Federal Register Vol. 81, No.152,

Background

Bovine tuberculosis is a contagious and infectious granulomatous disease caused by the bacterium Mycobacterium bovis. Although commonly defined as a chronic debilitating disease, bovine tuberculosis can occasionally assume an acute, rapidly progressive course. While any body tissue can be affected, lesions are most frequently observed in the lymph nodes, lungs, intestines, liver, spleen, pleura, and peritoneum. Although cattle are considered to be the true hosts of M. bovis, the disease has been reported in several other species of both domestic and nondomestic animals, as well as in humans.

At the beginning of the past century, tuberculosis caused more losses of livestock than all other livestock diseases combined. This prompted the establishment in the United States of the National Cooperative State/Federal Bovine Tuberculosis Eradication Program for tuberculosis in livestock.

In carrying out the national eradication program, the Animal and Plant Health Inspection Service (APHIS) issues and enforces regulations. The regulations require the testing of cattle and bison for tuberculosis, define the Federal tuberculosis status levels for States or zones (accredited-free, modified accredited advanced, modified accredited, accreditation preparatory, and nonaccredited), provide the criteria for attaining and maintaining those status levels, and contain testing and movement requirements for cattle and bison leaving States or zones of a particular status level. These regulations are contained in 9 CFR part 77 and in the Bovine Tuberculosis Eradication Uniform Methods and Rules, 1999 (UMR), which is incorporated by reference into the regulations.

The status of a State or zone is based on its prevalence of tuberculosis in cattle and bison, the effectiveness of the State's tuberculosis eradication program, and the degree of the State's compliance with standards for cattle and bison contained in the UMR. The regulations provide that a State may request partitioning into specific geographic regions or zones with different status designations (commonly referred to as split-State status) if bovine tuberculosis is detected in a portion of a State and the State demonstrates that it meets certain criteria with regard to zone classification.

In an interim rule effective and published in the Federal Register on September 18, 2008 (73 FR 54063-54065, Docket No. APHIS-2008-0067), we amended the tuberculosis regulations for cattle and bison by removing the State of California from the list of accredited-free States for bovine tuberculosis and reclassified the State as modified accredited advanced. Because two affected cattle herds had been detected in California since November 2007, the State no longer met our requirements for accredited-free status. That action was necessary to reduce the likelihood of the spread of bovine tuberculosis within the United States. As a result of that action, cattle or bison moved interstate from anywhere in California have had to meet the testing requirements that apply to animals from modified accredited advanced States or zones.

The State of California has requested that the State be reclassified from modified accredited advanced to accredited-free. Based on the findings of a review of the tuberculosis eradication program in California conducted during the week of April 18 to 22, 2016, APHIS has determined that the State meets the criteria for advancement of status contained in the regulations.

State animal health officials in California have demonstrated that the State enforces and complies with the provisions of the UMR. The State of California has demonstrated that it has zero percent prevalence of cattle and bison herds affected with tuberculosis and has had no findings of tuberculosis in any cattle or bison in the State since the last affected herd completed a test-and-remove herd plan and was released from quarantine in July 2014. Therefore, California has demonstrated that the State meets the criteria for accredited-free status as set forth in the definition of accredited-free State or zone in § 77.5 of the regulations.

Based on our evaluation of California's request, we are classifying the entire State of California as accredited-free.

Immediate action is warranted to relieve restrictions on the interstate movement of cattle and bison from the State of California. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this action effective less than 30 days after publication in the Federal Register.

We will consider comments we receive during the comment period for this interim rule (see DATES above). After the comment period closes, we will publish another document in the Federal Register. The document will include a discussion of any comments we receive and any amendments we are making to the rule.

This interim rule is subject to Executive Order 12866. However, for this action, the Office of Management and Budget has waived its review under Executive Order 12866.

In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. The full analysis may be viewed on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov) or obtained from the person listed under FOR FURTHER INFORMATION CONTACT.

Tuberculosis testing, including veterinary fees, costs approximately $10 to $15 per head. Approximately 100,000 tuberculosis tests were conducted in California in 2015, to meet the import requirements imposed by other States. Based on this information, the annual cost savings associated with advancing the tuberculosis status of California from modified accredited advanced to accredited-free will range from $1 million to $1.5 million. We note that Federal interstate movement testing requirements for modified accredited advanced States were suspended by a Federal Order issued in April 2010. The $1 million to $1.5 million in savings that will be realized represents less than 0.02 percent of the approximately $10 billion earned from California's cattle and milk sales.

Entities that may be affected by the interim rule fall into various categories of the North American Industry Classification System. The majority of the affected businesses are small entities.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.

This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule has no retroactive effect and does not require administrative proceedings before parties may file suit in court challenging this rule.

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

Accordingly, we are amending 9 CFR part 77 as follows:

Background

BIS established the ECCN 0Y521 series to identify items that warrant control on the CCL but are not yet identified in an existing ECCN (77 FR 22191, April 13, 2012). Items are added to the ECCN 0Y521 series by the Department of Commerce, with the concurrence of the Departments of Defense and State, and other agencies as appropriate, upon a determination that an item should be controlled because it provides at least a significant military or intelligence advantage to the United States or because foreign policy reasons justify such control. In this matter, the Department of Energy also concurred in the control imposed. The ECCN 0Y521 series is a temporary holding classification with a limitation that while an item is temporarily classified under ECCN 0Y521, the U.S. Government works to adopt a control through the relevant multilateral regime(s), in this case the Nuclear Suppliers Group, to determine an appropriate longer-term control over the item, or that the item does not warrant control on the CCL.

Items classified under ECCN 0Y521, including the items identified in this interim final rule as 0A521 and 0E521 items, remain so-classified for one year from the date a final rule identifying the item is published in the Federal Register amending the EAR, unless the item is re-classified under a different ECCN, under an EAR99 designation, or the 0Y521 classification is extended. During this time, the U.S. Government determines whether it is appropriate to submit a proposed control to the applicable export control regime (e.g., the Nuclear Suppliers Group) for potential multilateral control, with the understanding that multilateral controls are preferable when practical. An item's ECCN 0Y521 classification may be extended for two one-year periods to provide time for the U.S. Government and multilateral regime(s) to reach agreement on controls for the item, and provided that the U.S. Government has submitted a proposal to obtain multilateral controls over the item. Further extension beyond three years may occur only if the Under Secretary for Industry and Security makes a determination that such extension is in the national security or foreign policy interests of the United States. An extension or re-extension, including a determination by the Under Secretary for Industry and Security, will be published in the Federal Register.

The license requirements and policies for the ECCN 0Y521 series appear in § 742.6(a)(7) of the EAR. ECCN 0Y521 items are subject to a nearly worldwide license requirement (i.e., for every country except Canada) with a case-by-case license review policy, through regional stability (RS Column 1) controls. The description and status of ECCN 0Y521 items appear in Supplement No. 5 to part 774 of the EAR, along with any item-specific license exceptions, where applicable. Unless otherwise indicated, License Exception GOV is the only license exception available and is applicable to all ECCN 0Y521 series items, including those items identified in this notice, if the item is within the scope of § 740.11(b)(2)(ii) (Exports, reexports, and transfers (in-country) made by or consigned to a department or agency of the U.S. Government), as provided in § 740.2(a)(14).

In this rule, BIS amends the EAR to make targets made of or containing lithium “specially designed” for the production of tritium by insertion in the core of a nuclear reactor and related “development” and “production” technology subject to the EAR and imposes a license requirement on the items. These items are being added to the 0Y521 series pursuant to a determination by the Department of Commerce, with the concurrence of the Departments of Defense, State and Energy, that the items should be controlled because they provide a significant military or intelligence advantage to the United States or because foreign policy reasons justify such controls.

ECCN 0A521 No. 1, which appears in the table found in Supplement No. 5 to part 774 of the EAR, covers targets made of or containing lithium “specially designed” for the production of tritium by insertion in the core of a nuclear reactor.

ECCN 0E521 No. 1 covers technology required for the “development” or “production” of items classified under ECCN 0A521 No. 1.

License applications for these items may be submitted through SNAP-R in accordance with § 748.6 of the EAR. Exporters are directed to include detailed descriptions and technical specifications with the license application, and identify the item's ECCN.

The rule is being issued in interim final form because while the government believes that it is in the national security interests of the United States to immediately implement these controls, it also wants to provide the interested public with an opportunity to comment on the new controls of the items. Comments may be submitted in accordance with the DATES and ADDRESSES sections of this rule. BIS will review and, if appropriate, address such comments through rulemaking consistent with the process described in the April 13, 2012 final rule creating the ECCN 0Y521 series (77 FR 22191).

Although the Export Administration Act expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013) and as extended by the Notice of August 7, 2015, 80 FR 48233 (August 11, 2015), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222 as amended by Executive Order 13637.

1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to, nor is subject to a penalty for failure to comply with, a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless that collection of information displays a currently valid OMB control number. This rule affects two approved collections: (1) The Simplified Network Application Processing + System (control number 0694-0088), which carries a burden hour estimate of 43.8 minutes, including the time necessary to submit license applications, among other things, as well as miscellaneous and other recordkeeping activities that account for 12 minutes per submission; and (2) License Exceptions and Exclusions (0694-0137). BIS does not believe that this rule will materially increase the number of submissions under these collections.

3. This rule does not contain policies with Federalism implications as that term is defined under E.O. 13132.

4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring prior notice, the opportunity for public comment and a delay in effective date are inapplicable because this regulation involves a military or foreign affairs function of the United States (See 5 U.S.C. 553(a)(1)). BIS, with the concurrence of the U.S. Departments of Defense and State, is implementing this rule because the items identified for the ECCN 0Y521 series in this rule provide a significant military or intelligence advantage to the United States. Immediate imposition of a license requirement is necessary to effect the national security and foreign policy goals of this rule. Immediate implementation will allow BIS to prevent exports of these items to users and for uses that pose a national security threat to the United States or its allies. If BIS delayed this rule to allow for prior notice and opportunity for public comment, the resulting delay in implementation would afford an opportunity for the export of these items to users and uses that pose such a national security threat, thereby undermining the purpose of the rule. In addition, if parties receive notice of the U.S. Government's intention to control these items under 0Y521 once a final rule was published, they might have an incentive to either accelerate orders of these items or attempt to have the items exported prior to the imposition of the control.

Further, BIS finds good cause to waive the 30-day delay in effectiveness under 5 U.S.C. 553(d)(3). Immediate implementation of these changes will allow BIS to prevent exports of these items to users and for uses that pose a national security threat to the United States or its allies. If BIS delayed this rule to allow for a 30-day delay in effectiveness, the resulting delay in implementation would afford an opportunity for the export of these items to users and uses that pose such a national security threat, thereby undermining the purpose of the rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are not applicable. Accordingly, no regulatory flexibility analysis is required and none has been prepared. Although notice and opportunity for comment are not required, BIS is issuing this rule as an interim final rule with a request for comments. All comments must be in writing and submitted via one or more of the methods listed under the ADDRESSES caption to this notice. All comments (including any personal identifiable information) will be available for public inspection and copying. Those wishing to comment anonymously may do so by submitting their comment via regulations.gov and leaving the fields for identifying information blank.

Accordingly, part 774 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows:

In the Federal Register of May 4, 2016 (81 FR 26687), FDA solicited comments concerning the direct final rule for a 75-day period ending July 18, 2016. FDA stated that the effective date of the direct final rule would be on September 16, 2016, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comments.

FDA is issuing this refuse to accept rule under direct final rule procedures. The rule identifies deficiencies that will result in FDA's refusal to accept certain tobacco product submissions under sections 905, 910, and 911 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (21 U.S.C. 387e, 387j, and 387k).1 Because these submissions will be refused before they enter FDA's review queue, more resources will be available for submissions that are ready for further review. This rule establishes a refuse to accept process for premarket tobacco product submissions, including premarket tobacco product applications (PMTAs), modified risk tobacco product applications (MRTPAs), substantial equivalence (SE) applications (also called SE reports), and exemption requests (including subsequent abbreviated reports).

The rule explains when FDA will refuse to accept a premarket submission, including PMTAs, MRTPAs, SE applications, and exemption requests (including subsequent abbreviated reports). The rule is based on FDA's experience in reviewing these submissions. Under the rule, FDA will refuse to accept a premarket submission that: (1) Does not pertain to a tobacco product; (2) is not in English (or does not include a complete translation); (3) is submitted in an electronic format that FDA cannot process, read, review, or archive; (4) does not include the applicant's contact information; (5) is from a foreign applicant and does not include the name and contact information of an authorized U.S. agent (authorized to act on behalf of the applicant for the submission); (6) does not include a required form(s); (7) does not identify the tobacco product; (8) does not identify the type of submission; (9) does not include the signature of a responsible official authorized to represent the applicant; or (10) does not include an environmental assessment or claim of a categorical exclusion, if applicable. If FDA refuses to accept the submission, FDA will send the contact (if available) a notification. If the submission is accepted for further review, FDA will send an acknowledgement letter.

In the Federal Register of November 21, 1997 (62 FR 62466), FDA described the procedures on when and how the Agency will employ direct final rulemaking (this guidance document may be accessed at http://www.fda.gov/regulatoryinformation/guidances/ucm125166.htm). We have determined that this rule is appropriate for direct final rulemaking because we believe it is noncontroversial and we anticipate no significant adverse comments. Consistent with our procedures on direct final rulemaking, FDA is publishing elsewhere in this issue of the Federal Register a companion proposed rule with the same codified language as this direct final rule to add a rule describing when FDA would refuse to accept submissions due to deficiencies. The companion proposed rule provides a procedural framework within which the rule may be finalized in the event that the direct final rule is withdrawn because of any significant adverse comments. The comment period for the direct final rule runs concurrently with the companion proposed rule.

We are providing a comment period on the direct final rule of 75 days after the date of publication in the Federal Register. If we receive any significant adverse comments, we intend to withdraw this direct final rule action before its effective date by publication of a notification in the Federal Register. A significant adverse comment is defined as a comment that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants terminating a direct final rulemaking, we will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice and comment process in accordance with section 553 of the Administrative Procedure Act (5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside the scope of the rule will not be considered significant or adverse under this procedure. A comment recommending a regulation change in addition to those in the rule would not be considered a significant adverse comment unless the comment provides a reasonable explanation for why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to an amendment, paragraph, or section of this rule and that provision can be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not subject of a significant adverse comment.

If any significant adverse comments are received during the comment period, FDA will publish, before the effective date of this direct final rule, a document withdrawing the direct final rule. If we withdraw the direct final rule, any comments received will be applied to the proposed rule and will be considered in developing a final rule using the usual notice and comment procedures. If FDA receives no significant adverse comments during the specified comment period, FDA intends to publish a confirmation document, before the effective date of the direct final rule, confirming the effective date.

FDA is issuing this refuse to accept rule as a means of efficiently handling submissions that do not meet a threshold of acceptability for FDA review, e.g., the submission lacks certain information FDA needs for substantive review of the submission. Currently, FDA often expends extensive time and resources in attempts to obtain information and resolve the deficiencies identified in the rule simply to begin substantively processing the submission. FDA expects that the rule will enhance the quality of the submissions and that submissions will move expeditiously through the review process. In addition, this rule will help submitters better understand the common hurdles FDA encounters in conducting a substantive review of submissions.

The rule identifies deficiencies that FDA has seen across types of premarket submissions and will result in FDA refusing to accept the submission. This rule applies to all tobacco product applications; we note that there are additional deficiencies that are not covered in this rule that may arise for specific types of premarket submissions that will also result in FDA's refusal to accept that specific type of premarket submission (e.g., a PMTA fails to contain specimens of the labeling proposed to be used for such tobacco product under section 910(b)(1)(F) of the FD&C Act).

FDA's refusal to accept a tobacco product submission will not preclude an applicant from resubmitting a new submission that addresses the deficiencies. In addition, acceptance of a submission will not mean that FDA has determined that the submission is complete, but rather only that the submission has met the basic, minimum threshold for acceptance. Substantive review of the submission will begin once FDA accepts the submission, and for submissions with filing requirements (i.e., PMTAs and MRTPAs), once filed. The rule establishes a general process for refusing to accept submissions for premarket tobacco product review, including PMTAs, MRTPAs, SE applications, and exemption requests (including subsequent abbreviated reports). Because administratively incomplete submissions will be refused before FDA begins substantive review, we will be able to use our resources on submissions that are more complete and better prepared for further review. In addition, FDA intends to determine, as soon as practicable, whether the submission will be accepted. We expect the amount of time it takes FDA to make this determination to be relatively quick, however, it may vary depending on the volume of submissions received at any one time. FDA remains committed to an efficient product review process and intends to establish and implement performance goals for this action once it has experience with the volume of submissions it will receive after the deeming rule becomes effective. FDA expects the performance goals to be generally similar to other Agency performance goals, i.e. a certain percentage of RTA determinations made within a defined period of time, and with the percentage rising over time.

Section 701(a) of the FD&C Act (21 U.S.C. 371(a)) provides FDA with authority to issue regulations for the efficient enforcement of the FD&C Act. This rule allows FDA to more efficiently use our resources to review premarket submissions under sections 905, 910, and 911 of the FD&C Act. FDA has processed and reviewed many submissions since the enactment of the Tobacco Control Act, and submissions with the deficiencies identified in the rule have been repeatedly identified by FDA as reflecting submissions that are incomplete and not prepared for further review.

We are adding part 1105 (21 CFR part 1105) to title 21, specifically § 1105.10. Section 1105.10(a) provides that FDA will refuse to accept, as soon as practicable, PMTAs, MRTPAs, SE applications, and exemption requests (including subsequent abbreviated reports), for the reasons listed in paragraphs (a)(1) through (10), if applicable:

• Section 1105.10(a)(1) states that FDA will refuse to accept a tobacco product submission that does not pertain to a tobacco product. This provision addresses a submission that refers to a product that does not meet the definition of a “tobacco product” under section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)) and, therefore, is not subject to FDA's tobacco product authorities.

• Section 1105.10(a)(2) states that FDA will refuse to accept a submission that is not in the English language or does not contain complete English translations of any information included with the submission. FDA is unable to read and process such submissions.

• Section 1105.10(a)(3) provides that FDA will refuse to accept a submission if it is provided in an electronic format that FDA cannot process, read, review, and archive. As with submissions that are not in English (or fail to include an English translation), FDA is unable to read and process such submissions. FDA provides information on the electronic formats that it can read, process, review, and archive at http://www.fda.gov/tobaccoproducts/guidancecomplianceregulatoryinformation/manufacturing/default.htm.

• Section 1105.10(a)(4) provides that FDA will refuse to accept any submission that does not contain contact information, including the applicant's name and address. If a submission omits the contact information, FDA will not be able to contact the applicant regarding the submission, e.g., with questions or followup related to the submission. In this instance, FDA also will likely be unable to provide notice of the Agency's refusal to accept the submission under § 1105.10(c).

• Section 1105.10(a)(5) provides that FDA will refuse to accept a submission from a foreign applicant if the submission does not list an authorized U.S. agent, including the agent's U.S. address. FDA is requiring identification of a U.S. agent for two reasons. First, a U.S. agent is important to help CTP ensure adequate notice is provided to applicants for official Agency communications. FDA may be unable to confirm that adequate notice of Agency action or correspondence concerning premarket submissions is provided to foreign applicants as FDA cannot necessarily confirm receipt of correspondence sent internationally. Accordingly, the designation of a U.S. agent provides an official contact to the Agency who can receive the information or documentation on behalf of the applicant. Providing notice regarding that application to the U.S. agent will constitute notice to the foreign applicant. Second, FDA requires identification of a U.S. agent to assist FDA in communication with the foreign applicant and help the Agency to efficiently process applications and avoid delays. In many instances during the application review process, FDA has reached out numerous times to foreign applicants and has either been unable to speak with the applicant or unable to directly communicate questions and/or concerns. This impediment, which occurs more for foreign applicants than domestic applicants, has resulted in delays or terminations in the review of specific applications and a slowdown of the premarket application process as a whole. A U.S. agent will act as a communications link between FDA and the applicant and will facilitate timely correspondence between FDA and foreign applicants, including responding to questions concerning pending applications and, if needed, assisting FDA in scheduling meetings with the foreign applicants to resolve outstanding issues before Agency action is taken. Additionally, the identified U.S. agent will be authorized to act on behalf of the foreign applicant for that specific application.

• Section 1105.10(a)(6) provides that FDA will refuse to accept the submission if it does not include any required FDA form(s). At the time of this direct final rule, FDA has not yet issued any forms to accompany premarket submissions. In the event that FDA does issue such a form(s), the Agency will give interested parties notice and opportunity to comment on such forms in accordance with rulemaking procedures and the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

• Section 1105.10(a)(7) provides that FDA will refuse to accept a submission that does not contain the following product-identifying information (for the product that is the subject of the submission and, if applicable, for the predicate): The manufacturer of the tobacco product; the product name, including brand and subbrand; product category (e.g., cigarette) and subcategory (e.g., combusted, filtered); package type (e.g., box) and package quantity (e.g., 20 per box); and characterizing flavor (i.e., applicants must state the characterizing flavor, such as menthol, or state that there is no characterizing flavor present in the tobacco product). For example, in table 1, FDA has supplied a list of recommended categories and subcategories of some tobacco products to assist applicants in providing product-identifying information in their submissions. Note that there may be other information FDA needs to identify a particular product, e.g., descriptors (such as “premium”) that are separate from the product name. If this is the case, such information should be provided by the applicant in the initial submission to facilitate FDA's efficient review.

This product-specific information helps ensure that the product is within CTP's purview and enables FDA to appropriately identify the specific product that is the subject of the submission. Specifically, this information is necessary to both review the submission itself and to issue an order that appropriately identifies the tobacco product that is subject to the order. For example, an SE submission contains a comparison between the predicate and new products. If FDA does not know the exact products that are being compared, FDA will be unable to sufficiently understand and evaluate the comparison to determine whether the products are substantially equivalent. As another example, if an applicant does not specify whether its proposed new product contains a characterizing flavor, FDA will not be able to issue an order as it will not know the specific product for which the applicant is seeking an order (e.g., product X menthol or product X cinnamon.)

• Section 1105.10(a)(8) provides that FDA will refuse to accept a submission if the applicant fails to indicate the type of submission (i.e., PMTA, MRTPA, SE application, or exemption request or subsequent abbreviated report), because that information is necessary to enable FDA to begin an appropriate review of the submission.

• Section 1105.10(a)(9) provides that FDA will refuse to accept a submission if it does not contain a signature of a responsible official, authorized to represent the applicant who either resides in or has a place of business in the United States. A signature provides assurance to FDA that the submission is both intended by the applicant and ready for review. Responsible officials also should be aware that under 18 U.S.C. 1001, it is illegal to knowingly and willingly submit false information to the U.S. Government.

• Section 1105.10(a)(10) applies only to PMTAs, MRTPAs, SE applications, and exemption requests (this subsection does not apply to the subsequent abbreviated report). For these submissions, this paragraph provides that FDA will refuse to accept the submission if it does not include an environmental assessment (EA) or a valid claim of categorical exclusion. Under § 25.15(a) (21 CFR 25.15(a)), all submissions requesting FDA action require the submission of either a claim of categorical exclusion or an EA. Because an EA is required for an initial exemption request, it is not also required for an abbreviated report, and thus is not a basis for FDA to refuse to accept an abbreviated report. In addition, § 25.15(a) provides that FDA may refuse to file a submission if the included EA fails to address “the relevant environmental issues.” Because the SE and SE Exemption pathways do not include a filing stage, FDA intends to determine such adequacy at the acceptance stage for those pathways.2 The EA or claim of categorical exclusion must be made for the Agency action being proposed (e.g., issuance of an SE order for introduction of such new tobacco product into interstate commerce for commercial distribution in the United States.). For information on preparing an EA, refer to § 25.40.

Section 1105.10(b) provides that if FDA does not identify a reason under paragraph (a) for refusing to accept a submission, then the Agency may accept it for processing and further review. If FDA does accept the submission, the Agency intends to send the submitter an acknowledgement letter stating that FDA has accepted the submission for processing and further review. This letter will also include a premarket submission tracking number.

Section 1105.10(c) provides that if FDA identifies a reason under paragraph (a) for refusing to accept a premarket review submission, we will notify the applicant in writing of the reason(s) and that FDA has not accepted the submission for processing and further review. However, FDA will be unable to provide this notification when the contact information is insufficient, for example, has not been provided or is not legible. If FDA refuses to accept the submission for one or more of the reasons stated in § 1105.10, the submitter may revise the submission to correct the deficiencies and resubmit it to FDA as a new submission.

This direct final rule will be effective 60 days after the comment period ends.

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

We have analyzed this direct final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.

We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that would have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive Order; consequently, a tribal summary impact statement is not required.

We have determined under 21 CFR 25.30(h) that this 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.

We have examined the impacts of the direct 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 us 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). We believe that this direct final rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this final rule establishes a procedure that FDA is responsible for implementing and has the effect of providing entities with useful feedback on the readiness of a submission, we certify that the direct final rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to 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 $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This direct final rule would not result in expenditure in any year that meets or exceeds this amount.

This rule identifies 10 significant and common deficiencies in premarket tobacco submissions that will cause FDA to refuse to accept them. Encouraging submissions that are free of the deficiencies listed in this rule does not represent a change in Agency expectations. One of the 10 deficiencies is required by statute (i.e., must be a tobacco product). One of the deficiencies is required by another regulation (i.e., must comply with environmental considerations). The remaining eight deficiencies are basic expectations for an application to enter the review process. Therefore, this rule clarifies these expectations. This clarification will result in cost savings for both the applicant and FDA as less time is spent by FDA working with applicants to address these significant deficiencies. Applicants will have clarity about basic expectations of the requirements needed for acceptance of premarket applications. In addition, refusing to accept submissions with these deficiencies allows Agency staff to more efficiently process submissions and quickly move those submissions without these deficiencies into review of substantial scientific issues.

Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR chapter I is amended by adding part 1105 to subchapter K to read as follows:

The Oregon Department of Transportation requested that the US 101 Bridge, near Reedsport, Oregon, remain in the closed-to-navigation position to update the electric control panels. The US 101 Bridge crosses the Umpqua River at mile 11.1 and provides 36 feet of vertical clearance above mean high water when in the closed-to-navigation position. This deviation allows the US 101 Bridge to remain in the closed-to-navigation position and need not open for maritime traffic from 7 a.m. on August 16, 2016 until 5 p.m. August 18, 2016. The normal operating schedule of this bridge is detailed at 33 CFR 117.893(a).

Waterway usage on this part of the Umpqua River includes vessels ranging from occasional commercial tug and barge to small pleasure craft. ODOT has coordinated with local mariners in this regard, and no objections have been received. No immediate alternate route is available for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation. Vessels which do not require an opening of the bridge may continue to transit beneath the bridge during this repair period.

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

I. Table of Abbreviations COTP Captain of the Port DHS Department of Homeland Security FR Federal Register LIS Long Island Sound NPRM Notice of Proposed Rulemaking NAD 83 North American Datum 1983 II. Background Information and Regulatory History

This rulemaking establishes 9 safety zones for fireworks displays. Each event and its corresponding regulatory history are discussed below.

The Hoffman Wedding Fireworks Display is a first time marine event with no regulatory history.

The Pyro Engineering Inc. Fireworks Display is a first time marine event with no regulatory history.

The Sag Harbor Fire Department Fireworks Display is a recurring marine event with regulatory history. A safety zone was established for this event in 2015 via a temporary final rule entitled, “Safety Zones; Marine Events held in the Sector Long Island Sound Captain of the Port Zone.” This rulemaking was published on Friday, August 14, 2015 in the Federal Register (80 FR 48692).

The Montalbano Wedding Fireworks Display is a first time marine event with no regulatory history.

The Village of Saltaire Fireworks Display is a recurring marine event with regulatory history. A safety zone was established for this event in 2015 via a temporary final rule entitled, “Special Local Regulations and Safety Zones; Marine Events held in the Sector Long Island Sound Captain of the Port Zone.” This rulemaking was published on Monday, May 18, 2015 in the Federal Register (80 FR 28176).

The Baker Annual Summer Celebration is a first time marine event with no regulatory history.

The Gestal Wedding Fireworks Display is a first time marine event with no regulatory history.

The Clinton Chamber of Commerce Fireworks Display is a recurring marine event with regulatory history. A safety zone was established for this event in 2015 via a temporary final rule entitled, “Safety Zones; Marine Events held in the Sector Long Island Sound Captain of the Port Zone.” This rulemaking was published on Friday, August 14, 2015 in the Federal Register (80 FR 48692).

The East Hampton Fire Department Fireworks Display is a recurring marine event with regulatory history and is cited in 33 CFR 165.151(9.1). This event has been included in this rule due to deviation from the cite date.

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM with respect to this rule because doing so would be impracticable. The event sponsors were late in submitting the marine event applications. These late submissions did not give the Coast Guard enough time to publish a NPRM, take public comments, and issue a final rule before these events take place. Thus, waiting for a comment period to run would inhibit the Coast Guard's mission to keep the ports and waterways safe.

Under 5 U.S.C. 553(d)(3), and for the same reasons stated in the preceding paragraph, the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register.

The Coast Guard is issuing this temporary rule under authority in 33 U.S.C. 1231. The Captain of the Port (COTP) Long Island Sound has determined that the safety zones established by this temporary final rule are necessary to provide for the safety of life on navigable waterways before, during, and after these scheduled events.

This rule establishes 9 safety zones for ten fireworks displays. The location of these safety zones are as follows:

This rule prevents vessels from entering, transiting, mooring, or anchoring within the areas specifically designated as a safety zone and restricts vessel movement around the locations of the marine events to reduce the safety risks associated with it during the period of enforcement unless authorized by the COTP or designated representative.

The Coast Guard will notify the public and local mariners of these safety zones through appropriate means, which may include, but are not limited to, publication in the Federal Register, the Local Notice to Mariners, and Broadcast Notice to Mariners.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

The Coast Guard determined that this rulemaking is not a significant regulatory action for the following reasons: (1) The enforcement of these safety zones will be relatively short in duration; (2) persons or vessels desiring to enter these safety zones may do so with permission from the COTP LIS or a designated representative; (3) these safety zones are designed in a way to limit impacts on vessel traffic, permitting vessels to navigate in other portions of the waterway not designated as a safety zone; and (4) the Coast Guard will notify the public of the enforcement of this rule via appropriate means, such as via Local Notice to Mariners and Broadcast Notice to Mariners to increase public awareness of this safety zone.

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

While some owners or operators of vessels intending to transit these regulated areas may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator. Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT.

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

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This temporary rule involves the establishment of ten temporary safety zones. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination will be available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

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

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

The Coast Guard will enforce a safety zone for the annual Point to LaPointe Swim in 33 CFR 165.943(a)(7) from 7:15 a.m. until 10:15 p.m. August 6, 2016. This safety zone will include all waters between Bayfield, WI and Madeline Island, WI within an imaginary line created by the following coordinates: 46°48′50.97″ N., 090°48′44.28″ W., moving southeast to 46°46′44.90″ N., 090°47′33.21″ W., then moving northeast to 46°46′52.51″ N., 090°47′17.14″ W., then moving northwest to 46°49′03.23″ N., 090°48′25.12″ W. and finally running back to the starting point.

Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Duluth or his designated on-scene representative. The Captain of the Port's designated on-scene representative may be contacted via VHF Channel 16.

This notice is issued under authority of 33 CFR 165.943 and 5 U.S.C. 552(a). In addition to this notice in the Federal Register, the Coast Guard will provide the maritime community with advance notification of the enforcement of this safety zone via Broadcast Notice to Mariners.

On April 19, 2016, the Coast Guard published an NPRM in the Federal Register titled 2016 Wings over Vermont Air Show (81 FR 22944). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action. No public comments or request for a public meeting were received during the NPRM process.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP is establishing a safety zone for the Wings over Vermont Air Show from 9 a.m. to 6 p.m. on August 12-14, 2016 on Lake Champlain, along the shoreline of Burlington, VT. The safety zone will cover all navigable waters, extending to and including the breakwater bounded by the following coordinates: 44°29′24″ N./073°14′44″ W.; 44°29′24″ N./073°14′03″ W.; 44°28′56″ N./073°14′03″ W.; 44°28′50″ N./073°13′48″ W.; 44°28′12″ N./073°13′33″ W.; 44°27′47″ N./073°14′03″ W.; 44°27′25″ N./073°14′03″ W.; 44°27′25″ N./073°14′44″ W. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 10 a.m. to 5 p.m. aerobatic displays. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. The regulatory text appears at the end of this document.

The purpose of this rulemaking is to ensure the safety of spectator vessels and other traffic using the navigable waters near or around the designated aeronautical box.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget.

The Coast Guard has determined that this rule is not a significant regulatory action for the following reasons: The safety zone will be of limited duration and will only be in effect during a portion of three days, it will allow vessels to transit in waters directly adjacent to the safety zone, and coordinated efforts have been made to direct ferry traffic around the safety zone so not to disrupt regularly scheduled ferry service on Lake Champlain. Additionally, maritime advisories will be posted in the Local Notice to Mariners and the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine Channel 16 prior to and during the entire duration of the enforcement period.

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

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section IV.A this rule will not have a significant economic impact on any vessel owner or operator.

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

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

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under the Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting a portion of three days and will prohibit entry into without permission from the COTP. Normally such actions are categorically excluded from further review under paragraph 34 of figure 2-1 of Commandant Instruction M16475.1D. A preliminary environmental analysis checklist supporting this is available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

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

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

Purpose of Program: The purpose of the EAG program is to enhance the quality of assessment instruments and assessment systems used by States for measuring the academic achievement of elementary and secondary school students.

Program Authority: Section 6112 of the Elementary and Secondary Education Act of 1965 (ESEA), as amended by the No Child Left Behind Act of 2001 (NCLB), and section 1203(b)(1) of the ESEA, as amended by the Every Student Succeeds Act (Pub. L. 114-95) (ESSA).

We published a notice of proposed priorities for this program in the Federal Register on April 18, 2016 (81 FR 22550) (NPP). That notice contained background information and our reasons for proposing the particular priorities.

Except for minor revisions, there are no differences between the proposed priorities and these final priorities.

These priorities are for use in addition to those published in the 2011 notice of final priorities, requirements, definitions, and selection criteria (76 FR 21985) (2011 NFP) and the 2013 notice of final priorities, requirement, definitions, and selection criteria for this program (78 FR 31343) (2013 NFP).

Public Comment: In response to our invitation in the NPP, eight parties submitted comments on the proposed priorities.

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 of any changes in the priorities since publication of the NPP follows.

Comment: Five commenters expressed support for the proposed priorities and noted the potential for grants awarded under the EAG program to improve State assessment systems. Three commenters expressed views on how the Department should distribute awards across priorities under the EAG program. One commenter strongly recommended that Priority 2 be designated as an absolute priority in the EAG competition.

Discussion: We appreciate the support for these priorities and agree that projects funded under them will support States in continuously improving their assessment systems to measure college- and career-readiness. This notice establishes priorities that can be used in any future competition, but does not establish how those priorities are designated in any particular competition. For the competition funded with FY 2016 funds, as announced in the notice inviting applications published elsewhere in this issue of the Federal Register, Priorities 1, 2, and 3 will be competitive preference priorities. The grant application and competition process will determine the number and types of projects funded under each priority.

Changes: None.

Comment: One commenter encouraged the Department to consider requiring content developed under proposed projects to be made freely available to others. This commenter noted that, even if content is made publicly available, it is not always accessible due to the use of proprietary software or applications.

Discussion: We recognize the benefit of sharing work developed under the EAG program to serve as models and resources for other States, which is why Priorities 1 and 2 require an applicant responding to them to provide a dissemination plan. Sharing resources and lessons learned from grantees is a key goal of the grant program.

Additionally, the notice of final priorities, requirements, definitions, and selection criteria for this program published in the Federal Register on April 19, 2011 (76 FR 21985) (2011 NFP) includes a requirement that, unless otherwise protected by law or agreement as proprietary information, an eligible applicant awarded a grant under this program must make any assessment content (i.e., assessments and assessment items) and other assessment-related instruments developed with funds from this competition freely available to States, technology platform providers, and others that request it for the purposes of administering assessments, provided that those parties receiving assessment content comply with consortium or State requirements for test or test item security.

Further, as with any grant, and consistent with 2 CFR 200.315, the Department reserves a royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use, and to authorize others to use, for Federal government purposes, the copyright in any work developed under a grant (or contract under a grant) in this program, and any rights of copyright to which a grantee or contractor purchases ownership with grant support.

As the Department has these tools available to require grantees to make publicly available work developed under the EAG program, we do not believe any related change to the priorities is necessary.

Changes: None.

Comment: One commenter encouraged the Department to explicitly advocate for innovative, efficient, accessible, and fair testing for English learners in each priority, including by: Including English language proficiency assessments in Priority 1; requiring grantees implementing projects under Priority 1 to include English learners and their families as a representative sample in any research and development activities and gather evidence that innovative item types are accessible to English learners; requiring projects under Priority 2 to include representation from English learners, parents of English learners, and teachers of English learners. The commenter expressed support for the requirement in Priority 3 that SEAs ensure tests are fair for all students and particularly commended the reference to English learners. The commenter also recommended requiring States proposing projects under Priority 3 to ensure that tests are fully transparent to English learners and their parents and to solicit feedback on the usefulness of assessments from English learners and their parents.

Discussion: The Department recognizes the unique needs of English learners and the importance of ensuring that they are included in State assessment systems and assessed fairly. Having an assessment system that validly, reliably, and fairly measures the academic achievement of all elementary and secondary school students is vital to providing necessary information to inform instructional decisions and program evaluation, and to improve outcomes for all students. These priorities are intended to benefit all students, including English learners and students with disabilities, by enhancing the quality of assessment instruments and systems used by States for measuring the academic achievement of all elementary and secondary school students.

For example, paragraph (a)(2) of Priority 1 requires applicants to ensure the validity, reliability, and fairness of the assessments and the comparability of student data; to meet this requirement, applicants will need to address how they will evaluate the fairness of their innovative item types for all students, including English learners. The Department believes that strong assessment audits, as required under Priority 3, will ensure that tests are fully transparent to all students and their parents and will include mechanisms for soliciting feedback from all students and their parents, including English learners.

Additionally, in the past, the Department has funded several projects that targeted improving the assessment of English language proficiency (see www2.ed.gov/programs/eag/awards.html for a complete listing of past awards made under this authority). Given that these grants are still active and the first English language proficiency assessments developed under these grants were administered for the first time in the 2015-2016 school year, the Department does not think it necessary to include a specific reference to English language proficiency assessments. Items for summative assessments in reading/language arts, mathematics, and science are the focus of this competition.

However, there is nothing that would preclude the submission of a proposal under these priorities that specifically addresses the assessment of English learners.

Changes: None.

Comment: None.

Discussion: The Department recognizes the benefit of sharing work developed under the EAG program with other States, which is why Priorities 1 and 2 require an applicant responding to them to provide a dissemination plan. However, the NPP did not include information regarding the content of such a dissemination plan. The Department believes that it is important to clarify for applicants the expectations of such a dissemination plan.

Changes: The Department added language to Priorities 1 and 2 to specify that applicants must propose dissemination plans to share lessons learned and best practices.

Comment: Two commenters proposed including additional innovative assessment item types in this priority. One commenter suggested that obtaining information on students' English language proficiency through a content assessment could be listed as an example of an innovation. Another commenter recommended that the Department include assessments that measure student behaviors and goals (e.g., persistence or dependability) in this priority, in addition to mastery of academic content.

Discussion: While the Department included examples of new innovative item types, such as performance tasks, simulations, and interactive, multi-step, technology-rich items, applicants may propose projects to develop other kinds of innovative item types as long as they meet the requirements of the priority. As such, we do not include a comprehensive list of innovative item types or design approaches a State could choose to develop. The statutory authority for this program specifically references the assessment of academic achievement, and the assessment systems developed by States to meet the requirements under title I, part A of the ESEA must measure the academic achievement of students in, at a minimum, reading/language arts, mathematics, and science. As a result, the Department believes it would not be appropriate to exclusively focus on innovative assessments that focused on non-academic skills.

Changes: None.

Comment: One commenter suggested adding a requirement to this priority that applicants articulate a theory of action for how innovative assessment systems and design approaches will support deeper student learning.

Discussion: The Department believes that innovative item types and modular assessment approaches allow students to gain valuable experience by demonstrating complex work and critical thinking skills. Assessments can improve student learning by providing data that can support and inform instruction, particularly if the data are timely and targeted. However, the primary focus of the priority is developing new methods for measuring student knowledge and skills to determine college- and career-readiness. As such, the Department believes it is important for applicants to focus their proposals on the complex tasks of developing, evaluating, and implementing new, innovative item types or developing approaches to transforming traditional summative assessment forms into a series of modular assessment forms. The Department agrees with the commenter that developing a sound theory of action for any large research and development proposal in educational assessment is a good project planning tool, but does not believe it is necessary to explicitly make this a priority or requirement.

Changes: None.

Comment: One commenter recommended that the Department clarify the meaning of the term “competency-based assessment” to communicate that such an assessment supports competency-based determinations and is not a type of assessment.

Discussion: The Department appreciates this recommendation, but believes that clarification of the term “competency-based assessment” is not needed in the priority itself. The priority indicates that innovative item types may include those item types that can support competency-based assessments. This term, also used in the President's Testing Action Plan (see www.ed.gov/news/press-releases/fact-sheet-testing-action-plan), is used to describe a system of assessments that allows students to demonstrate their learning throughout the school year and focuses on the application of skills and knowledge. The Department believes that innovative item types, including performance tasks, can be useful as part of a competency-based assessment. In addition, the Department believes that the term is recognized by experts in the field but that there may be variations in how it is applied and that proposals should define this type of assessment in the context of the proposed design and plan of work.

Change: None.

Comment: One commenter suggested that the design of technology-based items, interactive tools, and user interfaces proposed in projects under this priority be based on a Principled Assessment Design framework that takes into account principles of universal design for learning.

Discussion: The priority requires applicants to ensure the quality, validity, reliability, and fairness of the assessment or assessment items and comparability of student data. The Department acknowledges that universal design for learning is a nationally recognized method for taking into account the needs of all students when designing an assessment item, test, or system and that this method can help to promote fairness in assessment, and also notes that assessments administered to fulfill the requirements of title I, part A of the ESEA, recently reauthorized by the ESSA, must address universal design for learning.

Changes: We revised this priority to include a reference to universal design for learning.

Comment: One commenter suggested that we require applicants to present a high-quality plan for leveraging other Federal funds to improve educators' assessment literacy and support parental engagement.

Discussion: The Department agrees that assessment literacy and parent engagement in assessment systems are important goals. We also support States' efforts to carefully examine how Federal and other funding sources can best be leveraged to support their goals and to sustain work supported by time-limited grant funding. As part of the President's Testing Action Plan, the Department released a Dear Colleague Letter in February 2016 (see www2.ed.gov/admins/lead/account/saa/16-0002signedcsso222016ltr.pdf) that provides examples of how funds under titles I, II, III, and VI of the ESEA can be used to increase assessment literacy and parent engagement. However, in order to allow applicants flexibility to use appropriate funds to best meet their needs, we decline to prescribe that States use other Federal funding, in addition to any EAG funding awarded, for these purposes.

Changes: None.

Comment: One commenter recommended that assessment reporting be focused on “stakeholders closest to students” who can use the data to improve student learning.

Discussion: The Department agrees that it is important for information on student performance to be made available to stakeholders close to students, such as educators and parents, in a timely fashion and in a format that provides actionable information to guide instruction and supports for students. In paragraph (b) of Priority 2, the Department requires that States include educators and parents in the development of score reports and paragraph (b)(1)(ii) focuses on educators' and parents' assessment literacy.

Changes: None.

Comment: Two commenters recommended that the Department require States to develop both enhanced score reporting templates and digital mechanisms for communicating assessment results.

Discussion: The Department appreciates the support for this priority and agrees that it is important to improve the utility of information about student performance included in reports of assessment results. However, because we recognize that States have different goals and may already have initiatives underway to develop score reporting templates or digital mechanisms to communicate assessment results, we do not think it is appropriate to make both activities required under Priority 2.

Changes: None.

Comment: Two commenters provided several recommendations for how States could improve score reporting, particularly to meet parents' needs. For example, both commenters recommended that States share contextual information with parents through a cover letter accompanying the score report. One commenter also suggested that States: Include clear, actionable next steps for parents; ensure that information is communicated in parent-friendly language; prioritize the content of the score report to avoid overwhelming parents; seek parent feedback on score reporting materials; and ensure that reports are personalized and culturally sensitive.

Discussion: The Department believes that these comments provide helpful examples of how an applicant might address needs related to score reporting and improve the utility of information about student performance included in score reports.

Changes: We have revised this priority to include the commenters' suggestions regarding clear and actionable next steps for parents as an example.

Comment: One commenter suggested that the Department require or strongly incentivize States to provide training for educators on data and using data to inform instruction.

Discussion: The Department agrees that ensuring educators understand assessment data and can use that information to guide instruction and supports for students is an important part of making assessments worth taking. The President's Testing Action Plan also highlights this as a key area of focus for States and districts. For this reason, we have included improving assessment literacy of educators and parents as one of the activities applicants could choose to include in projects proposed under this priority. However, because we recognize that States have different goals and may already have initiatives underway to support assessment literacy, we do not think it is appropriate to make this a required component of projects proposed under Priority 2.

Changes: We have included in Priority 2 examples of how applicants might improve assessment literacy by providing training on test development and interpretation of test scores.

Comment: One commenter recommended that the Department remove Proposed Priority 3, given that States may use other Federal funds to conduct assessment audit activities.

Discussion: The Department agrees that there may be opportunities for States and local educational agencies (LEAs) to leverage other Federal funds to conduct assessment audit activities beginning with FY 2017, such as the State assessment grant funds authorized under section 1201 of the ESEA, as amended by the ESSA, and the dedicated funds for assessment audit work authorized under section 1202 of the ESEA, as amended by the ESSA. For this reason, the Department has: limited the amount of grant funding an applicant could receive under this priority; required that projects under Priority 3 be no longer than 12 months; and required that projects include a longer-term plan for implementation using other funding sources. However, the Department believes that funding grants under this priority presents a valuable opportunity for applicants to lay the groundwork for activities in this area and begin the important work of evaluating all assessments administered in the State and its LEAs.

Changes: None.

Comment: One commenter suggested that the Department reframe the priority to focus on assessment systems and clarify that the goal of assessment inventories is to ensure that States' balanced systems of assessments work together to provide information to relevant stakeholders.

Discussion: The Department believes that this priority, as written, already emphasizes the importance of analyzing entire assessment systems, rather than individual assessments. Assessment inventories proposed by applicants must include a review of all assessments at the Federal, State, and local levels and must include feedback from stakeholders on the entire assessment system.

The Department agrees that assessments should provide clear and actionable information about students' knowledge and skills to stakeholders. However, consistent with the President's Testing Action plan, we believe that assessment inventories should not be focused only on whether assessments provide feedback to stakeholders, but should also ensure that tests are high quality, worth taking, time limited, fair for all students, and tied to improved student learning.

Changes: None.

Comment: One commenter proposed that the Department remove the requirement that State educational agencies (SEAs) review State and LEA activities related to test preparation to make sure those activities are focused on academic content and not on test-taking skills.

Discussion: The Department believes that low-quality test preparation strategies are a poor use of students' time and that students perform best on high-quality assessments that measure critical thinking and complex skills when they have been exposed to strong instruction. As such, we maintain that ensuring that test preparation strategies and activities are focused on academic content instead of test-taking skills is an important part of reviewing and improving assessment systems.

Changes: None.

Comment: None.

Discussion: In the NPP, paragraph (a)(2) of Priority 3 indicated that the purpose of assessments is to help schools meet their goals. Although we believe that assessments provide valuable information about school performance and can help schools to assess progress toward their goals, the Department believes that assessments have other purposes that are important for applicants to consider as they address Priority 3.

Changes: The Department adjusted the language in paragraph (a)(2) of Priority 3 to reflect that assessments are intended to measure student achievement and identify gaps in students' knowledge and skills.

Under this priority, SEAs must:

(a) Develop, evaluate, and implement new, innovative item types for use in summative assessments in reading/language arts, mathematics, or science;

(1) Development of innovative item types under paragraph (a) may include, for example, performance tasks; simulations; or interactive, multi-step, technology-rich items that can support competency-based assessments or portfolio projects;

(2) Projects under this priority must be designed to develop new methods for collecting evidence about a student's knowledge and abilities and ensure the quality, validity, reliability, and fairness (such as by incorporating principles of universal design for learning) of the assessment and comparability of student data; or

(b) Develop new approaches to transform traditional, end-of-year summative assessment forms with many items into a series of modular assessment forms, each with fewer items than the end-of-year summative assessment.

(1) To respond to paragraph (b), applicants must develop modular assessment approaches which can be used to provide timely feedback to educators and parents as well as be combined to provide a valid, reliable, and fair summative assessment of individual students.

(c) Applicants proposing projects under either paragraph (a) or (b) must provide a dissemination plan to share lessons learned and best practices such that their projects can serve as models and resources that can be shared with other States.

Under this priority, SEAs must:

(a) Develop innovative tools that leverage technology to score assessments;

(1) To respond to paragraph (a), applicants must propose projects to reduce the time it takes to provide test results to educators, parents, and students and to make it more cost-effective to include non-multiple choice items on assessments. These innovative tools must improve automated scoring of student assessments, in particular non-multiple choice items in reading/language arts, mathematics, or science; or

(b) Propose projects, in consultation with organizations representing parents (including parents of English learners and parents of students with disabilities), students, teachers, counselors, and school administrators to address needs related to score reporting and improve the utility of information about student performance included in reports of assessment results and provide better and more timely information to educators and parents;

(1) To respond to paragraph (b), applicants must include one or more of the following in their projects:

(i) Developing enhanced score reporting templates or digital mechanisms for communicating assessment results and their meaning (such as by providing clear and actionable next steps for parents);

(ii) Improving the assessment literacy of educators and parents to help them interpret test results and to support teaching and learning in the classroom (such as by providing training on test development and interpretation of test scores); and

(iii) Developing mechanisms for secure transmission and individual use of assessment results by teachers, students, and parents.

(c) Applicants proposing projects under either paragraph (a) or (b) must provide a dissemination plan for sharing lessons learned and best practices such that their projects can serve as models and resources that can be shared with other States.

(a) Under this priority, SEAs must—

(1) Review statewide and local assessments to ensure that each test is of high quality, maximizes instructional goals, has a clear purpose and utility, and is designed to help students demonstrate mastery of State standards;

(2) Determine whether assessments are serving their intended purpose to measure student achievement and identify gaps in students' knowledge and skills and to eliminate redundant and unnecessary testing; and

(3) Review State and LEA strategies and activities related to test preparation to make sure those strategies and activities are focused on academic content and not on test-taking skills.

(b) To meet the requirements in paragraph (a), SEAs must ensure that tests, including statewide and local assessments are—

(1) Worth taking, meaning that assessments are a component of good instruction and require students to perform the same kind of complex work they do in an effective classroom and the real world;

(2) High quality, resulting in actionable, objective information about students' knowledge and skills, including by assessing the full range of relevant State standards, eliciting complex student demonstrations or applications of knowledge, providing an accurate measure of student achievement, and producing information that can be used to measure student growth accurately over time;

(3) Time-limited, in order to balance instructional time and the need for assessments, for example, by eliminating duplicative assessments and assessments that incentivize low-quality test preparation strategies that consume valuable classroom time;

(4) Fair for all students and used to support equity in educational opportunity by ensuring that accessibility features and accommodations level the playing field so tests accurately reflect what all students, including students with disabilities and English learners, know and can do;

(5) Fully transparent to students and parents, so that States and districts can clearly explain to parents the purpose, the source of the requirement (if appropriate), and the use by teachers and schools, and provide feedback to parents and students on student performance; and

(6) Tied to improving student learning as tools in the broader work of teaching and learning.

(c) Approaches to assessment inventories under paragraph (a) must include:

(1) Review of the schedule for administration of all assessments required at the Federal, State, and local levels;

(2) Review of the purpose of, and legal authority for, administration of all assessments required at the Federal, State, and local levels; and

(3) Feedback on the assessment system from stakeholders, which could include information on how teachers, principals, other school leaders, and administrators use assessment data to inform and differentiate instruction, how much time teachers spend on assessment preparation and administration, and the assessments that administrators, teachers, principals, other school leaders, parents, and students do and do not find useful.

(d) Projects under this priority—

(1) Must be no longer than 12 months;

(2) Must include a longer-term project plan, understanding that, beginning with FY 2017, there may be dedicated Federal funds for assessment audit work as authorized under section 1202 of the ESEA, as amended by the ESSA, and understanding that States and LEAs may use other Federal funds, such as the State assessment grant funds, authorized under section 1201 of the ESEA, as amended by the ESSA, consistent with the purposes for those funds, to implement such plans; and

(3) Must have a budget of $200,000 or less.

Types of Priorities:

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.

The priorities included in this notice would benefit students, parents, educators, administrators, and other stakeholders by improving the quality of State assessment instruments and systems. Priority 1 will yield new, more authentic methods for collecting evidence about what students know and are able to do and provide educators with more individualized, easily integrated assessments that can support competency-based learning and other forms of personalized instruction. Priority 2 will allow for States to score non-multiple choice assessment items more quickly and at a lower cost and ensure that assessments provide timely, actionable feedback to students, parents, and educators. Priority 3 will encourage States to ensure that assessments are of high quality, maximize instructional goals, and have clear purpose and utility. Further, it will encourage States to eliminate unnecessary or redundant tests.

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.thefederalregister.org/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 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.

This Federal Register document, the petitions for reconsideration, the letters denying the petitions for reconsideration, and the document titled “Denial of Petitions for Reconsideration of Certain Startup/Shutdown Issues: MATS” (Reconsideration Response Document) are available in the dockets the EPA established under Docket ID No. EPA-HQ-OAR-2009-0234. The Reconsideration Response Document is available in the MATS docket by conducting a search of the title “Denial of Petitions for Reconsideration of Certain Startup/Shutdown Issues: MATS.” All documents in the dockets are listed on the www.regulations.gov Web site. Although listed in the index, some information is not publicly available, e.g., confidential business information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the EPA Docket Center (EPA/DC), Room 3334, EPA WJC West Building, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744 and the telephone number for the Air Docket is (202) 566-1742. This Federal Register document and the Reconsideration Response Document denying the petitions can also be found on the EPA's Web site at https://www.epa.gov/mats.

Section 307(b)(1) of the Clean Air Act (CAA) indicates which Federal Courts of Appeals have venue for petitions for review of final EPA actions. This section provides, in part, that the petitions for review must be filed in the United States Court of Appeals for the District of Columbia Circuit if: (i) The agency action consists of “nationally applicable regulations promulgated, or final action taken, by the Administrator,” or (ii) such actions are locally or regionally applicable, if “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.”

The EPA's actions denying the petitions for reconsideration are nationally applicable because the underlying rules—the “National Emission Standards for Hazardous Air Pollutants (NESHAP) From Coal- and Oil-Fired Electric Utility Steam Generating Units and Standards of Performance (NSPS) for Fossil-Fuel-Fired Electric Utility, Industrial-Commercial-Institutional, and Small Industrial-Commercial-Institutional Steam Generating Units,” are nationally applicable. Thus, any petitions for review of the EPA's decisions denying petitioners' requests for reconsideration must be filed in the United States Court of Appeals for the District of Columbia Circuit by October 7, 2016.

On February 16, 2012, pursuant to sections 111 and 112 of the CAA, the EPA published the final rules titled “National Emission Standards for Hazardous Air Pollutants From Coal- and Oil-Fired Electric Utility Steam Generating Units and Standards of Performance for Fossil-Fuel-Fired Electric Utility, Industrial-Commercial-Institutional, and Small Industrial-Commercial-Institutional Steam Generating Units” (77 FR 9304). The NESHAP issued pursuant to CAA section 112 is referred to as the Mercury and Air Toxics Standards (MATS), and the NSPS rule issued pursuant to CAA section 111 is referred to as the Utility NSPS. Following promulgation of the final rules, the Administrator received petitions for reconsideration of numerous provisions of both MATS and the Utility NSPS pursuant to CAA section 307(d)(7)(B). The EPA received 20 petitions for reconsideration of the MATS rule and 3 petitions for reconsideration of the Utility NSPS.

On November 30, 2012, the EPA issued a proposed rule reconsidering certain new source limits in MATS, the requirements applicable during periods of startup and shutdown for MATS and the Utility NSPS (for the particulate matter standard only), certain definitional and monitoring issues in the Utility NSPS, and additional technical corrections to both MATS and the Utility NSPS (77 FR 71323). On April 24, 2013, the EPA issued the final action on reconsideration of the new source MATS, the definitional and monitoring provisions in the Utility NSPS, and the technical corrections in both rules (78 FR 24073). The EPA issued the final action on reconsideration of the startup and shutdown provisions in the MATS and Utility NSPS on November 19, 2014 (79 FR 68777).

The EPA received two petitions for reconsideration of the November 19, 2014, final action on reconsideration of the startup and shutdown provisions in the MATS rule. One petition was submitted by the Environmental Integrity Project, the Chesapeake Climate Action Network, and the Sierra Club, and the other was submitted by the Utility Air Regulatory Group.

CAA section 307(d)(7)(B) states that “[o]nly an objection to a rule or procedure which was raised with reasonable specificity during the period for public comment (including any public hearing) may be raised during judicial review. If the person raising an objection can demonstrate to the Administrator that it was impracticable to raise such objection within such time or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule, the Administrator shall convene a proceeding for reconsideration of the rule and provide the same procedural rights as would have been afforded had the information been available at the time the rule was proposed.”

The EPA carefully reviewed the petitions for reconsideration and evaluated all issues raised to determine if they meet the CAA section 307(d)(7)(B) criteria for reconsideration. In separate letters to the petitioners, the EPA Administrator, Gina McCarthy, denied the petitions for reconsideration. The letters were accompanied by a separate Reconsideration Response Document that articulates in detail the rationale for the EPA's final responses. These documents are all available in the docket for this action.

On May 19, 2016, the EPA published a direct final rule that makes minor technical amendments to the performance specifications and test procedures for hydrogen chloride (HCl) continuous emission monitoring systems (CEMS). 81 FR 31515. In the direct final rule, the EPA stated that if we received adverse comment by July 5, 2016, the EPA would publish a timely withdrawal and address the comments in a subsequent final rule based on the proposed rule also published on May 19, 2016 (81 FR 31577). The May 19, 2016, direct final rule noted that if the EPA received adverse comment on an amendment, paragraph, or section of this rule and, if that provision may be severed from the remainder of the rule, the EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

In this instance, the EPA received an adverse comment on an amendment to the quality assurance provision in Procedure 6, related to above span requirements. 81 FR 31517. The portions of the direct final rule revising Performance Standard 18 are severable from the revisions to Procedure 6. Thus, the EPA is only withdrawing the revisions to Procedure 6. The EPA will address the comment in a subsequent final action, which will be based on the parallel proposed rule also published on May 19, 2016 (81 FR 31515). As stated in the parallel proposal, we will not institute a second comment period on this proposed action. The revisions to Performance Standard 18 in the May 19, 2016, direct final rule are not affected and will become effective on August 17, 2016, as provided in the direct final rule.

Accordingly, amendatory instruction 3 in the direct final rule published in the Federal Register on May 19, 2016, at 81 FR 31520, is withdrawn as of August 8, 2016.

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0561 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before October 7, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0561, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

In the Federal Register of October 21, 2015 (80 FR 63731) (FRL-9935-29), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 5F8369) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A, Concord, Ohio 44077. The petition requested that 40 CFR 180.613 be amended by establishing tolerances for residues of the insecticide flonicamid, [(N-(cyanomethyl)-4-trifluoromethyl)-3-pyridinecarboxamide) or (N-cyanomethyl-4-trifluoromethylnicotinamide (IUPAC))], in or on hops at 20 parts per million (ppm), tree nuts (crop group 14-12) except pistachio at 0.15 parts per million (ppm), pistachio at 0.60 parts per million (ppm). That document referenced a summary of the petition prepared by ISK Bioscience Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for flonicamid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with flonicamid follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by flonicamid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of November 14, 2012 (77 FR 67771) (FRL-9368-7).

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which the NOAEL and the LOAEL are identified. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for flonicamid used for human risk assessment is discussed in Unit III.B of the final rule published in the Federal Register of November 14, 2012.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to flonicamid, EPA considered exposure under the petitioned-for tolerances as well as all existing flonicamid tolerances in 40 CFR 180.613. EPA assessed dietary exposures from flonicamid in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for flonicamid; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, the chronic dietary exposure assessment was a conservative assessment conducted using tolerance-level residues, conservative ground water/drinking water estimates, and 100 percent crop treated (PCT).

iii. Cancer. Based on the data referenced in Unit III.A., EPA has concluded that flonicamid does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and PCT information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for flonicamid. Tolerance level residues and/or 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for flonicamid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of flonicamid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

The drinking water assessment was conducted using both a parent only exposure, and a total toxic residue approach, which considers the parent compound and its major degradates of concern. Total toxic residues include 4-trifluoromethylnicotinic acid (TFNA), 4-trifluoromethylnictinamide (TFNA-AM), 6-hydro-4-trifluoromethylnicotinic acid (TFNA-OH), N-(4-trifluoromethylnicotinoyl)glycine (TFNG), and N-(4-trifluoromethylnicotinoyl)glycinamide (TFNG-AM).

Based on the Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of flonicamid for chronic exposures for non-cancer assessments are estimated to be 0.94 parts per billion (ppb) for surface water and 9.92 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 9.92 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Flonicamid is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found flonicamid to share a common mechanism of toxicity with any other substances, and flonicamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that flonicamid does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicity database for flonicamid includes prenatal developmental toxicity studies in rats and rabbits and a multi-generation reproduction toxicity study in rats. There is no evidence of increased susceptibility (qualitative or quantitative) in rats or rabbits exposed to flonicamid in utero in the prenatal developmental studies or in young rats in the multi-generation reproduction study. No developmental effects were seen in rabbits. In the multi-generation reproduction study, developmental delays in the offspring (decreased body weights, delayed sexual maturation) were seen only in the presence of parental toxicity (kidney and blood effects). Also, there are clear NOAELs and LOAELs for all effects. The degree of concern for prenatal and/or postnatal susceptibility is, therefore, low due to the lack of evidence of qualitative and quantitative susceptibility.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X, except as noted below. That decision is based on the following findings:

i. The toxicity database for flonicamid is nearly complete. The database is missing a subchronic inhalation study. A subchronic inhalation study is required because the use of an oral POD results in MOEs which do not meet the target MOE for a waiver (MOE=1,000). The Agency notified the registrant of the Data Call-In (DCI) for the 28-day inhalation study on January 5, 2016 and is awaiting submission of the study. In the absence of a subchronic inhalation study, EPA has retained a 10X FQPA SF to assess risks for inhalation exposure scenarios. However, residential inhalation exposures are not expected.

ii. The available data base for flonicamid includes acute and subchronic neurotoxicity studies. As discussed in Unit III.A., EPA has concluded that the clinical signs observed in those studies were not the result of a neurotoxic mechanism and therefore a developmental neurotoxicity study is not required.

iii. There is no evidence that flonicamid results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The chronic dietary food exposure assessment was based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to flonicamid in drinking water. These assessments will not underestimate the exposure and risks posed by flonicamid.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, flonicamid is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to flonicamid from food and water will utilize 30% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for flonicamid. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of flonicamid is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). A short-term adverse effect was identified; however, flonicamid is not registered for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for flonicamid.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, flonicamid is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for flonicamid.

5. Aggregate cancer risk for U.S. population. Based on the information referenced in Unit III.A., EPA has concluded that the cPAD is protective of possible cancer effects from flonicamid, and as evidenced in Unit III.E.2, aggregate exposure to flonicamid is below the cPAD.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to flonicamid residues.

Adequate enforcement methodology (FMC Method No. P-3561M, a liquid chromatography with tandem mass spectrometry (LC/MS/MS) method) is available to enforce the tolerance expression for flonicamid and its metabolites in or on plant commodities.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not proposed an MRL for flonicamid in or on pistachio. The Codex has established an MRL for flonicamid in or on hops at 20.0 ppm. These MRLs are the same as the tolerances established for flonicamid in the United States. The Codex has also established MRLs for flonicamid in or on almond and pecan at 0.01 ppm. These MRLs are different than the tolerances established for flonicamid in the United States. The U.S. cannot harmonize the Nut, tree, group 14-12, except pistachio tolerance with the Codex MRLs on pecan and almond because residue field trial data show residues well above 0.01 ppm.

The Agency is removing certain commodities from the table at § 180.613 (a) to eliminate redundancies upon the establishment of new crop group tolerances that were not identified in the petition: Cucumber at 1.5 ppm and okra at 0.40 ppm.

Therefore, tolerances are established for residues of flonicamid, [(N-(cyanomethyl)-4-trifluoromethyl)-3-pyridinecarboxamide) or (N-cyanomethyl-4-trifluoromethylnicotinamide (IUPAC))], in or on hops at 20.0 ppm, tree nuts (crop group 14-12) except pistachio at 0.15 ppm, and pistachio at 0.60 ppm.

Also, as a housekeeping measure, the Agency is removing three individual tolerances that are subsumed within other crop group tolerances contained in § 180.613: Cucumber at 1.5 ppm is superseded by inclusion in the established vegetable, cucurbit, group 9 tolerance at 1.5 ppm; and okra at 0.40 ppm is superseded by inclusion in the established vegetable, fruiting, group 8-10 tolerance at 0.40 ppm.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

In volume 81, number 124 of the Federal Register of Tuesday June 28, 2016 on page 41858, the following corrections are made:

1. On page 41858 the RIN in the heading is corrected to read as follows: 1024-AE34

2. On page 41858, in the second column, the text following • Federal eRulemaking Portal: http://www.regulations.gov. is corrected to read: Search for the Docket Number DOI-2016-0004 or RIN 1024-AE34 and follow the instructions for submitting comments.

The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register.

In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

Accordingly, 44 CFR part 64 is amended as follows:

This is a summary of the Commission's Report and Order in GN Docket No. 15-206, adopted on June 24, 2016, and released on July 12, 2016. The full text of this document is available for public inspection during regular business hours in the FCC Reference Center, Room CY-A257, 445 12th Street SW., Washington, DC 20554, or online at http://transition.fcc.gov/Daily_Releases/Daily_Business/2016/db0712/FCC-16-81A1.pdf. In this Report and Order, the FCC adopts final rules requiring submarine cable licensees to report service outages through the network outage reporting systems (NORS). In doing so, the FCC seeks to improve overall submarine cable reliability and resiliency by enhancing the FCC's visibility into the operational status of submarine cables, which will permit the FCC to track and analyze outage trends. The Report and Order requires all submarine cable licensees to report service outages to the FCC, defined as a failure or significant degradation in the performance of a licensee's cable service regardless of whether the traffic can be re-routed to an alternate path. Licensees must report outages, including those caused by planned maintenance, of a portion of a submarine cable system for more than 30 minutes, or the failure or significant degradation of any fiber pair lasing for four hours or more. Lastly, the Report and Order will improve submarine cable deployment conditions and resiliency through better coordination of inter-agency permit review.

1. This Report and Order serves the public interest and promotes the national and economic security of the nation by requiring submarine cable licensees to report to the Federal Communications Commission (“Commission” or “FCC”) when submarine (or “undersea”) cable outages occur and communications over those facilities are disrupted. By moving—as we do today—from an ad hoc outage reporting system to one that will ensure the Commission has a dependable, holistic view of the operating status of submarine cables, we will be in a better position to examine the resiliency posture of submarine cable infrastructure and to ensure the reliability of the critical national security and economic communications that transit it. In this Report and Order, we:

• Require submarine cable licensees to report to the Commission service outages, defined as “a failure or significant degradation in the performance of a licensee's cable service regardless of whether the traffic can be re-routed to an alternate path.”

• Specify that an outage requires reporting when there is:

○ An outage, including those caused by planned maintenance, of a portion of a submarine cable system between submarine line terminal equipment (SLTE) at one end of the system and SLTE at another end of the system for more than 30 minutes; or

○ The failure or significant degradation of any fiber pair, including losses due to terminal equipment issues, on a cable segment for four hours or more, regardless of the number of fiber pairs that comprise the total capacity of the cable segment.

• Define the reporting requirements to include a Notification within eight hours (to become four hours after three years) of the time of determining that a reportable outage has occurred; an Interim Report within 24 hours of receiving a Plan of Work (relating to repairs); and a Final Report within seven days of completing repair.

• Clarify the content required in the reports to allow for the fact that not all requested information may be known when the reports are due.

• Treat the information provided through this reporting system as confidential, consistent with section 4.2 of our rules for existing outage reporting.

• Provide that these requirements will become effective six months after OMB approval of these rules to provide ample time for implementation.

2. Background. Submarine cables provide the conduit for the vast majority of voice, data and Internet connectivity between the mainland United States and consumers in Alaska, Hawaii, Guam, American Samoa, the Northern Mariana Islands, Puerto Rico, and the U.S. Virgin Islands, as well as the connectivity between the United States and the rest of the world. Accordingly, the operation and maintenance of the approximately 60 undersea cables licensed in the United States are essential to the nation's economic stability, national security and other vital public interests. Presently, submarine cable licensees are not required to report on their cables' operational status. Rather, licensees provide such operational information to the Commission on a voluntary, ad hoc basis through the Commission's Undersea Cable Information System (UCIS). This ad hoc approach contrasts significantly with the Commission's part 4 outage reporting requirements for other communication services which require targeted information on the cause and effects of communications outages, establishes specific reporting triggers and thresholds, and provides deadlines for those reports to be made. Furthermore, the Network Outage Reporting System (NORS) established for part 4 data reporting has not previously provided the Commission with the necessary information to analyze undersea cable disruptions, as the system was designed for different types of infrastructure outage reporting, not submarine cable reporting, and lacks the data fields necessary to report on submarine cable infrastructure.

3. We find that a mandatory outage reporting regime is necessary to provide the Commission with greater visibility into the availability and health of these networks to allow it to better track and analyze submarine cable resiliency, and suggest or take appropriate actions when the data so indicate, i.e., before there is a significant problem. The need for such reporting is only heightened when, as is the case with submarine cable infrastructure, the facilities are few, are vital to U.S. economic activity and national security, have unique vulnerabilities in their environment, and are exceptionally challenging to repair. Further, it is clear that UCIS has failed to become the comprehensive source of information about undersea cable outages it was intended to be: Few reports are filed; those that are filed are inconsistent from entity to entity; and the design of UCIS lacks the analytical capabilities necessary for the Commission to perform meaningful analysis.

4. We recognize that redundancies (i.e., traffic re-route engineering) are already in place for many cables that prevent or at least mitigate service outages, but this argument misses the broader goal of the proposed mandatory reporting regime, which is that both the cables and the services provided over them must be protected. For the Commission to ensure the stability of submarine cable infrastructure, it must have greater visibility than what is currently provided through UCIS into the connectivity and capacity of all undersea cables landing in the United States. And, even though we recognize that the low number of reports filed in UCIS might be due to a low number of reportable outages, the record suggests otherwise. As mere examples, the outages discussed above are important evidence of how it is not only the number of outages, but rather, also the potential impact of the outages, as well as the deficit in the Commission's situational awareness of a major outage, that convince us that reporting needs to be mandatory and of the scope described herein. Accordingly, we adopt the mandatory reporting regime for undersea cable operators described below. This regime will replace UCIS in its entirety and we direct the Bureau to retire UCIS upon the effective date of these rules.

5. Reporting Obligations. To effectively achieve undersea cable infrastructure assurance, consistent with part 4 traditionally, we will define reportable outages without regard to a licensee's or provider's re-routing of the traffic carried over a given cable, or some other measure requiring a complete loss of service. Accordingly, we define “outage” as “a failure or significant degradation in the performance of a licensee's cable service regardless of whether the traffic can be re-routed to an alternate path.”

6. Though there are redundant configurations in some, but not all submarine cable infrastructure, we adopt our proposal to require a reporting obligation regardless of whether traffic is re-routed, and we use the broader term “path” to avoid analysis of whether the traffic was specifically re-routed to another cable. For the purpose of promoting and advancing the national security and public safety interests served by our U.S.-based landings and connections as a whole, we need to assess outages across the total undersea cable environment serving the United States. For example, in some situations the redundant paths could be over-utilized due to an emerging problem, such as an expansive coastline area disruption affecting several independent submarine cables. Using such an approach would help us understand operability of submarine cables holistically to better safeguard reliability of this important part of the nation's communications system.

7. We also modify our proposed definition to limit reportable events to failures or “significant” degradation in the performance of a communications provider's cable. As explained in the section below on outage reporting triggers, we are adjusting our metrics to require the reporting of only significantly degraded service and not all incidents of degraded service, which will better align our outage reporting rules for submarine cables with our current part 4 outage reporting requirements. Further, our adjustment to include “significant” degradation is consistent with our long established outage reporting requirement that an outage includes events where even “some traffic might be getting through during a period of massive disruption” (See, e.g. , Amendment of Part 63 of the Commission's Rules to Provide for Notification by Common Carriers of Service Disruptions, CC Docket No. 91 273, Report and Order, 7 FCC Rcd 2010, 2010, para. 11 (1992).

8. Reportable Outage Metrics. We adopt a modified outage reporting metric to capture significant degradations and to simplify reporting in general. Under the originally proposed metric, events causing performance failures would not be reportable until all connectivity was lost. We therefore modify both proposed metrics, addressing the connectivity and capacity metrics to account for performance failures and events resulting from planned maintenance.

9. Connectivity is an important metric but we are persuaded to modify it to exclude reporting that could be burdensome and of limited value. Accordingly, we adopt a modified version of the connectivity metric proposed by the Submarine Cable Coalition and require reporting when there is an outage, including those caused by planned maintenance, of a portion of a submarine cable system between SLTE at one end of the system and SLTE at another end of the system for more than 30 minutes. We are persuaded to make this modification in order to limit the burdens caused by reporting routine terminal equipment issues that can be corrected rapidly. While the Submarine Cable Coalition does not specifically define the term “SLTE” in its comments, it is commonly understood to be part of the “dry plant” comprised of “signal processing equipment and optical multiplexing equipment that allows transmission over the submarine cable.” Thus, we focus on issues resulting in outages that fall between the SLTE due to problems with the “wet plant,” including the submarine cable, repeaters, optical equalizer, and branching unit. We believe 30 minutes, not three hours, is an appropriate timeframe to trigger a reporting obligation for such failures because damage or repair to facilities between the SLTE likely indicates a long-term problem that will not be cleared quickly, so there is no benefit to further delaying reporting.

10. Further, to simplify our original capacity metric (i.e., reporting required when fifty percent or more of the capacity of the submarine cable, in either the transmit or receive mode, is lost for at least 30 minutes), we adopt a modification of our original proposal. In doing so, we also seek to create a reporting backstop that is broader than the connectivity metric described above and designed to capture events that affect even a single fiber pair, yet provide a longer window before the event becomes reportable. We adopt a metric requiring a report for the failure or significant degradation of any fiber pair, including losses due to terminal equipment issues, on a cable segment for four hours or more, regardless of the number of fiber pairs that comprise the total capacity of the cable segment. Because issues may arise at the landing station that will affect submarine cable system operation, we include outages that are due to SLTE failures.

11. Covered Entities. We adopt a requirement that all licensees, regardless of when the license was obtained, must comply with license conditions, including the outage reporting rules we now adopt. We agree with Docomo that there is no public policy reason to exempt submarine cable licensees from the obligation to report. All licensees are integral components in the provision of submarine cable infrastructure, and the Commission could not meet its goal of acquiring a comprehensive viewpoint of the operational status of all submarine cables if certain licensees were exempted. We believe with the flexibilities discussed below, pre-2002 licensees would be unlikely to have increased burden compared to post-2002 licensees. Most pre-2002 cables operate as a consortium. Consortium cables generally use construction and maintenance agreements (C&MA), which can be amended to incorporate new regulatory requirements as necessary. To the extent that extra flexibility or time is required to revise the C&MAs to ensure compliance with the outage reporting requirements adopted herein, we address that below.

12. In light of concerns raised regarding the operations of consortiums or that of a cable with multiple licensees, we choose to permit, but not require, a Responsible Licensee designation. We have made this decision to add flexibility to the Responsible Licensee system due to the concerns expressed about how our rules could be complicated given the nature of consortiums, including their size, domestic/foreign composition, potential language barriers, and time zone challenges, as well as how compliance review will add to costs for reporting. Consortium members are in the best position to determine which member is best placed to comply and meet the reporting obligation for the consortium, such as a U.S. landing operator or a Network Operations Center (NOC) operator. We agree with Verizon that under this approach, licensees and non-licensees, including those operating with pre-2002 licensees, are free to negotiate and allocate the underlying risk and financial responsibility. Nonetheless, should a Responsible Licensee be designated, it must register with and keep the Commission updated as to its Responsible Licensee status pursuant to our rules. We will hold the Responsible Licensee responsible for reporting compliance once designated and registered with the Commission.

13. If no Responsible Licensee is designated with the Commission or in effect at the time of an outage, each party experiencing a reportable outage can be held responsible for reporting and liable should the Commission need to pursue enforcement action. This is a departure from our proposal to hold all consortium members jointly and severally liable when a cable experiences an outage, in order to provide additional flexibility to covered providers. In this way we limit enforcement liability to those licensees experiencing an outage.

14. Content of Notification. We require licensees to provide a preliminary notification in NORS (all reports described herein are to be filed in NORS in a system designed specifically for submarine cable outage reporting) once it has been determined that an undersea cable outage has occurred. We find that having awareness of an outage, even without certain information about that outage, helps achieve our goal of improving situational awareness as to the operational status of undersea cable networks. Reporting via widely available electronic means is affordably feasible and quite often a normal part of operations. As proposed in the Notice, notifications must contain the name of the reporting entity; the name of the cable and a list of all licensees for that cable; whether the event is planned or unplanned; and contact information for the Commission. We recognize, however, that access to information about the root cause, approximate location, and estimated duration of an outage will often be unavailable in the period immediately following an operator's determination that there has been an undersea cable outage. Accordingly, we modify our original proposal from the Notice and require such information only if known at the time of the notification.

15. We acknowledge that the root cause of an outage many times cannot be determined until after repair work is done, and only seldom is it known at the time of an outage. Accordingly, in their notifications licensees must provide a brief description of the event and need only include information on the root cause if known at the time. If the root cause is unknown, licensees should specify as such and provide further information where available in Interim or Final Reports.

16. With respect to the location of an outage, licensees must provide the name of the nearest cable landing station if known, as well as its best estimate of the location of the event, expressed in either, nautical miles and the direction from the nearest cable landing station, or in approximate latitude and longitude coordinates. We have added “the direction from” the nearest cable landing station (e.g., 15 nautical miles west of [the cable landing station]” to improve clarity in reporting, if known. We acknowledge that undersea cables traverse vast distances, and it can be a complicated and time-consuming task to determine the location of an undersea cable outage. Though we only proposed that licensees report the “approximate location” of an outage, we clarify that we do not seek to divert time and attention away from service restoration efforts by requiring licensees to provide this information. As with root cause information, licensees must provide this information if known at the time of the notification, and if unknown, licensees should provide further detail where possible in subsequent reports.

17. With respect to the duration of the event, licensees must provide their best estimate in the notification, but supplement with further information as it becomes available in their Interim or Final Reports. As with root cause and location information, our aim in including this information in the notification is to provide preliminary situational awareness in the immediate wake of an outage, which can be supplemented or corrected through later reports.

18. Timeframe for Notification. Again, we recognize that the determination of root cause, approximate location, and duration of an outage typically takes much longer than 120 minutes after the determination that an outage has occurred. Moreover, we agree with commenters that licensees' primary objective in the wake of an outage should be to restore service, and that reporting obligations should be subordinate to that objective. As discussed above, we modify our original notification proposal to require licensees to provide root cause information, approximate location, and estimated duration of an outage only when available. The notification process is intended to be preliminary in nature and simply provide notice of, not necessarily detail about, an undersea cable outage, for purposes of situational awareness.

19. We also emphasize that the timeframe for reporting starts upon “the time of determining that an event is reportable” and not necessarily the moment that an event becomes reportable. Several commenters, in arguing that the Commission's proposed notification timeframe is infeasible, point to difficulties in receiving the initial notification. For example, AT&T asserts that “most notifications of the occurrence of outages on consortium cables that AT&T receives from foreign consortium parties are not provided within two hours of the cable failure.” Even if the foregoing complications arose preventing a licensee from knowing of an outage when it became reportable, the licensee would only be “on the clock” to report the event when it determines (i.e., has knowledge that) the event is reportable. This distinction should alleviate many of the concerns that licensees will need to implement new network monitoring processes.

20. We continue to believe that licensees can report within the proposed two-hour timeframe from determining that an event is reportable, particularly as they need not provide substantive detail on the root cause, location, or duration of the outage if unavailable at that time; we believe that quick notification is an essential element in achieving the Commission's goal of developing comprehensive situational awareness of submarine cable infrastructure. We additionally note our view that many of the submarine cable operators have the technical capabilities to near-instantly detect outages and are standard within the industry.

21. That said, given the support on the record for a longer notification timeframe and AT&T's statements that it will need time to implement these requirements with its consortium partners, we will initially, for a three year period from the effective date of these rules, require licensees to notify the Commission of an outage within eight hours of determining that an event is reportable. Three years after the effective date of these rules, licensees will be responsible for filing notifications within four hours of determining that an event is reportable. After three years, the Commission will open a proceeding to revisit. We find that allowing four hours from the time of determining an event is reportable, not when the event necessarily becomes reportable, is feasible, particularly as we have allowed for licensees to include approximations and best estimates in their filings. This phased-in approach will give licensees ample time to hone their reporting structure while still achieving the aforementioned goal of prompt situational awareness. A further elongated timeframe does not as adequately serve the Commission's goal of acquiring rapid situational awareness of submarine cable infrastructure.

22. Content of Interim Report. We adopt modified Interim Report content requirements to address concerns that a root cause may not always be known in this adjusted timeframe. We require licensees to report on all of the elements described above in the original proposal, observing that many of these elements (name of the reporting licensee; the name of the cable and a list of all licensees for that cable; the date and time of onset of the outage; and a contact name, contact email address, and contact telephone number by which the Commission's technical staff may contact the reporting entity) will be auto-filled from the Notification and thus will likely require no additional work on the part of the reporting entity barring administrative changes. These fields remain important for basic factual references and we see no reason to exclude them from the Interim Report. We will also continue to require a brief description of the event, including root cause; nearest cable landing station; approximate location of the event (either, in nautical miles and the direction from the nearest cable landing station or in latitude and longitude); and the best estimate of the duration of the event. These are the fields that will supply the Commission with necessary situational awareness about the status of the outage, particularly when the information is updated from that which we received in the Notification. We depart slightly from our original proposal, however, and will now only require the root cause description if known at the time. We are persuaded by commenters' arguments that the root cause may need extended analysis and sometimes may not be known until the repair is completed. We have again added “the direction from” the nearest cable landing station (e.g., “15 nautical miles west of [the cable landing station]” to improve clarity in reporting, if known. We emphasize that an approximate location of the event and best estimate of the duration of the event are all that is required; licensees will not be penalized for the later-determined accuracy of these interim responses if they are submitted in good faith. We also adopt our proposal that Interim Reports are not required for planned outages so long as the planned nature of the event was appropriately signaled in the Notification.

23. Timeframe for Interim Report. We adopt a modified reporting timeframe for the Interim Report. Accordingly, we will require licensees to file an Interim Report, if required, within 24 hours of receipt of the Plan of Work, which we believe strikes the appropriate balance between allowing licensees sufficient time for necessary coordination to amply inform the Commission with useful and timely information.

24. Final Report. In the Notice, we proposed to require licensees to file a Final Report seven days after the repair is completed. We proposed that the following elements be required in a Final Report: The name of the reporting entity; the name of the cable; whether the outage was planned or unplanned; the date and time of onset of the outage (for planned events, this is the start date and time of the repair); a brief description of the event; nearest cable landing station; approximate location of the event (either in nautical miles from the nearest cable landing station or in latitude and longitude); duration of the event; the restoration method; a contact name, contact email address, and contact telephone number by which the Commission's technical staff may contact the reporting entity.

25. The two components of the Final Report that differ from the Notification and the Interim Report are (1) the duration of the event and (2) the restoration method. The Notice proposed that this type of Final Report, with the inclusion of these two additional elements, would enable the Commission to work directly with communication providers using a data-driven method on collaborative reliability improvement initiatives that will produce measurable results for undersea cables.

26. Contents of Final Report. As with both the Notification and Interim Reports, we understand the commenters' concerns that particular information may not be known at the time the repairs have been completed given the complexities of undersea cable repairs. We also take into account that submarine cable licensees often work together in consortiums, and that although one member may know a certain element of the Final Report, the information may not make its way to other consortium members who are also experiencing an outage or disruption on the same cable. For these reasons, we adopt our proposals for the content reporting obligations for the Final Report, but with a modification for the “brief description of the event.” Here, in a Final Report, a licensee will need to provide the root cause in its brief description of the event only if known at the time of filing. Both Verizon and AT&T noted that in some cases, completion of the root cause analysis may not be known in the proposed timeframe, and in some instances, never be determined. Nonetheless, the Commission expects providers to conduct reasonable due diligence to ascertain the root cause of an event. We have also again added “the direction from” the nearest cable landing station (e.g., “15 nautical miles west of [the cable landing station]”) to improve clarity in reporting, if known.

27. After the submission of the Final Report, particular details of an event may become known or change as research is done and repairs are completed. In order for the Commission to obtain the most accurate information, previous Final Reports (and only Final Reports) must be supplemented after the Final Report if that information materially alters the previously reported material. Amendments to Final Reports should be made in good faith.

28. The parallels of the Final Report content to our existing part 4 rules, in conjunction with the NORS platform, create an efficient, streamlined and user-friendly system when implementing these new procedures. Furthermore, we believe that the contents of the Final Report would be easily compiled, as NORS interface automatically populates the fields where information required duplicates that of the Notification and Interim Report, so the reporting licensee would not have to reenter data unless it is to amend or edit a previously-supplied response. We note that the Commission recently adopted a Further Notice of Proposed Rulemaking which sought comment on applying a two-step reporting process to all covered services, which, if adopted, would apply to submarine cable outage reporting. Interested parties may file comments on this issue in the part 4 proceeding.

29. Timeframe for Final Report. We adopt our proposal to require licensees to file a Final Report seven calendar days after the repair is completed. There is substantial record support for requiring submission of this critical information within a week following the repair completion. The Commission has a responsibility to ensure the reliability and security of the nation's communications infrastructure, and obtaining timely information on communications service disruptions is essential to that goal.

30. We are not persuaded by the proposal to extend the deadline to a minimum of 45 days. We find that a majority of the information that must be included in a Final Report is readily available following the repair of the submarine cable. As mentioned above, the Commission is aware of the unique nature of submarine cable repairs, which is why the Final Report shall be amended, when necessary. Therefore, we decline to adopt Latam's proposal of a 45-day minimum for a Final Report deadline. The seven day requirement we adopt today provides the Commission critical network outage information within a reasonable time.

31. Good Faith Requirements in Section 4.11. We adopt substantially the same wording codified in Section 4.11 of our rules for the submarine cable outage reporting system. We are cognizant of the complexities and uncertainties that may arise with outages resulting from a damaged cable. However, the good faith and attestation requirements will not be violated if the authorized personnel submitting a report does in fact submit all of the information known to them, in good faith, at the time of reporting. Also, as made clear above, licensees have the duty to amend their Final Reports, in good faith, if the licensee later learns that the reported information is inaccurate. Accordingly, consistent with support from the record, we will require a good faith requirement and an attestation consistent with Section 4.11.

32. Confidentiality of Submarine Outage Reports and Data. We adopt our proposal that undersea cable reporting information is to be treated as presumptively confidential consistent with Section 4.2 of the Commission's rules governing outage reporting. Maintaining the confidentiality of submarine cable outage data is critical to safeguarding weaknesses or damage to our national communications infrastructure that could potentially facilitate enemies targeting our nation's key resources. The Communications Act of 1934 charges the Commission with promoting “the safety of life and property through the use of wire and radio communication.” (47 U.S.C. 151). Releasing detailed and sensitive information regarding submarine cable outages and disruptions would contradict this core mission of the Commission. We will, however, share information with DHS as is customary with our part 4 outage reports. This model is consistent with the Commission's past precedent for outage reporting and we do not see a need to depart here from that practice solely for submarine cable outage reporting.

33. We also note that the Commission recently adopted a Further Notice of Proposed Rulemaking addressing many of these same issues and has not yet decided if or how it will change its outage report information sharing practices more broadly. Interested parties may file comments on this issue in the part 4 proceeding. We believe that a broader proceeding is a better context for making decisions on how outage information should be shared more generally, and allow for submarine cable outage information sharing to be considered in that context. We also observe that initiating this program in a manner that is consistent with the confidentiality in other part 4 reporting would allow for reevaluation at a later date of a different approach.

34. Implementation. These rules will become effective six (6) months after OMB approval of this information collection, representing a balance between industry's needs to adequately prepare for these reporting requirements and the Commission's need to obtain timely situational awareness of the operational status of the nation's submarine cable infrastructure. As the incident in the CNMI has shown, the Commission cannot continue to wait for licensees to take advantage of the current voluntary approach. Yet, we find that a six month extension is warranted to allow those providers who did not previously report such outages to develop processes for doing so. We also recognize that consortium members may need additional time to determine reporting structures. We do not believe extending the rule implementation date beyond six months from OMB approval is warranted because of the significant adjustments to the proposed rules to add in flexibility and clarify responsibilities.

35. Interagency Coordination. In the Notice, we directed the International Bureau, in coordination with the Public Safety and Homeland Security Bureau, to “reach out to relevant government agencies, under its existing delegated authority,” to “develop and improve interagency coordination processes and best practices vis-à-vis submarine cable deployment activities and related permits and authorizations to increase transparency and information sharing among the government agencies, cable licensees, and other stakeholders.” We note that the Bureaus have met with several of the stakeholders since the Submarine Cable Outage Notice was adopted and that work on this matter is ongoing. We agree with commenters' that interagency coordination is very important to protect submarine cable infrastructure. To this end, the International Bureau, in coordination with the Public Safety and Homeland Security Bureau, will continue to lead interagency coordination efforts to help increase transparency and information sharing among the government agencies, cable licensees, and other stakeholders and promote improved interagency coordination processes to mitigate threats to undersea cables and facilitate new projects to improve geographic diversity.

36. Potential Costs of Compliance. The record makes clear that there are additional costs, beyond the Notice's initial $8,000 cost estimate (premised upon the costs of filing the three versions of outage reports for 50 events) that should be factored into our total estimate of the costs of the regulations we enact today. Our finding that this cost figure should be adjusted, however, is not a result of the Notice failing to account for costs; instead the Notice affirmatively sought comment on items such as implementation costs, the extent to which the information required is not available in the normal course of business, and the costs of inter-licensee negotiations that are unique to consortium submarine cables.

37. As an initial matter, we note that many of the proposals that commenters claimed would inflate the costs have been revised or clarified in an effort to reduce burdens in response to the record. For example, we limited the reporting on issues related to terminal-equipment to those events lasting four hours, and thus presumably eliminated many of the “mundane” events from the reporting requirement, thereby reducing compliance costs. We extended the proposed reporting timeframes for the Notification and the Interim Report while clarifying that reports are due within a set period from when the licensee determines that the event is reportable, not from when the event itself becomes reportable. In this way, we alleviate the concerns of those that claim they would have to update their entire network monitoring system in order to comply. We also allowed for best estimate reporting on many of the fields that commenters indicated would be costly to identify with precision on a timely basis. We have taken the Responsible Licensee system, which was explicitly designed to mitigate burdens by having only one licensee per submarine cable report on behalf of other licensees on that cable, and allowed licensees not to use that system if they find it burdensome.

38. Thus, while we acknowledge that $8,000 figure may not represent the total cost of compliance and that upward adjustments should be made, the record on industry costs does not speak with specificity or even generalities to the requirements we have enacted given our record-based modifications. Accordingly, we instead recognize the OMB-approved 2014 UCIS collection of $305,000. We note that the costs associated with UCIS also included costs beyond those which we now require. UCIS asked licensees to provide four categories of information for each submarine cable with a cable landing in the United States: (1) A terrestrial route map; (2) a location spreadsheet; (3) a general description of restoration plans in the event of an incident; and (4) system restoration messages. As we described in the Notice, “the first three categories are static insofar as the route, the geographic coordinates (i.e., location), and restoration plans change infrequently. Information provided in the fourth category is dynamic, insofar as such messages should be updated after an incident and during the repair process.” It is the fourth category of reporting system restoration messages that is directly analogous to the outage reporting requirements we enact.

39. The costs of UCIS associated with the three “static” categories represented $183,000 of the $305,000 total, with the system restoration messages accounting for $122,000 in reporting costs annually for the industry. This $122,000 annual cost estimate was derived from use of two conservative assumptions. First, that a single set of outage reports would involve as many as 40 hours, rather than only the two hours that we estimate above. Second, that all 61 cables licensed in 2014 would experience an outage every year. (We used the number of licensed cables, rather than the number of cable licensees, because it is common for multiple licensees to operate on a single cable, and past experience indicates that consortia (or multiple licensees operating on a single cable) generally designate only one licensee to prepare and file the report.) We then used an estimated labor rate of $50 rather than $80 per hour, to be consistent with the 2014 OMB Supporting Statement's UCIS cost estimate. Thus, 40 × 61 × $50 = $122,000. If we increased this figure by 25 percent (to account for moving from 40 to 50 hours reporting per licensee per year), we would arrive at a total of approximately $152,500 for an analogous reporting requirement. We find this to be a credible annual burden estimate based on the record and analogous UCIS processes, as confirmed by industry. Moreover, even if expected costs were to include all four elements of the UCIS collection at a total cost of $335,500, we would still, as discussed below, consider this a minimal cost in comparison to the potential benefits from our improved ability to monitor outages on cables that are so vital to both our economy and national security.

40. Public Interest Benefits. We continue to find that the relative concentration of submarine cables serving as conduits for traffic to and from the United States render the Commission's situational awareness and ability to facilitate communications alternatives not only beneficial, but vital to the public interest. These submarine cables are the primary conduit for connectivity between the contiguous United States and Alaska, Hawaii, American Samoa, Guam, the Northern Marianas, Puerto Rico, and the U.S. Virgin Islands. They also carry 95 percent of U.S. international communications, with the potential for significant impacts on national security and the economy. In some circumstances, the public welfare cost of outage of such communications could be extremely high, as lives and tremendous financial interests are at stake. It is precisely because there is a very substantial public interest in the submarine cables that the Commission has authority to license the use of submarine cables and to condition the use of those lines. Simply put, there is too much riding on these cables for the Commission to be less than fully aware about the status of these crucial lines of communication.

41. We find that the anticipated benefits of the rules that we adopt today clearly outweigh the costs to providers, even with the adjustments made above. When the Commission adopted its original part 4 rules, it observed that previous outage reports required of wireline carriers enabled it to initiate investigations and, when appropriate, take corrective action with respect to certain carriers. The Commission explained that, “[e]nsuring that the United States has reliable communications requires us to obtain information about communications disruptions and their causes to prevent future disruptions that could otherwise occur from similar causes, as well as to facilitate the use of alternative communications facilities while the disrupted facilities are being restored.” This situation was borne out when the Commission was hampered in its ability to respond to the CNMI outage due to delayed situational awareness. Based on the record, we conclude that it is entirely appropriate and in the public interest for this agency to systematize, coordinate, review and analyze outage reports from various sources across the industry because this will help ensure that best practices will be identified and shared and recurring problems can be eliminated or mitigated. The Commission's improved situational awareness will help ensure that licensees are consistently and appropriately acting to ensure the availability of submarine cable service, which has direct benefits to public safety and the national defense.

42. Legal Authority. We find that the Commission in fact possesses ample authority to regulate reporting as to the restoration and repair of undersea cables and effects on the related facilities licensed by the Commission. NASCA appears to misunderstand our recitation and reliance on legal authority. The Commission is instituting a uniform and tailored system of accountability designed to ensure that the licenses granted to submarine cable licensees are used to supply “just and reasonable . . . service in the operation and use of cables so licensed[,]” and we have explained why our role is critical here where the communications facilities at issue bear on national security and the economy and why the existing voluntary regime fails to adequately inform that role. In other words, the reporting requirements are designed to inform our understanding of whether the facilities that the Commission has licensed are working. Although our intent is to defer to licensees to institute the necessary repairs to their facilities and consider them to have adequate incentive to do so such that our direct involvement seems unwarranted at this time, it could be that enhancing our situational awareness will have the added benefit of improving licensees' broader understanding of outage events. The main goal of our requirements, however, is to help ensure that submarine cable service will be reasonably available.

43. As explained above, availability of service is essential given that submarine cables carry at least 95 percent of international communications traffic in and out of the United States and are the primary means of connectivity for numerous U.S. states and territories. As a result, submarine cable connectivity plays a vital role in the nation's security and economy. Accordingly, we conclude that that the Cable Landing License Act and Executive Order provide the Commission with ample authority to adopt the outage reporting requirements and compliance obligations as proposed in the Notice and as adopted today, and it is critical that we exercise it.

44. Procedural Matters. Regulatory Flexibility Act. Pursuant to the Regulatory Flexibility Act of 1980, as amended, the Commission's Final Regulatory Flexibility Analysis (FRFA) relating to this Report and Order.

45. Paperwork Reduction Act. This document contains new information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. It will be submitted to the Office of Management and Budget (OMB) for review under Section 3507(d) of the PRA. OMB, the general public, and other Federal agencies are invited to comment on the new or modified information collection requirements contained in this proceeding.

46. In addition, we note that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), we previously sought specific comment on how the Commission might further reduce the information collection burden for small business concerns with fewer than 25 employees. In this present document, we have assessed the effects of the new rules adopted herein, which require submarine cable licensees to report when they experience outages of certain durations and causes, on small business concerns and find that the rules adopted here minimize the information collection burden on such entities.

47. Congressional Review Act. The Commission will send a copy of this Report & Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

48. Final Regulatory Flexibility Analysis. We adopt measures to improve the utility and effectiveness of the current scheme for receiving information on submarine cable outages, with the ultimate goal of enhancing both our overall understanding of submarine cable system status and our knowledge regarding specific outages disruptions and restoration efforts. At present, the Commission receives information regarding the operational status of submarine cables on an ad hoc and voluntary basis. We adopt the rules herein with the goal of improving the efficiency and utility of the reporting process for outages and repairs of the submarine cable network, which is a vital feature of the national and international communications infrastructure.

49. The operational status of submarine cables carries commercial, economic, social, financial, and national security implications. It is vital that the United States maintain a robust and secure communications network that can continue to provide service in spite of significant equipment or system failure, and submarine cables are an integral part of that network.

50. Description and Estimate of the Number of Small Entities to Which the Proposed Rules Will Apply. The rules adopted in the Report and Order apply only to entities licensed to construct and operate submarine cables under the Cable Landing License Act. The Report and Order requires only submarine cable licensees affected by a service outage to file outage reports with the Commission describing the outage and restoration. The entities that the Report and Order requires to file reports are a mixture of both large and small entities. The Commission has not developed a small business size standard directed specifically toward these entities. However, as described below, these entities fit into larger categories for which the SBA has developed size standards that provide these facilities or services.

51. Facilities-based Carriers. Facilities-based providers of international telecommunications services would fall into the larger category of interexchange carriers. Neither the Commission nor the SBA has developed a small business size standard specifically for providers of interexchange services. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers.

52. Wired Telecommunications Carriers. This industry comprises establishments primarily engaged in operating and/or providing access to transmission facilities and infrastructure that they own and/or lease for the transmission of voice, data, text, sound, and video using wired telecommunications networks. Transmission facilities may be based on a single technology or a combination of technologies. Establishments in this industry use the wired telecommunications network facilities that they operate to provide a variety of services, such as wired telephony services, including VoIP services; wired (cable) audio and video programming distribution; and wired broadband Internet services. By exception, establishments providing satellite television distribution services using facilities and infrastructure that they operate are included in this industry.” In this category, the SBA deems a wired telecommunications carrier to be small if it has 1,500 or fewer employees. Census data for 2007 shows 3,188 firms in this category. Of these, 3,144 had fewer than 1,000 employees. On this basis, the Commission estimates that a substantial majority of the providers of wired telecommunications carriers are small.

53. In the 2009 annual traffic and revenue report, 38 facilities-based and facilities-resale carriers reported approximately $5.8 billion in revenues from international message telephone service (IMTS). Of these, three reported IMTS revenues of more than $1 billion, eight reported IMTS revenues of more than $100 million, 10 reported IMTS revenues of more than $50 million, 20 reported IMTS revenues of more than $10 million, 25 reported IMTS revenues of more than $5 million, and 30 reported IMTS revenues of more than $1 million. Based solely on their IMTS revenues the majority of these carriers would be considered non-small entities under the SBA definition.

54. The 2009 traffic and revenue report also shows that 45 facilities-based and facilities-resale carriers (including 14 who also reported IMTS revenues) reported $683 million for international private line services; of which four reported private line revenues of more than $50 million, 12 reported private line revenues of more than $10 million, 30 reported revenues of more than $1 million, 34 reported private line revenues of more than $500,000; 41 reported revenues of more than $100,000, while 2 reported revenues of less than $10,000.

55. The 2009 traffic and revenue report also shows that seven carriers (including one that reported both IMTS and private line revenues, one that reported IMTS revenues and three that reported private line revenues) reported $50 million for international miscellaneous services, of which two reported miscellaneous services revenues of more than $1 million, one reported revenues of more than $500,000, two reported revenues of more than $200,000, one reported revenues of more than $50,000, while one reported revenues of less than $20,000. Based on its miscellaneous services revenue, this one carrier with revenues of less than $20,000 would be considered a small business under the SBA definition. Based on their private line revenues, most of these entities would be considered non-small entities under the SBA definition.

56. Providers of International Telecommunications Transmission Facilities. According to the 2012 Circuit-Status Report, 61 U.S. international facility-based carriers filed information pursuant to Section 43.82. Some of these providers would fall within the category of Inter-exchange Carriers, some would fall within the category of Wired Telecommunications Carriers, while others may fall into the category of All Other Telecommunications.

57. All Other Telecommunications. This industry comprises establishments primarily engaged in providing specialized telecommunications services, such as satellite tracking, communications telemetry, and radar station operation. This industry also includes establishments primarily engaged in providing satellite terminal stations and associated facilities connected with one or more terrestrial systems and capable of transmitting telecommunications to, and receiving telecommunications from, satellite systems. Establishments providing Internet services or voice over Internet protocol (VoIP) services via client-supplied telecommunications connections are also included in this industry. The SBA has developed a small business size standard for All Other Telecommunications, which consists of all such firms with annual receipts of $ 32.5 million or less. For this category, Census Bureau data for 2007 show that there were 2,383 firms that operated for the entire year, and of those firms, a total of 2,346 had annual receipts less than $25 million. Consequently, we conclude that the majority of All Other Telecommunications firms can be considered small.

58. Operators of Undersea Cable Systems. The Report and Order adopts reporting requirements for submarine cable facilities in the event of an outage. Neither the Commission nor the SBA has developed a size standard specifically for operators of undersea cables. Such entities would fall within the large category of Wired Telecommunications Carriers.

59. Operators of Non-Common Carrier International Transmission Facilities. Carriers that provide common carrier international transmission facilities over submarine cables are not required to report on outages, though the Report and Order seeks comment on whether such carriers should be required to provide outage reports. Neither the Commission nor the SBA has developed a small business size standard specifically for providers of non-common carrier terrestrial facilities. The operators of such terrestrial facilities would fall within the larger category of Wired Telecommunications Carriers.

60. Incumbent Local Exchange Carriers. Because some of the international terrestrial facilities that are used to provide international telecommunications services may be owned by incumbent local exchange carriers, we have included small incumbent local exchange carriers in this present RFA analysis, to the extent that such local exchange carriers may operate such international facilities. (Local exchange carriers along the U.S.-border with Mexico or Canada may have local facilities that cross the border.) Neither the Commission nor the SBA has developed a small business size standard specifically for incumbent local exchange carriers. The appropriate size standard under SBA rules is for the category Wired Telecommunications Carriers.

61. Description of Projecting Reporting, Recordkeeping, and Other Compliance Requirements. The Report and Order adopts outage reporting requirements for all submarine cable licensees. An outage occurs when a licensee experiences an event in which (1) An outage related to damages or replacements of a portion of submarine cable system between the submarine line terminal equipment (SLTE) at one end of the system and the SLTE at another end of the system for more than 30 minutes; or (2) there is a loss of any fiber pair, including losses due to terminal equipment, on a cable segment for four hours or more, regardless of the number of fiber pairs that comprise the total capacity of the cable segment. After a triggering event, the reporting requirement consists of three filings, the Notification, an Interim Report for unplanned outages, and the Final Report, which provide the Commission important data to improve the Commission's situational awareness on the operational status of submarine cables. The production and transmission of these reports to the Commission may require the use of professionals such as attorneys, engineers, or accountants. However, we conclude that such reports will be based on information already within the reporting entity's possession, and therefore these should be considered routine reports.

62. Steps Taken to Minimize Significant Economic Impact on Small Entities, and Significant Alternatives Considered. The RFA requires an agency to describe any significant, specifically small business, alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) the establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage or the rule, or any part thereof, for small entities.”

63. Ordering Clauses. Accordingly, IT IS ORDERED pursuant to sections 1, 4(i), 4(j), 4(o), of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), (j), and (o), and pursuant to the Cable Landing License Act of 1921, 47 U.S.C. 34-39 and 3 U.S.C. 301 that this Report and Order in GN Docket No. 15-206 IS ADOPTED.

64. IT IS FURTHER ORDERED that parts 1 and 4 of the Commission's rules ARE AMENDED.

65. IT IS FURTHER ORDERED that this Report and Order SHALL BE effective six months after approval of the Office of Management and Budget under the Paperwork Reduction Act.

66. IT IS FURTHER ORDERED that the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, SHALL SEND a copy of this Report and Order, including the Final Regulatory Flexibility Analysis, to the Chief Counsel for Advocacy of the Small Business Administration.

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 1 and 4 as follows:

Good Cause Exemption From Delayed Effect Date and Notice and Comment

Section 553(b)(3)(B) of title 5, U.S. Code, authorizes agencies to dispense with notice and comment procedures for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” In this instance, the Moving Ahead for Progress in the 21st Century Act (MAP-21) required the Federal Motor Carrier Safety Administration (FMCSA) to create a database for records pertaining to drug and alcohol program violations by commercial motor vehicle operators. As part of that legislative mandate, MAP-21 included a definition of the term “service agent” that is inconsistent with the current definition of “service agent” in DOT's drug and alcohol testing regulation at 49 CFR 40.3. This final rule amends the DOT regulation so that it is consistent with MAP-21 and clarifies the scope of the definition of service agent, as the term applies throughout the DOT Agencies that utilize 49 CFR part 40, including FMCSA. Since the definition of “service agent” found in 49 CFR part 40 is now inconsistent with MAP-21, DOT finds that notice and public comment to this final rule, as well as any delay in its effective date, is unnecessary as the change is already effective under the statute.

This rulemaking is promulgated pursuant to the Omnibus Transportation Employee Testing Act (OTETA) of 1991 (Pub. L. 102-143, 105 Stat. 952, (Oct. 28, 1991)) and MAP-21 (Pub. L. 112-141, 126 Stat. 802, (July 6, 2012).

Historically, service agents have played an integral role in many DOT-regulated employers' drug and alcohol testing programs. Many employers use their service agents as advisors and rely on their services to maintain compliance with DOT regulations. Service agents who are focused on compliance typically increase efficiencies and contribute to the safety of the traveling public.

MAP-21 is a transportation reauthorization bill signed into law on July 6, 2012. In response to section 32402 of the bill, codified at 49 U.S.C. 30106a, FMCSA issued a proposed rule, 79 FR 9703 (Feb. 20, 2014), to create the Commercial Driver's License Drug and Alcohol Clearinghouse (Clearinghouse) under 49 CFR part 382. The Clearinghouse would be a database containing drug and alcohol test program violations by the holders of commercial driver's licenses (CDLs) subject to 49 CFR part 382. The proposal contained, among other things, a provision that would permit motor carrier employers to designate service agents to perform various tasks on their behalf within the Clearinghouse (e.g., reporting employees' drug and alcohol violations to the Clearinghouse). MAP-21 defines a service agent as “a person or entity, other than an employee of the employer, who provides services to employers or employees under the [DOT-wide drug and alcohol] testing program” (49 U.S.C. 31306a(m)(8)).

For more than sixteen years, the term “service agent” has been defined as, “any person or entity, other than an employee of the employer, who provides services specified under this part to employers and/or employees in connection with DOT drug and alcohol testing requirements. This includes, but is not limited to, collectors, BATs [Breath Alcohol Technicians] and STTs [Saliva Testing Technicians], laboratories, MROs [Medical Review Officers], substance abuse professionals, and C/TPAs [Consortia/Third Party Administrators]. To act as service agents, persons and organizations must meet the qualifications set forth in applicable sections of this part. Service agents are not employers for purposes of this part.” (49 CFR 40.3)

In addition, over the years, the service agent industry has grown and it provides many services to DOT-regulated employers. As technology has grown, service agents have branched into providing electronic services. As the sophistication of the drug and alcohol testing industry has grown, we have seen service agents offer auditing services to DOT-regulated employers. Given the fact that additional services have been offered to employers related to DOT's drug and alcohol program, the types of providers that fall into the definition of service agent have evolved.

In this final rule, we are deleting from the current definition of “service agent” the phrases “specified under this part” and “set forth in applicable sections of this part” (both of which refer to 49 CFR part 40). We have also inserted the language “if applicable” to the definition because we believe that it is important to continue to note that if a DOT regulation requires specific qualifications, then the service agent must comply. In so doing, we are conforming to MAP-21 and clarifying that the expanding range of drug and alcohol program services has been included in this definition.

Changes to Federal regulations must undergo several analyses. First, Executive Orders 12866 and 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in 5 U.S.C. 601 et seq., requires agencies to analyze the economic impact of regulatory changes on small entities. The Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.) requires that DOT consider the impact of paperwork and other information collection burdens imposed on the public and, under the provisions of PRA section 3507(d), obtain approval from OMB for each collection of information it conducts, sponsors, or requires through regulations. Section (a)(5) of division H of the Fiscal Year 2005 Omnibus Appropriations Act, Public Law 108-447, 118 Stat. 3268 (Dec. 8, 2004) and section 208 of the E-Government Act of 2002, Public Law 107-347, 116 Stat. 2889 (Dec. 17, 2002) requires DOT to conduct a Privacy Impact Assessment (PIA) of a regulation that will affect the privacy of individuals. Finally, the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.) requires DOT to analyze this action to determine whether it will have an effect on the quality of the environment. This portion of the preamble summarizes the DOT's analyses of these impacts with respect to this final rule.

This final rule is not a significant regulatory action under Executive Order 12866 and 13563, as well as the Department's Regulatory Policies and Procedures. This rule deletes a term used in the current definition of “service agent” in 49 CFR part 40. Its provision conforms to MAP-21 and includes entities that provide additional services with respect to DOT mandated drug and alcohol testing. This rule does not propose any major policy changes or impose significant new costs or burdens.

The Regulatory Flexibility Act of 1980 (Pub. L. 96-354, “RFA”), 5 U.S.C. 601 et seq., establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation. To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.” The RFA covers a wide-range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.

Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA. However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) provides that the head of the agency may so certify, and a regulatory flexibility analysis will not be required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.

Service agents provide useful services that employers may use in order to maintain compliance with DOT regulations. This rule creates no additional burdens for service agents or the DOT-regulated employers that utilize their services. DOT has long interpreted its regulation in part 40 to encompass all services “in connection with DOT drug and alcohol testing requirements” performed by service agents. See 49 CFR 40.3. Thus, in accordance with 5 U.S.C. 605(b), I certify that this rule will not have a significant economic impact on a substantial number of small entities.

The PRA requires that the DOT consider the impact of paperwork and other information collection burdens imposed on the public. The rule does not create an impact of paperwork and other information collection burdens.

The revised definition of “service agent” does not have any impact with respect to the Privacy Act.

The agency has analyzed the environmental impacts of this proposed action pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.) and has determined that it is categorically excluded pursuant to DOT Order 5610.1C, Procedures for Considering Environmental Impacts (44 FR 56420, Oct. 1, 1979). Categorical exclusions are actions identified in an agency's NEPA implementing procedures that do not normally have a significant impact on the environment and therefore do not require either an environmental assessment (EA) or environmental impact statement (EIS). See 40 CFR 1508.4. In analyzing the applicability of a categorical exclusion, the agency must also consider whether extraordinary circumstances are present that would warrant the preparation of an EA or EIS. Id. Paragraph 3.c.5 of DOT Order 5610.1C incorporates by reference the categorical exclusions for all DOT Operating Administrations. This action is covered by the categorical exclusion listed in the Federal Highway Administration's implementing procedures, “[p]romulgation of rules, regulations, and directives.” 23 CFR 771.117(c)(20). The purpose of this rulemaking is to revise the regulation to conform to recent legislation that changed the definition of the term “service agent” in the DOT drug and alcohol testing regulations. The agency does not anticipate any environmental impacts, and there are no extraordinary circumstances present in connection with this rulemaking.

An electronic copy of a rulemaking document may be obtained by using the Internet—

1. Search regulations.gov (http://www.regulations.gov) for the docket number listed at the beginning of this document; or

2. Search the Office of the Federal Register's Web page (https://www.federalregister.gov) for the RIN listed at the beginning of this document.

In consideration of the foregoing, the Department of Transportation amends part 40 of Title 49, Code of Federal Regulations, as follows:

The snapper-grouper fishery of the South Atlantic includes lesser amberjack, almaco jack, and banded rudderfish, and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

The recreational ACL for the other jacks complex is 267,799 lb (121,472 kg), round weight. Under 50 CFR 622.193(l)(2)(i), NMFS is required to close the recreational sector for the other jacks complex when the recreational ACL has been reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined that the recreational sector for this complex is projected to reach its ACL by August 9, 2016. Therefore, this temporary rule implements an AM to close the recreational sector for the other jacks complex in the South Atlantic, effective 12:01 a.m., local time, August 9, 2016, until January 1, 2017, the start of the next fishing year.

During the recreational closure, the bag and possession limits for the fish in the other jacks complex in or from the South Atlantic EEZ are zero. Additionally, NMFS closed the commercial sector for the other jacks complex effective on August 9, 2016, upon reaching the commercial ACL. Therefore, on August 9, 2016, no commercial or recreational harvest of fish in the other jacks complex from the South Atlantic EEZ is permitted for the remainder of 2016. The commercial sector for the other jacks complex re-opens on January 1, 2017.

The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of the fish in the other jacks complex, a component of the South Atlantic snapper-grouper fishery, and is consistent with the Magnuson-Stevens Act and other applicable laws.

This action is taken under 50 CFR 622.193(l)(2)(i) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and public comment.

This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA) finds that the need to immediately implement this action to close the recreational sector for the other jacks complex constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule implementing the AM itself has been subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because of the need to immediately implement this action to protect the other jacks complex. Prior notice and opportunity for public comment would require time and would potentially allow the recreational sector to exceed its ACL.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

The small-mesh multispecies fishery is managed primarily through a series of exemptions from the Northeast Multispecies Fisheries Management Plan. Regulations governing the red hake fishery are found at 50 CFR part 648. The regulations describing the process to adjust inseason commercial possession limits of northern red hake are described in § 648.86(d)(4) and (5). These regulations require the Regional Administrator to reduce the northern red hake possession limit from 3,000 lb (1,361 kg) to 1,500 lb (680 kg) when landings have been projected to reach or exceed 45 percent of the total allowable landings (TAL). The northern red hake possession limit is required to be further reduced to 400 lb (181 kg) if landings are projected to reach or exceed 62.5 percent of the TAL, unless such a reduction would be expected to prevent the TAL from being reached. The setting of these inseason adjustment thresholds were established in the final rule implementing the small-mesh multispecies specifications for 2015-2017, published in the Federal Register on May 28, 2015 (80 FR 30379).

These measures were imposed because the annual catch limits (ACL) for northern red hake were exceeded for the 2012 and 2013 fishing years, and northern red hake was experiencing overfishing. To reduce the risk of continued overfishing on the stock and to better constrain catch to the ACL, we implemented this possession limit reduction trigger.

Based on commercial landings data reported through July 23, 2016, the northern red hake fishery is projected to reach 45 percent of the TAL on July 31, 2016. Based on this projection, reducing the commercial northern red hake possession limit to 1,500 lb (680 kg) is required to prevent the TAL from being exceeded. Upon the effective date of this action, no person may possess on board or land more than 1,500 lb (680 kg) of northern red hake, per trip for the remainder of the fishing year.

This action is taken under 50 CFR part 648 and is exempt from review under Executive Order 12866.

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

In the Aleutian Islands subarea, the portion of the 2016 pollock total allowable catch (TAC) allocated to the Aleut Corporation directed fishing allowance (DFA) is 9,700 metric tons (mt) as established by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016), and as adjusted by reallocations (81 FR 16097, March 25, 2016).

As of August 1, 2016, the Administrator, Alaska Region, NMFS, (Regional Administrator) has determined that 8,000 mt of the Aleut Corporation pollock DFA in the Aleutian Islands subarea will not be harvested. Therefore, in accordance with § 679.20(a)(5)(iii)(B)(4), NMFS reallocates 8,000 mt of A season pollock DFA from the Aleutian Islands subarea to the 2016 Bering Sea subarea DFAs. The 8,000 mt of the Aleut Corporation pollock DFA is added to the 2016 Bering Sea non-CDQ DFAs. As a result, the 2016 harvest specifications for pollock in the Aleutian Islands subarea included in the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016), and as adjusted by reallocations (81 FR 16097, March 25, 2016) are revised as follows: 1,700 mt to the annual Aleut Corporation pollock DFA and 1,700 mt to the A season Aleut Corporation pollock DFA. Furthermore, pursuant to § 679.20(a)(5), Table 5 of the final 2016 and 2017 harvest specifications for groundfish in the Bering Sea and Aleutian Islands (81 FR 14773, March 18, 2016, and 81 FR 16097, March 25, 2016), is revised to make 2016 pollock allocations consistent with this reallocation. This reallocation results in adjustments to the 2016 pollock allocations established at § 679.20(a)(5).

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the reallocation of Aleutian Island subarea pollock. Since the pollock fishery is currently underway, it is important to immediately inform the industry as to the final Bering Sea and Aleutian Islands pollock allocations. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery; allow the industry to plan for the fishing season and avoid potential disruption to the fishing fleet as well as processors; and provide opportunity to harvest increased seasonal pollock allocations while value is optimum. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as August 1, 2016.

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

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