On September 30, 2014 (79 FR 58664), the NRC published a direct final rule amending its regulations in parts 30, 37, 73, and 150 of Title 10 of the Code of Federal Regulations (10 CFR) by removing the SGI-M designation of the security-related information for large irradiators, manufacturer and distributors, and for transport of category 1 quantities of radioactive material. The direct final rule also removed the SGI-M designation of the security-related information for the transportation of irradiated reactor fuel that weighs 100 grams or less in net weight of irradiated fuel. The security-related information for these facilities and the transportation of certain materials will no longer be designated as SGI-M and will be protected under the information protection requirements that apply to other materials licensees that possess category 1 and category 2 quantities of radioactive material.

In the direct final rule, the NRC stated that if no significant adverse comments were received, the direct final rule would become effective on January 28, 2015. The NRC received one public comment from an anonymous commenter (ADAMS Accession No. ML14302A494) on the companion proposed rule. The commenter stated that the rule should be amended because it will require an additional information protection requirement on the product. The commenter also stated that the additional requirement would be needed so that the information relating to the product “would not get leaked.” The NRC staff reviewed this comment and concluded that this comment is not a significant adverse comment as defined in NUREG-BR-0053, Revision 6, “United States Nuclear Regulatory Commission Regulations Handbook” (ADAMS Accession No. ML052720461), because the comment does not present a reason or issue that warrants a substantive response. The comment does not aid the NRC's understanding of any concern with the NRC's decision to remove the SGI-M designations from some categories of information. Information that merits protection now falls within the information protection provisions of 10 CFR part 37. Therefore, this direct final rule will become effective as scheduled.

The NRC is issuing revised NUREG-2155 (Rev 1), “Implementation Guidance of 10 CFR part 37, `Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material,' ” to conform the guidance to the direct final rule by removing references to the SGI-M designation and to make minor editorial changes and updates. The guidance is available in ADAMS under Accession No. ML15016A172.

In the Federal Register (FR) on September 30, 2014, in FR Doc. 2014-23256, on page 58669, the following corrections are made to the table entitled, “Compatibility Table for Direct Final Rule:”

1. In the column entitled, “Existing,” in the seventh row, correct the compatibility category “NRC” for § 37.43(d)(1) to read “C”.

2. In the column entitled, “New,” in the seventh row, add compatibility category “C” for § 37.43(d)(1).

These minor and administrative changes correct an error in the original document and do not change the substantive responsibilities of any person or entity regulated by the NRC.

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2011-13-09, Amendment 39-16732 (76 FR 37255, June 27, 2011). AD 2011-13-09 applied to all Airbus Model A330-200, -200F, and -300 series airplanes. The NPRM published in the Federal Register on August 26, 2014 (79 FR 50869).

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2013-0245, dated October 2, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A330-200, -200F, and -300 series airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0587-0002.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (79 FR 50869, August 26, 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 this AD as proposed, with minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (79 FR 50869, August 26, 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 50869, August 26, 2014).

We estimate that this AD affects 76 airplanes of U.S. registry.

The actions required by AD 2011-13-09, Amendment 39-16732 (76 FR 37255, June 27, 2011), and retained in this AD take about 1 work-hour per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the actions that were required by AD 2011-13-09 is $85 per product.

We also estimate that it will take about 1 work-hour per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $6,460, or $85 per product.

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 that 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/#!docketDetail;D=FAA-2014-0587; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section.

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 Pilatus Aircraft Ltd. Model PC-7 airplanes. The NPRM was published in the Federal Register on October 7, 2014 (79 FR 60389). 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. Since the NPRM was issued, the MCAI was revised based on revised service information. The NPRM we issued already referenced the revised service information. The revised MCAI states:

We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the proposal and the FAA's response to the comment.

Tom Langen of Pilatus commented that the NPRM (79 FR 60389, October 7, 2014) referred to MCAI AD HB-2014-001, dated July 25, 2014. Since issuance of the NPRM, the MCAI was revised to AD HB-2014-001R1, dated October 22, 2014. The revised MCAI clarified P/N 116.35.07.271 needed to be replaced where the other P/N 116.35.07.345 should be inspected and not automatically replaced. Tom Langen requested we revise paragraph (f)(3) of the AD to read like the revised MCAI.

We agree. We revised this AD as requested.

We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting the AD with the change described previously and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (79 FR 60389, October 7, 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 60389, October 7, 2014).

We also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

Pilatus Aircraft Ltd. has issued Pilatus PC-7 Service Bulletin No: 51-001, Revision No. 1, dated August 26, 2014. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI. The service bulletin describes procedures for inspecting for stress corrosion and replacing various parts of the airplane structure made of aluminum alloy AA2024-T351. You can find this service information on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-0770.

We estimate that this AD will affect 10 products of U.S. registry. We also estimate that it would take about 30 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 $4,700 per product.

Based on these figures, we estimate the cost of the AD on U.S. operators to be $72,500, or $7,250 per product.

In addition, we estimate that any necessary follow-on actions would take about 14 work-hours and require parts costing $10,000, for a cost of $11,190 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-2014-0770; 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 supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 to supersede AD 2011-14-06, Amendment 39-16741 (76 FR 42024, July 18, 2011). AD 2011-14-06 applied to Airbus Model A318, A319, A320, and A321 series airplanes. The SNPRM published in the Federal Register on May 28, 2014 (79 FR 30492). We preceded the SNPRM with a notice of proposed rulemaking (NPRM) that published in the Federal Register on August 13, 2013 (78 FR 49213).

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2013-0147, dated July 16, 2013 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A318, A319, A320, and A321 series airplanes. The MCAI states:

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the SNPRM (79 FR 30492, May 28, 2014) and the FAA's response to each comment.

United Airlines (UAL), Delta Airlines (DAL), and Virgin America asked that we extend the compliance time for incorporation of Airbus A318/A319/A320/A321 ALS Part 2—Damage-Tolerant Airworthiness Limitation Items (DT ALI), Revision 02, dated May 28, 2013. UAL stated that it would like to manage the task incorporation on an individual basis. UAL proposed that we revise the compliance times specified in paragraph (n) of the SNPRM (79 FR 30492, May 28, 2014) as follows: “After the effective date of this AD, incorporate each task into the program within the specific threshold/interval provided.” DAL and Virgin America stated that, to provide time to revise the maintenance program and perform any related tasks that might exceed the compliance thresholds specified in the ALI, the grace period specified in paragraph (n) of the SNPRM should be changed from 4 to 12 months.

DAL asked for more time to update the maintenance program to incorporate Airbus A318/A319/A320/A321 ALS Part 2—Damage-Tolerant Airworthiness Limitation Items (DT ALI), Revision 02, dated May 28, 2013. DAL and Virgin America requested 9 months, as opposed to 30 days, because 9 months was the allowed compliance time for incorporating airworthiness limitation items into the maintenance program required by AD 2011-14-06, Amendment 39-16741 (76 FR 42024, July 18, 2011).

We acknowledge the commenters' concerns; however, we do not agree to extend the compliance times for incorporation of the tasks into the maintenance program. We based the compliance times in this AD primarily on our assessment of the safety risk. Since some safety issues are more time-sensitive than others, we consider the overall risk to the fleet, including the severity of the failure and the likelihood of the occurrence of the failure. In this case, the primary reason for requiring incorporation of Airbus A318/A319/A320/A321 ALS Part 2—Damage-Tolerant Airworthiness Limitation Items (DT ALI), Revision 02, dated May 28, 2013, is to cover extension of the design service goal and preliminary results from widespread fatigue damage.

Therefore, we do not agree to extend the grace period or compliance times for incorporation of the tasks into the maintenance program. However, under the provisions of paragraph (p)(1) of this AD, we will consider requests for approval of extending the compliance time based on the current status of the maintenance and inspection programs relative to the ALI tasks if sufficient data are submitted to substantiate that it would provide an acceptable level of safety. We have not changed this AD in this regard.

Since late 2006, we have included a standard paragraph titled “Airworthy Product” in all MCAI ADs in which the FAA develops an AD based on a foreign authority's AD.

We have become aware that some operators have misunderstood or misinterpreted the Airworthy Product paragraph to allow the owner/operator to use messages provided by the manufacturer as approval of deviations during the accomplishment of an AD-mandated action. The Airworthy Product paragraph does not approve messages or other information provided by the manufacturer for deviations to the requirements of the AD-mandated actions. The Airworthy Product paragraph only addresses the requirement to contact the manufacturer for corrective actions for the identified unsafe condition and does not cover deviations from other AD requirements. However, deviations to AD-required actions are addressed in 14 CFR 39.17, and anyone may request the approval for an alternative method of compliance to the AD-required actions using the procedures found in 14 CFR 39.19.

To address this misunderstanding and misinterpretation of the Airworthy Product paragraph, we have changed the paragraph and retitled it “Contacting the Manufacturer.” This paragraph now clarifies that for any requirement in this AD to obtain corrective actions from a manufacturer, the actions must be accomplished using a method approved by the FAA, the European Aviation Safety Agency (EASA), or Airbus's EASA Design Organization Approval (DOA).

The Contacting the Manufacturer paragraph also clarifies that, if approved by the DOA, the approval must include the DOA-authorized signature. The DOA signature indicates that the data and information contained in the document are EASA-approved, which is also FAA-approved. Messages and other information provided by the manufacturer that do not contain the DOA-authorized signature approval are not EASA-approved, unless EASA directly approves the manufacturer's message or other information.

This clarification does not remove flexibility previously afforded by the Airworthy Product paragraph. Consistent with long-standing FAA policy, such flexibility was never intended for required actions. This is also consistent with the recommendation of the Airworthiness Directive Implementation Aviation Rulemaking Committee to increase flexibility in complying with ADs by identifying those actions in manufacturers' service instructions that are “Required for Compliance” with ADs. We continue to work with manufacturers to implement this recommendation. But once we determine that an action is required, any deviation from the requirement must be approved as an alternative method of compliance.

We also have decided not to include a generic reference to either the “delegated agent” or “design approval holder (DAH) with State of Design Authority design organization approval,” but instead we have provided the specific delegation approval granted by the State of Design Authority for the DAH.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the SNPRM (79 FR 30492, May 28, 2014) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the SNPRM (79 FR 30492, May 28, 2014).

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

We estimate that this AD affects 851 airplanes of U.S. registry.

The actions required by AD 2011-14-06, Amendment 39-16741 (76 FR 42024, July 18, 2011), and retained in this AD take about 1 work-hour per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the required actions is $85 per product.

We also estimate that it will take about 1 work-hour per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $72,335, or $85 per product.

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 that 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/#!docketDetail;D=FAA-2013-0692; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone 800-647-5527) is in the ADDRESSES section.

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

In Order No. 676-H, the Federal Energy Regulatory Commission (Commission) amended its regulations to incorporate by reference, with certain enumerated exceptions, the latest version (Version 003) of the Standards for Business Practices and Communication Protocols for Public Utilities adopted by the Wholesale Electric Quadrant (WEQ) of the North American Energy Standards Board (NAESB) as mandatory enforceable requirements. 1 Order No. 676-H requires public utilities to comply with the incorporated Version 003 business practice standards by February 2, 2015, with the exception of those standards related to the NITS OASIS template, for which compliance is required by April 25, 2016. Several entities have requested a time extension for compliance with the February 2, 2015 implementation date.

Upon consideration of these requests for extension of time, the Commission will extend the requirement for compliance with the Version 003 business practice standards not related to the NITS OASIS template to and including May 15, 2015, for all entities subject to these requirements. All other compliance obligations set forth in Order No. 676-H remain in force. We will consider further requests for extension for particular standards in future orders. 2

Table of Acronyms DHS Department of Homeland Security FR  Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

The Coast Guard is establishing this Special Local Regulation on the waters of the Gulf of Mexico in the vicinity of Clearwater Beach, Florida during the Clearwater Super Boat National Championship. On September 10, 2014, the Coast Guard published a notice proposing this final rule. One comment was received in favor of this regulation.

The race is scheduled to take place annually from approximately 10 a.m. to 5 p.m. during the last Saturday and Sunday of September. This rule is necessary to protect the safety of race participants, participant vessels, spectators, and the general public on the navigable waters of the United States during the event.

The legal basis for the rule is the Coast Guard's authority to establish special local regulations: 33 U.S.C. 1233.

The purpose of the rule is to provide for the safety of life on navigable waters of the United States during the Clearwater Super Boat National Championship.

The Coast Guard received one comment related to this event during the comment period and there was no request for a public meeting made during the comment period. The one comment received was in support of the regulation.

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.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered the impact of this rule on small entities. 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.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

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. 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 would not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule would 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 would not create an environmental risk to health or risk to safety that might disproportionately affect children.

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

This rule 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 made a preliminary determination 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 is categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. A environmental analysis checklist supporting this determination is available in the docket where indicated under ADDRESSES .

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

Throughout this document wherever “we,” “us,” or “our” is used, we mean the EPA.

Section 110 of the CAA requires states to develop and submit to EPA a SIP to ensure that state air quality meets National Ambient Air Quality Standards (NAAQS). The NAAQS currently address six criteria pollutants: Carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide. Each federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin through air pollution regulations and control strategies. EPA-approved SIP provisions and control strategies are federally enforceable. States revise the SIP as needed and submit revisions to EPA for approval.

On August 31, 2009, the New Mexico Environmental Improvement Board (EIB) adopted amendments to the New Mexico Administrative Code (NMAC) at Title 20, Chapter 2, Parts 2, 74 and 79. Governor Richardson submitted these amendments as a revision to the New Mexico SIP in a letter dated June 11, 2009.

As part of this action, EPA is addressing only the revisions to the NMAC at Title 20, Chapter 2, Part 2, Definitions that were contained in the revisions adopted on August 31, 2009. This includes the addition of two definitions: “PM 2.5 ” and “PM 2.5 emissions.” EPA is not addressing the revisions to Parts 74 and 79, which were previously addressed in a separate action. See 75 FR 72688.

EPA is also taking this opportunity to recodify the General Definitions of the NMAC as part of this action. The New Mexico EIB adopted the recodification of Title 20, Chapter 2, Part 2 in 2002.

As detailed in the Technical Support Document (TSD) accompanying this action, the definitions of “PM 2.5 ” and “PM 2.5 emissions” that were submitted as additions to the New Mexico SIP have been reviewed and were found to be consistent with EPA's federal regulations. The 2002 recodification of Title 20, Chapter 2, Part 2 is administrative in nature, does not contain substantive changes, and is approvable.

For the reasons stated above and in the TSD, EPA is taking direct final action to approve revisions to the New Mexico SIP pertaining to the General Definitions section at NMAC, Title 20, Chapter 2, Part 2, Definitions, as adopted on August 31, 2009, and submitted as SIP revisions on June 11, 2009. EPA is also approving the recodification of Title 20, Chapter 2, Part 2 adopted in 2002 as part of this action.

We are approving the revisions to the New Mexico SIP under section 110 of the Act. We are publishing this rule without prior proposal because we view this as a noncontroversial amendment and anticipate no significant adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the SIP revision if significant adverse comments are received. This rule will be effective on March 27, 2015 without further notice unless we receive significant adverse comment by February 25, 2015. If we receive significant adverse comments, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so now. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 27, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposed of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

Section 553(d) of the Administrative Procedure Act (APA), 5 U.S.C. Chapter 5, generally provides that rules may not take effect earlier than 30 days after they are published in the Federal Register . EPA is issuing this final rule under section 307(d)(1) of the Clean Air Act, which states: “The provisions of section 553 through 557 . . . of Title 5 shall not, except as expressly provided in this section, apply to actions to which this subsection applies.” Thus, section 553(d) of the APA does not apply to this rule. EPA is nevertheless acting consistently with the policies underlying APA section 553(d) in making this rule effective on January 26, 2015. APA section 553(d) allows an effective date less than 30 days after publication for a rule that “that grants or recognizes an exemption or relieves a restriction.” 5 U.S.C. 553(d)(1). Since today's action grants an exemption for limited laboratory and analytical uses from the general prohibition on production or import of Class I ozone depleting substances after their phaseout dates, EPA is making this action effective immediately upon publication.

Entities potentially regulated by this action include: (1) Pharmaceutical preparations manufacturing businesses (NAICS code 325412); (2) medical and diagnostic laboratories (NAICS code 621511); (3) research and development in the physical, engineering, and life sciences (NAICS code 54171); and (4) environmental consulting services (NAICS code 541620). This list is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be regulated by this action. To determine whether your facility, company, business, or organization could be regulated by this action, you should carefully examine the regulations promulgated at 40 CFR part 82, subpart A. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding section.

The Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol, or Protocol) is the international agreement to reduce and eventually eliminate the global production and consumption  1 of ozone-depleting substances (ODS). This goal is accomplished through adherence by each country that is a Party to the Protocol to phaseout schedules for specific controlled substances. The Protocol established January 1, 1996, as the date by which the production and import of most substances classified as “class I controlled substances” under the Clean Air Act (CAA or Act)—including chlorofluorocarbons (CFCs), carbon tetrachloride, and methyl chloroform  2 —were to be phased out in developed countries, including the United States. The Clean Air Act grants EPA the authority to implement the Protocol's phaseout schedules in the United States. Section 604 of the Clean Air Act requires EPA to issue regulations phasing out production and consumption of class I ODS according to a prescribed schedule. EPA's phaseout regulations for ODS are codified at 40 CFR part 82, subpart A.

The Montreal Protocol provides exemptions that allow for the continued import and/or production of ODS for specific uses. For most class I ODS, the Parties may collectively grant exemptions to the ban on production and import of ODS for uses that they determine to be “essential.” For example, with respect to CFCs, Article 2A(4) provides that the phaseout will apply “save to the extent that the Parties decide to permit the level of production or consumption that is necessary to satisfy uses agreed by them to be essential.” Similar language appears in the control provisions for halons (Art. 2B), carbon tetrachloride (Art. 2D), methyl chloroform (Art. 2E), hydrobromofluorocarbons (Art. 2G), and chlorobromomethane (Art. 2I). As defined by Decision IV/25 of the Parties, “use of a controlled substance should qualify as `essential' only if: (i) It is necessary for the health, safety or is critical for the functioning of society (encompassing cultural and intellectual aspects); and (ii) there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health.”

Decision X/19 under the Montreal Protocol (taken in 1998) allowed a general exemption for essential laboratory and analytical uses through December 31, 2005. EPA codified this exemption at 40 CFR part 82, subpart A. While the Clean Air Act does not specifically provide for this exemption, EPA determined that an exemption for essential laboratory and analytical uses was allowable under the Act as a de minimis exemption. EPA addressed the de minimis exemption in a regulation issued March 13, 2001 (66 FR 14760).

Decision X/19 also requested the Montreal Protocol's Technology and Economic Assessment Panel (TEAP), a group of technical experts from various Parties, to report annually to the Parties to the Montreal Protocol on laboratory and analytical procedures that could be performed without the use of controlled substances. It further stated that at future Meetings of the Parties (MOPs), the Parties would decide whether such procedures should no longer be eligible for exemptions. Based on the TEAP's recommendation, the Parties to the Montreal Protocol decided in 1999 (Decision XI/15) that the general exemption no longer applied to the following uses: testing of oil and grease and total petroleum hydrocarbons in water; testing of tar in road-paving materials; and forensic finger-printing. EPA incorporated these exclusions at Appendix G to subpart A of 40 CFR part 82 on February 11, 2002 (67 FR 6352).

At the 18th MOP, the Parties acknowledged the need for methyl bromide for laboratory and analytical procedures, and added methyl bromide to the ODS under the essential laboratory and analytical use exemption. Decision XVIII/15 outlined specific uses and exclusions for methyl bromide under the exemption. EPA incorporated specific uses of methyl bromide in the essential laboratory and analytical use exemption at Appendix G to subpart A of 40 CFR part 82 on December 27, 2007 (72 FR 73264).

In November 2009, at the 21st MOP, the Parties in Decision XXI/6 extended the global laboratory and analytical use exemption through December 31, 2014. Based on this decision, EPA amended the regulation at 40 CFR 82.8(b) to extend the essential laboratory and analytical use exemption through December 31, 2014 (76 FR 77909, December 15, 2011). Decision XXI/6 also notes laboratory and analytical uses of ODS for which the TEAP and its Chemicals Technical Options Committee (CTOC), determined that alternative procedures exist. However, the Parties did not exclude any of those procedures from the exemption for laboratory and analytical uses.

In November 2014, the Parties in Decision XXVI/5 extended the global laboratory and analytical use exemption through December 31, 2021. This final rule extends the laboratory and analytical use exemption found in 40 CFR 82.8(b) to match the recent international decision.

A detailed discussion of the laboratory and analytical uses of ODS can be found in the regulation issued by EPA on March 13, 2001 (66 FR 14760). That rule also discusses how the controls in place for laboratory and analytical uses provide adequate assurance that very little, if any, environmental damage will result from the handling and disposal of the small amounts of class I ODS used in such applications, due to the Appendix G requirements for small quantity and high purity. For example, class I ODS must be sold in cylinders three liters or smaller or in glass ampoules 10 milliliters or smaller. Since issuing the original exemption, EPA has not received information that would suggest a significant environmental effect from this exemption.

U.S. production and consumption of ODS under the laboratory and analytical use exemption is on a general decline, indicating that many users have been able to transition from ozone-depleting substances. However, certain laboratory procedures continue to require the use of class I substances in the United States. Because non-ODS replacements for the class I substances have not been identified for all uses, EPA is extending this exemption through December 31, 2021.

EPA received one substantive comment in response to the proposed rule, which was supportive of extending the exemption through December 31, 2021. The commenter, a manufacturer of ozone-depleting substances used as solvents under the exemption, agreed that non-ODS replacements for class I substances have not been identified, and stated that the low volume of usage of these chemicals and their exclusive use in professionally managed analytical laboratories means there is very low risk that environmental damage will occur.

EPA believes an extension of seven years is warranted, as it is unlikely that non-ODS replacements will be in place for all laboratory and analytical uses prior to that time. Decision XXVI/5 encourages parties to continue to investigate the possibility of replacing ozone-depleting substances in laboratory and analytical uses. EPA did not receive comments from standards organizations that continue to use ODS in their standards or from laboratories that have transitioned to ozone-safe alternatives. EPA intends to continue to work to investigate barriers to transitioning from ozone-depleting substances to alternatives for this limited use.

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2060-0170. This action extends but does not modify the existing exemption from the phaseout of class I ODS.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This action provides an otherwise unavailable benefit to those companies that obtain ozone-depleting substances under the essential laboratory and analytical use exemption. We have therefore concluded that this action will relieve regulatory burden for all directly regulated small entities.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector. This action merely extends the essential laboratory and analytical use exemption from the 1996 and 2005 phaseouts of class I ODS production and consumption until December 31, 2021.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175. This rule does not significantly or uniquely affect the communities of Indian tribal governments, nor does it impose any enforceable duties on communities of Indian tribal governments. This action extends the essential laboratory and analytical use exemption from the 1996 and 2005 phaseouts of class I ODS production and consumption until December 31, 2021. Thus, Executive Order 13175 does not apply to this action.

This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. A discussion of this action's health and risk effects are contained in the direct final rule establishing the De Minimis Exemption for Laboratory Essential Uses (66 FR 14760; March 13, 2001). The controls in place for laboratory and analytical uses provide adequate assurance that very little, if any, environmental impact will result from the handling and disposal of the small amounts of class I ODS used in such applications.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income, or indigenous populations because it does not affect the level of protection provided to human health or the environment. The controls in place for laboratory and analytical uses provide adequate assurance that very little, if any, environmental impact will result from the handling and disposal of the small amounts of class I ODS used in such applications.

This action is subject to the CRA, and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. The CRA allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and comment rulemaking procedures are impracticable, unnecessary or contrary to the public interest (5 U.S.C. 808(2)). The EPA has made a good cause finding for this rule as discussed in the Supplementary Information section of the preamble, including the basis for that finding.

For the reasons set out in the preamble, 40 CFR part 82 is amended 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 Georgia, including the issuance of new permits implementing those requirements, until the State is granted authorization to do so.

On September 17, 2012, Georgia submitted a final complete program revision application, seeking authorization of changes to its hazardous waste program that correspond to certain Federal rules promulgated between July 1, 2007 and June 30, 2011 (also known as RCRA Clusters XVIII through XXI). EPA concludes that Georgia's application to revise its authorized program meets 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 Georgia final authorization to operate its hazardous waste program with the changes described in the authorization application, and as outlined below in Section G of this preamble.

Georgia 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 application, subject to the limitations of HSWA, as discussed above.

The effect of this decision is that the changes described in Georgia's authorization application will become part of the authorized State hazardous waste program, and will therefore be federally enforceable. Georgia 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 State regulations for which Georgia is being authorized by today's action are already effective and enforceable requirements under State law, and are not changed by today's action.

Along with this direct final rule, EPA is publishing a separate document in the “Proposed Rules” section of today's 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 preamble.

If EPA receives comments that oppose this authorization, EPA will withdraw today's 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 today's 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.

Georgia initially received final authorization on August 7, 1984, effective August 21, 1984 (49 FR 31417), to implement the RCRA hazardous waste management program. EPA granted authorization for changes to Georgia's program on the following dates: July 7, 1986, effective September 18, 1986 (51 FR 24549); July 28, 1988, effective September 26, 1988 (53 FR 28383); July 24, 1990, effective September 24, 1990 (55 FR 30000); February 12, 1991, effective April 15, 1991 (56 FR 5656); May 11, 1992, effective July 10, 1992 (57 FR 20055); November 25, 1992, effective January 25, 1993 (57 FR 55466); February 26, 1993, effective April 27, 1993 (58 FR 11539); November 16, 1993, effective January 18, 1994 (58 FR 60388); April 26, 1994, effective June 27, 1994 (59 FR 21664); May 10, 1995, effective July 10, 1995 (60 FR 24790); August 30, 1995, effective October 30, 1995 (60 FR 45069); March 7, 1996, effective May 6, 1996 (61 FR 9108); September 18, 1998, effective November 17, 1998 (63 FR 49852); October 14, 1999, effective December 13, 1999 (64 FR 55629); November 28, 2000, effective March 30, 2001 (66 FR 8090); July 16, 2002, effective September 16, 2002 (67 FR 46600); November 19, 2002, effective January 21, 2003 (67 FR 69690); July 18, 2003, effective September 16, 2003 (68 FR 42605); January 27, 2005, effective April 20, 2005 (70 FR 12973); April 25, 2006, effective June 26, 2006 (71 FR 23864); and May 2, 2013, effective July 1, 2013 (78 FR 25579).

On September 17, 2012, Georgia submitted a final complete program revision application, seeking authorization of its changes in accordance with 40 CFR 271.21. EPA now makes an immediate final decision, subject to receipt of written comments that oppose this action, that Georgia'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 Georgia final authorization for the following program changes:

This final rule is designed to establish fees for the following: (1) Reviewing applications submitted to NIOSH; (2) issuing a certificate of approval; (3) modifying a certificate of approval; (4) maintaining a certificate of approval; (5) performing specific, standard laboratory tests which are requested by applicants; (6) developing and/or performing novel tests which are required to evaluate respirator performance; (7) qualifying applicant respirator production sites and quality systems; (8) verifying quality system performance through manufacturing site quality audits; (9) verifying commercially available respirator performance through product quality audits; (10) replacing testing equipment; and (11) providing and maintaining laboratories and office space.

The preamble is organized as follows:

Interested persons or organizations were invited to participate in this rulemaking by submitting written views, recommendations, and data. In addition, HHS invited comments specifically on the following:

(1) To delay the implementation of the approval  1 maintenance fee specified in “Respirator Certification Fee Schedule A—Administrative Fees”  2 until 4 months after the publication date of the final rule to allow current approval holders to adjust their inventory of old, obsolete, or marginally profitable certificates of approval. In particular, HHS invited comments on whether 4 months after publication of the final rule allows for a sufficient amount of time to make such adjustments; and

(2) One year as the minimum amount of time for new fees to remain in effect to provide manufacturers sufficient time to plan for application submissions and to determine which approvals to maintain.

Substantive comments were submitted by 11 interested parties, both to the rulemaking docket and during the public meeting held April 30, 2013. Commenters included respirator manufacturers, trade associations, and a private testing laboratory.

Under 42 CFR part 84—Approval of Respiratory Protective Devices, NIOSH approves respirators used by workers in mines and other workplaces for protection against hazardous atmospheres. The Mine Safety and Health Administration (MSHA) and the Occupational Safety and Health Administration (OSHA) require U.S. employers to supply NIOSH-approved respirators to their employees whenever the employer requires the use of respirators. NIOSH currently charges fees for the examination, inspection, and testing of such respirators which is necessary to grant the required approval. This final rule is designed to ensure that all approval activities are covered by appropriate fees, to update the fees charged, and to create a mechanism for routinely updating fees in the future.

Accordingly, with this rule, and for the reasons discussed in the notice of proposed rulemaking published on March 27, 2013 (78 FR 18535), HHS updates the fee structure for the inspection, approval, and certification of manufacturers' respirators to cover the costs of these processes, and establishes a process to periodically update these fees through rulemaking as necessary to remain current with changes to costs arising from factors such as inflation, new certification requirements, and technological changes.

This final rule amends several sections in 42 CFR part 84 and replaces Subpart C—Fees in its entirety. The revisions establish a new fee structure designed to enable NIOSH to fully recover the costs associated with the examination, inspection, and testing of complete respirator assemblies. Unlike the existing fee structure, the new fee structure takes into account the complexity of the class of respirator and the amount of testing required, as well as the work and resources required to perform the testing. Also, the new fee structure charges applicants for the costs of issuing, modifying, and maintaining certificates of approval, production facility inspection (site qualification fee), and for verification of ongoing quality system compliance and commercial product performance.

The fee schedule is divided into two parts—Fee Schedule A comprises annual (fixed) fees; Fee Schedule B comprises application-based fees, including fees for individual test procedures. The fee schedules are included in new Appendices A and B to the regulatory text in Part 84. The final rule and fee schedules will be effective on May 26, 2015. As described in Appendix A, annual fees, including records maintenance, quality assurance maintenance, maintenance of testing and approval facilities, and maintenance of test equipment, will not be invoiced until 2015. As described in the fee schedule, NIOSH will send invoice previews to manufacturers for maintenance fees in July 2015 and final invoices in September 2015, with payment expected no later than October 30, 2015; all other services will be billed upon completion of the project for which they were conducted. Subsequent fee schedules will be updated periodically by notice and comment rulemaking in the Federal Register , according to the provisions in § 84.23, discussed below.

The following summary of public comments and NIOSH responses to the comments is organized by topic and by section, and describes and explains the provisions of the final rule.

Comment: Six commenters express unequivocal support for the fee increases. Of the six, some state that they understand NIOSH's need to raise testing and certification fees, after not having done so in over 40 years. Two suggest that it is reasonable for manufacturers to expect NIOSH to provide improved services as a result of the higher fees.

Two commenters express concern that increased fees would reduce worker safety. Specifically, one commenter is concerned that the fee increase may cause “manufacturers [to] scale back their research and development.” Another suggests that higher fees would be “passed on to the user in the form of higher prices.”

Response: NIOSH recognizes the concerns expressed by the commenters. However, NIOSH does not believe that the fee increases, being relatively minor (as discussed in Section IV.A. of this preamble) could have a negative effect on research and development activities or the appropriate use of respirators. Furthermore, in accordance with OMB Circular No. A-25 Revised (OMB Circular), it is NIOSH's obligation to “ensure that each service, sale, or use of Government goods or resources provided by an agency to specific recipients be self-sustaining.”

Comment: Three commenters state that it is imperative that NIOSH does not transfer resources resulting in a reduction in service or an increase in certification processing time. The commenters encourage NIOSH to use the increased fees to add equipment or otherwise improve the certification process. Some commenters further assert that NIOSH should use the revised fees to establish firm certification time requirements or to maintain its current goal of completing respirator approvals within 90 days. Finally, one commenter indicates that some certification agencies offer expedited service for a higher fee and encourages NIOSH to pursue this possibility.

Response: NIOSH has historically used retained fees within the certification program to maintain and improve current operations ( e.g., to replace equipment and supplies), and intends to continue using the collected fees to augment certification activities. NIOSH is committed to working with manufacturers to maintain efficient turnaround times and expeditiously process the certification applications. NIOSH is also committed to equitable treatment of applicants without regard to ability or willingness to pay and accordingly will not establish expedited testing services on a supplemental fee basis.

Comment: One commenter suggests that the revised fees should support a higher priority for correlation testing.

Response: The revised fee schedules are not intended to support a higher priority for correlation testing, although NIOSH will continue to provide this service to applicants. NIOSH prioritizes activities that most directly increase, monitor, and ensure the quality of the national inventory of respiratory protective devices.

Comment: Several of the annual administrative and maintenance fees in Fee Schedule A are applicable “per every active approval on file with NIOSH.” Two commenters request clarification of the meaning of the phrase “every active approval on file,” and ask whether “every active approval” is intended to indicate every respirator model or every NIOSH testing and certification (TC) number.

Response: “Every active approval” means every TC number on file with NIOSH; TC numbers are issued to identify specific respirator approvals. NIOSH recognizes three kinds of approvals: active, obsolete, and revoked/rescinded; the NIOSH Certified Equipment List (CEL) contains all active and obsolete approvals and does not contain revoked/rescinded (delisted) TC numbers. Together, active and obsolete approvals are referred to as “listed” approvals.

Active approvals are those under which a manufacturer is currently authorized by NIOSH to produce and offer for sale respirator configurations represented as NIOSH-approved devices.

Obsolete approvals are also considered to be active approvals because the respirator model is still being used in the workplace and the manufacturer can continue to sell spare parts for the fielded units even though the device is no longer being manufactured and there is no plan to resume production. NIOSH retains and actively maintains the records of obsolete approvals.

Delisted approvals have been removed from the CEL product listings through either NIOSH revocation for cause or the approval holder's request for voluntary rescission of approval. NIOSH archives the records of revoked or rescinded approvals.

Where applicable to both active and obsolete approvals in the fee schedule, NIOSH has replaced the term “active” with “listed.”

Comment: One commenter suggests that NIOSH should determine how a manufacturer can obsolete an approval.

Response: To obsolete an approval, manufacturers should submit a Standard Application for the Approval of Respirators to NIOSH and specify in the “application type” section of the application that they desire to obsolete the existing approval. The Standard Application Procedure for the Certification of Respirators under 42 CFR 84 ( Standard Application Procedure ) will be updated to inform manufacturers of the procedures to follow to obsolete an approval.

Comment: Three commenters express concern that the NIOSH Certified Equipment List (CEL) and the manufacturers' internal records of approvals may not agree. They would also like a method for resolving discrepancies and ask that NIOSH provide a list of current active, obsolete, and inactive approvals.

Response: NIOSH considers the information in the Certified Equipment List to be correct and that the CEL is the official location of these records. If an approval holder has a discrepancy they should contact NIOSH for resolution and clarification. As requested, NIOSH will send each manufacturer a list of current approvals.

Comment: Two manufacturers express concerns that the procedures for assigning approval (TC) numbers to respirator configurations are not well-defined or consistent. Commenters argue that NIOSH practice is to issue “separate approval numbers for variations of a device rather than allowing variations to be included in the umbrella of a single approval,” and that more approval numbers will result in more fees.

Response: NIOSH determines whether a requested configuration can be evaluated as a modification to an existing approval or requires a new TC number during the application review process. If a change is made to an approved respirator configuration that allows the end-user to be able to build more than one unique configuration that does not visually appear the same or does not provide the same protections as the approved configuration, a new TC number is issued for the modified configuration. If the modification does not substantially change the appearance or performance of the respirator, the modification will be incorporated into the existing TC number. The original configuration will retain the existing TC number.

Comment: One commenter suggests that the Standard Application for the Approval of Respirators should be revised to include the standard test procedure (STP) identification numbers to assist in aligning certification activities and expected fees.

Response: NIOSH concurs with the need for improved tools and information for manufacturers to align activities with fees, and accepts the recommendation to link the STPs to certification activities and fees in the Standard Application Procedure, which will be revised for this purpose.

Comment: One commenter suggests that NIOSH pursue the use of private sector laboratories to do certification testing rather than establishing fees to cover the current costs of testing by the government.

Response: NIOSH has, at times, used third parties to perform certain specific parts of respirator testing activities. For example, chemical warfare agent tests (conducted to evaluate chemical, biological, radiological, and nuclear protections) are presently performed by the U.S. Army Edgewood Chemical and Biological Center with oversight provided by NIOSH. NIOSH is continuing to assess options for third party testing. However, the matter is outside the scope of this rulemaking. No changes to the final rule are made in response to this comment.

Comment: One commenter is concerned about the use of the terms “air-supplying” and “air-supplied” rather than “atmosphere-supplying” to specify one of the broad groupings of respirators referenced in the proposed rule preamble and in Fee Schedule B. The commenter's specific concern is whether respirators that supply oxygen by means of chemical oxygen generation or using compressed oxygen will no longer be approved by NIOSH.

Response: Respirators approved by NIOSH fall into two broad categories: “Air- or atmosphere-supplying” and “air- or atmosphere-purifying.” NIOSH has consistently used the phrases “air-supplying” and “air-supplied” throughout 42 CFR part 84 and other official NIOSH documents to refer to respirators which supply air to the respirator user from remote air supplies, chemical generation of oxygen, controlled release of compressed oxygen, or other means of supplying air/oxygen. The Occupational Safety and Health Administration uses the term “atmosphere-supplying respirator ” in 29 CFR 1910.134 to refer to a respirator that supplies the respirator user with breathing air from a source independent of the ambient atmosphere, and includes supplied-air respirators (SARs) and self-contained breathing apparatus (SCBA) units. NIOSH considers the terms “air-supplying,” “air-supplied,” and “atmosphere-supplying” to be equivalent.

NIOSH will continue to use the phrases “air-supplying” or “air-supplied” to describe this type of respirator. Use of these terms does not reflect any change in policy or regulation about the types of respirators which are referenced or will be approved.

Comment: One commenter expresses concern that NIOSH's plan to base fees on the number of existing approvals will minimize fees to small companies that hold a limited number of approvals but also may give them an unfair advantage by conveying benefits and services which are not fully covered by the fees that they are charged. For example, the commenter points out that because the new fees will be assessed per every active approval on file with NIOSH, manufacturers with few approvals will not be charged for “services and benefits that they alone receive,” such as the quality site audit.

Response: NIOSH is committed to ensuring that the fees charged to small and large companies are commensurate with their costs. NIOSH finds that a fee based on the number of approvals held is appropriate for recovering fixed costs. However, because NIOSH does acknowledge this approach may not always recover the full cost of services to companies with a very limited number of approvals, NIOSH is expanding the use of the concept of fixed costs and variable costs to the quality assurance maintenance (site audit), maintenance of product performance (product audit), and site qualification fees (discussed below). Where possible, fixed costs will be broken out and based on the broadest possible base (such as number of approval holders or number of listed approvals held). Likewise, variable costs will be calculated and fees will be based on one or more measures associated with the work performed. NIOSH has determined that these modifications will more equitably support the actual usage of the various NIOSH services as well as contributing to the costs for maintaining their continued availability.

This existing section establishes definitions of terms found in the Part 84 regulations.

Comment: One commenter indicates that NIOSH must add a definition for NIOSH National Personal Protective Technology Laboratory (NPPTL). Another commenter indicates that the definition of Certification and Quality Assurance Branch (CQAB) should be stricken from 42 CFR 84.2.

Response: The definition of NPPTL was proposed in the notice of proposed rulemaking and is included in 42 CFR 84.2. Further, NIOSH agrees that the definition of “Certification and Quality Assurance Branch” is outdated, and is stricken from § 84.2. The term “Certification and Quality Assurance Branch” is replaced with “National Personal Protective Technology Laboratory (NPPTL).” As discussed below, all references to the “Certification and Quality Assurance Branch” are stricken from all of Part 84. Finally, the definition of “Institute” is also slightly amended to include the acronym “NIOSH.”

This existing section establishes procedures for submitting applications to NIOSH for respirator approval. Although no comments were received on this section, changes have been made to this section to clarify that applications must be submitted in accordance with the Standard Application Procedure. The text has also been changed to acknowledge that the NIOSH National Personal Protective Technology Laboratory may use an independent laboratory to conduct certification testing, at its discretion.

Section 84.12 specifies the requirements for submitting respirators to NIOSH for certification testing. Paragraph (b) of this existing section is revised to identify NPPTL as the entity to which applicants must deliver respirator units for certification testing. Although no comments were received on this section, the text has been changed slightly to clarify our intent.

Proposed § 84.19 was intended to specify the effective dates of various parts of the rule. However, because this section was confusing and NIOSH's intent better communicated by extending the effective date of the rule and clarifying the dates in the fee schedule, this section has been stricken.

Comment: Two commenters suggest alternate phase-in schedules for the new fees, citing a concern that manufacturers will find the 4-month implementation plan to be a hardship. One suggests that NIOSH should phase in the new fee schedule over the course of 3 years; the other was to delay implementation for 18 months for current approval holders.

Response: After consideration of public comments as well as programmatic administrative concerns, NIOSH has found it appropriate to extend the effective date of this final rule to 120 days after publication. Accordingly, the application-based fees in Appendix B, as well as the product audit fee in Appendix A will be effective and applicable beginning on [INSERT DATE 120 DAYS AFTER PUBLICATION IN THE Federal Register ]. The fixed fees in Appendix A will be determined on a typical annual period. Manufacturers will be sent an invoice preview showing initial fixed (annual) fee assessments for records maintenance, quality assurance maintenance, and maintenance of testing and approval facilities and test equipment in July 2015 and a final invoice in September (with payment expected by the end of October 2015). If an approved respiratory protective product has been selected for evaluation in a product audit as part of the planned quality assurance maintenance activities for the upcoming year, the invoice will include a fee to cover NIOSH purchase of audit product samples. The assessed fee for purchase of audit samples can be reduced or eliminated if test samples are made available to NIOSH without charge.

Section 84.20 replaces existing § 84.20 in its entirety. Paragraph (a) establishes the fee structure for the examination, inspection, and testing required to issue, maintain, and modify certificates of approval. Paragraph (b) specifies the activities for which NIOSH will charge fees, including (1) application and approval processing; (2) approval maintenance, including records management, product audits, and site audits; and (3) the qualification of new respirator production sites. Finally, paragraph (c) specifies the activities for which NIOSH does not intend to charge fees. HHS received many comments on the specific fees within § 84.20; those comments and the corresponding responses are identified by paragraph, below. Changes have been made to the rule text to better clarify our intent, and changes to the fee schedule have been made in response to public comment. The specific changes are discussed below.

Comment: One commenter believes that applications vary in complexity and, therefore, more NIOSH resources will be required for issuing, modifying, and maintaining certificates of approval for more complicated devices as compared to simpler ones. According to the commenter, applications requiring more resources should result in higher fees than ones requiring less information and material.

Response: The commenter correctly points out that the time to process different applications is variable. NIOSH concurs that this variability is not reflected anywhere in the current or updated fees process. The proposed fee was calculated to cover an application time of 4 ± 2 hours, which is the average amount of time it takes NIOSH to complete a review of the application. In NIOSH's experience, very few applications require more than 6 hours to complete. To address variation between application processing times, NIOSH will retain a single basic application fee of $200 per application to be submitted with each application. Because NIOSH has not historically tracked application processing times, we will monitor the application processing times to obtain current information during implementation of the new fee structure. As discussed below, the fee schedules will be reviewed every two years to assure that the fees are being assessed as intended.

Comment: Two commenters observed that modifications of approvals vary in complexity and, therefore, the resources required for processing them vary as well. Applications requiring more resources should cost more than ones requiring less information and material. Another commenter suggests that fees for modification of approvals ( e.g., “adding new cleaning and disinfection procedures to the Instructions for Use, document format changes and any other type of modification to the records that may be currently on file at NIOSH where testing is not required”) should incur lower fees or include only the application fee and not the product modification fee.

Response: The modification of approval fee covers the cost of issuing the modification, which is basically a fee for generating a written letter to approval holders acknowledging the modification of certification. The costs associated with processing approval modifications do not vary significantly. Differences in the complexity of a modification of approval are captured in the same way as applications for new approval with the variable application and testing fees. The application fee is set at $100 for each new approval granted; the approval modification fee is set at $50 for each modification of an existing approval. No changes to the fee schedule have been made in response to this comment.

Comment: One commenter does not concur with NIOSH's assertion that records maintenance fees are predicated on an analysis of the OMB Circular, which requires agencies to establish charges for special benefits provided to specific recipients. One example of a special benefit is a license to carry on a specific activity. The commenter “contends that the special recipient is actually the respirator user,” and not the manufacturer.

Response: As discussed in the notice of proposed rulemaking (78 FR 18535, 18537), NIOSH finds that because manufacturers derive economic benefit from the sale of respirators which would not be possible without NIOSH approval, the approval is a license, and the manufacturer is the special beneficiary. Although the current fee structure and rates have not been adjusted in recent years to cover the actual program costs for the examination, inspection, and testing of complete respirator assemblies, the principle of the government recovering fees from the applicant are traceable to the origins of the standards.

Comment: Eight stakeholders comment on the records maintenance fee. One questions whether the fee implies that NIOSH will review all approvals annually, and recommends that we base the records maintenance fee on the complexity of the device and the number of records associated with the approval. Another asserts that since NIOSH does not maintain samples of approved products, approvals should require very little maintenance, and that there should be no costs to manufacturers. The commenter further states that the records maintenance fee “appears to be more of a NIOSH imposed manufacturer tax.” The remaining commenters feel either that records maintenance fees should be the same for all approvals regardless of status, or alternatively that they should not be the same and should instead be based on the approval status (active, obsolete, or revoked/rescinded).

Response: The records maintenance fee pays for the computer database used to hold and access all of the records of listed (active and obsolete) approvals. The fee also pays for NIOSH staff to maintain and modify the database. All active and obsolete approval records must be retained, retrievable, and maintained, even though they may not be routinely used, reviewed, or inspected.

NIOSH has considered basing the fee on the number of approval holders (manufacturers) or, alternatively, on the number of records in the files. Neither of these options would improve the proposed fee structure in terms of equitably distributing costs among approval holders. Therefore, HHS finds it appropriate to establish a flat fee for records maintenance for all listed approvals, based on the number of active and obsolete approvals contained in the NIOSH Certified Equipment List, as presented in the proposed rule.

Comment: One commenter agrees that the facilities maintenance fee is fixed and independent of certification activity or approval status in any given year. Two commenters suggest that maintenance fees should be based on the activity status of respirator approvals. Two commenters state that any maintenance fee is an economic hardship that could “ultimately lead to diminished availability of variations and choices to the users.”

Response: Maintenance of facilities is a fixed cost. NIOSH has determined that it is equitable to spread this cost over all approvals. For these purposes, the activity status of an application is not an important cost factor. NIOSH has retained the proposed maintenance of facilities fees.

Comment: One commenter suggests that testing equipment depreciation be spread out over the life of the equipment. One manufacturer comments that the testing fees should be modified to capture the depreciation cost associated with maintaining testing capacity.

Response: Maintenance of test equipment is a fixed cost. NIOSH can neither predict which applications will be submitted by manufacturers, nor which pieces of equipment will be required to support these applications. Therefore, we cannot estimate the use of each piece of equipment and incorporate that into the testing fees schedule. However, NIOSH recognizes that listed approvals identified as obsolete are not expected to require the use of test equipment. Accordingly, NIOSH has determined that it is equitable to spread this cost over all listed active approvals and to exempt facilities maintenance fees for listed obsolete approvals, and has so amended Fee Schedule A.

Comment: One commenter asks if the site qualification fee is intended for new manufacturers who do not yet have NIOSH approvals or if it is intended for the routine ongoing factory quality system audits. Four commenters state that the $5000 fixed cost for a new site qualification should be reconsidered in favor of charging direct and true costs.

Response: The site qualification fee is different from the quality assurance maintenance (site audit) fee: The former provides for a one-time inspection of new production facilities; the latter for the ongoing manufacturing quality system audits NIOSH requires of approval holders. As discussed in the notice of proposed rulemaking (78 FR 18535, 18544), the site qualification program is designed to cover three groups of manufacturers. The first group consists of manufacturers with no approvals who want to receive a 3-letter manufacturer's code. This is the first step in submitting a respirator for NIOSH approval. The code is issued after receipt of an application if NIOSH is satisfied that the potential approval holder has the capabilities and documented system required to manufacture a quality product; the site qualification inspection is a tool to provide that assurance. The manufacturers in this group are basically unknown to NIOSH, and will have a site visit to determine their manufacturing abilities and credibility to become an approved respirator manufacturer.

The second group consists of manufacturers that have one or more listed NIOSH-approved respirators and that are in the process of opening a new manufacturing site for the production of respirators. These manufacturers will require a document review to determine their manufacturing capabilities to produce approved respirators at the new site.

The third group consists of NIOSH approval holders that have been acquired by another entity and the manufacturing site for the production of approved respirators is relocated to a new site. These manufacturers will also require a document review to determine their manufacturing capabilities to produce approved respirators at the new site.

In response to public comments, NIOSH has reconsidered the site qualification fee, which will now distinguish between the cost of a paper-based review for the new manufacturing site of an existing approval holder and the actual cost of a one-time site visit for manufacturers with no existing approvals. Flat fees will be established for the inspection of domestic and foreign manufacturing sites, respectively. Fee Schedule B has been amended accordingly.

Comment: Six commenters express concern about using the number of approvals as the basis for calculating the quality site audit fee. All six commenters suggest that the fees should be tied to the actual (or average) cost to perform each site audit. One commenter asks for clarification of the intent of this fee, and claims that the quality assurance maintenance fee and the maintenance of product performance fee (discussed below) will result in economic hardship to manufacturers, which in turn will impact the U.S. workforce and the “overall safety of the working public.”

Response: The fees for the site audit program are divided between management of the site audit program (largely fixed costs) and individual quality audits and associated expenses (variable costs). NIOSH has modified the site audit fee in response to the commenters' request that the fee be more equitably allocated. Accordingly, the quality assurance maintenance (site audit) fee will be a combination of fixed and variable costs. Beginning in 2015, manufacturers will be charged annually a flat fee per every manufacturing site registered with NIOSH (those sites that exclusively conduct design activities are exempt from this annual fixed fee). Variable fees will be billed within the fiscal year during which the site audit is conducted, and are established based on the duration of the audit (either 1 or 2 days) and whether the site is domestic or outside the United States. Any site that is not scheduled to be audited within a fiscal year will not be billed the variable fee for that year. The variable cost fee also applies to sites that only do design. Fee Schedule A has been amended accordingly.

Comment: One commenter stated that NIOSH should not be billing manufacturers for product audits because manufacturers have no input in determining which products NIOSH will select for audit. One commenter feels that, “[s]ince NIOSH does not typically maintain samples of approved products there should be no reason to charge the Manufacturers a fee for the maintenance.” If a change of the product or design of any type is requested by the manufacturer, it will be submitted to NIOSH as an Extension of Approval at which time the submittal fee is charged.” Another commenter states that NIOSH should charge each approval holder directly for the cost of product audits, rather than add the fee to a modification request. One commenter further supports the use of a respirator selection audit logic to establish an audit schedule for the upcoming year, allowing NIOSH time to notify manufacturers that a charge is forthcoming.

Response: The maintenance of product performance fee allows NIOSH to purchase and test commercially available respirators for audit. The purpose of the NIOSH product audit program is to select respirators for sale in the marketplace and test them in the laboratory to verify that approved manufacturing systems are meeting NIOSH quality standards. Participating in the product audit program is an obligation of all approval holders, and all listed approvals are subject to audit.

NIOSH has a process in place to identify and help prioritize the identification of respirator configurations for audit activities. NIOSH introduced the “Default to Test” procedures in 2009 to support the product audit program. These procedures were implemented to help locate and procure samples of product for testing, and were developed to work within funding limitations that constrained the number and types of respirator configurations as well as how many products NIOSH could accommodate for testing and evaluation. NIOSH is exploring approaches to be able to efficiently, effectively, and economically obtain candidate respirators for product audit without placing undue burden on the manufacturers of those products. The increased fees recovered for product audits will enable NIOSH to redesign the product audit program, to make its scope and content more consistent with the wide variety of products being marketed under the NIOSH approval label.

Manufacturers can defray the audit costs by providing sample units rather than providing funds to NIOSH to purchase the samples. Respirators selected for audit may be obtained from distributors and other typically available market outlets, or directly from the manufacturer during production runs.

In response to comments, NIOSH agrees to de-couple the maintenance of product performance (product audit) fee from the fee for approval modification. The product audit fee is segmented into an annual fixed cost fee and a variable cost fee that is assessed based on the respirators chosen to be tested each year. The fixed cost portion of the fee is designed to cover the cost of staff associated with product audit program management. The variable fee is designed to cover the cost to NIOSH of obtaining sample respirators and performing the audit tests. This variable fee will be collected for the same fiscal year in which the product audit is scheduled to occur. The fee schedules have been changed accordingly.

Comment: One commenter inquires whether the closed-circuit escape respirators sampled in the Long-Term Field Evaluation (LTFE) program will be billed to the approval holder as a component of the product audit sampling program.

Response: Although the LTFE program is a component of the product audit program, respirators used in the LTFE program are currently not billed to the approval holder. Approval holders will, however, be billed for closed-circuit escape respirators chosen for routine audit sampling.

Section 84.21 specifies how fees will be calculated and administered. Although no comments were received on this section, the rule text is changed to better clarify our intent.

Section 84.22 establishes the procedure NIOSH will use to invoice applicants. Although there are no changes made to this section as a result of public comment, HHS is making slight adjustments to the rule text in paragraphs (a) and (b) to clarify our intent.

Comment: Four commenters ask that the fee system be as simple as possible and that manufacturers receive a single, consolidated maintenance invoice at the same time each year. One commenter asks whether manufacturers will be invoiced on a calendar year or on the U.S. Government fiscal year basis. They also requested that online billing be available so that manufacturers can “view and update their records without an overabundance of paperwork.”

Response: NIOSH intends to send a single consolidated invoice for annual maintenance fee assessments in the month of September, with payment expected in October. Pay.gov will be available for online fee collection, and we expect it to become the preferred means for the collection of fees in the future.

Comment: One manufacturer concurs that NIOSH should have the ability to impose sanctions on manufacturers who may miss one or several payments, but requests clarification regarding what constitutes a missed payment. The commenter proposes that a minimum period of 120 days from the date of the invoice be allowed before the payment is considered to be “missed.”

Response: Standard government contracts are written in terms of “net 60 days.” This implies a standard payment period of 60 days. Late payment notices are typically sent at 60 and 90 days. Missed payment activity would typically start at 120 days. Accordingly, NIOSH will send late payment notices at 60 and 90 days and missed payment activity will start at 120 days.

Section 84.23 establishes the fee schedules for NIOSH's respirator certification activities.

Comment: Three commenters ask that NIOSH provide a formal mechanism for public comment prior to any future revisions to the fee schedules.

Response: NIOSH agrees to propose future fee schedule revisions in the Federal Register , subject to public comment. Accordingly, the fee schedules are added to 42 CFR part 84 in a new Appendix A (annual fees) and a new Appendix B (application-based fees).

Comment: One commenter suggests that a 1-year period between revisions of fees schedules will not allow sufficient time for companies to plan. The commenter proposes a fixed 5-year interval for fee revisions with no revisions outside of the 5-year cycle.

Response: HHS agrees that the proposed 1-year interval between revisions of the fee schedules may not provide sufficient time for planning; however the 5-year minimum suggested by the commenter will be inadequate to keep fees reasonably updated. Variables such as inflation and other factors that might affect the cost of testing supplies will be taken into account as NIOSH updates the fee schedules. Accordingly, in response to public comment and in accordance with the OMB Circular, the rule text is changed to establish a 2-year minimum interval for fee schedule revisions. The text is further changed to indicate that the fee schedules will not be revised at least once every 5 years, as proposed, and instead will be revised as needed based on the biennial reviews.

Section 84.24 allows NIOSH the discretion to conduct special or additional examinations, inspections, or tests, apart from those specified for a particular respirator class under this Part, as might be necessary due to unusual characteristics of the respirator design, manufacturing information, or product samples. The text has been changed to acknowledge that the NIOSH National Personal Protective Technology Laboratory may use an independent laboratory to conduct certification testing, at its discretion. No comments were received on this section.

Section 84.36 informs manufacturers that respirators for which a formal certificate of modification has been issued should be delivered to the National Personal Protective Technology Laboratory, rather than the Certification and Quality Assurance Branch.

Existing §§ 84.41 and 84.43 establish requirements for quality control plans and records. These sections are amended to replace reference to the “Certification and Quality Assurance Branch” with “National Personal Protective Technology Laboratory.”

Existing § 84.66 establishes procedures for the withdrawal of respirator certification applications. Paragraph (b) directs stakeholders to the fee calculation procedures in § 84.21(e) for the withdrawal of applications, where NIOSH has already performed some administrative and/or testing services. There are no changes made to this section as a result of public comment.

Comment: In response to NIOSH's statement in the preamble to the proposed rule that more information about billing will be available in the guidance document Standard Application Procedure, one commenter says that the current edition of the Standard Application Procedure does not address billing under the new rule and that the new billing procedures were not made available for public comment.

Response: NIOSH respirator certification fee estimates will be calculated according to the procedures established in § 84.21. Paragraph (e) of that section concerns those applications for which a manufacturer opts to withdraw an application but NIOSH has already begun application review and testing. In that case, according to § 84.21(e), the applicant will be invoiced for services already performed by NIOSH.

Although HHS provided an opportunity to comment on the proposed withdrawal billing procedures in § 84.21(e), no comments were received.

Existing § 84.76 establishes minimum requirements for facepieces and eyepieces for self-contained breathing apparatus. The text in paragraph (b) is amended to replace “Certification and Quality Assurance Branch” with “National Personal Protective Technology Laboratory.”

Existing § 84.79 establishes minimum requirements for breathing gas. The text in paragraphs (c) and (d) is amended to replace “Certification and Quality Assurance Branch” with “National Personal Protective Technology Laboratory.”

Existing § 84.81 establishes minimum requirements for compressed breathing gas and liquefied breathing gas. The text in paragraph (d) is amended to replace “Certification and Quality Assurance Branch” with “National Personal Protective Technology Laboratory.”

Existing § 84.97 establishes the method NIOSH uses to measure the concentration of carbon dioxide in inspired gas in open- and closed-circuit respirators. The text in paragraph (a) is amended to replace “Certification and Quality Assurance Branch” with “National Personal Protective Technology Laboratory.”

Existing § 84.110 includes descriptions of different types of gas masks. The text in paragraph (c) is amended to replace “Certification and Quality Assurance Branch” with “National Personal Protective Technology Laboratory.”

Existing § 84.113 establishes requirements for the color and markings of canisters and cartridges or labels. The text is amended to replace “Certification and Quality Assurance Branch” with “National Personal Protective Technology Laboratory.”

Existing § 84.119 establishes the minimum requirements for facepieces and eyepieces for gas masks. The text in paragraph (b) is amended to replace “Certification and Quality Assurance Branch” with “National Personal Protective Technology Laboratory.”

Existing § 84.136 establishes the minimum requirements for facepieces, hoods, and helmets for gas masks. The text in paragraph (b) is amended to replace “Certification and Quality Assurance Branch” with “National Personal Protective Technology Laboratory.”

Existing § 84.141 establishes the minimum requirements for breathing gas for supplied-air respirators. The text in paragraphs (b) and (c) is amended to replace “Certification and Quality Assurance Branch” with “National Personal Protective Technology Laboratory.”

Existing § 84.193 establishes requirements for the color and markings of all cartridges or labels. The text is amended to replace “Certification and Quality Assurance Branch” with “National Personal Protective Technology Laboratory.”

Existing § 84.258 is removed from subpart N. This section contains a special respirator fee schedule for vinyl chloride respirators. The fees established by this final rule under § 84.21 apply to this group of respirators. No comments were received on this section.

Existing § 84.1102 is removed from subpart KK. This section contains a special respirator fee schedule for a series of respirators, including powered air purifying respirators. The fees that are established by this final rule under § 84.21 apply to this group of respirators. No comments were received on this section.

Existing § 84.1136 establishes the minimum requirements for facepieces, hoods, and helmets for dust, fume, mist, pesticide, paint spray, and powered air-purifying high efficiency respirators and combination gas masks. The text in paragraph (b) is amended to replace “Certification and Quality Assurance Branch” with “National Personal Protective Technology Laboratory.”

Existing § 84.1154 establishes requirements for two or more canisters and for color and markings of canisters or cartridges and labels for facepieces, hoods, and helmets for dust, fume, mist, pesticide, paint spray, and powered air-purifying high efficiency respirators and combination gas masks. The text in paragraph (b) is amended to replace “Certification and Quality Assurance Branch” with “National Personal Protective Technology Laboratory.”

Existing § 84.1157 establishes minimum requirements for the performance and protection of chemical cartridge respirators with particulate filters. The text in paragraphs (d)(5) and (e)(5) is amended to replace “Certification and Quality Assurance Branch” with “National Personal Protective Technology Laboratory.”

Appendix A is added to Part 84 to establish the fee schedule for annual (fixed) respirator certification fees. Appendix B is added to Part 84 to establish the fee schedule for application-based respirator certification fees.

Executive Order 12866 and Executive Order 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).

This final rule is not being treated as a “significant regulatory action” within the meaning of E.O. 12866. The final rule is not considered economically significant, as defined in section 3(f)(1) of the executive order, and does not raise novel policy issues or have any of the other effects specified in section 3(f)(2)-(4). Thus, this rule has not been reviewed by the Office of Management and Budget (OMB).

NIOSH approves two categories of respirators: air-purifying respirators (APR), which filter contaminants in the environment (ambient air); and air-supplying respirators (ASR), which provide the user with clean breathing air (from a supply separate from the ambient air). APR includes particulate respirators, like the disposable N95 commonly used in healthcare settings; the elastomeric respirator with replaceable filters ( i.e., “gas mask”); and the powered air-purifying respirator (PAPR), which employs a battery-powered blower to move breathing air through the filters.

ASR includes respirators that deliver breathing air to the wearer, using either compressed or chemical breathing air or a remote source. The respirator types in this category include the self-contained breathing apparatus (SCBA) commonly worn by members of the fire service; the closed-circuit escape respirator (CCER) used for emergency escape in underground coal mining and on-board ships; and the airline (air hose) respirator used for industrial chemical and paint applications and hazardous materials management.

Of the U.S. respirator market of products approved by NIOSH, approximately 35 percent of approval holders are U.S. companies and 65 percent are foreign. The foreign component of this distribution has nearly doubled since 2000, and is largely represented by manufacturers producing low-cost filtering facepiece respirators. The North American respiratory protection market generated revenues around $1,830 million in 2007, the most recent data available. 3 A summary of market segmentation, by respirator type, is offered in Table 1, below.

As discussed in the notice of proposed rulemaking, OMB Circular A-25 Revised requires that the NIOSH respirator program be self-sustaining, and that the Agency recover the full cost of certification and testing services offered to respirator manufacturers. With this final rule, HHS sets fees for these services based upon costs generated in a typical calendar year, 2009. The data and analyses discussed here were generated at the outset of the drafting of this final rule, and NIOSH believes there has been minimal inflation affecting the NIOSH costs in the years since. All of the fees incorporate direct and indirect costs of providing testing and approval services, including personnel costs, physical overhead, and management and supervisory costs. For the purposes of this final rule, an average hourly cost of $50 per hour (rounded figure from Table 2) was used as a reasonable estimate; in cases where there were special or unique costs ( e.g. chemicals for testing, travel for site audits), those costs were accounted for over and above the hourly cost.

Fixed costs are approximately $500,000 per year. These are the costs required to ensure the continued availability of a testing laboratory and are reasonably independent of the number of respirators tested or reviewed at any given time. These costs are broken down in Table 3, below.

The fee schedules that are the basis for the analysis below are broken down into annual (fixed) fees (including product performance maintenance [product audits], records maintenance, quality assurance maintenance [site audits], facility maintenance, and testing capacity maintenance [test equipment depreciation]), and approval-based fees (including application, approval, approval modification, and site qualification fees, as well as all laboratory tests conducted on air-supplied and air-purifying respirators, and respirators certified for use against chemical, biological, radiological, and nuclear agents). HHS offers the following explanation for the fee structure established in this rulemaking:

Application: The application fee allows NIOSH to process the paperwork associated with a new application request. New applications were estimated at 4 hours of processing time with no other expenses. Thus, the new application processing fee is set at $200. In 2009, NIOSH processed 435 applications and would have received payments in the amount of $87,000.

Approval: A fee is charged for each new approval granted an applicant. Because the issuance of new approvals is estimated to require 2 hours each above the base application fee, the fee is set at $100. In 2009, NIOSH granted 700 approvals  4 and would have received payments in the amount of $70,000.

Approval Modification: An approval-holder may apply to NIOSH for the modification of an existing approval. Requests to obsolete a certificate of approval are considered to be modifications of an existing approval. Modified approval activities are estimated to require 1 hour each above the base application fee. Thus, the modification fee is set at $50. In 2009, NIOSH granted 820 modifications of approval  5 and would have received payments in the amount of $41,000.

Records Maintenance: The proposed fee schedule is changed to clarify that this fee applies to all active and obsolete, or listed, approvals. Each listed approval is estimated to require 1 hour of records maintenance time per year. The maintenance fee is set at $50. Manufacturers held a total of 6,800 current approvals (active and obsolete) in 2009 and would have remitted maintenance payments in the amount of $340,000.

Quality Assurance Maintenance (site audit): The quality assurance maintenance fee will cover the costs of the quality auditing program. As discussed above, the proposed fee schedule is amended in response to commenters who suggested that the site audit fee reflect the actual cost to perform each audit. Accordingly, the fee is changed from the proposal to base the fee on each active approval on file with NIOSH. The cost to NIOSH for conducting facility audits depends on many variables, including the number of manufacturing sites, the size of the manufacturing sites, the quality performance of the manufacturing sites, the location of the sites, and whether the respirators are used for mining. Therefore, a fixed fee for quality audits will be charged annually per every manufacturing site registered with NIOSH, which is set at $3,000 per every manufacturing site registered with NIOSH. Sites which do only design, but not production, are excluded from this fixed fee. In addition to the fixed annual fee, NIOSH will also bill for the average cost of a site audit based on audit duration and geographic location (domestic or foreign), during the same fiscal year in which the audit occurs. Sites which do only design, but not production, will be charged the variable fee during the same fiscal year in which the audit occurs.

The initial schedule for these variable fees is:

Maintenance of Product Performance (product audit): The product performance maintenance fee will cover the costs of the product audit program. As discussed above, the proposed fee schedule is changed in response to public comments to charge each approval holder directly for the cost of product audits, rather than link the fee to modification requests. Product audits are conducted on approved respirators and these respirators are, typically, obtained through normal commercial purchases. One of the central factors in determining which respirators to purchase and test is whether significant modifications have been made from the original, approved design. Accordingly, a fee for product performance audits will be added to each modification of approval requested. The product performance maintenance fee is set at $761 per approval holder ($53,300 staffing/70 approval holders). The variable cost portion of the fee is designed to cover the cost of obtaining respirators and performing the testing. This cost will be billed directly to the approval holder in the October billing for testing to be performed within the next 12 months. In 2009, NIOSH conducted 42 product audits; the variable portion of the fee would have been $70,000.

Site qualification: The site qualification fee provides for a one-time inspection of new production facilities. As discussed above, the proposed fee schedule is changed in response to public comments to charge each approval holder directly for the cost of site qualification inspections. A flat fee is established for existing approval holders, who will undergo a paper review only: $400 per each request. Non-approval holders will be charged $2,500 for inspection of a domestic facility, and $7,500 for an international site visit. The fee for non-approval holders includes travel expenses for personnel (including travel to sites outside the United States) as well as hourly charges. 6 Each site qualification is estimated to take 4 hours of preparation time, 16 hours in travel time, 16 hours on-site, and 4 hours of document/report time for a total of $2000 in staff costs (40 hours × $50/hour). In 2009, NIOSH performed 12 paper reviews for existing approval holders (12 × 400 = 4,800), and 4 domestic (4 × 2,500 = 10,000) and 2 foreign (2 × 7,500 = 15,000) site qualification audits, which would have resulted in payments in the amount of $30,000.

Maintenance of Testing and Approval Facilities: The facility maintenance fee will cover the costs of the respirator certification facilities located at the HHS-owned site in Pittsburgh, Pennsylvania. The costs for utilities, security, maintenance, maintenance equipment, maintenance staff and facilities management staff are included in this fee. The proposed fee schedule is changed to clarify that this fee applies to all active and obsolete, or listed, approvals. Facility maintenance is considered to be a fixed cost and independent of the certification activity in any given year. Accordingly, this fee will be assessed annually per listed approval. In 2009, the facility operating costs specific to respirator certification were $233,156 and manufacturers held 6,800 current approvals (active and obsolete). A fee of $34.00 per approval would have returned $231,200 to the program.

Maintenance of Test Equipment: The testing capacity maintenance fee is designed to recover the depreciation of testing equipment used for respirator certification. Equipment depreciation is typically considered to be a fixed cost and, therefore, NIOSH has classified it as an administrative (maintenance) fee. In accordance with the comments discussed above, the proposed fee schedule is changed to clarify that this fee applies to all active, and not obsolete, approvals. The fee itself is unchanged because the number of obsolete approvals included in the calculation of the proposed fee was insignificant. The testing capacity maintenance fee will be assessed annually per active approval. In 2009, the total cost of all certification equipment was $2,510,000. A 10 year amortization schedule is consistent with the life expectancy used in the purchasing of this equipment; therefore the annual depreciation of testing equipment is $251,000. In 2009, manufacturers held 6,800 approvals. A fee of $36.00 per each active approval would have returned $244,800 to the program.

Testing: The fees for each individual test are specified in Fee Schedule B. The testing fees include the cost of materials and equipment as well as hourly wages. Testing fees are established by analyzing the time, equipment, chemicals and supplies required for each individual test. The actual tests performed by NIOSH in 2009 generated estimated fees of $717,000 for that year. Unlike other fees charged by NIOSH, fees for testing respirators against chemical, biological, radiological, and nuclear (CBRN) agents have been recently generated and are currently billed according to the actual cost of testing performed by either U.S. military laboratories or by the NIOSH National Personal Protective Technology Laboratory. Accordingly, manufacturers should refer to the U.S. Army Research, Development and Engineering Command Edgewood Chemical Biological Center (ECBC) Web site at http://www.ecbc.army.mil/ for a list of current testing costs. Costs for tests listed in Fee Schedule B and identified by the symbol “#” may not be reflective of current prices charged by ECBC. In 2009, NIOSH performed three CBRN tests and received payments in the amount of $150,000. These CBRN fees have been excluded from Table 4.

In order to use the existing accounting system, the fees have also been grouped into three categories—administrative/evaluation, testing, and audit activities—as summarized in Table 4, below.

In Table 4, above, the administrative/evaluation category includes most of the NPPTL Technology Evaluation Branch overhead in addition to the certification activities. HHS estimates that 75 percent of this category provided services that were directly related to billable certification activities. The testing category targets maintenance of certification equipment, laboratory supplies, and testing. HHS estimates that 85 percent of this category provides services directly related to billable certification testing activities. The audit category includes both the site audit and product audit activities. HHS estimates that 100 percent of this category provides services directly related to billable audit activities.

The fixed fee categories are recoverable operating expenses of the respirator certification activity. However, they have not historically been part of the NIOSH National Personal Protective Technology Laboratory budget process and, therefore, they are broken out here separately. The facilities maintenance costs have been appropriated through NIOSH appropriation requests. Equipment replacement has been handled as either (a) a special one-time request related to special circumstances or special needs; or (b) as a distribution from retained user fees provided by manufacturers for certification activities.

This final rule is designed to recover the costs associated with providing services for the examination, inspection, and testing of respirators for the purposes of issuing, modifying, and maintaining certificates of approval. The current annual cost for this program is $2,500,000. NIOSH currently recovers approximately 10 to 20 percent of these costs under an outdated fee schedule that has remained in effect since 1972. NIOSH estimates that the total additional cost of this rulemaking to the 70 manufacturers of NIOSH-approved respirators would be between $2,000,000 and $2,500,000 annually, approximately 0.125 percent of the almost $2 billion industry, and less than 2.5 percent of the $100 million significance threshold.

The final rule will not interfere with state, local, and tribal governments in the exercise of their governmental functions.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., requires each agency to consider the potential impact of its regulations on small entities, including small businesses, small governmental units, and small not-for-profit organizations. HHS certifies this rule under the RFA, but prepared an Initial Regulatory Flexibility Analysis in order to solicit feedback regarding the impact of this rulemaking on revenues of small entities.

This rule updates the user fee structure for the certification of respiratory protective devices. The current fee structure, in place since 1972, has limited the Agency's ability to recover the majority of costs for respirator testing and certification. The current fee structure charges a set fee for the examination, inspection, and testing of eight broad groups of respirators. A single fixed fee is specified for each type of respirator without regard to the complexity of the respirator or the number of specific tests which are required. For example, the examination, inspection, and testing of a self-contained breathing apparatus for entry and escape, 1 hour or more costs $3,500; for a single hazard gas mask, the cost is $1,100; a supplied-air respirator will cost $750 for examination, inspection, and testing (42 CFR 84.20). As a result, NIOSH currently recovers only about 10 to 20 percent of the costs to provide initial certification and testing activities.

The OMB Circular requires that the NIOSH respirator certification program be self-sustaining, and that the Agency recover the full cost of certification, maintenance and testing (see Section II.C. in the notice of proposed rulemaking published on March 27, 2013 (78 FR 18535)). NIOSH's objective is to recover all of these costs. The fee schedules include fees for each individual test required to grant a new approval or modification of an approval; processing the paperwork associated with any application request; granting a new approval or modifying an existing approval; maintaining each approval held during the year; and inspecting new production facilities.

This final rule applies only to those companies that hold NIOSH approvals for certified respirators, or wish to apply for such approvals. It does not duplicate, overlap, or conflict with other rules.

There are 70 respirator manufacturers that hold NIOSH approvals. Of this group, 10 manufacturers are considered large companies; 35 are approval-holders based outside of the United States; and 25 are classified as small businesses as defined under the Small Business Act for this industry sector (NAICS 339113—Surgical Appliance and Supplies Manufacturing), employing fewer than 500 employees. Accordingly, HHS has given consideration to the potential impact of this rule on these 25 companies.

HHS must establish whether the final rule has a significant economic impact on a substantial number of small businesses. According to HHS guidance, 5 percent or more of affected small businesses within an industry is considered a substantial number of businesses; an average annual impact on small businesses of 3-5 percent or more is considered a significant economic impact. Given that 25 of 70 regulated companies that comprise the respirator industry are small businesses, HHS considers a significant number to be affected by this final regulation. Many of these small companies are privately owned and, therefore, do not release public financial statements. However, as discussed below, the final rule does not exceed the HHS threshold for economic significance. For the purposes of this analysis, HHS has further categorized the small companies into three groups, as presented in Table 6 below.

In order to predict the effects of the new fee structure, the existing fees submitted to NIOSH for approval activities were examined for the years 2005 through 2009 inclusive. This 5-year period was considered to be representative of typical approval activities. The recent past is the best model that NIOSH has to predict likely application behavior in the near future. 7

The current fee structure specifies a single fee for each type of respirator approval. This type of fee structure tends to favor those companies that demand extensive services and disadvantage companies that have fairly simple, easily executed requests. In order to better balance actual fees charged with actual services requested, the fees have been reallocated to be proportionate to the extent of services required.

HHS is committed to ensuring that the regulatory burden does not disproportionately impact small businesses. Accordingly, the fee structure takes into account the complexity of the testing required to approve a respirator model. Typically, small companies have simple approval requests with few testing requirements. By designing a fee structure which would charge for the actual testing performed and individual fees which would be based on the number of active and obsolete approvals held, small companies would not pay for potential services that they do not use. Likewise, small companies typically have a limited number of listed approvals, so maintenance fees based on the number of listed approvals would minimize the fees charged to small companies versus large companies. Simply increasing the fees under the existing fee structure would impose a competitive disadvantage on small companies, because any fixed increase in fees would represent a greater percentage of revenue for small companies than for large companies. This is particularly relevant for the respirator manufacturers since the smallest companies have 1-10 employees while the largest significantly exceed 1,000 employees.

Tables 7, 8, and 9, below, address the costs for existing approval holders. The site qualification fee has not been incorporated into those figures.

Table 9—Comparison of Current and New Fees   Group 1 Group 2 Group 3 Group 4 Avg. current fees per year per company ($) 850 2,050 4,150 8,100 Avg. new fees per year per company ($) 2,340 9,345 18,310 134,100 Avg. increase in cost per company ($) 1,490 7,295 14,160 126,000 Avg. percentage increase per company (%) 175 356 341 1,556 Percentage of current fees paid per group (%) 6 12 22 60 Percentage of new fees paid per group (%) 1.5 5 8 85.5

A site qualification fee will likely be triggered very infrequently. The types of events that will trigger a site audit include: The company becomes an approval holder for the first time (Event 1); the approval holder moves to or adds a new production site (Event 2); or the approval holder is sold and production moves to a new site (Event 3). The site qualification fee (covering costs for inspection of either a domestic or foreign manufacturing site) will apply to all new approval holders, since their facilities will not have been previously qualified. NIOSH does not believe that this fee represents a significant entry cost, in relation to the costs required to newly manufacture NIOSH-certified respirators. In any event, these do not represent new costs imposed on existing small businesses in respirator manufacturing impacted by this rulemaking.

For both small and large companies, the most common reason that a site qualification fee will be required is Event 2. That is, a company either adds a new production site or moves the existing production site to a new facility. The cost of qualifying a new production site will be very small ($400) compared to the costs of acquiring, designing, staffing, and beginning production at a new site.

Small companies often experience type 3 events. They are often sold and then relocated by the acquiring company. Again, the cost of qualifying a production site will be very small compared to the cost of buying a company and relocating it.

As discussed above, financial information from the small respirator manufacturers is difficult to discover, as many of these companies are privately held and are not required to file public financial statements. The only component of total revenues that is publically available is salary data. Attempts to determine the other production costs and/or the levels of profits for these companies did not generate reliable or consistent data. In order to estimate the revenues of these companies, statistics from the 2007 Economic Census for NAICS code 339113 were used. As a base for the revenues, it was assumed that the company needed, at a minimum, to cover the cost of its staff. Staffing levels were placed at the smallest likely levels for each size group.

As can be seen in Table 10, below, even using the limited estimator of salaries as a surrogate for total revenues, the cost of the final rule does not, on average, reach the HHS threshold of more than 3 percent of revenues for the final rule to be considered significant for any of the groups of companies.

This document announces that, on October 1, 2014, OMB approved the information collection requirements contained in the Commission's Report and Order, FCC 13-138, published at 78 FR 77210, December 20, 2013. The OMB Control Number is 3060-1203. The Commission publishes this document as an announcement of the effective date of the requirements. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 1-C823, 445 12th Street SW., Washington, DC 20554. Please include the OMB Control Number, 3060-1203, in your correspondence. The Commission will also accept your comments via email at PRA@fcc.gov.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on October 1, 2014, for the new information collection requirements contained in the Commission's rules at 47 CFR 79.107(c), 79.108(a)(5), 79.108(c) through(e), and 79.110.

Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-1203.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-1203.

OMB Approval Date: October 1, 2014.

OMB Expiration Date: October 31, 2017.

Title: Section 79.107 User Interfaces Provided by Digital Apparatus; Section 79.108 Video Programming Guides and Menus Provided by Navigation Devices; Section 79.110 Complaint Procedures for User Interfaces, Menus and Guides, and Activating Accessibility Features on Digital Apparatus and Navigation Devices.

Form Number: N/A.

Respondents: Business or other for-profit entities; individuals or households; not-for-profit institutions; and state, local, or tribal governments.

Number of Respondents and Responses: 4,245 respondents; 509,484 responses.

Estimated Time per Response: 0.0167 to 5 hours.

Frequency of Response: On occasion reporting requirement; Third party disclosure requirement; Recordkeeping requirement.

Obligation to Respond: Voluntary. The statutory authority for this information collection is contained in the Twenty-First Century Communications and Video Accessibility Act of 2010, Public Law 111-260, 124 Stat. 2751, and Sections 4(i), 4(j), 303(r), 303(u), 303(aa), 303(bb), and 716(g) of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 303(r), 303(u), 303(aa), 303(bb), and 617(g).

Total Annual Burden: 22,198 hours.

Total Annual Cost: $70,500.

Nature and Extent of Confidentiality: Confidentiality is an issue to the extent that individuals and households provide personally identifiable information. As required by the Privacy Act, 5 U.S.C. 552a, the FCC published a system of records notice (SORN), FCC/CGB-1, “Informal Complaints, Inquiries, and Requests for Dispute Assistance,” in the Federal Register on August 15, 2014 (79 FR 48152), which became effective on September 24, 2014. The Commission believes that it provides sufficient safeguards to protect the privacy of individuals who file complaints under 47 CFR 79.110.

Privacy Act Impact Assessment: The Privacy Impact Assessment (PIA) for Informal Complaints and Inquiries was completed on June 28, 2007. It may be reviewed at: http://www.fcc.gov/omd/privacyact/Privacy_Impact_Assessment.html. The Commission is in the process of updating the PIA to incorporate various revisions to it as a result of revisions to the SORN.

Needs and Uses: On October 31, 2013, in document FCC 13-138, the Commission released a Report and Order and Further Notice of Proposed Rulemaking , MB Docket Nos. 12-108, 12-107, FCC 13-138, adopting rules implementing portions of the Twenty-First Century Communications and Video Accessibility Act of 2010 (CVAA) related to accessible user interfaces and video programming guides and menus. These rules are codified at 47 CFR 79.107, 79.108, 79.109, and 79.110. Pursuant to section 204 of the CVAA, the Report and Order adopts rules requiring digital apparatus to make appropriate built-in functions ( i.e. , those used for the reception, play back, or display of video programming) accessible to individuals who are blind or visually impaired. Pursuant to section 205 of the CVAA, the Report and Order adopts rules requiring navigation devices to make on-screen text menus and guides for the display or selection of multichannel video programming audibly accessible. The Report and Order also requires Section 204 digital apparatus to provide access to closed captioning and video description through a mechanism that is reasonably comparable to a button, key, or icon, and requires Section 205 navigation devices to provide access to closed captioning through a mechanism that is reasonably comparable to a button, key, or icon.

In accordance with the Act (16 U.S.C. 1531 et seq. ) and Reorganization Plan No. 4 of 1970 (35 FR 15627; October 6, 1970), NMFS has jurisdiction over the marine taxa identified in this rule. Under section 4(a)(2) of the Act, NMFS must decide whether a species under its jurisdiction should be classified as an endangered or threatened species. NMFS makes these determinations via its rulemaking process. We, the Service, are then responsible for publishing final rules to amend the List in title 50 of the Code of Federal Regulations (CFR) at 50 CFR 17.11(h).

On June 4, 2013, NMFS published a proposed rule (78 FR 33300) to list the narrow sawfish ( Anoxypristis cuspidata ), dwarf sawfish ( Pristis clavata ), largetooth sawfish (collectively Pristis pristis; formerly Pristis pristis, Pristis microdon, and Pristis perotteti ), green sawfish ( Pristis zijsron ), and the non-U.S. distinct population segment (DPS) of smalltooth sawfish ( Pristis pectinata ) as endangered species. NMFS solicited public comments on the proposed rule through August 5, 2013. On August 7, 2013, NMFS published a notice extending the comment period through September 19, 2013 (78 FR 48134). On December 12, 2014, NMFS published a final rule (79 FR 73977) to list the five species of sawfish as endangered species. The largetooth sawfish ( P. perotteti ) was already listed under the Act as endangered on July 12, 2011 (76 FR 40822), but this final listing concerns the entire largetooth sawfish species ( P. pristis ) as it is currently classified, which also includes the species formerly classified as P. perotteti and P. microdon.

The listing of the five sawfish species is effective as of January 12, 2015. In the December 12, 2014, final rule (79 FR 73977), NMFS addressed all public comments received in response to the proposed rule. By publishing this final rule, we are simply taking the necessary administrative step to codify these changes in the List at 50 CFR 17.11(h). We are also revising the current CFR entry for the U.S. DPS of smalltooth sawfish to make the presentation of information in that entry consistent with the new sawfish entries being added to the List via this rule; the changes to that entry are not substantive.

Because NMFS provided a public comment period on the proposed rules for these taxa, and because this action of the Service to amend the List in accordance with the determination by NMFS is nondiscretionary, the Service finds good cause that the notice and public comment procedures of 5 U.S.C. 553(b) are unnecessary for this action. We also find good cause under 5 U.S.C. 553(d)(3) to make this rule effective immediately. The NMFS rules extended protection under the Act to these species and listed them in 50 CFR part 224; this rule is an administrative action to add the species to the List at 50 CFR 17.11(h). The public would not be served by delaying the effective date of this rulemaking action.

We have determined that an environmental assessment, as defined under the authority of the National Environmental Policy Act of 1969, need not be prepared in connection with regulations adopted pursuant to section 4(a) of the Act. We outlined our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council (Council) under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

In the Aleutian Islands subarea, the portion of the 2015 pollock total allowable catch (TAC) allocated to the Community Development Quota (CDQ) directed fishing allowance (DFA) is 1,900 metric tons (mt) as established by the final 2014 and 2015 harvest specifications for groundfish in the BSAI (79 FR 12108, March 4, 2014), and as adjusted by an inseason adjustment (80 FR 188, January 5, 2015).

As of January 15, 2015, the Administrator, Alaska Region, NMFS, (Regional Administrator) has determined that 1,900 mt of pollock CDQ DFA in the Aleutian Islands subarea will not be harvested. Therefore, in accordance with § 679.20(a)(5)(iii)(B)( 4 ), NMFS reallocates 1,900 mt of pollock CDQ DFA from the Aleutian Islands subarea to the 2015 Bering Sea subarea allocations. The 1,900 mt of pollock CDQ DFA is added to the 2015 Bering Sea CDQ DFA. As a result, the 2015 harvest specifications for pollock in the Aleutian Islands subarea included in the final 2014 and 2015 harvest specifications for groundfish in the BSAI (79 FR 12108, March 4, 2014) are revised as follows: 0 mt to CDQ DFA. Furthermore, pursuant to § 679.20(a)(5), Table 3 of the final 2014 and 2015 harvest specifications for groundfish in the BSAI (79 FR 12108, March 4, 2014), as adjusted by the inseason adjustment (80 FR 188, January 5, 2015), is revised to make 2015 pollock allocations consistent with this reallocation. This reallocation results in adjustments to the 2015 CDQ pollock allocations established at § 679.20(a)(5).

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the reallocation of AI pollock. Since the pollock fishery opens January 20, 2015, it is important to immediately inform the industry as to the final Bering Sea subarea pollock allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery; allow the industry to plan for the fishing season and avoid potential disruption to the fishing fleet as well as processors; and provide opportunity to harvest increased seasonal pollock allocations while value is optimum. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of January 15, 2014.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.20 and is exempt from review under Executive Order 12866.