Notices. Final rule
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/register/2007/04/09/07-1718·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 8025-01-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-27012; Directorate Identifier 2006-NM-188-AD; Amendment 39-15017; AD 2007-07-15] RIN 2120-AA64 Airworthiness Directives; Airbus Model A300 B4-601, A300 B4-603, A300 B4-605R, A300 C4-605R Variant F, A310-204, and A310-304 Airplanes Equipped With General Electric CF6-80C2 Engines AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT).
ACTION: Final rule. SUMMARY: The FAA is superseding an existing airworthiness directive (AD), which applies to certain Airbus Model A300 B4-600, B4-600R, C4-605R Variant F, and F4-600R (collectively called A300-600) series airplanes; and Model A310 series airplanes. That AD currently requires a one-time inspection for damage of the integrated drive generator
(IDG)electrical harness and pyramid arm, and repair if necessary. This new AD adds new repetitive inspections, which, when initiated, terminate the inspection required by the existing AD. This new AD also requires repairing damage and protecting the harness. This new AD also provides for optional terminating action for the repetitive inspections. This new AD also removes certain airplanes from the applicability of the existing AD. This AD results from a report of structural damage on the forward pyramid arm of an engine pylon due to chafing of the IDG electrical harness against the structure of the pyramid arm. We are issuing this AD to prevent electrical arcing in the engine pylon, which could result in loss of the relevant alternating current
(AC)bus bar, reduced structural integrity of the engine pylon, and possible loss of control of the airplane. DATES: This AD becomes effective May 14, 2007. The Director of the Federal Register approved the incorporation by reference of certain publications listed in the AD as of May 14, 2007. On May 13, 2004 (69 FR 23090, April 28, 2004), the Director of the Federal Register approved the incorporation by reference of Airbus All Operators Telex A310-54A2038, dated February 19, 2004; and Airbus All Operators Telex A300-54A6037, dated February 19, 2004. ADDRESSES: You may examine the AD docket on the Internet at *http://dms.dot.gov* or in person at the Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC. Contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France, for service information identified in this AD. FOR FURTHER INFORMATION CONTACT: Tom Stafford, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-1622; fax
(425)227-1149. SUPPLEMENTARY INFORMATION: Examining the Docket You may examine the airworthiness directive
(AD)docket on the Internet at *http://dms.dot.gov* or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone
(800)647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section. Discussion The FAA issued a notice of proposed rulemaking
(NPRM)to amend 14 CFR part 39 to include an AD that supersedes AD 2004-09-01, amendment 39-13590 (69 FR 23090, April 28, 2004). The existing AD applies to certain Airbus Model A300 B4-600, B4-600R, C4-605R Variant F, and F4-600R (collectively called A300-600) series airplanes; and Model A310 series airplanes. That NPRM was published in the **Federal Register** on January 26, 2007 (72 FR 3764). That NPRM proposed to require a one-time inspection for damage of the integrated drive generator
(IDG)electrical harness and pyramid arm, and repair if necessary. That NPRM proposed to add new repetitive inspections, which, when initiated, would terminate the inspection required by the existing AD. That NPRM also proposed to require repairing damage and protecting the harness. That NPRM also proposed to provide for optional terminating action for the repetitive inspections. That NPRM also proposed to remove certain airplanes from the applicability of the existing AD. Comments We provided the public the opportunity to participate in the development of this AD. No comments have been received on the NPRM or on the determination of the cost to the public. Change to Applicability We have removed Airbus Model A310-308 airplanes from the applicability of this AD. That model is not listed as an FAA-certified model in our type certificate data sheets. Conclusion We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD with the change described previously. We have determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD. Costs of Compliance The following table provides the estimated costs for U.S. operators to comply with this AD. Estimated Costs Action Work hours Average labor rate per hour Cost of parts Cost per airplane Number of U.S.- registered airplanes Fleet cost One-time inspection (from AD 2004-09-01) 2 $80 $0 $160 100 $16,000. Repetitive inspections and harness protection (new requirement) 4 80 0 $320, per inspection cycle 100 $32,000, per inspection cycle. New optional modification 8 80 2,460 $3,100 Up to 100 Up to $310,000. 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 AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD:
(1)Is not a “significant regulatory action” under Executive Order 12866;
(2)Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
(3)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this 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, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA amends 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 removing amendment 39-13590 (69 FR 23090, April 28, 2004) and by adding the following new airworthiness directive (AD): **2007-07-15 Airbus:** Amendment 39-15017. Docket No. FAA-2007-27012; Directorate Identifier 2006-NM-188-AD. Effective Date
(a)This AD becomes effective May 14, 2007. Affected ADs
(b)This AD supersedes AD 2004-09-01. Applicability
(c)This AD applies to Airbus Model A300 B4-601, A300 B4-603, A300 B4-605R, A300 C4-605R Variant F, A310-204, and A310-304 airplanes; certificated in any category; equipped with General Electric CF6-80C2 engines without full-authority digital electronic control (FADEC); excluding airplanes on which Airbus Modification 13184 was done in production. Unsafe Condition
(d)This AD results from a report of structural damage on the forward pyramid arm of an engine pylon due to chafing of the integrated drive generator
(IDG)electrical harness against the structure of the pyramid arm. We are issuing this AD to prevent electrical arcing in the engine pylon, which could result in loss of the relevant alternating current
(AC)bus bar, reduced structural integrity of the engine pylon, and possible loss of control of the airplane. Compliance
(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Restatement of Certain Requirements of AD 2004-09-01 All Operators Telex Reference
(f)The term “All Operators Telex,” or “AOT,” as used in paragraphs (g), (h), and
(j)of this AD, means the following AOTs, as applicable:
(1)For Model A300 B4-601, A300 B4-603, A300 B4-605R, and A300 C4-605R Variant F airplanes: Airbus AOT A300-54A6037, dated February 19, 2004; and
(2)For Model A310-204, and A310-304 airplanes: Airbus AOT A310-54A2038, dated February 19, 2004. Inspection
(g)At the applicable time in paragraph (g)(1) or (g)(2) of this AD, do a one-time detailed inspection for discrepancies of the IDG harness, harness bracket, retaining fasteners, and pyramid arm, in accordance with the applicable AOT.
(1)For airplanes on which Airbus Modification 07591 has not been incorporated as of May 13, 2004 (the effective date of AD 2004-09-01): Within 10 days after May 13, 2004.
(2)For airplanes on which Airbus Modification 07591 has been incorporated as of May 13, 2004: Within 600 flight hours after May 13, 2004. Note 1: For the purposes of this AD, a detailed inspection is defined as: “An intensive visual examination of a specific structural area, system, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at intensity deemed appropriate by the inspector. Inspection aids such as mirror, magnifying lenses, etc., may be used. Surface cleaning and elaborate access procedures may be required.” Related Investigative and Corrective Actions for Damaged Electrical Harness
(h)If any discrepancy in the IDG electrical harness, fretting at the convoluted conduits, or contact between the IDG electrical harness and the pyramid arms is found during the inspection required by paragraph
(g)of this AD: Before further flight, do the applicable related investigative actions and corrective actions in accordance with the applicable AOT. Corrective Action for Damaged Electrical Harness Bracket, Retaining Fasteners, or Pyramid Arm
(i)If any discrepancy in the electrical harness bracket, retaining fasteners, or pyramid arm is found during the inspection required by paragraph
(g)of this AD: Before further flight, repair in accordance with a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; the Direction Générale de l'Aviation Civile
(DGAC)(or its delegated agent); or the European Aviation Safety Agency
(EASA)(or its delegated agent). After the effective date of this AD, repair in accordance with a method approved by the FAA or the EASA. No Reporting Requirement for Paragraph
(g)of this AD
(j)Although the referenced AOTs describe procedures for submitting certain information to the manufacturer, no report is required for the inspection required by paragraph
(g)of this AD. New Requirements of this AD Repetitive Inspections
(k)Within 6 months after the effective date of this AD, and thereafter at intervals not to exceed 12 months: Do a detailed inspection for damage of the IDG harness and the pylon pyramid arms, and protect the harness. Do the actions in accordance with Airbus Service Bulletin A300-24-6097, dated March 3, 2006 (for Model A300 B4-601, A300 B4-603, A300 B4-605R, and A300 C4-605R Variant F airplanes); or A310-24-2100, dated March 3, 2006 (for Model A310-204, and A310-304 airplanes). The initial inspection terminates the requirements of paragraph
(g)of this AD. If any discrepancy is found: Before further flight, repair in accordance with the applicable service bulletin; except, where the service bulletin specifies to contact the manufacturer for repair instructions, this AD requires repair using a method approved by either the Manager, International Branch, ANM-116; or the EASA (or its delegated agent). Report
(l)At the applicable times specified in paragraphs (l)(1) and (l)(2) of this AD, submit a report of the findings (both positive and negative) of each inspection required by paragraph
(k)of this AD. Send the report to Airbus Customer Services Directorate, Department AI/SE-E43, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France. The report must include the information specified in Appendix 01 of Airbus Service Bulletin A300-24-6097 or A310-24-2100, both dated March 3, 2006, as applicable. Under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 *et seq* .), the Office of Management and Budget
(OMB)has approved the information collection requirements contained in this AD and has assigned OMB Control Number 2120-0056.
(1)For each inspection done after the effective date of this AD: Send the report within 30 days after the inspection.
(2)If an inspection was done before the effective date of this AD: Send the report within 30 days after the effective date of this AD. Optional Terminating Action
(m)Replacement of the bracket feeder on the pylons terminates the requirements of this AD if the bracket feeder is replaced in accordance with Airbus Service Bulletin A300-54-6038, dated May 12, 2006 (for Model A300 B4-601, A300 B4-603, A300 B4-605R, and A300 C4-605R Variant F airplanes); or A310-54-2039, dated May 12, 2006 (for Model A310-204, and A310-304 airplanes); as applicable. Alternative Methods of Compliance (AMOCs) (n)(1) The Manager, International Branch, ANM-116, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)Before using any AMOC approved in accordance with § 39.19 on any airplane to which the AMOC applies, notify the appropriate principal inspector in the FAA Flight Standards Certificate Holding District Office. Related Information
(o)EASA airworthiness directive 2006-0155, dated June 1, 2006, also addresses the subject of this AD. Material Incorporated by Reference
(p)You must use the service information identified in Table 1 of this AD to perform the actions that are required by this AD, unless the AD specifies otherwise. Table 1.—Required Material Incorporated by Reference Airbus Service information Date All Operators Telex A300-54A6037 February 19, 2004. All Operators Telex A310-54A2038 February 19, 2004. Service Bulletin A300-24-6097, including Appendix 01 March 3, 2006. Service Bulletin A310-24-2100, including Appendix 01 March 3, 2006. You must use the service information identified in Table 2 of this AD to perform the optional terminating action, if accomplished, unless the AD specifies otherwise. Table 2.—Optional Material Incorporated by Reference Airbus Service information Date Service Bulletin A300-54-6038 May 12, 2006. Service Bulletin A310-54-2039 May 12, 2006.
(1)The Director of the Federal Register approved the incorporation by reference of the service information identified in Table 3 of this AD in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Table 3.—New Material Incorporated by Reference Airbus Service Bulletin Date A300-24-6097, including Appendix 01 March 3, 2006. A300-54-6038 May 12, 2006. A310-24-2100, including Appendix 01 March 3, 2006. A310-54-2039 May 12, 2006.
(2)On May 13, 2004 (69 FR 23090, April 28, 2004), the Director of the Federal Register approved the incorporation by reference of Airbus All Operators Telex A310-54A2038, dated February 19, 2004; and Airbus All Operators Telex A300-54A6037, dated February 19, 2004.
(3)Contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France, for a copy of this service information. You may review copies at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal-register/cfr/ibr-locations.html.* Issued in Renton, Washington, on March 28, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-6450 Filed 4-6-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2005-20944; Directorate Identifier 2003-NE-64-AD; Amendment 39-15018; AD 2007-08-01] RIN 2120-AA64 Airworthiness Directives; General Electric Company CT7-5, -7, and -9 Series Turboprop Engines AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Final rule. SUMMARY: The FAA is superseding an existing airworthiness directive
(AD)for General Electric Company
(GE)CT7-5A2, -5A3, -7A, -7A1, -9B, -9B1, and -9B2, -9C, -9C3, -9D, and -9D2 turboprop engines, with certain part number (P/N) and serial number stage 2 turbine aft cooling plates installed. That AD currently requires a onetime eddy current inspection
(ECI)of boltholes in certain P/N stage 2 turbine aft cooling plates. This AD expands the population of affected CT7 turboprop engine models, but reduces the number of cooling plates affected. It also requires a onetime ECI of boltholes in certain P/N stage 2 turbine aft cooling plates with specific serial numbers. This AD results from the manufacturer expanding the list of affected engine models and identifying the affected stage 2 turbine aft cooling plates by serial number. We are issuing this AD to prevent separation of the stage 2 turbine aft cooling plate, resulting in uncontained engine failure and damage to the airplane. DATES: This AD becomes effective May 14, 2007. The Director of the Federal Register approved the incorporation by reference of certain publications listed in the regulations as of May 14, 2007. ADDRESSES: You can get the service information identified in this AD from General Electric Aircraft Engines CT7 Series Turboprop Engines, 1000 Western Ave, Lynn, MA 01910; telephone
(781)594-3140, fax
(781)594-4805. You may examine the AD docket on the Internet at *http://dms.dot.gov* or in Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC. FOR FURTHER INFORMATION CONTACT: Mark Bouyer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; telephone
(781)238-7755; fax
(781)238-7199. SUPPLEMENTARY INFORMATION: The FAA proposed to amend 14 CFR part 39 with a proposed AD. The proposed AD applies to GE CT7-5A2, -5A3, -7A, -7A1, -9B, -9B1, and -9B2 turboprop engines, with certain P/N and serial number stage 2 turbine aft cooling plates installed. We published the proposed AD in the **Federal Register** on March 31, 2006 (71 FR 16248). That action proposed to expand the population of affected CT7 turboprop engine models required to undergo a onetime ECI of boltholes in certain P/N stage 2 turbine aft cooling plates. That action also proposed to reduce the number of cooling plates affected by identifying the serial numbers. Examining the AD Docket You may examine the docket that contains the AD, any comments received, and any final disposition 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 on the plaza level of the Department of Transportation Nassif Building at the street address stated in ADDRESSES . Comments will be available in the AD docket shortly after the DMS receives them. Comments We provided the public the opportunity to participate in the development of this AD. We have considered the comments received. Clarification of ECI Requirements GE suggests that we clarify paragraph
(f)of this AD to limit the required ECI to stage 2 turbine aft cooling plates that are being returned to service. This change would eliminate any requirement to ECI cooling plates that are not going to be reused. We agree. If the cooling plate is not going to be reused, there is no need to ECI it immediately after it is removed. Paragraph
(h)of this AD requires an ECI of all cooling plates affected by this AD before they are returned to service. We made the clarification to paragraph (f). Clarification of Onetime Inspection GE proposes that we add a terminating action statement to clarify that the ECI is a onetime inspection and repetitive inspections of the stage 2 turbine aft cooling plate is unnecessary. We do not agree. This information is already included in paragraph (f), which specifies that the inspection is a onetime ECI. We did not change the AD. Question on Compliance Threshold of 6,000 Cycles-in-Service
(CIS)GE also questions whether the calculated compliance threshold of 6,000 CIS is viable given the amount of time required to publish the AD. We do not agree. The number of engine cycles that will accumulate during the AD review process will not change the safety assessment that is based on the calculated compliance time. We did not change the AD. Conclusion We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD. Costs of Compliance We estimate that this AD will affect 494 engines installed on airplanes of U.S. registry. We also estimate that it will take about 1 work-hour per engine to perform the actions, and that the average labor rate is $80 per work-hour. Based on the number of cracks found in the inspected engines, we estimate that 2.5 percent of the 494 engines will require replacing stage 2 turbine aft cooling plates because of rejection by the onetime ECI. Required parts will cost about $17,000 per engine. Based on these figures, we estimate the total cost of the AD to U.S. operators to be $243,520. 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 AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that this AD:
(1)Is not a “significant regulatory action” under Executive Order 12866;
(2)Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
(3)Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary at the address listed under ADDRESSES . List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. Adoption of the Amendment Accordingly, under the authority delegated to me by the Administrator, the Federal Aviation Administration amends 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 removing Amendment 39-14247 70 FR 54835, September 19, 2005, and by adding a new airworthiness directive, Amendment 39-15018, to read as follows: **2007-08-01 General Electric Company:** Amendment 39-15018. Docket No. FAA-2005-20944; Directorate Identifier 2003-NE-64-AD. Effective Date
(a)This airworthiness directive
(AD)becomes effective May 14, 2007. Affected ADs
(b)This AD supersedes AD 2005-18-01, Amendment 39-14247. Applicability
(c)This AD applies to General Electric Company
(GE)CT7-5A2/-5A3/-7A/-7A1/-9B/-9B1/-9B2/-9C/-9C3/-9D/-9D2 turboprop engines with stage 2 turbine aft cooling plates, part number (P/N) 6064T07P01, 6064T07P02, 6064T07P05, or 6068T36P01 installed. These engines are installed on, but not limited to, Construcciones Aeronauticas, SA CN-235 series and SAAB Aircraft AB SF340 series airplanes. Unsafe Condition
(d)This AD results from the manufacturer expanding the list of affected engine models and identifying the affected stage 2 turbine aft cooling plates by serial number. We are issuing this AD to prevent separation of the stage 2 turbine aft cooling plate, resulting in uncontained engine failure and damage to the airplane. Compliance
(e)You are responsible for having the actions required by this AD performed at the next engine or hot section module shop visit, but before accumulating an additional 6,000 cycles-in-service after the effective date of the AD, unless already done. Onetime Eddy Current Inspection
(f)Perform a onetime ECI of the stage 2 turbine aft cooling plates P/N 6064T07P01, 6064T07P02, 6064T07P05, or 6068T36P01, that are listed by serial number in Section 4, Appendix A, of GE Alert Service Bulletin
(ASB)No. CT7-TP S/B 72-A0464, Revision 04, dated December 12, 2005, and that will be returned to service. Use 3.B.(1) through 3.B.(3) of GE ASB No. CT7-TP S/B 72-A0464, Revision 4, dated December 12, 2005 to perform the inspection.
(g)For stage 2 turbine aft cooling plates that do not pass the Return to Service Criteria, do either of the following:
(1)Replace the stage 2 turbine aft cooling plate with a new cooling plate that has a serial number that is not listed in Section 4, Appendix A, of GE ASB No. CT7-TP S/B 72-A0464, Revision 04, dated December 12, 2005, or
(2)Replace the stage 2 turbine aft cooling plate with a cooling plate that meets the acceptance criteria of 3.B.(1) through 3.B.(3) of GE ASB No. CT7-TP S/B 72-A0464, Revision 4, dated December 12, 2005.
(h)After the effective date of this AD, do not install any stage 2 turbine aft cooling plates with serial numbers identified in Section 4, Appendix A, without inspecting the cooling plate as specified in 3.B.(1) through 3.B.(3) of GE ASB No. CT7-TP S/B 72-A0464 Revision 04, December 12, 2005. Previous Credit
(i)Eddy current inspections of the stage 2 turbine aft cooling plate boltholes done before the effective date of this AD that use GE ASB No. CT7-TP S/B 72-A0464, dated February 25, 2003; or Revision 1, dated March 12, 2003; or Revision 2, dated May 9, 2003; or Revision 3, dated July 23, 2004, comply with the requirements specified in this AD. Definition of Engine or Hot Section Module Shop Visit
(j)For the purposes of this AD, an engine or hot section module shop visit is defined as the introduction of the engine or hot section module into a shop that includes separating major case flanges. Alternative Methods of Compliance
(k)The Manager, Engine Certification Office, has the authority to approve alternative methods of compliance for this AD if requested using the procedures found in 14 CFR 39.19. Related Information
(l)Contact Mark Bouyer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; e-mail: *mark.bouyer@faa.gov* ; telephone
(781)238-7755; fax
(781)238-7199, for more information about this AD. Material Incorporated by Reference
(m)You must use General Electric Alert Service Bulletin No. CT7-TP S/B 72-A0464, Revision 04, dated December 12, 2005, to perform the actions required by this AD. The Director of the Federal Register approved the incorporation by reference of this service bulletin in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Contact General Electric Aircraft Engines CT7 Series Turboprop Engines, 1000 Western Ave, Lynn, MA 01910; telephone
(781)594-3140; fax
(781)594-4805 for a copy of this service information. You may review copies at the FAA, New England Region, Office of the Regional Counsel, 12 New England Executive Park, Burlington, MA; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal-register/cfr/ibr-locations.html.* Issued in Burlington, Massachusetts, on April 2, 2007. Peter A. White, Acting Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. E7-6446 Filed 4-6-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Office of the Secretary 14 CFR Part 331 [Docket OST-2006-25906] RIN 2105-AD61 Procedures for Reimbursement of General Aviation Operators and Service Providers in the Washington, DC Area AGENCY: Office of the Secretary, DOT. ACTION: Final rule. SUMMARY: This rule provides reimbursement to fixed-base general aviation operators and providers of general aviation ground support services at five metropolitan Washington, DC area airports, for the direct and incremental financial losses they incurred while the airports were closed due to Federal government actions taken after the terrorist attacks on September 11, 2001. The airports are: Ronald Reagan Washington National Airport; College Park Airport in College Park, Maryland; Potomac Airfield in Fort Washington, Maryland; Washington Executive/Hyde Field in Clinton, Maryland; and Washington South Capitol Street Heliport in Washington, DC. DATES: This rule is effective May 9, 2007. FOR FURTHER INFORMATION CONTACT: Interested persons with questions about this regulation should contact James R. Dann, U.S. Department of Transportation, Office of General Counsel, 400 7th Street, SW., Room 10102, Washington, DC 20590; telephone 202-366-9154. Interested persons with questions about how to apply for assistance, the status of application reviews, etc. should contact Tim Carmody, U.S. Department of Transportation, Office of Aviation Analysis, 400 7th Street, SW., Room 6417, Washington, DC 20590; telephone 202-366-2348. Application materials and data sources that may assist applicants in preparing applications are available at the Department of Transportation, Office of the Secretary's Web site at *http://ostpxweb.dot.gov/aviation/index.html* under “Programs,” and then “General Aviation Operator and Services Reimbursement: Procedures for Reimbursement of General Aviation Operators and Service Providers in the Washington, DC Area.” SUPPLEMENTARY INFORMATION: Following the terrorist attacks on the United States on September 11, 2001, general aviation activity in the Washington, DC metropolitan area was suspended. Five airports were most affected: Ronald Reagan Washington National Airport (DCA); College Park Airport in College Park, Maryland; Potomac Airfield in Fort Washington, Maryland; Washington Executive/Hyde Field in Clinton, Maryland; and Washington South Capitol Street Heliport in Washington, DC. While DCA and the three Maryland airports have since been reopened to transient general aviation traffic, the volume of general aviation activity has not returned to pre-September 11, 2001 levels due to continuing security restrictions, and the South Capitol Street Heliport was not reopened to general aviation traffic and is now used exclusively by the Washington DC Metropolitan Police. Because of the reduction in general aviation activity at these locations, the fixed-base operators and service providers that supported general aviation were also affected, with many claiming that they were incurring sustained and significant financial losses due to the closures. These fixed-base operators and service providers were not eligible for either compensation or loan guarantees under the Air Transportation Safety and System Stabilization Act, Pub. L. 107-42 (Sept. 22, 2001), which had been enacted to provide compensation to “air carriers” who had incurred financial losses due to the terrorist attacks. Under that program, approximately $4.6 billion has been paid to qualifying air carriers. In 2003, the United States House of Representatives Committee on Appropriations requested that the Department of Transportation
(DOT)prepare a report detailing the documented financial losses by holders of real property leases at the five affected airports that were attributable to the Federal actions since September 11, 2001. (House Report 108-243, July 30, 2003, p. 8.) The Committee stated that such a report would assist the Congress in considering “potential federal reimbursement for a portion of these unusual financial losses.” In October 2005, the Secretary of Transportation submitted to the Committee the requested report, which was entitled: *Estimated Financial Losses to Selected General Aviation Entities in the Washington, DC Area Final Report* (October 2005 DOT study). A copy of this Report has been placed onto the Office of the Secretary's Web site, at the address noted above. (See For Further Information Contact ). The October 2005 DOT study identified sixteen general aviation leaseholders at the five airports, and estimated the financial losses that each incurred during its study period (which ran from September 11, 2001 to January 23, 2004) due to the Federal actions taken after the terrorist attacks. The estimates reflected the difference in net income stated on a pre-tax basis between what the companies projected for the study period and the actual pre-tax net income for that period, and included both losses in pre-tax net income and one-time costs attributable directly to compliance with new restrictions or regulations resulting from the terrorist attacks. In formulating its estimates, the Department's consultant relied primarily on voluntary information provided by each entity, and while interviews were conducted to confirm the general reasonableness and consistency of the numbers provided, no independent analysis, audit or certification was conducted. Therefore, the October 2005 DOT study advised that these estimates were merely preliminary and meant solely to inform Congress in determining whether and in what amount to appropriate funds to reimburse these general aviation entities. The October 2005 DOT study also indicated that, if compensation were to be made available, “the financial data establishing the basis for any payment, especially forecast revenue, cost and net income, should * * * be subject to a more rigorous verification regime.” ( *Estimated Financial Losses to Selected General Aviation Entities in the Washington, DC Area Final Report, at fn. 3.* ) The total estimated financial losses for the period reviewed were $10,443,936, with more than half of that amount being reported for one firm, Signature Flight Support. The estimates were in current dollars and reflected no consideration for the time value of money. On November 30, 2005, the Transportation, Treasury, Housing and Urban Development, the Judiciary, the District of Columbia, and Independent Agencies Appropriation Act, 2006, became law. Section 185 of the Act provides for the reimbursement of “fixed-base general aviation operators and the providers of general aviation ground support services” at the five cited airports for the “direct and incremental financial losses incurred while such airports were closed to general aviation operations, or as of the date of enactment of this provision in the case of airports that have not reopened to such operations, by these operators and service providers solely due to actions of the Federal government following the terrorist attacks on the United States that occurred on September 11, 2001.” The Act provides up to $17 million to reimburse these general aviation entities; however, it states that, of the $17 million provided, an amount not to exceed $5 million, if necessary, is to be available on a pro rata basis to fixed-base general aviation operators and the providers of general aviation ground support services located at the three Maryland airports: College Park Airport in College Park, Maryland; Potomac Airfield in Fort Washington, Maryland; and Washington Executive/Hyde Field in Clinton, Maryland. Section 185 further states that the appropriated funds included the cost of “an independent verification regime”; that no funds shall be obligated or distributed to such general aviation entities until an independent audit is completed; that losses incurred as the result of violations of law, or through fault or negligence of such entities or of third parties (including airports) are not eligible for reimbursement; and that the obligation and expenditure of funds are conditional upon full release of the United States Government for all claims for financial losses resulting from such actions. On October 4, 2006, the Department published in the **Federal Register** a Notice of Proposed Rulemaking
(NPRM)in order to implement this Act (71 FR 58546 *et seq.* ). There, the Department proposed definitions of various terms found in the Act; the eligibility requirements for applicants; the methodology for determining the losses to be reimbursed, including the forms by which applications would be made; the time periods at each airport for which reimbursement of losses would be made; the procedures for verifying and auditing claims; and various other matters. The Department invited comments on its proposals, and 16 responsive comments were received. Below, we summarize the comments that we received and describe our response to those comments, including, where appropriate, the modifications we are making based upon those comments. Eligibility of Airports Per Se To Apply for Reimbursement One commenter, a small airport, contended that airports should be eligible for reimbursement for their losses under the Rule, because they “provide leaseholds to those who operate, service, and otherwise support general aviation aircraft,” and simply by doing so provide “general aviation ground support services.” *DOT Response:* DOT believes that Section 185 should not be read, and was not meant to be read, to include airports *per se* as “providers of general aviation ground support services” eligible for reimbursement under this program. First, providing a facility that others may use for general aviation support is not the same as itself providing “services” to general aviation, and the latter formulation represents an interpretation that is more faithful to the language Congress actually used. Second, Congress clearly knows what an “airport” is, and if it intended that airports “as airports” be reimbursed for losses it surely would have plainly provided for that in Section 185, rather than using the less direct “providers of general aviation services” language it chose. Finally, Congress, DOT, and other public authorities have used other vehicles to provide financial assistance to airports to reflect increased security and other requirements after the September 11 terrorist attacks, under which we understand various airports here recovered at least some elements of their added costs. The history of this legislation indicates that it was designed to assist those general aviation entities who were not eligible under other programs to recover their losses after 9/11. Of course, if an airport here can show that it served as a fixed-base operator, or provider of general aviation ground support services as those terms are defined in Section 331.3 of the Rule, then it would qualify in that capacity for reimbursement under this program. Eligibility of General Aviation Entities That Did Not Operate at One of the Five Airports on September 11, 2001 Glenwood Aviation, a leaseholder and fixed-base general aviation operator at the South Capitol Street Heliport who initiated operations there after the September 11 attacks (specifically, on October 1, 2002), expressed concern that certain language in the NPRM preamble, proposed rule, and application forms could be construed as precluding it from qualifying for reimbursement. DOT's language causing this concern generally referenced eligible applicants as limited to those that had operations at one or more of the five airports on September 11, 2001. The commenter stated that, in fact, Section 185 imposes no such restriction, and should be read more broadly to include the commenter within the class eligible for reimbursement. *DOT Response:* The relevant language of Section 185 appropriates funds to reimburse general aviation operators and the providers of general aviation ground support services “at” the five airports for direct and incremental financial losses, incurred while the airports were closed solely due to the actions of the Federal government after the terrorist attacks of September 11, 2001. Thus, the commenter is correct in asserting that the legislative language does not limit general aviation entities eligible for reimbursement to those operating at one or more of the airports on September 11, 2001. The commenter does not disclose, in its comment, how it became the fixed-base operator at South Capitol Street, and in particular, whether it has any contractual relationship with its predecessor, Air Pegasus. Air Pegasus abandoned its lease to operate at that facility on September 30, 2002, and Glenwood Aviation states that it began its operations on October 1, 2002, the following day. If Glenwood is simply asserting rights to reimbursement based on an assignment of these rights to it by Air Pegasus, the Department would consider its application so long as there is a full disclosure of this basis for doing so, the necessary information from Air Pegasus was supplied, and copies of the contractual documents are attached. However, if the commenter's theory of recovery is not as an assignee, there is a further issue: Section 185 limits reimbursement to those losses that were incurred “solely due to the actions of the Federal government *following the terrorist attacks on the United States that occurred on September 11, 2001”* (emphasis supplied). On October 1, 2002, when the commenter began its operations at South Capitol Street, the Federal government had already taken its actions to close that facility to general aviation operations. The commenter knew or had constructive knowledge of that closure, and presumptively assumed the risk when it negotiated the lease and began its operations that security or other considerations could require that the facility remain closed for some time, and perhaps never be reopened at all. Further, the status and uncertain future of the heliport should have permitted one then negotiating for a lease to obtain terms reflecting this risk-laden situation. Thus, in these instances, the notion that a “loss” was incurred “solely” due to actions taken by the Federal government following the attacks—and not due at least in part to miscalculation of risk or failure to adequately provide for it—is difficult to envision. Nonetheless, because the statute itself does not foreclose reimbursement to applicants that were not operating at one of the airports on September 11, we will not foreclose reimbursement to this or other similarly-situated parties without affording them an opportunity to demonstrate, to DOT's satisfaction, that they can meet the other requirements of the statute and regulation. To meet those requirements, they would still need to supply an actual or, if none exists, a reasonable forecast showing post-9/11 business expectations absent the actions of the Federal government following the September 11 terrorist attacks, and show further that any claimed losses were solely due to those actions. DOT will therefore modify § 331.5 to read as follows: “If you are or were a fixed-base general aviation operator or provider of general aviation ground support services (collectively “operators or providers”) at an eligible airport or airports in the Washington, DC area, and incurred direct or incremental losses during the applicable reimbursement periods stated at § 331.13 that were solely due to the actions of the Federal government following the terrorist attacks on the United States on September 11, 2001, you may apply for reimbursement under this part * * *. ” DOT will also modify the application form item 3 on Appendix A to read “At which of the following airports did the applicant operate as a fixed-base operator or provider of general aviation ground support services during the eligible period for reimbursement?” These modifications do not reflect any change to the reimbursement methodology that will be employed, or to the showing of loss and sole cause for loss that will be necessary to have an application approved. Reimbursement Methodology A number of commenters raised concerns about the inclusiveness of the rule's methodology for determining the eligibility of losses. They maintained that losses due to foreclosure on homes, loss in value of real property, the adverse effect on their credit, fixed expenses, required maintenance, the cost of loans, personal savings invested in the business, and debts and wages that had gone unpaid should constitute eligible losses for which there would be reimbursement. Several also indicated that DOT's “lost profits” approach failed to recognize that some GA entities were small businesses, which tended to reinvest in the business rather than “take profits.” *DOT Response:* As background, the reimbursement methodology proposed by DOT in the NPRM relied on an applicant's forecast of revenues and expenses had the 9/11 attacks not occurred, which would then be compared with the actual revenues and expenses that occurred for the period of eligibility. As proposed, the claimant would generally be reimbursed for the difference in forecast revenues and expenses and actual revenues and expenses for the period. Some of the loss items asked about by commenters would be addressed within this reimbursement scheme. For example, their forecasts would presumably itemize their projected “fixed expenses,” “maintenance,” “wages,” etc., and their actual expenses for those same items over the reimbursement period would be tallied. However, personal (as opposed to business) losses are not compensable under Section 185, nor can DOT reimburse for speculative losses or for losses that were not fully borne, in the normal course of business, during the allowable eligibility period. As to debt and equity investment represented by loans and use of personal funds, these would normally be reported as “debt and equity investment” on the balance sheet of the business as offsets to increased cash in compliance with accounting principles. The reimbursement methodology proposed by DOT would permit carrying the interest on the loan as a non-operating business expense on the income statement. This expense, along with other non-operating expenses and operating expenses would be, in essence, subtracted from forecast revenues to produce an adjusted income, to be compared against forecast income in determining the amount of any loss. Funds “reinvested” back into a company constitute an investment that would be carried as additional capital invested (an increase in equity), or retained earnings, on the balance sheet. These retained earnings or additional invested capital increase the value of the firm that inures to the benefit of equity holders on a continuing basis, and so would not be reimbursed as a loss within the proposed methodology. DOT believes its methodology for determining loss is appropriately comprehensive and fully satisfies the intent of Congress. We therefore are not proposing any modifications to it as a result of the comment process. Tax Treatment Issues One commenter questioned whether the intent of the legislation is to reimburse for damages rather than replacement of income, in which case the Rule should specify that any reimbursements should be tax-free. Another commenter urged that the Department's reference to net income be clarified to specify income before taxes, and that any other calculations of amount should be based on income before tax. *DOT Response:* DOT does not view the language or intent of the legislation as providing reimbursement for damages, and disagrees that payments under the reimbursement program should be tax-free. DOT agrees with the second comment, viewing Section 185 as providing for reimbursement of losses through payments that essentially serve as replacement revenues to offset the losses incurred while the airports were closed due to Federal government actions. These replacement revenues, like normal business revenues, would be subject to taxes. Since the reimbursements granted here would be subject to taxation, they should not be calculated on the basis of taxes that have already been paid. For clarification, we are therefore revising § 331.7 to change four references to “net income” to read “net income before taxes” instead, and, in the application form, modifying the reimbursement claim form by using the term “adjusted income,” which reflects the net of operating revenues and expenses and certain prescribed non-operating expenses and revenues upon which taxes are calculated. Mitigation of Losses One commenter, who had been able to recapture some losses by moving operations to another, non-impacted airport, argued that “although it is possible to estimate, it would be complex and somewhat judgmental for [it] to attempt to measure secondary effects at other locations, not reflected in any financial documents, that may be attributable in part to the closure by the government of operations at DCA and to determine how this may or may not have affected [its] DCA's losses.” It further asserted that, as a company with operations around the world, it engaged in many aviation and non-aviation income-producing activities before and after September 11, 2001, which have no relationship with the shutdown of DCA and should not be a factor relating to its reimbursement. *DOT Response:* DOT is proposing no change to the Rule in this regard. If an applicant was able to derive increased profits at another airport or airports as a result of diversion of traffic due to closure of one or more of the eligible airports, then those increases should serve to offset its reimbursable losses. While quantifying that offset amount may be “complex and somewhat judgmental,” the commenter conceded that it was possible to estimate, and DOT staff and, if necessary, an independent audit can help to ensure that an appropriate adjustment is made. If a narrower methodology were adopted, focusing only on an entity's revenues and expenses associated with an eligible airport and ignoring the fact that some operations had migrated to another airport and produced income there, it could produce a windfall profit for the entity that DOT believes was not intended by Congress. Time Value of Money The intent of Congress was to reimburse eligible claimants for “the direct and incremental financial losses incurred.” In the NPRM, we proposed that applicants would report forecasted net income for the applicable reimbursement period and actual net income earned for that period. We explicitly excluded from the reimbursement the time value of money through the payment of interest on lost profits for the period of time the funds were available for use, tentatively determining that, as a legal matter, the Department is precluded from payment of interest under the circumstances present here. *See, e.g., United States* v. *Alcea Bank of Tillamooks,* 341 U.S. 48, 49 (1951). While several commentators asserted that interest should be reimbursable in the context of compensation paid pursuant to a governmental taking, such as the closure of airports, we do not believe that this comparison is valid. As noted below, the analogy to a governmental taking is inapt. A closer analogy is to the compensation paid under the Air Transportation Safety and System Stabilization Act, Pub. Law 107-42. That compensation, which was distributed in up to three tranches over time, did not include interest payments in any of the three distributions, including payments made even into 2004 and 2005. While the time period for applicants under Section 185 does differ from the time periods for applicants under the Stabilization Act, we believe that the payment of interest should be excluded here as it was there. One commenter asserted that, however the Department must treat interest, “time value of money” represents a different concept and may and should be paid. In its view, the time value of money reflects the erosion in the value of money due to inflation, as well as the fact that funds available for use today can be put to productive use that will increase returns in the future. However, the erosion in the value of money is compensated for by paying interest, and, as explained, DOT is precluded by law from paying interest. However, as to lost capital earnings, the reimbursement calculus does permit an applicant to receive compensation if it can successfully demonstrate that its forecast showed a likely increase in net income that was planned for further investment at a reasonable rate, which increase and investment did not occur due to Federal government actions after September 11. In doing so, applicants must provide suitable supporting documentation for their specific claims because it would be highly speculative to hypothesize as to how earnings would have been reinvested and how those investments would fare, especially in the volatile economic climate after September 11. DOT will not simply provide a generalized “time value” percentage to all claims, which would effectively be a payment in lieu of interest. Fifth Amendment Taking A large fixed-base operator argued that reimbursement under this program should follow just compensation principles of the Fifth Amendment, specifically in the payment of interest. This commenter asserted that the intent of Section 185 was to reimburse claimants for the effective taking of their property, in accordance with the Fifth Amendment to the Constitution. *DOT Response:* DOT has not used a Fifth Amendment takings approach in proposing its methodology for reimbursing eligible GA entities. This action is consistent with and follows from the decision of the United States Court of Appeals for the Federal Circuit, in *Air Pegasus of DC, Inc.* v. *United States* , 424 F. 3d 1206 (2005). In affirming a decision by the United States Court of Federal Claims, the Federal Circuit there found that the Federal regulations restricting aviation activity in the District of Columbia area did not effect a taking of the private property of Air Pegasus, a lessee of real property at the South Capitol Street Heliport. Fifth Amendment takings precedents are thus not applicable to our Rulemaking here. Lobbying Expenses One commenter questioned the NPRM's general preclusion of legal and lobbying expenses as eligible for reimbursement. The commenter argued that general lobbying and legal expenses are reasonable expenses, and a necessary cost of doing business. However, it allowed that lobbying expenses specifically incurred in an effort to “obtain funding for the shutdown” may be excluded by law. *DOT Response:* The Department believes this comment has merit, and accordingly will modify § 331.7(g) of the Rule to read: “Lobbying and attorneys” fees incurred to promote reimbursement for losses resulting from the terrorist attacks or enact Section 185 of Pub. L. 109-115 are not eligible for reimbursement.” The Department will also modify § 331.21(i) of the Rule to change “lobbying expenses” to “lobbying expenses incurred to promote reimbursement for losses resulting from the terrorist attacks or enact Section 185 of Pub. L. 109-115.” Eligible Reimbursement Period Section 185 provides reimbursement for losses incurred while the five airports “were closed to general aviation operations, or [up to] the date of enactment of this provision [i.e., November 30, 2005] in the case of airports that have not reopened to such operations. * * * ” Only one airport, the South Capitol Street Heliport, remained closed to general aviation traffic through November 30, 2005. The other four airports were reopened to general aviation in stages:
(1)First, after September 11, 2001, but only via special waiver,
(2)then, opened to limited general aviation operations for based aircraft,
(3)and then, opened to include transient traffic. Due to continuing security restrictions, in no case has general aviation activity reached the same level as it had before September 11, 2001. Because the statute speaks in terms of binary “closed” and “reopened” airports, admitting of no intermediate stages, the issue arises as to what point during the reopening process the airports ceased to be “closed” and should be considered “reopened” for purposes of determining the ending date for any reimbursement payments. The NPRM addressed the issue at length. It proposed that the airports be considered reopened for purposes of the statute as of the date that transient traffic was permitted back. Under that proposal, the ending date for eligibility for reimbursement at Ronald Reagan Washington National Airport would be October 18, 2005; for College Park, Potomac, and Washington Executive/Hyde Field would be February 13, 2005; and for the South Capitol Street Heliport, since it was never reopened to transient general aviation traffic, the date of enactment of the Act, or November 30, 2005. Three commenters with interests at one of the Maryland airports, and one national association on behalf of Ronald Reagan Washington National Airport, argued that general aviation activity at these airports remains subject to security restrictions and that the airports are not operating at their pre-9/11 levels. While not contesting the fact that the four airports allow transient traffic to land, these commenters urged that the eligibility period be extended to the latest possible ending date in recognition of the fact general aviation aircraft do not have the same practical access to these airports as they did before September 11, 2001. *DOT Response:* DOT agrees that the levels of general aviation activity at none of the five airports have returned to those experienced prior to September 11, 2001. However, it is clear that, aside from the South Capitol Street heliport, the airports are no longer closed to general aviation traffic and have reopened to some degree; the question is whether they have “reopened” in the sense that Congress provided in the Act. The commenters did not address the Department's reasoning, in the NPRM, that Congress must not have considered all five airports to be “closed” at the time it passed the statute. Had it done so, Congress would have simply provided for reimbursement through the date of enactment of the Act for each of the airports, and not provided for a case-by-case determination as to when each “reopened.” Congress of course was aware of the continuing security requirements and operational restrictions at the airports, and nothing in relevant legislative history indicates any basis other than airport “reopening” as the point at which eligibility for reimbursement was to terminate. The Department believes that the interpretation it proposed in the NPRM is the one most consistent with the Act's language, and provides for a reasonably generous and consistent treatment among the airports. As a result, we have not modified the ending dates for the reimbursement periods in this Final Rule. Hyde Field Closure A number of commenters having their businesses or interests at Hyde Field argued that excluding any reimbursements for the period that airport was closed for the second time due to a security violation is not in keeping with the intent of the legislation and would create an undue hardship for them. Typically, they further asserted that they were not responsible for any violations, that the closure was for a minor security violation that should have taken but a few days to resolve, and that the length of the closure was due to government delay. *DOT Response:* Section 185 states, “That losses incurred as a result of violations of law, or through fault or negligence, of such operators and service providers or of third parties (including airports) are not eligible for reimbursements.” While the commenters may be correct that they themselves may not have been at fault or otherwise responsible for the security violation that closed the airport, neither was the United States, and the statute authorizes reimbursement only for losses that were “ *solely* due to the actions of the Federal government following the terrorist attacks on the United States that occurred on September 11, 2001.” Moreover, the exclusionary language is directed at a situation like the one at Hyde Field, and the legislative intent is clear that reimbursements not be available if the losses were proximately caused by third parties and not the United States. As a consequence, the Department determines that Hyde Field and its general aviation service providers will not be eligible for reimbursement during the period that the airport was closed as a result of violations of the law. Washington, DC Air Defense Identification Zone
(ADIZ)One comment raised concerns about the economic impact of the Washington, DC Air Defense Zone
(ADIZ)on other airports and businesses in the Washington, DC metropolitan area. The comment further proposed that the ADIZ should be rescinded or modified to reduce the economic impact on airports. *DOT Response:* Any losses that are not covered by Section 185 of the 2006 Appropriations Act are outside the scope of this rule and compensation for such losses is beyond the authority of the Department. Modifications to the ADIZ, the flight restrictions and maintenance of the ADIZ security zone are also not within the scope of this Rule. Independent Audit Costs The NPRM preamble stated that “larger claims, and any questioned claims, would be subject to audit,” and that the Department is “proposing to retain the flexibility to recover the costs of the audit from the amount of reimbursement.” While the NPRM did not go on to explain the reasoning behind the latter proposal, it was intended to provide an incentive for applicants to resolve their reimbursement claims short of an audit. It would also prevent audit costs from always being spread as overhead across the entire program, which could unfairly reduce reimbursements on a pro rata basis for small entities whose applications did not give rise to any issues on review. One commenter, a large entity, asserted that the large size of a claim should not dictate that it must be audited, and that audits should only occur where claims are unresolved after DOT consultation. It also argued that Section 185 provides funding for both audits and reimbursement of all eligible losses up to the $17 million ceiling. Thus, in its view, “Full reimbursement should be made for any accepted claim unless all the funds available have been expended and the Department has no choice but to reimburse an applicant for less than its accepted claim for losses.” Several other commenters asserted that Section 185 does not provide for any reductions in reimbursement for audit costs, one adding that the costs of an audit can be substantial, and if this offset principle were effectuated it could swallow up the entire amount of a claim. *DOT Response:* While larger claims are more likely to involve significant issues and to require an audit, the decision to audit a claim will be based on the Department's evaluation of the completeness and reasonableness of a claimant's entire application. While DOT has the flexibility to offset the cost of an audit against the reimbursement amount, it will do so only when reimbursements would need to be reduced because ceiling amounts have been reached, and where the reason for the audit involved questioned amounts that could not be resolved informally. Moreover, the maximum offset would be one-third of the total audit cost incurred by the Department. A reduction by one-third is considered sufficient to achieve the aims of dissuading unsupported claims and encouraging cooperation during the resolution process. It is, of course, entirely possible that an audit would sustain the full amount of an applicant's claim, in which case the claim would be paid in full (subject of course to the overall $17 million ceiling). Only applicants whose claims are not supported by audits would have their verified reimbursement allocations reduced, by a maximum of one-third of their total Departmental audit costs. Reimbursement for Professional Fees Used in the Application Process A trade association argued that fees for professional service used in the application process for reimbursement should be eligible for repayment by the Federal government. The association stated that many of the applicants are small businesses that do not have the resources to outsource attorney or accountant services to assist in the application process, and that the application process required activities that would not be necessary absent the events of September 11 and the subsequent airport closures. *DOT Response:* Upon review, DOT agrees that the application process would benefit, overall, if claimants were able to utilize the services of professionals familiar with accounting standards and rules in submitting their applications. Particularly where applicants are subject to audit and, potentially, to have to pay the costs of that audit if any part of their claim is rejected, DOT believes they should have professionals available to them to help ensure that their applications comply with generally accepted accounting standards and thereby meet the Department's requirements. Accordingly, we are amending the application form to include a separate line item for professional accounting services required in the submission of the application, which DOT may reimburse at 80%. (A sharing of cost will reduce the prospect for the provision of unnecessary services.) No reimbursements will be made for more general accounting or other legal or professional services, and all claims will be subject to a review for reasonableness. Invoices for services rendered must be attached to the application form to allow for prompt determinations to be made on allowability. The reimbursement would also be capped at a maximum amount of $2,000, which should be more than sufficient in at least the great majority of cases for an accountant to provide the services needed. Submission Period Several commenters requested an extension of our proposed submission deadline of 30 calendar days from the effective date of the Final Rule. Two suggested a minimum submission period of 90 days. We recognize that some small claimants may need additional time to compile their supporting data; however, consideration of giving extra time must also factor in other concerns that potential applicants are interested in receiving their reimbursement as soon as possible. On this point, a trade association had complained that DOT had already taken considerable time to publish the NPRM, and called for the remainder of the process to be “clear, concise, and timely.” In order to balance these competing concerns, and also to provide sufficient time for accounting professionals to assist applicants, we are establishing a submission period of 60 calendar days from the effective date of the final rule. We believe that this extension will benefit potential applicants that require additional time without burdening all applications with 90-day waits. Funds Available if Set-Aside Reimbursements Underrun $5 Million Section 185 requires at least $5 million to be set aside for claims originating from College Park Airport, Potomac Airpark, and Washington Executive/Hyde Field. One commenter requested that DOT clarify what it will do with any funds remaining after all claims are processed from these three airports. *DOT Response:* Under the statutory language, after the claims from these designated airports are processed, if there are any funds remaining from the $5 million set-aside, then that money will be available to reimburse valid claims originating from other airports. To clarify this point in the Rule, DOT will add a Section 331.37, to read as follows: § 331.37. What will happen to any remaining funds if operators and providers at the three Maryland airports make reimbursable claims totaling less than $5 million? If the operators and providers who are eligible for the $5 million set-aside do not exhaust the funds designated under the set-aside, then any remaining money from the set-aside will be made available for other valid claims made under this Part. Assistance Available During the Application Process A trade association commented that many of the applicants eligible for reimbursement are small businesses and do not regularly develop full financial statements and forecasts. The association therefore requested that Departmental staff be flexible and provide as much assistance as possible to the applicants that need help. *DOT Response:* As discussed above, DOT will provide fee reimbursements, to a limited degree, to enable small businesses to obtain professional assistance in preparing their applications. We have also posted other potentially useful information on DOT's Web site. DOT personnel will, to the extent resources permit, answer general questions and provide information on such matters as reimbursement eligibility and processing status. However, DOT staff will not be able to assist in the actual preparation of the applications, or provide tax or accounting advice or interpretations. Regulatory Analyses and Notices Executive Order 12866 and DOT Regulatory Policies and Procedures This rule is nonsignificant for purposes of Executive Order 12866 and the Department of Transportation's Regulatory Policies and Procedures. The rule establishes procedures to provide reimbursement to eligible applicants from funds appropriated by Congress. The Department administers a number of programs entailing similar procedures. This rule therefore does not represent a significant departure from existing regulations and policy. Furthermore, once implemented, this rule would have only minimal cost impacts on regulated parties. Federalism This rule does not directly affect the States, the relationship between the national government and the States, or the distribution of power among the national government and the States, such that consultation with the States and local governments is required under Executive Order 13132. Regulatory Flexibility Act The Department certifies that this rule would not have significant economic effects on a substantial number of small entities. Many of the applicants for reimbursements are likely to be small entities. However, the overall benefits to be provided to applicants are modest in size and application costs themselves are likely to be low. In the aggregate, the cost among all applicants for gathering information and submitting an application should range from $2,501 to $5,003. Paperwork Reduction Act This rule contains information collection requirements subject to the Paperwork Reduction Act of 1995, specifically the application documents that fixed-base general aviation operators and providers of general aviation ground support services must submit to the Department to obtain compensation. The title, description, and respondent description of the information collections are shown below as well as an estimate of the annual recordkeeping and periodic reporting burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. *Title:* Procedures (and Form) for Reimbursement of General Aviation Operators and Service Providers in Washington, DC Area. *Need for Information:* The information is required to administer the requirements of the Act. *Use of Information:* The Department of Transportation will use the data submitted by the fixed-base general aviation operators and providers of general aviation ground support services to determine their reimbursement for direct and incremental financial losses incurred while the airports were closed due to Federal government actions taken after the terrorist attacks on September 11, 2001. *Frequency:* For this final rule, the Department will collect the information once from fixed-base general aviation operators and providers of general aviation ground support services. *Respondents:* The respondents include an estimated 24 fixed-base general aviation operators and providers of general aviation ground support service. This estimate is based on the number of fixed-base general aviation operators and providers of general aviation ground support services identified in the October 2005 DOT study. *Burden Estimate:* Total applicant burden of between $2,501 and $5,003 based on a burden of between three
(3)and six
(6)hours per applicant and a weighted average cost per hour of $34.74. *Form(s):* The data will be collected on the Form entitled, “Application Form for Reimbursement Under Section 185 of Public Law 109-115,” and referenced in this part. *Average Burden Hours per Respondent:* A weighted average of four
(4)hours per application. The Department has requested approval from the Office of Management and Budget for this information collection. Other Statutes and Executive Orders There are a number of other statutes and Executive Orders that apply to the rulemaking process that the Department must consider in all rulemakings, but which the Department has determined are not sufficiently implicated by this rule to require further action. Specifically, this rule does not impact the human environment under the National Environmental Policy Act, does not concern constitutionally protected property rights such that Executive Order 12630 is implicated, does not involve policies with tribal implications such that Executive Order 13175 is invoked, does not concern civil justice reform under Executive Order 12988, does not involve the protection of children from environmental risks under Executive Order 13045, and will not result in expenditures by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. List of Subjects in 14 CFR Part 331 Air Transportation, Airports, Airspace, Claims, Grant programs, Reporting and recordkeeping requirements. Issued this 28th day of March, 2007, at Washington DC. Mary E. Peters, Secretary of Transportation. For the reasons set forth in the preamble, the Department adds 14 CFR part 331 to read as follows: PART 331—PROCEDURES FOR REIMBURSEMENT OF GENERAL AVIATION OPERATORS AND SERVICE PROVIDERS IN THE WASHINGTON, DC AREA Subpart A—General Provisions Sec. 331.1 What is the purpose of this part? 331.3 What do the terms used in this part mean? 331.5 Who may apply for reimbursement under this part? 331.7 What losses will be reimbursed? 331.9 What funds will the Department distribute under this part? 331.11 What are the limits on reimbursement to operators or providers? 331.13 What is the eligible reimbursement period under this part? 331.15 How will other grants, subsidies, or incentives be treated by the Department? 331.17 How will the Department verify and audit claims under this part? 331.19 Who is the final decision maker on eligibility for, and amounts of reimbursement? Subpart B—Application Procedures 331.21 What information must operators or providers submit in their applications for reimbursement? 331.23 In what format must applications be submitted? 331.25 To what address must operators or providers send their applications? 331.27 When are applications due under this part? Subpart C—Set-Aside for Operators and Providers at Certain Airports 331.31 What funds are available to applicants under this subpart? 331.33 Which operators and providers are eligible for the set-aside under this subpart? 331.35 What is the basis upon which operators and providers will be reimbursed through the set-aside under this subpart? 331.37 What will happen to any remaining funds if operators and providers at the three Maryland airports make reimbursable claims totaling less than $5 million? Appendix to Part 331—Application Form for Reimbursement Under Section 185 of Public Law 109-115 Authority: 49 U.S.C. 322(a). Subpart A—General Provisions § 331.1 What is the purpose of this part? The purpose of this part is to establish procedures to implement section 185 of the Transportation, Treasury, Housing and Urban Development, the Judiciary, the District of Columbia, and Independent Agencies Appropriation Act, 2006 (“the Act” or “the 2006 Appropriation Act”), Public Law 109-115, 119 Stat. 2396. Section 185 is intended to reimburse certain fixed-base general aviation operators or providers of general aviation ground support services at five airports in the Washington, DC metropolitan area for direct and incremental losses due to the actions of the Federal government to close airports to general aviation operations following the terrorist attacks of September 11, 2001. § 331.3 What do the terms used in this part mean? The following terms apply to this part: *Airport* means Ronald Reagan Washington National Airport; College Park Airport in College Park, Maryland; Potomac Airfield in Fort Washington, Maryland; Washington Executive/Hyde Field in Clinton, Maryland; or Washington South Capitol Street Heliport in Washington, DC. *Closed* or *closure* means the period of time until the first general aviation operations were generally permitted at Ronald Reagan Washington National Airport; until November 30, 2005 at Washington South Capitol Street Heliport; or the earliest that transient traffic was generally permitted to return to the three Maryland airports. *Department* means the U.S. Department of Transportation and all its components, including the Office of the Secretary
(OST)and the Federal Aviation Administration (FAA). *Direct and incremental losses* means losses incurred by a fixed-base general aviation operator or a provider of general aviation ground support services as a result of the Federal government's closure of an airport following the terrorist attacks against the United States on September 11, 2001. These losses do not include any losses that would have been incurred had the terrorist attacks on the United States of September 11, 2001 not occurred. *Fixed-base general aviation operator* means an entity based at a particular airport that provides services to and support for general aviation activities, including the provision of fuel and oil, aircraft storage and tie-down, airframe and engine maintenance, avionics repair, baggage handling, deicing, and the provision of air charter services. The term does not include an entity that exclusively provides products for general aviation activities (e.g. a parts supplier). *Forecast* or *forecast data* means a projection of revenue and expenses during the eligible reimbursement period had the attacks of September 11, 2001 not occurred. *Incurred* means to become liable or subject to (as in “to incur a debt”). *Loss* means something that is gone and cannot be recovered. *Provider of general aviation ground support services* means an entity that does not qualify as a fixed-base general aviation operator but operates at a particular airport and supplies services, either exclusively or predominantly, to support general aviation activities, including flight schools or security services. The term does not include an entity that exclusively provides products for general aviation activities (e.g. a parts or equipment supplier). *You* means fixed-base general aviation operators or providers of general aviation ground support services. § 331.5 Who may apply for reimbursement under this part? If you are or were an eligible fixed-base general aviation operator or provider of general aviation ground support services (collectively “operators or providers”) at an eligible airport or airports in the Washington, DC area, and incurred direct or incremental losses during the applicable reimbursement periods stated at § 331.13 that were solely due to the actions of the Federal government following the terrorist attacks on the United States on September 11, 2001, you may apply for reimbursement under this part. If you are applying for reimbursement based on losses at more than one airport, then you must submit separate applications for each airport. For example, if you are a provider of general aviation ground support services at Ronald Reagan Washington National Airport and Potomac Airfield in Fort Washington, Maryland, you must submit two separate applications. § 331.7 What losses will be reimbursed?
(a)You may be reimbursed an amount up to the difference between the adjusted income you actually or reasonably forecasted for the eligible reimbursement period and the actual adjusted income you earned during the eligible reimbursement period. If you did not forecast for the eligible reimbursement period or any part of the eligible reimbursement period, you may be reimbursed for the difference between what you can show you would have reasonably expected to earn as adjusted income during that period had the airport at which you are or were an operator or provider not been closed as the result of Federal government actions, and the actual adjusted income you earned during the eligible reimbursement period. Adjusted income is calculated on a pretax basis. It is the total of Operating Profit or Loss (i.e., Total Operating Revenues minus Total Operating Expenses) and Nonoperating Income (Loss); however, it excludes certain expenses, including lobbying expenses that were incurred to promote reimbursement for losses after the terrorist attacks or enact what became Section 185 of Pub. L. 109-115. Extraordinary, non-recurring, or unusual adjustments, and capital losses are normally ineligible for reimbursement. If you wish to claim for such an adjustment or loss, you must demonstrate that such adjustments were solely attributable to the Federal government's closure of the five Washington-area airports, are in conformity with Generally Accepted Accounting Principles, were fully borne within the statutory reimbursement period, that the loss was not discretionary in nature, and that reimbursement would not be duplicative of other relief.
(b)A temporary loss that you recovered after the attacks of September 11, 2001, or that you expect to recover, is not eligible for reimbursement under this part. You will not be reimbursed for those losses incurred through your own fault, negligence, or violation of law, or because of the actions of a third party (e.g. an airport).
(c)If you engaged in any non-aviation income-producing activities after September 11, 2001, such income must be reported under question number 5 in the appendix to this part.
(d)So called “cost savings” claims (i.e. increasing the claimed amount of reimbursement by reducing actual expenses to “adjust” for savings in expense categories asserted not to have been affected by the terrorist attacks) are not eligible for reimbursement.
(e)You cannot claim reimbursement for the lost time value of money (i.e. interest on lost profits for the period of time the funds were not available for your use).
(f)Lobbying fees and attorneys' fees incurred to promote reimbursement for losses after the terrorist attacks or enact Section 185 of Pub. L. 109-115 are not eligible for reimbursement.
(g)Your calculation of revenues, expenses and income must be based on financial documents maintained in the ordinary course of business that were prepared for the eligible reimbursement period, such as income statements, statements of operations, profit-and-loss statements, operating forecasts, budget documents or other similar documents. § 331.9 What funds will the Department distribute under this part? The Department will distribute the full amount of reimbursement it determines is payable to you under section 185 of the Act. Payment may be made in one or more installments. § 331.11 What are the limits on reimbursement to operators or providers?
(a)You are eligible to receive reimbursement subject to the set-aside (subpart C of this part) for eligible operators or providers at College Park Airport in College Park, Maryland; Potomac Airfield in Fort Washington, Maryland; and Washington Executive/Hyde Field in Clinton, Maryland. The amount available to you as reimbursement may be reduced to cover the cost of independent verification and auditing, as set forth in § 331.17.
(b)If you receive more reimbursement than the amount to which you are entitled under section 185 of the Act or the subpart C set-aside, the Department will notify you of the basis for the determination and the amount that you must repay to the Department. The Department will follow collection procedures under the Federal Claims Collection Act of 1966 (31 U.S.C. 3701 *et seq.* ) to the extent required by law, in recovering such overpayments.
(c)Payment will not be made to you until you have agreed to release the United States Government for all claims for financial losses resulting from the closure of the five airports in the Washington, DC area. The Department will provide a release form to applicants that must be completed before any payment is made under Section 185 of the Act. § 331.13 What is the eligible reimbursement period under this part? The eligible reimbursement period for direct and incremental losses differs by airport:
(a)For Ronald Reagan Washington National Airport the eligibility period for reimbursement is from September 11, 2001 until October 18, 2005.
(b)For College Park Airport in College Park, Maryland, the eligibility period for reimbursement is from September 11, 2001 until February 13, 2005.
(c)For Potomac Airfield in Fort Washington, Maryland, the eligibility period for reimbursement is from September 11, 2001 until February 13, 2005.
(d)For the Washington South Capitol Street Heliport in Washington, DC, the eligibility period for reimbursement is from September 11, 2001 to November 30, 2005.
(e)For Washington Executive/Hyde Field in Clinton, Maryland, there are two eligibility periods for reimbursement. The first period is from September 11, 2001 until May 16, 2002. The second period is from September 29, 2002 until February 13, 2005. § 331.15 How will other grants, subsidies, or incentives be treated by the Department? Grants, subsidies, or incentives that you have received during the eligible reimbursement period, either directly or indirectly, from Federal, State, and local entities, to reimburse you for the cost of operations and capital improvements associated with implementing security programs, or maintaining or providing general aviation services and facilities, will be considered revenues and should be reported as such on your application. § 331.17 How will the Department verify and audit claims under this part? Departmental staff will initially review each claim in detail, and contact you should questions arise. If they are unable to satisfactorily resolve the matter following consultation with you, your claim will be forwarded to the Office of the Inspector General, or another independent auditor, for verification and, if necessary, an audit. In addition, the Department may consult with, or make referrals to, other government agencies, including the Department of Justice. If an audit is necessary, a ceiling amount reached, and the audit does not support the claimed amount, your reimbursement may be reduced to cover one-third the cost of the audit. § 331.19 Who is the final decision maker on eligibility for, and amounts of reimbursement? The Assistant Secretary of Aviation and International Affairs will make a final determination of your eligibility and the amount of reimbursement you will receive. Subpart B—Application Procedures § 331.21 What information must operators or providers submit in their applications for reimbursement?
(a)You must submit the *Application Form for Reimbursement under Section 185 of Public Law 109-115* (“Application Form”), located in the appendix to this part, along with the profit and loss statements, forecasts, or other financial documents (collectively “supporting financial documents”) generated as a routine matter for the purposes of managing your business, and relied upon in completing your application.
(b)To the extent that your calculation of revenues, expenses and incomes are based on monthly records, you must adjust your calculation, on a pro-rata basis, to conform to the eligibility period. For example, if you utilize a monthly financial record to prepare a calculation of your September 2001 revenues, you should apportion your results for the period between September 11 and September 30, 2001.
(c)If multiple forecasts were prepared for the same period, you must utilize the one most recently approved, prior to September 11, 2001, so long as it is otherwise objective and reliable.
(d)If you provided information to the Department as part of its study entitled *Estimated Financial Losses to Selected General Aviation Entities in the Washington, DC Area* (Oct. 2005) (“2005 General Aviation Study”), you should not simply reiterate the same data provided to the Department at that time; you must provide the most current information that is available to you. If you do reiterate that same data provided to the Department for the 2005 General Aviation Study, the basis for your estimates must be verifiable from the supporting financial documents that you submit with your application.
(e)Failure to include all required information will delay consideration of your application by the Department and may result in a rejection. You have the burden to document and substantiate your claim; the Department will provide reimbursement only if it is satisfied that payment is fully supported.
(f)If, prior to September 11, 2001, you did not prepare a forecast covering the entire eligible reimbursement period, or if the forecast you completed is not relevant to the information required by this part, you may submit an “after-the-fact” estimate of the amount that you would have reasonably expected to accrue as adjusted income had the airport at which you are or were an operator or provider not closed. “After-the-fact” estimates must consider items particular to your business, including labor agreements and the terms of contracts in place at the time of the eligible reimbursement period, short-term or long-term budget documents, documents submitted in support of applications for loans or lines-of-credit, and other similar documents. You must explain the methodology that you used when preparing your reconstructed forecast.
(g)You must certify that the information on the application in the appendix to this part and all of the supporting financial documents that you are submitting is true and accurate under penalty of law and that you acknowledge that falsification of information may result in prosecution and the imposition of a fine and/or imprisonment.
(h)You must retain all materials you relied upon to establish your claim for losses.
(i)You must provide mitigating expenses, lobbying expenses incurred to promote reimbursement for losses after the terrorist attacks or enact Section 185 of the Act, and special expenses, as well as extraordinary adjustments, as instructed in the appendix to this part.
(j)If you need professional accounting services to assist in the preparation of your application, you may claim reimbursement for 80% of the actual amount you paid for such services, up to a maximum reimbursement of $2,000. You may claim reimbursement only for professional services; your own time in applying for reimbursement is not reimbursable. Any claim for professional accounting services must be accompanied with appropriate documentation as to the nature and extent of services performed, the amount billed, and payment. Employment or use of such professional services does not relieve you of the responsibility for the accuracy and completeness of the application.
(k)If you believe that the release of financial information provided to the Department in support of your application would cause you substantial harm if released by the Department to the public upon an appropriately made request, you may request that the Department hold portions of your application as confidential. Your request must specify the portions of your application that should be held by the Department as confidential, and you must provide an explanation as to how the release of such information would cause you substantial harm. § 331.23 In what format must applications be submitted?
(a)The Application Form, located in the appendix to this part, must be submitted in hardcopy format and, if possible, in electronic format. The Department has made available an electronic version of this form at the following Web site: *http://ostpxweb.dot.gov/aviation/index.html.* (Click on “Programs” and scroll to “General Aviation Operator and Service Provider Reimbursement.”
(b)All supporting financial documents must be submitted in hard copy. In addition, you may submit financial and accounting tabular data in Excel spreadsheet format, utilizing a 3.5″ floppy disk, compact disk, or flash memory device, and doing so may expedite the processing of your claim.
(c)Faxed and e-mailed applications are not acceptable and will not be considered. § 331.25 To what address must operators or providers send their applications?
(a)You must submit your application and all required supporting information, to the following address: U.S. Department of Transportation, Office of Aviation Analysis (X-50)Aviation Relief Desk, Room 6401, 400 7th Street, SW., Washington, DC 20590.
(b)Your application must be submitted via courier or an express package service, such as registered U.S. Postal Service, Federal Express, UPS, or DHL.
(c)If complete applications are not submitted to the address in paragraph
(a)of this section, they will not be accepted by the Department. § 331.27 When are applications due under this part? You must submit your application by June 8, 2007. Subpart C—Set-Aside for Operators or Providers at Certain Airports § 331.31 What funds are available to applicants under this subpart? The Department is setting aside a sum of $5 million to reimburse eligible operators or providers, as set forth in section 185 of the Act. § 331.33 Which operators and providers are eligible for the set-aside under this subpart? Operators or providers at the following three airports during the eligible reimbursement periods are eligible for the set-aside:
(a)College Park Airport in College Park, Maryland;
(b)Potomac Airfield in Fort Washington, Maryland; and
(c)Washington Executive/Hyde Field in Clinton, Maryland. § 331.35 What is the basis upon which operators or providers will be reimbursed through the set-aside under this subpart? Operators or providers eligible under this subpart will be reimbursed pursuant to the same procedures set forth in subpart B of this part. If total losses for all eligible claims at the three airports set forth in § 331.31 of this part are less than $5 million, then such claims will be paid in full. If the total losses for all eligible claims at the three airports set forth in § 331.31 of this part exceed $5 million, then the total losses will be divided on a pro rata basis, and a proportionate amount for each claim will be distributed to applicants. § 331.37 What will happen to any remaining funds if operators and providers at the three Maryland airports make reimbursable claims totaling less than $5 million? If the operators and providers who are eligible for the $5 million set-aside do not exhaust the funds designated under the set-aside, then any remaining money from the set-aside will be made available for other valid claims made under this part. Appendix to Part 331—Application Form for Reimbursement Under Section 185 of Public Law 109-115 1. Applicant name: ___________ 2. Applicant address: 3. At which of the following airports did the applicant operate as a fixed-base operator or provider of general aviation ground support services during the eligible period for reimbursement? • Ronald Reagan Washington National Airport ☐ • College Park Airport in College Park, Maryland ☐ • Potomac Airfield in Fort Washington, Maryland ☐ • Washington Executive/Hyde Field in Clinton, Maryland ☐ • Washington South Capitol St. Heliport, Washington, DC ☐ 4. Briefly describe the nature of the applicant's operations as a fixed-base general aviation operator or a provider of general aviation ground support services at each airport during the eligible period for reimbursement. 5. Did the applicant or any part of it conduct non-fixed-base general aviation activities or provide non-aviation ground support services during the 2001 through 2005 period? ☐ Yes. Briefly describe the non-fixed-base general aviation activities and non-aviation ground support services. ☐ No. 6. Briefly describe how the events of September 11, 2001 affected the applicant's operations as a fixed-base general aviation operator or a provider of general aviation ground support services. 7. In response to the events of September 11, 2001, did the applicant take any action to lessen or offset the impact of those events? ☐ Yes. Briefly describe those actions and the effect they had on the applicant. ☐ No. 8. Has the applicant filed income taxes for any period between 1999 and 2005? ☐ Yes. Specify the filing status under which the applicant filed (corporation, partnership, sole proprietorship, etc.) ☐ No. 9. Baseline Financial Data and Forecasts. Attach to this Appendix copies of your profit and loss statements, or such financial records as you generated as a routine matter for the use of management, for the periods 1999 through 2005, that show your actual financial results. Similarly, attach copies of any actual forecasts that you prepared for both these baseline periods and for any part of the reimbursement periods that were prepared prior to September 11, 2001. 10. The requested amount of reimbursement claimed below must be based on a comparison of actual operating results (revenues, expenses and profits or losses), adjusted as indicated, with a similarly adjusted company forecast/budget of operating results that existed prior to September 11, 2001 if such a forecast/budget was actually prepared. If the applicant did not prepare any such pre-September 11 forecasts, or prepared them for less than the full reimbursement period, an after-the-fact estimate of what the applicant can document can reasonably be expected to earn during the remaining eligible period may be submitted. If such an after-the-fact estimate is used, describe below the period for which it applies and the methodology that was used to determine it. 11. Reimbursement Claim Financial Data Column A Column B Column C Pre 9-11-01 Forecast or after-the-fact estimate for the eligible period* Actual results for the eligible period* Column A minus Column B Line 1—Total Operating Revenues Line 2—Total Operating Expenses Line 3—Operating Profit or
(Loss)Line 4—Nonoperating Revenue Line 5—Nonoperating Expenses Line 6—Nonoperating income
(loss)before taxes Line 7—Professional Application Fee (@80%, max. $2000) Total—Adjusted Income Line 3 plus line 6 and line 7 in the last column The table above applies to the period 9-11-01 through 2-13-05 for the three Maryland airports, including Washington Executive/Hyde Field. However, for Hyde Field please prepare separate claims for the periods before, during and after the ineligible period, 5-17-02 through 9-28-02. For Ronald Reagan Washington National Airport, the eligible period is from 9-11-02 through 10-18-05 and for Washington South Capitol Street Heliport, the period is from 9-11-01 through 11-30-05. Lobbying expenses incurred to promote reimbursement for losses after the terrorist attacks or enact Section 185 of Public Law 109-115 are to be excluded from both Columns A and B. 12. Has the applicant or any of its subsidiaries or affiliates received grants, subsidies, incentives or similar payments from local, state, or Federal governmental entities in support of the security, maintenance and provision of general aviation services and facilities furnished in response to the events of September 11, 2001? (This includes payments under the Aviation Transportation Security Act
(ATSA)Public Law 107-71 November 19, 2001, and the Airport Improvement Program (AIP)). ☐ Yes. Enter amount = $______ . ☐ No. 13. Has the applicant or any of its subsidiaries or affiliates incurred lobbying expenses, mitigating expenses, or special expenses (as described in the section captioned “What information must operators or providers submit in their applications for reimbursement?”), or extraordinary, non-recurring, or unusual adjustments? ☐ Yes. Briefly describe these expenses and the amount of each, and state if they have been included in or excluded from the totals in the table at item number 11. ☐ No. 14. Certification. I certify the above information and all attached documents as true and accurate under penalty of law, and acknowledge that falsification of information may result in prosecution and imposition of a fine and/or imprisonment. Signature of Company Official (must be President, CEO, COO, or CFO) Printed Name of Company Official Position (President, CEO, COO, or CFO) of Company Official Phone Number of Company Official: (voice)
(fax)Date Name of Contact Person (if different from above) Position of Contact Person (if different from above) Phone Number of Contact Person: (voice)
(fax)E-mail Address of Contact Person: Instructions for Completing Application Form for Reimbursement Under Section 185 of Public Law 109-115 1. Applicant name. This is the person or legal entity who undertakes to act as a fixed-base general aviation operator or who provides general aviation ground support services, directly or by a lease or any other arrangement. 2. Applicant address. The applicant address is that location within the local tax authority jurisdiction that is held out to the public as the business or airport address. 3. Airport of operation on September 11, 2001. This question asks the applicant to identify those airports in the Washington, DC area where it provided either fixed-base general aviation services or general aviation ground support services on September 11, 2001. Check as many airports as you served on September 11, 2001. 4. Briefly describe the nature of the applicant's operations as a fixed-base general aviation operator or a provider of general aviation ground support services at each airport during the eligible period for reimbursement. You should describe the specific fixed-base general aviation services or general aviation ground support services that you provided at each of the airports. 5. Did the applicant or any part of it conduct non-fixed-base general aviation activities or provide non-aviation ground support services during the 2001 through 2005 period? Check “Yes” if you conducted any non-fixed-base general aviation activities or provided non-aviation ground support services during the 2001 through 2005 period. Describe the activities that you undertook during this period that did not directly support general aviation at the airport. 6. Briefly describe how the events of September 11, 2001 affected the applicant's operations as a fixed-base general aviation operator or a provider of general aviation ground support services. You should describe how the level and conduct of your operations as a fixed-base general aviation operator or your operations as a provider of general aviation ground support services were changed as a result of September 11, 2001 and the ensuing security restrictions that were imposed by the Federal government. 7. Did the applicant undertake any actions to lessen or offset the impact of the Federal government's closure of airports in the Washington, DC area following the attacks of September 11, 2001? Check “Yes” if you attempted to minimize the impact that the terrorist attacks of September 11, 2001 had on your business. Briefly describe your actions and the effect that they had on you. Include any activities or services undertaken after September 11, 2001 that did not provide support for general aviation but that did provide revenues to sustain your business. 8. Has the applicant filed income taxes for any period between 1999 and 2005? Check “Yes” if you filed income taxes during this period, and indicate the filing status under which you filed your income tax returns. 9. Baseline Financial Data and Forecasts. Attach to this Appendix copies of your profit and loss statements, or such financial records as you generated as a routine matter for the use of management, for the periods 1999 through 2005, that show your actual financial results. Similarly, attach copies of any actual forecasts that you prepared for both these baseline periods and for any part of the reimbursement periods that were prepared prior to September 11, 2001. This question directs applicants to provide the Department with certain financial documents in order to verify and substantiate their claims. Documents that you have already prepared should be sufficient. When necessary, you should supplement these documents with footnotes or explanations that are pertinent to your reimbursement claim. The financial data may include such documents as income statements, statements of operations, forecasts of operating results, income projections, pro forma budget projections, budget documents, tax preparation support material, information presented in investment perspectives and registrations, or other similar information that in whole or in part cover the period from 1999 through 2005. 10. The requested amount of reimbursement claimed below must be based on a comparison of actual operating results (revenues, expenses and profits or losses) (adjusted as shown), with a similarly adjusted company forecast of operating results that existed prior to September 11, 2001 if such a forecast was actually prepared. If the applicant did not prepare any such pre-September 11 forecasts, or prepared them for less than the full reimbursement period, an after-the-fact estimate of what the applicant can document that it reasonably expected to earn during the remaining eligible period may be submitted. If such an after-the-fact estimate is used, describe below the period for which it applies and the methodology that was used to determine it. Indicate here whether an “after-the-fact” forecast was prepared, and briefly describe the methodology used in preparing the forecast. Your methodology must take into account items relevant to your businesses, such as the terms of existing contracts, short-term or long-term budget documents, documents submitted in support of applications for loans or lines-of-credit, existing labor agreements and leasing agreements, and other similar types of documents. In preparing your “after-the-fact” forecast, you may wish to consult a July 2001 report prepared for the FAA, entitled Forecasting Aviation Activity by Airport. This report was prepared by GRA, Incorporated (GRA), for the FAA's Office of Aviation Policy Plans Statistical and Forecast Branch (APO-110). While the Department recognizes that fixed-base general aviation operators and providers of general aviation ground support services are different entities than larger airports at which scheduled service is provided, the Department believes that this document offers relevant guidance to applicants who do not prepare forecasts as part of regular business operations. This July 2001 report may be accessed at: *http://www.faa.gov/data_statistics/aviation_data_statistics/forecasting/media/AF1.doc.* The July 2001 report explains the basic steps usually utilized in preparing forecasts, including: Identifying parameters and measures to forecast; collecting forecast information of expected revenues or expenses, including budgets; gathering and evaluating data; selecting a forecast method (such as regression and trend analysis, share analysis, or exponential smoothing); applying methods and evaluating results; and summarizing and documenting the results. Additionally, data sources to assist you in making adjustments to your forecast are available from the Department's Web site at *http://ostpxweb.dot.gov/aviation/index.html* (Click on “Programs” and scroll down to “General Aviation Operator and Service Provider Reimbursement”). The Department notes that, while it can answer questions for applicants that might arise while applicants develop forecasts, the Department is not in a position to propose or develop projections for applicants. 11. Reimbursement Claim. For purposes of completing the information in the reimbursement claim table, total operating revenues (line 1) include the inflow of funds to the applicant resulting from the sale of goods and services related to the activities of a fixed-base operator or a provider of general aviation services. Examples include, but are not limited to, monetary amounts or value received for providing: aircraft fuel or oil; delivery of aircraft fuel or oil; transient and long-term storing, tie down parking and sheltering of aircraft; maintenance, inspection, checking, upgrading of aircraft and aircraft related equipment and for polishing and cleaning property and equipment; providing flight instruction services and materials; and miscellaneous items for purchase such as maps, books, flight clothing, sectional charts, devices and parts for aircraft, food services, hospitality services, auto rentals, aircraft custodial and sanitation services, assistance grants from state and Federal government agencies, insurance payments, and revenues derived from the business activities conducted at alternative airports to those that were closed. Total operating expenses (line 2) include the cost to the applicant of providing the goods and services related to the activities of a fixed-base operator or a provider of general aviation services. Examples include, but are not limited to: Labor costs for all categories of employees (including compensation, vacation and sick leave pay, medical benefits, workmen's compensation contributions, accruals or annuity payments to pension funds, training reimbursements, professional fees, licensing fees, educational or recreational activities for the benefit of the employee, stock incentives, etc.); the cost of fuel and oil including nonrefundable aircraft fuel and oil taxes; insurance; flight and ground equipment parts; general services purchased for flight or ground equipment maintenance; depreciation of flight and ground equipment; amortization of capitalized leases for flight and ground equipment; provisions for obsolescence and deterioration of spare parts; insurance premiums; and rental expenses of flight and ground equipment expenses associated with business activities conducted at alternative airports to those that were closed. Advertising, promotion and publicity expenses, landing fees, clearance, customs and duties, utilities, bookkeeping, accounting, recordkeeping and legal services are also part of the total operating expenses. Operating profit or loss is calculated by subtracting the total operating expenses from the total operating revenues. If the total operating revenues exceed the total operating expenses, the calculation results in an operating profit. If the total operating expenses exceed the total operating revenues, the calculation results in an operating loss. Nonoperating income and expenses include: income and loss incident to commercial ventures not inherently related to the direct provision of fixed-base operator services or general aviation ground support services; other revenues and expenses attributable to financing or other activities that are extraneous to and not an integral part of general aviation services; and special recurrent items of a nonperiod nature. Examples of non-operating income include, but are not limited to: Interest income; foreign exchange gains; equity investment in an investor controlled company; intercompany transactions; dividend income; and net unrealized gains on marketable equity securities. Examples of non-operating expenses include, but are not limited to: Interest on long-term debt and capital leases; interest on short-term debt; imputed interest capitalized; amortization of discount and expense on debt; foreign exchange losses; fines or penalties imposed by governmental authorities; costs related to property held for future use; donations to charities, social and community welfare purposes; losses on reacquired and retired or resold debt securities; and losses on uncollectible non-operating receivables. For reasons set forth elsewhere in § 331.7 of this part, you may not include lobbying expenses that were incurred to promote reimbursement for losses after the terrorist attacks or enact Section 185 of Pub. L. 109-115. Non-operating income is the result of subtracting the non-operating expenses from the non-operating revenues. Professional application fees provide for reimbursement of 80 percent of the cost of professional accounting services required in the preparation and submission of the application. Adjusted Income for each of the Columns A and B is the sum of the Operating profit (or loss) (line 3) plus line 6, Non-operating income (loss). Each line of Column C is the result of subtracting Column B from Column A, except on line 7, Professional Application Fees, where the claimant may enter 80 percent of professional application fees (up to a maximum of $2,000). The Adjusted Income figure on the Total line of Column C represents the amount claimed as total reimbursement; it may of course be adjusted as the result of Department review. All Adjusted Income figures do not reflect taxes due in the current period, as a consequence, reimbursements will be pre-tax and income taxes may be due on reimbursed funds. The difference between column A and B is the basis for column C. This constitutes the total amount of your claim for reimbursement. As the eligibility periods, for the most part, begin and end on days other than the first or last days of the month, quarter or year, data from already existing financial statements must be adjusted, on a pro rata basis, to reflect the eligibility periods. For example, the period of eligibility for all applicants begins on September 11, 2001 and therefore, the only time period during the month of September that is eligible for reimbursement is September 11 through September 30, a period of 20 days. Applicants should be prepared to show both how they apportioned such financial data into the reimbursement periods, and why they chose the apportionment approach used. Applicants can then use these estimates for the specified periods at the beginning and end of the eligible period to add to the financial amounts for 2002, 2003, and 2004 to calculate the total amounts sought in Appendix A. 12. Has the applicant or any of its subsidiaries or affiliates received grants, subsidies, incentives or similar payments from local, state, or Federal governmental entities in support of the security, maintenance and provision of general aviation services and facilities furnished in response to the events of September 11, 2001? (This includes payments under the Aviation and Transportation Security Act of 2001 (Public Law 107-38) and the Airport Improvement Program under the Airport and Airway Improvement Act of 1982 (Public Law 97-248).) This question requires that you disclose all grants, subsidies, or incentives that you received during the eligible reimbursement period, either directly or indirectly, from Federal, State, and local entities, to reimburse you for the cost of operations and capital improvements associated with implementing security programs, or maintaining or providing general aviation services and facilities. 13. Has the applicant or any of its subsidiaries or affiliates incurred lobbying expenses, mitigating expenses, or special expenses (as described in the section captioned “What information must operators or providers submit in their applications for reimbursement?”), or extraordinary adjustments? Check “Yes” if you incurred any such expenses or experienced any such adjustments. You must briefly describe the nature of such expenses and adjustments, including the amounts. Additionally, you must indicate whether or not such expenses or adjustments have been included in or excluded from the totals in the table at item number 11. Lobbying includes any amount paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress. Mitigating expenses include the utilization of property, the provision of services and the sale of goods that were undertaken to mitigate losses arising from the Federal government's closure of airports attendant to the September 11, 2001 attack. These could include expenses incurred for the provision of services and sale of goods moved from restricted airports to unrestricted airports or compensation for non-aviation oriented goods and services provided at restricted airports. Mitigating expenses may also include operating expenses for aviation-related fixed assets or capital utilized outside of the restricted airport. Special expenses include, but are not limited to, moving expenses, additional security equipment and facilities, and loss on sales of assets that arose from the direct imposition of restrictions during the period September 11, 2001 through the applicable eligible date. Any item reported under Special Expenses shall not also be expensed in other expense categories that are reflected in the calculation of the reimbursement claim. Details regarding special expenses should be noted in footnotes. Extraordinary adjustments are events or transactions that are material to your business and unusual in nature and infrequent in occurrence. 14. Certification. You must certify that all information contained on the Background and Eligibility Form *and* the documents submitted in support of your application (e.g., profit and loss statements, actual forecasts, after-the-fact forecasts, etc.) are accurate. This certification is made under penalty of law. Falsification may be grounds for monetary and/or criminal sanctions. This certification must be made by a company President, CEO, COO, or CFO. [FR Doc. E7-6350 Filed 4-6-07; 8:45 am] BILLING CODE 4910-9X-P DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 18 CFR Part 101 [Docket No. RM04-12-000] Accounting and Financial Reporting for Public Utilities Including RTOs; Notice of Extension of Time April 2, 2007. AGENCY: Federal Energy Regulatory Commission, DOE. ACTION: Final rule: notice of extension of time. SUMMARY: On December 16, 2005, the Commission issued Order No. 668, a Final Rule amending the Commission's regulations to update the accounting and reporting requirements for public utilities and licensees, including independent system operators and RTOs. Because the Commission has updated the submission software used to file FERC Form Nos. 1 and 1-F, the Commission is issuing a notice extending the filing deadline for the filing of 2006 FERC Form Nos. 1 and 1-F. DATES: The filing deadline for 2006 FERC Form Nos. 1 and 1-F is extended to May 18, 2007. FOR FURTHER INFORMATION CONTACT: Brenda D. Devine, Division of Financial Regulation, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426,
(202)502-8522. SUPPLEMENTARY INFORMATION: Notice Granting Extension of Time for Filing FERC Form Nos. 1 and 1-F On December 16, 2005, the Commission issued Order No. 668, a Final Rule amending the Commission's regulations to update the accounting and reporting requirements for public utilities and licensees, including independent system operators and regional transmission organizations. 1 Order No. 668 amended FERC Form Nos. 1 and 1-F by adding new schedules and revising existing schedules in the forms. The Commission updated the submission software used to file FERC Form Nos. 1 and 1-F to reflect the new financial reporting requirements of Order No. 668. 1 *Accounting and Financial Reporting for Public Utilities Including RTOs,* Order No. 668, FERC Stats. & Regs. ¶ 31,199 (2005), *reh'g denied,* Order No. 668-A, FERC Stats. & Regs. ¶ 31,215 (2006), *reh'g denied,* 117 FERC ¶ 61,066 (2006). The annual filing date for FERC Form Nos. 1 and 1-F is April 18. However, in light of the software changes made to implement Order No. 668, the filing deadline for the 2006 FERC Form Nos. 1 and 1-F is extended until May 18, 2007. Philis J. Posey, Acting Secretary. [FR Doc. E7-6511 Filed 4-6-07; 8:45 am] BILLING CODE 6717-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 179 [Docket No. 2003F-0088 (formerly 03F-0088)] Irradiation in the Production, Processing and Handling of Food AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; response to objections and denial of requests for a hearing. SUMMARY: The Food and Drug Administration
(FDA)is responding to objections and is denying requests that it has received for a hearing on the final rule that amended the food additive regulations by establishing a new maximum permitted energy level of x-rays for treating food of 7.5 million electron volts
(MeV)provided that the x-rays are generated from machine sources that use tantalum or gold as the target material, with no change in the maximum permitted dose levels or uses currently permitted by FDA's food additive regulations. After reviewing the objections to the final rule and the requests for a hearing, the agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for removing the amendment to the regulation. FOR FURTHER INFORMATION CONTACT: Andrew J. Zajac, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1267. SUPPLEMENTARY INFORMATION: I. Introduction FDA published a notice in the **Federal Register** of March 13, 2003 (68 FR 12087), announcing the filing of food additive petition, FAP 3M4745, by Ion Beam Applications to amend the food additive regulations in § 179.26 *Ionizing radiation for the treatment of food* (21 CFR 179.26) by increasing the maximum permitted energy level of x-rays for treating food from 5 to 7.5 MeV. The rights to this petition were subsequently transferred to Sterigenics International, Inc. In response to this petition, FDA issued a final rule in the **Federal Register** of December 23, 2004 (69 FR 76844) permitting the safe use of 7.5 MeV x-rays for treating food provided that the x-rays are generated from machine sources that use tantalum or gold as the target material, with no change in the maximum permitted dose levels or uses currently permitted by FDA's food additive regulations (the 7.5 MeV x-ray final rule). The preamble to the final rule advised that objections to the final rule and requests for a hearing were due within 30 days of the publication date (i.e., by January 24, 2005). II. Objections and Requests for a Hearing Section 409(f) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(f)) provides that, within 30 days after publication of an order relating to a food additive regulation, any person adversely affected by such order may file objections, specifying with particularity the provisions of the order “deemed objectionable, stating reasonable grounds therefore, and requesting a public hearing upon such objections.” FDA may deny a hearing request if the objections to the regulation do not raise genuine and substantial issues of fact that can be resolved at a hearing ( *Community Nutrition Institute* v. *Young* , 773 F.2d 1356, 1364 (D.C. Cir. 1985), *cert. denied* , 475 U.S. 1123 (1986)). Under the food additive regulations at 21 CFR 171.110, objections and requests for a hearing are governed by part 12 (21 CFR part 12) of FDA's regulations. Under § 12.22(a), each objection must meet the following conditions:
(1)Must be submitted on or before the 30th day after the date of publication of the final rule;
(2)must be separately numbered;
(3)must specify with particularity the provision of the regulation or proposed order objected to;
(4)must specifically state each objection on which a hearing is requested; failure to request a hearing on an objection constitutes a waiver of the right to a hearing on that objection; and
(5)must include a detailed description and analysis of the factual information to be presented in support of the objection if a hearing is requested; failure to include a description and analysis for an objection constitutes a waiver of the right to a hearing on that objection. Following publication of the 7.5 MeV x-ray final rule, FDA received about 100 objections within the 30-day objection period. All but one of these submissions expressed general opposition to increasing the maximum permitted energy level of x-rays used to irradiate food and to food irradiation. Most of these objections were form letters, identically worded, urging FDA to conduct additional studies on the effects of 7.5 MeV x-rays on food and objecting “to the agency's decision knowing that some amount of radioactivity could be created in food treated with 7.5 MeV.” While most of these objections requested a hearing, no evidence was submitted in support of these objections that could be considered in an evidentiary hearing. These submissions expressing general opposition raise no factual issue for resolution and, therefore, do not justify a hearing. 1 The one submission raising specific objections was a letter from Public Citizen with six objections to the 7.5 MeV x-ray final rule. The letter requested a hearing on issues raised by each objection. These objections are addressed in section IV of this document. 1 A large number of these form letters were submitted after the close of the objection period. Tardy objections fail to satisfy the requirements of 21 U.S.C. 348(f)(1) and need not be considered by the agency ( *ICMAD* v. *HEW* , 574 F.2d 553, 558 n.8 (D.C. Cir), *cert. denied* , 439 U.S. 893 (1978)). III. Standards for Granting a Hearing Specific criteria for deciding whether to grant or deny a request for a hearing are set out in § 12.24(b). Under that regulation, a hearing will be granted if the material submitted by the requester shows, among other things, the following:
(1)There is a genuine and substantial factual issue for resolution at a hearing; a hearing will not be granted on issues of policy or law;
(2)the factual issue can be resolved by available and specifically identified reliable evidence; a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions;
(3)the data and information submitted, if established at a hearing, would be adequate to justify resolution of the factual issue in the way sought by the requestor; a hearing will be denied if the data and information submitted are insufficient to justify the factual determination urged, even if accurate;
(4)resolution of the factual issue in the way sought by the person is adequate to justify the action requested; a hearing will not be granted on factual issues that are not determinative with respect to the action requested (e.g., if the action would be the same even if the factual issue were resolved in the way sought);
(5)the action requested is not inconsistent with any provision in the act or any FDA regulation; and
(6)the requirements in other applicable regulations, e.g., 21 CFR 10.20, §§ 12.21, and 12.22, and in the notice issuing the final regulation or the notice of opportunity for hearing are met. A party seeking a hearing is required to meet a “threshold burden of tendering evidence suggesting the need for a hearing” ( *Costle* v. *Pacific Legal Foundation* , 445 U.S. 198, 214-215 (1980), *reh. denied* , 446 U.S. 947 (1980), citing *Weinberger* v. *Hynson, Westcott & Dunning, Inc.* , 412 U.S. 609, 620-621 (1973)). An allegation that a hearing is necessary to “sharpen the issues” or to “fully develop the facts” does not meet this test ( *Georgia Pacific Corp.* v. *EPA* , 671 F.2d 1235, 1241 (9th Cir. 1982)). If a hearing request fails to identify any factual evidence that would be the subject of a hearing, there is no point in holding one. In judicial proceedings, a court is authorized to issue summary judgment without an evidentiary hearing whenever it finds that there are no genuine issues of material fact in dispute and a party is entitled to judgment as a matter of law (see Rule 56, Federal Rules of Civil Procedure). The same principle applies in administrative proceedings (see § 12.28). A hearing request must not only contain evidence, but that evidence should raise a material issue of fact concerning which a meaningful hearing might be held ( *Pineapple Growers Ass'n* v. *FDA* , 673 F.2d 1083, 1085 (9th Cir.1982)). Where the issues raised in the objection are, even if true, legally insufficient to alter the decision, the agency need not grant a hearing (see *Dyestuffs and Chemicals, Inc.* v. *Flemming* , 271 F.2d 281 (8th Cir. 1959), *cert. denied* , 362 U.S. 911 (1960)). FDA need not grant a hearing in each case where an objector submits additional information or posits a novel interpretation of existing information (see *United States* v. *Consolidated Mines & Smelting Co.* , 455 F.2d 432 (9th Cir. 1971)). In other words, a hearing is justified only if the objections are made in good faith and if they “draw in question in a material way the underpinnings of the regulation at issue” ( *Pactra Industries* v. *CPSC* , 555 F.2d 677 (9th Cir. 1977)). Finally, courts have uniformly recognized that a hearing need not be held to resolve questions of law or policy (see *Citizens for Allegan County, Inc.* v. *FPC* , 414 F.2d 1125 (D.C. Cir. 1969); *Sun Oil Co* . v. *FPC* , 256 F.2d 233, 240 (5th Cir.), *cert. denied* , 358 U.S. 872 (1958)). Even if the objections raise material issues of fact, FDA need not grant a hearing if those same issues were adequately raised and considered in an earlier proceeding. Once an issue has been so raised and considered, a party is estopped from raising that same issue in a later proceeding without new evidence. The various judicial doctrines dealing with finality can be validly applied to the administrative process. In explaining why these principles “self evidently” ought to apply to an agency proceeding, the U.S. Court of Appeals for the District of Columbia Circuit wrote: “The underlying concept is as simple as this: Justice requires that a party have a fair chance to present his position. But overall interests of administration do not require or generally contemplate that he will be given more than a fair opportunity.” *Retail Clerks Union, Local 1401* v. *NLRB* , 463 F.2d 316, 322 (D.C. Cir. 1972). (See *Costle* v. *Pacific Legal Foundation* , supra at 215-220. See also *Pacific Seafarers, Inc.* v. *Pacific Far East Line, Inc.* , 404 F.2d 804 (D.C. Cir. 1968), *cert. denied* , 393 U.S. 1093 (1969).)) In summary, a hearing request must present sufficient credible evidence to raise a material issue of fact and the evidence must be adequate to resolve the issue as requested and to justify the action requested. IV. Analysis of Objections and Response to Hearing Requests The letter from Public Citizen raises six issues that they believe to be factual and requests a hearing based on these objections. FDA addresses each of the objections in the following paragraphs, as well as the evidence and information filed in support of each, comparing each objection and the information submitted in support of it to the standards for granting a hearing in § 12.24.
(1)Public Citizen contends that FDA did not adequately account for the fact that an electron beam on an x-ray target is not monoenergetic, and that a significant portion of the beam may be higher than the nominal energy, resulting in higher neutron production in the food and more activity. Public Citizen cites a published paper in the petition in which the authors note that measurements and calculations of a 7.5 MeV setting actually correspond to 8.1 MeV 0.8 MeV. The objection does not raise a genuine and substantial issue of fact for resolution at a hearing. Contrary to the objection, the final rule does not set a “nominal energy” limit. The final rule sets out 7.5 MeV as the maximum energy permitted. X-rays from machine sources at energies exceeding 7.5 MeV are not permitted by the final rule. Further, the objection provides no evidence to support the contention that safety concerns regarding inherent limitations on the precision of setting and measuring voltage were not considered. The paper referred to in the objection, Gregoire, O., Cleland, M.L., Wakeford, Mittendorfer, et al., “Radiological Safety of Food Irradiation With High Energy X-Rays: Theoretical Expectations and Experimental Evidence,” 2002, was included as a reference in the final rule and counters the objection. The paper discusses the radiological implications of irradiating meat with 7.5 MeV x-rays to an x-ray dose of 15 kGy, which is more than twice the maximum dose allowed for meat irradiation (4.5 kGy maximum for refrigerated meat and 7.0 kGy maximum for frozen meat) (see § 179.26(b)). Experiments were performed with x-ray machines that use two different types of electron accelerators, one delivering electrons with a narrow electron energy spread, the other delivering a broad energy spread. The Gregoire paper concluded that risk to individuals from intake of food irradiated with x-rays from 7.5 MeV electrons, even with a broad energy spread, would be trivial. In the experiments discussed in the Gregoire paper, the equipment was set to achieve a voltage of 7.5 MeV. Measurements (including calculations) to verify the precision of the settings estimated that the machine produced electrons at an energy of approximately 8.1 MeV, with an uncertainty margin of 0.8 MeV. In other words, within the limits of precision of the measurements, the energy of the electrons used to produce the x-rays was shown to be greater than 7.3 MeV but less than 8.9 MeV. FDA notes that even though the equipment in this experiment produced a higher energy level than permitted by the regulation, the results show that any radioactivity that might be induced at that higher energy level is trivially small. Public Citizen has not raised a genuine and substantial issue of fact and has not provided any information that contradicts the agency's safety determination. Thus, a hearing is not justified based on this objection (§ 12.24(b)(1) and (2)).
(2)Public Citizen claims that FDA has concluded that any induced activity in food from treating it with 7.5 MeV x-rays is safe without a standard for a “safe” level of induced activity in food and further objects to any additional radiation level in treated food. The objection does not cite any support for its contention that FDA must establish a general standard for a safe level of induced activity in food beyond the act's requirements for food additive approvals. The use of x-rays to treat food is a food additive under the act's definition of “food additive,” which includes any source of radiation intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food (section 201(s) of the act) (21 U.S.C. 321(s)). Section 409 of the act requires that a regulation approving a food additive must prescribe, with respect to the proposed uses of the additive, the conditions under which the additive may be safely used. Further, section 409 of the act sets out that no such regulation can issue if a fair evaluation of the data fails to establish that the proposed use of the food additive, under the conditions of use to be specified in the regulation, will be safe. FDA has defined “safe” and “safety” by regulation to mean that “there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” (21 CFR 170.3(i)). In accordance with the requirements of section 409 of the act and the food additive regulations, FDA determined that food treated with 7.5 MeV x-rays is safe by comparing the total annual dose from eating irradiated foods with the annual dose from naturally occurring radionuclides in the food. FDA's determination was based on its review of the data in the record, including the reports referenced in the final rule from the International Atomic Energy Agency, Gregoire et al., and the independent evaluation of the data by Oak Ridge National Laboratory. FDA concluded based on these analyses that any radioactivity that may be induced in any food treated with 7.5 MeV x-rays will be trivially low and that any potential human exposure due to consumption of irradiated food will be inconsequential compared to that from radionuclides that are present naturally in food. Public Citizen's objection presents no factual evidence that FDA has overlooked in reaching the decision that 7.5 MeV x-rays are safe for treating food under the conditions of use specified in the regulation. Thus, Public Citizen has failed to justify a hearing on this issue (§ 12.24(b)(2)).
(3)Public Citizen objects to the agency's approval of 7.5 MeV x-rays for treating food without assessing the risk of getting cancer from eating food with added radioactivity. The objection points to a paper by Ari Brynjolfsson, cited by the petitioner, which estimates the lifetime cancer risk from eating foods irradiated with 7.5 MeV x-rays to be 0.8 per million. 2 FDA disagrees with Public Citizen's assertion that it did not consider the risk of getting cancer from eating food treated with 7.5 MeV x-rays during its review of FAP 3M4745. As stated in the preamble of the rule, FDA contracted with Oak Ridge National Laboratory
(ORNL)to perform an independent evaluation of the data in the administrative record, including an evaluation of cancer risk. The ORNL evaluation was placed in the docket when the rule published. ORNL concluded that because the factors used in the data in the administrative record to estimate cancer risk are based on much higher doses than permitted in the rule, the data in the administrative record, including the data in the Brynjolfsson paper, cannot be applied with any credibility to extrapolate cancer risk to the extremely low potential doses that a person might receive from consuming food treated with 7.5 MeV x-rays. The extrapolations that would be required would yield estimated risks far too small to reliably measure or verify. FDA agrees with this conclusion. 2 Public Citizen incorrectly states in their objection that the cancer risk estimated by the author is 0.08 per million. The only evidence referenced by Public Citizen in support of its assertion is the Brynjolfsson paper, which was part of the administrative record and was considered in ORNL's evaluation of the data and FDA's safety determination. Therefore, Public Citizen has not identified any evidence to support its assertion that was not already considered by FDA in its safety determination. A hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions (21 CFR 12.24(b)(2)).
(4)Public Citizen asserts that FDA did not comply with § 170.22 (21 CFR 170.22), which states that a food additive will not be granted a tolerance that will exceed 1/100th of the maximum amount demonstrated to be without harm to experimental animals unless evidence is submitted which justifies use of a different safety factor. Public Citizen expresses the view that this non-compliance includes not only the failure to conduct any animal experiments using foods irradiated with 7.5 MeV x-rays, but also the failure to calculate a 100-to-1 safety factor or submit evidence that justifies the use of a different safety factor. The objection does not include any evidence or support for the contention that animal experiments are required to be conducted to determine whether a proposed use of a food additive is safe. The safety criteria that must be considered by the agency before a food additive regulation is issued are listed in 21 U.S.C. 348(c)(5). The act does not prescribe what safety tests should be performed to determine whether an additive is safe. Public Citizen's objection references the regulation in § 170.22 which sets out a safety factor of 100-to-1 in applying animal experimentation data to man (that is, the additive will not be approved for use in an amount greater than 1/100th of the maximum amount demonstrated to be without harm to experimental animals), unless evidence is submitted which justifies use of a difference safety factor. That regulation concerns how to apply animal experimentation data when it exists. It does not, however, require that animal testing be done in all food additive safety determinations. Because of the extremely low levels of induced radioactivity in food from the use of 7.5 MeV x-rays, it would not be possible to measure any toxicological effects from this induced activity in food fed to animals even with the most sensitive toxicological testing. Consequently, animal testing is neither necessary nor helpful to demonstrate the safety of food treated with 7.5 MeV x-rays. Rather, safety was demonstrated by showing that calculated estimates of radiation exposure from induced activity in food from the use of 7.5 MeV x-rays is far below the exposure from activity resulting from radionuclides that are present naturally in food. FDA concluded that such an analysis provides information that is far more sensitive to potential effects than can be obtained from the use of animal studies. Public Citizen has submitted no information to establish that the animal and other testing it recommended is required to demonstrate safety, or even that such testing would be valid to assess safety. Because Public Citizen provided no evidence to consider in support of its assertion, FDA is denying the request for a hearing on this point because a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions (21 CFR 12.24(b)(2)).
(5)Public Citizen asserts that by FDA failing to comply with § 170.22, FDA did not comply with § 170.20 (21 CFR 170.20), which states that “the Commissioner will be guided by the principles and procedures for establishing the safety of food additives stated in current publications of the National Academy of Sciences National Research Council.” Section 170.22 pertains to safety factors to be applied to animal experimentation data in determining whether a proposed use of a food additive is safe. As discussed previously in item 4, no animal studies were necessary nor were any conducted to demonstrate that the use of 7.5 MeV x-rays is safe for treating food. Because the provisions of § 170.22 do not apply to the agency's review of FAP 3M4745, Public Citizen's assertion that FDA did not comply with § 170.20 because it did not comply with § 170.22 is without merit. Therefore, this objection is not a basis for a hearing because there is no genuine and substantial issue of fact for resolution (§ 12.24(b)(1)).
(6)Public Citizen asserts that FDA did not comply with 21 U.S.C. 348(c)(3)(A), which states that “No such regulation shall issue if a fair evaluation of the data before the Secretary—(A) fails to establish that the proposed use of the food additive, under the conditions of use to be specified in the regulation, will be safe: *Provided* , That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man.” Nor has FDA complied with § 170.3(i), which defines “safe” as “there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” Public Citizen has not provided any evidence to support these allegations or that contradicts or challenges the agency's safety determination. The agency finds that this objection is merely a general description of Public Citizen's position, and that it does not raise a factual issue for resolution at a hearing. Therefore, FDA is denying the requests for a hearing on this point because there is no genuine and substantial issue of fact for resolution at a hearing, and a hearing will not be granted on the basis of mere allegations or denials or general descriptions of positions and contentions (§ 12.24(b)(1) and (b)(2)). V. Summary and Conclusions Section 409 of the act requires that a food additive be shown to be safe prior to marketing. Under § 170.3(i), a food additive is “safe” if there is a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use. In the final rule approving the use of 7.5 MeV x-rays for treating food, FDA concluded, based on its evaluation of the data submitted in the petition and other relevant material, that the use of 7.5 MeV x-rays proposed in the petition for treating food is safe under the conditions set forth in the regulation codified at § 179.26. The petitioner has the burden to demonstrate the safety of the additive in order to gain FDA approval. Once FDA makes a finding of safety, the burden shifts to an objector, who must come forward with evidence that calls into question FDA's conclusion ( *American Cyanamid Co.* v. *FDA* , 606 F.2d 1307, 1314-1315 (D.C. Cir. 1979)). None of the objections received contained evidence to support a genuine and substantial issue of fact. Nor has any objector established that the agency overlooked significant information in reaching its conclusion. Therefore, the agency has determined that the objections that requested a hearing do not raise any substantial issue of fact that would justify an evidentiary hearing (§ 12.24(b)). Accordingly, FDA is not making any changes in response to the objections and is denying the requests for a hearing. Dated: March 27, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-6646 Filed 4-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 803, 814, 820, 821, 822, 874, 886, 1002, 1005, and 1020 [Docket No. 2007N-0104] Medical Devices; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. SUMMARY: The Food and Drug Administration
(FDA)is amending certain medical device regulations to correct typographical errors and to ensure accuracy and clarity in the agency's regulations. EFFECTIVE DATE: April 9, 2007. FOR FURTHER INFORMATION CONTACT: Philip Desjardins, Center for Devices and Radiological Health (HFZ-215), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-2343. SUPPLEMENTARY INFORMATION: FDA is amending its regulations in parts 803, 814, 820, 821, 822, 874, 886, 1002, 1005, and 1020 to correct typographical errors, and update addresses, telephone numbers, and wording to ensure accuracy and clarity in the agencies medical device regulations. Publication of this document constitutes final action on these changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because these errors are nonsubstantive. I. Highlights of the Final Rule FDA is making changes to correct typographical and other minor errors in certain device regulations in parts 803, 814, 820, 821, 822, 874, 886, 1002, 1005, and 1020 (21 CFR 803, 814, 820, 821, 822, 874, 886, 1002, 1005, and 1020). 1. FDA is revising § 803.11 and replacing “301-443-8818” with “240-276-3151.” 2. FDA is revising § 803.11 and replacing “ *http://www.fda.gov/cdrh/mdr/mdr-forms.html* ” with “ *http://www.fda.gov/medwatch/getforms.htm* .” 3. FDA is revising § 803.21(a) and replacing “301-443-8818” with “240-276-3151.” 4. FDA is revising § 803.21(a) and replacing “ *http://www.fda.gov/cdrh/mdr/373.html* ” with “ *http://www.fda.gov/cdrh/mdr/mdr-forms.html* .” 5. FDA is revising § 814.20(g) and replacing “FDA has issued a PMA guidance document to assist the applicant in the arrangement and content of a PMA. This guidance document is available on the Internet at *http://www.fda.gov/cdrh/dsma/pmaman/front.html* . This guidance document is also available upon request from the Center for Devices and Radiological Health, Division of Small Manufacturers Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, FAX 301-443-8818” with “Additional information on FDA policies and procedures, as well as links to PMA guidance documents, is available on the Internet at *http://www.fda.gov/cdrh/devadvice/pma/* .” 6. FDA is revising § 820.1(e) and replacing “Division of Small Manufacturers Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., telephone 1-800-638-2041 or 1-301-443-6597, FAX 301-443-8818” with “Division of Small Manufacturers, International and Consumer Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., telephone 1-800-638-2041 or 240-276-3150, FAX 240-276-3151.” 7. FDA is revising § 821.2(c) and removing the words “and Surveillance.” 8. FDA is revising § 822.7(b) and replacing “( *www.fda.gov/cdrh/resolvingdisputes* ), and from the CDRH Facts-on-Demand system (800-899-0381 or 301-827-0111)” with “( *http://www.fda.gov/cdrh/ombudsman/dispute.html* ).” 9. FDA is revising § 822.15 and replacing “You may obtain guidance regarding dispute resolution procedures from the Center for Devices and Radiological Health's
(CDRH)Web site ( *www.fda.gov/cdrh/resolvingdisputes/ombudsman.html* ) and from the CDRH Facts-on-Demand system (800-899-0381 or 301-827-0111, document number 1121)” with “You may obtain guidance regarding dispute resolution procedures from the Center for Devices and Radiological Health's (CDRH's) Web site ( *www.fda.gov/cdrh/ombudsman/* ).” 10. FDA is revising § 822.22(b) and replacing “You may obtain guidance documents that discuss these mechanisms from the CDRH Web site and from the CDRH Facts-on-Demand System (800-899-0381 or 301-827-0111)” with “You may obtain guidance documents that discuss these mechanisms from the Center for Devices and Radiological Health's (CDRH's) Web site.” 11. FDA is revising § 874.4420 and replacing “tonsil suction tub” with “tonsil suction tube.” 12. FDA is revising § 874.4420 and replacing “ear suction tub” with “ear suction tube.” 13. FDA is revising the section title in § 886.1090 and replacing “Haidlinger” with “Haidinger.” 14. FDA is revising § 886.1090(a) and replacing “Haidlinger” with “Haidinger.” 15. FDA is revising § 1002.7 and replacing “shall be addressed to the Center for Devices and Radiological Health, Electronic Product Reports, Office of Compliance (HFZ-307), 2098 Gaither Rd., Rockville, MD 20850” with “shall be addressed to the Center for Devices and Radiological Health, ATTN: Electronic Product Reports, Radiological Health Document Control (HFZ-309), Office of Communication, Education, and Radiation Programs, 9200 Corporate Blvd, Rockville, MD 20850. 16. FDA is revising § 1002.10 and replacing “Center for Devices and Radiological Health, Electronic Product Reports, Office of Compliance (HFZ-307), 2098 Gaither Rd., Rockville, MD 20850” with “Center for Devices and Radiological Health, ATTN: Electronic Product Reports, Radiological Health Document Control (HFZ-309), Office of Communication, Education, and Radiation Programs, 9200 Corporate Blvd, Rockville, MD 20850.” 17. FDA is revising § 1002.20(b) and replacing “Director, Center for Devices and Radiological Health, 5600 Fishers Lane, Rockville, MD 20857” with “Center for Devices and Radiological Health, ATTN: Accidental Radiation Occurrence Reports (HFZ-240), Office of Communication, Education, and Radiation Programs, 9200 Corporate Boulevard, Rockville, MD 20850.” 18. FDA is revising § 1002.50(c)(3) and replacing “Office of Compliance (HFZ-307)” with “Office of Communication, Education, and Radiation Programs (HFZ-240).” 19. FDA is revising § 1005.11 and replacing “5600 Fishers Lane, Rockville, MD 20857” with “(HFZ-204), 9200 Corporate Blvd., Rockville, MD 20857.” 20. FDA is revising § 1005.25(b) and adding “(HFZ-240).” 21. FDA is revising § 1020.30(c) and replacing “Office of Compliance and Surveillance” with “Office of Communication, Education, and Radiation Programs.” II. Environmental Impact The agency has determined under 21 CFR 25.30(i) that this final rule is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement was required. III. Analysis of Impacts FDA has examined the impacts of the final rule under Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this rule corrects only typographical and nonsubstantive errors in existing regulations and does not change in any way how devices are regulated, the agency certifies that the final rule will 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 final rule to result in any 1-year expenditure that would meet or exceed this amount. IV. Paperwork Reduction Act of 1995 FDA has determined that this final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. V. Federalism FDA has analyzed this final 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 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. VI. The Technical Amendments This rule updates and corrects existing regulations to ensure accuracy and clarity. This administrative action is limited to correcting typographical errors; updating changes in addresses, web site locations, and telephone numbers; and clarifying regulation terminology. It makes no changes in substantive requirements. For the effective date of this final rule see EFFECTIVE DATE . Because this final rule is an administrative action, FDA has determined that it has no substantive impact on the public. It imposes no costs, and merely makes technical administrative changes in the Code of Federal Regulations
(CFR)for the convenience of the public. FDA, therefore, for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and public comment are unnecessary. List of Subjects 21 CFR Part 803 Imports, Medical devices, Reporting and recordkeeping requirements. 21 CFR Part 814 Administrative practice and procedure, Confidential business information, Medical devices, Medical research, Reporting and recordkeeping requirements. 21 CFR Part 820 Medical devices, Reporting and recordkeeping requirements. 21 CFR Part 821 Imports, Medical devices, Reporting and recordkeeping requirements. 21 CFR Part 822 Medical devices, Reporting and recordkeeping requirements. 21 CFR Part 874 Medical devices. 21 CFR Part 886 Medical devices, Ophthalmic goods and services. 21 CFR Part 1002 Electronic products, Radiation protection, Reporting and recordkeeping requirements. 21 CFR Part 1005 Administrative practice and procedure, Electronic products, Imports, Radiation protection, Surety bonds. 21 CFR Part 1020 Electronic products, Medical devices, Radiation protection, Reporting and recordkeeping requirements, Television, X-rays. Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 803, 814, 820, 821, 822, 874, 886, 1002, 1005, and 1020 are amended as follows: PART 803—MEDICAL DEVICE REPORTING 1. The authority section for part 803 continues to read as follows: Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374. 2. Section 803.11 is revised to read as follows: § 803.11 What form should I use to submit reports of individual adverse events and where do I obtain these forms? If you are a user facility, importer, or manufacturer, you must submit all reports of individual adverse events on FDA MEDWATCH Form 3500A or in an electronic equivalent as approved under § 803.14. You may obtain this form and all other forms referenced in this section from any of the following:
(a)The Consolidated Forms and Publications Office, Beltsville Service Center, 6351 Ammendale Rd., Landover, MD 20705;
(b)FDA, MEDWATCH (HF-2), 5600 Fishers Lane, Rockville, MD 20857, 301-827-7240;
(c)Division of Small Manufacturers, International, and Consumer Assistance, Office of Communication, Education, and Radiation Programs, Center for Devices and Radiological Health
(CDRH)(HFZ-220), 1350 Piccard Dr. Rockville, MD 20850, by e-mail: *DSMICA@CDRH.FDA.GOV* , or FAX: 240-276-3151;
(d)On the Internet at *http://www.fda.gov/medwatch/getforms.htm* . 3. In § 803.21, paragraph
(a)is revised to read as follows: § 803.21 Where can I find the reporting codes for adverse events that I use with medical device reports?
(a)The MEDWATCH Medical Device Reporting Code Instruction Manual contains adverse event codes for use with FDA Form 3500A. You may obtain the coding manual from CDRH's Web site at *http://www.fda.gov/cdrh/mdr/mdr-forms.html* ; and from the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, 1350 Piccard Dr., Rockville, MD 20850, FAX: 240-276-3151, or e-mail to *DSMICA@CDRH.FDA.GOV* . PART 814—PREMARKET APPROVAL OF MEDICAL DEVICES 4. The authority section for part 814 continues to read as follows: Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 373, 374, 375, 379, 379e, 381. 5. In § 814.20, paragraph
(g)is revised to read as follows: § 814.20 Application.
(g)Additional information on FDA policies and procedures, as well as links to PMA guidance documents, is available on the Internet at *http://www.fda.gov/cdrh/devadvice/pma/* . PART 820—QUALITY SYSTEMS REGULATION 6. The authority section for part 820 continues to read as follows: Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383. 7. In § 820.1, paragraph (e)(1) is revised to read as follows: § 820.1 Scope.
(e)*Exemptions or variances* .
(1)Any person who wishes to petition for an exemption or variance from any device quality system requirement is subject to the requirements of section 520(f)(2) of the act. Petitions for an exemption or variance shall be submitted according to the procedures set forth in § 10.30 of this chapter, the FDA's administrative procedures. Guidance is available from the Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., telephone 1-800-638-2041 or 240-276-3150, FAX 240-276-3151. PART 821—MEDICAL DEVICE TRACKING REQUIREMENTS 8. The authority section for part 821 continues to read as follows: Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 374. 9. In § 821.2, paragraph
(c)is revised to read as follows: § 821.2 Exemptions and variances.
(c)An exemption or variance is not effective until the Director, Office of Compliance, CDRH, approves the request under § 10.30(e)(2)(i) of this chapter. PART 822—POSTMARKET SURVEILLANCE 10. The authority section for part 822 continues to read as follows: Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374. 11. In § 822.7, paragraph
(b)is revised to read as follows: § 822.7 What should I do if I do not agree that postmarket surveillance is appropriate?
(b)You may obtain guidance documents that discuss these mechanisms from the Center for Devices and Radiological Health's (CDRH's) Web site ( *http://www.fda.gov/cdrh/ombudsman/dispute.html* ). 12. Section 822.15 is revised to read as follows: § 822.15 How long must I conduct postmarket surveillance of my device? The length of postmarket surveillance will depend on the postmarket surveillance question identified in our order. We may order prospective surveillance for a period up to 36 months; longer periods require your agreement. If we believe that a prospective period of greater than 36 months is necessary to address the surveillance question, and you do not agree, we will use the Medical Devices Dispute Resolution Panel to resolve the matter. You may obtain guidance regarding dispute resolution procedures from the Center for Devices and Radiological Health's (CDRH') Web site ( *www.fda.gov/cdrh/ombudsman/* ). The 36-month period refers to the surveillance period, not the length of time from the issuance of the order. 13. In § 822.22, paragraph
(b)is revised to read as follows: § 822.22 What recourse do I have if I do not agree with your decision?
(b)You may obtain guidance documents that discuss these mechanisms from the Center for Devices and Radiological Health's (CDRH's) Web site. PART 874—EAR, NOSE, AND THROAT DEVICES 14. The authority section for part 874 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 15. In § 874.4420, paragraph
(a)is revised to read as follows: § 874.4420 Ear, nose, and throat manual surgical instrument.
(a)*Identification* . An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar. PART 886—OPHTHALMIC DEVICES 16. The authority section for part 886 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. 17. In § 886.1090, the section title and paragraph
(a)are revised to read as follows: § 886.1090 Haidinger brush.
(a)*Identification* . A Haidinger brush is an AC-powered device that provides two conical brushlike images with apexes touching which are viewed by the patient through a Nicol prism and intended to evaluate visual function. It may include a component for measuring macular integrity. PART 1002—RECORDS AND REPORTS 18. The authority section for part 1002 continues to read as follows: Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 374. 19. In § 1002.7, the introductory text is revised to read as follows: § 1002.7 Submission of data and reports. All submissions such as reports, test data, product descriptions, and other information required by this part, or voluntarily submitted to the Director, Center for Devices and Radiological Health, shall be filed with the number of copies as prescribed by the Director, Center for Devices and Radiological Health, and shall be signed by the person making the submission. The submissions required by this part shall be addressed to the Center for Devices and Radiological Health, ATTN: Electronic Product Reports, Radiological Health Document Control (HFZ-309), Office of Communication, Education, and Radiation Programs, 9200 Corporate Blvd., Rockville, MD 20850. 20. In § 1002.10, the introductory text is revised to read as follows: § 1002.10 Product reports. Every manufacturer of a product or component requiring a product report as set forth in table 1 of § 1002.1 shall submit a product report to the Center for Devices and Radiological Health, ATTN: Electronic Product Reports, Radiological Health Document Control (HFZ-309), Office of Communication, Education, and Radiation Programs, 9200 Corporate Blvd., Rockville, MD 20850, prior to the introduction of such product into commerce. The report shall be distinctly marked “Radiation Safety Product Report of (name of manufacturer)” and shall: 21. In § 1002.20, paragraph
(b)is revised to read as follows: § 1002.20 Reporting of accidental radiation occurrences.
(b)Such reports shall be addressed to the Center for Devices and Radiological Health, ATTN: Accidental Radiation Occurrence Reports (HFZ-240), Office of Communication, Education, and Radiation Programs, 9200 Corporate Blvd., Rockville, MD 20850, and the reports and their envelopes shall be distinctly marked “Report on 1002.20” and shall contain all of the following information where known to the manufacturer:
(1)The nature of the accidental radiation occurrence;
(2)The location at which the accidental radiation occurrence occurred;
(3)The manufacturer, type, and model number of the electronic product or products involved;
(4)The circumstances surrounding the accidental radiation occurrence, including causes;
(5)The number of persons involved, adversely affected, or exposed during the accidental radiation occurrence, the nature and magnitude of their exposure and/or injuries and, if requested by the Director, Center for Devices and Radiological Health, the names of the persons involved;
(6)The actions, if any, which may have been taken by the manufacturer, to control, correct, or eliminate the causes and to prevent reoccurrence; and
(7)Any other pertinent information with respect to the accidental radiation occurrence. 22. In § 1002.50, paragraph (c)(3) is revised to read as follows: § 1002.50 Special exemptions.
(c)* * *
(3)Such conditions as are deemed necessary to protect the public health and safety. Copies of exemptions shall be available upon request from the Center for Devices and Radiological Health, Office of Communication, Education, and Radiation Programs (HFZ-240), 9200 Corporate Blvd., Rockville, MD 20850. PART 1005—IMPORTATION OF ELECTRONIC PRODUCTS 23. The authority section for part 1005 continues to read as follows: Authority: 42 U.S.C. 263d, 263h. 24. Section 1005.11 is revised to read as follows: § 1005.11 Payment for samples. The Department of Health and Human Services will pay for all import samples of electronic products rendered unsalable as a result of testing, or will pay the reasonable costs of repackaging such samples for sale, if the samples are found to be in compliance with the requirements of the Radiation Control for Health and Safety Act of 1968. Billing for reimbursement shall be made by the owner or consignee to the Center for Devices and Radiological Health (HFZ-204), 9200 Corporate Blvd., Rockville, MD 20857. Payment for samples will not be made if the sample is found to be in violation of the Act, even though subsequently brought into compliance pursuant to terms specified in a notice of permission issued under § 1005.22. 25. In § 1005.25, paragraph
(b)is revised to read as follows: § 1005.25 Service of process on manufacturers.
(b)A manufacturer designating an agent must address the designation to the Center for Devices and Radiological Health (HFZ-240), 9200 Corporate Blvd., Rockville, MD 20850. It must be in writing and dated; all signatures must be in ink. The designation must be made in the legal form required to make it valid and binding on the manufacturer under the laws, corporate bylaws, or other requirements governing the making of the designation by the manufacturer at the place and time where it is made, and the persons or person signing the designation shall certify that it is so made. The designation must disclose the manufacturer's full legal name and the name(s) under which the manufacturer conducts the business, if applicable, the principal place of business, and mailing address. If any of the products of the manufacturer do not bear his legal name, the designation must identify the marks, trade names, or other designations of origin which these products bear. The designation must provide that it will remain in effect until withdrawn or replaced by the manufacturer and shall bear a declaration of acceptance duly signed by the designated agent. The full legal name and mailing address of the agent must be stated. Until rejected by the Secretary, designations are binding on the manufacturer even when not in compliance with all the requirements of this section. The designated agent may not assign performance of his function under the designation to another. PART 1020—PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS 26. The authority section for part 1020 continues to read as follows: Authority: 21 U.S.C. 351, 352, 360e-360j, 360gg-360ss, 371, 381. 27. In § 1020.30, paragraph
(c)is revised to read as follows: § 1020.30 Diagnostic x-ray systems and their major components.
(c)*Manufacturers' responsibility* . Manufacturers of products subject to §§ 1020.30 through 1020.33 shall certify that each of their products meet all applicable requirements when installed into a diagnostic x-ray system according to instructions. This certification shall be made under the format specified in § 1010.2 of this chapter. Manufacturers may certify a combination of two or more components if they obtain prior authorization in writing from the Director of the Office of Communication, Education, and Radiation Programs of the Center for Devices and Radiological Health. Manufacturers shall not be held responsible for noncompliance of their products if that noncompliance is due solely to the improper installation or assembly of that product by another person; however, manufacturers are responsible for providing assembly instructions adequate to assure compliance of their components with the applicable provisions of §§ 1020.30 through 1020.33. Dated: March 28, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-6290 Filed 4-6-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Parts 1300 and 1313 [Docket No. DEA-292I] RIN 1117-AB06 Implementation of the Combat Methamphetamine Epidemic Act of 2005; Notice of Transfers Following Importation or Exportation AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Interim Final Rule with Request for Comment. SUMMARY: This regulation implements section 716 of the Combat Methamphetamine Epidemic Act
(CMEA)of 2005 (21 U.S.C. 971 as amended), which was enacted on March 9, 2006. DEA is amending its regulations to require additional reporting for import, export, and international transactions involving all List I and List II chemicals. This rule implements section 716 of the CMEA which extends current reporting requirements for importations, exportations, and international transactions involving List I and List II chemicals. DATES: This rule is effective May 9, 2007. Written comments must be postmarked, and electronic comments must be sent, on or before May 9, 2007. ADDRESSES: To ensure proper handling of comments, please reference “Docket No. DEA-292” on all written and electronic correspondence. Written comments being sent via regular mail should be sent to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/ODL. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA Federal Register Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301. Comments may be directly sent to DEA electronically by sending an electronic message to *dea.diversion.policy@usdoj.gov.* Comments may also be sent electronically through *http://www.regulations.gov* using the electronic comment form provided on that site. An electronic copy of this document is also available at the *http://www.regulations.gov* Web site. DEA will accept attachments to electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file formats other than those specifically listed here. FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537 at
(202)307-7297. SUPPLEMENTARY INFORMATION: DEA's Legal Authority DEA implements the Comprehensive Drug Abuse Prevention and Control Act of 1970, often referred to as the Controlled Substances Act
(CSA)and Controlled Substances Import and Export Act (21 U.S.C. 801 *et seq.* ), as amended. DEA publishes the implementing regulations for this statute in Title 21 of the Code of Federal Regulations (CFR), Parts 1300 to end. These regulations are designed to ensure that there is a sufficient supply of controlled substances for legitimate medical purposes and to deter the diversion of controlled substances to illegal purposes. The CSA mandates that DEA establish a closed system of control for manufacturing, distributing, and dispensing controlled substances. Any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances must register with DEA (unless exempt) and comply with the applicable requirements for the activity. The CSA as amended also requires DEA to regulate the manufacture and distribution of chemicals that may be used to manufacture controlled substances. Listed chemicals that are classified as List I chemicals are important to the manufacture of controlled substances. Those classified as List II chemicals may be used to manufacture controlled substances. On March 9, 2006, the President signed the CMEA of 2005, which is Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005 (Pub. L. 109-177). DEA is promulgating this rule as an interim final rule rather than a proposed rule because the changes being made merely codify statutory provisions. Much of the statute is self-implementing; the changes discussed in this rule became effective on March 9, 2006. An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act
(APA)(5 U.S.C. 553), including Notice of Proposed Rulemaking and the opportunity for public comment, if it is determined to be unnecessary, impracticable, or contrary to the public interest. The requirements of the CMEA of 2005 included in this rulemaking were set out in such detail as to be self-implementing. Therefore the changes in this rulemaking provide conforming amendments to make the language of the regulations consistent with that of the law. DEA has no authority to revise the changes and is simply implementing, and making its regulations conform to, the statute. Combat Methamphetamine Epidemic Act of 2005 The portion of the CMEA being implemented in this rulemaking addresses the importation, exportation, and international transactions of all List I and List II chemicals. Section 716 of the CMEA (21 U.S.C. 971 as amended) closes a loophole in the current regulatory system for imports, exports, and international transactions of listed chemicals used in the illicit manufacture of controlled substances. Prior to enactment of the CMEA, a company that wanted to import or export any List I or List II chemical was required to either:
(1)Notify the Department of Justice 15 days in advance of the import or export; or
(2)be a company that previously imported or exported a listed chemical and that was proposing to import from or export the chemicals to a customer with whom the company had previously dealt. (See 21 U.S.C. 971(a), (b)) A problem can arise, however, when the sale that the importer or exporter originally planned falls through. When this happens, the importer or exporter must quickly find a new buyer for the chemicals on what is called the “spot market”—a wholesale market. Sellers are often under presure to find a buyer in a short amount of time, meaning that they may be tempted to entertain bids from companies without a strong record of preventing diversion. More importantly, DEA is not made aware of, and has no opportunity to review, such transactions in advance in order to suspend them if there is a danger of diversion to the clandestine manufacture of a controlled substance. Section 716 of the CMEA extends the current reporting requirements—as well as the current exemption for regular importers and regular customers—to post-import and post-export transactions of List I and List II chemicals. Importers, exporters, brokers, and traders are now required to notify DEA, before the transaction is to take place, of certain information regarding their downstream customers. If the person to whom the chemical is being transferred is not a regular customer, the importer, exporter, broker, or trader must notify DEA no later than 15 days before the transaction is to take place; upon receipt, DEA will have 15 days to review the notification. Specifically, the United States importer or exporter must provide the name and address of each person to whom the listed chemicals will be transferred, and the name and quantity of the listed chemicals to be transferred, including package information. This person is referred to as the “transferee” of the United States importer or exporter. The spot market reporting requirements also apply, to a limited extent, to United States brokers and traders that arrange international transactions ( *i.e.* , transactions between customers in two foreign countries). For a United States exporter, the transferee is the foreign importer. Thus, this aspect of the new requirement does not represent a change for United States exporters, who have previously notified DEA of information on their purchasers. For a United States broker or trader, the transferee is the foreign customer purchasing the listed chemicals. Again, this requirement is not a change for brokers and traders, who have previously notified DEA of information on their purchasers. The requirement is, however, a change for United States importers. For a United States importer, the “transferee” is the person to whom the importer transfers the listed chemicals—the downstream customer. Until the CMEA, importers were required to provide information regarding their suppliers, but not regarding the parties purchasing the chemicals in the United States. Under the CMEA, importers will have to list both the foreign supplier and each United States customer for the imported chemical. The provision of customer information by the importer provides DEA with an opportunity to evaluate the transaction. DEA will have 15 days from the time the customer information is submitted to review the transaction and determine whether it may be diverted to the clandestine manufacture of a controlled substance. If DEA determines that the transaction does not pose an unacceptable risk of diversion, DEA will take no action. The importer will thus be granted regular importer status for transactions involving the specific chemical to be imported to the specific customer. The transferee—the downstream customer—will be granted regular customer status for imports of the specified chemical by the specified importer. DEA must review each import transaction based not only on the chemical to be imported, but also on the transferee to whom the chemical will be transferred. If, after submission of the initial DEA Form 486, Import/Export Declaration, the importer, exporter, broker, or trader will not be transferring the listed chemical to the person initially named on the DEA Form 486, or if the importer or exporter will be transferring a greater quantity than originally indicated on the DEA Form 486, then the importer, exporter, broker, or trader must file an amended DEA Form 486 reporting the change. This is a new requirement for both United States importers and exporters, as well as brokers and traders. This amendment must provide the name of the new prospective customer and/or the greater quantity of the listed chemical to be transferred. The requirement to notify DEA of a change in the transferee or an increase in the quantity of the chemical to be transferred applies to amended DEA Forms 486 in the same manner that it applies to original submissions. Thus, if an importer, exporter, broker, or trader is required to file an initial advance notice with DEA 15 days before the transaction is to take place, and the originally planned sale falls through, the importer, exporter, broker, or trader is required to file a second advance notice with DEA, identifying the new proposed purchaser. DEA will again have 15 days to review the new transaction and determine whether it may be diverted to the clandestine manufacture of a controlled substance. In the case of a transaction reported by a broker or trader, DEA cannot suspend the transaction, but could alert authorities in the foreign country involved in the transaction of the risk of diversion. In addition, even if an importer or exporter did not have to file an initial notification—either because he is a regular importer selling to a regular customer, or an exporter selling to a regular customer—if the newly arranged spot market sale is to a new customer ( *i.e.* , not a “regular customer”), the importer or exporter must file an advance notice 15 days prior to transferring the chemical to the new customer. As is the case under existing law, a suspension can be appealed through an administrative hearing. (See 21 U.S.C. 971(c)(2)) If, however, the new proposed purchaser qualifies as a “regular customer” under existing law, the importer or exporter is not required to file a second advance notice 15 days prior to the transfer of the listed chemical. Rather, notice must be filed on or before the date of the transfer. Note that the second notice may occur after importation or exportation. (Brokers and traders are required to report all regulated international transactions.) If DEA determines that a listed chemical shipment handled by a regular importer or a regular customer (including a regular customer who is substituted for the original customer listed on the original advance notification) may be diverted to the clandestine manufacture of a controlled substance, DEA may disqualify the regular importer or regular customer status of such importer or customer and may suspend the shipment. If the importer or customer (including a new proposed customer) is not a regular importer or customer, then DEA may suspend the shipment, since there would be no regular importer or regular customer status to disqualify. The procedures are set forth in the new regulatory text at 21 CFR 1313.16(d). Similarly, in the case of an export of a listed chemical that may be diverted to the clandestine manufacture of a controlled substance, DEA may disqualify the regular customer status of the transferee and suspend the shipment. See 21 CFR 1313.26(d). Finally, within 30 days after the importation, exportation, or international transaction is completed, the importer, exporter, broker, or trader must send DEA a return declaration containing information regarding the transaction, including the name of the transferee, date the import or export and any subsequent transfer occurred, the name of the chemical transferred, the actual quantity transferred, the container, and any other information that DEA may specify. This is a new requirement for United States importers, exporters, brokers, and traders. For importers, a single return declaration may include the information for both the importation and distribution. If the importer has not distributed all chemicals imported by the end of the initial 30-day period, the importer must file supplemental return declarations no later than 30 days from the date of any further distribution, until the distribution or other disposition of all chemicals imported under the import notification or any update are accounted for. In addition, if an importer, exporter, broker, or trader files a DEA Form 486, but the transfer covered fails to take place ( *e.g.* , the import or export is canceled prior to shipment), the person must file an amended DEA Form 486 to notify DEA of the cancellation. These additional filings will ensure that DEA has an accurate record of importations, exportations, and international transactions. Summary of Changes Made by This Interim Final Rule The table below provides a comparison of the previous requirements regarding imports, exports, and international transactions with the new requirements of the CMEA: Table 1.—Comparison of Previous and New Requirements Requirement Previous rule New rule Notify DEA prior to import/export/international transactions Yes Yes. Identify source of imports/international transactions Yes Yes. Identify transferees of exports/international transactions Yes Yes. Identify transferees (downstream customers) of imports No Yes. Notify DEA of change in transferees of exports and international transactions prior to transaction No Yes. Notify DEA of change in transferees (downstream customers) of imports prior to transaction No Yes. Notify DEA of increase in chemical quantity transferred for exports and international transactions prior to transaction No Yes. Notify DEA of increase in chemical quantity transferred for import transactions prior to transaction No Yes. File return declaration when imports/exports and international transactions are distributed No Yes. File subsequent return declaration if entire quantity of import not distributed within 30 days of importation No Yes. Specific Changes Made by This Interim Final Rule In this interim final rule, DEA is incorporating the provisions of section 716 of the CMEA into Title 21 of the Code of Federal Regulations. Specific changes are discussed below. Certain definitions relating to listed chemicals in section 1300.02 are being revised or amended. The definition of “established business relationship” is being revised to remove language regarding foreign customers; this definition is now a general definition relating to any business relationship, either import or export. Further, parts of this definition are moved to new Section 1313.05, requirements of an established business relationship. The definition of “established record as an importer” is being revised by moving certain information into new Section 1313.08. Finally, the definition of “regular customer” is being revised to update the cross reference. As noted previously, Section 1313.05 is added to specify requirements of an established business relationship. Information in this section was previously found in the definition of “established business relationship.” As noted previously, Section 1313.08 is added to specify requirements for establishing a record as an importer. Information in this section was previously found in the definition of “established record as an importer.” Section 1313.15(a) is being amended to update the cross reference accordingly. Section 1313.12, requirement of authorization to import, is amended by revising paragraph
(c)to add the requirement that, to qualify for a waiver of the 15 day advance notice, not only does the importer have to be known to DEA as a regular importer, but also that the customer must meet the requirements in Section 1313.05 to be regarded as a regular customer. The effect of this new requirement is that, effective May 9, 2007, all persons previously granted regular importer status will be required to provide advance notification of imports with information regarding transferees, even for customers that they did business with in the past. This advance notification will provide DEA the opportunity to review and approve the customer as a regular customer (see the new definition in Section 1300.02 and the requirements in new Section 1313.05). If the 15-day notification period elapses without DEA taking action, then that importer is granted regular importer status for all imports of that particular chemical intended for the specified customer. Section 1313.13, contents of import declaration, is amended by requiring the importer to provide information regarding the person or persons to whom the importer intends to transfer the chemical. Section 1313.16 is added to specify requirements regarding transfers after importation, Section 1313.26 is added to specify requirements regarding transfers after exportation, and Section 1313.32 is amended to specify requirements for brokers and traders regarding international transactions. These requirements specify what the U.S. importer, the U.S. exporter, or the U.S. broker or trader must do if an originally planned sale falls through and the importer or exporter arranges a subsequent spot market sale, as explained earlier in the preamble. For brokers and traders, the situation is somewhat more complicated because the broker or trader does not control the sale. If a transaction is not completed, the broker or trader could be asked to find another buyer for the chemical or the broker or trader may not be involved in arranging the subsequent sale. If the broker or trader arranges a subsequent sale to replace the previously arranged transaction, this transaction is a new transaction and must be reported as such; a return declaration must be filed when the transaction is completed. Sections 1313.17(a), 1313.27(a), and 1313.35(a) are added to specify the requirement that within 30 days of the completion of a transaction, the importer, exporter, broker, or trader must send DEA a return declaration containing information regarding the transaction, including the name of the transferee, date the import, export, or international transaction and any subsequent transfer occurred, the name of the chemical transferred, the actual quantity transferred, the container, and any other information that DEA may specify. Sections 1313.17(b), 1313.27(b), and 1313.35(b) are added to specify the requirement that if an importation, exportation, or international transaction reported on a DEA Form 486 fails to be completed, the importer, exporter, broker, or trader must file an amendment to the Form 486 to notify DEA. Revision of DEA Form 486: Import/Export Declaration for Precursor and Essential Chemicals To comply with the changes made to the Controlled Substances Act by the Combat Methamphetamine Epidemic Act of 2005, DEA is revising the existing DEA Form 486, Import/Export Declaration. DEA notes that this form has not been revised or amended since its inception in 1989. Thus, this form has not kept pace with subsequent legislation including the Domestic Chemical Diversion Control Act of 1993, the Comprehensive Methamphetamine Control Act of 1996, and the Methamphetamine Anti-Proliferation Act of 2000. Therefore, some of the changes DEA is making to this form are not directly related to the CMEA. However, these changes are necessary for ease of use and clarity of the form. Changes being made include the following: • Changing the title of the form to: “Import/Export Declaration for List I and List II Chemicals” to more accurately characterize the use of the form. • Adding a check box for “international transaction” in addition to existing fields for “import” and “export.” • Adding fields for DEA registration number and company identifier, if applicable. • Adding a field for the foreign permit number, if applicable. • Adding check boxes for the type of submission of the form: “original,” “amended,” and “withdrawn.” • Adding fields for the actual date and quantity imported. • Adding fields for reporting by importers of the person to whom the listed chemical will be transferred, the downstream customer, per requirements of the CMEA. • Adding fields regarding return declaration by importers and exporters. • Removing the certification by the Customs District Director; this certification is now the responsibility of the importer or exporter as part of the return declaration. • Eliminating a number of fields, including: gross weight of chemicals imported/exported; intermediate carriers; address of intermediate consignees. • Reorganizing layout for clarity. Implementation of This Rule Effective May 9, 2007, all United States importers and exporters of List I and List II chemicals must use the revised DEA Form 486 to notify DEA of their imports and exports. This revised form will be available on the Diversion Control Program Web site, *http://www.deadiversion.usdoj.gov.* Effective May 9, 2007, all persons previously granted regular importer status will no longer hold that status. Every import of a List I and List II chemical must be reported to DEA not later than 15 days prior to the proposed importation. This report must include the name of the person to whom the chemical is proposed to be transferred and the amount of the chemical proposed to be transferred. DEA will evaluate each proposed importation based not only on the chemical to be imported but on the transferee information supplied by the importer as well. This process will allow for the establishment of regular customer status by transferees of United States importers, and for establishment of regular importer status by importers importing a specific listed chemical intended for sale to a specific customer. Effective May 9, 2007, all persons importing and exporting List I and List II chemicals must provide the above discussed return declarations to DEA. Note Regarding Importation of the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine This rulemaking addresses all List I and List II chemicals. While ephedrine, pseudoephedrine, and phenylpropanolamine are List I chemicals and are covered by these regulations, other provisions of section 721 of the CMEA require the reporting of certain information regarding the foreign chain of distribution of these three List I chemicals. Other provisions of the CMEA require that these three List I chemicals be imported only if there is a medical, scientific, or other legitimate purpose for these chemicals. DEA is addressing these provisions in a separate rulemaking. Persons importing ephedrine, pseudoephedrine, and phenylpropanolamine are required to comply with the provisions of this rule until such time as the rulemaking regarding provision of information about the foreign chain of distribution is promulgated. At that time, persons importing these three List I chemicals will then be subject to those additional requirements. Further, since the CMEA requires that these three List I chemicals be imported only if there is a medical, scientific, or other legitimate purpose for these chemicals, DEA must establish import quotas for ephedrine, pseudoephedrine, and phenylpropanolamine. DEA is addressing these provisions in separate rulemakings. Regulatory Certifications Administrative Procedure Act (5 U.S.C. 553) The Administrative Procedure Act
(APA)generally requires agencies to publish a notice of proposed rulemaking and allow for a period of public comment prior to implementing new rules. The APA also provides, however, that agencies can be excepted from these requirements when “the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” (5 U.S.C. 553(b)(B). DEA has concluded that “good cause” exists to promulgate this rule as an interim final rule rather than a proposed rule because the mandates of the CMEA were set forth in such detail as to be self-implementing. The changes announced in this interim final rule render DEA's regulations consistent with the new provisions of the CMEA. Since DEA is without authority to revise this rule based on public comments, DEA finds that notice and opportunity for comment are unnecessary and impracticable under the APA (5 U.S.C. 553(b)(B)). DEA is cognizant of the fact that exceptions to the APA's notice and comment procedures are to be “narrowly construed and only reluctantly countenanced.” *American Federation of Government Employees* v. *Block* , 655 F2d 1153, 1156 (D.C. Cir. 1981) (quoting *New Jersey Department of Environmental Protection* v. *EPA* , 626 F2d 1038, 1045 (D.C. Cir. 1980)). Based on the detailed requirements set forth in the CMEA which give no discretion in their implementation, however, DEA finds that the invocation of the “good cause” exception, and the issuance of this rule as an interim final rule, is justified. Regulatory Flexibility Act The Deputy Administrator hereby certifies that this rulemaking has been drafted in accordance with the Regulatory Flexibility Act
(RFA)(5 U.S.C. 605(b)). The RFA applies to rules that are subject to notice and comment. Because this rule is simply codifying statutory provisions, DEA has determined, as explained above, that public notice and comment are not necessary. Consequently, the RFA does not apply. Executive Order 12866 The Deputy Administrator further certifies that this rulemaking has been drafted in accordance with the principles in Executive Order 12866 § 1(b). It has been determined that this is “a significant regulatory action.” Therefore, this action has been reviewed by the Office of Management and Budget (OMB). As discussed above, this action is codifying statutory provisions and involves no agency discretion. This statutory change imposes minimal costs on United States importers, exporters, brokers, and traders; they simply have to file a form with DEA in advance of spot market transactions. They must also provide a return declaration after the import or export has occurred. Paperwork Reduction Act As discussed previously, the DEA is revising an information collection by revising the information collected on DEA Form 486: Import/Export Declaration for List I and List II Chemicals [OMB information collection 1117-0023]. Those changes have been discussed above, and are necessary for DEA to implement the provisions of the CMEA of 2005. The Department of Justice, DEA, has submitted the following information collection request to the OMB for review and clearance in accordance with review procedures of the Paperwork Reduction Act of 1995. The information collection is published to obtain comments from the public and affected agencies. All comments and suggestions, or questions regarding additional information, to include obtaining a copy of the information collection instrument with instructions, should be directed to Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537. Written comments and suggestions from the public and affected agencies concerning the collection of information are encouraged. Your comments on the information collection-related aspects of this rule should address one or more of the following four points:
(1)Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2)Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3)Enhance the quality, utility, and clarity of the information to be collected; and
(4)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, *e.g.* , permitting electronic submission of responses. Overview of this information collection:
(1)*Type of Information Collection:* revision of an existing collection.
(2)*Title of the Form/Collection:* Import/Export Declaration for List I and List II Chemicals.
(3)*Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection:* *Form Number:* DEA Form 486. Office of Diversion Control, Drug Enforcement Administration, U.S. Department of Justice.
(4)*Affected public who will be asked or required to respond, as well as a brief abstract:* *Primary:* business or other for-profit. *Other:* none. *Abstract:* Persons importing, exporting, and conducting international transactions with List I and List II chemicals must notify DEA of those transactions in advance of their occurrence, including information regarding the person(s) to whom the chemical will be transferred and the quantity to be transferred. For importations, persons must also provide return declarations, confirming the date of the importation and transfer, and the amounts of the chemical transferred. This information is used to prevent shipments not intended for legitimate purposes.
(5)*An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond:* Number of respondents Number of responses Average time per response Total hours Form 486 (export) 225 7,917 0.2 hour (12 minutes) 1,583.4 hours. Form 486 (export return declaration) 225 7,917 0.08 hour (5 minutes) 659.75 hours. Form 486 (import) 216 2,278 0.25 hour (15 minutes) 569.5 hours. Form 486 (import return declaration)* 216 2,506 0.08 hour (5 minutes) 208.8 hours. Form 486 (international transaction) 9 111 0.2 hour (12 minutes) 22.2 hours. Form 486 (international transaction return declaration) 9 111 0.08 hour (5 minutes) 9.25 hours. Quarterly reports for imports of acetone, 2-butanone, and toluene 110 440 0.5 hour (30 minutes) 220 hours. Total 225 3,272.9 hours. * DEA assumes 10% of all imports will not be transferred in the first thirty days and will necessitate submission of a subsequent return declaration.
(6)*An estimate of the total public burden (in hours) associated with the collection:* DEA estimates that this collection will take 3,272.9 hours annually. If additional information is required, contact: Lynn Bryant, Department Clearance Officer, Information Management and Security Staff, Justice Management Division, Department of Justice, Patrick Henry Building, Suite 1600, 601 D Street, NW., Washington, DC 20530. Executive Order 12988 This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform. Executive Order 13132 This rulemaking does not preempt or modify any provision of State law; nor does it impose enforcement responsibilities on any State; nor does it diminish the power of any State to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132. Unfunded Mandates Reform Act of 1995 This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $118,000,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. Congressional Review Act This rule is not a major rule as defined by § 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. List of Subjects 21 CFR Part 1300 Chemicals, Drug traffic control. 21 CFR Part 1313 Administrative practice and procedure, Drug traffic control, Exports, Imports, Reporting and recordkeeping requirements. For the reasons set out above, 21 CFR parts 1300 and 1313 are amended as follows: PART 1300—DEFINITIONS 1. The authority citation for part 1300 continues to read as follows: Authority: 21 U.S.C. 802, 871(b), 951, 958(f). 2. Section 1300.02 is amended by revising paragraphs (b)(12), (b)(13), and (b)(25) to read as follows: § 1300.02 Definitions related to listed chemicals.
(b)* * *
(12)The term *established business relationship* means the regulated person has imported or exported a listed chemical at least once within the past six months, or twice within the past twelve months from or to a foreign manufacturer, distributor, or end user of the chemical that has an established business with a fixed street address. A person or business that functions as a broker or intermediary is not a customer for purposes of this definition.
(13)The term *established record as an importer* means that the regulated person has imported a listed chemical at least once within the past six months, or twice within the past twelve months from a foreign supplier.
(25)The term *regular customer* means a person with whom the regulated person has an established business relationship for a specified listed chemical or chemicals that has been reported to the Administration subject to the criteria established in part 1313 of this chapter. PART 1313—IMPORTATION AND EXPORTATION OF LIST I AND LIST II CHEMICALS 3. The authority citation for part 1313 continues to read as follows: Authority: 21 U.S.C. 802, 830, 871(b), 971. 4. The heading of part 1313 is revised to read as set forth above. 5. Section 1313.05 is added to read as follows: § 1313.05 Requirements for an established business relationship. To document that an importer or exporter has an established business relationship with a customer, the importer or exporter must provide the Administrator with the following information in accordance with the waiver of 15-day advance notice requirements of § 1313.15 or § 1313.24:
(a)The name and street address of the chemical importer or exporter and of each regular customer;
(b)The telephone number, contact person, and where available, the facsimile number for the chemical importer or exporter and for each regular customer;
(c)The nature of the regular customer's business ( *i.e.* , importer, exporter, distributor, manufacturer, etc.), and if known, the use to which the listed chemical or chemicals will be applied;
(d)The duration of the business relationship;
(e)The frequency and number of transactions occurring during the preceding 12-month period;
(f)The amounts and the listed chemical or chemicals involved in regulated transactions between the chemical importer or exporter and regular customer;
(g)The method of delivery (direct shipment or through a broker or forwarding agent); and
(h)Other information that the chemical importer or exporter considers relevant for determining whether a customer is a regular customer. 6. Section 1313.08 is added to read as follows: § 1313.08 Requirements for establishing a record as an importer. To establish a record as an importer, the regulated person must provide the Administrator with the following information in accordance with the waiver of the 15-day advance notice requirements of § 1313.15:
(a)The name, DEA registration number (where applicable), street address, telephone number, and, where available, the facsimile number of the regulated person and of each foreign supplier; and
(b)The frequency and number of transactions occurring during the preceding 12 month period. 7. Section 1313.12 is amended by revising paragraph
(c)to read as follows: § 1313.12 Requirement of authorization to import.
(c)The 15-day advance notification requirement for listed chemical imports may be waived for the following:
(1)Any importation that meets both of the following requirements:
(i)The regulated person has satisfied the requirements for reporting to the Administration as a regular importer of the listed chemicals.
(ii)The importer intends to transfer the listed chemicals to a person who is a regular customer for the chemical, as defined in § 1300.02 of this chapter.
(2)A specific listed chemical, as set forth in paragraph
(f)of this section, for which the Administrator determines that advance notification is not necessary for effective chemical diversion control. 8. Section 1313.13 is amended by revising paragraph (c)(4) and adding paragraph (c)(5) to read as follows: § 1313.13 Contents of import declaration.
(c)* * *
(4)The name, address, telephone number, telex number, and, where available, the facsimile number of the consigner in the foreign country of exportation; and
(5)The name, address, telephone number, and where available, the facsimile number of the person or persons to whom the importer intends to transfer the listed chemical and the quantity to be transferred to each transferee. 9. Section 1313.15 is amended by revising paragraph
(a)to read as follows: § 1313.15 Waiver of 15-day advance notice for regular importers.
(a)Each regulated person seeking designation as a “regular importer” shall provide, by certified mail return receipt requested, to the Administration such information as is required under § 1313.08 documenting their status as a regular importer. 10. Section 1313.16 is added to read as follows: § 1313.16 Transfers following importation.
(a)In the case of a notice under § 1313.12(a) submitted by a regulated person, if the transferee identified in the notice is not a regular customer, the importer may not transfer the listed chemical until after the expiration of the 15-day period beginning on the date on which the notice is submitted to the Administration.
(b)After a notice under § 1313.12(a) or
(d)is submitted to the Administration, if circumstances change and the importer will not be transferring the listed chemical to the transferee identified in the notice, or will be transferring a greater quantity of the chemical than specified in the notice, the importer must update the notice to identify the most recent prospective transferee or the most recent quantity or both (as the case may be) and may not transfer the listed chemical until after the expiration of the 15-day period beginning on the date on which the update is submitted to the Administration, except that the 15-day restriction does not apply if the prospective transferee identified in the update is a regular customer. The preceding sentence applies with respect to changing circumstances regarding a transferee or quantity identified in an update to the same extent and in the same manner as the sentence applies with respect to changing circumstances regarding a transferee or quantity identified in the original notice under § 1313.12(a) or (d).
(c)In the case of a transfer of a listed chemical that is subject to a 15-day restriction, the transferee involved shall, upon the expiration of the 15-day period, be considered to qualify as a regular customer, unless the Administration otherwise notifies the importer involved in writing.
(d)With respect to a transfer of a listed chemical with which a notice or update referred to in § 1313.12(a) or
(d)is concerned:
(1)The Administration—
(i)May, in accordance with the same procedures as apply under §§ 1313.51 through 1313.57, order the suspension of the transfer of the listed chemical by the importer involved, except for a transfer to a regular customer, on the ground that the chemical may be diverted to the clandestine manufacture of a controlled substance (without regard to the form of the chemical that may be diverted, including the diversion of a finished drug product to be manufactured from bulk chemicals to be transferred), subject to the Administration ordering the suspension before the expiration of the 15-day period with respect to the importation (in any case in which such a period applies); and
(ii)May, for purposes of this paragraph (d), disqualify a regular customer on that ground.
(2)From and after the time when the Administration provides written notice of the order under paragraph (d)(1)(i) of this section (including a statement of the legal and factual basis for the order) to the importer, the importer may not carry out the transfer.
(e)For purposes of this section:
(1)The term *transfer,* with respect to a listed chemical, includes the sale of the chemical.
(2)The term *transferee* means a person to whom an importer transfers a listed chemical. 11. Section 1313.17 is added to read as follows: § 1313.17 Return declaration or amendment to Form 486 for imports.
(a)Within 30 days after a transaction is completed, the importer must send to the Administration a return declaration containing particulars of the transaction, including the date, quantity, chemical, container, name of transferees, and any other information as the Administration may specify. A single return declaration may include the particulars of both the importation and distribution. If the importer has not distributed all chemicals imported by the end of the initial 30-day period, the importer must file supplemental return declarations no later than 30 days from the date of any further distribution, until the distribution or other disposition of all chemicals imported under the import notification or any update are accounted for.
(b)If an importation for which a Form 486 has been filed fails to take place, the importer must file an amended Form 486 notifying the Administration that the importation did not occur. 12. Section 1313.26 is added to read as follows: § 1313.26 Transfers following exportation.
(a)In the case of a notice under § 1313.21(a) submitted by a regulated person, if the transferee identified in the notice, *i.e.* , the foreign importer, is not a regular customer, the regulated person may not transfer the listed chemical until after the expiration of the 15-day period beginning on the date on which the notice is submitted to the Administration.
(b)After a notice under § 1313.21(a) is submitted to the Administration, if circumstances change and the exporter will not be transferring the listed chemical to the transferee identified in the notice, or will be transferring a greater quantity of the chemical than specified in the notice, the exporter must update the notice to identify the most recent prospective transferee or the most recent quantity or both (as the case may be) and may not transfer the listed chemical until after the expiration of the 15-day period beginning on the date on which the update is submitted to the Administration, except that the 15-day restriction does not apply if the prospective transferee identified in the update is a regular customer. The preceding sentence applies with respect to changing circumstances regarding a transferee or quantity identified in an update to the same extent and in the same manner as the sentence applies with respect to changing circumstances regarding a transferee or quantity identified in the original notice under paragraph
(a)of this section.
(c)In the case of a transfer of a listed chemical that is subject to a 15-day restriction, the transferee involved shall, upon the expiration of the 15-day period, be considered to qualify as a regular customer, unless the Administration otherwise notifies the exporter involved in writing.
(d)With respect to a transfer of a listed chemical with which a notice or update referred to in § 1313.21(a) is concerned:
(1)The Administration—
(i)May, in accordance with the same procedures as apply under §§ 1313.51 through 1313.57, order the suspension of the transfer of the listed chemical by the exporter involved, except for a transfer to a regular customer, on the ground that the chemical may be diverted to the clandestine manufacture of a controlled substance (without regard to the form of the chemical that may be diverted, including the diversion of a finished drug product to be manufactured from bulk chemicals to be transferred), subject to the Administration ordering the suspension before the expiration of the 15-day period with respect to the exportation (in any case in which such a period applies); and
(ii)May, for purposes of this paragraph (d), disqualify a regular customer on that ground.
(2)From and after the time when the Administration provides written notice of the order under paragraph (d)(1)(i) of this section (including a statement of the legal and factual basis for the order) to the exporter, the exporter may not carry out the transfer.
(e)For purposes of this section:
(1)The term *transfer,* with respect to a listed chemical, includes the sale of the chemical.
(2)The term *transferee* means a person to whom an exporter transfers a listed chemical. 13. Section 1313.27 is added to read as follows: § 1313.27 Return declaration or amendment to Form 486 for exports.
(a)Within 30 days after a transaction is completed, the exporter must send to the Administration a return declaration containing particulars of the transaction, including the date, quantity, chemical, container, name of transferees, and any other information as the Administration may specify.
(b)If an exportation for which a Form 486 has been filed fails to take place, the exporter must file an amended Form 486 notifying the Administration that the exportation did not occur. 14. Section 1313.32 is amended by adding paragraphs
(d)and
(e)to read as follows: § 1313.32 Requirement of authorization for international transactions.
(d)After a notice under paragraph
(a)of this section is submitted to the Administration, if circumstances change and the broker or trader will not be transferring the listed chemical to the transferee identified in the notice, or will be transferring a greater quantity of the chemical than specified in the notice, the broker or trader must update the notice to identify the most recent prospective transferee or the most recent quantity or both (as the case may be). The preceding sentence applies with respect to changing circumstances regarding a transferee or quantity identified in an update to the same extent and in the same manner as the sentence applies with respect to changing circumstances regarding a transferee or quantity identified in the original notice under paragraph
(a)of this section.
(e)For purposes of this section:
(1)The term *transfer* , with respect to a listed chemical, includes the sale of the chemical.
(2)The term *transferee* means a person to whom an exporter transfers a listed chemical. 15. Section 1313.35 is added to read as follows: § 1313.35 Return declaration or amendment to Form 486 for international transactions.
(a)Within 30 days after a transaction is completed, the broker or trader must send to the Administration a return declaration containing particulars of the transaction, including the date, quantity, chemical, container, name of transferees, and any other information as the Administration may specify.
(b)If a transaction for which a Form 486 has been filed fails to take place, the broker or trader must file an amended Form 486 notifying the Administration that the transaction did not occur. Dated: March 30, 2007. Michele M. Leonhart, Deputy Administrator. [FR Doc. 07-1718 Filed 4-6-07; 8:45 am]
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U.S. Code
- Federal Aviation Administration§ 106
- Purposes§ 3501
- Public information; agency rules, opinions, orders, records, and proceedings§ 552
- General powers§ 322
- Definitions and application§ 3701
- Food additives§ 348
- Definitions; generally§ 321
- Rule making§ 553
- Misbranded drugs and devices§ 352
- Adulterated drugs and devices§ 351
- Prohibited acts§ 331
- Notification, suspension of shipment, and penalties with respect to importation and exportation of listed chemicals§ 971
- Congressional findings and declarations: controlled substances§ 801
- Avoidance of duplicative or unnecessary analyses§ 605
- Definitions§ 802
CFR
- May I address the unsafe condition in a way other than that set out in the airworthiness directive?§ 39.19
- Ionizing radiation for the treatment of food.§ 179.26
- Procedure for objections and hearings.§ 171.110
- Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure.§ 10.20
- Definitions.§ 170.3
- Ruling on objections and requests for hearing.§ 12.24
- Safety factors to be considered.§ 170.22
- General principles for evaluating the safety of food additives.§ 170.20
- General.§ 25.30
- Updated notice for change in circumstances.§ 1313.16
- Updated notice for change in circumstances.§ 1313.26
50 references not yet in our index
- 14 CFR 39
- 1 CFR 51
- 14 CFR 331
- Pub. L. 107-42
- 341 U.S. 48
- 424 F.3d 1206
- Pub. L. 109-115
- 119 Stat. 2396
- Pub. L. 107-71
- Pub. L. 107-38
- Pub. L. 97-248
- 18 CFR 101
- 21 CFR 179
- 773 F.2d 1356
- 475 U.S. 1123
- 21 CFR 12
- 574 F.2d 553
- 439 U.S. 893
- 445 U.S. 198
- 446 U.S. 947
- 412 U.S. 609
- 671 F.2d 1235
- 673 F.2d 1083
- 271 F.2d 281
- 362 U.S. 911
- 455 F.2d 432
- 555 F.2d 677
- 414 F.2d 1125
- 256 F.2d 233
- 358 U.S. 872
- 463 F.2d 316
- 404 F.2d 804
- 393 U.S. 1093
- 606 F.2d 1307
- 21 CFR 803
- 5 USC 601-612
- Pub. L. 104-4
- 21 CFR 814
- 21 CFR 820
- 21 CFR 821
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