Background

The regulations in 9 CFR 113.8 provide criteria for acceptable in vitro potency tests for the serial release of live and inactivated veterinary biological products. As provided in the regulations, the potency of inactivated products is evaluated by comparing the relative antigen content of the product to an unexpired reference using a parallel line immunoassay or another acceptable procedure. The footnote in paragraph (c) of this section refers to one method that can be used to evaluate the relative antigen content using Supplementary Assay Method (SAM) 318 and relative potency calculation software available from Veterinary Services' Center for Veterinary Biologics (CVB). CVB is no longer providing or updating the software, and the written method for using the software, described in SAM 318, will no longer be used. Therefore, we are removing that footnote.

This rule relates to internal agency management. Therefore, pursuant to 5 U.S.C. 553, notice of proposed rulemaking and opportunity to comment are not required, and this rule may be made effective less than 30 days after publication in the Federal Register . Further, since this rule relates to internal agency management, it is exempt from the provisions of Executive Orders 12866 and 12988. Finally, this action is not a rule as defined by the Regulatory Flexibility Act, and thus is exempt from the provisions of that Act.

This rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Accordingly, 9 CFR part 113 is amended as follows:

I. Background

In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144, July 9, 2012), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register announcing this classification.

In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on October 8, 2010, classifying the InBios DENV Detect IgM Capture ELISA into class III, because it was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, or a device which was subsequently reclassified into class I or class II. On October 20, 2010, InBios International Inc., submitted a request for de novo classification of the InBios DENV Detect IgM Capture ELISA under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II.

In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request for de novo classification in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls will provide reasonable assurance of the safety and effectiveness of the device.

The device is assigned the generic name dengue virus serological reagents, which are identified as devices that consist of antigens and antibodies for the detection of dengue virus and dengue antibodies in individuals who have signs and symptoms of dengue fever or dengue hemorrhagic fever. The detection aids in the clinical laboratory diagnosis of dengue fever or dengue hemorrhagic fever caused by dengue virus.

FDA has identified the following risks to health associated with this type of device and the measures required to mitigate these risks:

FDA believes that the measures set forth in the special controls guideline entitled “Class II Special Controls Guideline: Dengue Virus Serological Reagents” are necessary, in addition to general controls, to mitigate the risks to health described in table 1.

Therefore, on April 8, 2011, FDA issued an order to the petitioner classifying dengue virus serological reagents into class II. FDA is codifying this device type by adding § 866.3945).

Following the effective date of this final classification order, any firm submitting a 510(k) premarket notification for this device type will need to comply with the special controls.

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this type of device is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the dengue virus nucleic acid amplification test reagents they intend to market.

The Agency has determined under 21 CFR 25.34(b) that this action is of type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final administrative order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801 and 21 CFR 809.10 have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) establish a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under the FD&C Act, FDA clears or approves the three classes of medical devices for commercial distribution in the United States through three regulatory processes: Premarket approval (PMA), product development protocol, and premarket notification (a premarket notification is generally referred to as a “510(k)” after the section of the FD&C Act where the requirement is found). The purpose of a premarket notification is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. Under section 513(i) of the FD&C Act, a device is substantially equivalent if it has the same intended use and technological characteristics as a predicate device, or has different technological characteristics but data demonstrate that the new device is as safe and effective as the predicate device and does not raise different issues of safety or effectiveness.

FDA determines whether new devices are substantially equivalent to previously offered devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807). Section 510(k) of the FD&C Act and the implementing regulations in part 807, subpart E, require a person who intends to market a medical device to submit a premarket notification submission to FDA before proposing to begin the introduction, or delivery for introduction into interstate commerce, for commercial distribution of a device intended for human use.

In accordance with section 513(f)(1) of the FD&C Act, devices that were not in commercial distribution before May 28, 1976, the date of enactment of the 1976 amendments, generally referred to as postamendment devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless FDA classifies the device into class I or class II by issuing an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval or the device is reclassified into class I or class II. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act and part 807 of FDA's regulations.

Section 513(f)(2) of the FD&C Act establishes procedures for “de novo” risk-based review and classification of postamendment devices automatically classified into class III by section 513(f)(1). Under these procedures, any person whose device is automatically classified into class III by section 513(f)(1) of the FD&C Act may seek reclassification into class I or II, either after receipt of an order finding the device to be not substantially equivalent, in accordance with section 513(i), to a predicate device that does not require premarket approval, or at any time after determining there is no legally marketed device upon which to base a determination of substantial equivalence. In addition, under section 513(f)(3) of the FD&C Act, FDA may initiate, or the manufacturer or importer of a device may petition for, the reclassification of a device classified into class III under section 513(f)(1).

A nucleic acid-based in vitro diagnostic device for the detection of M. tuberculosis complex in respiratory specimens is a postamendment device classified into class III under section 513(f)(1) of the FD&C Act in 1995. Consistent with the FD&C Act and FDA's regulations in 21 CFR 860.130(a), FDA is reclassifying these devices from class III into class II because there is sufficient information from FDA's accumulated experience with these devices to establish special controls that can provide a reasonable assurance of the device's safety and effectiveness.

Nucleic acid-based in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens are qualitative nucleic acid-based in vitro diagnostic devices intended to detect M. tuberculosis complex nucleic acids extracted from human respiratory specimens. These devices are non-multiplexed and intended to be used as an aid in the diagnosis of pulmonary tuberculosis when used in conjunction with clinical and other laboratory findings. These devices do not include devices intended to detect the presence of organism mutations associated with drug resistance. Respiratory specimens may include sputum (induced or expectorated), bronchial specimens (e.g., bronchoalveolar lavage or bronchial aspirate), or tracheal aspirates.

At an FDA/Centers for Disease Control (CDC)/National Institute of Allergy and Infectious Diseases public workshop entitled “Advancing the Development of Diagnostic Tests and Biomarkers for Tuberculosis,” held in Silver Spring, MD, on June 7 and 8, 2010, the class III designation for nucleic acid-based in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens was raised as a barrier to advancing M. tuberculosis diagnostics (Ref. 1). Based on discussion at the public workshop, FDA agreed to consider this issue further and subsequently convened a meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee on June 29, 2011. Panel members were asked to discuss if sufficient risk mitigation was possible for FDA to initiate the reclassification process from class III to class II devices for this intended use through the drafting of a special controls guidance. All panel members expressed the opinion that sufficient data and information exist such that the risks of false positive and false negative results can be mitigated to allow a special controls guidance to be created that would support reclassification from class III to class II for nucleic acid-based in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens (Ref. 2). All outside speakers at the open public hearing session during the meeting also spoke in favor of reclassification.

No comments were received on the proposed rule issued on June 19, 2013.

FDA is reclassifying nucleic acid-based in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens from class III to class II. FDA believes that reclassifying this device into class II with special controls (guideline document) provides reasonable assurance of the safety and effectiveness of the device. Section 510(m) of the FD&C Act provides that a class II device may be exempt from the premarket notification requirements under section 510(k), if the Agency determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this device, FDA believes that premarket notification is necessary to provide reasonable assurance of safety and effectiveness and, therefore, is not exempting the device from the premarket notification requirements.

After considering the information discussed by the Microbiology Devices Panel during the June 29, 2011, meeting, the published literature, and the medical device reporting system reports, FDA believes the following risks are associated with nucleic acid-based in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens: (1) False positive test results may lead to incorrect treatment of the individual with possible adverse effects. The patient may be subjected to unnecessary isolation and/or other human contact limitations. Unnecessary contact investigations may also occur; (2) false negative test results could result in disease progression and the risk of transmitting disease to others; and (3) biosafety risks to health care workers handling specimens and control materials with the possibility of transmission of tuberculosis infection to health care workers.

FDA, consistent with the opinions expressed by the Microbiology Devices Panel of the Medical Devices Advisory Committee, believes that the establishment of special controls, in addition to general controls, provides reasonable assurance of the safety and effectiveness of nucleic acid-based in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens.

1. The safety and effectiveness of nucleic acid-based systems for M. tuberculosis complex have become well-established since approval of the first device for this use in 1995.

2. The risk of false positive test results can be mitigated by specifying minimum performance standards in the special controls guideline and including information regarding patient populations appropriate for testing in the device labeling. Additional risk mitigation strategies include the indication for use that the device be used as an aid to the diagnosis of pulmonary tuberculosis in conjunction with other clinical and laboratory findings. The device also should be accurately described and have labeling that addresses issues specific to these types of devices.

3. The risk of false negative test results can be mitigated by specifying minimum performance standards for test sensitivity in the special controls guideline and ensuring that different patient populations are included in clinical trials. Additional risk mitigation strategies include the indication for use that the device be used as an aid to the diagnosis of pulmonary tuberculosis in conjunction with other clinical and laboratory findings. The device also should be accurately described and have appropriate labeling that addresses issues specific to these types of devices.

4. Biosafety risks to health care workers handling specimens and control materials with the possibility of transmission of tuberculosis infection to health care workers could be addressed similarly to existing devices of this type that we have already approved. It is believed there are no additional biosafety risks introduced by reclassification from class III to class II. The need for appropriate biosafety measures can be addressed in labeling recommendations that are included in the special controls guideline and by adherence to recognized laboratory biosafety procedures.

Based on FDA's review of published literature, the information presented by outside speakers invited to the Microbiology Devices meeting, and the opinions of panel members expressed at that meeting, FDA believes that there is a reasonable basis to determine that nucleic acid-based in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens can provide the significant benefit of rapid detection of infection in patients with suspected tuberculosis as compared to traditional means of diagnosis. For patients with acid-fast smear negative tuberculosis, nucleic acid-based in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens are currently the only laboratory tests available for rapid detection of active pulmonary tuberculosis. Rapid identification of patients with active tuberculosis may have significant benefits to the infected patient by earlier diagnosis and management as well as potentially significant effects on the public health by limiting disease spread.

Nucleic acid-based in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens have been approved for marketing by FDA for over 15 years. There is substantial scientific and medical information available regarding the nature, complexity, and problems associated with these devices. Revised public health recommendations for use, published by CDC on January 16, 2009, recommended the use of nucleic acid amplification testing in conjunction with acid-fast microscopy and culture and specifically states that “Nucleic acid amplification testing should be performed on at least one respiratory specimen from each patient with signs and symptoms of pulmonary [tuberculosis] for whom a diagnosis of [tuberculosis] is being considered but has not yet been established, and for whom the test result would alter case management or [tuberculosis] control activities” (Ref. 3).

FDA believes that the measures set forth in the special controls guideline entitled “Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens” are necessary, in addition to general controls, to mitigate the risks to health described in section VI. As seen in table 1, the special controls set forth in the guideline for this device address each of the identified risks.

As of the effective date of this rule, nucleic acid-based in vitro diagnostic devices for the detection of M. tuberculosis complex in respiratory specimens will be reclassified into class II. The reclassification will be codified in 21 CFR 866.3372. Firms submitting a 510(k) for a nucleic acid-based in vitro diagnostic device for the detection of M. tuberculosis complex in respiratory specimens will need either to: (1) Comply with the particular mitigation measures set forth in the special controls guideline or (2) use alternative mitigation measures, but demonstrate to the Agency's satisfaction that alternative measures identified by the firm will provide at least an equivalent assurance of safety and effectiveness. Adherence to the criteria in the guideline, in addition to the general controls, is necessary to provide a reasonable assurance of the safety and effectiveness of the devices.

Persons interested in obtaining a copy of the guideline may do so by using the Internet. A search capability for all Center for Devices and Radiological Health guidelines and guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm . The guideline is also available at http://www.regulations.gov .

To receive “Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens,” you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number 1788 to identify the guideline you are requesting.

The Agency has determined under 21 CFR 25.34(b) that this reclassification action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires Agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain state requirements “different from or in addition to” certain Federal requirements applicable to devices. (See section 521 of the FD&C Act (21 U.S.C. 360k); Medtronic v. Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, 128 S. Ct. 999 (2008)). The special controls established by this final rule create “requirements” for specific medical devices under 21 U.S.C. 360k, even though product sponsors have some flexibility in how they meet those requirements. (See Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997)).

This rule refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 56.115 have been approved under OMB control number 0910-0130; the collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801 and 21 CFR 809.10 have been approved under OMB control number 0910-0485.

This special controls guideline reflects changes the Agency is making to clarify its position on the binding nature of special controls. The changes include referring to the document as a “guideline,” as that term is used in section 513(a) of the FD&C Act, which the Secretary has developed and disseminated to provide a reasonable assurance of safety and effectiveness for class II devices, and not a “guidance,” as that term is used in 21 CFR 10.115. The guideline clarifies that firms will need either to: (1) Comply with the particular mitigation measures set forth in the special controls guideline or (2) use alternative mitigation measures, but demonstrate to the Agency's satisfaction that those alternative measures identified by the firm will provide at least an equivalent assurance of safety and effectiveness. Finally, the guideline uses mandatory language to emphasize that firms must comply with special controls to legally market their class II devices. These revisions do not represent a change in FDA's position about the binding effect of special controls, but rather are intended to address any possible confusion or misunderstanding.

FDA has examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the reclassification relieves manufacturers of premarket approval requirements of section 515 of the FD&C Act (21 U.S.C. 360e) it would not create new burdens. Thus, the Agency certifies that the rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $141 million, using the most current (2013) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this rule to result in any 1-year expenditure that would meet or exceed this amount.

The proposed rule was issued on June 19, 2013 (78 FR 36698). The comment period closed August 19, 2013, and FDA did not receive any comments. We revise the analysis of impact presented in the proposed rule with more current data, and adjust for inflation. Our estimate of benefits annualized over 20 years is $12.34 million at a 3 percent discount rate and $8.02 million at a 7 percent discount rate. The change in pre- and post-marketing requirements between a 510(k) and a PMA lead to benefits in the form of reduced submission costs, review-related activities, and inspections. Another unquantifiable benefit from the rule is that a decrease in entry could lead to further product innovation. FDA is unable to quantify the costs that could arise if there is a change in risk which could lead to adverse events, recalls, warning letters, or unlisted letters. Table 2 summarizes the estimated costs and benefits.

The full discussion of economic impacts is available in docket FDA-2013-N-0544 at http://www.regulations.gov , and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 4).

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

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

Purpose of Program: The NRC Program provides grants to institutions of higher education or consortia of such institutions to establish, strengthen, and operate comprehensive and undergraduate foreign language and area or international studies centers that will be national resources for (a) teaching of any modern foreign language; (b) instruction in fields needed to provide full understanding of areas, regions, or countries in which the modern language is commonly used; (c) research and training in international studies and the international and foreign language aspects of professional and other fields of study; and (d) instruction and research on issues in world affairs that concern one or more countries.

Applicable Program Regulations: 34 CFR parts 655 and 656.

We published a notice of proposed priorities for this program in the Federal Register on March 18, 2014 (79 FR 15077). That notice contained background information and our reasons for proposing the particular priorities.

There are differences between the proposed priorities and these final priorities as discussed in the Analysis of Comments and Changes section elsewhere in this notice.

Public Comment: In response to our invitation in the notice of proposed priorities, 25 parties submitted comments on the proposed priorities.

We discuss substantive issues under the number of the item to which they pertain. Generally, we do not address technical and other minor changes.

Analysis of Comments and Changes: An analysis of the comments and any changes in the priorities since publication of the notice of proposed priorities follows.

Comment: Several commenters stated that by defining an MSI for the purpose of this priority using eligibility under the programs authorized by Title III or Title V of the Higher Education Act of 1965, as amended (HEA), the Department unduly limits the pool of institutions with which NRCs could potentially collaborate. They also observed that opportunities to reach and impact substantially more underrepresented and underserved populations will be missed if NRC institutions only collaborate with institutions that are eligible to receive assistance under Title III or Title V of the HEA. The commenters suggested alternative strategies to give NRC institutions more flexibility in achieving the access and diversity goals of the priority. For example, one institutional commenter noted that there are no Title III or V institutions in its State, but, to fulfill its urban access mission, it serves high enrollments of low-income, underrepresented, and minority students through a long-standing partnership with the local public school system. When students from the local public school system are admitted as undergraduate students, they are familiar with, and more likely to participate in, area studies and world language courses and study abroad opportunities. The same commenter also noted that to support underrepresented, low-income, and underserved students, the institution has established valuable partnerships with local agencies so that a continuum of resources is available to low-income and minority students before and after they are admitted to the institution. The commenter suggested that encouraging grantees to devise innovative strategies and partnerships that respond to local circumstances in order to reach more low-income and minority students is more consistent with the Department's emphasis on outcome-based performance measures than is requiring grantees to respond to a proscribed priority.

A rural institution commented that it does not have an MSI or a community college in its geographic locale. It observed that partnerships with MSIs and community colleges should not be prioritized over a rural institution's capacity to provide area studies courses and less commonly taught language training to undergraduate students who are underrepresented minorities. The commenter also suggested that, instead of requiring collaborative activities with MSIs or community colleges, an NRC should be able to meet the priority by incorporating international dimensions into the NRC institution's undergraduate curriculum. According to the commenter, this would serve to attract and retain minority students and permit the NRC to focus its instruction and outreach efforts on underrepresented undergraduates on its campus, with the goal of increasing diversity in area studies programs.

Two commenters observed that many NRC institutions independently serve high numbers of underrepresented, underserved, or minority students, and if they have to allocate limited financial resources to support external collaborative activities, this will further strain their budgets and divert institutional resources from their students who are equally deserving of international education training opportunities. Another commenter noted that although it is both an MSI and an NRC institution, its internal activities and programming to support underrepresented and underserved groups do not meet the intent of the priority because the priority focuses on proposing collaborative activities with other MSIs. The commenter suggested that, in cases where an NRC institution is also a Title III- or Title V-eligible MSI, this priority should allow such an institution to focus on intra-campus collaborative activities as well as on collaborative activities with other MSIs and community colleges.

Discussion: We appreciate the commenters' concern that the definition of MSI is too narrow for the purpose of the priority and the alternative strategies they offered. However, we do not believe that the suggested strategies would achieve an important goal of this priority, which is to provide Title III and Title V institutions opportunities to access the resources available at Title VI institutions, through collaboration among Title III, Title V, and Title VI institutions. Further, institutions that are eligible to receive assistance under Title III, part A, Title III, part B, and Title V include Historically Black Colleges and Universities (HBCUs), predominately black institutions, Hispanic-serving institutions, and tribal colleges, among others. Accordingly, NRC institutions have a variety of options for collaboration, covering a wide range of underrepresented and underserved populations. Considering that community colleges are also included in this priority, we believe that there is sufficient opportunity for applicants to meet this priority. We, therefore, do not agree that the definition of an MSI for the purposes of this priority is too narrow.

We also believe that there are sufficient opportunities for collaboration between an NRC institution that is not in close proximity to MSIs or community colleges. For example, the institution may, among other things, use technology to connect with other institutions or offer faculty travel grants to bring faculty to the institution.

In regard to the concerns about using limited NRC grant funds to conduct the collaboration activities described in the priority, we do not think that the activities, if planned cost-effectively, will require significant portions of grant funds. In addition, the goal is not only to reach underserved students but to support collaboration with Title III and Title V institutions to improve international education on their campuses.

For an applicant that meets the definition of an MSI, we agree that it is appropriate to allow that institution to meet the priority by conducting intra-campus collaborative activities instead of, or in addition to, collaborative activities with other MSIs or community colleges. An example of an intra-campus collaborative activity would be a project involving the faculty in the Department of Social Sciences and the Portuguese language instructors to develop a language across the curriculum course about food security issues in Latin America.

Changes: We have revised the priority language to permit institutions that are eligible under Title III or Title V to propose intra-campus collaborative activities instead of, or in addition to, collaborative activities with other MSIs or community colleges.

Comment: One commenter suggested that it would be helpful if we provide a list of eligible Title III, part A, Title III, part B, and Title V institutions.

Discussion: We agree that making this information readily available to applicants will help them in addressing and meeting this priority.

Changes: None. We will provide the information on the institutions that currently meet this definition in the notice inviting applications.

Comment: One commenter recommended that we remove the singular modifier before MSI and before community college to clarify that collaborative activities may be proposed with more than one MSI or more than one community college.

Discussion: We agree with the commenter's suggestion and are making this change to ensure we do not limit the number of entities that are able to collaborate under this priority.

Changes: We have revised the priority to make it clear that an institution can collaborate with multiple MSIs or community colleges.

Comment: All commenters expressed concern about priority 2 because many institutions of higher education do not have a school or college of education or do not provide pre-service teacher certification training. They further observed that at many institutions, pre-service teacher training is offered through the schools of social sciences, liberal arts, or natural sciences, or the college of arts and sciences or through emerging models in teacher credential programs that are decentralized outside of the schools or colleges of education. The same commenters recommended that we revise the proposed priority to include options such as teacher credentialing programs, programs of teacher education, or post-baccalaureate programs. Three commenters recommended that we revise the priority to permit institutions that do not have schools or colleges of education to collaborate with institutions in their geographical location that have schools or colleges of education. Similarly, all commenters recommended that we expand the priority to allow applicants to propose collaborative activities with colleges or schools of education on or off the NRC campus.

Discussion: We agree with these suggestions. We believe that these revisions will offer more flexibility and reflect how different institutions of higher education operate in practice, while ensuring that the intent and objectives of the priority are still met. In addition, we note that the units listed in the final priority are not exhaustive, meaning that an institution could also collaborate with similar types of units that are not specifically mentioned in the priority and institutions that are on or off the NRC campus.

Changes: We have revised the priority to allow collaboration with units such as schools or colleges of education, schools of liberal arts and sciences, post-baccalaureate teacher education programs, and teacher preparation programs. We also have expanded the priority to permit collaborative activities with units or institutions that are on or off the NRC campus.

Comment: Several commenters raised concerns that the priority does not take into consideration that there is a limited job market for new teachers with credentials to teach less commonly taught languages (LCTLs), partly because LCTLs are not integrated into kindergarten through grade 12 (K-12) education or supported by the States.

Specifically, one commenter noted that giving priority to NRCs that contribute to the training and credentialing of new teachers is particularly problematic for NRCs that focus on languages and world areas such as Southeast Asia (SEA), because world areas like SEA are almost entirely absent from State-mandated K-12 curricula. The commenter further noted that through the training of Ph.D., Master of Arts, and Bachelor of Arts students, an NRC institution that focuses on SEA is educating the future post-secondary teachers of Southeast Asian Studies, thereby meeting a vital national interest. Similarly, another commenter cited the discontinuance of its Russian language teaching program due to low enrollment in the face of a weak job market. The commenter argued against encouraging students to pursue a teaching certification when there is no market for the credential.

Another commenter recommended that we either eliminate the portion of the priority regarding credentialing more foreign language teachers or tailor the priority to those specific LCTLs that require additional teachers to meet existing and expected future instructional needs within the K-12 system.

Another commenter suggested that we remove the last clause in the proposed priority relating to the credentialing of foreign language teachers because the commenter believed that LCTL instruction is adequately addressed by the first clause regarding the integration of world languages into teacher education. The commenter stated that teachers who are hired to teach other content courses but who also have foreign language training often have the opportunity to expose students to LCTLs in conjunction with other teaching activities. The commenter further noted that the first part of the priority already addresses this indirect path by which the NRCs can support and encourage the inclusion of more language instruction in elementary through secondary school classrooms. Encouraging teachers in training to study LCTLs has the potential to increase the overall availability of instruction in LCTLs in regular classroom activities.

Discussion: We do not agree that the portion of the priority relating to the credentialing of foreign language teachers is adequately addressed by the first part of the priority regarding the integration of world languages into teacher education. The preparation and credentialing of foreign language teachers in LCTLs is a distinct and formal process that might not necessarily occur under the broader collaboration categories in the first clause. We wish to encourage preparation and credentialing of foreign language teachers in LCTLs to the extent that there is demand for teachers of those languages, and therefore will maintain that option in the priority. Nonetheless, this activity is not required to meet this priority.

However, the commenters have provided a sound rationale to revise the priority as it relates to the credentialing of foreign language teachers in LCTLs. We agree that, due to limited State support and the lack of integration of language teaching into elementary and secondary education nationwide, there is low or no demand for teachers of some LCTLs. Accordingly, we agree with the suggestion that we limit the priority to LCTLs for which there is a demand for additional teachers to meet existing and expected future K-12 language program needs.

Changes: We have revised the priority to allow applicants to focus their teacher preparation and credentialing efforts on those specific LCTLs for which there is a demand for additional teachers to meet existing and expected future K-12 language program needs.

Applications that propose significant and sustained collaborative activities with one or more Minority-Serving Institutions (MSIs) (as defined in this notice) or with one or more community colleges (as defined in this notice). These activities must be designed to incorporate international, intercultural, or global dimensions into the curriculum at the MSI(s) or community college(s), and to improve foreign language, area, and international studies or international business instruction at the MSI(s) or community college(s). If an applicant institution is an MSI or a community college (as defined in this notice), that institution may propose intra-campus collaborative activities instead of, or in addition to, collaborative activities with other MSIs or community colleges.

For the purpose of this priority:

Community college means an institution that meets the definition in section 312(f) of the Higher Education Act of 1965, as amended (HEA) (20 U.S.C. 1058(f)); or an institution of higher education (as defined in section 101 of the HEA (20 U.S.C. 1001)) that awards degrees and certificates, more than 50 percent of which are not bachelor's degrees (or an equivalent) or master's, professional, or other advanced degrees.

Minority-Serving Institution means an institution that is eligible to receive assistance under sections 316 through 320 of part A of Title III, under part B of Title III, or under Title V of the HEA.

Applications that propose collaborative activities with units such as schools or colleges of education, schools of liberal arts and sciences, post-baccalaureate teacher education programs, and teacher preparation programs on or off the national resource center campus. These collaborative activities are designed to support the integration of an international, intercultural, or global dimension and world languages into teacher education and/or to promote the preparation and credentialing of more foreign language teachers in less commonly taught languages (LCTLs) for which there is a demand for additional teachers to meet existing and expected future kindergarten through grade 12 language program needs.

When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the Federal Register . The effect of each type of priority follows:

Absolute priority: Under an absolute priority, we consider only applications that meet the priority (34 CFR 75.105(c)(3)).

Competitive preference priority: Under a competitive preference priority, we give competitive preference to an application by (1) awarding additional points, depending on the extent to which the application meets the priority (34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets the priority over an application of comparable merit that does not meet the priority (34 CFR 75.105(c)(2)(ii)).

Invitational priority: Under an invitational priority, we are particularly interested in applications that meet the priority. However, we do not give an application that meets the priority a preference over other applications (34 CFR 75.105(c)(1)).

This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.

Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);

(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.

This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

We have also reviewed this final regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

We are issuing these final priorities only on a reasoned determination that their benefits justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.

We also have determined that this regulatory action does not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.

This document provides early notification of our specific plans and actions for this program.

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT .

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.gpo.gov/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site. You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov.

Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Purpose of Program: The purpose of the FLAS Program is to provide allocations of academic year and summer fellowships to institutions of higher education or consortia of institutions of higher education to assist meritorious undergraduate and graduate students undergoing training in modern foreign languages and related area or international studies.

Applicable Program Regulations: 34 CFR parts 655 and 657.

We published a notice of proposed priority for this program in the Federal Register on March 18, 2014 (79 FR 15081). That notice contained background information and our reasons for proposing the particular priority.

There are differences between the proposed priority and this final priority as discussed in the Analysis of Comments and Changes section elsewhere in this notice.

Public Comment: In response to our invitation in the notice of proposed priority, 11 parties submitted comments on the proposed priority.

We group major issues according to subject. Generally, we do not address technical and other minor changes.

Analysis of Comments and Changes: An analysis of the comments and any changes in the priority since publication of the notice of proposed priority follows.

Comments: Three commenters expressed support for the priority. Two commenters remarked that the priority was appropriate and feasible to implement.

Discussion: We appreciate the commenters' support.

Changes: None.

Comments: Three commenters expressed concern that the priority went beyond the statutory authority that establishes that fellowship awards be merit based. Specifically, one commenter suggested that section 608 of the Higher Education Act of 1965, as amended (HEA), limits the Department to the criterion of “excellence” for FLAS awards. Another commenter stated that “high academic achievement” as described in 34 CFR 657.3(c) is the only legally authorized criterion for selection of fellows.

Discussion: The Department believes that it has legal authority to establish this priority. Neither the selection criteria in section 608(a) of the HEA nor the eligibility criteria in § 657.3, including the criteria regarding the type of program the applicant is enrolled in and whether the applicant shows potential for high academic achievement, is changed by this priority. In other words, a student must meet the criteria in section 608(a) of the HEA and in § 657.3 before the student could receive preference from an institution, based on financial need, under this priority. We also note that fellowship applicants who do not receive the preference described in the priority may still be awarded fellowships.

Changes: None.

Comments: Four commenters remarked on the increased burden of administering the priority. One commenter noted that FLAS coordinators would have to field more financial aid inquiries from students. Two commenters claimed that it may be difficult or impossible to share financial aid information across institutions for FLAS fellows who apply from other institutions.

One commenter suggested that an institution's FLAS award selection processes would have to be significantly changed to meet the priority. Another commenter remarked that the institution's admissions policies would have to be revised because its graduate programs do not require a demonstration of financial need to be eligible for scholarships or funding.

Three commenters suggested that the inclusion of financial need criteria in the selection of students for FLAS fellowships would create student privacy concerns that would burden administrative staff. The commenters remarked that the inclusion of student financial data would require changes in the award process and additional staff training to securely process the sensitive information.

Two commenters noted the increased burden for students to have to fill out the Free Application for Federal Student Aid (FAFSA) in order to be competitive for a FLAS award. One commenter cited that a minority of graduate students fills out a FAFSA form, and, accordingly, graduate students would have to complete a FAFSA solely to qualify for a preference under the priority.

Discussion: We agree that administering this priority will require the academic department that awards fellowships to field more financial aid inquiries from students and coordinate with the institution's financial aid office. We believe this additional work will not present an unreasonable burden on the institution. Additional student inquiries and increased coordination with other offices on campus do not outweigh the importance of directing fellowship aid where it is most needed. We also do not believe it is difficult or impossible for an institution to obtain financial aid information related to a summer applicant who attends another institution. A student may request that the Department send an Institutional Student Information Record (ISIR) to an additional school through FAFSA on the Web, and the new institution will receive the information the next business day.

We also do not believe that the burden to protect the privacy of student information will be significant given that an institution should already have in place requirements for the protection of student information. In addition, the financial aid office could limit the information that it transmits to the academic department to cover only the student's expected family contribution (EFC), rather than providing all of the student's ISIR information to the academic department. In addition, an institution may meet the priority by committing to use a preference for students with financial need beginning in the 2015-2016 academic year, which will provide institutions with time to address any necessary staff training.

We also do not believe that it is unreasonable to require a graduate student who seeks to obtain a competitive preference for a fellowship to submit a FAFSA. The potential benefit to the graduate student outweighs the inconvenience of completing a FAFSA. Moreover, a student may be awarded a FLAS fellowship even if he or she did not submit a FAFSA, depending on the number of fellowships available to the institution and the characteristics of the other applicants. Nonetheless, we recognize that this may require the institution to educate its students about the requirement to submit a FAFSA in order to potentially receive preference under the priority.

Although this priority may add another layer to the fellowship selection process, we do not believe that the selection process will require significant changes, as an institution can obtain this financial information without an undue burden. Nonetheless, in response to commenters' concerns regarding administrative burden we have revised the priority language to allow an institution at the time of application to propose a preference for students who have financial need only for undergraduate students, only for graduate students, or for both types of students. This allows an institution flexibility in deciding whether it is feasible to consider financial need for only its undergraduate students, its graduate students, or all students.

We also have revised the priority to allow an institution to start using the preference in the 2015-2016 academic year. We believe this extra time for implementation will allow institutions to create the required processes on their campuses to implement the priority.

Changes: We have made two revisions to the priority. First, we have revised the priority to allow an institution to use a preference for students who have financial need only for undergraduate students, only for graduate students, or for both types of students. We also revised the priority to provide that an institution may meet the priority by committing to start using the preference in the 2015-2016 academic year, rather than in the first year of the grant as we originally proposed.

Comments: Three commenters expressed concern regarding the feasibility of implementing the FLAS selection process under this priority due to the timing of the release of financial aid information. They noted that their selection committees typically meet in February and notify FLAS fellows who have been selected by March. These commenters believed that this timeframe was not achievable under the proposed priority because FAFSA data are not available until March or April. A commenter provided two reasons why FLAS awards need to be determined in March before the availability of FASFA data. First, the commenter said that summer FLAS fellows must be notified of the FLAS committee's decision by March so that they can apply to summer programs and submit their overseas program requests to the Department's IFLE staff. Second, the commenter noted that academic year awards for incoming students need to be determined by March so that the institution can recruit competitive students who must make graduate school decisions by April 15.

Two commenters remarked that the financial aid criteria will complicate the selection process but have little impact on the selection of FLAS fellows at the graduate level. A commenter noted that most graduate students are full-time students with limited sources of funding, and so they would likely qualify on the basis of financial need anyway. A commenter noted that the principal determinant of a graduate student's financial need would be the student's marital status and presence or absence of dependents, and the commenter suggested that these factors are not appropriate selection criteria for making FLAS award decisions.

Discussion: We do not agree that the requirements of the priority will impede institutions in making awards by their usual deadlines. Students may submit FAFSAs to the Department beginning January 1, including through FAFSA on the Web. The Department processes records every weekday, except Federal holidays, and institutions generally receive the results of a FAFSA within one to two days after the student submits the FAFSA. If the institution wants students to apply for FLAS grants by February, it can instruct applicants who want to be considered for a preference based on financial need that they must submit the FAFSA before the selection committee meets in February.

Based on the previously described revisions to the priority language, institutions have the option to apply the priority to undergraduates only. Nonetheless, while it is possible that a preference for graduate students demonstrating financial need may consequently benefit students with spouses or children, we believe that assisting those students with financial need before awarding fellowships to students who have not demonstrated need is the most responsible use of scarce resources.

Changes: None.

Comments: Three commenters suggested that the financial aid criterion will negatively affect the students whom the priority intends to assist. One commenter said that students with financial need who may be eligible to receive scholarships other than FLAS awards would appear to have low unmet need on account of scholarships the students may later turn down, and so they would be disadvantaged in the FLAS selection process. Another commenter noted that some academic departments provide more generous fellowship and teacher assistant stipends than others. Students from these departments would be categorized as less needy and therefore less competitive for FLAS awards, and the departments would be penalized for their financial aid policies.

Discussion: Our intent through this priority is to provide FLAS fellowships to students with financial need. To avoid penalizing needy students who may have received other scholarship offers, we have revised the priority language to indicate that a student's need should be determined based on the student's EFC, which reflects the student's financial circumstances before other aid, such as scholarships, is considered.

Changes: We revised the priority to add language indicating that a student's need is to be calculated using the student's EFC, which reflects the student's financial circumstances before other aid, such as scholarships, is taken into account.

Comment: One commenter suggested that FLAS awards be made available to students from other colleges and universities regardless of whether a student is enrolled in an institution with an allocation of FLAS fellowships.

Discussion: Under § 657.3 (b)(1) of the FLAS Program regulations, a student is eligible to receive a fellowship if the student is enrolled in an institution receiving an allocation of fellowships. The Department does not have the authority to revise the priority absent a change to the regulations.

Changes: None.

Priority: Applications that propose to give preference when awarding fellowships to undergraduate students, graduate students, or both, to students who demonstrate financial need as indicated by the students' expected family contribution, as determined under part F of title IV of the Higher Education Act of 1965, as amended. This need determination will be based on the students' financial circumstances and not on other aid. The applicant must describe how it will ensure that all fellows who receive such preference show potential for high academic achievement based on such indices as grade point average, class ranking, or similar measures that the institution may determine. For grants awarded with fiscal year 2014 funds, the preference applies to fellowships awarded for study during academic years 2015-16, 2016-17, and 2017-18.

When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the Federal Register . The effect of each type of priority follows:

Absolute priority: Under an absolute priority, we consider only applications that meet the priority (34 CFR 75.105(c)(3)).

Competitive preference priority: Under a competitive preference priority, we give competitive preference to an application by (1) awarding additional points, depending on the extent to which the application meets the priority (34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets the priority over an application of comparable merit that does not meet the priority (34 CFR 75.105(c)(2)(ii)).

Invitational priority: Under an invitational priority, we are particularly interested in applications that meet the priority. However, we do not give an application that meets the priority a preference over other applications (34 CFR 75.105(c)(1)).

This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.

Under Executive Order 12866, the Secretary must determine whether this proposed regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);

(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.

This final regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

We have also reviewed this final regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);

(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

We are issuing this final priority only on a reasoned determination that its benefits justify its costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.

We also have determined that this regulatory action does not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

Intergovernmental Review: This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.

This document provides early notification of our specific plans and actions for this program.

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT .

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.gpo.gov/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov . Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

The information in this Supplementary Information section of this preamble is organized as follows:

Entities potentially affected by this final rule include owners and operators of emission sources in all industry groups planning to locate or located in Indian country. Categories and entities potentially affected by this action are expected to include:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be subject to the federal Indian country minor NSR program, and therefore potentially affected by this action. To determine whether your facility is affected by this action, you should examine the applicability criteria in 40 CFR 49.151 through 49.161 (i.e., the federal Indian country minor NSR rule). If you have any questions regarding the applicability of this action to a particular entity, contact the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

In addition to being available in the docket, an electronic copy of this final rule will also be available on the World Wide Web. Following signature by the EPA Administrator, a copy of this final rule will be posted in the regulations and standards section of the EPA's NSR home page located at http://www.epa.gov/nsr .

The following acronyms, abbreviations and units are used in this preamble:

The purpose of this rulemaking is to revise certain provisions in the federal Indian country minor NSR rule  1 (the Rule) to streamline implementation by expanding the list of appropriately exempted units/activities and clarifying language related to source construction. Specifically, we are adding five categories to the list of units/activities that are exempt from the federal Indian country minor NSR rule, and revising another category, because their emissions are deemed insignificant. Listing these categories explicitly for exemptions means that many applicants and reviewing authorities will not need to calculate potential emissions for those activities.

In the Rule, the term “commence construction” is used in two different contexts, i.e., the provisions governing construction prohibition, and also the provisions specifying that construction must occur within 18 months of the final permit issuance date. We are clarifying this distinction by adding two separate definitions for those situations: “begin construction” and “commence construction.” Further, we are replacing “commence construction” with “begin construction” in certain sections of the regulatory text for consistency with the new definitions. Finally, this rule reaffirms the 30-day advance notification requirement for relocation of true minor sources after reconsideration of this provision.

Section 110(a)(2)(C) of the Clean Air Act (Act) requires that every state implementation plan (SIP) include a program to regulate the construction and modification of stationary sources, including a permit program as required in parts C and D of title I of the Act, to ensure attainment and maintenance of the National Ambient Air Quality Standards (NAAQS). The permitting program for minor sources is addressed by section 110(a)(2)(C) of the Act, which we commonly refer to as the minor NSR program. A minor source means a source that has a potential to emit (PTE) lower than the major NSR applicability threshold for a particular pollutant as defined in the applicable nonattainment major NSR program or any regulated NSR pollutant with respect to the Prevention of Significant Deterioration (PSD) program.

States must develop minor NSR programs designed to attain and maintain the NAAQS in a manner most suitable for the circumstances of the particular state. The federal requirements for state minor NSR programs are outlined in 40 CFR 51.160 through 51.164. These federal requirements for minor NSR programs are considerably less prescriptive than those for major sources to facilitate the development of programs that best reflect a state's chosen approach to achieving the required result. As a result, the requirements vary substantially across the state minor NSR programs.

Furthermore, sections 301(a) and 301(d)(4) of the Act, as implemented through the Tribal Authority Rule  2 (TAR), provide the EPA with a broad degree of discretion in developing a program to regulate new and modified minor sources in Indian country.

The “Review of New Sources and Modifications in Indian country” ( i.e., Indian country NSR rule) final rule was established under the authority of sections 301(a) and (d) of the Act and the TAR and published in the Federal Register on July 1, 2011 (76 FR 38748). This rule established a federal implementation plan (FIP) for Indian country that includes two NSR programs for the protection of air resources in Indian country. These two new NSR programs work together with the pre-existing PSD program at 40 CFR 52.21 3 and the title V operating permits program at 40 CFR part 71  4 to provide a comprehensive permitting program for Indian country to ensure that air quality in Indian country will be protected in the manner intended by the Act.

One regulation created by the Indian country NSR rule, which we refer to as the “federal Indian country minor NSR rule,” is codified at 40 CFR 49.151-49.161 and applies to new and modified minor sources and to minor modifications at existing major sources throughout Indian country where there is no EPA-approved plan in place. The second regulation, which we refer to as the “Indian country nonattainment major NSR rule,” is codified at 40 CFR 49.166-49.173 and applies to new and modified major sources in areas of Indian country that are designated as not attaining the NAAQS (nonattainment areas). The Indian country NSR rules ensure that Indian country will be protected in the manner intended by the Act by establishing a preconstruction permitting program for new or modified minor sources, minor modifications at major sources, and new major sources and major modifications in nonattainment areas.

Under the federal Indian country minor NSR rule, new minor sources with a PTE equal to or greater than the minor NSR thresholds and modifications at existing minor sources, as well as minor modifications at major sources, with allowable emissions increases equal to or greater than the minor NSR thresholds, must apply for and obtain a minor NSR permit prior to beginning construction of the new source or modification. The effective date of the federal Indian country minor NSR rule was August 30, 2011. To facilitate the effective implementation of the federal Indian country minor NSR program, some components of the rule were phased in. Generally, the applicability of the preconstruction permitting rules to new synthetic minor sources  5 began on the rule's effective date, August 30, 2011; for new or modified true minor sources and minor modifications at major sources, 6 the rule applies beginning the earlier of September 2, 2014, or 6 months after the publication of a final general permit for that source category in the Federal Register (40 CFR 49.151(c)(1)(iii)(B)). In addition, existing true minor sources in Indian country were required to register with their reviewing authority by March 1, 2013.

No tribe is currently administering an EPA-approved PSD program. Therefore, the EPA has been implementing a FIP to issue PSD permits for major sources in attainment areas of Indian country (40 CFR 52.21). There are also no tribes currently administering an EPA-approved nonattainment major NSR program, so the EPA is the reviewing authority under a FIP (40 CFR 49.166 through 49.175). Only a few tribes are administering EPA-approved minor NSR programs. Accordingly, the EPA administers minor NSR programs in most areas of Indian country under a FIP (40 CFR 49.151 through 49.165).

Sections 301(d) and 110(o) of the Act provide eligible tribes the opportunity to develop their own tribal programs and we encourage eligible tribes to develop their own minor and nonattainment major NSR programs, as well as a PSD major source program, for incorporation into tribal implementation plans (TIPs). Tribes may use the tribal NSR FIP program as a model if they choose to develop their own EPA-approved TIPs.

This section discusses the final amendments to the federal Indian country minor NSR rule and our rationale for those amendments.

This final rule adds five categories (and also expands one category) to the current list of units/activities that are exempt from the existing federal Indian country minor NSR rule. We are adding these units/activities to 40 CFR 49.153(c) because their potential emissions are insignificant and generally well below the minor source thresholds. These additional exemptions will reduce regulatory burden by eliminating the need for applicants and/or permitting agencies to calculate their potential emissions to verify that minor source permitting thresholds are not triggered. Adding these exemption categories fulfills the commitment we made in the preamble to the federal Indian country minor NSR rule (July 1, 2011; 76 FR 38759) to assess whether to add other activities to the list of exempted units/activities.

The following units/activities are being added to the exempt category list under 40 CFR 49.153(c):

• Emergency generators used solely to provide electrical power during power outages: in attainment areas the total site-rated horsepower rating shall be below 1,000; in nonattainment areas classified Serious or lower, the total site-rated horsepower shall be below 500. In areas classified Severe or Extreme, no exemption applies.

• Stationary internal combustion engines with a horsepower rating less than 50.

• Furnaces or boilers used for space heating that use only gaseous fuel with a total maximum heat input (i.e., from all units combined) at or below: in attainment areas, 10 million British thermal units per hour (MMBtu/hr); in nonattainment areas classified as Serious or lower, 5 MMBtu/hr; and in nonattainment areas classified as Severe or Extreme, 2 MMBtu/hr.

• Single family residences and residential buildings with four or fewer dwelling units.

• Air conditioning units used for human comfort that do not exhaust air pollutants to the atmosphere from any manufacturing or other industrial processes.

Also, we are modifying the existing exemption for food preparation, as we proposed, to include the cooking of food by other than wholesale businesses that both cook and sell cooked food. Lastly, we have decided not to finalize the proposed exemption category for forestry and silvicultural activities for the reasons explained under section V below.

This final rule adds definitions for the terms “begin construction” and “commence construction” with only a minor change to the definitions we proposed. These definitions were proposed to better distinguish those situations where activity is prohibited without a permit from those situations where construction needs to occur within a specified period of time after permit issuance to maintain a valid permit. The only change being made to the proposed definitions in the final rule is that the term “grading” is being added to the list of activities that are allowed without a permit within the definition of “begin construction.” We discuss this change further under the public comments discussion in section V of this preamble. We are also finalizing the changes we proposed without revision to use “begin construction,” rather than “commence construction,” in those sections of the federal Indian country minor NSR rule where the regulatory text addresses actions that are prohibited prior to permit issuance. This makes our use of “commence construction” more consistent with the EPA's major NSR program, and, thus minimizing any potential confusion.

Also, we are finalizing the revised regulatory text in 40 CFR 49.151(c)(1)(iii)(B) clarifying our intent that true minor sources are not required to obtain a permit unless construction of such source, or modification, occurs on or after the date that is the earlier of 6 months after a final general permit for that specific source category is published in the Federal Register , or September 2, 2014. 7

We requested public comment on the relocation provision under 40 CFR 49.160(d)(1) that requires the owner/operator of a true minor source to notify the relevant reviewing authority in writing 30 days prior to relocating an existing source. Specifically, we sought comment on possibly reducing the advance notification period from 30 days to as few as 10 days. After reviewing the public comments received on this topic, we have decided to retain the 30-day advance notification period since a clear basis for reducing the notification period was not provided, and because several reasons for retaining the current 30-day period were given. In the process of reviewing the comments addressing the advance notification provision, we did become aware that relocation of individual pieces of equipment, rather than entire sources, can occur often in certain industries, and therefore we provide further discussion addressing those situations in section V of this preamble.

Finally, to better clarify advance notification requirements when a source relocation results in a change in the reviewing authority (e.g., the source moves from a reservation in EPA Region 8 to a reservation in EPA Region 6), we are finalizing the proposed changes to 40 CFR 49.160(d)(1) specifying that a source must notify both the existing and new reviewing authorities in that case.

The EPA provided a 60-day review and comment period on this rulemaking, which closed on August 5, 2013. We received seven comment letters (two industry letters, one state/local agency letter, three tribal letters and one private citizen letter) on the proposed amendments. The subsections that follow provide the significant comments and responses. The Response to Comments document that contains a summary of all comments received on the proposed amendments and the responses to those comments, is available in the docket.

Comment: One state/local commenter appreciates that additional exemptions may be needed; however, the commenter expressed an overall concern (that applies broadly to several of the exemption categories proposed) that the exemptions are inconsistent with their region's air quality rules. The commenter believes that exempting these sources from permitting will provide a competitive advantage to sources in Indian country compared to sources on non-tribal lands.

The commenter cites a specific concern with the competitive advantage issue in light of the EPA's recent proposed “detachment” of Morongo Indian country from California's South Coast Air Basin and the lowering of the classification of the Morongo reservation from Extreme to Serious ozone nonattainment ( Note: the proposed reclassification identified by the commenter was finalized on September 23, 2013 (78 FR 58189)). The commenter states that the Morongo lands are located directly upwind from the Coachella Valley, a Severe ozone nonattainment area, and therefore the commenter is concerned that exempting certain sources from permitting in Indian country will result in negative air quality impacts thereby delaying attainment of the NAAQS in downwind airsheds for both non-tribal lands and certain tribal areas.

The commenter urges the EPA to adopt requirements specific to areas of Indian country that are classified as either Severe or Extreme ozone nonattainment areas, just as the EPA has adopted lower minor NSR emission thresholds in the existing rule for nonattainment areas as opposed to attainment areas.

Response: Prior to the August 30, 2011, effective date of the federal Indian country minor NSR rule, codified in 40 CFR part 49, promulgated July 1, 2011 (76 FR 38748), there were no emission reduction requirements for new minor sources within areas of Indian country such as the Morongo Reservation. We point this out to highlight that the federal Indian country minor NSR rule has already reduced any potential competitive advantage cited by the commenter by requiring pre-construction permits for sources (with emissions above permitting thresholds) where prior to August 30, 2011, there were no such requirements.

As discussed in the July 1, 2011, final rule, while section 182(e)(2) of the Act specifies an emissions increase threshold of “0” tons/year (tpy) for existing major sources in Extreme ozone nonattainment areas, we do not believe these thresholds are appropriate for minor sources and operators within Indian country. Nonetheless, we are mindful of the need to protect the NAAQS and, as discussed later in comment responses related to exemptions for emergency generators and boilers/furnaces, we have made some revisions to the exemption criteria in the final rule amendments.

Comment: One state/local commenter expressed concern with the proposed exemption threshold for emergency generators under 500 horsepower (HP) in nonattainment areas and asserted it would create an imbalance between tribal lands and the surrounding non-tribal areas classified as Severe or Extreme nonattainment for ozone. Air quality regulations that apply to sources within the commenter's jurisdiction specify emission limits for nitrogen oxide (NO X ) and particulate matter (PM) for all engines over 50 HP. The commenter believes engines on tribal lands, which would be exempt from permitting under the EPA's proposed criteria, would emit NO X in amounts above the 0.8 tpy and 1.8 tpy levels that new and older model engines, respectively, must meet under the state air district's Best Available Control Technology (BACT) requirements. The commenter states that these types of engines are controllable and contribute to ozone and therefore should be subject to NSR permitting.

The commenter also cited a report from the World Health Organization  8 that declared diesel PM to be a human carcinogen. The commenter states that emissions from three standby generators (approximately 900 HP in total) can create cancer risks exceeding 25 in a million, even if operated only 50 hours/year. The commenter elaborates that a 500 HP emergency generator, operating for 500 hours/year, would create even higher risk (than the engines totaling 900 HP in the earlier example) due to its longer operating period, and therefore PM should be controlled from these units and they should be subject to NSR since the EPA's source-specific rules are not applicable to these units.

Response: One of our objectives for proposing activities/units for exemption was to reduce burden on source owners. We believe that emergency generators with horsepower ratings below the exemption thresholds will predominately have emissions below the minor source permitting thresholds and therefore the proposed exemption would potentially save source owners the effort of estimating their emissions solely to demonstrate that emissions are well below the permitting threshold.

However, we also recognize the commenter's concerns regarding the impacts of sources in Indian country to portions of the South Coast Air Basin that are classified Severe or Extreme nonattainment for ozone. We are required by title I of the Act to ensure attainment and maintenance of the NAAQS. Accordingly, after considering the comment, we believe that an exemption for emergency generators is not appropriate in ozone nonattainment areas classified Severe or Extreme, and we have revised exemption language in the final rule accordingly. As finalized, the total site-rated 500 HP exemption for emergency generators in ozone nonattainment areas will only apply in ozone nonattainment areas classified Serious or lower. The site-rated 1,000 HP exemption proposed for attainment areas remains unchanged in this final rule.

Comment: One state/local commenter believes that boilers and/or furnaces below the proposed heat input rates should not be exempt from minor NSR permitting in ozone nonattainment areas classified as Severe or higher because it would provide a competitive advantage to sources locating in Indian country. The commenter explains that the South Coast Air Quality Management District's (SCAQMD) air quality rules require controls for NO X at levels below the proposed exemption rates of 5 million Btu/hr for nonattainment areas; 10 million Btu/hr for attainment areas. The commenter refers to SCAQMD's NO X emission limits of 9 ppm for natural gas boilers having heat input rates between 2 million Btu/hr and 5 million Btu/hr to be met by January 1, 2012. In addition to that requirement, natural gas industrial furnaces must meet an emissions limit of 30 ppm (Rule 1147) and NO X controls for fan-type central furnaces under 175,000 Btu/hr are required as well (Rule 1111). The commenter states that the permitting exemption under Rule 219(b)(2) applies only to boilers and furnaces under 2 million Btu/hr.

Response: We believe the commenter raises a valid concern regarding the potential impacts to portions of the South Coast Air Basin classified as Severe or Extreme ozone nonattainment areas that are adjacent to/downwind from Indian country. In certain cases the proposed exemption could make it more difficult for downwind non-Indian country areas to achieve attainment of the NAAQS, which would be contrary to the requirements of title I of the Act. To minimize the likelihood of this occurring in the areas with higher ozone nonattainment classifications, we are finalizing a lower heat input rate (than the proposed 5 million Btu/hr which would have applied in all nonattainment areas) for Severe and Extreme ozone nonattainment areas. The heat input rate exemption for nonattainment areas in the final rule is specified as follows: for nonattainment areas classified Serious and lower, the exemption rate is heat input rates at or below 5 million Btu/hr; for ozone nonattainment areas classified as Severe or Extreme, the exemption level is a heat input rate at or below 2 million Btu/hr. The heat input rate exemption proposed for attainment areas remains unchanged.

Comment: One tribal commenter supports this proposed exemption. The commenter states the view that while emissions from road construction and maintenance are of particular concern ( Note: while the commenter did not specify, we assume the comment is referring to activities related to the proposed exemption category), “such emissions do not rise to a level requiring their removal from the list of proposed exemptions.” The commenter further states that permitting requirements for road construction and maintenance will impact timely repair and maintenance of roads on the commenter's lands. The commenter also mentions that open burning, a potential source of emissions on their lands, is regulated by the Bureau of Indian Affairs. Therefore the commenter believes the proposed exemption for forestry and silvicultural activities is reasonable and will save permitting resources.

One state/local commenter requests that the proposed exemption category be modified or deleted. The commenter voices concern with significant emissions from road construction and maintenance, and logging activities. The commenter also expresses concern with the potential for multiple pieces of equipment to collectively exceed the minor source thresholds, such as engines associated with wood chippers, a consideration the EPA noted in identifying units/activities to propose for exemption (June 4, 2013; 78 FR 33270). The commenter urges the EPA to delete the proposed exemption and instead rely on the attainment and nonattainment area NO X thresholds (10 tpy and 5 tpy, respectively) to determine when a permit must be obtained. As an alternative, the commenter suggests that specific types of equipment could be exempted instead of the entire category if the EPA determines them to have de minimis emissions.

Response: One reason we proposed the forestry/silvicultural category for exemption was to be consistent with the exemptions list in the Federal Air Rule for Indian Reservations, which applies in Indian country in the Northwest. A second reason we proposed this category for exemption was that we believed all emissions within the category would be de minimis in nature. Therefore, subjecting them to NSR permitting would provide little environmental benefit. Both commenters express some concern with the emissions associated with forestry and silvicultural activities, and one commenter identifies a situation where emissions could exceed de minimis levels.

Upon considering available information, we have concluded that a category-wide exemption is not the most appropriate approach to managing emissions for forestry and silvicultural activities. This conclusion is based on our recognizing the broad range of activities and potential emissions sources that could be part of this category and the potential to inadvertently exclude units with significant emissions. Due to the broad nature of activities under this category, we believe that there might be cases where permitting of certain emission units is needed to protect air quality, which would be precluded under a category-wide exemption. Based on that concern, we believe it is more appropriate to use the emission thresholds in the existing rule (e.g., NO X : 10 tpy and 5 tpy in attainment and nonattainment areas, respectively) to determine source permitting requirements and not have a broad, category-wide exemption. Therefore the exemption for forestry and silvicultural activities is not included in the final amendments.

Comment: One industry association commenter notes that the proposed definition of “begin construction” lists certain activities that can be conducted before the source has obtained a permit. 9 The commenter states that the list is more restrictive than the Agency's long standing approach to permissible activities. The commenter refers to a policy memo addressing activities allowed without a permit  10 and states that the EPA should not deviate from previously established policies.

Response: We agree with the commenter. Our intent was to include the same list of activities in the proposed definition that have been historically allowed under the EPA policy prior to obtaining a permit. We inadvertently omitted the term “grading” from the list in the proposed definition. We have added grading to the activities allowed under the definition of “begin construction” in the final rule to maintain consistency with the existing EPA policy.

Comment: One tribal commenter believes that at least 30 days notice is warranted for relocation of a non-portable source since a new permit may be required, and, in that case, the permitting authority will need sufficient time to process the application and issue a permit. The commenter elaborates that for a portable source, a 10-day notice requirement may be sufficient since its permit will likely include pre-approved new locations. The commenter agrees with the EPA's interpretation that these time periods apply where an entire source is relocated, noting that relocation of one or more pieces of equipment or emission units requires consultation with the source's reviewing authority to determine if a modification will occur under the federal Indian country minor NSR rule.

Another tribal commenter believes that, based on their permitting experience, in situations where a registered source relocates to a new, previously unapproved location, the permitting authority should have at least 30 days to review the relocation request. The commenter states that this time period is needed for tribal and historic preservation reviews to be performed.

One industry association commenter reiterates comments made in its petition for reconsideration on the July 1, 2011, final federal Indian country minor NSR rule stating that sources often relocate on short notice and occasionally change a previously planned relocation with little advance warning. The commenter states that the 30-day advance notice requirement is incompatible with oil and gas sector operations. In a subsequent teleconference, the commenter clarified that their primary concern involves relocation of one or more pieces of equipment or emissions units and not entire sources. 11 In response to the EPA's request for comment on the notification provision, the commenter agrees with the EPA's statement that there is no requirement for advance approval, or a permit, for a registered source that relocates prior to September 2, 2014. The commenter suggests that, in those cases, there is no need or value to an advance notification as long as the source continues to comply with its permit. The commenter elaborates that there will be sufficient opportunity after relocation to notify the EPA of any change. The commenter offers that one possible approach is the one used under 40 CFR 63.9(j), and could be adopted in the tribal rule. 12 The commenter also references the recently promulgated oil and gas sector New Source Performance Standards (NSPS) which allows for a lag time between source startup and the determination of whether controls are required.

Response: We specifically requested comment on the case where the source relocates before September 2, 2014 (i.e., where no permit is required). As discussed in the preamble for the proposed amendments (78 FR 33723), a true minor source that relocates in that situation does not need prior approval from its reviewing authority. The notification provision simply specifies advance notification in that case. However, it was not clear in some tribal comments if they were addressing the situation where relocation occurs before September 2, 2014, or on or after that date, since the need for a permit was mentioned by commenters. For that latter case, as stated in the proposal, a previously unpermitted portable source (e.g., a hot-mix asphalt plant) that relocates on or after September 2, 2014, will be required to obtain a permit prior to relocation, and we believe that any such permit will contain provisions addressing any future relocation. In this case of relocation on/after September 2, 2014, the permit application fulfills the advance notification requirement. In addition, we believe in cases where a permit is required the permitting process addresses the tribal and historic preservation obligations cited by the commenters. Because none of the commenters presented examples of a situation where the 30-day advance notification provision justifies a reduction, we are retaining the 30-day notification period. In the additional discussion below, we are clarifying that the advance notice relocation provision is intended to apply to entire sources and not individual pieces of equipment or emissions units.

Comment: One industry association commenter referenced the EPA's discussion in the proposed rule preamble addressing permitting obligations for true minor sources that relocate (78 FR 33273). The commenter disagrees with the EPA's statement that a true minor source constructed before September 2, 2014, that relocates after that date will have to obtain a permit. The commenter states that relocation is not tantamount to a modification of such a source and therefore the need for a permit is not triggered. The commenter clarified in a subsequent teleconference  13 that most of the situations addressed in the comments involve relocation or replacement of single pieces of equipment, not entire facilities, in the oil and gas sector.

Further, the commenter disagrees with the EPA's statement in the proposed rule preamble that a true minor source constructed after September 2, 2014, must obtain a permit for the original location and any subsequent relocation not specifically pre-authorized in the original permit. The commenter believes the EPA should clarify that permit conditions listing specific sites for relocation are not required. The commenter states that this approach would be particularly important for general permits where the ability to relocate would have to be based on generic criteria. The commenter believes no other approach would work with a general permit.

Response: The registration program and relocation provisions in 40 CFR 49.160(d)(1) apply to an entire true minor source, and are not applicable to an individual piece of equipment that is merely a part of the true minor source. The registration program is used for developing an inventory of emissions throughout Indian country to help us manage and protect air quality. We understand from the commenter that in oil and gas sector operations moving a single piece of equipment from one facility to another, or replacing a piece of equipment with a new one, can occur on a regular basis. For clarification purposes, we believe it would be beneficial to both sources and reviewing authorities for us to list the different situations involving a piece of equipment (a unit) that we believe will be most common, and specify the outcome with respect to minor NSR permitting. While we have listed expected outcomes below, the source owner/operator should still verify with its reviewing authority that the “matching” situation listed below, and its stated outcome, applies to its case:

(1) A unit at a permitted source is replaced “in kind” (i.e., the replacement unit is of the same size, capacity, horsepower, etc. as the existing unit)—The owner/operator should notify the reviewing authority as specified in its permit. If the existing permit conditions do not address equipment replacement/relocation, then the source should send a notification letter to its reviewing authority no later than 60 days following replacement of the unit.

(2) A unit at a registered but unpermitted source is replaced in kind—No new notification to the reviewing authority is required since this unit is already part of the inventory.

(3) A unit is moved within the boundary of a permitted or registered source—No new notification to the reviewing authority required, unless otherwise specified in the permit.

(4) A unit planned for addition (i.e., not replacement) at either a permitted or registered source, with PTE above the minor NSR thresholds—The owner/operator of the true minor source must first obtain a minor source permit before installing the unit at the new location beginning on September 2, 2014. 14

(5) One or more units (with combined PTE between the minor and major source thresholds) that are relocated to an entirely new location (i.e., a greenfield facility)—(a) Prior to September 2, 2014, the owner/operator of the true minor source must register with its reviewing authority within 90 days of beginning operation at the new location in accordance with 40 CFR 49.160(c)(1)(ii); (b) On or after September 2, 2014, the owner/operator of the true minor source must obtain a minor NSR permit from the reviewing authority at the new location before beginning construction.

(6) A unit moved from one registered source to another registered source before the September 2, 2014, permitting deadline—The source must notify the reviewing authority of removal of the unit from the originating source (to update its inventory) and also notify the reviewing authority of the addition of the unit at the destination source within 60 days following the change in location.

Comment: One industry association commenter states that, in the existing federal Indian country minor NSR rule, true minor sources constructed or modified after August 30, 2011, are required to obtain a permit. The commenter notes that the EPA proposed to revise this applicability date until September 2, 2014, and the commenter supports this change.

Response: We believe the commenter may have misinterpreted the existing requirements within 49.151(c)(1)(iii). Our intent under the existing rule has always been that true minor sources do not need a permit if they begin construction before September 2, 2014. We proposed changes to the regulatory text on June 4, 2013, that are intended to clarify the nature of this deadline. We are finalizing these proposed changes to the regulatory text to make this intent clear.

This action is not a “significant regulatory action” under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

This action does not impose any new information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The action will not create any new requirements under the federal Indian country minor NSR program, but rather will simplify minor source registrations and permit applications for some sources, potentially reducing burden. The Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations for the federal Indian country minor NSR program (40 CFR 49.151 through 49.161) under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., and has assigned OMB control number 2060-0003. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9.

The Regulatory Flexibility Act generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedures Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations and small governmental jurisdictions.

For purposes of assessing the impacts of this final action on small entities, small entity is defined as: (1) A small business as defined in the U.S. Small Business Administration size standards at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise that is independently owned and operated and is not dominant in its field.

After considering the economic impacts of this final action on small entities, I certify that this final action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analysis is to identify and address regulatory alternatives “which minimize any significant economic impact of the rule on small entities.” 5 U.S.C. 603 and 604. Thus, 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, or otherwise has a positive economic effect, on all of the small entities subject to the rule.

This final action will not create any new requirements under the federal Indian country minor NSR program, and therefore would not impose any additional burden on any sources (including small entities). This final action will simplify minor source registrations and reduce the burden of applicability determinations for some sources compared to the existing rule, potentially reducing burden for all entities, including small entities. We have therefore concluded that this final rule will be neutral or relieve the regulatory burden for all affected small entities.

This action contains no federal mandate under the provisions of Title II of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-1538 for state, local and tribal governments, in the aggregate, or the private sector in any 1 year. This action will not create any new requirements under the federal Indian country minor NSR program, but rather will simplify minor source registrations and reduce the burden of applicability determinations for some sources. Therefore, this action is not subject to the requirements of sections 202 or 205 of UMRA.

This action is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. As noted previously, the effect of this final rule will be neutral or relieve regulatory burden.

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, as specified in Executive Order 13132. This final rule will revise the federal Indian country minor NSR program, which applies only in Indian country, and will not, therefore, affect the relationship between the national government and the states or the distribution of power and responsibilities among the various levels of government.

Subject to the Executive Order 13175 (65 FR 67249, November 9, 2000), the EPA may not issue a regulation that has tribal implications, that imposes substantial direct compliance costs and that is not required by statute, unless the federal government provides the funds necessary to pay the direct compliance costs incurred by tribal governments or the EPA consults with tribal officials early in the process of developing the proposed regulation and develops a tribal summary impact statement.

The EPA has concluded that this final rule will have tribal implications. However, it will neither impose substantial direct compliance costs on tribal governments, nor preempt tribal law. This final rule will have tribal implications since it revises the federal Indian country minor NSR program, which applies to both tribally-owned and privately-owned sources in Indian country. As with the existing rule, the revised rule will be implemented by the EPA, or a delegate tribal agency assisting the EPA with administration of the rules, until replaced by an EPA-approved tribal implementation plan. The effect of this final rule will be to simplify compliance with, and administration of, the federal Indian country minor NSR program, so any impact on tribes would be in the form of reduced burden and cost.

Prior to proposing the rule amendments, we presented highlights of the expected changes to tribal environmental staff during a conference call with the National Tribal Air Association on February 28, 2013, and asked for comments. Following signature of the proposed amendments on May 23, 2013, the EPA mailed letters to over 560 tribal leaders to offer consultation. In addition, to help facilitate the tribes' decision concerning our offer of consultation, we held conference calls on June 17 and 20, 2013, with tribal environmental officials where we provided an overview of the proposed changes and answered any questions. We did not receive any requests for consultation from tribal governments. Lastly, we have taken into account the comments submitted from three tribes on the proposed amendments and fully considered those comments in finalizing the amendments in today's rule.

The EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.

This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not a significant regulatory action under Executive Order 12866.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, 12(d) (15 U.S.C. 272 note) directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., materials specifications, test methods, sampling procedures and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs the EPA to provide Congress, through the OMB, explanations when the agency decides not to use available and applicable voluntary consensus standards.

This rulemaking does not involve technical standards. Therefore, the EPA has not considered the use of any voluntary consensus standards.

Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies and activities on minority populations and low-income populations in the United States.

The EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. This final rule will simplify minor source registrations and permit applications for some sources under the federal Indian country minor NSR program, but will not relax control requirements or result in greater emissions under the program.

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. The EPA will submit a report containing this rule 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). This rule will be effective on the date of publication, i.e., on June 30, 2014.

Under section 307(b)(1) of the Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the District of Columbia Circuit by July 29, 2014. Any such judicial review is limited to only those objections that are raised with reasonable specificity in timely comments. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes 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. Under section 307(b)(2) of the Act, the requirements of this final action may not be challenged later in civil or criminal proceedings brought by us to enforce these requirements.

The statutory authority for this action is provided by sections 101, 110, 112, 114, 116 and 301 of the CAA as amended (42 U.S.C. 7401, 7410, 7412, 7414, 7416 and 7601).

For the reasons stated in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as set forth below.

EPA is approving New York's SIP revision updating their existing ten-year carbon monoxide (CO) maintenance plan with another ten-year plan for the New York portion of the New York-Northern New Jersey-Long Island (NYCMA) CO area which includes the following seven counties: Bronx, Kings, Nassau, New York, Queens, Richmond and Westchester. The reader is referred to the March 25, 2014 (79 FR 16265) proposal for details on this rulemaking.

EPA received one comment that supports our proposed approval of the updated CO maintenance plan. EPA is approving the New York SIP revision request.

EPA is approving New York's SIP revision updating their existing ten-year CO maintenance plan for the New York portion of the New York-Northern New Jersey-Long Island (NYCMA) CO area. EPA is also approving the 2007 CO base year emissions inventory and the CO motor vehicle emissions budgets all dated May 9, 2013.

Under the Clean Air Act, 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 Order 12866 (58 FR 51735, October 4, 1993);

• 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, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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 July 29, 2014. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes 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).)

Therefore, 40 CFR part 52 is amended as follows:

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

The background for today's action is discussed in detail in our February 14, 2014 proposal (79 FR 8916). In that notice, we proposed to approve revisions to the Texas SIP at 30 TAC Sections 101.1 and 106.4 submitted on May 19, 2011, for the implementation of the 1997 and 2006 PM 2.5 NAAQS. EPA also proposed to find that the Texas PSD NSR SIP met the PM 2.5 PSD requirements contained in the federal regulations as of December 9, 2013, including regulation of NO X and SO 2 as PM 2.5 precursors, regulation of condensables, and PM 2.5 increments.

We received comments from the Texas Industry Project (TIP) on our February 14, 2014 proposal. The comments we received can be accessed in their entirety from the www.regulations.gov Web site (Docket No. EPA-R06-OAR-2011-0495). The TIP generally expressed support for our proposed rulemaking, but did request clarification on certain issues. Following is a summary of the comments submitted from TIP and EPA's response.

Comment: TIP requests that EPA acknowledge that ammonia is not regulated as a precursor for PM 2.5 for PSD permitting under the Texas SIP. The commenter also presented information about EPA's treatment of ammonia and volatile organic compounds (VOC) as precursors to PM 2.5 in the federal PSD Program. Specifically, the commenter referenced EPA's May 16, 2008 NSR PM 2.5 Implementation Rule; the lack of a significant emission rate for VOC or ammonia in the federal PSD rules at 40 CFR 51.166(b)(23)(i); and the definition of “regulated NSR pollutant” where VOC is presumed out and ammonia is not mentioned at 40 CFR 51.166(b)(49).

Response: As discussed below, EPA agrees with the commenter's conclusion that this approval action of the Texas PM 2.5 SIP will not result in regulating ammonia or VOCs as precursors to PM 2.5 . Federal rules do not require the Texas PSD program to regulate VOCs or ammonia as precursors to PM 2.5 .

In the May 16, 2008 NSR PM 2.5 Implementation Rule, the EPA finalized revisions to the PSD program to govern regulation of SO 2 , NO X and VOCs as regulated NSR pollutants. For purposes of PSD, SO 2 is a regulated NSR pollutant under all circumstances; NO X is presumptively regulated as an NSR pollutant, unless the State or EPA demonstrates that emissions of NO X from sources in a specific area are not a significant contributor to that area's ambient PM 2.5 concentrations; and VOCs are presumptively not regulated as an NSR pollutant, unless the State or EPA demonstrates that emissions of VOCs from sources in a specific area are a significant contributor to that area's ambient PM 2.5 concentrations. See 40 CFR 51.166(b)(49)(i)( b )-( d ), 52.21(b)(50)(i)( b )-( d ). The EPA did not include ammonia as a regulated NSR pollutant for purposes of PSD.

As to nonattainment NSR, States were not required to regulate ammonia as a PM 2.5 precursor for a specific nonattainment area unless either the state or EPA provided a satisfactory demonstration that ammonia emissions from sources in a specific nonattainment area are a significant contributor to that area's ambient PM 2.5 concentrations. See 40 CFR 51.165(a)(1)(xxxvii)(C)( 4 ). However, the EPA clarified that “the action of any State identifying ammonia emissions as a significant contributor to a nonattainment area's PM 2.5 concentrations, or our approval of a nonattainment SIP doing so, does not make ammonia a regulated NSR pollutant for the purposes of PSD in any attainment or unclassifiable areas nationally.” See 73 FR 28321, 28330.

Texas was therefore not required by the EPA to address ammonia in its PSD regulations and there is no indication that Texas intended to identify ammonia as a regulated NSR pollutant for purposes of PSD permitting for PM 2.5 . Texas also did not revise its PSD regulations to regulate VOCs as a PM 2.5 precursor, as neither Texas nor the EPA demonstrated that emissions of VOCs from sources in the State significantly contribute to PM 2.5 concentrations in the State. The EPA is approving the Texas SIP as regulating only SO 2 and NO X as PM 2.5 precursors for purposes of PSD permitting. No changes were made to our final rule as a result of this comment.

We are approving the May 19, 2011, submittal for the State of Texas revising 30 TAC Sections 101.1(25), (75), (76), and (78) and 106.4(a)(1) and (a)(4) for the implementation of the 1997 and 2006 PM 2.5 NAAQS and non-substantive revisions to 30 TAC 106.4(a)(2) and (c) as proposed. We also find that the Texas PSD NSR SIP satisfies the PM 2.5 PSD requirements contained in federal regulations as of December 9, 2013. This action is being taken under section 110 and part C of the Act.

Also in this action we are making a ministerial revision to the Texas SIP to reflect a recent EPA final approval of the Texas PSD program. In Title 40 of the Code of Federal Regulations, Part 52, § 52.2303, paragraph (a)(2) is corrected to reflect the January 6, 2014, Federal Register EPA final action (79 FR 551) that replaced two provisions of the Texas PSD Supplement, paragraphs (a) and (b) of Board Order 87-09.

Under the Clean Air Act, 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 Order 12866 (58 FR 51735, October 4, 1993);

• 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).

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 July 29, 2014. 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:

This action provides notice of the EPA's adequacy finding regarding the second 10-year PM 10 limited maintenance plan for Kent, Seattle, and Tacoma (LMP) for purposes of transportation conformity. The EPA's finding was made pursuant to the adequacy review process for implementation plan submissions delineated at 40 CFR 93.118(f)(1) under which the EPA reviews the adequacy of a state implementation plan (SIP) submission prior to the EPA's final action on the implementation plan.

The State submitted the LMP to the EPA on November 25, 2013. Pursuant to 40 CFR 93.118(f)(1), the EPA notified the public of its receipt of this plan and its review for an adequacy determination on the EPA's Web site and requested public comment by no later than January 10, 2014. Additionally, the EPA announced the public comment period on the entire LMP in the Federal Register on December 26, 2013 (78 FR 78311). The EPA received a request to extend the comment period and announced a comment period extension to March 10, 2014 in a notice published on February 6, 2014 (79 FR 7126). The EPA received no comments on the on-road vehicle portion of the plan during the comment period. As part of our review, we also reviewed comments on the LMP submitted to the State of Washington during the State's public process. There were no adverse comments directed at the on-road portion of the plan that were submitted during the State hearing process regarding the new Plan.

However, the EPA did receive adverse comments on potential future emissions in the non-road portion of the LMP. Nevertheless, the EPA believes it is appropriate to find this LMP adequate for purposes of transportation conformity while the EPA continues to review the plan and comments received. This adequacy finding is not dispositive of the EPA's ultimate approval or disapproval of the LMP.

The EPA notified Ecology in a letter dated April 9, 2014 (adequacy letter), subsequent to the close of the EPA comment period, that the EPA had found the LMP to be adequate for use for transportation conformity purposes. A copy of the adequacy letter and its enclosure are available in the docket for this action and at the EPA's conformity Web site: http://www.epa.gov/otaq/stateresources/transconf/adequacy.htm .

Pursuant to 40 CFR 93.109(l), limited maintenance plans are not required to contain on-road motor vehicle emissions budgets. Accordingly, as a result of this adequacy finding, regional emissions analyses will no longer be required as a part of the transportation conformity demonstrations for PM 10 for the Kent, Seattle, and Tacoma areas. However, other conformity requirements still remain such as consultation (40 CFR 93.112), transportation control measures (40 CFR 93.113), and project level analysis (40 CFR 93.116).

Transportation conformity is required by section 176(c) of the Clean Air Act. Transportation conformity to a SIP means that on-road transportation activities will not produce new air quality violations, worsen existing violations, or delay timely attainment of the national ambient air quality standards. The minimum criteria by which we determine whether a SIP is adequate for conformity purposes are specified at 40 CFR 93.118(e)(4). The EPA's analysis of how the LMP satisfies these criteria is found in the adequacy letter and its enclosure. The EPA's adequacy review is separate from the EPA's SIP completeness review and it is not dispositive of the EPA's ultimate action on the SIP.

Eastern U.S./Canada Area Daily VMS Reporting. Prior to FY 2013, the regulatory text for the catch monitoring/attribution program for Georges Bank (GB) cod and haddock required that all GB cod and haddock caught on a trip in which a vessel fished in both the Western and Eastern U.S./Canada Areas be attributed to the Eastern Area. In practice, we attributed catch of these stocks to areas fished based on our understanding that Amendment 16 to the FMP intended this result; however, the regulatory text was inadvertently left unchanged from pre-Amendment 16 measures.

In commenting on a proposed rule for Amendment 48 to the FMP (78 FR 18188; March 25, 2013), which included a measure to correct this inadvertent language holdover, the New England Fishery Management Council (Council) objected to the proposed revision, stating it was inconsistent with their intent in Amendment 16. Because the proposed change was meant to reflect Council intent regarding Amendment 16, we withdrew its proposed revision, leaving the original text in place in the final rule (i.e., GB cod and haddock catch would be attributed to the Eastern U.S./Canada Area). We noted this change as an interim measure, but asked for comments as it varied from the proposed rule. We then received a second comment letter from the Council on the interim measure, retracting the first statement of intent, and supporting the approach we first proposed. The Council also suggested that the requirement for daily reporting of catch in the Eastern Area should be reinstituted as allowed under Amendment 16 through Regional Administrator authority to better ensure timely and accurate reporting for quota monitoring purposes.

Based on the second Council letter, we announced on July 10, 2013, that Eastern U.S./Canada Area catch monitoring was being changed from the interim method to a system that apportions catch based on area fished, consistent with the recommendation of the Council and the 2013 proposed rule measure. We published the final rule for this monitoring method on August 29, 2013 (78 FR 53363). Accounting for all FY 2013 trips has been retroactively revised from the interim approach to the area fished method. Such changes were considered to be within the purview of the Regional Administrator (§ 648.85(a)(3)(ii)(A)).

The Amendment 16 final rule (75 FR 18262; April 9, 2010) also intended to remove the requirement for sector vessels to submit daily VMS catch reports when declared into the U.S./Canada Management Area, as well as the two Eastern U.S./Canada Special Access Programs (SAPs; the Closed Area II Yellowtail Flounder/Haddock SAP and the Eastern U.S./Canada Haddock SAP), because the requirement for a weekly sector manager report was determined to be sufficient by the Regional Administrator. This intent was captured in the preamble of the proposed and final rules for Amendment 16; however, this change was not reflected in the regulatory text at § 648.85(a)(3)(v). Subsequently, the Council requested that we implement a daily reporting requirement for the Eastern U.S./Canada Area to address misreporting and ensure more accurate and timely reporting for this area. As part of the rulemaking on August 29, 2013 (78 FR 53363), we announced our intention to require sector vessels declared to fish in the Eastern U.S./Canada Area to submit daily VMS catch reports. We did not, and do not, intend to change the weekly reporting requirement for vessels declared only into the Western U.S./Canada Area.

Because the daily reporting requirement is already specified in the regulations (§ 648.85(a)(3)(v)) for vessels declared into the Eastern U.S./Canada Area, this provision need not change, except to clarify that the daily reporting requirement does not apply to vessels declared only into the Western U.S./Canada Area. Accordingly, this action modifies the reporting requirement of § 648.85(a)(3)(v) to clarify that only sector vessels that have declared into the Eastern U.S./Canada Area are required to submit daily catch reports, and that, for vessels declared only into the Western U.S./Canada Area, sectors must continue to submit weekly sector catch reports. The intent of this action is to improve the accuracy of reporting of the Eastern U.S./Canada Area.

De Minimis Unused Sector ACE Carryover. In conjunction with the rule implementing Framework Adjustment 50 for FY 2013, we issued rulemaking under section 305(d) of the Magnuson-Stevens Act to clarify how accounting for year-to-year unused sector ACE carryover would be handled beginning in FY 2014 (78 FR 26172; May 3, 2013). The applicable regulations outlining the carryover system, including the revisions made in Framework Adjustment 50, can be found in § 648.87(b)(1)(i)(F)( 1 )-( 5 ).

Our clarification specified that sectors would be held accountable for any overage of the sector-specific sub-annual catch limit (sub-ACL) if the total fishery level ACL were exceeded in any given year, consistent with the existing accountability measures regulations. The clarification makes explicitly clear that sectors would be accountable for carried-over catch used if the total ACL is exceeded, except for a nominal de minimis amount to be determined by NMFS. We believe providing a nominal amount of carryover is an important safety consideration because, by allowing some carryover, vessels could elect to forego some portion of, or entire, late-season fishing trips for safety reasons, knowing that they could instead harvest the de minimis amount in the next fishing year, irrespective of any accountability measures. Substantial explanation of the carryover program accounting is provided in Framework 50 and the associated rulemaking documents, and is not repeated here.

Recently, the U.S. District Court (District of Columbia) found that the FY 2013 carryover catch accounting measures implemented as a transition-year approach, before a system that maintained full accountability if total ACLs are exceeded, violated the Magnuson-Stevens Act. We will be developing a separate emergency rulemaking to implement a remedy for carryover of FY 2013 catch to 2014.

Eastern U.S./Canada Area Daily VMS Reporting. NMFS approves the requirement for sector vessels declared to fish in the Eastern U.S./Canada Area to submit daily VMS catch reports. The reports must be submitted in 24-hour intervals for each day, and are required to include at least the following information:

1. VTR serial number or other universal ID specified by the Regional Administrator;

2. Date fish were caught and statistical area in which the fish were caught; and

3. Total pounds of cod, haddock, yellowtail flounder, winter flounder, witch flounder, pollock, American plaice, redfish, Atlantic halibut, ocean pout, Atlantic wolffish, and white hake kept (in pounds, live weight) in each broad stock area, specified in § 648.10(k)(3), as instructed by the Regional Administrator.

The regulations at § 648.85(a)(3)(v) currently require sector vessels to submit daily reports if they declare into a U.S./Canada Area. This rule does not require a substantive change to the regulations for vessels declared into the Eastern U.S./Canada Area, because daily reporting is needed in the Eastern U.S./Canada Area to ensure accurate catch reporting. However, although the previous regulatory text required daily reporting for vessels declared into the Western U.S./Canada Area, weekly sector catch reports have been determined to be sufficient for that area. Therefore, the regulatory text at § 648.85(a)(3)(v) is modified to delete the daily reporting requirement for such vessels.

Pursuant to the regulations at § 648.10(k)(2), vessels that have declared their intent to fish within multiple Broad Stock Areas must submit a trip-level hail report via VMS. This report must include the landed weight of regulated species and total retained catch, unless the vessel is fishing in a special management program such as the Eastern U.S./Canada Area, and is required to submit daily reports via VMS. With this rule, a sector vessel on a trip declared into the Eastern U.S./Canada Area and fishing in multiple Broad Stock Areas is exempt from the requirement to submit a trip-level catch report.

A sector vessel using an annually approved sector exemption from the requirement to declare intent to fish in either the Closed Area II Yellowtail Flounder/Haddock SAP or the Eastern U.S./Canada Haddock SAP from the dock (known as flexing) will be required to submit a report to indicate their catch for the trip up until the time they declare into the Eastern U.S./Canada SAP. Once declared into either of these SAPs, the sector vessel must submit daily reports for the remainder of the trip.

De Minimis Unused Sector ACE Carryover. NMFS approves the measure to provide 1 percent of the annual sector sub-annual catch limit (sub-ACL) as the de minimis carryover amount, starting in FY 2014. This de minimis amount of carryover, if used, will not be specifically counted against the sector ACE or ACL for accountability purposes. The full sub-ACL is still allocated to sectors as ACE (i.e., not reduced by 1 percent). The existing carryover provision that allows up to 10 percent of unused sector ACE to be carried over remains in effect; however, any carried over catch in excess of the de minimis amount will be counted against the sector ACE and overall ACL for accountability purposes if the total fishery-level ACL is exceeded.

By using a nominal amount of the sector-specific sub-ACL in the derivation process, the resulting 1-percent de minimis carryover falls within the management uncertainty buffer established for sectors. This approach ensures that the de minimis value is in line with catch limits established for the FY in which carryover may be taken. For FY 2015 and beyond, NMFS approves this approach of using 1 percent of the sector sub-ACL for the year in which carryover would be harvested as the default de minimis amount. The actual value may vary year-to-year based on the sub-ACLs specified for the year. NMFS will publish the actual de minimis amount in conjunction with either Council initiated frameworks implementing ACLs or in sector ACE adjustment rules.

NMFS modifies the text at § 648.14(k)(11)(iv)(A) to clarify the reporting requirements by removing the word “landings” from the paragraph.

NMFS modifies the text at § 648.85(a)(3)(v) in order to clarify that the authority granted to the NMFS Regional Administrator to remove the daily reporting requirements for special management programs is separate and distinct from the regulatory requirement. This modification moves the language explaining the Regional Administrator's authority to a new subsection (§ 648.85(a)(3)(v)(B)) with a further clarification that the Regional Administrator's authority also includes modification of reporting requirements.

On March 17, 2014, we proposed this rule and requested public comments (79 FR 14635). We received two comments, one relating to the Eastern U.S./Canada Area daily catch reporting, and the other relating to the de minimis carryover.

Comment 1: The Cape Cod Commercial Fishermen's Alliance (CCCFA) expressed continued concern for the potential for misreporting of GB cod caught in the Eastern Area as Western Area GB cod. CCCFA stated that, although daily reporting for trips declared into the Eastern Area will help, it is insufficient to prevent the misreporting on unobserved trips catching cod.

Response: The intent of this rule is to increase accuracy of reporting, and is based on a recommendation made by the Council. We agree with the Council that daily reporting should increase the accuracy and timeliness of Eastern U.S./Canada area catch reporting for quota monitoring. However, NMFS agrees that misreporting still has the potential to occur, and welcomes suggestions that would further reduce the potential for misreporting.

Comment 2: The Council disagreed that it was within our authority under MSA section 305(d) to clarify the existing Amendment 16 carryover program. Similar comments were submitted by the Council in conjunction with Framework 50 rulemaking where we implemented carryover accounting clarification and introduced the de minimis concept.

Response: NMFS clarified in Framework 50 how carryover will be accounted for purposes of accountability measures, in order to ensure that NMFS can discharge its responsibility to implement the carryover provisions in a manner consistent with the Magnuson-Stevens Act, particularly provisions requiring the prevention of overfishing. Such clarification is well within the agency's authority and is wholly consistent with the intent of section 305(d) of the Magnuson-Stevenson Act. None of the pre-existing carryover regulations implemented by Amendment 16 were changed by this clarification: Sectors may continue to carryover up to 10 percent of unused ACE from the previous fishing year.

However, the 2014 approach allows fishermen to rely on some guarantee of a de minimis amount of carryover without consequences to promote safety at sea and management predictability.

NMFS makes one change from the proposed rule in this action, in that it clarifies the manner in which a sector vessel using an annually approved sector exemption to flex into either the Closed Area II Yellowtail Flounder/Haddock SAP or the Eastern U.S./Canada Haddock SAP from the dock will submit a trip and daily reports indicating their catch.

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that the management measures in this final rule are consistent with the NE Multispecies FMP, other provisions of the Magnuson-Stevens Act, and other applicable law.

Pursuant to the procedures established to implement section 6 of Executive Order (E.O.) 12866, the Office of Management and Budget has determined that this final rule is not significant.

This final rule does not contain policies with federalism or “takings” implications as those terms are defined in E.O. 13132 and E.O. 12630, respectively.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. We received no comments on that certification. As a result, a regulatory flexibility analysis is not required, and was not prepared.

For the reasons set out in the preamble, 50 CFR part 648 is amended as follows: