Federal Register Vol. 80, No.54,

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Lockheed Martin Corporation/Lockheed Martin Aeronautics Company Model 382, 382B, 382E, 382F, and 382G airplanes. The NPRM published in the Federal Register on October 16, 2014 (79 FR 62075). The NPRM was prompted by an evaluation by the DAH indicating that the upper and lower rainbow fittings on the outer wing are subject to WFD. The NPRM proposed to require repetitive inspections of the upper and lower rainbow fittings on the outer wing to detect cracks propagating from fasteners attaching the fittings to skin panels, and related investigative and corrective actions if necessary; and replacement of the upper and lower rainbow fittings on the outer wing. We are issuing this AD to prevent fatigue cracking of the upper and lower rainbow fittings on the outer wing and skin-panel-to-fitting fastener holes, which could result in reduced structural integrity of the airplane and possible separation of the wing from the airplane.

We gave the public the opportunity to participate in developing this AD. We have considered the comment received. The commenter supported the NPRM (79 FR 62075, October 16, 2014).

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (79 FR 62075, October 16, 2014) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (79 FR 62075, October 16, 2014).

We reviewed Lockheed Martin Aeronautics Company Service Bulletin 382-57-95, including Appendix A, dated December 16, 2013. The service bulletin describes procedures for inspection and replacement of the upper and lower rainbow fittings on the outer wing, and corrective actions. This service information is reasonably available; see ADDRESSES for ways to access this service information.

We estimate that this AD affects 20 airplanes of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary replacements that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need these replacements:

We have received no definitive data that would enable us to provide cost estimates for on-condition actions for cracking of the skin-panel-to-fitting fastener holes specified in this AD.

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.

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),

(3) Will not affect intrastate aviation in Alaska, and

(4) 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.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to add an AD that would apply to British Aerospace Regional Aircraft Model Jetstream Series 3101 and Jetstream Model 3201 airplanes. That NPRM was published in the Federal Register on December 31, 2014 (79 FR 78726), and proposed to supersede AD 2014-06-03, Amendment 39-17807 (79 FR 17395, March 28, 2014).

The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states that:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (79 FR 78726, December 31, 2014) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (79 FR 78726, December 31, 2014) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (79 FR 78726, December 31, 2014).

We reviewed British Aerospace Jetstream Series 3100 and 3200 Service Bulletin No. 32-JM7862, Revision 3, dated October 3, 2014; and British Aerospace Jetstream Series 3100 and 3200 Service Bulletin No. 32-A-JA140940, Original Issue, dated October 3, 2014. The service information describes procedures for modifying the LH and RH MLG at the forward spigot and inspecting for migration of the special washer, taking corrective action as necessary. This service information is reasonably available; see ADDRESSES for ways to access this service information.

We estimate that this AD will affect 44 products of U.S. registry. We also estimate that it will take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $170 per product.

Based on these figures, we estimate the cost of this AD to the U.S. operators to be $14,960, or $340 per product.

We accept modification of the MLG, if done before the effective date of this AD, using earlier versions of the service information. However, the earlier versions of the service information require additional inspections with possible corrective actions.

In addition, we estimate that any necessary follow-on actions that may be required if using an earlier version of the service information would take about 1 work-hour to inspect for special washer migration and corrosion damage and require parts costing $100 for replacement of the special washer and application of witness paint, if necessary, for a cost of $185 per product. We have no way of determining the number of products that may need these actions.

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.

We 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 this AD:

(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),

(3) Will not affect intrastate aviation in Alaska, and

(4) 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.

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-1093; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to add an AD that would apply to GA 8 Airvan (Pty) Ltd Model GA8-TC320 airplane. The NPRM was published in the Federal Register on January 6, 2015 (80 FR 419). The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (80 FR 419, January 6, 2015) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (80 FR 419, January 6, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 419, January 6, 2015).

We reviewed GippsAero Mandatory Service Bulletin SB-GA8-2014-115, Issue 1, dated October 6, 2014. The GippsAero Mandatory Service Bulletin SB-GA8-2014-115, Issue 1, dated October 6, 2014 describes procedures for inspecting the orientation of the engine isolator mounts to verify proper installation, re-installing if necessary, and installing steel washers on the forward side of each side of the engine isolator mounts. This service information is reasonably available; see ADDRESSES for ways to access this service information.

We estimate that this proposed AD will affect 13 products of U.S. registry. We also estimate that it would take about 5 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $10 per product.

Based on these figures, we estimate the cost of this AD on U.S. operators to be $5,655, or $435 per product.

According to the manufacturer, all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

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.

We 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 this AD:

(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),

(3) Will not affect intrastate aviation in Alaska, and

(4) 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.

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-1123; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

On December 12, 2014 the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to establish Class E en route domestic airspace at the Coaldale VORTAC, Coaldale, NV (79 FR 73854). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. One comment was received from the National Business Aviation Association in support of the proposal. Subsequent to publication, the FAA found Class E airspace already exists for the Coaldale VORTAC, NV. Therefore, this final rule is an amendment versus establishment of controlled airspace.

Class E airspace designations are published in paragraph 6006, of FAA Order 7400.9Y, dated August 6, 2014, and effective September 15, 2014, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.9Y, airspace Designations and Reporting Points, dated August 6, 2014, and effective September 15, 2014. FAA Order 7400.9Y is publicly available as listed in the ADDRESSES section of this final rule. FAA Order 7400.9Y lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 modifies Class E en route domestic airspace extending upward from 1,200 feet above the surface at the Coaldale VORTAC navigation aid, Coaldale, NV. By this action, aircraft are contained while in IFR conditions under control of Oakland ARTCC by vectoring aircraft from en route airspace to terminal areas. This action enhances the safety and management of controlled airspace within the NAS. The Title heading for this document is changed from Establishment of Class E Airspace to Amendment of Class E Airspace, Coaldale, NV, with minor edits, as Class E airspace already exists for the Coaldale VORTAC, Coaldale, NV.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (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) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at the Coaldale VORTAC, Coaldale, NV.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(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) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary. This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(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) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part § 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(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) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary.

This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(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) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

We published a Notice of Proposed Rulemaking (NPRM) in the Federal Register on February 20, 2014 (79 FR 9663). The preamble to the NPRM discussed the changes from our current rules and our reasons for proposing those changes.1 In the NPRM, we proposed to clarify our regulations to require you to inform us about or submit all evidence known to you that relates to your disability claim, subject to two exceptions for certain privileged communications. We explained that this requirement would include the duty to submit all evidence from any source in its entirety, unless subject to one of these exceptions. We also proposed to require your representative to help you obtain the information or evidence that we would require you to submit under our regulations.

We provided 60 days for the public to comment on the NPRM. We received 85 comments. The comments came from members of the public, advocacy groups, legal organizations, members of the disability advocacy community, and several national groups of Social Security claimants' representatives. After carefully considering the comments, we are adopting our proposed rule revisions, with the changes described below, in this final rule.

We provide summaries of the significant comments that were relevant to this rulemaking and our responses to those comments below. Some commenters supported the proposed changes. We appreciate those comments, but we have not summarized or responded to them because they do not require a response.

Comment: Several commenters said our proposal in 20 CFR 404.1512(a) and 416.912(a) for claimants to submit evidence that “relates” to their disability claims is less clear than our current requirement to submit evidence that is “material” to the disability determination. Other commenters said the word “relates” is too vague and claimants will not know, for example, if they must inform us about medical treatment for a physical impairment when they have alleged disability based solely on a mental impairment. Several of these commenters said requiring claimants to submit information that “relates” to their disability claims would be an invasion of privacy, as it could include every matter about a claimant's health history (for example, an abortion or HIV status). Other commenters said it would be difficult for claimants to know whether non-medical information, such as from social media or other types of proceedings (for example, a worker's compensation claim), “relates” to their disability claims.

Response: We disagree with the commenters. Unless the context indicates otherwise, we generally intend for the words we use in our regulations to be construed according to their ordinary meaning. In final §§ 404.1512(a) and 416.912(a), we intend for the word “relates” to have its ordinary meaning, which is to show or establish a logical or causal connection between two things. Our current rules already incorporate this concept in the definition of evidence. Under our current rules, and under this final rule, we define evidence as “anything you or anyone else submits to us or that we obtain that relates to your claim.” In our experience, neither claimants nor their representatives have had any difficulty determining whether something qualified as “evidence” under this definition.

Our current regulations, however, describe a claimant's duty to submit evidence in several ways and suggest that claimants must furnish medical and non-medical evidence that is “material” to the disability determination. The issue of what is “material” involves legal judgment. As we explained in the NPRM, by requiring claimants to submit all evidence that “relates” to their disability claims, we are removing the need to make that type of judgment.2

In addition, we expect claimants to exercise their reasonable, good faith judgment about what evidence “relates” to their disability claims keeping in mind, however, that the meaning of “relates” is broad and includes anything that has a logical or causal connection whether it is favorable or unfavorable to the claim. It is also important to note that we consider all of a claimant's impairments for which we have evidence, not just the ones alleged,3 and we consider the combined effect of all impairments.4 We are also required, subject to certain exceptions, to develop a complete medical history for at least the 12 months preceding the date of the disability application.5 Therefore, evidence of treatment for conditions other than the one alleged by the claimant could relate to the disability claim. For example, if a claimant alleged a back impairment, the treatment records from health care providers other than the treating orthopedic surgeon (for example, from a family doctor who has rendered treatment for a condition other than the one alleged) may contain related information. Therefore, we may ask the claimant if he or she saw other providers during the period at issue. In addition, if the back impairment arose out of an injury at work, we would expect the claimant, upon our request, to inform us whether he or she filed a worker's compensation claim. If so, we may obtain the records from that claim, because they may contain evidence that “relates” to the claim for disability.

However, we would expect our adjudicators to exercise their reasonable, good faith judgment when requesting information or evidence from claimants. For example, we would not require a claimant to disclose treatment for a health matter such as an abortion, if the claimant alleged disability based on a genetic disorder.

Comment: Several commenters recommended that we not revise our regulations regarding the submission of evidence, because they believed our current rules work well. Several of these commenters said claimants already have a duty to inform us about all medical treatment received and submit evidence that is “material” to the disability determination. Some of these commenters also said no change was necessary regarding the submission of evidence by representatives, because attorneys have an ethical duty not to withhold evidence. Some of these commenters said our current “Rules of conduct and standards of responsibility for representatives,” which apply to attorney and non-attorney representatives,6 are sufficient to ensure the submission of complete evidence on behalf of claimants. One of these commenters recommended that we impose harsher penalties on representatives who withhold evidence that is unfavorable to the disability claim.

Response: We did not adopt the comments. As we explained in the NPRM, our current regulations describe a claimant's duty to submit medical and non-medical evidence in several ways, and they could be clearer about the duty to submit all evidence (both favorable and unfavorable) that relates to the disability claim.7 Similarly, our current regulations governing the conduct of representatives describe their related duty to submit evidence in several ways; those regulations could also be clearer.8 We provide that greater clarity in this final rule. The need for greater clarification also implicates program integrity because, as we explained in the NPRM, we know that we do not always receive complete evidence from claimants or their representatives.9 Clarifying our rules regarding the duty to submit all evidence that relates to the disability claim will “enable us to obtain more complete case records and adjudicate claims more accurately.” 10

In addition, as we previously stated, our current regulations suggest that claimants and their representatives must make legal judgments about what is “material” to the disability claim. Our final rule removes the need to make that type of legal judgment.

Comment: Several commenters questioned how claimants would inform us about all evidence that “relates” to their disability claims and asked whether they will have to volunteer this information or simply respond to our specific requests. Some of these commenters said it would be burdensome and unrealistic to require claimants, particularly those who are unrepresented, homeless, or who have mental impairments, to disclose on a voluntary basis every disability-related statement or activity. Other commenters asked whether claimants should memorialize, and then submit to us, all of the disability-related statements they made to others (for example, to doctors, friends, or family members). One of the commenters asked whether the duty to submit all evidence would require claimants to disclose the names of all people with personal knowledge of the claim. Another commenter asked whether claimants would have a duty to supplement information they previously submitted, if they later become aware of additional responsive information. Another commenter asked if claimants would have to disclose the existence of evidence, which they were unaware of at the time of our initial request, but that they became aware of later. One commenter asked whether the duty to submit all evidence would apply at the Appeals Council level.

Response: We use a standardized process for obtaining information and evidence from claimants about their disability claims. For example, in the adult disability application process, we ask a variety of questions about the claimant's medical condition, work activity, job history, and medical treatment.11 Under final §§ 404.1512(a) and 416.912(a), we expect claimants to comply with their duty to submit evidence by providing all information known to them that relates to these requests. We may also make other types of requests for information and evidence that we would expect claimants to provide.12

Aside from responding fully to our specific requests, claimants also submit other evidence to us. Claimants do not have to memorialize statements made to others or disclose the names of all people with personal knowledge of their claims, unless they would like us to consider that information. Final §§ 404.1512(c) and 416.912(c) require only that claimants submit all evidence “received” from another source in its entirety.

For claimants who need assistance in responding to our requests for information and evidence, we currently provide that assistance. For example, when a claimant submits a disability application, we ask the claimant to provide the name of someone we can contact who knows about the claimant's medical condition and can help the claimant with his or her disability claim. We also provide special procedures for obtaining evidence from homeless claimants 13 and instruct our adjudicators on how to assist claimants with mental impairments when requesting information or evidence from them.14

The duty to inform us about or submit all evidence that relates to the disability claim is ongoing, and we have modified proposed (now final) §§ 404.1512(a) and 416.912(a) to clarify that claimants must disclose any additional evidence related to their disability claims about which they become aware. Therefore, after we have made a request for a particular type of information or evidence, claimants must supplement their previous response, if they become aware of additional related evidence. Claimants must also disclose the existence of evidence that they were unaware of at the time of our initial request, but become aware of later on. This ongoing duty applies at each level of the administrative review process, including the Appeals Council level if relates to the period which is the subject of the most recent hearing decision.

Comment: Several commenters recommended that we only require claimants to submit evidence in specific categories (for example, medical records), which was one of several options suggested by the Administrative Conference of the United States (ACUS) in its Final Report.15 These commenters said this requirement would be preferable to the more general requirement we proposed in §§ 404.1512(a) and 416.912(a) (for the submission of all evidence that “relates” to the disability claim), because it would minimize the need for claimants or their representatives to make legal judgments about whether evidence is “material” or “relevant.” One of these commenters also said it would be difficult for claimants to know what constitutes related unfavorable evidence.

Response: We did not adopt these comments. We considered ACUS's suggestion that we identify a particular category of documents that a claimant must identify or produce with some reasonable degree of certainty, but we decided that it was not practical for several reasons. First, there is a wide variety of evidence that could relate to a disability claim, and it is difficult to specify all of the potential categories in a regulation (aside from medical records, which we need to determine disability in all cases). Second, as we previously stated, we removed the need for claimants to make any legal judgments about what evidence they should submit. By requiring the submission of all evidence that “relates” to the disability claim in final §§ 404.1512(a) and 416.912(a), claimants will only have to inform us about or submit evidence that has a logical or causal connection with their disability claims; such evidence will necessarily include both favorable and potentially unfavorable evidence. Thus, there will be no need for claimants to determine what constitutes “unfavorable” evidence.

Comment: Several commenters said we should not require claimants to submit evidence that relates to their disability claims if it is unfavorable. For example, some of these commenters said unfavorable evidence could be inaccurate or unreliable, or it could come from doctors who are biased against claimants or are not knowledgeable about certain impairments. Another commenter said the requirement to submit all evidence that relates to the disability claim would preclude representatives from exercising their professional judgment about what evidence they should submit in support of their clients' disability claims. One commenter expressed concern that the requirement could mean claimants would have to submit statements by those who have a personal grudge (for example, a former spouse). Another commenter believed the requirement to submit unfavorable evidence might deter claimants from seeking medical evaluations that could lead to helpful treatment out of fear they might have to disclose this information later in a disability claim.

Response: We disagree with the commenters. We proposed to require claimants to submit all evidence (favorable or unfavorable) that relates to their disability claims because we believe a more complete record will give us a fuller picture of the extent of a claimant's impairments and the limitations they impose. As a result, we expect that the changes we are making in this final rule will enable us to make more accurate disability determinations and decisions, consistent with Congress's intent and our responsibility to ensure the proper stewardship of the disability program. Allowing claimants (or their representatives) to inform us about or submit only the evidence that they would like us to consider would undermine that goal. It would also be inconsistent with Congress's intent in enacting section 201 of the Social Security Protection Act of 2004 (SSPA),16 which authorizes us to impose a civil monetary penalty on a claimant who should have come forward to notify us of changed circumstances that affect eligibility, but failed to do so. As we previously stated, we expect our adjudicators to exercise their reasonable, good faith judgment when requesting evidence from claimants that relates to the disability claim. Therefore, we do not believe claimants or their representatives will have to respond to requests for information or evidence that are burdensome or pertain to unrelated matters.

In addition, it is fair to require the disclosure of related but potentially unfavorable evidence, because claimants (or their representatives) can explain to us why they believe we should give such evidence little or no weight. Claimants and their representatives routinely make arguments for and against certain evidence in other types of cases, and they can also make these arguments in disability cases. Moreover, we do not base our determinations or decisions on only one piece of evidence when we adjudicate a claim. Rather, our adjudicators must base their determinations and decisions on the preponderance of the evidence.17 Because we base our determinations or decisions on a preponderance of the evidence, we do not believe the commenter's concern that unfavorable evidence could be inaccurate or unreliable, or could come from a medical source who is biased or not knowledgeable about certain impairments, requires us to make any revisions to the final rule. In addition, we disagree with one commenter's suggestion that the duty to submit potentially unfavorable evidence might deter people from seeking medical evaluations and treatment out of fear they might have to disclose this evidence in a future disability claim. We believe that view is speculative and contrary to how people behave, which is to act in their best interests by seeking medical treatment when needed.

Comment: Several commenters said our proposal to require the submission of all evidence that relates to the disability claim makes the determination process more formal and adversarial. Some of these commenters believed this requirement would be inconsistent with our duty to gather evidence regarding the claim. One of these commenters said that providing claimants with the protections of attorney-client privilege and the attorney work product doctrine was inconsistent with the informal and non-adversarial nature of our current disability determination process.

Response: We disagree with the commenters. In fact, the non-adversarial nature of our disability determination process is what requires us to ensure a high level of cooperation from claimants. Moreover, we did not propose any change to how we determine disability at any level of the administrative review process. In the NPRM, we stated that our disability system is “non-adversarial,” and we reaffirmed our duty to “assist claimants in developing the medical and non-medical evidence we need to determine whether or not they are disabled.” 18 The requirement for claimants to inform us about or submit all evidence that relates to the disability claim does not change the process for how we determine disability. Rather, as we have stated repeatedly, this requirement will simply enable us to make more accurate disability determinations, because we will have more complete case records on which to make those determinations.

Comment: Several commenters expressed concern about claimants who conceal evidence from their representatives, either intentionally or by mistake, and asked whether we would penalize the representative in these situations. Some of the commenters also expressed concern about unrepresented claimants who mistakenly withhold evidence from us that we believe relates to the disability claim. These commenters believed it would be unfair for us to penalize these claimants, especially if their mistakes were due to a cognitive difficulty.

Response: As we previously stated, under our final rule, we expect claimants to exercise their reasonable, good faith judgment about what evidence “relates” to their disability claims consistent, of course, with the meaning of the term “relates,” which could include unfavorable evidence. Our final rule does not broaden or otherwise alter the Commissioner's statutory authority to impose a civil monetary penalty under the SSPA.19 The standard for imposing a civil monetary penalty under the SSPA requires the Commissioner to find that a person withheld “disclosure of, a fact which the person knows or should know is material to the determination of any initial or continuing right to . . . [benefits or payments].” 20 The Commissioner must also find that the person “knows, or should know, that the statement or representation with such omission is false or misleading or that the withholding of such disclosure is misleading.” 21 Given the standard set forth in the SSPA, we do not expect that a claimant who mistakenly withholds evidence due to a cognitive deficit would be subject to a civil monetary penalty. We also do not expect that a representative would be subject to a civil monetary penalty under the SSPA if the representative's client concealed evidence from him or her. It is also important to note, as we previously stated, that we assist any claimant who requests help in responding to our requests for information or evidence, and we have special procedures when requesting information or evidence from homeless claimants and those with mental impairments.

Comment: Several commenters suggested that rather than revise our regulations regarding the submission of evidence by claimants and their representatives, we should instead do more to obtain the evidence we need to decide disability claims. For example, one of these commenters recommended that we assign a government representative to work with claimants (or their representatives) to ensure the development of needed evidence. Another commenter suggested that we consider expanding our own obligation to assist claimants in obtaining medical records.

Response: We did not adopt the comments, some of which are outside the scope of this rulemaking proceeding. As we explained in the NPRM, under our current regulations, we assist claimants in developing the medical and non-medical evidence we need to determine disability throughout the administrative review process.22 Representatives (attorney and non-attorney) also assist claimants in submitting evidence and in complying with our requests for evidence.23 Therefore, we do not believe it is necessary to assign an additional government representative to assist claimants or their representatives in the evidence collection process. In any event, such a suggestion is outside the scope of this rulemaking proceeding.

In addition, we are always striving to find better methods of obtaining medical and other evidence we need to decide disability claims. For example, use of health information technology (HIT) enables us to access and organize a person's complete medical records upon receipt of a claim. We continue to expand our use of HIT and explore ways of improving the medical and non-medical evidence collection process.

Comment: Several commenters expressed concern about our removal of the term “relevant” in proposed §§ 404.1512(b)(1)(iii) and 416.912(b)(1)(iii). Sections 404.1512(b)(3) and 416.912(b)(3) currently refer to evidence of disability-related statements made by the claimant or others “or any other relevant statements” made by the claimant “to medical sources during the course of examination or treatment, or to us during interviews, on applications, in letters, and in testimony in our administrative proceedings.” Without the term “relevant,” the commenters asked whether there would be any limit on the scope of these “other statements,” which we require claimants to disclose under this final rule.

Response: We removed the term “relevant” in proposed (now final) §§ 404.1512(b)(1)(iii) and 416.912(b)(1)(iii) to avoid confusion with the standard for submission of evidence in this final rule, which is the submission of all evidence that “relates” to the disability claim. These sections must still be read, however, in conjunction with final §§ 404.1512(b) and 416.912(b), where we define the term “evidence” as “anything you or anyone else submits to us or that we obtain that relates to your claim.” (Emphasis added). All of the categories of “evidence” that we go on to define in these sections, such as the “other statements” referred to in final §§ 404.1512(b)(1)(iii) and 416.912(b)(1)(iii), are, therefore, limited in scope to those that relate to the disability claim.

Comment: Two commenters expressed concern about our extension of the protections afforded by attorney-client privilege and the attorney work product doctrine in proposed §§ 404.1512(b)(2)(iii) and 416.912(b)(2)(iii) to non-attorney representatives. One of these commenters said non-attorney representatives have no experience or knowledge of what these privileges protect; therefore, the claimants they represent may not have the same protections as claimants who are represented by attorneys. The other commenter said it was not practical or reasonable to require non-attorneys to make legal judgments about what communications would be subject to these privileges. This commenter also said that extension of these privileges to non-attorney representatives would cause confusion and uncertainty, resulting in detriment to claimants.

Response: We disagree with the commenters for several reasons. First, we defined both types of privileges in plain language and gave examples of what would and would not be covered by each privilege in the NPRM and in this final rule.24 Second, our current “Rules of conduct and standards of responsibility” apply to all representatives,25 and we do not believe there is any basis to distinguish between attorney and non-attorney representatives regarding their duty to help obtain the evidence that claimants must submit. We would disadvantage certain claimants if we did not apply the protections afforded by these privileges to non-attorney representatives. For example, claimants who are represented by non-attorney representatives would have to disclose information that a claimant represented by an attorney representative would not be required to disclose. Finally, as recommended by ACUS, we believe that any changes to our evidence regulations should apply to both attorney and non-attorney representatives because, under the Social Security Act and our rules, a claimant has the right to be represented by either an attorney or a qualified non-attorney representative.26

Comment: Several commenters said the requirement for attorney representatives to assist claimants in submitting related but unfavorable evidence would violate their state bar ethics rules requiring the preservation of client confidentiality and zealous representation. One of these commenters said this requirement would also violate state bar rules because it would require the submission of attorney work product. Some of the commenters expressed concern about situations where claimants direct their attorneys to withhold unfavorable evidence, which may leave the attorneys with having to choose between following their clients' instructions and complying with a representative's duty to help the claimant obtain the information or evidence that he or she must submit under the final rule.

Response: We disagree with the commenters. In proposed (now final) §§ 404.1512(b)(2)(i) and 416.912(b)(2)(i), we exclude from the definition of evidence oral and written communications between claimants and their representatives (attorney or non-attorney) that are, or would be, subject to the attorney-client privilege, unless the claimant voluntarily discloses them to us. In proposed (now final) §§ 404.1512(b)(2)(ii) and 416.912(b)(2)(ii), we also exclude from the definition of evidence the information that is generally subject to the attorney work product doctrine.27 We drafted the requirement for claimants to inform us about or submit all evidence that relates to the disability claim with the attorney client and attorney work product privileges in mind, and believe that the final rule does not require an attorney to violate his or her ethical duty to keep client communications confidential 28 or require the submission of attorney work product.

In addition, while we acknowledge that state bar rules generally require client confidentiality and zealous representation, we do not believe state bar rules prevent an attorney from complying with our Federal rule, which requires a representative to help a claimant satisfy his or her disclosure obligation. As ACUS noted, the American Bar Association's (ABA) Model Rules of Professional Conduct permit attorneys to disclose otherwise confidential information if “other law” or a “court order” requires the disclosure.29 These rules would constitute such “other law.” In addition, as one leading legal scholar in this area has noted, “none of the opinions” that various State bars have issued on a representative's duty to submit adverse evidence in connection with a disability claim “suggests that an attorney may violate federal law because of a state bar ethics rule.” 30 Moreover, “Even if a state's bar rules did not contain provisions similar to Model Rules 1.6(b)(6) or 8.5(b), the notion that an attorney could be punished by his or her state bar for complying with federal law in a federal forum is antithetical to the Supremacy Clause” of the Constitution and the Supreme Court's decision in Sperry v. Florida ex rel. Florida Bar, 373 U.S. 379 (1963).31 In short, “there is no merit to the argument that an SSA rule mandating that an attorney disclose adverse evidence would subject an attorney to sanctions by his or her state bar.” 32

Furthermore, we are unaware of any other forum that permits attorneys to withhold unfavorable evidence, if it relates to an issue in the case. Under this final rule, we expect all representatives (attorney or non-attorney) to inform the claimants they represent that we do not permit the withholding of any evidence related to the disability claim, even if it is unfavorable. Accordingly, in the situation described by several commenters where the claimant directs the representative to withhold unfavorable evidence, that communication is privileged, but the evidence would still have to be produced.

Comment: One commenter recommended that we extend the protections afforded by attorney-client privilege to non-authorized representatives, such as physicians, licensed clinical social workers, and other licensed health care providers. The commenter noted that many of these professionals engage in privileged communications with their patients, and they sometimes assist patients with their disability claims. Therefore, the commenter said we should also regard these communications as privileged.

Response: We did not adopt the comment. When claimants apply for disability benefits, they sign an authorization form that permits all medical and certain other sources to disclose all medical records and other information related to the claimant's ability to perform tasks.33 Therefore, claimants cannot keep these otherwise privileged communications about their physical or mental condition(s) private.

Comment: One commenter believed that our exception for privileged communications between claimants and their representatives, unless voluntarily disclosed by the claimant, would permit us to communicate directly and impermissibly with claimants instead of their representatives.

Response: We disagree with the commenter. In final §§ 404.1512(b)(2)(i) and 416.912(b)(2)(i), we exclude from the definition of “evidence,” 34 oral and written communications between claimants and their representatives, unless the claimant voluntarily discloses them to us. The attorney-client privilege belongs to the client, and only the client can waive this privilege. The exception for voluntary disclosure of otherwise privileged communications in final §§ 404.1512(b)(2)(i) and 416.912(b)(2)(i) is in recognition of this legal principle; it does not mean we intend to communicate directly with claimants who have representatives assisting them with their disability claims.35

Comment: Several commenters asked why we proposed a more limited version of the work product doctrine in §§ 404.1512(b)(2)(ii) and 416.912(b)(2)(ii) than is recognized under Rule 26(b) of the Federal Rules of Civil Procedure. Several of these commenters said a more limited version of the work product doctrine would deter representatives from having candid discussions with a claimant's medical sources, due to the potential of having to disclose an unfavorable or inaccurate written report. Some commenters said that representatives would have to disclose written opinions received from medical experts, even if the expert was not going to testify. The commenters recommended we adopt the full scope of the work product doctrine, so representatives could withhold this type of evidence.

Response: We did not adopt the comments. We proposed a more limited version of the work product doctrine because we believe program integrity requires us to obtain complete medical evidence (favorable or unfavorable) in disability claims. Therefore, we expressly stated in proposed (now final) §§ 404.1512(b)(2)(ii) and 416.912(b)(2)(ii) that representatives could not withhold any medical evidence or medical source opinions based on the attorney work product doctrine. As we explained in the NPRM, if a claimant's medical source sends his or her representative medical records or a written opinion about the claimant's medical condition, the representative cannot withhold those records or that opinion based on the work product doctrine adopted under these rules.36 If those records or that opinion contains an inaccuracy or unfavorable information, then claimants or their representatives can explain this to us.

In addition, representatives may still protect from disclosure their consultation with any medical source about the claimant's medical condition. As we stated previously, if a representative takes notes during a discussion with a claimant's medical source, those notes are protected from disclosure as work product. Moreover, under the final rule, the representative does not have to request a written opinion from any medical source. Therefore, representatives can fully investigate the merits of any disability claim, and they do not have to disclose the results of their investigation, unless they obtain a medical record or a written opinion from a medical source.

Comment: Many commenters asked whether our proposal in §§ 404.1512(c) and 416.912(c) to require the submission of evidence from a source in its entirety would create a duty on the part of claimants (or their representatives) to request and submit all medical records from all treating sources. Several commenters asked whether claimants (or their representatives) should request all records from a treating source or only those dated after the onset of disability. Some of the commenters noted that medical records could be costly and difficult for some claimants to obtain. One of these commenters said treating sources do not always send all the records requested, and another commenter noted that sometimes a doctor sends records for someone other than the claimant by mistake. Another commenter described the example of a hospital file numbering 1000 pages or more and asked whether a representative could simply request and submit the discharge summary. Other commenters asked whether we would still be requesting and paying for medical records from sources identified by claimants. One commenter asked whether claimants would now have to obtain and submit not only all medical evidence, but also all non-medical evidence that relates to the disability claim. Another commenter recommended that we lower the burden on claimants to submit all related non-medical evidence, because its evidentiary value is less than that of medical evidence. Another commenter suggested we require claimants to submit only medical evidence in its entirety.

Response: We are modifying proposed (now final) §§ 404.1512(c) and 416.912(c) to clarify that claimants must submit evidence “received” from another source in its entirety. We did not intend in these sections to impose a duty on claimants or their representatives to request and submit all evidence (medical and non-medical) from all sources, and we believe this clarification makes that intent more clear. For example, if claimants or their representatives request only the discharge summary from a hospital chart, we require them to submit only what they receive in response to that request in its entirety. We would not require them to request and pay for all of the other records from that hospitalization. We would also not require them to submit any record for a person other than the claimant, sent by mistake, because it clearly would not relate to the disability claim.

Moreover, as we proposed in §§ 404.1512(a) and 416.912(a) and explained in the NPRM, by requiring claimants “to inform us about or submit” all evidence that relates to the disability claim, we are not shifting our responsibility for developing the record to claimants 37 or their representatives.38 For example, we currently request the names and addresses of medical sources in our disability application process.39 Under the final rule, we expect claimants to respond fully by providing that information; we will then obtain the records from those sources. As we previously stated, we also expect claimants to respond fully to any other requests we make for information or evidence related to their disability claims.

Comment: Many commenters expressed concern about our requirement for claimants to submit evidence from another source in its entirety, because it would require the submission of potentially duplicative evidence. One of these commenters described the example of when a representative submits medical records from a treating source and then requests updated records; the source sends everything he or she has already provided, plus the updated records. Another commenter noted that our adjudicators sometimes instruct claimants (or their representatives) not to submit duplicative records. The commenters recommended we not require the submission of evidence that is already in the claim file, because that evidence can be costly for claimants to resubmit and time-consuming for our adjudicators to review. To avoid duplicative evidence, one commenter recommended that we not require claimants to submit any evidence previously submitted by them. Other commenters recommended that we simply not require the submission of any duplicative evidence.

Response: We partially adopted the comments by clarifying in final §§ 404.1512(c) and 416.912(c) that evidence from another source must be submitted in its entirety “unless you previously submitted the same evidence to us or we instruct you otherwise.”

For example, in the scenario described above about the receipt of duplicative medical records from a treating source, the representative is only required to submit the updated records; he or she would not have to submit any record duplicative of the one previously submitted. In addition, by “duplicative,” we mean an exact duplicate of a document in the record, and not simply the substance of what is in the record.

The other exception we provide in final §§ 404.1512(c) and 416.912(c) is for when one of our adjudicators directs claimants or their representatives not to submit duplicative evidence; in that case, they would not have to submit that evidence under the final rule. We do not believe it is advisable to preclude the submission of all duplicative evidence, however, because this would impose a duty on claimants to review their files before submitting new evidence. For claimants who do not have representatives, this could be a significant burden in some cases. Not requiring claimants (or their representatives) to resubmit the same evidence they previously submitted is, however, reasonable. We believe the two limited exceptions for duplicative evidence specified in final §§ 404.1512(c) and 416.912(c) will underscore the importance of submitting evidence received from another source in its entirety and better ensure our goal of having more complete case records on which to make more accurate disability determinations and decisions.

Comment: One commenter believed the proposed revisions to our regulations governing the submission of evidence would require claimants to get representatives.

Response: We disagree with the commenter. We did not propose any change to our regulations that would require claimants to get representatives. In addition, by stating that the claimant's duty to submit evidence now includes the option to simply “inform us about” evidence that relates to the disability claim,40 we believe it will be easier for claimants to comply with their duty to submit evidence. Our responsibility to assist claimants in developing the record also remains unchanged.

Comment: Many commenters said our requirement in proposed §§ 404.1512(c) and 416.912(c) for claimants to submit evidence from another source in its entirety would burden our adjudicators with an excessive amount of potentially irrelevant evidence. Several of these commenters noted, for example, that medical records from some sources (such as the Department of Veterans Affairs) can be voluminous, and the time spent reviewing those records would cause delays in the adjudication of disability claims. Several of these commenters said a provider's medical records could include evidence that is unrelated to the disability claim. Other commenters expressed concern about whether our adjudicators would carefully review voluminous records submitted by claimants (or their representatives). Several commenters said it would be preferable for claimants or their representatives to exercise their own judgment and submit only those records or other evidence that they think is relevant.

Response: We disagree with the commenters. We do not believe the requirement to submit all evidence received from another source in its entirety will burden our adjudicators with having to review unnecessary evidence in most cases. First, as we previously stated, we did not intend in proposed (now final) §§ 404.1512(c) and 416.912(c) to require claimants (or their representatives) to request and submit all medical and non-medical evidence from all sources, and we modified these sections to clarify that claimants must only submit evidence “received” from another source in its entirety. We did not adopt the comments recommending that we permit claimants or their representatives to decide what evidence they would like to submit from these other sources, because this would undermine the purpose of the final rule, which is to enable us to have more complete records on which to adjudicate claims more accurately.

Second, as we previously stated, we modified proposed (now final) §§ 404.1512(c) and 416.912(c) to require the submission of evidence received from another source in its entirety, unless previously submitted by the claimant or otherwise instructed by us in a particular case. We believe these exceptions to the general requirement for submission of evidence in its entirety will reduce the receipt of duplicative and, therefore, unnecessary evidence.

Finally, we do not share the concerns of the commenters who said the submission of voluminous documents by claimants or their representatives would burden our adjudicators and delay the adjudication of disability claims. For example, when a claimant has had extensive medical treatment, it is already our practice to request complete medical records, unless we can decide the claim based on minimal objective medical evidence, as in the case of a compassionate allowance.41 Our program experience shows that our adjudicators have little difficulty reviewing medical and other evidence expeditiously to find the information they need to decide the claim. We also continue to expand our use of HIT, which enables us to speed our review of medical records, even when they are voluminous. We intend to take full advantage of this technology as it becomes more widespread in the medical community.

We consulted with the Office of Management and Budget (OMB) and determined that this final rule meets the criteria for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563. Therefore, OMB reviewed it.

We certify that this final rule would not have a significant economic impact on a substantial number of small entities because it affects individuals only. Therefore, a regulatory flexibility analysis is not required under the Regulatory Flexibility Act, as amended.

These rules do not create any new or affect any existing collections and, therefore, do not require Office of Management and Budget approval under the Paperwork Reduction Act.

For the reasons stated in the preamble, we amend subparts J, P, and R of part 404, subparts A and D of part 405, and subparts I, N, and O of part 416 as set forth below:

The Antiviral Drugs Advisory Committee was established on October 7, 1980 (see 45 FR 79025, November 28, 1980). The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of acquired immune deficiency syndrome, human immunodeficiency virus related illnesses, and other viral, fungal and mycobacterial infections. The Committee is no longer needed and was terminated on February 15, 2015.

Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), the Agency finds good cause to dispense with notice and public comment procedures and to proceed to an immediate effective date on this rule. Notice and public comment and a delayed effective date are unnecessary and are not in the public interest as this final rule merely removes the name of the Antiviral Drugs Advisory Committee from the list of standing advisory committees in § 14.100 (21 CFR 14.100).

Therefore, the Agency is amending § 14.100(c) as set forth in the regulatory text of this document.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 14 is amended as follows:

In a document published in the Federal Register of September 17, 2013 (78 FR 57105), we announced that we had filed a color additive petition (CAP 3C0298) submitted by Wm. Wrigley Jr. Company, c/o Exponent Inc., 1150 Connecticut Ave. NW., Suite 1100, Washington, DC 20036 (petitioner). The petition proposed to amend the color additive regulations in § 73.200 Synthetic Iron Oxide (21 CFR 73.200) by expanding the safe use of synthetic iron oxide as a color additive to include use in soft and hard candy, mints, and chewing gum. The petitioner requested that the proposed uses be permitted at levels consistent with current good manufacturing practice (GMP). The petition also proposed to lower the specification limit for lead in synthetic iron oxide for human food use from 10 milligrams per kilogram (mg/kg; 10 parts per million (ppm)) to 5 mg/kg (5 ppm).

Currently, synthetic iron oxides and their hydrated forms are approved as color additives for the following direct uses in human food, drugs, and cosmetics: (1) In sausage casings intended for consumption in an amount not exceeding 0.10 percent by weight of the finished food (§ 73.200); (2) in ingested or topically-applied drugs with a limit for ingested drugs of 5 milligrams, calculated as elemental iron, per day for labeled or prescribed dosages (21 CFR 73.1200); and (3) in cosmetics generally, including cosmetics applied to the area of the eye, in amounts consistent with GMP (21 CFR 73.2250).

Synthetically prepared iron oxides and their hydrated forms include red iron oxide, yellow iron oxide, black iron oxide, and brown iron oxide, which is a blend of various iron oxides. For the subject petition, synthetic iron oxides are intended to be used in soft and hard candy, mints, and chewing gum in amounts consistent with GMP. The maximum GMP use level for iron oxides depends on the color of the iron oxide and the application. We have determined that the amount of the color additive used in these foods is self-limiting (Ref. 1). Therefore, there is no need for a specific upper limit on the percent by weight of iron oxide in hard and soft candies, mints, and chewing gum in the regulation for these foods.

Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive cannot be listed for a particular use unless the data and information available to FDA establishes that the color additive is safe for that use. FDA's color additive regulations in 21 CFR 70.3(i) define “safe” to mean that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive. To establish with reasonable certainty that a color additive intended for use in food is not harmful under its intended conditions of use, we consider the estimated human dietary exposure to the additive, the additive's toxicological data, and other relevant information (such as published literature) available to us. We compare an individual's estimated daily intake (EDI) of the additive from all sources to an acceptable daily intake (ADI) established by toxicological data. The EDI is determined by projections based on the amount of the additive proposed for use in particular foods and on data regarding the amount consumed from all sources of the additive. We typically use the EDI for the 90th percentile consumer of a color additive as a measure of high chronic dietary exposure.

To support the safety of the proposed uses of synthetic iron oxide, Wrigley provided information about iron intake expected to result from the proposed new uses of synthetic iron oxide, as well as intake from other sources of iron. There are many dietary sources of iron, including from food ingredients, dietary supplements, and from food that contains naturally occurring iron. Specifically, Wrigley submitted detailed exposure estimates of iron that took into account the following: (1) The proposed uses of synthetic iron oxide as a color additive in soft and hard candy, mints, and chewing gum based on the maximum anticipated use levels; (2) the current use of synthetic iron oxide to color sausage casings; (3) background iron from conventional food based on the iron content declared on food labels; (4) iron from dietary supplements; and (5) oral exposure to iron oxides from their use as color additives in lipstick. These exposure estimates assumed that all of the iron that is present is absorbed in the gastrointestinal tract. Wrigley also provided exposure estimates to iron that took into account the bioavailability of iron from all current dietary sources, proposed uses, and lipstick. Wrigley compared these intake estimates to the Tolerable Upper Intake Level (UL) for iron established by the Institute of Medicine (IOM) of the National Academies. Based on this and other information, Wrigley concluded that the proposed use of synthetic iron oxide to color soft and hard candy, mints, and chewing gum is safe.

Using food consumption data from the 2003-2008 National Health and Nutrition Examination Survey (NHANES), Wrigley's estimated exposure to iron from the proposed uses in soft and hard candy, mints and chewing gum for the U.S. population (2 years of age and older) to be 16.3 mg/p/day (d) for the 90th percentile consumer. Wrigley also provided dietary exposure estimates to iron for children 2 to 5 years of age, children 2 to 13 years of age, and adolescents and adults 14 years of age and older. For these population groups, Wrigley estimated the exposure to iron from the proposed uses at the 90th percentile to be 12.2 mg/p/d, 15.6 mg/p/d, and 16.4 mg/p/d, respectively. Wrigley also estimated the cumulative exposure to iron from all food sources (current and proposed) for the U.S. population (2 years of age and older) to be 40.6 mg/p/d for the 90th percentile consumer. Wrigley also provided dietary exposure estimates to iron for children 2 to 5 years of age, children 2 to 13 years of age, and adolescents and adults 14 years of age and older. For these population groups, Wrigley estimated the exposure to iron at the 90th percentile to be 31.2 mg/p/d, 34.6 mg/p/d, and 41.5 mg/p/d, respectively. In addition, Wrigley estimated exposure to iron from all food sources (current and proposed) and lipstick for females 10 to 13 years old, and 14 years of age and older. The exposure at the 90th percentile for these two population groups was 33.8 mg/p/d and 40.2 mg/p/d, respectively. Wrigley noted that these exposure estimates are conservative and assume that all of the iron present is bioavailable. We have no further questions regarding Wrigley's exposure estimates for iron in food and cosmetics and conclude that the petitioner's exposure estimates are sufficiently conservative to account for the use of iron oxides in ingested drugs (Ref. 2). We also conclude that exposure from indirect uses of iron oxides, such as for colorants for food-contact polymers authorized in 21 CFR 178.3297, would not significantly contribute to the overall exposure to iron oxides.

To address the bioavailability of iron, Wrigley provided information showing approximately 18 percent of iron from conventional foods and dietary supplements is bioavailable, and that about 1 percent of iron from synthetic iron oxide is bioavailable. Based on this information, Wrigley provided exposure estimates that take into account the bioavailability of iron. Wrigley estimated the exposure to bioavailable iron from the proposed uses at the 90th percentile to be 0.16 mg/p/d, 0.12 mg/p/d, 0.16 mg/p/d, and 0.16 mg/p/d for the U.S. population (2 years of age and older), children 2 to 5 years of age, children 2 to 13 years of age, and adolescents and adults 14 years of age and older, respectively. Wrigley estimated the cumulative exposure to bioavailable iron from all food sources (current and proposed) at the 90th percentile to be 6.02 mg/p/d, 4.68 mg/p/d, 4.99 mg/p/d, and 6.21 mg/p/d for the U.S. population (2 years of age and older), children 2 to 5 years of age, children 2 to 13 years of age, and adolescents and adults 14 years of age and older, respectively. For females 10 to 13 years old, and 14 years of age and older, Wrigley estimated exposure to bioavailable iron from all food sources (current and proposed) and lipstick to be 5.07 mg/p/d and 6.12 mg/p/d, respectively (Ref. 2).

In 2000, the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board at the IOM conducted an extensive review of relevant published scientific literature to determine dietary reference intakes and ULs for iron. The IOM published a detailed report that included a UL for iron of 40 mg/d for children (2 to 5 years of age and 2 to 13 years of age), and a UL of 45 mg/d for adolescents and adults (14 years of age and older) (Ref. 3).

The IOM considers the UL as the highest daily intake level of a nutrient that poses no risk of adverse effects when the nutrient is consumed over long periods of time. The UL is determined using a risk assessment model developed specifically for nutrients and, generally speaking, may consider intake from such sources as food, water, nutrient supplements, and pharmacological agents. The dose-response assessment, which concludes with an estimate of the UL, is built upon three toxicological concepts commonly used in assessing the risk of exposures to chemical substances: No-observed-adverse-effect level, lowest-observed-effect level, and an uncertainty factor. We considered the ULs established by the IOM relative to the intake estimates as the primary basis for assessing the safety of iron from the proposed uses of synthetic iron oxide. We also reviewed scientific articles on the safety of iron submitted by Wrigley, as well as other relevant published studies available to FDA.

The exposure estimates to iron from all food sources, including the proposed use of synthetic iron oxide in soft and hard candy, mints, and chewing gum, at the 90th percentile for children 2 to 5 years of age and for children 2 to 13 years of age, without taking into account the bioavailability of the iron, is 31.2 mg/p/d and 34.6 mg/p/d, respectively. Both of these exposure estimates are below the UL for these age groups. The exposure estimate to iron from all food sources (current and proposed) and lipstick for females 10 to 13 years old at the 90th percentile of 33.8 mg/p/d is also below the UL established for this group. For adolescents and adults 14 years of age and older, the exposure estimate for iron at the 90th percentile of 41.5 mg/p/d is below the UL of 45 mg/p/d for adolescents 14 to 18 years of age. Similarly, the exposure estimate to iron from all food sources and lipstick for females 14 years of age and older of 40.2 mg/p/d at the 90th percentile is below the UL of 45 mg/p/d for adolescents and adults (14 years of age and older). Because the EDI of iron from all current and proposed food sources at the 90th percentile for each population group, which was estimated using conservative assumptions, is below the corresponding IOM UL for that population group, even without taking into account the low bioavailability of the iron from the petitioned uses, we conclude that there is a reasonable certainty of no harm from the proposed use of synthetic iron oxide as a color additive in soft and hard candy, mints, and chewing gum (Ref. 4).

As discussed in section I, the petitioner proposed to lower the specification limit for lead in synthetic iron oxide for human food use in 21 CFR 73.200 from 10 mg/kg to 5 mg/kg. To support the lower lead specification, the petitioner submitted data on lead levels from batch analyses of synthetic iron oxide. The data demonstrates that the proposed lead limit of 5 ppm is achievable with the use of good manufacturing practices in the production of the color additive (Ref. 5). Because the lower specification limit is achievable, and also because the lower specification limit is consistent with the safe use of the color additive, we are lowering the lead specification limit for lead in synthetic iron oxide for human food as proposed. The lower specification applies to both the petitioned new use of synthetic iron oxide to color candy, chewing gum, and mints, as well as to the already-approved use of synthetic iron oxide for human food use in the coloring of sausage casings.

Based on the data and information in the petition and other relevant material, we conclude that the petitioned use of synthetic iron oxide in soft and hard candy, mints, and chewing gum is safe. We further conclude that the additive will achieve its intended technical effect and is suitable for the petitioned use. Consequently, we are amending the color additive regulations in 21 CFR part 73 as set forth in this document. In addition, based upon the factors listed in 21 CFR 71.20(b), we conclude that batch certification of synthetic iron oxide is not necessary for the protection of public health.

In accordance with § 71.15 (21 CFR 71.15), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in § 71.15, we will delete from the documents any materials that are not available for public disclosure.

We previously considered the environmental effects of this rule as stated in the September 17, 2013, notice of filing for CAP 3C0298 (78 FR 57105). We stated that we had determined, under 21 CFR 25.32(k), that this action is of a type that does not individually or cumulatively have a significant effect on the human environment such that neither an environmental assessment nor an environmental impact statement is required. We have not received any new information or comments that would affect our previous determination.

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Our review of this petition was limited to section 721 of the FD&C Act. This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, the Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amended the FD&C Act to, among other things, add section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)). Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (ll)(4) of the FD&C Act applies. In our review of this petition, we did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food products containing this color additive. Accordingly, this final rule should not be construed to be a statement that a product containing this color additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all color additive final rules that pertain to food and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

This rule is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Division of Dockets Management (see ADDRESSES) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision to which you object and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.

It is only necessary to send one set of documents. Identify documents with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register.

The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. (FDA has verified the Web site addresses in this reference section, but FDA is not responsible for any subsequent changes to Web sites after this document publishes in the Federal Register.)

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 73 is amended as follows:

Legal Authority

The DEA implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. 21 U.S.C. 801-971. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), chapter II. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety.

Under the CSA, each controlled substance is classified into one of five schedules based upon its potential for abuse, currently accepted medical use, and the degree of dependence the substance may cause. 21 U.S.C. 812. The initial schedules of controlled substances established by Congress are found at 21 U.S.C. 812(c), and the current list of all controlled substances is published at 21 CFR part 1308. 21 U.S.C. 812(a).

The CSA provides the Attorney General with the authority to temporarily control a substance under schedule I for two years without regard to the requirements of 21 U.S.C. 811(b) if he/she finds that such action is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. 811(h). If proceedings to permanently control a substance are initiated pursuant to 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary control for up to one year. 21 U.S.C. 811(h)(2). The Attorney General has delegated this authority to the Administrator of the DEA. 28 CFR 0.100.

The Synthetic Drug Abuse Prevention Act of 2012 (SDAPA) became effective on July 9, 2012.1 SDAPA amended the CSA by permanently controlling “cannabimimetic agents” and 26 other specific substances in schedule I. At that time, some of the 26 permanently controlled substances were temporarily controlled and listed in 21 CFR 1308.11(g), including the following substances: 1-pentyl-3-(1-naphthoyl)indole (JWH-018); 1-butyl-3-(1-naphthoyl)indole (JWH-073); 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200); 5-(1,1-dimethyloctyl)-2-(3-hydroxycyclohexyl)-phenol (cannabicyclohexanol or CP-47,497 C8 homologue); 2 4-methyl-N-methylcathinone (mephedrone); and 3,4-methylenedioxypyrovalerone (MDPV).3

On January 4, 2013, the DEA published a final rule permanently placing cannabimimetic agents and all 26 substances specified in SDAPA into schedule I (including the 6 substances noted above that were previously temporarily controlled).4

The substance 3,4-methylenedioxy-N-methylcathinone (methylone) was not permanently controlled through SDAPA. However, DEA temporarily controlled methylone on October 21, 2011, pursuant to 21 U.S.C. 811(h), and listed it in 21 CFR 1308.11(g)(7).5 On January 4, 2013, subparagraph (g) of 21 CFR 1308.11 was redesignated as subparagraph (h), and methylone was renumbered in section 1308.11(h)(1); it also inadvertently remained on the list of temporarily controlled substances in section 1308.11(h)(7). The DEA permanently controlled methylone in schedule I by a final rule published in the Federal Register on April 12, 2013.6

Because the above noted substances are permanently controlled in schedule I, the DEA is making technical and conforming amendments to the regulations by removing the above referenced 7 substances (JWH-018; JWH-073; JWH-200; CP-47,497 C8 homologue; mephedrone; MDPV; and methylone) from the list of temporarily controlled substances and redesignating the numerical order of the remaining controlled substances that are currently subject to temporary control.

An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act (APA), 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 under 5 U.S.C. 533(b)(3)(B). This rule provides technical and conforming amendments to the DEA's regulations and imposes no new or substantive requirement on the public or DEA registrants. As such, the DEA has determined that notice and opportunity for public comment on this rule are unnecessary. In addition, because this is not a substantive rule and as the DEA finds good cause under 5 U.S.C. 553(d)(3) for the above reasons, this final rule shall take effect upon the date of publication in the Federal Register.

The Administrator certifies that this is not a significant regulatory action within the meaning of Executive Order 12866 and the principles reaffirmed in Executive Order 13563, as it makes only technical amendments to the current regulations. Such actions are exempt from review by the Office of Management and Budget (OMB).

This rule meets the applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.

This rule does not have federalism implications warranting the application of Executive Order 13132. This rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.

This rule does not involve a collection of information within the meaning of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521.

This rule does not have tribal implications warranting the application of Executive Order 13175. The rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This rule is not a major rule as defined by Section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). 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 for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; 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. However, pursuant to the CRA, the DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.

For the reasons set out above, 21 CFR part 1308 is amended as follows:

California Department of Transportation has requested a temporary change to the operation of the Commodore Schuyler F. Heim highway bridge, mile 4.9, over Cerritos Channel, at Long Beach, CA. The drawbridge navigation span provides a vertical clearance of 37 feet above Mean High Water in the closed-to-navigation position and a maximum of 43 feet due to construction falsework over the channel at the bridge. The draw opens on signal; except that, from 6:30 a.m. to 8 a.m. and 3:30 p.m. to 6 p.m., Monday through Friday except Federal holidays, the draw need not be opened for the passage of vessels, as required by 33 CFR 117.147(a). Navigation on the waterway is commercial and recreational.

The drawspan will be secured in the closed-to-navigation position from 10 p.m. on March 15, 2015 to 2 a.m. on March 16, 2015; and from 10 p.m. on March 22, 2015 to 2 a.m. on March 23, 2015 to allow Southern California Edison Company to switch electrical power for the bridge to another source. This temporary deviation has been coordinated with the waterway users. No objections to the proposed temporary deviation were raised.

Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is an alternate route around Terminal Island for routine and emergency navigation. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The South Park highway bridge is a double bascule span drawbridge that requires under bridge maintenance. King County Road Services Division requested a deviation to the published drawbridge operation schedule to enable timely completion of the required bridge maintenance. The South Park highway bridge is located in the Duwamish Waterway, mile 3.8, at Seattle, WA, and provides 34.8 feet of vertical clearance at center span while in the closed position, 30 feet of vertical clearance at the extreme east and west ends of the navigable channel, and unlimited vertical clearance with half of the bascule bridge in the fully open position. Vertical clearances are referenced to mean high-water elevation (MHW). Horizontal clearance is 128 feet. However, horizontal clearance may be restricted by construction barges.

The normal operation schedule for the bridge is in 33 CFR 117.1041, which specifies that the draws of each bridge across the Duwamish Waterway shall open on signal, except the draw of the South Park highway bridge, mile 3.8, which need not be opened for the passage of vessels from 6:30 a.m. to 8:00 a.m. and 3:30 p.m. to 5:00 p.m., Monday through Friday, except Federal holidays.

The deviation period is effective from 12:01 a.m. on March 17, 2015 to 11:59 p.m. on March 28, 2015, and allows the drawbridge to remain closed to mariners needing a full channel double bascule opening. For mariners that only require a single leaf, half channel, drawbridge opening, such an opening will be given upon signal. A drawtender will be present 24 hours a day, 7 days week. To request a single leaf opening, mariners may utilize any of the following methods: (1) Via VHF maritime radio; (2) telephone; (3) one prolonged blast followed quickly by one short blast and one prolonged blast.

Waterborne traffic on this stretch of the Duwamish waterway consists of vessels ranging from small pleasure craft, sailboats, small tribal fishing boats, and commercial tug and tow, and mega yachts. Vessels able to pass under the bridge in the closed positions may do so at anytime, but are advised to use caution as the area surrounding the bridge has numerous construction craft and equipment occupying half of the navigational channel. The bridge will be able to open half of the bridge for emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform users of the waterway of the change in operating schedule for the bridge through our Local and Broadcast Notices to Mariners so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Table of Acronyms BNM Broadcast Notices to Mariners CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not using the Notice of Proposed Rulemaking (NPRM) Process. The Coast Guard, with recommendations from the Pittsburgh Ice Committee (comprised of Army Corps of Engineers—Pittsburgh District, National Weather Service, Marine Safety Unit Pittsburgh, and Chairperson of the Waterways Navigation Committee), has established a safety zone on all waters of the Allegheny Rivers within the COTP Pittsburgh Zone. This safety zone will remain in effect February 26, 2015, until April 1, 2015 or ice conditions within the COTP Pittsburgh Zone have improved, whichever occurs earlier. This safety zone is the result of significant ice formation within the navigable channels of the Allegheny River, due to extended periods of sub-freezing temperatures. Waterway users will be informed of the decisions by the Pittsburgh Ice Committee during the Industry Teleconference that is hosted by MSU Pittsburgh. This emergent situation does not allow time for the NPRM Process. After full review of information provided by the Pittsburgh Ice Committee, Army Corps of Engineers—Pittsburgh District, and National Weather Service, the Coast Guard has determined that immediate action establishing additional safety measures is necessary to ensure public safety during the next several weeks. Delaying the implementation of this rule by completing the NPRM Process is contrary to public interest. Immediate action is needed to protect persons, property, and vessels transiting into, out of, or within the COTP Pittsburgh Zone during sub-freezing temperatures and resulting ice accumulations.

For the same reasons discussed above, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Providing 30 days notice would unnecessarily delay the effective date and would be impracticable and contrary to public interest because immediate action is needed to protect persons, property, and vessels transiting into, out of, or within the COTP Pittsburgh Zone.

The COTP Pittsburgh Zone has recently experienced consecutive weeks of sub-freezing temperatures. Accumulations of ice have formed on the Allegheny River resulting in vessels not being able to transit the river.

The legal basis and authorities for this rule are found in 33 U.S.C. 1231, 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish and define regulatory safety zones.

The Coast Guard is establishing a safety zone for all waters of the Allegheny Rivers within the COTP Pittsburgh Zone, which includes mile 1.0 to mile 72.0 on the Allegheny River. Entry into this zone is prohibited to all vessels and persons, except persons and vessels specifically authorized by the COTP Pittsburgh. This rule is effective immediately and will be enforced February 26, 2015, until April 1, 2015 or ice conditions within the COTP Pittsburgh Zone have improved, whichever occurs earlier. As stated in the Basis and Purpose section above, on the recommendation from the Pittsburgh Ice Committee, entry into this zone is prohibited to all vessels and persons, except persons and vessels specifically authorized by the COTP Pittsburgh.

The COTP Pittsburgh will inform the public through Broadcast Notices to Mariners (BNM) of details regarding enforcement and any changes to this safety zone during ice accumulation conditions.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

This rule is not significant under the regulatory policies and procedures of the Department of Homeland Security (DHS). This rule will be in effect during emergency conditions involving ice accumulation on the Allegheny River. While some impacts on routine navigation will be recognized by waterway users, the recommendation for this emergency safety measure came from the Pittsburgh Ice Committee which is comprised of Army Corps of Engineers—Pittsburgh District, National Weather Service, Marine Safety Unit Pittsburgh, and Chairperson of the Waterways Navigation Committee. The Coast Guard will continue to make notifications to the marine community and local industry contacts that could be operating in the area during these conditions. Additionally, deviation from the rule may be requested and will be considered on a case-by-case basis by the COTP or a designated representative.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit mile 1.0 to mile 72.0 on the Allegheny River, from February 26, 2015, until April 1, 2015 or ice conditions within the COTP Pittsburgh Zone have improved, whichever occurs earlier. This emergency safety zone will not have a significant economic impact on a substantial number of small entities due to its limited scope and short duration.

Entry into this zone is prohibited to all vessels and persons, except persons and vessels specifically authorized by the COTP Pittsburgh. The Coast Guard will ensure that that the local marine community is aware of the safety zone through BNMs and other notification. Additionally, deviation from the rule may be requested and will be considered on a case-by-case basis by the COTP or a designated representative.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT, above.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995(44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT, section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule establishes an emergency safety zone for waters of the Allegheny River within the COTP Pittsburgh Zone. This rule is categorically excluded from further review under paragraph 34(g) of figure 2-1 of the Commandant Instruction an environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

A. Why are revisions to state programs necessary?

States which have received final authorization from EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and ask EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to EPA's regulations in 40 Code of Federal Regulations (CFR) parts 124, 260 through 268, 270, 273, and 279.

New Federal requirements and prohibitions imposed by Federal regulations that EPA promulgates pursuant to the Hazardous and Solid Waste Amendments of 1984 (HSWA) take effect in authorized States at the same time that they take effect in unauthorized States. Thus, EPA will implement those requirements and prohibitions in Tennessee, including the issuance of new permits implementing those requirements, until the State is granted authorization to do so.

On March 9, 2010 and January 15, 2013, Tennessee submitted final complete program revision applications seeking authorization of changes to its hazardous waste program that correspond to certain Federal rules promulgated between July 1, 2004 and June 30, 2006 (also known as RCRA Clusters XV and XVI). Tennessee supplemented these applications on September 16, 2014. EPA concludes that Tennessee's applications to revise its authorized program meet all of the statutory and regulatory requirements established by RCRA, as set forth in RCRA section 3006(b), 42 U.S.C. 6926(b), and 40 CFR part 271. Therefore, EPA grants Tennessee final authorization to operate its hazardous waste program with the changes described in the authorization applications, and as outlined below in Section G of this document.

Tennessee has responsibility for permitting treatment, storage, and disposal facilities within its borders and for carrying out the aspects of the RCRA program described in its revised program applications, subject to the limitations of HSWA, as discussed above.

The effect of this decision is that the changes described in Tennessee's authorization applications will become part of the authorized State hazardous waste program, and will therefore be federally enforceable. Tennessee will continue to have primary enforcement authority and responsibility for its State hazardous waste program. EPA retains its authorities under RCRA sections 3007, 3008, 3013, and 7003, including its authority to:

• Conduct inspections, and require monitoring, tests, analyses, or reports;

• Enforce RCRA requirements, including authorized State program requirements, and suspend or revoke permits; and

• Take enforcement actions regardless of whether the State has taken its own actions.

This action does not impose additional requirements on the regulated community because the regulations for which Tennessee is being authorized by this action are already effective and enforceable requirements under State law, and are not changed by this action.

Along with this direct final rule, EPA is publishing a separate document in the “Proposed Rules” section of this issue of the Federal Register that serves as the proposal to authorize these State program changes. EPA did not publish a proposed rule before today because EPA views this as a routine program change and does not expect comments that oppose this approval. EPA is providing an opportunity for public comment now, as described in Section E of this document.

If EPA receives comments that oppose this authorization, EPA will withdraw this direct final rule by publishing a document in the Federal Register before the rule becomes effective. EPA will base any further decision on the authorization of the State program changes on the proposed rule mentioned in the previous section, after considering all comments received during the comment period, and will address all such comments in a later final rule. You may not have another opportunity to comment on these State program changes. If you want to comment on this authorization, you must do so at this time.

If EPA receives comments that oppose only the authorization of a particular change to the State hazardous waste program, EPA will withdraw that part of this direct final rule, but the authorization of the program changes that the comments do not oppose will become effective on the date specified above. The Federal Register withdrawal document will specify which part of the authorization will become effective, and which part is being withdrawn.

Tennessee initially received final authorization on January 22, 1985, effective February 5, 1985 (50 FR 2820), to implement a RCRA hazardous waste management program. EPA granted authorization for changes to Tennessee's program on the following dates: June 12, 1987, effective August 11, 1987 (52 FR 22443); June 1, 1992, effective July 31, 1992 (57 FR 23063); May 8, 1995, effective July 7, 1995 (60 FR 22524); August 24, 1995, effective October 23, 1995 (60 FR 43979); May 23, 1996, effective July 22, 1996 (61 FR 25796); January 30, 1998, effective March 31, 1998 (63 FR 4587); September 15, 1999, effective November 15, 1999 (64 FR 49998); October 26, 2000, effective December 26, 2000 (65 FR 64161); December 26, 2001, effective February 25, 2002 (66 FR 66342); April 11, 2003, effective June 10, 2003 (68 FR 17748); March 14, 2005, effective May 13, 2005 (70 FR 12416); May 11, 2006, effective July 10, 2006 (71 FR 27405); and October 5, 2012, effective December 4, 2012 (77 FR 60919).

On March 9, 2010 and January 15, 2013, Tennessee submitted final complete program revision applications seeking authorization of its changes in accordance with 40 CFR 271.21. Tennessee supplemented these applications on September 16, 2014. EPA now makes an immediate final decision, subject to receipt of written comments that oppose this action, that Tennessee's hazardous waste program revisions are equivalent to, consistent with, and no less stringent than the Federal program, and therefore satisfy all of the requirements necessary to qualify for final authorization. Therefore, EPA grants Tennessee final authorization for the following program changes: