provided for statistical purposes only. Any results of this research are subject to BEA disclosure protection. All BLS employees with access to these data will become BEA Special Sworn Employees—meaning that they, under penalty of law, must uphold the data's confidentiality. J. Steven Landefeld, Director, Bureau of Economic Analysis. [FR Doc. E7-23506 Filed 12-3-07; 8:45 am] BILLING CODE 3510-06-P DEPARTMENT OF COMMERCE International Trade Administration [A-533-808] Stainless Steel Wire Rods from India: Final Results of Antidumping Duty Administrative Review and Notice of Rescission of Antidumping Duty Administrative Review in Part AGENCY: Import Administration, International Trade Administration, Department of Commerce. SUMMARY: On September 12, 2007, the Department of Commerce published the preliminary results of an administrative review of the antidumping duty order on stainless steel wire rods from India and a notice of intent to rescind the antidumping duty administrative review in part. The administrative review currently covers one manufacturer/exporter, Mukand Ltd., and the review period is December 1, 2005, through November 30, 2006. We stated our intent to rescind the review with respect to the manufacturer/exporter Sunflag Iron & Steel Co., Ltd., in our preliminary results. We have received no comments from interested parties on our preliminary results. We have made no changes to our calculations for the final results of review and, accordingly, have found that Mukand Ltd. made sales at less than normal value in the U.S. market. The final weighted-average dumping margin for this company is listed below in the section entitled “Final Results of the Review.” In addition, we have rescinded the administrative review of sales of stainless steel wire rods made by Sunflag Iron & Steel Co., Ltd. EFFECTIVE DATE: (December 4, 2007. FOR FURTHER INFORMATION CONTACT: Edythe Artman, AD/CVD Enforcement, Office 5, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230, telephone:
(202)482-3931. SUPPLEMENTARY INFORMATION: Background On September 12, 2007, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty order on stainless steel wire rods from India and a notice of intent to rescind the antidumping duty administrative review in part. See *Stainless Steel Wire Rods from India: Preliminary Results of Antidumping Duty Administrative Review and Notice of Intent to Rescind Antidumping Duty Administrative Review in Part* , 72 FR 52079 (September 12, 2007). We invited interested parties to comment on the preliminary results but received no comments from the parties. Rescission of Review in Part In the preliminary results of review, we stated our intent to rescind the administrative review with respect to sales of stainless steel wire rods (wire rods) made by Sunflag Iron & Steel Co., Ltd. (Sunflag), during the period of review because we had initiated a new-shipper review of these sales. See *Stainless Steel Wire Rod from India: Notice of Initiation of Antidumping Duty New-Shipper Review* , 72 FR 13088 (March 20, 2007). We thus preliminarily determined that it was appropriate to rescind the administrative review with respect to Sunflag pursuant to 19 CFR 351.214(j), which permits a rescission when there are multiple reviews of the sales of a company. We received no comments from interested parties concerning our intent to rescind. Because Sunflag's sales are subject to a new-shipper review, we are rescinding the administrative review with respect to Sunflag pursuant to 19 CFR 351.214(j). Scope of the Order The merchandise under review is wire rods, which are hot-rolled or hot-rolled annealed and/or pickled rounds, squares, octagons, hexagons or other shapes, in coils. Wire rods are made of alloy steels containing, by weight, 1.2 percent or less of carbon and 10.5 percent or more of chromium, with or without other elements. These products are only manufactured by hot-rolling and are normally sold in coiled form, and are of solid cross section. The majority of wire rods sold in the United States are round in cross-section shape, annealed, and pickled. The most common size is 5.5 millimeters in diameter. The wire rods subject to this order are currently classifiable under subheadings 7221.00.0005, 7221.00.0015, 7221.00.0030, 7221.00.0045, and 7221.00.0075 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise subject to the order is dispositive of whether the merchandise is covered by the order. No Changes Since the Preliminary Results Because the Department received no comments on the preliminary results of review and it finds no other basis for changes in these results, it has made no changes in the final results from the preliminary results of review. Accordingly, we find that Mukand Ltd. (Mukand) made sales at less than normal value in the U.S. market during the period of review. Final Results of the Review We determine that the weighted-average dumping margin on Mukand's sales of stainless steel wire rods from India for the period December 1, 2005, through November 30, 2006, is 11.56 percent. Assessment Rates The Department will determine, and U.S. Customs and Border Protection
(CBP)shall assess, antidumping duties on all appropriate entries. We intend to issue appropriate assessment instructions directly to CBP 15 days after publication of these final results of review. In accordance with 19 CFR 351.212(b)(1), we have calculated a customer/importer-specific, per-unit amount for entries of subject merchandise during the period of review. The Department clarified its “automatic assessment” regulation on May 6, 2003. See *Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties* , 68 FR 23954 (May 6, 2003). This clarification applies to period-of-review entries of subject merchandise produced by Mukand where it did not know that its merchandise was destined for the United States. In such instances, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction. Cash-Deposit Requirements The following deposit requirements will be effective upon publication of this notice of final results of administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication, consistent with section 751(a)(1) of the Act:
(1)the cash-deposit rate for Mukand will be 11.56 percent;
(2)for previously reviewed or investigated companies not listed above, the cash-deposit rate will continue to be the company-specific rate published for the most recent period;
(3)if the exporter is not a firm covered in this review, a prior review, or the original less-than-fair-value investigation but the manufacturer is, the cash-deposit rate will be the rate established for the most recent period for the manufacturer of the merchandise; and
(4)the cash-deposit rate for all other manufacturers or exporters will continue to be the “all others” rate of 48.80 percent, which is the “all others” rate established in the less-than-fair-value investigation. See *Final Determination of Sales at Less Than Fair Value: Certain Stainless Steel Wire Rods from India* , 58 FR 54110, (October 20, 1993). These cash-deposit rates shall remain in effect until further notice. Notification to Importers This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties. Notification Regarding Administrative Protective Orders This notice also serves as a reminder to parties subject to an administrative protective order of their responsibility concerning the disposition of proprietary information disclosed under such an order in accordance with 19 CFR 351.305(a)(3). Timely notification of the return or destruction of administrative-protective-order materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an administrative protective order is a sanctionable violation. We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act. Dated: November 27, 2007. David M. Spooner, Assistant Secretary for Import Administration. [FR Doc. E7-23491 Filed 12-3-07; 8:45 am] BILLING CODE 3510-DS-S DEPARTMENT OF COMMERCE International Trade Administration [A-821-802] Initialed Draft Amendment to the Agreement Suspending the Antidumping Investigation on Uranium From the Russian Federation; Request for Comment AGENCY: Import Administration, International Trade Administration, Department of Commerce. SUMMARY: The Department of Commerce (“the Department”) and the Russian Federation's Federal Atomic Energy Agency (“Rosatom”) have initialed a draft amendment to the Agreement Suspending the Antidumping Investigation on Uranium from the Russian Federation (“Suspension Agreement”). The proposed amendment will allow the Russian Federation (“Russia”) to export Russian uranium products to the U.S. market in accordance with the export limits and other terms detailed in the amendment. The Department is now inviting interested parties to comment on the text of the proposed amendment. DATES: Comments must be submitted within thirty
(30)days from the publication of this notice. FOR FURTHER INFORMATION CONTACT: Sally C. Gannon at
(202)482-0162, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230. Background On October 30, 1992, the Department suspended the antidumping duty investigation involving uranium from Russia on the basis of an agreement by its government to restrict the volume of direct or indirect exports to the United States in order to prevent the suppression or undercutting of price levels of U.S. domestic uranium. * See Antidumping; Uranium from Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Ukraine, and Uzbekistan; Suspension of Investigations and Amendment of Preliminary Determinations, * 57 FR 49220 (October 30, 1992). The Suspension Agreement was subsequently amended, by agreement of both governments, on March 11, 1994, October 3, 1996, and May 7, 1997. *See, respectively, Amendment to Agreement Suspending the Antidumping Investigation on Uranium from the Russian Federation,* 59 FR 15373 (April 1, 1994); *Amendments to the Agreement Suspending the Antidumping Investigation on Uranium from the Russian Federation,* 61 FR 56665 (November 4, 1996); and *Amendment to Agreement Suspending the Antidumping Investigation on Uranium from the Russian Federation,* 62 FR 37879 (July 15, 1997). On July 31, 1998, the Department notified interested parties of an administrative change with respect to the Suspension Agreement. *See Agreement Suspending the Antidumping Investigation on Uranium from the Russian Federation,* 63 FR 40879 (July 31, 1998). Initialed Amendment On November 27, 2007, the Department and Rosatom initialed a new draft amendment to the Suspension Agreement. The proposed amendment allows for exports of Russian uranium products to the U.S. market in accordance with the export limits and other terms detailed in the amendment. The text of the draft amendment follows in Annex 1 to this notice. The Department invites interested parties to submit comments on the proposed amendment within 30 days of the publication date of this notice. Persons wishing to comment should file a signed original and six copies, by the dates specified above, addressed as follows: Assistant Secretary David M. Spooner, Import Administration, International Trade Administration, U.S. Department of Commerce, c/o Central Records Unit, Room 1874, Washington, DC 20230, *Attn:* Sally C. Gannon, Bilateral Agreements Unit, Room 4083. All information provided to the Department will be subject to release under Administrative Protective Order (“APO”) and should be submitted in accordance with 19 CFR 351.103 and 19 CFR 351.105 of the Department's regulations, including the service of copies of comments on interested parties to this proceeding. The APO and public service lists in this proceeding can be found at the following Web site address: *http://ia.ita.doc.gov/apo/apo-svc-lists.html.* The Department will consider all comments received by the close of the comment period. Dated: November 28, 2007. David M. Spooner, Assistant Secretary for Import Administration. Annex 1 November 20, 2007—Draft (Moscow) Amendment to the Agreement Suspending the Antidumping Investigation on Uranium From the Russian Federation Date The Agreement Suspending the Antidumping Investigation on Uranium from the Russian Federation is amended as set forth below. The Preamble is amended by deleting the last two paragraphs (which were added to the Agreement in 1994) and adding the following paragraph to the end: The Department and ROSATOM acknowledge that, for purposes of the Agreement, as amended (the “Agreement”), the successor in interest to MINATOM is the Federal Atomic Energy Agency (“ROSATOM”). All references to MINATOM in this Agreement shall be understood to indicate ROSATOM. All exports of Russian Uranium Products are executed through the Russian Government-Owned entity Techsnabexport (“TENEX”). All references to TENEX include its successors and its affiliated companies. All references to “Customs” shall be understood to indicate United States Customs and Border Protection. Section II.—Definitions—is amended by deleting definitions
(g)“U.S. producer,”
(h)“for consumption,”
(i)“End-user,”
(j)“Spot Contract,” and
(k)“Newly-produced,” and by adding the following definitions:
(l)“Russian Uranium Products” means all products described in Section III, Product Coverage, of the Agreement.
(m)“Low-Enriched Uranium” (“LEU”) means uranium of which the content of the fissile isotope uranium-235 has been increased through enrichment to more than 0.7 percent, but less than 20 percent, by weight.
(n)“Initial Core” means the LEU necessary to start a U.S. nuclear reactor that is entering service for the first time.
(o)“Effective Date” means the date on which this amendment is signed by both parties.
(p)“Year” or “Relevant Period” means “Calendar Year”. Section IV.—Export Limits—The following new paragraphs are added at the beginning of this Section. The status of the other provisions of Section IV is set forth in Appendix 1. A. Beginning on the Effective Date, TENEX may immediately enter into contracts for the sale of Russian Uranium Products in the United States, directly to U.S. utilities or otherwise. B. Beginning in 2011, Russian Uranium Products in any form may be exported to the United States up to the limits set forth below. These limits are expressed in KgU as LEU, at a product assay of 4.4 and a tails assay of 0.3 percent. The Department and ROSATOM will consult and agree within two months after the Effective Date on how to convert and apply against these export limits Russian Uranium Products, which are other than LEU. Russian Uranium Products exported to the United States will be counted against these export limits, employing the formula in Section II(a), where necessary. 1. The annual export limits are as follows: 2011—16,559 2012—24,839 2013—41,398 2014—485,279 2015—455,142 2016—480,146 2017—490,710 2018—492,731 2019—509,058 2020—514,754 These limits were derived from the reference data in the World Nuclear Association's 2005 “Global Nuclear Fuel Market Supply and Demand 2005-2030.” The Department shall adjust these export limits in 2016 and 2019 to match the projected reactor demand for subsequent years in that publication or its successor, and also to increase the total export limit for the remaining years by the net amount by which the export limits for previous years have fallen short of the export limits that would have been derived from the revised demand figures for those years, with any additional export allowances being divided equally between the revised export limits for the remaining years. Russian Uranium Products may be exported to the United States under a contract entered into after the Effective Date and approved by the Department under this Agreement, even if such exports exceed the export limits in effect at the time of delivery. 2. After the Effective Date, Russian Uranium Products may be sold in, and exported to, the United States to fulfill contracts for the supply of Initial Cores without being subject to the export limits in this Agreement. 3. After the Effective Date, LEU in the United States pursuant to the contracts described in Appendix C to the Agreement, and stored as of the Effective Date at the facilities of U.S. producers (i.e., the EUP stockpile), may be sold in the United States or exported from the United States without being subject to the export limits in this Agreement, provided such sales occur prior to January 1, 2014. Any amount sold after December 31, 2013, shall be charged against the export limit for the year in which it is sold or the first subsequent year in which the export limit has not been reached. 4. After the Effective Date, Russian Uranium Products may be imported for processing and certified for re-export pursuant to Sections IV. G and H, without being subject to the export limits in Section IV.B.1. C. If, at any time, the Department determines that the available supply of Russian Uranium Products is or will be insufficient to meet U.S. demand, the Department may increase the export limits in this Agreement. D. Except for any increase added pursuant to Section IV.C, if, in any year, the Department permits any Russian Uranium Products to enter the United States in excess of the export limit for that year, the amount of the excess shall be charged against the export limit for the first subsequent year in which the export limit has not been contractually obligated. If the amount entered in any year falls below the export limit for that year, the amount of the shortfall may be added to the export limit for the subsequent year, up to 10 percent of the export limit for the year in which the shortfall occurs. E. In negotiating contracts involving the export of Russian Uranium Products to the United States, ROSATOM/TENEX shall charge market rates for conversion. F. The Russian LEU in reactor fuel rods or assemblies exported to the United States shall be counted against the export limits in this Agreement. ROSATOM/TENEX shall charge market rates for fuel rods and assemblies themselves. The following sentence is added at the end of the sixth paragraph of Section IV.H., which begins “For re-export entered under the 36 month limitation* * *”: The Department of Commerce shall instruct Customs to liquidate such entries as promptly as possible, and in all cases within ten
(10)days of receiving confirmation of the re-export shipment out of the United States. If the Department does not issue such instruction to Customs within ten
(10)days of receiving confirmation of the re-export shipment out of the United States, on the next business day, the Department shall provide ROSATOM with a written explanation of the exact and specific reason(s) for the delay and a date certain by which the Department shall issue instructions to Customs to liquidate the entries. The Department shall provide notice of re-export of any such uranium to TENEX. N. Russian Uranium Products sold pursuant to a multi-year contract entered into after the Effective Date and approved by the Department may be delivered in accordance with the provisions of this Amendment regardless of any modification to or reduction in the quantity that may be delivered under the export limits or any modification to or any interruption in the effectiveness of, including termination of, this Agreement. Section V.—Export License/Certificates—is amended by replacing paragraphs B and C with the paragraphs below and adding new paragraph F as follows: B. Export licenses shall be issued, and export certificates shall be endorsed by the competent Russian Government authority, for all direct and indirect exports of Russian Uranium Products to the United States. Such export certificates shall remain valid for entry into the United States for 120 days from the Date of Export. C. Russian Uranium Products may enter the United States if:
(1)They were sold pursuant to a contract approved by the Department under this Agreement;
(2)are accompanied by
(a)a valid export license and certificate and
(b)a valid purchase and/or delivery order issued in accordance with the contract approved by the Department under this Agreement showing the specific product and tails assays, as applicable; and
(3)do not exceed the export limits in Section IV. F. Any contract, or amendment thereto, for the sale of Russian Uranium Products for exportation to the United States shall be submitted to the Department for approval, along with the documents listed in Appendix 2 to this Amendment. If the maximum quantities to be exported under a contract, when cumulated with the maximum quantities that may be exported under all other approved contracts, are not in excess of the export limits under this Agreement, and the information listed in Appendix 2 has been submitted to the Department, the Department shall approve the contract within 15 days (or the next business day if the 15th day falls on a weekend or holiday). Section VII.—Anticircumvention—is amended by replacing Section VII.D with new paragraph D and adding new paragraph J as follows: D. In addition to the above requirements, the Department shall direct Customs to require all importers of uranium products into the United States, regardless of stated country of origin, to submit at the time of entry written statements certifying the following: 1. The country(ies) in which the ore was mined and, if applicable, converted, enriched, and/or fabricated, for all imports; and 2. That the uranium products being imported were not obtained under any arrangement, swap, exchange, or other transaction designed to circumvent the export limits established by the Agreement, or the limitations set forth in 43 U.S.C. 2297h-10(b) of the USEC Privatization Act, 42 U.S.C. 2297h, *et seq.* , and the *Procedures for Delivery of HEU Natural Uranium Component in the United States* , as revised. *Procedures for Delivery of HEU Natural Uranium Component in the United States* , 64 FR 42930 (August 6, 1999). J. Neither ROSATOM nor TENEX will circumvent this Agreement or frustrate the attainment of its objectives by entering into any contract involving the exportation to the United States of LEU in quantities exceeding the export limits in this Agreement. Section VIII.—Monitoring—is amended by adding the reporting requirements listed in Appendix 3 to this Amendment. Section XII.—Duration—is amended by replacing the first two paragraphs with the following: As of the Effective Date of this Amendment, each of the petitioners in the suspended investigation, or their legal successors, has filed with the Department an irrevocable letters expressly withdrawing the petition in the antidumping investigation, effective December 31, 2020. These letters are attached to this Amendment as Appendix 4. The Agreement will terminate on December 31, 2020. Upon its termination on December 31, 2020, the Department shall terminate the antidumping investigation effective on that date. The Department, before the Effective Date, acknowledges the remand of the U.S. Court of International Trade of September 26, 2007, in *Techsnabexport* v. *United States* , Ct. No. O6-00228, including the Court's direction that “Commerce follow the precedent by which it is bound, articulated in the Eurodif cases.” As directed by the Court of International Trade, the Department will abide by the Eurodif decisions in its determination of the likelihood of continued or recurring dumping. Therefore, on the Effective Date, Techsnabexport will file a motion in *Techsnabexport* v. *United States* under Rule 41 of the U.S. Court of International Trade Rules. The United States will not appeal the September 26th decision in *Techsnabexport* v. *United States* . In addition, the Department shall conduct sunset reviews under 19 U.S.C. 1675(c) in the years 2011 and 2016. All parties agree that the sunset reviews shall be expedited, pursuant to 19 U.S.C. 1675(C)(4) and (C)(3)(B), respectively, at both the Department of Commerce and the International Trade Commission. Section XIII.—Conditions—is amended by adding, before the first paragraph, an “A,” and by adding the following new paragraph at the end of Section XIII: B. This Agreement will be applied consistent with any applicable decision of the U.S. Courts, including the *Eurodif* decisions. Such decisions shall be applied to this Agreement (including by amendment, if necessary) no later than six
(6)months after the appropriate decision, unless the Department and ROSATOM agree otherwise. Section XIV.—Other Provisions—is amended by replacing existing paragraph B with the following new paragraph B, and by replacing the second part of paragraph C with the following: B. For all purposes relating to the Agreement, the Department and ROSATOM shall be represented by, and all communications and notices shall be given and addressed to: *Department Contact:* United States Department of Commerce, Assistant Secretary for Import Administration, International Trade Administration, Washington, DC 20230 *ROSATOM Contact:* State Secretary, Deputy Director, Federal Atomic Energy Agency (ROSATOM), Staromonetnyy per., 26, 119180, Moscow, Russian Federation C. If U.S. law, regulation, administrative practice, or policy should change in any manner, including by U.S. court decision or legislative or administrative action, that would result in relatively less favorable treatment for the Russian Federation as compared to any other country, or if the United States should enter into any agreement or understanding or take any action that would cause that result, the parties will promptly, *i.e.* , within six
(6)months, enter into consultations with a view to amending this Agreement so as to eliminate such less favorable treatment to the extent permitted by U.S. law. Signed on this ____ day of _______, 2007. For ROSATOM: S.V. Kiriyenko *Director, Federal Atomic Energy Agency (ROSATOM)* For the United States Department of Commerce: Carlos M. Gutierrez *U.S. Secretary of Commerce* Appendix 1 Section IV.—Export Limits—The status of the other paragraphs of Section IV, other than the newly-added paragraphs, is as follows: 1994 matched sales provisions (IV, IV.A—IV.E)—hereby deleted 1992 Sections IV.A—IV.C.1—deleted in 1994 1992 Sections IV.C 2-3 and IV.D—hereby deleted 1992 Sections IV.E—IV.G—remain in effect 1992 Section IV.H, first two paragraphs—deleted in 1997 1997 Section H—remains in effect 1992 Sections IV.I—IV.M.1 remain in effect 1996 Section IV.M.2—remains in effect 1992 Section IV.M.2—ineffective as of 1997 Appendix 2 Pursuant to Section V.F, the following documents should accompany any contract for the sale of Russian Uranium Products for exportation to the United States, which is submitted to the Department for approval: 1. A copy of the signed contract pursuant to which the Russian Uranium Products shall be imported (showing the contract date and key terms such as price, quantity, delivery requirements and estimated delivery schedule); 2. A description of the physical material being imported; 3. Identification of the Russian supplier of the Russian Uranium Products; 4. For each contract, the maximum volume of each type of Russian Uranium Product that may be exported to the United States pursuant to the contract each year; 5. For sales pursuant to Section IV.B.2, the documentation necessary to demonstrate that deliveries meet the definition of Initial Cores ( *e.g.* , a combined construction and operating license (COL), etc.). Appendix 3 Pursuant to Section VIII, the following additional reporting requirements are agreed to by ROSATOM and the Department: 1. Beginning the Effective Date, no later than 30 days after the end of each calendar quarter, to the extent permitted by Russian law, ROSATOM shall submit an updated master export schedule to the Department showing the following for each year (from the first year of validity of the Amendment through 2020) for any material to be delivered in the United States pursuant to contracts under this Agreement:
(a)Estimated deliveries, and
(b)completed deliveries. All such reports submitted by ROSATOM shall be subject to release under Administrative Protective Order (“APO”) to counsel for interested parties to the proceeding. 2. Beginning the Effective Date, no later than 30 days after the end of each semi-annual period, to the extent permitted by U.S. law, the Department shall provide semi-annual reports to ROSATOM, via its U.S. attorney under APO, of all individual imports (for consumption and for processing and re-export) of Russian Uranium Products to the United States, together with such additional information as is necessary and appropriate to monitor implementation of the Agreement, as agreed to by the Department and ROSATOM. For every transaction for which the Department withholds information on the basis that its disclosure is not permitted under U.S. law, the Department shall submit to ROSATOM the fullest description permitted under U.S. law of the information withheld and the legal basis for not disclosing it. 3. For purposes of the Department's reporting on imports for consumption, to the extent permitted under U.S. law, the Department shall provide the following: a. Quantity: Indicate units of measure sold and/or entered, *e.g.* , pounds U308, Kilograms U, SWU, etc. b. Date of Importation: The date Customs confirmed the Department's shipment clearance instructions. c. Date of Export: The date the Export Certificate is endorsed. d. Export Certificate: The Export Certificate number corresponding to each individual import. e. Total Sales Value: Indicate currency used. f. Importer of Record: Name and address. 4. For purposes of the Department's reporting on imports for processing and re-export, to the extent permitted under U.S. law, the Department shall provide the following: a. Filing date of request for approval filed with the Department. b. Certificate for Re-Export number, as listed on the Certificate for Re-Export. c. Date of issuance by ROSATOM of the Certificate for Re-Export, as listed on the Certificate for Re-Export. d. Date of Export, as listed on the Certificate for Re-Export. e. Party requesting approval, as listed on the request for approval. f. Customer, as listed on the Certificate for Re-Export. g. Total quantity, expressed in KgU, U308 and, as applicable, SWUs, as listed on the Certificate for Re-Export. h. Date of importation, as relied upon by the Department for purposes of determining annual usage of the quota. i. Timeframe for re-export (i.e., 12-month or 36-month), as listed on the Certificate for Re-Export. j. Scheduled date for re-export, as relied upon by the Department for purposes of determining annual usage of the quota. k. Notice of re-export filed with the Department, including the date of such notification and the actual date of re-export. [FR Doc. E7-23490 Filed 12-3-07; 8:45 am] BILLING CODE 3510-DS-P DEPARTMENT OF COMMERCE International Trade Administration [C-475-819] Certain Pasta From Italy: Notice of Extension of Time Limit for the Final Results of the Tenth Countervailing Duty Administrative Review AGENCY: Import Administration, International Trade Administration, Department of Commerce. DATES: *Effective Dates:* December 4, 2007. FOR FURTHER INFORMATION CONTACT: Andrew McAllister or Brandon Farlander, AD/CVD Operations, Office 1, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington DC 20230; telephone:
(202)482-1174 and
(202)482-0182, respectively. SUPPLEMENTARY INFORMATION: Background On August 6, 2007, the Department published the preliminary results of the 2005 administrative review of the countervailing duty order on certain pasta (“pasta”) from Italy. *See Certain Pasta from Italy: Preliminary Results of the Tenth Countervailing Duty Administrative Review,* 72 FR 43616 (August 6, 2007). This review covers three manufacturers/exporters of the subject merchandise to the United States: De Matteis Agroalimetare S.p.A. (“De Matteis”), Atar S.r.L. (“Atar”), and Antonio Pallante S.r.L. (“Pallante”). In the preliminary results, we stated that we would issue our final results for the countervailing duty administrative review no later than 120 days after the date of publication of the preliminary results ( *i.e.* , December 4, 2007). Extension of Time Limit for Final Results Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (“the Act”), requires the Department to issue the final results in an administrative review within 120 days of the publication date of the preliminary results. However, if it is not practicable to complete the review within this time period, section 751(a)(3)(A) of the Act allows the Department to extend the time limit for the final results to a maximum of 180 days. The Department has determined that completion of the final results of this review within the original time period is not practicable due to legal and factual issues that have arisen since the issuance of our preliminary results of review. Specifically, the Department requires additional time to review interested parties' comments on De Matteis' November 5, 2007, supplemental questionnaire response. Thus, in accordance with section 751(a)(3)(A) of the Act, the Department is extending the time period for issuing the final results of review by an additional 60 days, until February 4, 2008. This notice is published pursuant to sections 751(a)(2)(B)(iv) and 777(i)(1) of the Act. Dated: November 28, 2007. Stephen J. Claeys, Deputy Assistant Secretary for Import Administration. [FR Doc. E7-23488 Filed 12-3-07; 8:45 am] BILLING CODE 3510-DS-P DEPARTMENT OF COMMERCE International Trade Administration [Application No. 85-13A18] Export Trade Certificate of Review ACTION: Notice of Issuance of an Amended Export Trade Certificate of Review to U.S. Shippers Association. SUMMARY: The U.S. Department of Commerce has issued an amended Export Trade Certificate of Review (“Certificate”) to the U.S. Shippers Association (“USSA”) on November 27, 2007. USSA's application to amend its Certificate was announced in the **Federal Register** on September 14, 2007 (72 FR 52552), and an amended notice of application for amendment was published on October 4, 2007 (72 FR 56727). The original Certificate No. 85-00018 was issued to USSA on June 3, 1986, and announced in the **Federal Register** on June 9, 1986 (51 FR 20873). The previous amendment (No. 85-12A018) was issued to USSA on April 6, 2006, and announced in the **Federal Register** April 12, 2006 (71 FR 18721). FOR FURTHER INFORMATION CONTACT: Jeffrey Anspacher, Director, Export Trading Company Affairs, International Trade Administration, by telephone at
(202)482-5131 (this is not a toll-free number) or E-mail at *oetca@ita.doc.gov* . SUPPLEMENTARY INFORMATION: Title III of the Export Trading Company Act of 1982 (15 U.S.C. Sections 4001-21) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. The regulations implementing Title III are found at 15 CFR part 325 (2006). Export Trading Company Affairs is issuing this notice pursuant to 15 CFR 325.6(b), which requires the Department of Commerce to publish a summary of the certification in the **Federal Register** . Under section 305(a) of the Act and 15 CFR 325.11(a), any person aggrieved by the Secretary's determination may, within 30 days of the date of this notice, bring an action in any appropriate district court of the United States to set aside the determination on the ground that the determination is erroneous. Description of Amended Certificate USSA's Export Trade Certificate of Review has been amended to: 1. Add each of the following companies and persons as a new “Member” of the Certificate within the meaning of section 325.2(1) of the Regulations (15 C.F.R. 325.2(1)): Taminco, Inc.; Taminco Higher Amines, Inc.; and Taminco Methylamines, Inc., each located in Allentown, PA, and Salvatore Di Paola and Carrie M. Bowden, both of Missouri City, TX; and 2. Delete Bayer CropScience, located in Research Triangle Park, NC. The effective date of the amended certificate is September 4, 2007, the date on which USSA's application to amend was deemed submitted. A copy of the amended Certificate will be kept in the International Trade Administration's Freedom of Information Records Inspection Facility, Room 4001, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230. Dated: November 28, 2007. Jeffrey Anspacher, Director, Export Trading Company Affairs. [FR Doc. E7-23501 Filed 12-3-07; 8:45 am] BILLING CODE 3510-DR-P DEPARTMENT OF COMMERCE National Institute of Standards and Technology National Construction Safety Team Advisory Committee Meeting AGENCY: National Institute of Standards and Technology, United States Department of Commerce. ACTION: Notice of open meeting. SUMMARY: The National Construction Safety Team
(NCST)Advisory Committee (Committee), National Institute of Standards and Technology (NIST), will meet via teleconference Tuesday, December 18, 2007, from 1 p.m. to 3 p.m. The meeting will be audio webcast so that the public may listen to the meeting as it takes place. The primary purpose of this meeting is for the NCST Advisory Committee to discuss its annual report to the Congress and for NIST to update the Committee on the status of the investigation of World Trade Center 7. The agenda may change to accommodate Committee business. The final agenda will be posted on the NIST Web site at *http://www.nist.gov/ncst.* DATES: The meeting will convene on Tuesday, December 18, 2007 at 1 p.m. and will adjourn at 3 p.m. The meeting will be conducted via teleconference. The live audio Web cast will be available to the public via a link on the NIST WTC Web site, *http://wtc.nist.gov.* ADDRESSES: The meeting will be held via teleconference. A live audio webcast of the meeting will be available via a link on the NIST WTC Web site, *http://wtc.nist.gov.* Please refer to the SUPPLEMENTARY INFORMATION section of this notice for additional information. FOR FURTHER INFORMATION CONTACT: Stephen Cauffman, National Construction Safety Team Advisory Committee, National Institute of Standards and Technology, 100 Bureau Drive, MS 8611, Gaithersburg, Maryland 20899-8611. Mr. Cauffman's e-mail address is *stephen.cauffman@nist.gov* and his phone number is
(301)975-6051. SUPPLEMENTARY INFORMATION: The Committee was established pursuant to Section 11 of the National Construction Safety Team Act (15 U.S.C. 7310 et seq.). The Committee is composed of six members, appointed by the Director of NIST, who were selected for their technical expertise and experience, established records of distinguished professional service, and their knowledge of issues affecting teams established under the NCST Act. The Committee will advise the Director of NIST on carrying out investigations of building failures conducted under the authorities of the NCST Act that became law in October 2002 and will review the procedures developed to implement the NCST Act and reports issued under section 8 of the NCST Act. Background information on the NCST Act and information on the NCST Advisory Committee is available at *http://www.nist.gov/ncst.* Pursuant to the Federal Advisory Committee Act, 5 U.S.C. app. 2, notice is hereby given that the National Construction Safety Team
(NCST)Advisory Committee (Committee), National Institute of Standards and Technology (NIST), will meet Tuesday, December 18, at 1 p.m. and will adjourn at 3 p.m. The meeting will be conducted by teleconference with a live audio webcast available to the public. The primary purpose of this meeting is for the NCST Advisory Committee to discuss its annual report to the Congress and for NIST to update the Committee on the status of the investigation of World Trade Center 7. The meeting will be conducted via teleconference with a live audio webcast. The final agenda will be posted on the NIST Web site at *http://www.nist.gov/ncst.* Individuals and representatives of organizations who would like to offer comments and suggestions related to items on the Committee's agenda for this meeting, are invited to request a place on the agenda. Approximately one-half hour will be reserved for public comments, and speaking times will be assigned on a first-come, first-served basis. The amount of time per speaker will be determined by the number of requests received, but is likely to be 5 minutes each. Questions from the public will not be considered during this period. Speakers who wish to expand upon their oral statements, those who had wished to speak but could not be accommodated on the agenda, and those who were unable to attend in person are invited to submit written statements to the National Construction Safety Team Advisory Committee, National Institute of Standards and Technology, 100 Bureau Drive, MS 8611, Gaithersburg, Maryland 20899-8611, via fax at
(301)975-6122, or electronically by e-mail to *ncstac@nist.gov.* Since the meeting will be held by teleconference, all those wishing to speak must submit their request by e-mail to the attention of Mr. Stephen Cauffman, *cauffman@nist.gov* by 5 p.m. EST on December 14, 2007. Instructions on how and when to call in for the public comment period will be provided to registered speakers by e-mail on December 17, 2007. Dated: November 28, 2007. Richard F. Kayser, Acting Deputy Director. [FR Doc. E7-23492 Filed 12-3-07; 8:45 am] BILLING CODE 3510-13-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XD82 Endangered and Threatened Species; 5-year Review AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice of availability of a 5-year review for Johnson's seagrass. SUMMARY: We, NMFS, announce the availability of a 5-year review for Johnson's seagrass ( *Halophila johnsonii* ) as required by the Endangered Species Act of 1973 (ESA). Johnson's seagrass was listed as threatened on September 14, 1998. Based on the best available scientific and commercial data, we conclude in the 5-year review that Johnson's seagrass remains a threatened species likely to become endangered within the foreseeable future. Therefore, based on our 5-year review, we recommend no change in listing. ADDRESSES: Additional information about the 5-year review may be obtained by writing to Shelley Norton, NMFS, Southeast Regional Office, Protected Resources Division, 263 13 th Avenue South, St. Petersburg, FL 33701 or send and electronic message to *Shelley.norton@noaa.gov* . Electronic copies of the 5-year review are available online at the NMFS Southeast Regional Office website: *http://sero.nmfs.noaa.gov/pr/protres.htm* . SUPPLEMENTARY INFORMATION: Background Under the ESA, a list of endangered and threatened wildlife and plant species must be maintained. The list is published at 50 CFR 17.11 (for animals) and 17.12 (for plants). Section 4(c)(2)(A) of the ESA requires that we conduct a review of listed species at least once every 5 years. On the basis of such reviews under section 4(c)(2)(B), we determine whether any species should be removed from the List (delisted), or reclassified from endangered to threatened or from threatened to endangered. In a 5-year review we consider the best scientific and commercial data and all new information that has become available since the listing determination or most recent status review of a species. NMFS and the NOAA Center for Coastal Fisheries and Habitat Research (CCFHR) initiated the 5-year review of Johnson's Seagrass in September 2006. The CCFHR and NMFS solicited information from the public through the **Federal Register** (71 FR 60108; October 12, 2006), as well as through personal and written communications with several educational institutions, Federal and state governments, and private research organizations. To complete the review, we evaluated all information that has become available on the species since 1997, the date of the last Johnson's seagrass biological status review. The completed 5-year review was peer reviewed. We conclude that the 5-year review meets the requirements of the ESA. Authority: 16 U.S.C. 1531 *et seq.* Dated: November 28, 2007. Angela Somma, Chief, Endangered Species Division, Office of Protected Resources, National Marine Fisheries Service. [FR Doc. E7-23503 Filed 12-3-07; 8:45 am] BILLING CODE 3510-22-S DEPARTMENT OF DEFENSE Office of the Secretary Autism Services Demonstration Project for TRICARE Beneficiaries Under the Extended Care Health Option Program AGENCY: Department of Defense. ACTION: Notice of an autism services demonstration project for TRICARE beneficiaries under the Extended Care Health Option program. SUMMARY: This notice is to advise interested parties of a Military Health System
(MHS)demonstration project entitled Enhanced Access to Autism Services Demonstration Project. The Department proposes a demonstration program under the Department's demonstration authority under 10 United States Code (U.S.C.) 1092 to expand the availability of Intensive Behavioral Intervention
(IBI)services (defined as an intensive application of certain behavior modification interventions) to Extended Care Health Option
(ECHO)program beneficiaries with autism. The demonstration program will permit TRICARE cost sharing of services by IBI tutors under a modified corporate services model. This demonstration will determine whether military families are able to make more effective use of the special education benefit in the ECHO program. Additionally, the demonstration will help determine the effectiveness of expanding the provider base in improving the access to services for TRICARE and attendant improvement in functional outcome for those military dependent children receiving services. For purposes of this demonstration, provider qualifications will be established by the Department pending development of national standards by a nationally recognized certifying body for ABA providers, which standards the Department determines appropriate for acceptance in the delivery of quality care under the program. The Department intends to retain the ECHO benefit as currently outlined in 32 Code of Federal Regulations
(CFR)199.5, except for the changes that will be implemented in the demonstration program noted above. DATES: *Effective Date:* 60 days after publication in the **Federal Register** . This demonstration will remain in effect for two years from the start date of the demonstration. ADDRESSES: TRICARE Management Activity, Office of the Chief Medical Officer, 5111 Leesburg Pike, Suite 810, Falls Church, VA 22041-3206. FOR FURTHER INFORMATION CONTACT: Captain Robert DeMartino, Office of the Chief Medical Officer, TRICARE Management Activity, telephone
(703)681-0064. SUPPLEMENTARY INFORMATION: A. Background The Military Health System
(MHS)is a $33 billion dollar enterprise, consisting of 76 military hospitals, over 500 military health clinics, and an extensive network of private sector health care partners, which provides medical care for over 9 million beneficiaries and Active Duty Service Members. While an accurate count of the number of military-dependent children with autism is not available, estimates based on prevalence rates in the general population suggest that among the more than 1.2 million children of Active Duty Military personnel, between 7,000-9,000 would carry one of the autism spectrum disorder diagnoses. Autistic spectrum disorders affect essential human behaviors such as social interaction, the ability to communicate ideas and feelings, imagination, and the establishment of relationships with others. A number of treatments, therapies and interventions have been introduced to ameliorate the negative impact of autism on these areas of concern. Intensive Behavioral Intervention
(IBI)services (defined as an intensive application of certain behavior modification interventions) have been shown to reduce or eliminate specific problem behaviors and teach new skills to individuals with autism. Applied behavior analysis (ABA), a systematized educational process of collecting data on a child's behaviors and using a variety of behavioral conditioning techniques to teach and reinforce desired behaviors while extinguishing harmful or undesired behaviors, is one of the best studied IBI interventions. Time-limited, focused ABA methods have been shown to reduce or eliminate specific problem behaviors and teach new skills to individuals with autism. B. The Extended Care Health Option
(ECHO)Program ECHO replaced the Program for Persons with Disabilities (PFPWD) on September 1, 2005, as authorized by section 701(b) of the National Defense Authorization Act for Fiscal Year 2002, Public Law 107-107, which revised subsections (d), (e), and
(f)of section 1079 of Title 10, United States Code, and is implemented under 32 CFR 199.5. Under ECHO, qualifying Active Duty family members may receive benefits not available under the basic program. For example, special education services are specifically excluded from the TRICARE basic program under 10 U.S.C. 1079(a)(9). Qualifying conditions under ECHO include moderate or severe mental retardation, a serious physical disability, or an extraordinary physical or psychological condition. Under 10 U.S.C. 1079(e), “* * * Extended benefits for eligible dependents * * * may include * * * training, rehabilitation, special education, and assistive devices.” IBI, as a behavioral intervention that shapes behaviors and teaches skills, is a special education service that can be cost-shared under ECHO. The government cost-share for these extended benefits is limited under 10 U.S.C. 1079(f)(2)(A) to a maximum of $2,500 per month. While participation in ECHO is voluntary, registration is required, by law, for a TRICARE beneficiary to receive the ECHO benefit. The registration process includes providing the managed care support contractor
(MCSC)with evidence that the beneficiary is enrolled in the Exceptional Family Member Program provided by the sponsor's branch of Service. C. The ECHO Program and Providers of ABA An authorized outpatient provider under the ECHO program must, under 32 CFR 199.6(e), be a provider otherwise authorized under the TRICARE basic program. Alternatively, if not recognized as such, if they provide services that are only authorized under the TRICARE ECHO program, such as special education services, the provider must meet all the applicable licensing and other regulatory requirements in that state, county, municipality or other governmental jurisdiction in which the ECHO service is rendered. In the absence of such licensing or regulatory requirements, the Director, TRICARE Management Activity, or designee determines the applicable requirements necessary to be an authorized provider. At the present time, no state is known to license or have explicit regulatory oversight over providers of ABA services. As a health plan, TRICARE is obligated to take reasonable steps to assure the safety, efficacy, and quality of care it provides. One of the most common ways that health plans can assure high quality care is to require that the providers they reimburse meet widely recognized and accepted minimum standards for knowledge, training and experience. The only available nationally recognized credential for IBI services is for ABA providers through the Behavior Analyst Certification Board
(BACB)which certifies providers at the bachelor's degree level (Board Certified Associate Behavior Analyst—BCABA) and at the master's degree level (Board Certified Behavior Analyst—BCBA). Absent state licensing or regulation of ABA providers, the Director, TRICARE Management Activity, established a requirement that ABA providers be certified by the BACB. It was expected that high demand for ABA services would provide incentive for large numbers of ABA providers to become certified BCBAs and BCABAs. The current TRICARE benefit allows cost sharing of BACB-certified ABA therapists when providing consultation to the beneficiary in the home or at school, designing and maintaining a behavioral treatment plan, providing hands-on IBI services, and training and supervising family members in delivery of IBI. TRICARE currently does not authorize the reimbursement of the “hands-on” provider of IBI services unless the provider is an authorized TRICARE provider as described above. Though the number of BCBAs and BCABAs continues to increase, it is widely recognized that there is a relative paucity of board certified analysts. As a result, it is difficult in most areas, especially rural areas, for beneficiaries to find TRICARE authorized ABA providers. The impact of the scarcity of certified providers is ameliorated by the commonly practiced business model in which a supervising or lead therapist develops the behavioral treatment plan for a child and then provides indirect supervision of the hands-on ABA tutors (also referred to as technicians or instructors) who engage in the one-on-one treatment with the child. In the best scenario, several tutors then provide each client with the recommended intensity of behavioral services (in the range of 8-40 hours a week). Unfortunately, such a provider type is not currently regulated by the states or within the industry, nor is this provider type officially recognized by the BACB. In addition, there is no state or industry oversight of IBI or ABA business entities, no standardized education or training of tutors, and no verification of basic protections such as criminal background checks as a condition of employment. Therefore, none of the criteria exist for tutors that were applied by the Director, TRICARE Management Activity, when authorizing BCABAs and BCBAs as individual providers under the ECHO program. D. Congressional Directives to the Department of Defense on Autism Services The John Warner National Defense Authorization Act for Fiscal Year 2007, section 717, required the Department to develop a plan to provide services to military-dependent children with autism within the authority of the ECHO program. Part of the plan was to develop a demonstration project to expand the availability of IBI services. This demonstration implements the plan outlined in the July 2007 report to Congress that met the section 717 requirement. E. Description of Demonstration Project The proposed demonstration project will modify the corporate services provider requirements of 32 CFR 199.6(f) as they apply to hands-on IBI tutors who engage in the one-on-one treatment with the child, while employed and supervised by an authorized IBI supervisor (requirements for TRICARE authorized IBI Tutors and IBI Supervisors will be detailed prior to the start of the demonstration project in the TRICARE Operations Manual, available at ( *http://manuals.tricare.osd.mil* ). Under 32 CFR 199.6(e)(2)(ii)(B), an ECHO outpatient care provider includes an individual, corporation, foundation, or public entity that predominantly renders services of a type uniquely allowable as an ECHO benefit. The TRICARE corporate service provider class under 32 CFR 199.6(f) is established to accommodate individuals who would meet the criteria for status as a TRICARE authorized individual professional provider as established by paragraph
(c)of section 199.6, but for the fact that they are employed directly or contractually by a corporation or foundation that provides principally professional services which are within the scope of the TRICARE basic program benefit. Currently, TRICARE authorizes IBI services only by ABA trained outpatient care providers who are generally individual practitioners, and many practices are not incorporated. As a result, they do not meet most of the requirements under 32 CFR 199.6(f) to qualify as a corporate service provider. This demonstration project will expand who is eligible to provide IBI supervisory services and require IBI Supervisors to meet the following criteria to qualify as a “corporate service” provider under this demonstration, and receive reimbursement for services provided by tutors implementing their treatment plan.
(1)IBI Tutors must be individuals who are employed directly or contractually by a TRICARE authorized IBI Supervisor.
(2)Payment for otherwise allowable services by tutors under this demonstration project may be made to a TRICARE-authorized IBI Supervisor subject to the applicable requirements, exclusions and limitations of this demonstration.
(3)The Director, TRICARE, Management Activity, or designee, may create discrete types within the allowable tutor category of provider established by this demonstration to improve the efficiency of TRICARE management.
(4)The Director, TRICARE Management Activity, or designee, may require, as a condition of authorization, that the IBI Supervisor, or the IBI Tutor established by this demonstration project:
(A)Maintain all applicable business license requirements of state or local jurisdictions.
(B)Cooperate fully with a designated utilization and clinical quality management organization which has a contract with the Department of Defense for the geographic area in which the provider does business;
(C)Render services for which direct or indirect payment is expected to be made by TRICARE only after obtaining TRICARE written authorization.
(5)Otherwise allowable services may be rendered at the authorized supervising IBI provider's place of business, or in the beneficiary's home under such circumstances as the Director, TRICARE Management Activity, or designee, determines to be necessary for the efficient delivery of such services.
(6)The Director, TRICARE Management Activity, or designee, may limit the term of a participation agreement for any category or type of provider established by this demonstration project.
(7)The Director, TRICARE Management Activity, or designee, shall determine whether the appropriate employment or contractual relationship exists between the IBI Supervisor and IBI Tutor. Such determination is conclusive and may not be appealed.
(8)Conditions of authorization. An applicant must also meet the following conditions to be eligible for authorization as a TRICARE corporate services provider under this demonstration project:
(A)Meet the qualifications and requirements for IBI Supervisors established by the Director, TRICARE Management Activity or designee; and
(B)Ensure that IBI Tutors meet the requirements for TRICARE authorization specified by The Director, TRICARE Management Activity or designee; and
(C)Comply with all applicable organizational and individual licensing or certification requirements that are extant in the state, county, municipality, or other political jurisdiction in which the provider renders services; and
(D)Has entered into a participation agreement approved by the Director, TRICARE Management Activity, or designee, which complies with the participation agreement requirements established by the Director; and
(E)Pricing and payment methodology: The pricing and payment of procedures rendered by a provider authorized under this demonstration project shall be limited to those methods for pricing and payment allowed by 32 CFR part 199 which the Director, TRICARE Management Activity, or designee, determines contribute to the efficient management of this demonstration project.
(F)Termination of participation agreement. A provider may terminate a participation agreement upon 45 days written notice to the Director, TRICARE Management Activity. This demonstration will test the advisability and feasibility of permitting TRICARE reimbursement for IBI services delivered by non-professional providers, under a modified corporate services model, in the absence of state or industry oversight. Neither the TRICARE Basic Program nor the ECHO program currently authorizes reimbursement for providers working within this type of unregulated corporate structure. Should the demonstration result in a determination to make a permanent change to the TRICARE benefit to permit reimbursement of services provided by IBI tutors under a corporate services model, such decision would require a change to the Code of Federal Regulations. In addition to provider qualifications, the demonstration project may outline criteria and requirements for covered services, limitations to the benefit, beneficiary eligibility, data gathering and use requirements and documentation of treatment effectiveness that are specific to services delivered under the demonstration project. F. Evaluation An evaluation of the demonstration will be conducted. The evaluation will be designed to use a combination of administrative and survey measures of health care outcomes (clinical, utilization, financial, and humanistic measures) to provide analyses and comment on the effectiveness of the demonstration in meeting its goal of providing increased access to safe, efficacious, and quality behavioral services for military children with autism. Dated: November 28, 2007. L.M. Bynum, Alternate OSD Federal Register Liaison Officer, Department of Defense. [FR Doc. E7-23477 Filed 12-3-07; 8:45 am] BILLING CODE 5001-06-P ELECTION ASSISTANCE COMMISSION Sunshine Act Notice AGENCY: United States Election Assistance Commission (EAC). ACTION: Notice of Public Meeting. DATE AND TIME: Tuesday, December 11, 2007, 9 a.m.-12 Noon (CST). PLACE: Omni Hotel Downtown, 700 San Jacinto Boulevard at 8th Street, Austin, TX 78701, Phone number
(512)476-3700. AGENDA: The Commission will consider the following items: Adoption of the 2006 Election Day Survey Report; an amendment to EAC policy on the voting system reports clearinghouse; whether to transfer National Voter Registration Act
(NVRA)regulations originally promulgated by the Federal Election Commission to a new Code of Federal Regulations
(CFR)site for EAC; individual State requests to change State-specific instructions to the national voter registration form. The Commission will receive end of year report presentations: From the EAC Testing and Certification; Election Administration Support; and Research Divisions and the EAC Executive Director. The Commission will elect officers and consider other administrative matters. This meeting will be open to the public. PERSON TO CONTACT FOR INFORMATION: Bryan Whitener, Telephone:
(202)566-3100. Thomas R. Wilkey, Executive Director, U.S. Election Assistance Commission. [FR Doc. 07-5938 Filed 11-30-07; 1:41 pm]
Connectionstraces to 32
Traces to 32 documents
register
U.S. Code
- Federal Aviation Administration§ 106
- Definitions; generally§ 321
- Regulations§ 216
- Avoidance of duplicative or unnecessary analyses§ 605
- Establishment, functions, and activities§ 272
- Regulations for drawbridges§ 499
- Purposes§ 3501
- Definitions§ 601
- Definitions§ 2297h
- Administrative review of determinations§ 1675
- Advisory committee§ 7310
- Congressional findings and declaration of purposes and policy§ 1531
- Contracts for medical care for spouses and children: plans§ 1079
CFR
- May I address the unsafe condition in a way other than that set out in the airworthiness directive?§ 39.19
- Delegation of rulemaking authority.§ 1.05-1
- Legally enforceable procedures.§ 51.160
- New shipper reviews under section 751(a)(2)(B) of the Act; expedited reviews in countervailing duty proceedings.§ 351.214
- Assessment of antidumping and countervailing duties; provisional measures deposit cap; interest on certain overpayments and underpayments.§ 351.212
- Calculation of export price and constructed export price; reimbursement of antidumping and countervailing duties.§ 351.402
- Access to business proprietary information.§ 351.305
- Central Records Unit and Administrative Protective Order and Dockets Unit.§ 351.103
- Public, business proprietary, privileged, and classified information.§ 351.105
- Publishing notices in the Federal Register.§ 325.6
- Judicial review.§ 325.11
- Definitions.§ 325.2
- TRICARE Extended Care Health Option (ECHO).§ 199.5
- TRICARE---authorized providers.§ 199.6
22 references not yet in our index
- 14 CFR 39
- 21 CFR 820
- 5 USC 601-612
- Pub. L. 104-4
- 21 CFR 210
- 21 CFR 211
- 33 CFR 117
- Pub. L. 104-121
- 44 USC 3501-3520
- 2 USC 1531-1538
- 42 USC 4321-4370f
- 40 CFR 52
- 40 CFR 51
- Pub. L. 104-13
- Pub. L. 107-347
- Pub. L. 94-472
- 43 USC 2297h-10(b)
- 15 USC 4001-21
- 15 CFR 325
- 50 CFR 17.11
- Pub. L. 107-107
- 32 CFR 199
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cites case law
Proposed Rules
Notice of proposed rulemaking (NPRM)
Cite14 CFR 39
Cite21 CFR 820
Cite5 USC 601-612
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