Tap any paragraph to write a margin note. Your notes collect in the Desk below the text and file under cases with @. The side-by-side margin rail opens on a larger screen.

Code · REGISTER · 2006-03-09 · Federal Aviation Administration (FAA), Department of Transportation (DOT) · Notices

Notices. Notice of proposed rulemaking (NPRM)

6,306 words·~29 min read·/register/2006/03/09/06-2183·

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

BILLING CODE 3510-22-S 71 46 Thursday, March 9, 2006 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2006-23809; Directorate Identifier 2005-NE-52-AD] RIN 2120-AA64 Airworthiness Directives; Turbomeca Arriel 2B Series Turboshaft Engines AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: The FAA proposes to adopt a new airworthiness directive
(AD)for Turbomeca Arriel 2B, 2B1, and 2B1A turboshaft engines. This proposed AD would require visually inspecting the splines of the high-pressure
(HP)pump drive gear shaft and coupling shaft assembly for wear. This proposed AD results from reports of uncommanded in-flight shutdowns of engines. We are proposing this AD to detect wear on the splines of the HP pump drive gear shaft and coupling shaft assembly, which could interrupt the fuel flow and cause an uncommanded in-flight shutdown of the engine on a single-engine helicopter. The in-flight shutdown of the engine could result in a forced autorotation landing or accident. DATES: We must receive any comments on this proposed AD by April 10, 2006. ADDRESSES: Use one of the following addresses to comment on this proposed AD. • DOT Docket Web site: Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • Government-wide rulemaking Web site: Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • Mail: Docket Management Facility; U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC 20590-0001. • Fax:
(202)493-2251. • Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Contact Turbomeca, 40220 Tarnos—France; Tel
(33)05 59 74 40 00; Telex 570 042; Fax
(33)05 59 74 45 15 for the service information identified in this proposed AD. FOR FURTHER INFORMATION CONTACT: Christopher Spinney, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; telephone
(781)238-7175; fax
(781)238-7199. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send us any written relevant data, views, or arguments regarding this proposal. Send your comments to an address listed under ADDRESSES. Include “Docket No. FAA-2006-23809; Directorate Identifier 2005-NE-52-AD” in the subject line of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments. We will post all comments we receive, without change, to *http://dms.dot.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of the DMS Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78) or you may visit *http://dms.dot.gov.* Examining the AD Docket You may examine the docket that contains the proposal, any comments received, and any final disposition in person at the Docket Management Facility Docket Office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Office (telephone
(800)647-5227) is 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 Docket Management Facility receives them. Discussion The Direction générale de l'aviation civile (DGAC), which is the airworthiness authority for France, recently notified us that an unsafe condition may exist on Turbomeca Arriel 2B, 2B1, and 2B1A turboshaft engines. The DGAC advises that they have received two reports of uncommanded in-flight engine shutdowns. Worn splines on the drive shaft of the HP pump assembly caused an interruption of the fuel flow to the engine and caused the engine to shutdown. Relevant Service Information We have reviewed and approved the technical contents of Turbomeca Mandatory Service Bulletin
(MSB)No. 292 73 2812, Update No. 2, dated June 28, 2005. That MSB describes procedures for visually inspecting the splines of the coupling shaft assembly and the splines of the HP pump drive gear shaft for wear. The DGAC classified this MSB as mandatory and issued airworthiness directive F-2005-188, dated November 23, 2005, in order to ensure the airworthiness of these Turbomeca Arriel 2B series turboshaft engines in France. FAA's Determination and Requirements of the Proposed AD These engines, manufactured in France, are type-certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. In keeping with this bilateral airworthiness agreement, the DGAC kept us informed of the situation described above. We have examined the DGAC's findings, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States. For this reason, we are proposing this AD, which would require: • For hydromechanical units
(HMUs)that have accumulated 450 hours or more on the effective date of the proposed AD, an initial visual inspection of the splines of the coupling shaft assembly and HP pump drive gear shaft for wear within 50 hours after the effective date of the proposed AD, and • For HMUs that have fewer than 450 hours on the effective date of the proposed AD, an initial visual inspection of the splines of the coupling shaft assembly and HP pump drive gear shaft for wear after accumulating 450 hours, but before accumulating 500 hours, and • A repetitive visual inspection of the splines of the coupling shaft assembly and HP pump drive gear shaft for wear every time you remove or install the HMU, and • Replacing the HMU and coupling shaft assembly if worn beyond limits. The proposed AD would require you to use the service information described previously to perform these actions. Costs of Compliance We estimate that this proposed AD would affect 107 engines installed on helicopters of U.S. registry. We also estimate that it would take about 1.0 work hours per engine to perform the proposed actions, and that the average labor rate is $65 per work hour. There are no required parts. Based on these figures, we estimate the total cost of the proposed AD to U.S. operators to be $6,955. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Under the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new airworthiness directive: **Turbomeca:** Docket No. FAA-2006-23809; Directorate Identifier 2005-NE-52-AD. Comments Due Date
(a)The Federal Aviation Administration
(FAA)must receive comments on this airworthiness directive
(AD)action by April 10, 2006. Affected ADs
(b)None. Applicability
(c)This AD applies to Turbomeca Arriel 2B, 2B1, and 2B1A turboshaft engines. These engines are installed on, but not limited to, Eurocopter AS350B3 and EC130B4 helicopters. Unsafe Condition
(d)This AD results from reports of uncommanded in-flight shutdowns of engines. We are issuing this AD to detect wear on the splines of the high-pressure
(HP)pump drive gear shaft and the coupling shaft assembly, which could interrupt the fuel flow and cause an uncommanded in-flight shutdown of the engine on a single-engine helicopter. The in-flight shutdown of the engine could result in a forced autorotation landing or accident. 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. Initial Visual Inspection
(f)Perform an initial visual inspection of the splines of the coupling assembly and the HP pump drive gear shaft for wear. Use 2.A. through 2.C.(2) of the Instructions to be Incorporated of Turbomeca Mandatory Service Bulletin
(MSB)No. 292 73 2812, Update No. 2, dated June 28, 2005, as follows:
(1)For hydraulic mechanical units
(HMUs)that have accumulated 450 or more hours time-since-new
(TSN)or time-since-overhaul
(TSO)on the effective date of this AD, inspect within 50 hours after the effective date of this AD. Replace the HMU if worn beyond limits.
(2)For HMUs that have fewer than 450 hours TSN or TSO on the effective date of this AD, inspect after accumulating 450 hours TSN or TSO, but before accumulating 500 hours TSN or TSO. Replace the HMU if worn beyond limits. Repetitive Visual Inspections
(g)Thereafter, perform a visual inspection of the splines of the coupling shaft assembly and the HP pump drive gear shaft for wear every time you remove or install the HMU. Use 2.A. through 2.C.(2) of the Instructions to be Incorporated of Turbomeca MSB No. 292 73 2812, Update No. 2, dated June 28, 2005. Replace the HMU and coupling shaft assembly if worn beyond limits. Alternative Methods of Compliance
(h)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
(i)DGAC airworthiness directive F-2005-188, dated November 23, 2005, also addresses the subject of this AD. Issued in Burlington, Massachusetts, on March 2, 2006. Thomas A. Boudreau, Acting Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. E6-3352 Filed 3-8-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2006-24104; Directorate Identifier 2005-NM-231-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Model A310-200 and -300 Series Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: The FAA proposes to adopt a new airworthiness directive
(AD)for certain Airbus Model A310-200 and -300 series airplanes. This proposed AD would require repetitive inspections for cracking of the flap transmission shafts, and replacing the transmission shafts if necessary. This proposed AD also would provide an optional terminating action for the repetitive inspections. This proposed AD results from reports of longitudinal cracks due to stress corrosion in the transmission shafts between the power control unit
(PCU)and the torque limiters of the flap transmission system. We are proposing this AD to detect and correct cracking of the flap transmission shaft, which could compromise shaft structural integrity and lead to a disabled flap transmission shaft and reduced controllability of the airplane. DATES: We must receive comments on this proposed AD by April 10, 2006. ADDRESSES: Use one of the following addresses to submit comments on this proposed AD. • DOT Docket Web site: Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • Government-wide rulemaking Web site: Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • Mail: Docket Management Facility, U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, room PL-401, Washington, DC 20590. • Fax:
(202)493-2251. • Hand Delivery: Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Contact Airbus, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France, for service information identified in this proposed AD. FOR FURTHER INFORMATION CONTACT: Thomas Stafford, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone
(425)227-1622; fax
(425)227-6590. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed in the ADDRESSES section. Include the docket number “FAA-2006-24104; Directorate Identifier 2005-NM-231-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments. We will post all comments we receive, without change, to *http://dms.dot.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78), or you may visit *http://dms.dot.gov* . Examining the Docket You may examine the AD docket on the Internet at *http://dms.dot.gov* , or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone
(800)647-5227) is located on the plaza level of the Nassif Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them. Discussion The Direction Générale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, notified us that an unsafe condition may exist on certain Airbus Model A310-200 and -300 series airplanes. The DGAC advises that reports have been received of longitudinal cracks due to stress corrosion in the transmission shafts between the power control unit and the torque limiters of the flap transmission system. This condition, if not corrected, could result in cracking of the flap transmission shafts, which could compromise shaft structural integrity and lead to a disabled flap transmission shaft and reduced controllability of the airplane. Relevant Service Information Airbus has issued Service Bulletin A310-27-2092, Revision 02, dated April 11, 2005. The service bulletin describes procedures for performing repetitive detailed inspections for stress corrosion cracking of the flap transmission shafts and replacing the transmission shafts with new or reconditioned shafts if necessary. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. The DGAC mandated the service information and issued French airworthiness directive F-2005-174, dated October 26, 2005, to ensure the continued airworthiness of these airplanes in France. Service Bulletin A310-27-2092, Revision 02, refers to Lucas Liebherr Service Bulletin 551A-27-624, Revision 1, dated August 18, 2000, as an additional source of service information for accomplishing the specified inspections. Service Bulletin A310-27-2092, Revision 02, refers to Airbus Service Bulletin A310-27-2095, dated March 29, 2000, as a source of service information for replacing the flap transmission shafts. Accomplishing the actions specified by Service Bulletin A310-27-2095 would terminate the inspections required by this proposed AD. Service Bulletin A310-27-2095 refers to Lucas Liebherr Service Bulletin 551A-27-M551-05, dated January 12, 2000, as an additional source of service information for replacing the flap transmission shafts. FAA's Determination and Requirements of the Proposed AD These airplane models are manufactured in France and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept the FAA informed of the situation described above. We have examined the DGAC's findings, evaluated all pertinent information, and determined that we need to issue an AD for airplanes of this type design that are certificated for operation in the United States. Therefore, we are proposing this AD, which would require accomplishing the actions specified in the Airbus service information described previously, except as discussed under “Difference Between French Airworthiness Directive and This Proposed AD.” Difference Between French Airworthiness Directive and This Proposed AD The applicability of French airworthiness directive F-2005-174 excludes airplanes on which Airbus Service Bulletin A310-27-2095 was accomplished in service. However, we have not excluded those airplanes in the applicability of this proposed AD; rather, this proposed AD includes a requirement to accomplish the actions specified in that service bulletin. This requirement would ensure that the actions specified in the service bulletin and required by this proposed AD are accomplished on all affected airplanes. Operators must continue to operate the airplane in the configuration required by this proposed AD unless an alternative method of compliance is approved. This difference has been coordinated with the DGAC. Clarification of Compliance Time French airworthiness directive F-2005-174 states, “If necessary, replace any defective shaft before the next flight * * *” However, we have determined that the words “if necessary” could be taken to mean that, when discovered, some defects might not be considered severe enough to require replacing the transmission shaft before further flight. Therefore, this proposed AD does not use the words “if necessary”, but would require any defective shaft to be replaced before further flight. Costs of Compliance This proposed AD would affect about 59 airplanes of U.S. registry. The proposed inspections would take about 1 work hour per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the proposed AD for U.S. operators is $3,835 or $65 per airplane, per inspection cycle. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration
(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **Airbus:** Docket No. FAA-2006-24104; Directorate Identifier 2005-NM-231-AD. Comments Due Date
(a)The FAA must receive comments on this AD action by April 10, 2006. Affected ADs
(b)None. Applicability
(c)This AD applies to Airbus Model A310-203, -204, -221, -222, -304, -322, -324, and -325 airplanes, certificated in any category; except for airplanes on which Airbus Modification 12247 has been embodied in production. Unsafe Condition
(d)This AD results from reports of longitudinal cracks due to stress corrosion in the transmission shafts between the power control unit
(PCU)and the torque limiters of the flap transmission system. We are issuing this AD to detect and correct cracking of the flap transmission shaft, which could compromise shaft structural integrity and lead to a disabled flap transmission shaft and reduced controllability 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. Inspection and Corrective Action
(f)At the earlier of the compliance times specified in paragraph (f)(1) or (f)(2) of this AD: Perform a detailed inspection for stress corrosion cracking of the flight transmission shafts located between the PCU and the torque limiters in accordance with the Accomplishment Instructions of Airbus Service Bulletin A310-27-2092, Revision 02, dated April 11, 2005. Thereafter, repeat the inspections as required by paragraph
(g)of this AD. Before further flight, replace any cracked transmission shaft discovered during any inspection required by this AD with a new or reconditioned shaft in accordance with the Accomplishment Instructions of Airbus Service Bulletin A310-27-2095, dated March 29, 2000.
(1)Within 2,000 flight hours after the last flap asymmetry protection test performed in accordance with Maintenance Planning Document
(MPD)task 275600-01-1.
(2)Within 8,000 flight cycles after the last flap asymmetry protection test performed in accordance with MPD task 275600-02-1 or 800 flight cycles after the effective date of this AD, whichever comes later. Note 1: Airbus Service Bulletin A310-27-2092, Revision 02, dated April 11, 2005, refers to Lucas Liebherr Service Bulletin 551A-27-624, Revision 1, dated August 18, 2000, as an additional source of service information for accomplishing the inspections. Note 2: Airbus Service Bulletin A310-27-2092, Revision 02, refers to Airbus Service Bulletin A310-27-2095, dated March 29, 2000, as a source of service information for replacing the flap transmission shafts. Note 3: Airbus Service Bulletin A310-27-2095 refers to Lucas Liebherr Service Bulletin 551A-27-M551-05, dated January 12, 2000, as an additional source of service information for replacing the flap transmission shafts. Repetitive Inspections
(g)Repeat the inspection required by paragraph
(f)of this AD at the applicable times specified in paragraph (g)(1), (g)(2), and (g)(3) of this AD.
(1)Before further flight after any occurrence of jamming of the flap transmission system.
(2)At intervals not to exceed 2,000 flight hours after each flap asymmetry protection test performed in accordance with MPD task 275600-01-1.
(3)At intervals not to exceed 8,000 flight cycles after each flap asymmetry protection test performed in accordance with MPD task 275600-02-1. Optional Terminating Action
(h)Replacing any flap transmission shaft with a new or reconditioned transmission shaft in accordance with the Accomplishment Instructions of Airbus Service Bulletin A310-27-2095, dated March 29, 2000, ends the inspections required for that transmission shaft only. Actions Performed Using Previously Issued Service Information
(i)Actions performed in accordance with Airbus Service Bulletin A310-27-2092, dated April 9, 1999, or Revision 01, dated December 11, 2001, are considered acceptable for compliance with the corresponding requirements of this AD. Alternative Methods of Compliance (AMOCs) (j)(1) The Manager, International Branch, ANM-116, FAA, Transport Airplane Directorate, 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
(k)French airworthiness directive F-2005-174, dated October 26, 2005, also addresses the subject of this AD. Issued in Renton, Washington, on February 28, 2006. Kalene C. Yanamura, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E6-3345 Filed 3-8-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF VETERANS AFFAIRS 38 CFR Part 17 RIN 2900-AM19 Medical: Informed Consent—Extension of Time Period and Modification of Witness Requirement for Signature Consent AGENCY: Department of Veterans Affairs. ACTION: Proposed rule. SUMMARY: This document proposes to amend the U.S. Department of Veterans Affairs
(VA)medical regulations on informed consent by making two substantive changes. We propose to extend the period of time during which a signed consent form remains valid from 30 to 60 days and eliminate the requirement that a third party witness the patient or surrogate and practitioner signing the consent form, except in those circumstances where the patient or surrogate signs with an “X” due to a debilitating illness or disability, i.e., significant physical impairment and/or difficulty in executing a signature due to an underlying health condition(s), or is unable to read or write. DATES: Comments must be received on or before: May 8, 2006. ADDRESSES: Written comments may be submitted by mail or hand delivery to: Director, Regulations Management (00REG1), Department of Veterans Affairs, 810 Vermont Ave., NW., Room 1068, Washington, DC 20420; fax comments to
(202)273-9026; or e-mail comments through *http://www.Regulations.gov.* Comments should indicate that they are submitted in response to “RIN 2900-AM19.” All comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 8 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call
(202)273-9515 for an appointment. FOR FURTHER INFORMATION CONTACT: Ruth Cecire, PhD., Policy Analyst, Ethics Policy Service, National Center for Ethics in Health Care (10E), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420; 202-501-2012 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: Section 7331 of title 38, United States Code (U.S.C.), directs the Secretary of Veterans Affairs to promulgate regulations to ensure that, to the maximum extent practicable, all patient care carried out under the authority of title 38 U.S.C. is accomplished with the informed consent of the patient or the patient's surrogate. These VA medical regulations, set forth at 38 CFR 17.32 and titled “Informed Consent”, were published in the **Federal Register** as a final rule on October 2, 1997 (62 FR 53961). The proposed rule would amend VA medical regulations on informed consent. Specifically, it would extend the time during which a signed consent form is valid from 30 to 60 days. Also, it would eliminate the requirement that a consent form be witnessed, except in those situations where the patient or surrogate signs with an “X”. We are specifically interested in obtaining comments from non-VA providers, patients and other concerned community members with respect to both of these changes. Often, the informed consent discussion takes place and the requisite forms are signed before a procedure is scheduled. Under the current rule, a signed consent form is valid for 30 days. If the procedure is later scheduled for a date beyond that 30 day window, the patient and practitioner must sign and date a new consent form. In our experience a number of treatments or procedures that require signature consent are scheduled more than 30 days in advance. Extending the period during which signed consent forms remain valid would enable patients to avoid having to return to the facility just to sign a new form or to re-sign when they come for the procedure. Under current regulations, witnesses who sign the consent form only attest to the fact that they saw the patient and the practitioner sign the form. They do not attest to the content of the informed consent discussion, or that the process was voluntary, or that the patient was capable of giving informed consent. Nor do they attest to the identity of the individuals signing the form. Experience has shown that finding an appropriate witness is sometimes difficult and creates an impediment to the timely completion of the informed consent process. Given the above, it is not clear that the witness requirement benefits the veteran, especially since there are other means to verify the signatures if there is a dispute, e.g., by comparing the signature on the form against other documents signed by the patient. Therefore, we do not think it necessary to continue this practice for general signature consent. However, two witnesses would still be required to sign the consent form when the patient or surrogate signs with an “X”. In addition, we propose to make the following non-substantive changes to § 17.32: in paragraph (a), removing “, e.g., a published numbered VA form (OF 522) or comparable form approved by the local VA facility”; and in paragraph (d)(2), removing “OF522”. These references to OF522, *Request for Administration of Anesthesia and Performance of Operations and Other Procedures,* are obsolete. Use of the OF522, which is a general form, in VA health care facilities is being phased out. Facilities now have access to procedure-specific VA-authorized consent forms. Unfunded Mandates The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in an expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any given year. This rule would have no such effect on State, local, or tribal governments, or the private sector. Paperwork Reduction Act of 1995 This rule contains no new collections of information under the Paperwork Reduction Act (44 U.S.C. 3501-3521). The existing information collections associated with the informed consent procedures under § 17.32 have been approved by OMB under 2900-0853. Executive Order 12866 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 Order classifies a rule as a significant regulatory action requiring review by the Office of Management and Budget if it meets any one of a number of specified conditions, including: Having an annual affect on the economy of $100 million or more; creating a serious inconsistency or interfering with an action of another agency, materially altering the budgetary impact of entitlements or the rights of entitlement recipients, or raising novel legal or policy issues. VA has examined the economic, legal, and policy implications of this proposed rule and concluded that it is a significant regulatory action because it raises novel policy issues. Regulatory Flexibility Act The Secretary hereby certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. The rule will affect only individuals and will not directly affect any small entities. Therefore, pursuant to 5 U.S.C. 605(b), this rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604. Catalog of Federal Domestic Assistance The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are 64.009, Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care; and 64.011, Veterans Dental Care. List of Subjects in 38 CFR Part 17 Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Foreign relations, Government contracts, Grant programs—health, Grant programs—veterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Philippines, Reporting and recordkeeping requirements, Scholarships and fellowships, Travel and transportation expenses, Veterans. Approved: November 29, 2005. Gordon H. Mansfield, Deputy Secretary of Veterans Affairs. For the reasons set out above, VA proposes to amend 38 CFR part 17 to read as follows: PART 17—MEDICAL 1. The authority citation for part 17 is revised to read as follows: Authority: 38 U.S.C. 501, 1721, and as stated in specific sections. 2. Section 17.32 is amended by: a. Revising the section heading. b. In paragraph (a), in the definition of *signature consent,* removing “, e.g., a published numbered VA form (OF 522) or comparable form approved by the local VA facility”. c. Revising paragraph (d)(2). d. Revising the authority citation at the end of the section. The revisions read as follows: § 17.32 Informed consent and advance care planning.
(d)* * *
(2)A patient or surrogate will sign with an “X” when the patient or surrogate has a debilitating illness or disability, i.e., significant physical impairment and/or difficulty in executing a signature due to an underlying health condition(s), or is unable to read or write. When the patient's or surrogate's signature is indicated by an “X”, two adults must witness the act of signing. By signing, the witnesses are attesting only to the fact that they saw the patient or surrogate and the practitioner sign the form. The signed form must be filed in the patient's medical record. A properly executed VA-authorized consent form is valid for a period of 60 calendar days. If, however, the treatment plan involves multiple treatments or procedures, it will not be necessary to repeat the informed consent discussion and documentation so long as the course of treatment proceeds as planned, even if treatment extends beyond the 60-day period. If there is a change in the patient's condition that might alter the diagnostic or therapeutic decision, the consent is automatically rescinded. (Authority: 38 U.S.C. 7331-7334) [FR Doc. E6-3290 Filed 3-8-06; 8:45 am] BILLING CODE 8320-01-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [R04-OAR-2005-AL-0002-200528b; FRL-8043-1] Approval and Promulgation of Implementation Plans; Alabama: State Implementation Plan Revision AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: EPA is approving revisions to the Alabama State Implementation Plan (SIP), submitted by the Alabama Department of Environmental Management
(ADEM)on September 11, 2003. The revisions include modifications to Alabama's open burning rules found at Alabama Administrative Code
(AAC)Chapter 335-3-3-.01. These revisions are part of Alabama's strategy to meet the national ambient air quality standards by reducing emissions of volatile organic compounds and nitrogen oxides. Open burning creates smoke that contains fine particles (PM <sup>2.5</sup> ) and precursors to ozone. ADEM has found that elevated levels of PM <sup>2.5</sup> mirror the months when ozone levels are highest (May-September). These rules are intended to help control levels of PM <sup>2.5</sup> and ozone precursors that contribute to high ozone and PM <sup>2.5</sup> levels. Today's action is being taken pursuant to section 110 of the Clean Air Act. In its September 11, 2003, submittal, ADEM also proposed SIP revisions to include changes to AAC Chapter 335-3-4, concerning opacity. EPA is not acting on that part of the revision at this time. In the Rules Section of this **Federal Register** , EPA is approving Alabama's SIP revision as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A rationale for the approval is set forth in the direct final rule, and incorporated herein by reference. If no significant, material, and adverse comments are received in response to this rule, no further activity is contemplated with regard to this proposed action. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed action. EPA will not institute a second comment period on this document. Any parties interested in commenting on this document should do so at this time. DATES: Written comments must be received on or before April 10, 2006. ADDRESSES: Comments may be submitted by mail to: Stacy DiFrank, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. Comments may also be submitted electronically, or through hand delivery/courier. Please follow the detailed instructions described in the direct final rule, ADDRESSES section which is published in the Rules Section of this **Federal Register** . FOR FURTHER INFORMATION CONTACT: Stacy DiFrank, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. The telephone number is
(404)562-9042. Ms. DiFrank can also be reached via electronic mail at *difrank.stacy@epa.gov.* SUPPLEMENTARY INFORMATION: For additional information, see the direct final rule which is published in the Rules Section of this **Federal Register** . Dated: February 17, 2006. A. Stanley Meiburg, Acting Regional Administrator, Region 4. [FR Doc. 06-2183 Filed 3-8-06; 8:45 am]
Connectionstraces to 9
★   the supreme law of the land   ★
Don't Tread on Me
E Pluribus Unum — out of many, one

"If you don't know your rights, you don't have any."

Marginalia · a citizen's law index
A research desk, not legal advice. Always read the cited source before relying on a summary.
Questions or an issue? support@self-law.org
disclaimerMarginalia is a research index, not a law firm. Nothing on this site is legal, tax, or financial advice and no attorney–client relationship is formed by using it. Statutes, regulations, and case law change; summaries, search results, AI output, and member posts may be incomplete, out of date, or wrong. Any interpretation drawn from material on this site should be validated by a licensed attorney in your jurisdiction before you act on it.