The Federal Reserve Banks make primary and secondary credit available to depository institutions as a backup source of funding on a short-term basis, usually overnight. The primary and secondary credit rates are the interest rates that the twelve Federal Reserve Banks charge for extensions of credit under these programs. In accordance with the Federal Reserve Act, the primary and secondary credit rates are established by the boards of directors of the Federal Reserve Banks, subject to the review and determination of the Board.

On July 31, 2019, the Board voted to approve a 1/4 percentage point decrease in the primary credit rate in effect at each of the twelve Federal Reserve Banks, thereby decreasing from 3.00 percent to 2.75 percent the rate that each Reserve Bank charges for extensions of primary credit. In addition, the Board had previously approved the renewal of the secondary credit rate formula, the primary credit rate plus 50 basis points. Under the formula, the secondary credit rate in effect at each of the twelve Federal Reserve Banks decreased by 1/4 percentage point as a result of the Board's primary credit rate action, thereby decreasing from 3.50 percent to 3.25 percent the rate that each Reserve Bank charges for extensions of secondary credit. The amendments to Regulation A reflect these rate changes.

The 1/4 percentage point decrease in the primary credit rate was associated with a decrease in the target range for the federal funds rate (from a target range of 2 1/4 to 2 1/2 percent to a target range of 2 to 2 1/4 percent) announced by the Federal Open Market Committee on July 31, 2019, as described in the Board's amendment of its Regulation D published elsewhere in today's Federal Register .

In general, the Administrative Procedure Act (“APA”)  1 imposes three principal requirements when an agency promulgates legislative rules (rules made pursuant to congressionally delegated authority): (1) Publication with adequate notice of a proposed rule; (2) followed by a meaningful opportunity for the public to comment on the rule's content; and (3) publication of the final rule not less than 30 days before its effective date. The APA provides that notice and comment procedures do not apply if the agency for good cause finds them to be “unnecessary, impracticable, or contrary to the public interest.”  2 Section 553(d) of the APA also provides that publication at least 30 days prior to a rule's effective date is not required for (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) a rule for which the agency finds good cause for shortened notice and publishes its reasoning with the rule. 3 The APA further provides that the notice, public comment, and delayed effective date requirements of 5 U.S.C. 553 do not apply “to the extent that there is involved . . . a matter relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.”  4

Regulation A establishes the interest rates that the twelve Reserve Banks charge for extensions of primary credit and secondary credit. The Board has determined that the notice, public comment, and delayed effective date requirements of the APA do not apply to these final amendments to Regulation A. The amendments involve a matter relating to loans and are therefore exempt under the terms of the APA. Furthermore, because delay would undermine the Board's action in responding to economic data and conditions, the Board has determined that “good cause” exists within the meaning of the APA to dispense with the notice, public comment, and delayed effective date procedures of the APA with respect to the final amendments to Regulation A.

The Regulatory Flexibility Act (“RFA”) does not apply to a rulemaking where a general notice of proposed rulemaking is not required. 5 As noted previously, a general notice of proposed rulemaking is not required if the final rule involves a matter relating to loans. Furthermore, the Board has determined that it is unnecessary and contrary to the public interest to publish a general notice of proposed rulemaking for this final rule. Accordingly, the RFA's requirements relating to an initial and final regulatory flexibility analysis do not apply.

For monetary policy purposes, section 19 of the Federal Reserve Act (“the Act”) imposes reserve requirements on certain types of deposits and other liabilities of depository institutions. 1 Regulation D, which implements section 19 of the Act, requires that a depository institution meet reserve requirements by holding cash in its vault, or if vault cash is insufficient, by maintaining a balance in an account at a Federal Reserve Bank (“Reserve Bank”). 2 Section 19 also provides that balances maintained by or on behalf of certain institutions in an account at a Reserve Bank may receive earnings to be paid by the Reserve Bank at least once each quarter, at a rate or rates not to exceed the general level of short-term interest rates. 3 Institutions that are eligible to receive earnings on their balances held at Reserve Banks (“eligible institutions”) include depository institutions and certain other institutions. 4 Section 19 also provides that the Board may prescribe regulations concerning the payment of earnings on balances at a Reserve Bank. 5 Prior to these amendments, Regulation D specified a rate of 2.35 percent for both IORR and IOER. 6

The Board is amending § 204.10(b)(5) of Regulation D to specify that IORR is 2.10 percent and IOER is 2.10 percent. This 0.25 percentage point decrease in each rate was associated with a decrease in the target range for the federal funds rate, from a target range of 2 1/4 to 2 1/2 percent to a target range of 2 to 2 1/4 percent, announced by the FOMC on July 31, 2019, with an effective date of August 1, 2019. The FOMC's press release on the same day as the announcement noted that:

A Federal Reserve Implementation note released simultaneously with the announcement stated:

As a result, the Board is amending § 204.10(b)(5) of Regulation D to change IORR to 2.10 percent and IOER to 2.10 percent.

In general, the Administrative Procedure Act (“APA”)  7 imposes three principal requirements when an agency promulgates legislative rules (rules made pursuant to congressionally delegated authority): (1) Publication with adequate notice of a proposed rule; (2) followed by a meaningful opportunity for the public to comment on the rule's content; and (3) publication of the final rule not less than 30 days before its effective date. The APA provides that notice and comment procedures do not apply if the agency for good cause finds them to be “unnecessary, impracticable, or contrary to the public interest.”  8 Section 553(d) of the APA also provides that publication at least 30 days prior to a rule's effective date is not required for (1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretive rules and statements of policy; or (3) a rule for which the agency finds good cause for shortened notice and publishes its reasoning with the rule. 9

The Board has determined that good cause exists for finding that the notice, public comment, and delayed effective date provisions of the APA are unnecessary, impracticable, or contrary to the public interest with respect to these final amendments to Regulation D. The rate changes for IORR and IOER that are reflected in the final amendments to Regulation D were made with a view towards accommodating commerce and business and with regard to their bearing upon the general credit situation of the country. Notice and public comment would prevent the Board's action from being effective as promptly as necessary in the public interest and would not otherwise serve any useful purpose. Notice, public comment, and a delayed effective date would create uncertainty about the finality and effectiveness of the Board's action and undermine the effectiveness of that action. Accordingly, the Board has determined that good cause exists to dispense with the notice, public comment, and delayed effective date procedures of the APA with respect to these final amendments to Regulation D.

The Regulatory Flexibility Act (“RFA”) does not apply to a rulemaking where a general notice of proposed rulemaking is not required. 10 As noted previously, the Board has determined that it is unnecessary and contrary to the public interest to publish a general notice of proposed rulemaking for this final rule. Accordingly, the RFA's requirements relating to an initial and final regulatory flexibility analysis do not apply.

In accordance with the Paperwork Reduction Act (“PRA”) of 1995, 11 the Board reviewed the final rule under the authority delegated to the Board by the Office of Management and Budget. The final rule contains no requirements subject to the PRA.

For the reasons set forth in the preamble, the Board amends 12 CFR part 204 as follows:

This final rule removes 32 CFR part 633, “Individual Requests for Access or Amendment of CID Reports of Investigation,” which was originally codified on July 27, 1979 (44 FR 44156), and most recently updated on May 17, 2013 (78 FR 29019). It has been determined that publication of this CFR part removal for public comment is impracticable, unnecessary, and contrary to public interest since it is based on removing content which is covered in DoD regulations at 32 CFR part 286, “DoD Freedom of Information Act (FOIA) Program” (last updated January 5, 2017, at 82 FR 1197), and 32 CFR part 310, “DoD Privacy Program” (last updated April 11, 2019 at 84 FR 14730).

Additional internal Army guidance is published in Army Regulation 190-45, “Law Enforcement Reporting,” (available at https://armypubs.army.mil/ProductMaps/PubForm/AR.aspx ) which was most recently updated on September 27, 2016.

This rule is not significant under Executive Order (E.O.) 12866, “Regulatory Planning and Review,” therefore, E.O. 13771, “Reducing Regulation and Controlling Regulatory Costs” does not apply.

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Sector Ohio Valley DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary 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 a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. It is impracticable to publish an NPRM because we must establish this safety zone by August 31, 2019 and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing this rule.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be contrary to the public interest because immediate action is needed to respond to the potential safety hazards associated with the Newburgh Fireworks display.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Ohio Valley (COTP) has determined that potential hazards associated with the fireworks display on August 31, 2019 will be a safety concern for anyone on a one-mile stretch of the Ohio River. The purpose of this rule is to ensure safety of persons, vessels, and the marine environment on the navigable waters in the regulated area before, during, and after the scheduled event.

This rule establishes a safety zone from 9:30 p.m. through 10 p.m. on August 31, 2019. The safety zone will cover all navigable waters, extending the entire width of the river, from mile marker (MM) 777.3 to MM 778.3. No vessels or persons will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

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 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, location, and duration of the temporary safety zone. This safety zone restricts transit on a one-mile stretch of the Ohio River for thirty minutes on one day. Moreover, the Coast Guard would issue Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and Marine Safety Information Bulletins (MSIBs) about this safety zone so that waterway users may plan accordingly for this short restriction on transit, and the rule would allow vessels to request permission to enter the 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 the temporary safety zone 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 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 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 Directive 023-01 and Environmental Planning COMDTINST 5090.1 (series), 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 rule involves a safety zone lasting only thirty minutes that will prohibit entry within a one-mile stretch of the Ohio River for one day. It is categorically excluded from further review under paragraph L60(a) in Table 3-1 of U.S. Coast Guard Environmental Planning Implementing Procedures 5090.1. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES .

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:

Purpose of Program: Section 616 of the IDEA requires States to submit to the Department, and make available to the public, a State performance plan (SPP) and an annual performance report (APR) with data on how each State implements both Parts B and C of the IDEA to improve outcomes for infants, toddlers, children, and youth with disabilities. Section 618 of the IDEA requires States to submit to the Department, and make available to the public, quantitative data on infants, toddlers, children, and youth with disabilities who are receiving early intervention and special education services under IDEA. The purpose of the Technical Assistance on State Data Collection program is to improve the capacity of States to meet IDEA data collection and reporting requirements under Sections 616 and 618 of the IDEA. Funding for the program is authorized under section 611(c)(1) of IDEA, which gives the Secretary the authority to reserve up to 1/2 of 1 percent of the amounts appropriated under Part B for each fiscal year to provide TA, where needed, to improve the capacity of States to meet the data collection and reporting requirements under Parts B and C of IDEA. The maximum amount the Secretary may reserve under this set-aside for any fiscal year is $25,000,000, cumulatively adjusted by the rate of inflation. Section 616(i) of IDEA requires the Secretary to review the data collection and analysis capacity of States to ensure that data and information determined necessary for the implementation of section 616 of IDEA are collected, analyzed, and accurately reported to the Secretary. It also requires the Secretary to provide TA, where needed, to improve the capacity of States to meet the data collection requirements, which include the data collection and reporting requirements in sections 616 and 618 of IDEA. Additionally, Division H of the Consolidated Appropriations Act of 2018 gives the Secretary the authority to use funds reserved under section 611(c) to “carry out other services and activities to improve data collection, coordination, quality, and use under Parts B and C of the IDEA.” Consolidated Appropriations Act, 2018; Div. H, Title III of Public Law 115-141; 132 Stat. 745 (2018).

Program Authority: 20 U.S.C. 1411(c), 1416(i), 1418(c), and 1442; and Department of Education Appropriations Act, 2018; Div. H, Title III of Public Law 115-141, Consolidated Appropriations Act, 2018; 132 Stat. 745 (2018).

Applicable Program Regulations: 34 CFR 300.702.

We published a notice of proposed priority and requirements for this program in the Federal Register on March 6, 2019 (84 FR 8059) (the NPP). The NPP contained background information and our reasons for proposing the particular priority and requirements.

There are differences between the NPP and this notice of final priority and requirements (NFP) as discussed in the Analysis of Comments and Changes section of this document. The most significant of these changes, as discussed below, is the addition of an indirect cost rate cap to the final requirements.

Public Comment: In response to our invitation in the NPP, 14 parties submitted comments on the proposed priority and requirements.

Generally, we do not address technical and other minor changes, or suggested changes the law does not authorize us to make under the applicable statutory authority. In addition, we do not address comments that raised concerns not directly related to the proposed priority and requirements.

Analysis of Comments and Changes: An analysis of the comments and changes in the priority and requirements since publication of the NPP follows. OSERS received comments on a number of specific topics from the proposed cap on the maximum allowable indirect cost rate to the topics for technical assistance. Each topic is addressed below.

Comments: Several commenters were supportive of the notice of proposed priority and requirements for this program as it was published in the Federal Register on March 6, 2019.

Discussion: The Department appreciates the commenters' support.

Changes: None.

Comments: None.

Discussion: As discussed in the NPP, the Department is particularly concerned about maximizing the efficiency and effectiveness of this investment. Given the purpose of the program, we believe a critical lever to meeting this goal is to ensure that TA is appropriately targeted to recipients with a known and ongoing need for support in reporting, analyzing, and using high quality IDEA data. As such, the Department is adding a requirement that applicants describe their proposed approach to prioritizing TA recipients with a particular focus on meeting the needs of States with ongoing data quality issues.

Changes: The final priority includes a requirement for applicants to describe their proposed approach to prioritizing TA recipients.

Comments: A number of commenters agreed with the purpose of the indirect cost cap, which is to maximize funds that go directly to provide TA to States to improve their capacity to meet the IDEA data collection and reporting requirements. These same commenters, however, believed that setting a cap on indirect costs would not achieve this goal and that it may negatively impact the program. They noted that indirect costs support a wide variety of purchases and activities, including, but not limited to, facilities, information technology (IT) services, and support personnel. Further, a subset of these commenters stated that a cap on indirect cost rates would limit competition, reduce the number of qualified applicants, and likely degrade the quality of TA services provided to States. Specifically, some of these commenters stated that a cap could make it cost prohibitive for small businesses to compete for the grant, as they could not absorb any unrecovered indirect costs. Additionally, it would make it harder for applicants to attract and retain qualified personnel, thus depressing the quality of services provided to States.

Discussion: The Department appreciates the stakeholder input it received in response to the specific directed question on the indirect cost cap proposal but disagrees that it would have a negative impact on the program. Regarding potential impact, the Department has done an analysis of the indirect cost rates for all current technical assistance centers funded under the Technical Assistance on State Data Collection programs as well as other grantees that are large, midsize, and small businesses and small nonprofit organizations and has found that, in general, total indirect costs charged on these grants by these entities were at or below 35 percent of total direct costs. We recognize that, dependent on the structure of the investment and activities, the modified total direct cost (MTDC) base could be much smaller than the total direct cost, which would imply a higher indirect cost rate than those calculated here. The Department arrived at a 40 percent rate to address some of that variation. Such a change accounts for a 12 percent variance between TDC and MTDC. However, we note that, in the absence of a cap, certain entities would likely charge indirect cost rates in excess of 40 percent of MTDC. Based on our review, it appears that those entities would likely be larger for-profit and nonprofit organizations, but these organizations appear to be outliers when compared to the majority of other large businesses as well as the entirety of OSEP's grantees. Setting an indirect cost rate cap at 40 percent is in line with the majority of applicant's existing negotiated rates with their cognizant Federal agency. Therefore, we do not believe that the cap we are setting in these final requirements would negatively impact the majority of entities' ability to recover indirect costs.

Regarding commenters' concerns that a cap on indirect costs would limit competition and reduce the number of qualified applicants, it is not clear how a cap would do so. The cap included in the final requirements does not limit the pool of eligible applicants because most entities' indirect cost rates are below the cap we are setting. Further, regarding the impact on the quality of TA services provided to States, we have no information indicating a direct correlation between an entity's negotiated indirect cost rate and its ability to attract and retain qualified personnel and thus their ability to provide high-quality TA services to States. Based on our analysis, there are many OSEP grantees that are able to effectively carry out project activities required by their individual grants with negotiated indirect cost rates under the cap included in the final requirements. Further, the Department's peer review process is intended to assess the ability of various applicants to provide high-quality TA to States. Finally, we do not believe the cap we are setting in these final requirements would result in an amount of unrecovered costs that would deter most prospective applicants. The prospective applicants could look at the cost cap prior to applying and either choose to absorb unrecovered costs or opt not to apply.

In light of these considerations, we have determined that placing an indirect cost cap that is the lesser of the percentage approved by the grantee's cognizant Federal agency and 40 percent for this priority is appropriate as it maximizes the availability of funds for the primary technical assistance purposes of this priority, which is to improve the capacity of States to meet the data collection and reporting requirements under Parts B and C of IDEA and to ultimately benefit programs serving children with disabilities.

Changes: Paragraph (d)(5) of the final requirements now includes an indirect cost cap that is the lessor of the percentage approved by the grantee's cognizant Federal agency and a cap of 40 percent on the reimbursement of indirect costs.

Comments: A number of commenters expressed concerns that many of the most qualified organizations could not compete because once indirect cost rates are set by, and audited by, a cognizant agency, they cannot be lowered for a single project.

Discussion: We considered this requirement based on 2 CFR 200.414(c)(1), which allows a Federal awarding agency to use an indirect cost rate different from the negotiated rate when required by Federal statute or regulation or when approved by a Federal awarding agency head based on documented justification when the Federal awarding agency implements, and makes publicly available, the policies, procedures, and general decision making criteria that their programs will follow to seek and justify deviations from negotiated rates. Federal discretionary grantees have historically been reimbursed for indirect costs at the rate that each grantee negotiates with its cognizant Federal agency, and we believe that use of the negotiated rate is appropriate for most grants in most circumstances. However, because funding for this program comes from funds reserved by the Department that would otherwise be allocated to States under Part B (which applies a restricted indirect cost rate to State grantees), we determined that using an indirect cost rate different from the negotiated rate was appropriate since it would maximize funds available to provide TA to States to improve their capacity to meet the IDEA data collection and reporting requirements.

Changes: None.

Comments: Numerous commenters expressed concerns that the implementation of an indirect cost rate limit would not impact each vendor equally or result in equal savings to the government, as categories of indirect costs vary across vendors.

Discussion: We appreciate the commenters' concerns and recognize that a cap on the indirect cost rate, although it would apply equally to all applicants, may be more difficult for particular entities to meet, particularly those with high negotiated indirect cost rates. However, as noted above, our analysis indicates that the rate established in the final requirements would not appear to create unreasonable burdens for many applicants. Further, it was not the Department's intention to institute a limit on the reimbursement of indirect costs by specific cost category, but rather to apply it as a percentage of MTDC. We have clarified in the final requirements that the limit applies to MTDC as defined in 2 CFR 200.68. As the MTDC is applied to the total direct costs of the grant, each grantee's MTDC will include direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and up to the first $25,000 of each subaward, thus ensuring equity across vendors.

Changes: The final requirement clarifies that the 40 percent maximum indirect cost rate is applied to MTDC as defined in 2 CFR 200.68.

Comments: Two commenters provided alternatives to setting a cap. One commenter proposed gauging competitiveness based on a vendor's total price in combination with the proposed quality and level of effort. A second commenter suggested that the program add a cost share requirement in lieu of an indirect cost cap. The commenter suggested that a modest cost share may not impact vendor economics to the same degree as a cap on indirect costs.

Discussion: The Department appreciates the commenters' suggestions. Regarding gauging competitiveness based on a vendor's total price in combination with the proposed quality and level of effort, this may represent a viable approach for contract procurement, but does not lend itself to making discretionary grant awards. Regarding the second commenter's recommendation to add a cost share requirement, the nature of the funding source for this program does not allow for a cost sharing requirement and, in addition, could have the unintended consequence of eliminating small businesses.

Changes: None.

Comments: One commenter advocated for the Department to provide clarification and guidance to States on what should be covered by indirect cost rates and how to determine appropriate indirect cost rates. Additionally, a second commenter suggested the Department allow States the flexibility to determine and justify funds allocated to indirect costs.

Discussion: The Department appreciates the commenters' suggestions. We were not proposing a cap on the indirect cost rates for State formula grants. Clarification or guidance on what is or is not an indirect cost can be obtained from the indirect cost office of the applicant's cognizant Federal agency.

Changes: None.

Comment: One commenter highlighted the need for the proposed center to support States in their data collection initiatives and to give States the leeway to identify issues that are particular to the State and its population.

Discussion: The Department agrees with the commenter, and believes that the center is already designed to support this objective. This center will design and provide TA on collecting, reporting, analyzing, and using high-quality IDEA Part C early intervention data and IDEA Part B preschool special education data based on needs identified by the States. States will have the opportunity to engage in TA with the center in various ways ( i.e., universal TA, targeted TA, and intensive TA). Through these different levels of TA, this center will be able to meet specific State requests for assistance related to collecting, reporting, analyzing, and using high-quality IDEA Part C early intervention data and IDEA Part B preschool special education data.

Changes: None.

Comment: One commenter voiced a concern that the resources generated by the proposed center may overlap with the resources provided by other Office of Special Education Programs (OSEP) funded TA centers. They highlighted the importance of clarifying each entity's role and reducing duplication of services to help States to make more efficient use of resources and cut costs.

Discussion: The Department agrees any overlap in the scopes of TA centers should be minimized and duplication should be avoided. The Department has redefined the scope of this center, as well as the scope of the National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate IDEA Part B Data, CFDA number 84.373Y, in order to minimize unnecessary overlap. Where similar topics are within scope for multiple TA centers, we believe that effective communication and collaboration among these centers will prevent duplication and assist States in efficiently identifying, accessing, and using resources provided by these centers.

Changes: We have revised the purpose of priority to remove TA on the section 618, Part B Child Count and Educational Environments data for children with disabilities ages 3 through 5 from the scope of this center. This TA will be provided by the National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate IDEA Part B Data, CFDA number 84.373Y. In addition, we revised paragraph (b)(5)(iv)(F) of the requirements to require applicants to propose a plan for collaborating and coordinating with the National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate IDEA Part B Data, and other Department-funded TA investments. Applicants must propose how they will align complementary work and jointly develop and implement products and services with other TA centers to meet the purposes of this priority and to develop and implement a coordinated TA plan when they are involved in a State. This structure that specifies more distinct portfolios of the centers ( i.e., less overlap) will make it easier for States to work with the two centers.

Comment: One commenter noted the States' continued need for data-related TA on significant disproportionality.

Discussion: States typically use Part B Child Count, Part B Educational Environment, and Part B Discipline data to analyze significant disproportionality. Since these data are outside of the scope of this priority, this center will not provide TA on this topic.

Changes: None.

Comment: One commenter voiced a concern with splitting the responsibilities of providing TA on the IDEA Part B preschool special education data between the proposed center and the National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate IDEA Part B Data, CFDA number 84.373Y. The commenter stated that splitting the responsibilities regarding the IDEA Part B preschool special education data across the two centers may require Part B data managers to work with both centers in order to improve the quality of their IDEA Part B preschool special education data.

Discussion: The Department appreciates the commenter's concerns. The Department believes that including IDEA Part B preschool special education data in the scope of this center makes senses for some of the IDEA data and including IDEA Part B preschool special education data in the scope of the National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate IDEA Part B Data, CFDA number 84.373Y, is appropriate for other IDEA data.

The Department believes that including the IDEA Part B preschool special education data required under IDEA section 616 for Indicators B-7 (Preschool Outcomes) and B-12 (Early Childhood Transition) within the scope for this center is appropriate because it will facilitate better linkages between the Part C data and the IDEA Part B preschool special education data on children with disabilities and the inclusion of the Part C and IDEA Part B preschool special education data in the Early Childhood Integrated Data Systems (ECIDS). This will allow for enhanced opportunities to improve the quality of data States are collecting, reporting, analyzing, and using related to children's transition from the Part C early intervention program to the Part B preschool special education program. In addition, due to the similarities in the type of data required under IDEA section 616 for Indicator C-3 (Infant and Toddler Outcomes) in the Part C SPP/APR and Indicator B-7 (Preschool Outcomes) in the Part B SPP/APR, it is more efficient to have this center provide TA on these data.

The Department believes that including the IDEA Part B preschool special education data required under IDEA section 618 (including the section 618, Part B Child Count and Educational Environments data) and those preschool data required under IDEA section 616 for indicators in the IDEA Part B State Performance Plan/Annual Performance Report (SPP/APR) that solely use the ED Facts data as the source for reporting, such as Indicator B-5 (Preschool Least Restrictive Environment), within the scope of the National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate IDEA Part B Data, CFDA number 84.373Y will allow States to obtain TA on IDEA data submitted via ED Facts from a single center. Since a State Part B data manager plays a significant role in submitting the IDEA data on children with disabilities ages 3 through 5 and children with disabilities ages 6 through 21 via ED Facts, the data manager will be able to access TA on these data through a single center. Finally, this will allow States to receive TA on IDEA data-related topics and analyses that are supported by and use IDEA section 618 data submitted via ED Facts.

Changes: None.

Comment: One commenter asked how this funding opportunity will benefit students from low income families.

Discussion: As specified by IDEA, the purpose of the Technical Assistance on State Data Collection program is to improve the capacity of States to meet IDEA data collection and reporting requirements. This center's primary audiences and recipients of TA will be State level staff who work with the IDEA Part B preschool special education programs and IDEA Part C early intervention programs. This center will not provide direct services to children with disabilities. This center will facilitate, support, and encourage the States use of data to improve IDEA program for all infants, toddlers, and children with disabilities served under IDEA.

Changes: None.

Comment: A commenter recommended that the Department collect data on students who identify in a gender-neutral category, use a different language/communication system, or are born in the United States but do not speak English as their first language, and on their socioeconomic status, parental English fluency, and parents' highest educational level.

Discussion: The Department appreciates the comment; however, this priority does not address the data collection and reporting requirements for States under IDEA. The ED Facts information collection package (OMB control number 1850-0925), which would more squarely address these issues, was published in the Federal Register on April 8, 2019 (84 FR 13913). It addressed the IDEA Section 618 Part B data collection requirements and was open for public comment from April 8, 2019, to May 8, 2019.

Changes: None.

Comment: One commenter stated that the definition of evidence-based practices (EBPs) used in the proposed requirements does not align with the highest level of available evidence, and that EBP is a dynamic process that requires ongoing evaluation.

Discussion: We understood the commenter to be recommending a higher level of evidence than required in the proposed requirements. We agree with the commenter regarding the importance of ensuring the provision of effective TA to States; however, we do not agree that the definition of EBPs used in the proposed requirements is insufficient. We are continually reviewing the effectiveness of services provided by our federally funded TA centers. We believe that the definition of EBPs used in the proposed requirements—the definition in 34 CFR 77.1—is well established and provides the necessary standards against which high-quality services may be judged for the purposes of making an award and monitoring the implementation of TA to improve the capacity of States to meet the data collection and reporting requirements under Parts B and C of IDEA.

Changes: None.

Comment: None.

Discussion: As a result of our further review of the proposed priority and requirements and public comments received for the two notices of proposed priority under the TA on State Data Collection program published in the Federal Register on March 6, 2019, we realized that the requirement to use 50 percent of the funds for intensive, sustained TA needed to be updated to align with the requirement in the priority establishing the National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate IDEA Part B Data, CFDA number 84.373Y. The Department believes that aligning the two priorities, whenever possible, will allow for more efficient collaborations and will allow the centers funded under these two priorities to provide a clear and seamless set of TA services related to collecting, reporting, analyzing, and using high-quality IDEA data on infants, toddlers, and children with disabilities, birth through age 21, to States.

Changes: We have changed the requirement to use 50 percent of the funds for intensive, sustained TA to a requirement to use 50 percent of funds for targeted and intensive TA to States.

Final Priority:

National Technical Assistance Center To Improve State Capacity To Collect, Report, Analyze, and Use Accurate Early Childhood IDEA Data.

The purpose of this priority is to fund a cooperative agreement to establish and operate a National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate Early Childhood IDEA Data (Center).

The Center will focus on providing TA on collecting, reporting, analyzing, and using Part C data required under sections 616 and 618 of IDEA and Part B data on children with disabilities, ages 3 through 5, required under section 616 of IDEA for those indicators that are not solely based on IDEA section 618 data ( e.g., Annual Performance Report (APR) Indicators B7 (Preschool Children with Improved Outcomes) and B12 (Transition Between Part C and Part B). The Center will provide TA to (1) improve States' capacity to collect, report, analyze, and use high-quality IDEA Part C data (including IDEA section 618 Part C data and IDEA section 616 Part C data) and IDEA Part B preschool special education data; and (2) enhance, streamline, and integrate statewide, child-level early childhood data systems (including Part C and Part B preschool special education data systems) to address critical policy questions that will facilitate program improvement, improve compliance accountability, and improve outcomes or results for children served under Part C and Part B preschool special education programs. These Part C early intervention and Part B preschool special education data systems must allow the States to: (1) Effectively and efficiently respond to all IDEA-related data submission requirements ( e.g., Part C section 616 and 618 data and Part B preschool special education data); (2) respond to critical policy questions that will facilitate program improvement and compliance accountability; and (3) comply with applicable privacy requirements, including the confidentiality requirements under Parts B and C of IDEA, the Privacy Rule under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR part 160 and subparts A and E of part 164), and the Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. 1232g) and its regulations at 34 CFR part 99.

The Center must be designed to achieve, at a minimum, the following expected outcomes:

(a) Increased capacity of States to collect, report, analyze, and use high-quality IDEA Part C data (including IDEA section 616 Part C data and section 618 Part C data);

(b) Increased capacity of States to collect, report, analyze, and use high-quality IDEA Part B preschool special education data;

(c) Increased number of States that use their Part C early intervention and Part B preschool special education data system to answer critical State-determined policy questions to drive program improvement, improve results for children with disabilities, and improve compliance accountability;

(d) Increased number of States with integrated or linked Part C early intervention and Part B preschool special education data;

(e) Increased number of States that use linked or integrated early childhood data to improve program compliance and accountability;

(f) Increased number of States with data system integration plans that allow for the linking of Part C and Part B preschool special education data as well as linking to other statewide longitudinal and early learning data systems and that comply with all applicable privacy laws;

(g) Increased capacity of States to implement and document Part C and Part B preschool special education data management policies and procedures and data system integration activities and to develop a sustainability plan to continue this data management and data system integration work in the future; and

(h) Increased capacity of States to address personnel training needs to meet the Part C and Part B preschool special education data collection and reporting requirements under sections 616 and 618 of IDEA through development of effective tools ( e.g., training modules) and resources ( e.g., new Part C Data Managers resources), as well as providing opportunities for in-person and virtual cross-State collaboration about Part C data (required under sections 616 and 618 of IDEA) and Part B preschool special education data collection and reporting requirements that States can use to train personnel in local programs and agencies.

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)).

The Assistant Secretary establishes the following requirements for this program. We may apply one or more of these requirements in any year in which this program is in effect.

Requirements:

Applicants must—

(a) Demonstrate, in the narrative section of the application under “Significance,” how the proposed project will—

(1) Address State challenges associated with early childhood data management and data system integration, including implementing early childhood data system integration and improvements; enhancing and streamlining Part C early intervention and Part B preschool special education data systems to respond to critical policy questions; using ECIDS for program improvement and compliance accountability for Part C early intervention and Part B preschool special education programs; and reporting high-quality IDEA Part C data (including IDEA section 616 Part C data and section 618 Part C data) and IDEA Part B preschool special education data to the Department and the public. To meet this requirement the applicant must—

(i) Present applicable national, State, or local data demonstrating the challenges of States to implement effective early childhood data management policies and procedures and data system integration activities, including integrating early childhood data systems across IDEA programs, other early learning programs, and other educational programs for school-aged students; linking Part C and Part B preschool special education program data; and using their Part C and Part B preschool special education data systems to respond to critical State-determined policy questions for program improvement and compliance accountability;

(ii) Demonstrate knowledge of current educational and technical issues and policy initiatives relating to early childhood data management and data system integration, data use, data privacy, Part C IDEA sections 616 and 618 data, Part B preschool special education data, and Part C and Part B preschool special education data systems; and

(iii) Present information about the current level of implementation of integrating or linking Part C and Part B preschool special education data systems; integrating or linking Part C and/or Part B preschool special education data systems with other early learning data systems; using Part C and Part B preschool special education data systems to respond to critical State-determined policy questions; and collecting, reporting, analyzing, and using high-quality IDEA Part C data (including IDEA section 616 Part C data and section 618 Part C data) and IDEA Part B preschool special education data; and

(2) Improve early childhood data management policies and procedures and data system integration activities used to collect, report, and analyze high-quality Part C and Part B preschool special education data; to integrate or link Part C and Part B preschool special education data systems as well as integrate or link these data with data on children participating in other early learning programs and data on school-aged children; and to develop and use robust early childhood data systems to answer critical State-determined policy questions and indicate the likely magnitude or importance of the improvements.

(b) Demonstrate, in the narrative section of the application under “Quality of project services,” how the proposed project will—

(1) Ensure equal access and treatment for members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. To meet this requirement, the applicant must describe how it will—

(i) Identify the needs of the intended recipients for TA and information; and

(ii) Ensure that products and services meet the needs of the intended recipients of the grant;

(2) Achieve its goals, objectives, and intended outcomes. To meet this requirement, the applicant must provide—

(i) Measurable intended project outcomes; and

(ii) In Appendix A, the logic model (as defined in 34 CFR 77.1) by which the proposed project will achieve its intended outcomes that depicts, at a minimum, the goals, activities, outputs, and intended outcomes of the proposed project;

(3) Use a conceptual framework (and provide a copy in Appendix A) to develop project plans and activities, describing any underlying concepts, assumptions, expectations, beliefs, or theories, as well as the presumed relationships or linkages among these variables, and any empirical support for this framework;

Note: The following websites provide more information on logic models and conceptual frameworks: www.osepideasthatwork.org/logicModel and www.osepideasthatwork.org/resources-grantees/program-areas/ta-ta/tad-project-logic-model-and-conceptual-framework.

(4) Be based on current research and make use of evidence-based  1 practices (EBPs). To meet this requirement, the applicant must describe—

(i) The current research on early childhood data management and data system integration, and related EBPs; and

(ii) How the proposed project will incorporate current research and EBPs in the development and delivery of its products and services;

(5) Develop products and provide services that are of high quality and sufficient intensity and duration to achieve the intended outcomes of the proposed project. To address this requirement, the applicant must describe—

(i) How it proposes to identify or develop the knowledge base on early childhood data management and data system integration;

(ii) Its proposed approach to universal, general TA, 2 which must identify the intended recipients, including the type and number of recipients, that will receive the products and services under this approach;

(iii) Its proposed approach to targeted, specialized TA, 3 which must identify—

(A) The intended recipients, including the type and number of recipients, that will receive the products and services under this approach;

(B) Its proposed approach to measure the readiness of potential TA recipients to work with the project, assessing, at a minimum, their current infrastructure, available resources, and ability to build capacity at the State and local levels; and

(C) The process by which the proposed project will collaborate with OSEP-funded centers and other federally funded TA centers to develop and implement a coordinated TA plan when they are involved in a State;

(iv) Its proposed approach to intensive, sustained TA  4 which must identify—

(A) The intended recipients, including the type and number of recipients, that will receive the products and services under this approach;

(B) Its proposed approach to addressing States' challenges associated with limited resources to engage in early childhood data system integration and enhancement activities that streamline the established Part C and Part B preschool special education data systems to respond to critical policy questions and to report high-quality IDEA data to the Department and the public, which should, at a minimum, include providing on-site consultants to the State lead agency (LA) or State educational agency (SEA) to—

(1) Model and document data management and data system integration policies, procedures, processes, and activities within the State;

(2) Develop and adapt tools and provide technical solutions to meet State-specific data needs; and

(3) Develop a sustainability plan for the State to continue the data management and data system integration work in the future;

(C) Its proposed approach to measure the readiness of the State LA and SEA personnel to work with the project, including their commitment to the initiative, alignment of the initiative to their needs, current infrastructure, available resources, and ability to build capacity at the State and local program and district levels;

(D) Its proposed approach to prioritizing TA recipients with a primary focus on meeting the needs of States with known ongoing data quality issues, as measured by OSEP's review of the quality of the IDEA sections 616 and 618 data;

(E) Its proposed plan for assisting State LAs and SEAs to build or enhance training systems that include professional development based on adult learning principles and coaching;

(F) Its proposed plan for working with appropriate levels of the education system ( e.g., State LAs, SEAs, regional TA providers, districts, local programs, families) to ensure that there is communication between each level and that there are systems in place to support the collection, reporting, analysis, and use of high-quality IDEA Part C data (including IDEA section 616 Part C data and section 618 Part C data) and IDEA Part B preschool special education data as well as early childhood data management and data system integration; and

(G) Its proposed plan for collaborating and coordinating with the National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate IDEA Part B Data, Department-funded TA investments, other federally funded TA investments, and Institute of Education Sciences/National Center for Education Statistics research and development investments, where appropriate, in order to align complementary work and jointly develop and implement products and services to meet the purposes of this priority and to develop and implement a coordinated TA plan when they are involved in a State;

(6) Develop products and implement services that maximize efficiency. To address this requirement, the applicant must describe—

(i) How the proposed project will use technology to achieve the intended project outcomes;

(ii) With whom the proposed project will collaborate and the intended outcomes of this collaboration; and

(iii) How the proposed project will use non-project resources to achieve the intended project outcomes.

(c) In the narrative section of the application under “Quality of the project evaluation,” include an evaluation plan for the project developed in consultation with and implemented by a third-party evaluator. 5 The evaluation plan must—

(1) Articulate formative and summative evaluation questions, including important process and outcome evaluation questions. These questions should be related to the project's proposed logic model required in paragraph (b)(2)(ii) of these requirements;

(2) Describe how progress in and fidelity of implementation, as well as project outcomes, will be measured to answer the evaluation questions. Specify the measures and associated instruments or sources for data appropriate to the evaluation questions. Include information regarding reliability and validity of measures where appropriate;

(3) Describe strategies for analyzing data and how data collected as part of this plan will be used to inform and improve service delivery over the course of the project and to refine the proposed logic model and evaluation plan, including subsequent data collection;

(4) Provide a timeline for conducting the evaluation and include staff assignments for completing the plan. The timeline must indicate that the data will be available annually for the Annual Performance Report (APR); and

(5) Dedicate sufficient funds in each budget year to cover the costs of developing or refining the evaluation plan in consultation with a third-party evaluator, as well as the costs associated with the implementation of the evaluation plan by the third-party evaluator.

(d) Demonstrate, in the narrative section of the application under “Adequacy of resources and quality of project personnel,” how—

(1) The proposed project will encourage applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability, as appropriate;

(2) The proposed key project personnel, consultants, and subcontractors have the qualifications and experience to carry out the proposed activities and achieve the project's intended outcomes;

(3) The applicant and any key partners have adequate resources to carry out the proposed activities;

(4) The proposed costs are reasonable in relation to the anticipated results and benefits and funds will be spent in a way that increases their efficiency and cost-effectiveness, including by reducing waste or achieving better outcomes; and

(5) The applicant will ensure that it will recover the lesser of: (A) Its actual indirect costs as determined by the grantee's negotiated indirect cost rate agreement with its cognizant Federal agency; and (B) 40 percent of its modified total direct cost (MTDC) base as defined in 2 CFR 200.68.

Note: The MTDC is different from the total amount of the grant. Additionally, the MTDC is not the same as calculating a percentage of each or a specific expenditure category. If the grantee is billing based on the MTDC base, the grantee must make its MTDC documentation available to the program office and the Department's Indirect Cost Unit. If a grantee's allocable indirect costs exceed 40 percent of MTDC as defined in 2 CFR 200.68, the grantee may not recoup the excess by shifting the cost to other grants or contracts with the U.S. Government, unless specifically authorized by legislation. The grantee must use non-Federal revenue sources to pay for such unrecovered costs.

(e) Demonstrate, in the narrative section of the application under “Quality of the management plan,” how—

(1) The proposed management plan will ensure that the project's intended outcomes will be achieved on time and within budget. To address this requirement, the applicant must describe—

(i) Clearly defined responsibilities for key project personnel, consultants, and subcontractors, as applicable; and

(ii) Timelines and milestones for accomplishing the project tasks;

(2) Key project personnel and any consultants and subcontractors will be allocated to the project and how these allocations are appropriate and adequate to achieve the project's intended outcomes;

(3) The proposed management plan will ensure that the products and services provided are of high quality, relevant, and useful to recipients; and

(4) The proposed project will benefit from a diversity of perspectives, including those of families, educators, TA providers, researchers, and policy makers, among others, in its development and operation.

(f) Address the following application requirements. The applicant must—

(1) Include, in Appendix A, personnel-loading charts and timelines, as applicable, to illustrate the management plan described in the narrative;

(2) Include, in the budget, attendance at the following:

(i) A one and one-half day kick-off meeting in Washington, DC, after receipt of the award, and an annual planning meeting in Washington, DC, with the OSEP project officer and other relevant staff during each subsequent year of the project period.

Note: Within 30 days of receipt of the award, a post-award teleconference must be held between the OSEP project officer and the grantee's project director or other authorized representative;

(ii) A two- and one-half-day project directors' meeting in Washington, DC, during each year of the project period; and

(iii) Three annual two-day trips to attend Department briefings, Department-sponsored conferences, and other meetings, as requested by OSEP;

(3) Include, in the budget, a line item for an annual set-aside of 5 percent of the grant amount to support emerging needs that are consistent with the proposed project's intended outcomes, as those needs are identified in consultation with, and approved by, the OSEP project officer. With approval from the OSEP project officer, the project must reallocate any remaining funds from this annual set-aside no later than the end of the third quarter of each budget period;

(4) Maintain a high-quality website, with an easy-to-navigate design, that meets government or industry-recognized standards for accessibility;

(5) Include, in Appendix A, an assurance to assist OSEP with the transfer of pertinent resources and products and to maintain the continuity of services to States during the transition to this new award period and at the end of this award period, as appropriate; and

(6) Budget at least 50 percent of the grant award for providing targeted and intensive TA to States.

This document does not preclude us from proposing additional priorities or requirements, subject to meeting applicable rulemaking requirements.

Under Executive Order 12866, it must be determined 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. Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not a “major rule,” as defined by 5 U.S.C. 804(2).

Under Executive Order 13771, for each new rule that the Department proposes for notice and comment or otherwise promulgates that is a significant regulatory action under Executive Order 12866 and that imposes total costs greater than zero, it must identify two deregulatory actions. For FY 2019, any new incremental costs associated with a new rule must be fully offset by the elimination of existing costs through deregulatory actions. Because the proposed regulatory action is not significant, Executive Order 13771 does not apply.

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 the final priority and requirements 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 these 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 Department believes that this regulatory action does not impose significant costs on eligible entities, whose participation in this program is voluntary. While this action does impose some requirements on participating grantees that are cost-bearing, the Department expects that applicants for this program will include in their proposed budgets a request for funds to support compliance with such cost-bearing requirements. Therefore, costs associated with meeting these requirements are, in the Department's estimation, minimal.

The Department believes that these benefits to the Federal government outweigh the costs associated with this action.

The Department believes that the priority and requirements are needed to administer the program effectively.

The final priority and requirements contain information collection requirements that are approved by OMB under OMB control number 1894-0006; the final priority and requirements do not affect the currently approved data collection.

Regulatory Flexibility Act Certification: The Secretary certifies that this final regulatory action would not have a significant economic impact on a substantial number of small entities. The U.S. Small Business Administration (SBA) Size Standards define proprietary institutions as small businesses if they are independently owned and operated, are not dominant in their field of operation, and have total annual revenue below $7,000,000. Nonprofit institutions are defined as small entities if they are independently owned and operated and not dominant in their field of operation. Public institutions are defined as small organizations if they are operated by a government overseeing a population below 50,000.

The small entities that this final regulatory action will affect are SEAs; LEAs, including charter schools that operate as LEAs under State law; institutions of higher education (IHEs); other public agencies; private nonprofit organizations; freely associated States and outlying areas; Indian Tribes or Tribal organizations; and for-profit organizations. We believe that the costs imposed on an applicant by the final priority and requirements will be limited to paperwork burden related to preparing an application and that the benefits of this proposed priority and these proposed requirements will outweigh any costs incurred by the applicant.

Participation in the Technical Assistance on State Data Collection program is voluntary. For this reason, the final priority and requirements will impose no burden on small entities unless they applied for funding under the program. We expect that in determining whether to apply for Technical Assistance on State Data Collection program funds, an eligible entity would evaluate the requirements of preparing an application and any associated costs, and weigh them against the benefits likely to be achieved by receiving a Technical Assistance on State Data Collection program grant. An eligible entity would probably apply only if it determines that the likely benefits exceed the costs of preparing an application.

We believe that the final priority and requirements will not impose any additional burden on a small entity applying for a grant than the entity would face in the absence of the proposed action. That is, the length of the applications those entities would submit in the absence of the proposed regulatory action and the time needed to prepare an application will likely be the same.

This final regulatory action will not have a significant economic impact on a small entity once it receives a grant because it would be able to meet the costs of compliance using the funds provided under this program.

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 . You may access the official edition of the Federal Register and the Code of Federal Regulations at www.govinfo.gov. At this site you can view this document, as well as all other documents of the 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.

Purpose of Program: Section 616 of the IDEA requires States to submit to the Department, and make available to the public, a State performance plan (SPP) and an annual performance report (APR) with data on how each State implements both Parts B and C of the IDEA to improve outcomes for infants, toddlers, children, and youth with disabilities. Section 618 of the IDEA requires States to submit to the Department, and make available to the public, quantitative data on infants, toddlers, children, and youth with disabilities who are receiving early intervention and special education services under IDEA. The purpose of the Technical Assistance on State Data Collection program is to improve the capacity of States to meet IDEA data collection and reporting requirements under Sections 616 and 618 of the IDEA to collect, analyze, and report the data used to prepare the SPP/APR. Funding for the program is authorized under section 611(c)(1) of IDEA, which gives the Secretary the authority to reserve up to 1/2 of 1 percent of the amounts appropriated under Part B for each fiscal year to provide TA activities, where needed, to improve the capacity of States to meet the data collection and reporting requirements under Parts B and C of IDEA. The maximum amount the Secretary may reserve under this set-aside for any fiscal year is $25,000,000, cumulatively adjusted by the rate of inflation. Section 616(i) of IDEA requires the Secretary to review the data collection and analysis capacity of States to ensure that data and information determined necessary for implementation of section 616 of IDEA are collected, analyzed, and accurately reported to the Secretary. It also requires the Secretary to provide TA, where needed, to improve the capacity of States to meet the data collection requirements, which include the data collection and reporting requirements in sections 616 and 618 of IDEA. Additionally, Division H of the Consolidated Appropriations Act of 2018 gives the Secretary authority to use funds reserved under section 611(c) to “carry out services and activities to improve data collection, coordination, quality, and use under Parts B and C of the IDEA.” Consolidated Appropriations Act, 2018; Div. H, Title III of Public Law 115-141; 132 Stat. 745 (2018).

Applicable Program Regulations: 34 CFR 300.702.

We published a notice of proposed priority and requirements for this program in the Federal Register on March 6, 2019 (84 FR 8054) (the NPP). The NPP contained background information and our reasons for proposing the particular priority and requirements.

There are differences between the NPP and this notice of final priority and requirements (NFP) as discussed in the Analysis of Comments and Changes section of this notice. The most significant of these changes, as discussed below, is the addition of an indirect cost rate cap to the final requirements.

Public Comment: In response to our invitation in the NPP, 12 parties submitted comments on the proposed priority and requirements.

Generally, we do not address technical and other minor changes. In addition, we do not address comments that raised concerns not directly related to the proposed priority and requirements.

Analysis of Comments and Changes: An analysis of the comments and changes in the priority and requirements since publication of the NPP follows. OSERS received comments on a number of specific topics from the proposed cap on the maximum allowable indirect cost rate to the topics for technical assistance. Each topic is addressed below.

Comments: One commenter specifically expressed support for the proposed center, and a number of other commenters noted the positive impact of the valuable TA they received from centers previously funded under this program.

Discussion: The Department appreciates the comments and agrees with the commenters. Centers, like the proposed center, funded under this program provide necessary and valuable TA to the States.

Changes: None.

Comments: None.

Discussion: As discussed in the NPP, the Department is particularly concerned about maximizing the efficiency and effectiveness of this investment. Given the purpose of the program, we believe a critical lever to meeting this goal is to ensure that TA is appropriately targeted to recipients with a known and ongoing need for support in reporting, analyzing, and using high quality IDEA data. As such, the Department is adding a requirement that applicants describe their proposed approach to prioritizing TA recipients with a particular focus on meeting the needs of States with ongoing data quality issues.

Changes: The final priority includes a requirement for applicants to describe their proposed approach to prioritizing TA recipients.

Comments: A number of commenters agreed with the purpose of the indirect cost cap, which is to maximize funds that go directly to provide TA to States to improve their capacity to meet the IDEA data collection and reporting requirements. These same commenters, however, believed that setting a cap on indirect costs would not achieve this goal and that it may negatively impact the program. They noted that indirect costs support a wide variety of purchases and activities, including, but not limited to, facilities, information technology (IT) services, and support personnel. Further, a subset of these commenters stated that a cap on indirect cost rates would limit competition, reduce the number of qualified applicants, and likely degrade the quality of TA services provided to States. Specifically, some of these commenters stated that a cap could make it cost prohibitive for small businesses to compete for the grant, as they could not absorb any unrecovered indirect costs. Additionally, it would make it harder for applicants to attract and retain qualified personnel, thus depressing the quality of services provided to States.

Discussion: The Department appreciates the stakeholder input it received in response to the specific directed question on the indirect cost cap proposal but disagrees that it would have a negative impact on the program. Regarding potential impact, the Department has done an analysis of the indirect cost rates for all current technical assistance centers funded under the Technical Assistance and Dissemination and Technical Assistance on State Data Collection programs as well as other grantees that are large, midsize and small businesses and small nonprofit organizations and has found that, in general, total indirect costs charged on these grants by these entities were at or below 35 percent of total direct costs. We recognize that, dependent on the structure of the investment and activities, the modified total direct cost (MTDC) base could be much smaller than the total direct cost, which would imply a higher indirect cost rate than those calculated here. The Department arrived at a 40 percent rate to address some of that variation. Such a change accounts for a 12 percent variance between TDC and MTDC. However, we note that, in the absence of a cap, certain entities would likely charge indirect cost rates in excess of 40 percent of MTDC. Based on our review, it appears that those entities would likely be larger for-profit and nonprofit organizations, but these organizations appear to be outliers when compared to the majority of other large businesses as well as the entirety of OSEP's grantees. Setting an indirect cost rate cap of 40 percent is in line with the majority of applicants' existing negotiated rates with the cognizant Federal agency. Therefore, we do not believe that the cap we are setting in these final requirements would negatively impact the majority of entities' ability to recover indirect costs.

Regarding commenters' concerns that a cap on indirect costs would limit competition and reduce the number of qualified applicants, it is not clear how a cap would do so. The cap included in the final requirements does not limit the pool of eligible applicants because most entities' indirect cost rates are below the cap we are setting. Further, regarding the impact on the quality of TA services provided to States, we have no information indicating a direct correlation between an entity's negotiated indirect cost rate and its ability to attract and retain qualified personnel and thus their ability to provide high-quality TA services to States. Based on our analysis, there are many OSEP grantees that are able to effectively carry out project activities required by their individual grants with negotiated indirect cost rates under the cap included in the final requirements. Further, the Department's peer review process is intended to assess the ability of various applicants to provide high-quality TA to States. Finally, we do not believe the cap we are setting in these final requirements would result in an amount of unrecovered costs that would deter most prospective applicants. The prospective applicants could look at the indirect cost cap prior to applying and either choose to absorb unrecovered costs or opt not to apply.

In light of these considerations, we have determined that placing an indirect cost cap that is the lesser of the percentage approved by the grantee's cognizant Federal agency and 40 percent for this priority is appropriate as it maximizes the availability of funds for the primary TA purposes of this priority, which is to improve the capacity of States to meet the data collection and reporting requirements under Parts B and C of IDEA and to ultimately benefit programs serving children with disabilities.

Changes: Paragraph (d)(5) of the final requirements now includes an indirect cost cap that is the lesser of the percentage approved by the grantee's cognizant Federal agency and a cap of 40 percent on the reimbursement of indirect costs.

Comments: A number of commenters expressed concerns that many of the most qualified organizations could not compete because once indirect cost rates are set by, and audited by, a cognizant agency, they cannot be lowered for a single project.

Discussion: Our analysis of indirect cost rates took into account 2 CFR 200.414(c)(1), which allows a Federal awarding agency to use an indirect cost rate different from the negotiated rate when required by Federal statute or regulation or when approved by a Federal awarding agency head based on documented justification when the Federal awarding agency implements, and makes publicly available, the policies, procedures, and general decision making criteria that their programs will follow to seek and justify deviations from negotiated rates. Federal discretionary grantees have historically been reimbursed for indirect costs at the rate that each grantee negotiates with its cognizant Federal agency, and we believe that use of the negotiated rate is appropriate for most grants in most circumstances. However, because funding for this program comes from funds reserved by the Department that would otherwise be allocated to States under Part B (which applies a restricted indirect cost rate to State grantees), we determined that using an indirect cost rate different from the negotiated rate was appropriate since it would maximize the funds available to provide TA to States to improve their capacity to meet the IDEA data collection and reporting requirements.

Changes: None.

Comments: Numerous commenters expressed concerns that the implementation of an indirect cost rate limit would not impact each vendor equally or result in equal savings to the government, as categories of indirect costs vary across vendors.

Discussion: We appreciate the commenters' concerns and recognize that a cap on the indirect cost rate, although it would apply equally to all applicants, may be more difficult for particular entities to meet, particularly those with high negotiated indirect cost rates. However, as noted above, our analysis indicates that the rate established in the final requirements would not appear to create unreasonable burdens for many applicants. Further, it was not the Department's intention to institute a limit on the reimbursement of indirect costs by specific cost category, but rather to apply it as a percentage of MTDC. We have clarified in the final requirements that the limit applies to MTDC as defined in 2 CFR 200.68. As the MTDC is applied to the total direct costs of the grant, each grantee's MTDC will include direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and up to the first $25,000 of each subaward, thus ensuring equity across vendors.

Changes: The final requirement clarifies that the 40 percent maximum indirect cost rate is applied to MTDC as defined in 2 CFR 200.68.

Comments: Two commenters provided alternatives to setting a cap. One commenter proposed gauging competitiveness based on a vendor's total price in combination with the proposed quality and level of effort. A second commenter suggested that the program add a cost share requirement in lieu of an indirect cost cap. The commenter suggested that a modest cost share may not impact vendor economics to the same degree as a cap on indirect costs.

Discussion: The Department appreciates the commenters' suggestions. Regarding gauging competitiveness based on a vendor's total price in combination with the proposed quality and level of effort, this may represent a viable approach for contract procurement, but does not lend itself to making discretionary grant awards. Regarding the second commenter's recommendation to add a cost share requirement, the nature of the funding source for this program does not allow for a cost sharing requirement and, in addition, could have the unintended consequence of eliminating small businesses.

Changes: None.

Comments: One commenter advocated for the Department to provide clarification and guidance to States on what should be covered by indirect cost rates and how to determine appropriate indirect cost rates. Additionally, a second commenter suggested the Department allow States the flexibility to determine and justify funds allocated to indirect costs.

Discussion: The Department appreciates the commenters' suggestions. We were not proposing a cap on the indirect cost rates for State formula grants. Clarification or guidance on what is or is not an indirect cost can be obtained from the indirect cost office of the applicant's cognizant Federal agency.

Changes: None.

Comments: A commenter recommended that the Department collect data on students who identify in a gender-neutral category, use a different language/communication system, or are born in the United States but do not speak English as their first language, and on their socioeconomic status, parental English fluency, and parents' highest educational level.

Discussion: The Department appreciates the comment; however, this priority does not address the data collection and reporting requirements for States under IDEA. The ED Facts information collection package (OMB control number 1850-0925), which would more squarely address these issues, was published in the Federal Register on April 8, 2019 (84 FR 13913). It addressed the IDEA Section 618 Part B data collection requirements and was open for public comment from April 8, 2019 to May 8, 2019.

Changes: None.

Comments: Some commenters noted that the proposed center did not include anything in its scope or focus related to TA on significant disproportionality. Commenters spoke to the continued need for data-related TA on significant disproportionality.

Discussion: The Department appreciates the commenters' concerns. At this time, however, the Department does not wish to emphasize specific IDEA sections 618 and 616 Part B data collection and reporting requirements that the proposed center would be required to address. Applicants will be required to demonstrate knowledge of current educational issues and policy initiatives ( e.g., significant disproportionality) about IDEA Part B data collection and reporting requirements and knowledge of State and local data collection systems, as appropriate. The Center would be expected to provide TA designed to meet the needs of States. Therefore, to the extent that particular TA recipients require support for any of the sections 618 and 616 Part B data collection or reporting requirements, the Center would provide the needed TA.

Changes: None.

Comments: Some commenters requested that we require the proposed center to work with the SEA when providing TA to local educational agencies (LEAs) within the State in order to ensure TA aligns with the State's requirements.

Discussion: The Department agrees with commenters on the need to include SEAs when TA is provided to an LEA within a State. We added language to the priority to clarify that TA to LEAs must occur in collaboration with the SEA.

Changes: We added language to paragraph (d) of the list of expected outcomes in the priority to require the Center to collaborate with the SEA in providing TA to LEAs.

Comments: A number of commenters requested further clarification about expectations for cross-State collaboration, and three commenters suggested the Department require the proposed center to support a State data manager advisory board.

Discussion: The Department agrees with the commenters regarding the importance of cross-State collaboration. Expectations for such collaboration were already included in paragraph (c) in the list of expected outcomes in the proposed priority, which the Department believes fully addresses the commenters' concerns.

Consequently, we do not believe an advisory board is necessary, and anticipate that the funded center would engage established data groups to determine the data manager needs as appropriate.

Changes: None.

Comment: One commenter recommended expanding the provision of targeted TA to States.

Discussion: The Department agrees with the commenter regarding the continued need to provide additional targeted TA to States. Targeted TA to groups of States on specific data processes and data collections is not only valuable to the State but also an efficient way to provide TA.

Changes: We revised what is now paragraph (f)(7) of the requirements to clarify that 50 percent of the grant award must go to support both targeted and intensive TA to States.

Comment: Several commenters voiced a concern with splitting the responsibilities of providing TA on the IDEA Part B preschool special education data between the proposed center and the National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate Early Childhood IDEA Data, CFDA number 84.373Z. The commenters stated that splitting the responsibilities regarding the IDEA Part B preschool special education data across the two centers may require Part B data managers to work with both centers in order to improve the quality of their IDEA Part B preschool special education data.

Discussion: The Department appreciates the commenters' concerns. The Department believes that including IDEA Part B preschool special education data in the scope of this center makes sense for some of the IDEA data and including IDEA Part B preschool special education data in the scope of the National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate Early Childhood IDEA Data, CFDA number 84.373Z, is appropriate for other IDEA data.

The Department believes that including the IDEA Part B preschool special education data required under IDEA section 618 (including the section 618, Part B Child Count and Educational Environments data) and those preschool data required under IDEA section 616 for indicators in the IDEA Part B State Performance Plan/Annual Performance Report (SPP/APR) that solely use the ED Facts data as the source for reporting, such as Indicator B-5 (Preschool Least Restrictive Environment), within the scope of this center will allow a State to obtain TA on IDEA data submitted via ED Facts from a single center. This structure that specifies more distinct portfolios of the centers ( i.e., less overlap) will make it easier for States to work with the two centers. Since a State Part B data manager plays a significant role in submitting the IDEA data on children with disabilities ages 3 through 5 and children with disabilities ages 6 through 21 via ED Facts, the data manager will be able to access TA on these data through a single center. Finally, this will allow States to receive TA on IDEA data-related topics and analyses that are supported by and use IDEA section 618 data submitted via ED Facts.

The Department believes that including the IDEA Part B preschool special education data required under IDEA Section 616 for Indicators B-7 (Preschool Outcomes) and B-12 (Early Childhood Transition) within the scope for the National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate Early Childhood IDEA Data, CFDA number 84.373Z, is appropriate because it will facilitate better linkages between the Part C data and the IDEA Part B preschool special education data on children with disabilities and the inclusion of the Part C and IDEA Part B preschool special education data in the Early Childhood Integrated Data Systems (ECIDS). This will allow for enhanced opportunities to improve the quality of data States are collecting, reporting, analyzing, and using related to children's transition from the Part C early intervention program to the Part B preschool special education program. In addition, due to the similarities in the type of data required under IDEA section 616 for Indicator C-3 (Infant and Toddler Outcomes) in the Part C SPP/APR and Indicator B-7 (Preschool Outcomes) in the Part B SPP/APR, it is more efficient to have the center funded under CFDA number 373Z provide TA on these data.

Changes: We have revised the purpose of the priority to include TA on the section 618, Part B Child Count and Educational Environments data for children with disabilities ages 3 through 5 and preschool data required under IDEA section 616 for indicators in the IDEA Part B SPP/APR that solely use the EDFacts data as the source for reporting, such as Indicator B-5 (Preschool Least Restrictive Environment), in the scope of this center.

Comments: One commenter stated that the definition of evidence-based practices (EBPs) used in the proposed requirements does not align with the highest level of available evidence, and that EBP is a dynamic process that requires ongoing evaluation.

Discussion: We understood the commenter to be recommending a higher level of evidence than required in the proposed requirements. We agree with the commenter regarding the importance of ensuring the provision of effective TA to States; however, we do not agree that the definition of EBPs used in the proposed requirements is insufficient. We are continually reviewing the effectiveness of services provided by our federally funded TA centers. We believe that the definition of EBPs used in the proposed requirements—the definition in 34 CFR 77.1—is well established and provides the necessary standards against which high-quality services may be judged for the purposes of making an award and monitoring the implementation of TA to improve the capacity of States to meet the data collection and reporting requirements under Part B of IDEA.

Changes: None.

Final Priority:

Technical Assistance on State Data Collection—National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate IDEA Part B Data.

Priority:

The purpose of this priority is to fund a cooperative agreement to establish and operate the National Technical Assistance Center to Improve State Capacity to Collect, Report, Analyze, and Use Accurate IDEA Part B Data (Data Center).

The Data Center will provide TA to help States better meet current and future IDEA Part B data collection and reporting requirements, improve data quality, and analyze and use section 616, section 618, and other IDEA data ( e.g., State Supplemental Survey-IDEA) to identify and address programmatic strengths and areas for improvement. This Data Center will focus on providing TA on collecting, reporting, analyzing, and using Part B data on children with disabilities ages 3 through 21 required under sections 616 and 618 of IDEA, including Part B data on children with disabilities ages 3 through 5 required under section 618 of IDEA for the Part B Child Count and Educational Environments data collection and under section 616 for indicators in the IDEA Part B SPP/APR that solely use the EDFacts data as the source for reporting, such as Indicator B-5 (Preschool Least Restrictive Environment). However, the Data Center will not provide TA on Part B data required under section 616 of IDEA for Indicators B7 (Preschool Outcomes) and B12 (Early Childhood Transition); TA on collecting, reporting, analyzing, and using Part B data associated with children with disabilities ages 3 through 5 for these indicators will be provided by the National IDEA Technical Assistance Center on Early Childhood Data Systems, CFDA number 84.373Z.

The Data Center must be designed to achieve, at a minimum, the following expected outcomes:

(a) Improved State data infrastructure by coordinating and promoting communication and effective data governance strategies among relevant State offices, including SEAs, LEAs, and schools to improve the quality of IDEA data required under sections 616 and 618 of IDEA;

(b) Increased capacity of States to submit accurate and timely data, to enhance current State validation procedures, and to prevent future errors in State-reported IDEA Part B data;

(c) Improved capacity of States to meet the data collection and reporting requirements under sections 616 and 618 of IDEA by addressing personnel training needs, developing effective tools ( e.g., training modules) and resources ( e.g., documentation of State data processes), and providing in-person and virtual opportunities for cross-State collaboration about data collection and reporting requirements that States can use to train personnel in schools, programs, agencies, and districts;

(d) Improved capacity of SEAs and LEAs, in collaboration with SEAs, to collect, analyze, and use both SEA and LEA IDEA data to identify programmatic strengths and areas for improvement, address root causes of poor performance towards outcomes, and evaluate progress towards outcomes;

(e) Improved IDEA data validation by using results from data reviews conducted by the Department to work with States to generate tools that can be used by States to lead to improvements in the validity and reliability of data required by IDEA and enable States to communicate accurate data to local consumers ( e.g., parents, school boards, the general public); and

(f) Increased capacity of States to collect, report, analyze, and use high-quality IDEA Part B data.

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)).

The Assistant Secretary establishes the following requirements for this program. We may apply these requirements in any year in which this program is in effect.

Requirements:

Applicants must—

(a) Demonstrate, in the narrative section of the application under “Significance,” how the proposed project will—

(1) Address the capacity needs of SEAs and LEAs to meet IDEA Part B data collection and reporting requirements and to increase their capacity to analyze and use section 616 and section 618 data as a means of both improving data quality and identifying programmatic strengths and areas for improvement. To meet this requirement the applicant must—

(i) Demonstrate knowledge of current educational issues and policy initiatives about IDEA Part B data collection and reporting requirements and knowledge of State and local data collection systems, as appropriate;

(ii) Present applicable national, State, and local data to demonstrate the capacity needs of SEAs and LEAs to meet IDEA Part B data collection and reporting requirements and use section 616 and section 618 data as a means of both improving data quality and identifying programmatic strengths and areas for improvement; and

(iii) Describe how SEAs and LEAs are currently meeting IDEA Part B data collection and reporting requirements and using section 616 and section 618 data as a means of both improving data quality and identifying programmatic strengths and areas for improvement.

(b) Demonstrate, in the narrative section of the application under “Quality of project services,” how the proposed project will—

(1) Ensure equal access and treatment for members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability. To meet this requirement, the applicant must describe how it will—

(i) Identify the needs of the intended recipients for TA and information; and

(ii) Ensure that products and services meet the needs of the intended recipients of the grant;

(2) Achieve its goals, objectives, and intended outcomes. To meet this requirement, the applicant must provide—

(i) Measurable intended project outcomes; and

(ii) In Appendix A, the logic model (as defined in 34 CFR 77.1) by which the proposed project will achieve its intended outcomes that depicts, at a minimum, the goals, activities, outputs, and intended outcomes of the proposed project;

(3) Use a conceptual framework (and provide a copy in Appendix A) to develop project plans and activities, describing any underlying concepts, assumptions, expectations, beliefs, or theories, as well as the presumed relationships or linkages among these variables, and any empirical support for this framework;

(4) Be based on current research and make use of evidenced-based  1 practices (EBPs). To meet this requirement, the applicant must describe—

(i) The current research on the capacity of SEAs and LEAs to report and use data, specifically section 616 and section 618 data, as a means of both improving data quality and identifying strengths and areas for improvement; and

(ii) How the proposed project will incorporate current research and EBPs in the development and delivery of its products and services;

(5) Develop products and provide services that are of high quality and sufficient intensity and duration to achieve the intended outcomes of the proposed project. To address this requirement, the applicant must describe—

(i) How it proposes to identify or develop the knowledge base on the capacity needs of SEAs and LEAs to meet IDEA Part B data collection and reporting requirements and SEA and LEA analysis and use of sections 616 and 618 data as a means of both improving data quality and identifying programmatic strengths and areas for improvement;

(ii) Its proposed approach to universal, general TA, 2 which must identify the intended recipients, including the type and number of recipients, that will receive the products and services under this approach;

(iii) Its proposed approach to targeted, specialized TA, 3 which must identify—

(A) The intended recipients, including the type and number of recipients, that will receive of the products and services under this approach; and

(B) Its proposed approach to measure the readiness of potential TA recipients to work with the project, assessing, at a minimum, their current infrastructure, available resources, and ability to build capacity at the local level; and

(iv) Its proposed approach to intensive, 4 sustained TA, which must identify—

(A) The intended recipients, including the type and number of recipients, that will receive the products and services under this approach; and

(B) Its proposed approach to measure the readiness of SEA and LEA personnel to work with the project, including their commitment to the initiative, alignment of the initiative to their needs, current infrastructure, available resources, and ability to build capacity at the SEA and LEA levels;

(C) Its proposed approach to prioritizing TA recipients with a primary focus on meeting the needs of States with known ongoing data quality issues, as measured by OSEP's review of the quality of the IDEA sections 616 and 618 data;

(D) Its proposed plan for assisting SEAs (and LEAs, in conjunction with SEAs) to build or enhance training systems related to the IDEA Part B data collection and reporting requirements that include professional development based on adult learning principles and coaching;

(E) Its proposed plan for working with appropriate levels of the education system ( e.g., SEAs, regional TA providers, LEAs, schools, and families) to ensure that there is communication between each level and that there are systems in place to support the capacity needs of SEAs and LEAs to meet Part B data collection and reporting requirements under sections 616 and 618 of the IDEA; and

(F) Its proposed plan for collaborating and coordinating with Department-funded TA investments and Institute of Education Sciences/National Center for Education Statistics research and development investments, where appropriate, in order to align complementary work and jointly develop and implement products and services to meet the purposes of this priority;

(6) Develop products and implement services that maximize efficiency. To address this requirement, the applicant must describe—

(i) How the proposed project will use technology to achieve the intended project outcomes;

(ii) With whom the proposed project will collaborate and the intended outcomes of this collaboration;

(iii) How the proposed project will use non-project resources to achieve the intended project outcomes; and

(c) In the narrative section of the application under “Quality of the project evaluation,” include an evaluation plan for the project developed in consultation with and implemented by a third-party evaluator. 5 The evaluation plan must—

(1) Articulate formative and summative evaluation questions, including important process and outcome evaluation questions. These questions should be related to the project's proposed logic model required in paragraph (b)(2)(ii) of these requirements;

(2) Describe how progress in and fidelity of implementation, as well as project outcomes, will be measured to answer the evaluation questions. Specify the measures and associated instruments or sources for data appropriate to the evaluation questions. Include information regarding reliability and validity of measures where appropriate;

(3) Describe strategies for analyzing data and how data collected as part of this plan will be used to inform and improve service delivery over the course of the project and to refine the proposed logic model and evaluation plan, including subsequent data collection;

(4) Provide a timeline for conducting the evaluation and include staff assignments for completing the plan. The timeline must indicate that the data will be available annually for the APR and at the end of Year 2 for the review process; and

(5) Dedicate sufficient funds in each budget year to cover the costs of developing or refining the evaluation plan in consultation with a third-party evaluator, as well as the costs associated with the implementation of the evaluation plan by the third-party evaluator.

(d) Demonstrate, in the narrative section of the application under “Adequacy of resources and quality of project personnel,” how—

(1) The proposed project will encourage applications for employment from persons who are members of groups that have traditionally been underrepresented based on race, color, national origin, gender, age, or disability, as appropriate;

(2) The proposed key project personnel, consultants, and subcontractors have the qualifications and experience to carry out the proposed activities and achieve the project's intended outcomes;

(3) The applicant and any key partners have adequate resources to carry out the proposed activities;

(4) The proposed costs are reasonable in relation to the anticipated results and benefits, and funds will be spent in a way that increases their efficiency and cost-effectiveness, including by reducing waste or achieving better outcomes; and

(5) How the applicant will ensure that it will recover the lesser of (a) its actual indirect costs as determined by the grantee's negotiated indirect cost rate agreement with its cognizant Federal agency; and (b) 40 percent of its modified total direct cost (MTDC) base as defined in 2 CFR 200.68.

(e) Demonstrate, in the narrative section of the application under “Quality of the management plan,” how—

(1) The proposed management plan will ensure that the project's intended outcomes will be achieved on time and within budget. To address this requirement, the applicant must describe—

(i) Clearly defined responsibilities for key project personnel, consultants, and subcontractors, as applicable; and

(ii) Timelines and milestones for accomplishing the project tasks;

(2) Key project personnel and any consultants and subcontractors will be allocated to the project and how these allocations are appropriate and adequate to achieve the project's intended outcomes;

(3) The proposed management plan will ensure that the products and services provided are of high quality, relevant, and useful to recipients; and

(4) The proposed project will benefit from a diversity of perspectives, including those of families, educators, TA providers, researchers, and policy makers, among others, in its development and operation.

(f) Address the following application requirements. The applicant must—

(1) Include, in Appendix A, personnel-loading charts and timelines, as applicable, to illustrate the management plan described in the narrative;

(2) Include, in the budget, attendance at the following:

(i) A one and one-half day kick-off meeting in Washington, DC, after receipt of the award, and an annual planning meeting in Washington, DC, with the OSEP project officer and other relevant staff during each subsequent year of the project period.

(ii) A two and one-half day project directors' meeting in Washington, DC, during each year of the project period;

(iii) Three annual two-day trips to attend Department briefings, Department-sponsored conferences, and other meetings, as requested by OSEP.

(3) Include, in the budget, a line item for an annual set-aside of 5 percent of the grant amount to support emerging needs that are consistent with the proposed project's intended outcomes, as those needs are identified in consultation with, and approved by, the OSEP project officer. With approval from the OSEP project officer, the project must reallocate any remaining funds from this annual set-aside no later than the end of the third quarter of each budget period;

(4) Maintain a high-quality website, with an easy-to-navigate design, that meets government or industry-recognized standards for accessibility;

(5) Include, in Appendix A, an assurance to assist OSEP with the transfer of pertinent resources and products and to maintain the continuity of services to States during the transition to this new award period and at the end of this award period, as appropriate; and

(6) Budget at least 50 percent of the grant award for providing targeted and intensive TA to States.

This document does not preclude us from proposing additional priorities or requirements, subject to meeting applicable rulemaking requirements.

Under Executive Order 12866, it must be determined 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. Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not a “major rule,” as defined by 5 U.S.C. 804(2).

Under Executive Order 13771, for each new rule that the Department proposes for notice and comment or otherwise promulgates that is a significant regulatory action under Executive Order 12866, and that imposes total costs greater than zero, it must identify two deregulatory actions. For Fiscal Year 2019, any new incremental costs associated with a new regulation must be fully offset by the elimination of existing costs through deregulatory actions. Because the proposed regulatory action is not significant, the requirements of Executive Order 13771 do not apply.

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 the final priority and requirements 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 these 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 Department believes that this regulatory action does not impose significant costs on eligible entities, whose participation in this program is voluntary. While this action does impose some requirements on participating grantees that are cost-bearing, the Department expects that applicants for this program will include in their proposed budgets a request for funds to support compliance with such cost-bearing requirements. Therefore, costs associated with meeting these requirements are, in the Department's estimation, minimal.

The Department believes that these benefits to the Federal government outweigh the costs associated with this action.

The Department believes that the priority and requirements are needed to administer the program effectively.

The final priority and requirements contain information collection requirements that are approved by OMB under OMB control number 1894-0006; the final priority and requirements do not affect the currently approved data collection.

Regulatory Flexibility Act Certification: The Secretary certifies that this final regulatory action would not have a significant economic impact on a substantial number of small entities. The U.S. Small Business Administration (SBA) Size Standards define proprietary institutions as small businesses if they are independently owned and operated, are not dominant in their field of operation, and have total annual revenue below $7,000,000. Nonprofit institutions are defined as small entities if they are independently owned and operated and not dominant in their field of operation. Public institutions are defined as small organizations if they are operated by a government overseeing a population below 50,000.

The small entities that this final regulatory action will affect are SEAs; LEAs, including charter schools that operate as LEAs under State law; institutions of higher education (IHEs); other public agencies; private nonprofit organizations; freely associated States and outlying areas; Indian Tribes or Tribal organizations; and for-profit organizations. We believe that the costs imposed on an applicant by the final priority and requirements will be limited to paperwork burden related to preparing an application and that the benefits of this final priority and these final requirements will outweigh any costs incurred by the applicant.

Participation in the Technical Assistance on State Data Collection program is voluntary. For this reason, the final priority and requirements will impose no burden on small entities unless they applied for funding under the program. We expect that in determining whether to apply for Technical Assistance on State Data Collection program funds, an eligible entity would evaluate the requirements of preparing an application and any associated costs, and weigh them against the benefits likely to be achieved by receiving a Technical Assistance on State Data Collection program grant. An eligible entity would probably apply only if it determines that the likely benefits exceed the costs of preparing an application.

We believe that the final priority and requirements will not impose any additional burden on a small entity applying for a grant than the entity would face in the absence of the final action. That is, the length of the applications those entities would submit in the absence of the final regulatory action and the time needed to prepare an application will likely be the same.

This final regulatory action will not have a significant economic impact on a small entity once it receives a grant because it would be able to meet the costs of compliance using the funds provided under this program.

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 . You may access the official edition of the Federal Register and the Code of Federal Regulations at www.govinfo.gov. 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.

Under Title VIII of the Alaska National Interest Lands Conservation Act (ANILCA) (16 U.S.C. 3111-3126), the Secretary of the Interior and the Secretary of Agriculture (Secretaries) jointly implement the Federal Subsistence Management Program. This program provides a preference for take of fish and wildlife resources for subsistence uses on Federal public lands and waters in Alaska. The Secretaries published temporary regulations to carry out this program in the Federal Register on June 29, 1990 (55 FR 27114), and published final regulations in the Federal Register on May 29, 1992 (57 FR 22940). The Program managers have subsequently amended these regulations a number of times. Because this program is a joint effort between Interior and Agriculture, these regulations are located in two titles of the Code of Federal Regulations (CFR): Title 36, “Parks, Forests, and Public Property,” and Title 50, “Wildlife and Fisheries,” at 36 CFR 242.1-242.28 and 50 CFR 100.1-100.28, respectively. The regulations contain subparts as follows: Subpart A, General Provisions; Subpart B, Program Structure; Subpart C, Board Determinations; and Subpart D, Subsistence Taking of Fish and Wildlife.

Consistent with subpart B of these regulations, the Secretaries established a Federal Subsistence Board to administer the Federal Subsistence Management Program. The Board comprises:

• A Chair appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture;

• The Alaska Regional Director, U.S. Fish and Wildlife Service;

• The Alaska Regional Director, National Park Service;

• The Alaska State Director, Bureau of Land Management;

• The Alaska Regional Director, Bureau of Indian Affairs;

• The Alaska Regional Forester, USDA Forest Service; and

• Two public members appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture.

Through the Board, these agencies participate in the development of regulations for subparts C and D, which, among other things, set forth program eligibility and specific harvest seasons and limits.

In administering the program, the Secretaries divided Alaska into 10 subsistence resource regions, each of which is represented by a Federal Subsistence Regional Advisory Council (Council). The Councils provide a forum for rural residents with personal knowledge of local conditions and resource requirements to have a meaningful role in the subsistence management of fish and wildlife on Federal public lands in Alaska. The Council members represent varied geographical, cultural, and user interests within each region.

The Board addresses customary and traditional use determinations during the applicable biennial cycle. Section __.24 (customary and traditional use determinations) was originally published in the Federal Register on May 29, 1992 (57 FR 22940). The regulations at 36 CFR 242.4 and 50 CFR 100.4 define “customary and traditional use” as “a long-established, consistent pattern of use, incorporating beliefs and customs which have been transmitted from generation to generation. . . .” Since 1992, the Board has made a number of customary and traditional use determinations at the request of affected subsistence users. Those modifications for fish and shellfish, along with some administrative corrections, were published in the Federal Register as follows:

The Departments published a proposed rule, Subsistence Management Regulations for Public Lands in Alaska—2019-20 and 2020-21 Subsistence Taking of Fish Regulations, on March 23, 2018 (83 FR 12689), to amend the fish section of subparts C and D of 36 CFR part 242 and 50 CFR part 100. The proposed rule opened a comment period, which closed on April 23, 2018. The Departments advertised the proposed rule by mail, email, web page, social media, radio, and newspaper, and comments were submitted via www.regulations.gov to Docket No. FWS-R7-SM-2017-0096. During that period, the Councils met and, in addition to other Council business, received suggestions for proposals from the public. The Board received a total of 23 proposals for changes to subparts C and D; this included 4 proposals that were deemed invalid because they were beyond the scope of the Board's authority, and one that was deferred from the previous fisheries cycle. After the comment period closed, the Board prepared a booklet describing the proposals and distributed it to the public. The proposals were also available online. The public then had an additional 70 days in which to comment on the proposals for changes to the regulations.

The 10 Councils met again, received public comments, and formulated their recommendations to the Board on proposals for their respective regions. The Councils had a substantial role in reviewing the proposed rule and making recommendations for the final rule. Moreover, a Council Chair, or a designated representative, presented each Council's recommendations at the Board's public meeting of April 15-18, 2019. These final regulations reflect Board review and consideration of Council recommendations, Tribal and Alaska Native corporation consultations, and public comments. The public received extensive opportunity to review and comment on all changes.

Of the 19 valid proposals, 8 were on the Board's non-consensus agenda and 11 were on the consensus agenda. The consensus agenda is made up of proposals for which there is agreement among the affected Councils, a majority of the Interagency Staff Committee members, and the Alaska Department of Fish and Game concerning a proposed regulatory action. Anyone may request that the Board remove a proposal from the consensus agenda and place it on the non-consensus agenda. The Board votes en masse on the consensus agenda after deliberation and action on all other proposals.

Of the proposals on the consensus agenda, the Board adopted two; adopted four with modification; and rejected five. Analysis and justification for the action taken on each proposal on the consensus agenda are available for review at the Office of Subsistence Management, 1011 East Tudor Road, Mail Stop 121, Anchorage, AK 99503, or on the Office of Subsistence Management website ( https://www.doi.gov/subsistence ). Of the proposals on the non-consensus agenda, the Board adopted three; adopted four with modification; and rejected one.

The Board rejected one non-consensus proposal. The rejected proposal was recommended for rejection by both affected Councils as noted below.

The Board rejected a deferred proposal to restructure the management plans, fishing schedules, and methods and means and allow for independent action to be taken by the Federal in-season manager on the Kuskokwim River. This action was supported by both affected Councils.

The Board adopted three proposals and adopted with modification four non-consensus proposals. Modifications were either suggested by the affected Council(s), developed during the analysis process, or developed during the Board's public deliberations. All of the adopted proposals were recommended for adoption by at least one of the Councils as noted below.

The Board adopted with modification one proposal to revise the drift gillnet fishery in District 4 and remove mesh depth restrictions. This action was supported by three Councils and opposed by one.

The Board adopted one proposal to allow the use of 6-inch or less mesh size prior to June 1 in the Kuskokwim River drainage. This action was supported by one Council and opposed by another.

The Board adopted one proposal with modification to allow the use of gillnets in tributaries of the Kuskokwim River during closures, in which salmon do not spawn. One Council supported the proposal and another supported with modification. The Board further modified the text to clarify the original intent of the proponent.

The Board adopted one proposal to revise the regulations for the take of salmon, without a permit, in Lake Clark and its tributaries and include the use of rod and reel. This action was supported by the affected Council.

The Board adopted one proposal with modification to place the permit conditions for the Prince William Sound Area into regulations. This action was supported by the affected Council.

The Board adopted one proposal that allows the use of one unit of gear per person fishing under the same (household) subsistence permit in the upper Copper River district.

The Board adopted one proposal to close the public waters of Neva Lake, Neva Creek, and South Creek to the harvest of sockeye salmon except by federally qualified users. This action was supported by the affected Council.

In the area-specific regulations for fish, Southeastern Alaska Area, Stikine River, the total annual guideline harvest level for this fishery has been deleted based on changes in the coordination requirements for the U.S./Canada Pacific Salmon Treaty, which went into effect on January 1, 2019.

These final regulations reflect Board review and consideration of Council recommendations, Tribal and Alaska Native corporation consultations, and public comments. Because this rule concerns public lands managed by an agency or agencies in both the Departments of Agriculture and the Interior, identical text will be incorporated into 36 CFR part 242 and 50 CFR part 100.

The Board has provided extensive opportunity for public input and involvement in compliance with Administrative Procedure Act requirements, including publishing a proposed rule in the Federal Register , participation in multiple Council meetings, additional public review and comment on all proposals for regulatory change, and opportunity for additional public comment during the Board meeting prior to deliberation. Additionally, an administrative mechanism exists (and has been used by the public) to request reconsideration of the Board's decision on any particular proposal for regulatory change (36 CFR 242.20 and 50 CFR 100.20). Therefore, the Board believes that sufficient public notice and opportunity for involvement have been given to affected persons regarding Board decisions.

In the more than 25 years that the Program has been operating, no benefit to the public has been demonstrated by delaying the effective date of the subsistence regulations. A lapse in regulatory control could affect the continued viability of fish or wildlife populations and future subsistence opportunities for rural Alaskans, and would generally fail to serve the overall public interest. Therefore, the Board finds good cause pursuant to 5 U.S.C. 553(d)(3) to make this rule effective upon the date set forth in DATES to ensure continued operation of the subsistence program.

A Draft Environmental Impact Statement that described four alternatives for developing a Federal Subsistence Management Program was distributed for public comment on October 7, 1991. The Final Environmental Impact Statement (FEIS) was published on February 28, 1992. The Record of Decision (ROD) on Subsistence Management for Federal Public Lands in Alaska was signed April 6, 1992. The selected alternative in the FEIS (Alternative IV) defined the administrative framework of an annual regulatory cycle for subsistence regulations.

A 1997 environmental assessment dealt with the expansion of Federal jurisdiction over fisheries and is available at the office listed under FOR FURTHER INFORMATION CONTACT . The Secretary of the Interior, with concurrence of the Secretary of Agriculture, determined that expansion of Federal jurisdiction does not constitute a major Federal action significantly affecting the human environment and, therefore, signed a Finding of No Significant Impact.

An ANILCA section 810 analysis was completed as part of the FEIS process on the Federal Subsistence Management Program. The intent of all Federal subsistence regulations is to accord subsistence uses of fish and wildlife on public lands a priority over the taking of fish and wildlife on such lands for other purposes, unless restriction is necessary to conserve healthy fish and wildlife populations. The final section 810 analysis determination appeared in the April 6, 1992, ROD and concluded that the Program, under Alternative IV with an annual process for setting subsistence regulations, may have some local impacts on subsistence uses, but will not likely restrict subsistence uses significantly.

During the subsequent environmental assessment process for extending fisheries jurisdiction, an evaluation of the effects of this rule was conducted in accordance with section 810. That evaluation also supported the Secretaries' determination that the rule will not reach the “may significantly restrict” threshold that would require notice and hearings under ANILCA section 810(a).

An agency may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. This rule does not contain any new collections of information that require OMB approval. OMB has reviewed and approved the collections of information associated with the subsistence regulations at 36 CFR part 242 and 50 CFR part 100, and assigned OMB Control Number 1018-0075 (expires August 31, 2019; in accordance with 5 CFR 1320.10, an agency may continue to conduct or sponsor this collection of information while the renewal submission is pending at OMB).

Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will review all significant rules. OIRA has determined that this rule is not significant.

Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq. ) requires preparation of flexibility analyses for rules that will have a significant effect on a substantial number of small entities, which include small businesses, organizations, or governmental jurisdictions. In general, the resources to be harvested under this rule are already being harvested and consumed by the local harvester and do not result in an additional dollar benefit to the economy. However, we estimate that two million pounds of meat are harvested by subsistence users annually and, if given an estimated dollar value of $3.00 per pound, this amount would equate to about $6 million in food value Statewide. Based upon the amounts and values cited above, the Departments certify that this rulemaking will not have a significant economic effect on a substantial number of small entities within the meaning of the Regulatory Flexibility Act.

Under the Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801 et seq. ), this rule is not a major rule. It does not have an effect on the economy of $100 million or more, will not cause a major increase in costs or prices for consumers, and does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

Title VIII of ANILCA requires the Secretaries to administer a subsistence priority on public lands. The scope of this Program is limited by definition to certain public lands. Likewise, these regulations have no potential takings of private property implications as defined by Executive Order 12630.

The Secretaries have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq., that this rulemaking will not impose a cost of $100 million or more in any given year on local or State governments or private entities. The implementation of this rule is by Federal agencies, and there is no cost imposed on any State or local entities or Tribal governments.

The Secretaries have determined that these regulations meet the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988, regarding civil justice reform.

In accordance with Executive Order 13132, the rule does not have sufficient Federalism implications to warrant the preparation of a Federalism summary impact statement. Title VIII of ANILCA precludes the State from exercising subsistence management authority over fish and wildlife resources on Federal lands unless it meets certain requirements.

The Alaska National Interest Lands Conservation Act, Title VIII, does not provide specific rights to Tribes for the subsistence taking of wildlife, fish, and shellfish. However, the Board provided federally recognized Tribes and Alaska Native corporations opportunities to consult on this rule. Consultation with Alaska Native corporations are based on Public Law 108-199, div. H, Sec. 161, Jan. 23, 2004, 118 Stat. 452, as amended by Public Law 108-447, div. H, title V, Sec. 518, Dec. 8, 2004, 118 Stat. 3267, which provides that: “The Director of the Office of Management and Budget and all Federal agencies shall hereafter consult with Alaska Native corporations on the same basis as Indian Tribes under Executive Order No. 13175.”

The Secretaries, through the Board, provided a variety of opportunities for consultation: Commenting on proposed changes to the existing rule; engaging in dialogue at the Council meetings; engaging in dialogue at the Board's meetings; and providing input in person, by mail, email, or phone at any time during the rulemaking process.

On April 15, 2019, the Board provided federally recognized Tribes and Alaska Native Corporations a specific opportunity to consult on this rule prior to the start of its public regulatory meeting. Federally recognized Tribes and Alaska Native Corporations were notified by mail and telephone and were given the opportunity to attend in person or via teleconference.

This Executive Order requires agencies to prepare Statements of Energy Effects when undertaking certain actions. However, this rule is not a significant regulatory action under E.O. 13211, affecting energy supply, distribution, or use, and no Statement of Energy Effects is required.

Theo Matuskowitz drafted these regulations under the guidance of Thomas C.J. Doolittle of the Office of Subsistence Management, Alaska Regional Office, U.S. Fish and Wildlife Service, Anchorage, Alaska. Additional assistance was provided by

• Daniel Sharp, Alaska State Office, Bureau of Land Management;

• Clarence Summers, Alaska Regional Office, National Park Service;

• Dr. Glenn Chen, Alaska Regional Office, Bureau of Indian Affairs;

• Carol Damberg, Alaska Regional Office, U.S. Fish and Wildlife Service; and

• Thomas Whitford, Alaska Regional Office, USDA Forest Service.

For the reasons set out in the preamble, the Federal Subsistence Board amends title 36, part 242, and title 50, part 100, of the Code of Federal Regulations, as set forth below.

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

On April 11, 2019, the EPA published a notice of proposed rulemaking (NPRM) proposing to approve the Progress Report, submitted by the Hawaii Department of Health (DOH) on October 20, 2017. 1 A detailed discussion of the Report and the EPA's rationale for approving the SIP revision is provided in the NPRM and will not be restated here.

The EPA's proposed action provided a 30-day public comment period that ended on May 13, 2019. During this period, we received five anonymous comments, two of which were identical. The two identical comments and one additional comment expressed general support for our proposed approval of the Report but did not address the specifics of our proposal and are therefore not addressed below. All five comments are included in the docket for this rulemaking. We summarize the two more detailed comments below and provide our responses.

Comment 1: The commenter states that Hawaii's Progress Report provides overwhelming evidence that Hawaii has successfully decreased human-generated emissions that contribute to the regional haze problem. The commenter points out that the Progress Report also states that point source emissions have increased 27 percent and that there have been significant increases in emissions from the “Other Fire/Prescribed Burning” category. The commenter believes that the EPA should compare these statistics to existing economic data to examine whether these pollution increases are due to higher production rates or increased carelessness of businesses. The commenter goes on to say that if “economic data claims that there has been a proportional increase, then Hawaii should implement incentives for companies that reduce emissions in future production.” The commenter then asserts that “if economic data states otherwise, Hawaii should adopt new business regulations that force companies to reduce emissions.” The commenter believes these “changes would further improve the results of the Hawaiian report—despite the already outstanding results.” The commenter concludes that after this research has been conducted, the EPA should approve the Report due to many of the outlined benefits, but that the EPA should also help Hawaii adopt policies that reduce burning and point source pollution. Finally, the commenter asserts that global warming is a large issue in 2019 and taking small steps to correct the effects of this international issue would not be harmful.

Response 1: We agree that Table 6.0-2, entitled “Differences in Statewide Anthropogenic Nitrogen Oxide Emissions” in the Hawaii Progress Report, which we reproduced in our proposed rulemaking as Table 5, 2 indicates that there was a 27 percent increase in nitrogen oxide (NO X ) emissions from point sources between 2005 and 2011. However, we note that the same table indicates that total NO X emissions from all anthropogenic sources combined decreased by four percent over that time period. Similarly, while there were increases in emissions of NO X , sulfur dioxide (SO 2 ) and volatile organic compounds (VOC) from the “Other Fire/Prescribed Burning” category between 2005 and 2011, there were overall decreases in anthropogenic NO X and SO 2 during the same period, and only a small (four percent) increase in anthropogenic VOC emissions. 3

In addition, as both the Progress Report and our proposed rulemaking noted, the dominant visibility-impairing pollutant in Hawaii's Class I areas during the first planning period was SO 2 . Therefore, the EPA's reasonable progress analysis for Hawaii for the first planning period focused primarily on significant sources of SO 2 and concluded that NO X emissions were a “secondary concern” during that period. 4 Thus, even if NO X emissions were not declining in the first planning period, their effect on visibility was secondary compared to SO 2 emissions during that period.

Finally, the portion of the comment about global warming is not germane to the EPA's proposed action on Hawaii's Progress Report.

Comment 2: The commenter asserts that the EPA should not approve Hawaii's Progress Report and the negative declaration stating that further revision of the existing regional haze plan is not needed at this time. The commenter states that the dominant cause of visibility impairment in Hawaii's Class I areas is sulfate compounds, and that over 96 percent of the sulfate emissions are from Hawaii's volcano. The commenter asserts that the eruption of an active volcano is unpredictable, so the sulfate compounds in the air also vary year to year. The commenter states that the current plan may improve visibility in Class I this year, but it does not represent it will account for the following years. The commenter further states that the current method and control procedures are effective and reliable, but because the commenter considers Hawaii to be a “high-risk” area given the number of visitors, the commenter asserts that the EPA needs to be extremely careful with people's safety.

Response 2: The commenter makes several distinct points. We agree with the commenter that volcanic eruptions are unpredictable and have year-to-year variability, resulting in variability in SO 2 emissions and sulfate-related visibility effects. However, Hawaii DOH does not have the ability to control or influence these emissions, and the goal of the regional haze program is to remedy visibility impairment resulting from man-made air pollution and does not require control of natural sources such as volcanoes. Therefore, we agree with Hawaii DOH's conclusion that “the existing implementation plan requires no further substantive revision at this time in order to achieve established goals for visibility improvement and emissions reductions,” and we find that Hawaii's conclusion is consistent with the Regional Haze Rule at 51.308(h)(1).

Additionally, the commenter states that the current plan may improve visibility in Class I areas this year, but that the plan does not account for subsequent years. The Progress Report only addresses the first regional haze planning period which extends to 2018; a SIP revision covering the second regional haze implementation period ending in 2028 is due to the EPA by July 31, 2021.

Finally, while we agree with the commenter regarding the importance of safety, it is important to note that the purpose of the regional haze program is to protect visibility. The CAA provides separate processes for addressing the health impacts of SO 2 , including the establishment of health-based national ambient air quality standards for SO 2 , the designation of areas as attainment or nonattainment based on ambient air quality data, and the development of SIPs to ensure attainment and maintenance of the SO 2 standard.

For the reasons described in our responses to comments, the comments received do not alter our proposed determination that the Hawaii Progress Report addresses the progress report and adequacy determination requirements for the first implementation period for regional haze Therefore, the EPA is approving Hawaii's Regional Haze Progress Report, submitted by Hawaii DOH on October 20, 2017, as meeting the applicable requirements of the CAA and the federal Regional Haze Rule, as set forth in 40 CFR 51.308(g), as a revision to the Hawaii SIP. The EPA is approving Hawaii's determination that the existing regional haze plan is adequate to meet the existing RPGs and requires no substantive revision as this time, as set forth in 40 CFR 51.308(h).

We have also determined that Hawaii fulfilled the requirements in 40 CFR 51.308(i) regarding state coordination with federal land managers.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k);

40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

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

• is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866;

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

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

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

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

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

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

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

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

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

The Congressional Review Act, 5 U.S.C. 801 et seq ., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register .

A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 11, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

EPA is taking final action to approve changes to the Jefferson County portion of the Kentucky SIP that were provided to EPA through a letter dated March 15, 2018. 1 Specifically, EPA is finalizing approval of the portions of these SIP revisions that make changes to the District's Regulation 6.31, Standards of Performance for Existing Miscellaneous Metal Parts and Products Surface Coating Operations, and Regulation 7.59, Standards of Performance for New Miscellaneous Metal Parts and Products Surface Coating Operations. 2 The March 15, 2018, SIP revisions add a new recordkeeping provision to both Regulation 6.31 and 7.59 and make a minor, administrative change that clarifies the applicability of Regulation 6.31. The SIP revisions update the current SIP-approved versions of Regulation 6.31 (Version 5) and Regulation 7.59 (Version 5) to Version 6 of each. In a notice of proposed rulemaking (NPRM) published on April 24, 2019 (84 FR 17127), EPA proposed to approve the aforementioned changes to Regulations 6.31 and 7.59 in the Jefferson County portion of the Kentucky SIP, which address the control of emissions from existing and new miscellaneous metal parts and products surface coating operations, respectively. The NPRM provides additional details regarding EPA's action. Comments on the NPRM were due on or before May 24, 2019. EPA received no comments on the proposed action, so EPA is now taking final action to approve the above-referenced revisions.

In this document, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of Jefferson County portion of the Kentucky SIP. Regulation 6.31, Standards of Performance for Existing Miscellaneous Metal Parts and Products Surface Coating Operations, Version 6, and Regulation 7.59, Standards of Performance for New Miscellaneous Metal Parts and Products Surface Coating Operations, Version 6, both State effective January 17, 2018. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 4 Office (please contact the person identified in the For Further Information Contact section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the State implementation plan, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 3

EPA is taking final action to approve the aforementioned changes to the Jefferson County portion of the Kentucky SIP. These rule revisions do not contravene federal permitting requirements or existing EPA policy, nor will they impact the National Ambient Air Quality Standards or interfere with any other applicable requirement of the Act.

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

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

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;

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

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

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

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

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

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

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

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

The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 11, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

40 CFR part 52 is amended as follows:

I. Background

On April 19, 2019 (84 FR 16426), EPA published a notice of proposed rulemaking (NPRM) for Delaware. In the NPRM, EPA proposed approval of Delaware's NNSR Certification for the 2008 8-hour ozone NAAQS. The formal SIP revision was submitted by the Department of Natural Resources and Environmental Control (DNREC) on behalf of the state of Delaware on June 29, 2018. Specifically, Delaware certified that its existing NNSR program, covering the Delaware portion of the Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE (Philadelphia Area) nonattainment area (which includes New Castle County) and the entire Seaford, DE (Seaford Area) nonattainment area (which includes Sussex County) for the 2008 8-hour ozone NAAQS, is at least as stringent as the requirements at 40 CFR 51.165, as amended by the final rule titled “Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements” (SIP Requirements Rule), for ozone and its precursors. 1 2 See 80 FR 12264 (March 6, 2015). This SIP revision was in response to EPA's final 2008 8-hour ozone NAAQS Findings of Failure to Submit for NNSR requirements. See 82 FR 9158 (February 3, 2017).

On March 12, 2008, EPA promulgated a revised 8-hour ozone NAAQS of 0.075 parts per million (ppm). See 73 FR 16436 (March 27, 2008). Under EPA's regulations at 40 CFR 50.15, the 2008 8-hour ozone NAAQS is attained when the three-year average of the annual fourth-highest daily maximum 8-hour average ambient air quality ozone concentration is less than or equal to 0.075 ppm.

Upon promulgation of a new or revised NAAQS, the CAA requires EPA to designate as nonattainment any area that is violating the NAAQS based on the three most recent years of ambient air quality data at the conclusion of the designation process. The Seaford and Philadelphia Areas were classified as marginal nonattainment for the 2008 8-hour ozone NAAQS on May 21, 2012 (effective July 20, 2012) using 2008-2010 ambient air quality data. See 77 FR 30088. On March 6, 2015, EPA issued the final SIP Requirements Rule, which establishes the requirements that state, tribal, and local air quality management agencies must meet as they develop implementation plans for areas where air quality exceeds the 2008 8-hour ozone NAAQS. See 80 FR 12264. Areas that were designated as marginal ozone nonattainment areas were required to attain the 2008 8-hour ozone NAAQS no later than July 20, 2015, based on 2012-2014 monitoring data. See 40 CFR 51.1103. The Seaford Area attained the 2008 8-hour ozone NAAQS by July 20, 2015 and the EPA Administrator signed a final Determination of Attainment (DOA) on April 11, 2016. See 81 FR 26697 (May 4, 2016). The Philadelphia Area did not attain the 2008 8-hour ozone NAAQS by July 20, 2015; however, the area did meet the CAA section 181(a)(5) criteria, as interpreted in 40 CFR 51.1107, for a one-year attainment date extension. Id. Therefore, in same rulemaking action, the EPA Administrator signed a final rule extending the Philadelphia Area 8-hour ozone NAAQS attainment date from July 20, 2015 to July 20, 2016. Id. 3

Based on initial nonattainment designations for the 2008 8-hour ozone NAAQS, as well as the March 6, 2015 final SIP Requirements Rule, Delaware was required to develop a SIP revision addressing certain CAA requirements for the Seaford and Philadelphia Areas, and submit to EPA a NNSR Certification SIP or SIP revision no later than 36 months after the effective date of the areas designations for the 2008 8-hour ozone NAAQS ( i.e., July 20, 2015). 4 See 80 FR 12264 (March 6, 2015). EPA is approving Delaware's June 29, 2018 NNSR Certification SIP revision for the 2008 8-hour ozone NAAQS.

This rulemaking action is specific to Delaware's NNSR requirements. NNSR is a preconstruction review permit program that applies to new major stationary sources or major modifications at existing sources located in a nonattainment area. The specific NNSR requirements for the 2008 8-hour ozone NAAQS are located in 40 CFR 51.160 through 165.

Delaware's SIP approved NNSR program, established in Title 7 Delaware Administrative Code (DE Admin Code) 1125 ( Requirements for Preconstruction Review ), apply to the construction and modification of major stationary sources in nonattainment areas. In its June 29, 2018 SIP revision, Delaware certified that the version of Title 7 DE Admin Code Section 1125 approved in the SIP is at least as stringent as the Federal NNSR requirements for the Seaford and Philadelphia Areas.

In addition, on February 3, 2017, EPA found that 15 states and the District of Columbia failed to submit SIP revisions in a timely manner to satisfy certain requirements for the 2008 8-hour ozone NAAQS that apply to nonattainment areas and/or states in the Ozone Transport Region (OTR). See 82 FR 9158. As explained in that rulemaking action, consistent with the CAA and EPA regulations, these Findings of Failure to Submit established certain deadlines for the imposition of sanctions, if a state does not submit a timely SIP revision addressing the requirements for which the finding is being made, and for the EPA to promulgate a Federal implementation plan (FIP) to address any outstanding SIP requirements.

EPA found, inter alia, that Delaware failed to submit SIP revisions in a timely manner to satisfy NNSR requirements for the Seaford and Philadelphia Areas. Delaware submitted its June 29, 2018 SIP revision to address the specific NNSR requirements for the 2008 8-hour ozone NAAQS, located in 40 CFR 51.160 through 165, as well as its obligations under EPA's February 3, 2017 Findings of Failure to Submit. EPA's analysis of how this SIP revision addresses the NNSR requirements for the 2008 8-hour ozone NAAQS and the Findings of Failure to Submit was discussed in the NPRM and will not be restated here.

EPA received two sets of comments on the April 19, 2019 NPRM. See 84 FR 16426. One set of comments was in support of EPA's proposed rulemaking action. With respect to the second set of comments, only one comment is relevant to this action and requires a response. A summary of the comment and EPA's response is discussed in this Section. A copy of the comments can be found in the docket for this rulemaking action.

Comment: The commenter makes note that volatile organic compounds (VOC) are defined as those in 40 CFR 51.100(s), but that Delaware's regulations don't include the correct version of what is being defined as a VOC. The commenter references EPA's February 12, 2019 NPRM, where EPA is approving Delaware's definition change of VOC. The commenter also notes suggests that EPA should wait until Delaware's regulations match the requirements in 40 CFR 51.165 exactly before approving this NNSR submission and suggests EPA to look at Delaware's regulation 1125. Lastly, the commenter notes that changes have also been made to the rules governing the Prevention of Significant Deterioration (PSD) program and related modeling requirements.

EPA Response: Delaware's certification applies to its NNSR program, not to its PSD program. The commenter's concerns related to PSD and related modeling are not relevant to EPA's action to approve Delaware's NNSR certification, and as such do not warrant consideration in the final rule.

EPA finalized its approval of the NPRM that the commenter referred to in their comments. In that February 12, 2019 rulemaking action, EPA proposed approval of Delaware's revision to Section 2 of 7 DE Admin Code 1101, where the state updated its definition of VOC to conform to EPA's current definition of VOC in 40 CFR 51.100(s). EPA finalized approval of that action on May 31, 2019. See 84 FR 25183.

EPA disagrees with the commenter's assertion that EPA should wait until Delaware's regulations match 40 CFR 51.165 exactly until it approves this rulemaking action. Delaware evaluated the necessary regulations for this rulemaking action and certified in its June 29, 2018 SIP revision that its existing Federally-approved NNSR program is at least as stringent as the Federal NNSR requirements found at 40 CFR 51.165, and based on EPA's analysis of that SIP revision, EPA agrees with Delaware and is moving forward to approve this rulemaking action.

EPA is approving Delaware's June 29, 2018 SIP revision addressing the NNSR requirements for the 2008 ozone NAAQS for the Seaford and Philadelphia Areas. EPA has concluded that Delaware's submission fulfills the 40 CFR 51.1114 revisions requirement, meets the requirements of CAA sections 110 and 172 and the minimum SIP requirements of 40 CFR 51.165, as well as its obligations under EPA's February 3, 2017 Findings of Failure to Submit. See 82 FR 9158.

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

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

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 11, 2019. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action pertaining to Delaware's NNSR program and the 2008 8-hour ozone NAAQS may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

40 CFR part 52 is amended as follows:

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-2018-0688 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 11, 2019. 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-2018-0688, 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. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of April 19, 2019 (84 FR 16430) (FRL-9991-14), 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 8F8696) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro, NC 27419. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide, pydiflumetofen, in or on root vegetable crop subgroup 1A at 0.30 parts per million (ppm); bulb vegetable crop subgroup 3-07A at 0.20 ppm; bulb vegetable crop subgroup 3-07B at 2 ppm; brassica leafy greens subgroup 4-16B at 50 ppm; brassica head and stem crop group 5-16 at 3 ppm; leaves of root and tuber vegetables, crop group 2 at 15.0 ppm; edible-podded legume vegetables subgroup 6A at 1.0 ppm; succulent shelled pea and bean subgroup 6B at 0.09 ppm; citrus fruit crop group 10-10 at 0.90 ppm; citrus oil at 15 ppm; pome fruit crop group 11-10 at 0.20 ppm; apple, wet pomace at 1.0 ppm; stone fruit, cherry subgroup 12-12A at 2.0 ppm; stone fruit, peach subgroup 12-12B at 1.0 ppm; stone fruit, plum subgroup 12-12C at 0.6 ppm; plum, prune at 1.5 ppm; bushberry crop subgroup 13-07B at 5 ppm; berries, low growing crop subgroup 13-07G, except cranberry and blueberry, at 1 ppm; tree nuts crop group 14-12, nutmeat at 0.05 ppm; almond hull at 9.0 ppm; cottonseed subgroup 20C, cotton undelinted seed at 0.4 ppm; cotton gin by-products at 7.0 ppm; sunflower subgroup 20B at 0.60 ppm; sorghum grain at 3.0 ppm; sorghum forage at 1.5 ppm; and sorghum stover at 10 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has modified the levels at which some of the commodities are being set as well as some of the commodity definitions. The reasons for these changes are explained in Unit IV.C.

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 pydiflumetofen including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pydiflumetofen 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.

The liver was a common target across species tested, likely in part due to the extensive first pass metabolism of absorbed pydiflumetofen. Liver effects were either concurrent with body weight depression and other target organ toxicity as in rats, or the first symptoms of treatment-related toxicity as in mice and dogs. Liver toxicity commonly manifested as increased liver weight concordant with hepatocyte hypertrophy in all species and was accompanied by increased cholesterol and triglyceride serum levels and a higher incidence of liver masses and eosinophilic foci of cellular alteration in mice and increased serum levels of liver enzymes and triglycerides in dogs. Male mice further exhibited a dose-dependent increase in the incidence of hepatocellular adenomas and carcinomas (accounted for separately and combined) and in the frequency of individual mice exhibiting multiple liver adenomas following chronic exposure. Treatment-related liver tumors were not observed in female mice nor in rats of either sex.

Body weight effects were also observed in rodents in response to treatment. Adult rats experienced depressed body weight following both subchronic (concurrent with liver toxicity) and chronic oral exposure (in isolation) and mice exhibited body weight depression following chronic exposure concurrent with symptoms of liver toxicity. A dose-dependent increase in the incidence and severity of thyroid gland follicular cell hypertrophy was also noted in rats following subchronic dietary exposure at doses greater than or equal to 587 milligrams/kilogram/day (mg/kg/day). The isolated thyroid findings occurred at a dose level over an order of magnitude above the subchronic and chronic point of departures (PODs) selected for risk assessment. In general, short and intermediate duration repeat dose oral exposures were well tolerated by adult rodents and dogs. Rodents were, however, considerably less tolerant of long-term exposure. Liver and body weight effects manifested at doses 25 and 12 times lower in chronic studies as compared to subchronic studies in mice and rats, respectively. A similar progression of toxicity was not evident in dogs.

The database does not support a conclusion that the pesticide is a neurotoxicant. Although a dose-dependent decrease in two locomotor activity parameters, number of rears and total distance traveled, was observed in female adult rats only within 6 hours of exposure following acute gavage oral exposure to doses greater than or equal to 300 milligrams/kilogram (mg/kg) in the acute neurotoxicity study, there were no neuropathology lesions or consistent evidence of other behavioral changes accompanying the depressed locomotor activity up to acute doses of 2,000 mg/kg. Detailed functional observations of rats and dogs following repeat dose dietary exposure did not identify similar changes in locomotor activity or any other behavioral changes indicative of neurotoxicity.

Body weight toxicity was not a unique observation in adults; it was also observed in rat offspring. In the two-generation reproduction study, rat pups exhibited significantly reduced weight during lactation that persisted through weaning and into adulthood. The pup body weight decrements were observed in the absence of parental toxicity indicating post-natal susceptibility to pydiflumetofen exposure. There was no evidence of enhanced fetal susceptibility following gestational exposure to pregnant rats or rabbits in the developmental studies.

Although there is some evidence of carcinogenicity in the database ( i.e., hepatocellular adenomas and carcinomas in male mice), the Agency has concluded that pydiflumetofen is not likely to be carcinogenic to humans at doses that do not induce a proliferative response in the liver. This conclusion is based on the limited nature of tumors seen in the available data (liver tumors found only in male mice), the fact that pydiflumetofen is not a mutagenic concern in vivo, and available mode of action data. The available mode of action data supports the Agency's conclusion that liver tumors are likely induced via activation of the constitutive androstane receptor (CAR) and subsequent stimulation of hepatocellular proliferation, and that hepatocellular proliferation is not likely to occur at the doses at which EPA is regulating exposure to pydiflumetofen. As a result, a non-linear approach using the chronic reference dose would adequately account for chronic toxicity, including carcinogenicity.

Pydiflumetofen exhibited low acute toxicity via the dermal and inhalation route. Acute dermal exposure to dermal doses of 5000 mg/kg elicited reduced activity in rats similar to observations following acute oral exposure, but it did not incur mortality. Acute exposure did not irritate the skin nor did it elicit dermal sensitization. No dermal or systemic toxicity was observed following repeat-dose dermal exposures up to 1000 mg/kg/day. Acute lethality from inhalation exposure was limited to high inhalation concentrations and it was a mild acute eye irritant. The requirement for the subchronic inhalation toxicity study was waived for the pydiflumetofen risk assessment based on a weight of evidence (WoE) approach that considered all of the available hazard and exposure information for pydiflumetofen, including: (1) the physical-chemical properties of pydiflumetofen indicated low volatility (vapor pressure is 3.98 × 10 -9 mm Hg at 25 °C); (2) the use pattern and exposure scenarios; (3) the margins of exposure for the worst case scenarios are ≥13,000 using an oral point of departure and assuming inhalation and oral absorption are equivalent; (4) pydiflumetofen exhibits low acute inhalation toxicity (Category IV); and (5) the current endpoints selected for risk assessment, liver toxicity and pup body weight decrements, were the most sensitive effects identified in the database and an inhalation study is not likely to identify a lower POD or more sensitive endpoint for risk assessment.

The toxicity of 2,4,6-trichlorophenol—a pydiflumetofen metabolite and residue of concern in livestock commodities—was evaluated based on studies from the open literature that were provided by the registrant, identified in a previous EPA review of 2,4,6-trichlorophenol ( https://www.epa.gov/sites/production/files/2016-09/documents/2-4-6-trichlorophenol.pdf ) and the Agency for Toxic Substance and Disease Registry (ATSDR) review of chlorophenols ( https://www.atsdr.cdc.gov/toxprofiles/tp107.pdf ), or retrieved in a search of the literature conducted for this risk assessment. Based on available information, the absorption, distribution, metabolism and elimination (ADME) for 2,4,6-trichlorophenol is similar to the ADME profile for pydiflumetofen: Near complete absorption and extensive metabolism followed by rapid excretion without appreciable tissue accumulation. Oral exposure to 2,4,6-trichlorophenol elicited effects in the liver, kidneys, and hematopoietic system as well as body weight depression. Subchronic oral exposure in rats elicited an increase in liver, kidney (males only), and spleen weight, an increase in total protein and albumin serum levels, a moderate to marked increase in splenic hematopoiesis, and an increased incidence of hepatocyte vacuolation.

Following chronic dietary exposure, male rats exhibited an increased incidence of leukemias, lymphomas, and nephropathy, and both sexes exhibited an increased incidence of bone marrow hyperplasia, leukocytosis, fatty metamorphosis in the liver, and chronic inflammation of the kidney. Tissue specific toxicity in mice was limited to the liver and manifest as an increased incidence of liver adenomas and carcinomas following chronic exposure. Adult body weight depression was observed in both rodent species. Mortality also occurred with greater frequency in both species at or above the limit dose. The few studies that examined developmental and offspring effects presented equivocal evidence of offspring toxicity following exposure to 2,4,6-trichlorophenol. Prenatal subchronic drinking water exposure in female rats led to a reduction in litter size and perinatal drinking water exposure in rats elicited changes in offspring spleen and liver weight; however, the health of the dams and its potential contribution to the manifestation of the offspring effects was not discussed in this study so it is unclear whether the offspring toxicity is a direct result of exposure or secondary to maternal toxicity. In a separate study, pup body weight decrements were observed in the presence and absence of parental toxicity following subchronic exposure, but the body weight effect was considered a consequence of the larger litter size rather than treatment. In any event, the effects seen in these studies occurred at doses above the endpoints selected for regulation of pydiflumetofen exposure.

These studies illustrate a spectrum of responses to increasing oral 2,4,6-trichlorophenol exposure: Isolated organ weight changes and a reduction in litter size were observed at doses as low as 30 mg/kg/day with adverse effects in the target tissues and significant body weight depression in adult animals manifesting when the oral dose exceeded 200 mg/kg/day. However, the 2,4,6-trichlorophenol doses that elicited the subchronic and chronic toxicity described above were not below the empirical no-observed-adverse-effect-levels (NOAELs) established in comparable pydiflumetofen guideline studies (after converting both to millimoles/kg/day) suggesting that direct exposure to 2,4,6-trichlorophenol is not more toxic than direct exposure to pydiflumetofen. Direct exposure to 2,4,6-trichlorophenol is anticipated from dietary exposures only. The PODs selected for pydiflumetofen are protective of the adverse effects reported in the 2,4,6-trichlorophenol literature and, therefore, are adequate for assessing direct dietary exposure to 2,4,6-trichlorophenol.

The carcinogenic potential of 2,4,6-tricholorophenol was assessed in 1990 by EPA and classified as a B2-probable human carcinogen in accordance with the 1986 cancer classification guidance based on an increased incidence of combined lymphomas and leukemias in male F344 rats and hepatocellular adenomas or carcinomas in male and female mice. Since that evaluation of 2,4,6-trichlorophenol, new literature has been published on the human relevance of leukemias in the F344 rat. The EPA re-evaluated the 2,4,6-trichlorophenol carcinogenicity literature and the broader scientific literature on rodent leukemia to determine if the data supported conducting a separate cancer assessment for 2,4,6-trichlorophenol. The rodent leukemia literature indicated that the leukemia finding in male F344 rats is common for this strain of rat, is highly variable, and lacks a direct human correlate. Although treatment-related, the EPA concluded the leukemia incidence in rats did not support a linear approach to cancer quantification given its questionable relevance to human health risk assessment. Furthermore, the incidence of lymphomas was not remarkable when examined independently from the leukemias and thus not evidence of carcinogenicity in isolation. The liver tumors observed in male and female mice were considered treatment-related; however, the tumors could not be solely attributed to 2,4,6-trichlorophenol exposure because the investigators did not account for known carcinogenic contaminants of commercial 2,4,6-trichlorophenol solutions that may have contributed to the induction of the liver tumors. These carcinogenic contaminants would not be present when 2,4,6-trichlorophenol is formed through metabolism; therefore, these data were not considered strong evidence of carcinogenicity and did not support a linear approach to 2,4,6-trichlorophenol cancer quantification for exposure resulting from pydiflumetofen use. The literature also did not suggest 2,4,6-trichlorophenol was a mutagenic concern in vivo.

Based on the limited evidence of carcinogenicity and mutagenicity for the metabolite, the EPA concluded that using the reference dose (RfD) approach with the chronic dietary POD selected for the pydiflumetofen dietary assessment would be adequate for assessing direct dietary exposure to 2,4,6-trichlorophenol from the proposed pydiflumetofen uses. Because the chronic POD selected for pydiflumetofen is 66 and 165x lower than the 2,4,6-trichlorophenol dose (on a molar basis) that elicited tumors in rats and mice, respectively, this approach will be protective of potential carcinogenicity from exposure to the metabolite. Consequently, a separate cancer dietary assessment for 2,4,6-trichlorophenol is not warranted at this time.

Specific information on the studies received and the nature of the adverse effects caused by pydiflumetofen as well as the NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document titled, “ Pydiflumetofen. Human Health Risk Assessment for New Foliar Uses on Berries, Low Growing, Crop Subgroup 13-07G; Brassica Head and Stem Crop Group 5-16; Brassica Leafy Greens Subgroup 4-16B; Bulb Vegetable Crop Subgroup 3-07A; Green Onion Crop Subgroup 3-07B; Bushberry Crop Subgroup 13-07B; Citrus Fruit Crop Group 10-10; Cottonseed Subgroup 20C; Edible-podded Legume Vegetables Subgroup 6A; Succulent Shelled Pea and Bean Subgroup 6B; Pome Fruit Crop Group 11-10; Root Vegetable Crop Subgroup 1A; Sorghum; Stone Fruit Crop Subgroups 12-12A, 12-12B, and 12-12C; Sunflower Subgroup 20B; Tree Nut Crop Group 14-12; Leaves of Root and Tuber Vegetable Crop Group 2; and New Seed Treatment Uses on Rapeseed Crop Subgroup 20A and Soybean; and Registration of a New Seed Treatment End-Use Product” on pages 56-69 in docket ID number EPA-HQ-OPP-2018-0688.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological 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 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticide.

A summary of the toxicological endpoints for pydiflumetofen used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of May 24, 2018 (83 FR 24036) (FRL-9976-66). Because the available data indicate that exposure to 2,4,6-trichlorophenol is not more toxic than direct exposure to pydiflumetofen and that there is insufficient information to warrant a separate cancer assessment of the metabolite at this time, EPA concludes that the endpoints for pydiflumetofen will be protective of effects from exposure to the metabolite 2,4,6-triclorophenol.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pydiflumetofen, EPA considered exposure under the petitioned-for tolerances as well as all existing pydiflumetofen tolerances in 40 CFR 180.699. EPA assessed dietary exposures from pydiflumetofen 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.

Such effects were identified for pydiflumetofen. In estimating acute dietary exposure, EPA used 2003-2008 food consumption data from the US Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT).

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used 2003-2008 food consumption data from USDA's NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance-level residues and 100 PCT.

iii. Cancer. As discussed in Unit III.A., the Agency has determined that a separate cancer assessment is not necessary for assessing exposure to pydiflumetofen. Because the chronic reference dose (cRfD) is below 10 mg/kg/day, i.e., the lowest dose known to induce hepatocellular proliferation based on available MOA data, the chronic assessment will be protective for assessing direct dietary exposure to pydiflumetofen. Also discussed in Unit II.A. is the Agency's conclusion that a separate cancer assessment is not required for assessing exposure to 2,4,6-trichlorophenol (free and conjugated) and the cRfD will be protective of potential carcinogenic effects.

iv. Anticipated residue and PCT information. EPA did not use anticipated residue or PCT information in the dietary assessment for pydiflumetofen. Tolerance-level residues and 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 pydiflumetofen and its degradate SYN545547 in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of pydiflumetofen. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Pesticides in Water Calculator (PWC) the estimated drinking water concentrations (EDWCs) of pydiflumetofen for acute exposures are estimated to be 10.4 parts per billion (ppb) for surface water and 113.3 ppb for ground water and for chronic exposures are estimated to be 3.37 ppb for surface water and 101 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For the acute dietary risk assessment, the water concentration value of 113.3 ppb was used to assess the contribution to drinking water. For the chronic dietary risk assessment, the water concentration of value 101 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).

Pydiflumetofen is registered for the following uses that could result in residential exposures: Golf course turf; and ornamentals grown in greenhouses, nurseries, and fields for residential planting. EPA assessed residential exposure using the following assumptions: Residential handler exposures are not expected since the turf and ornamental use labels indicate that the product is intended for use by professional applicators, while the crop use labels include the statement “Not for residential use.” As a result, residential handler exposures are not expected. There is the potential for residential short-term post-application exposure for individuals exposed as a result of being in an environment that has been previously treated with pydiflumetofen.

The quantitative exposure/risk assessment for residential post-application exposures is based on the short-term dermal exposure from contact with residues on treated golf course turf while golfing for adults, children 6 to less than 11 years old, and children 11 to less than 16 years old, and short-term dermal exposure from post-application activities with treated ornamental plants for adults and for children ages 6 to less than 11. Intermediate-term exposures are not expected.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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 pydiflumetofen to share a common mechanism of toxicity with any other substances, and pydiflumetofen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that pydiflumetofen 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 website at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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. There was no evidence of fetal sensitivity or toxicity in rat and rabbit developmental studies; however, quantitative offspring sensitivity was noted in the 2-generation reproduction study. Pup body-weight depression starting on day 4 of lactation and persisting into adulthood was observed at doses that did not elicit an adverse response in the parental rats. Although body weight was depressed in these animals after maturity and during the mating and post-mating period (specifically in males), it was considered evidence of offspring susceptibility because the lower body weight was a result of impaired growth in the pups. Reduced pup weight, reduced litter size, and increased liver and spleen weight in offspring was also noted following prenatal and perinatal exposure to the pydiflumetofen metabolite, 2,4,6-trichlorophenol. PODs were selected for each exposure scenario to be protective of the parent and metabolite offspring toxicity and offspring susceptibility in the risk evaluation.

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. That decision is based on the following findings:

i. The toxicity database for pydiflumetofen is complete.

ii. Regarding neurotoxicity, evidence of behavioral changes in the pydiflumetofen toxicity database was limited to adult rats in the acute neurotoxicity study (ACN). Female rats exhibited depressed locomotor activity in the form of fewer number of rears and less distance traveled following acute exposure to doses of pydiflumetofen ≥ 300 mg/kg (3x to 30x higher than the PODs selected for risk assessment). Male rats did not exhibit any symptoms of neurotoxicity following acute exposure up to 2,000 mg/kg/day. No evidence of neurotoxicity was observed in the subchronic rat and dog dietary studies that included additional detailed functional observations to identify neurological impairment nor in the routine clinical observations of the chronic studies and the guideline requirement for a subchronic neurotoxicity (SCN) study was waived. The concern for neurotoxicity in sensitive populations is low because the behavioral effects observed in the acute neurotoxicity studies have well-defined NOAEL/LOAELs, the PODs selected for risk assessment are protective of the acute behavioral change observed in females, there were no corresponding neuropathology changes in females exhibiting decreased locomotor activity, and there was no evidence of neurotoxicity following repeat-dose exposure.

iii. There was evidence of quantitative offspring sensitivity in the 2-generation reproduction study; however, as noted in Section D.2., PODs were selected for each exposure scenario to be protective of the offspring susceptibility in the risk evaluation.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed 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 pydiflumetofen in drinking water. EPA used similarly conservative assumptions to assess residential post-application exposure. These assessments will not underestimate the exposure and risks posed by pydiflumetofen.

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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to pydiflumetofen will occupy 9.5% of the aPAD for children 3 to 5 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to pydiflumetofen from food and water will utilize 29% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of pydiflumetofen 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).

Pydiflumetofen is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to pydiflumetofen.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 400 for adults, 560 for children 6 to less than 11 years old, and 2400 for children 11 to less than 16 years old. Because EPA's level of concern for pydiflumetofen is a MOE of 100 or below, these MOEs are not of concern.

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, pydiflumetofen 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 pydiflumetofen.

5. Aggregate cancer risk for U.S. population. As discussed in Unit III., the Agency has concluded that regulating on the chronic reference dose will be protective of potential carcinogenicity from exposure to pydiflumetofen. Because the chronic risk assessment did not exceed the Agency's level of concern, the Agency concludes there is not an aggregate cancer risk from exposure to pydiflumetofen.

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 pydiflumetofen residues.

Analytical multi-residue method QuEChERS (Quick, Easy, Cheap, Effective, Rugged, and Safe) as described in Eurofins validation study S14-05402 was independently validated in the following crop matrices: Lettuce (high water content), wheat grain (high starch content), oil seed rape (high oil content) and coffee bean (difficult commodity).

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: residuemethods@epa.gov.

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 established any MRLs for pydiflumetofen at this time.

EPA has modified several of the commodity definitions to be consistent with Agency nomenclature as well as the numerical expression of many of the proposed tolerance values to conform to current EPA policy on trailing zeroes.

For the tolerance in or on berries, low growing crop subgroup 13-07G, the proposed exceptions to the tolerance for lowbush blueberry and for cranberry are not appropriate, since use on both lowbush blueberry and cranberry are included on the proposed label 100-1601 and listed under directions for use on strawberry and low growing berry crop subgroup 13-07G.

EPA has modified several of the petitioned-for tolerances for the following reasons. For the tolerances in/on vegetable, root, subgroup 1A; nut, tree, group 14-12; pea and bean, succulent shelled, subgroup 6B; and fruit, citrus, group 10-10, the petitioner combined the individual commodities together in one calculator analysis when it is Agency practice to separate commodities. For the tolerances in/on vegetable, leaves of root and tuber, group 2 and sunflower subgroup 20B, the petitioner used U.S. residue data only where the Agency used both U.S. and Canadian residue data for harmonization purposes. For the tolerance in prune, the petitioner used the highest residue (HR) value from the field trials while the Agency's practice is to use the highest average field trial (HAFT) value from the field trials. For the tolerance in citrus oil, the Agency's practice is to use the HAFT and median concentration factor, and based on these data, the appropriate tolerance in citrus oil is 30 ppm; hence, the petitioned-for tolerance (15 ppm), the basis for which was not explained in the petition, is too low. As a result, several of the tolerance levels being established are different than those proposed by the petitioner.

Therefore, tolerances are established for residues of pydiflumetofen including its metabolites and degradates, in or on the following commodities. Compliance with the tolerance levels specified below is to be determined by measuring only pydiflumetofen (3-(difluoromethyl)- N -methoxy-1-methyl- N -[1-methyl-2-(2,4,6-trichlorophenyl)ethyl]-1 H -pyrazole-4-carboxamide) in or on the commodity: Almond, hulls at 9 ppm; apple, wet pomace at 1 ppm; berry, low growing, subgroup 13-07G at 1 ppm; brassica, leafy greens, subgroup 4-16B at 50 ppm; bushberry subgroup 13-07B at 5 ppm; cherry subgroup 12-12A at 2 ppm; cotton, gin byproducts at 7 ppm; cottonseed subgroup 20C at 0.4 ppm; fruit, citrus, group 10-10 at 1 ppm; fruit, citrus, group 10-10, oil at 30 ppm; fruit, pome, group 11-10 at 0.2 ppm; nut, tree, group 14-12 at 0.07 ppm; onion, bulb, subgroup 3-07A at 0.2 ppm; onion, green, subgroup 3-07B at 2 ppm; pea and bean, succulent shelled, subgroup 6B at 0.1 ppm; peach subgroup 12-12B at 1 ppm; plum, prune, dried at 1 ppm; plum subgroup 12-12C at 0.6 ppm; sorghum, grain, forage at 1.5 ppm; sorghum, grain, grain at 3 ppm; sorghum, grain, stover at 10 ppm; sunflower subgroup 20B at 0.5 ppm; vegetable, brassica, head and stem, group 5-16 at 3 ppm; vegetable, leaves of root and tuber, group 2 at 10 ppm; vegetable, legume, edible podded, subgroup 6A at 1 ppm; and vegetable, root, subgroup 1A at 0.5 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), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). 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:

The Atlantic shark fisheries are managed under the 2006 Consolidated Atlantic Highly Migratory Species (HMS) Fishery Management Plan (FMP), its amendments, and implementing regulations (50 CFR part 635) issued under authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq. ).

Under 50 CFR 635.24(a)(8), NMFS may adjust the commercial retention limits in the Atlantic shark fisheries during the fishing season. Before making any adjustment, NMFS must consider specified regulatory criteria (see § 635.24(a)(8)(i) through (vi)).

NMFS considered the inseason retention limit adjustment criteria listed at § 635.24(a)(8)(i) through (vi), which include:

• The amount of remaining shark quota in the relevant area, region, or sub-region to date, based on dealer reports.

Based on dealer reports through July 12, 2019, 24 percent of the 27.7 metric tons (mt) dressed weight (dw) shark quota for blacktip, 51 percent of the 85.5 mt dw shark quota for aggregated LCS, and 50 percent of the 13.4 mt dw for the hammerhead shark landings have been harvested in the eastern Gulf of Mexico sub-region. In the western Gulf of Mexico sub-region, 20 percent of the 255.8 mt dw shark quota for blacktip, 13 percent of the 72.0 mt dw shark quota for aggregated LCS, and less than 5 percent of the 11.9 mt dw for the hammerhead shark landings have been harvested. In total across the Gulf of Mexico region (eastern plus western sub-regions), approximately 80 percent of the blacktip, 66 percent of the aggregated LCS quota, and more than 70 percent of the hammerhead shark regional quotas remain available.

• The catch rates of the relevant shark species/complexes in the region or sub-region, to date, based on dealer reports.

Based on the current commercial retention limit and average catch rate of landings data from dealer reports, the amount of overall commercial blacktip shark, aggregated LCS, and hammerhead shark quota that remains available is high. Using current catch rates, projections indicate that the overall Gulf of Mexico landings would not reach 80 percent of any of the quotas before the end of the 2019 fishing year (December 31, 2019). Implementing a higher retention limit will better promote fishing opportunities and utilize available quotas throughout the Gulf of Mexico region.

• Estimated date of fishery closure based on when the landings reach or are projected to reach 80 percent of the quota given the realized catch rates.

Once the landings reach, or are projected to reach a threshold of 80 percent of the available aggregated LCS or hammerhead shark quotas and are projected to reach 100 percent before the end of the fishing season, NMFS would, as required by the regulations at § 635.28(b)(3), close the aggregated LCS and hammerhead shark management groups since they are “linked” quotas. The blacktip shark quotas in the Gulf of Mexico region are not linked to the aggregated LCS or hammerhead shark sub-regional quotas. If blacktip shark landings reach, or are projected to reach a threshold of 80 percent of the available quota and are projected to reach 100 percent before the end of the fishing season, NMFS would close the blacktip management group, consistent with existing regulations. Current overall regional catch rates for blacktip, aggregated LCS, and hammerhead sharks indicate all management groups would likely remain open for the remainder of the year. A higher retention limit should help make it possible to fully utilize the quotas in the Gulf of Mexico region.

• Effects of the adjustment on accomplishing the objectives of the 2006 Consolidated HMS FMP and its amendments.

Increasing the retention limit on the blacktip, aggregated LCS, and hammerhead shark management groups in the Gulf of Mexico region from 45 to 55 LCS other than sandbar sharks per vessel per trip would increase the fishery catch rates for the rest of the year and allow fishermen to capitalize on underutilized quota, consistent with the FMP's objective to manage Atlantic HMS fisheries for continuing optimum yield so as to provide the greatest overall benefit to the Nation, with respect to providing food production for commercial fisheries. The science-based quotas for the stocks would remain the same, consistent with previous actions, and ensure that the fisheries are managed consistent with conservation and management objectives in the 2006 Consolidated HMS FMP, as amended.

• Variations in seasonal distribution, abundance, or migratory patterns of the relevant shark species based on scientific and fishery-based knowledge.

The directed shark fisheries in the Gulf of Mexico region exhibit a mixed species composition, with a high abundance and distribution of aggregated LCS caught in conjunction with blacktip sharks. As a result, by increasing the harvest and landings on a per-trip basis, fishermen throughout the Gulf of Mexico region will likely experience equitable fishing opportunities and have a chance to fully utilize the available quotas.

• Effects of catch rates in one part of a region or sub-region precluding vessels in another part of that region or sub-region from having a reasonable opportunity to harvest a portion of the relevant quota.

NMFS has previously provided notice to the regulated community (83 FR 60777; November 27, 2018) that the goal of this year's fishery is to ensure fishing opportunities throughout the fishing year, consistent with conservation and management objectives for the stocks. While dealer reports indicate that, under current catch rates, the blacktip, aggregated LCS, and hammerhead shark management groups in the Gulf of Mexico region would remain open for the remainder of the year, the catch rates also indicate that the quotas would likely not be fully harvested under the current retention limit. If the harvest of these species is increased through an increased retention limit, NMFS estimates that the fishery would continue to remain open for the remainder of the year, and fishermen throughout the Gulf of Mexico region would have a reasonable opportunity to harvest a portion of the quota.

After considering the criteria discussed above, NMFS concluded that increasing the retention limit of the blacktip shark, aggregated LCS, and hammerhead shark management groups in the Gulf of Mexico region will allow for more utilization of the available quotas a for the rest of the year. Based on landings projections, under the current retention limits the overall Gulf of Mexico blacktip shark, aggregated LCS, and hammerhead shark quotas would not be reached by the end of the year. Therefore, NMFS is increasing the overall commercial blacktip shark, aggregated LCS, and hammerhead shark retention limit in the Gulf of Mexico region from 45 to 55 LCS other than sandbar sharks per vessel per trip.

On November 27, 2018 (83 FR 60777), NMFS announced that the 2019 commercial eastern Gulf of Mexico blacktip shark sub-regional quota was 27.7 mt dw (61,256 lb dw), the eastern Gulf of Mexico aggregated LCS sub-regional quota was 85.5 mt dw (188,593 lb dw), and the eastern Gulf of Mexico hammerhead shark sub-regional quota was 13.4 mt dw (29,421 lb dw), while the commercial western Gulf of Mexico blacktip shark sub-regional quota was 255.8 mt dw (563,799 lb dw), the western Gulf of Mexico aggregated LCS sub-regional quota was 72.0 mt dw (158,724 lb dw), and the western Gulf of Mexico hammerhead shark sub-regional quota was 11.9 mt dw (26,301 lb dw). Thus, the total Gulf of Mexico regional quotas are 283.5 mt dw (625,055 lb dw) for blacktip sharks; 157.5 mt dw (347,317 lb dw) for aggregated LCS; and 25.3 mt dw (55,722 lb dw) for hammerhead sharks. In the final rule, after considering public comment on the proposed rule (83 FR 45866, September 11, 2018), NMFS explained that if it appeared that the quota was being harvested too slowly, NMFS would consider increasing the retention limit, consistent with the applicable regulatory requirements. Dealer reports received through June14, 2019, indicate that 18 percent (50.2 mt dw), 29 percent (45.8 mt dw), and 23 percent (5.9 mt dw) of the available Gulf of Mexico regional blacktip, aggregated LCS, and hammerhead shark quotas, respectively, has been harvested. Increasing the retention limit provides the best opportunity to fully utilize these available quotas.

The boundary between the Gulf of Mexico region and the Atlantic region is defined at § 635.27(b)(1) as a line beginning on the East Coast of Florida at the mainland at 25°20.4′ N lat, proceeding due east. Any water and land to the south and west of that boundary is considered for the purposes of monitoring and setting quotas, to be within the Gulf of Mexico region. The boundary between the western and eastern Gulf of Mexico sub-regions is drawn along 88°00′ W long (§ 635.27(b)(1)(ii)). Persons fishing aboard vessels issued a commercial shark limited access permit under § 635.4 may still retain blacktip sharks, aggregated LCS, and/or hammerhead sharks management groups in the eastern Gulf of Mexico sub-region (east of 88°00′ W long).

Accordingly, as of August 12, 2019, NMFS is increasing the retention limit for the commercial blacktip shark, aggregated LCS, and hammerhead shark management groups in the Gulf of Mexico region for directed shark limited access permit holders from 45 LCS other than sandbar sharks per vessel per trip to 55 LCS other than sandbar sharks per vessel per trip. This retention limit adjustment does not apply to directed shark limited access permit holders if the vessel is properly permitted in the charter/headboat category and is engaged in a for-hire trip, in which case the recreational retention limits for sharks and “no sale” provisions apply (§ 635.22(a) and (c)); or if the vessel possesses a valid shark research permit under § 635.32 and a NMFS-approved observer is onboard, in which case the restrictions noted on the shark research permit apply.

The adjusted retention limit will remain at 55 LCS other than sandbar sharks per vessel per trip for the remainder of the 2019 fishing season, or until NMFS announces via a notice in the Federal Register another adjustment to the retention limit or a fishery closure, if warranted. All other retention limits and shark fishery regulations in the Gulf of Mexico region remain unchanged by this adjustment.

The Assistant Administrator for NMFS (AA) finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons:

Prior notice is impracticable because the regulatory criteria for inseason retention limit adjustments are intended to allow the agency to respond quickly to existing management considerations, including remaining available shark quotas, estimated dates for the fishery closures, the regional variations in the shark fisheries, and allowing fishermen to capitalize on underutilized quota. Additionally, regulations implementing Amendment 6 of the 2006 Atlantic Consolidated HMS FMP (80 FR 50074, August 18, 2015) intended that the LCS retention limit could be adjusted quickly throughout the fishing season to provide management flexibility for the shark fisheries and to allow fishermen to capitalize on underutilized quota, consistent with the FMP's objective to manage Atlantic HMS fisheries for continuing optimum yield so as to provide the greatest overall benefit to the Nation. Based on available shark quotas and informed by shark landings in previous seasons, responsive adjustment to the LCS commercial retention limit from the incidental level is warranted as quickly as possible to allow fishermen to take advantage of available quotas. For such adjustment to be practicable, it must occur in a timeframe that allows fishermen to take advantage of it.

Adjustment of the LCS fisheries retention limit in the Gulf of Mexico region will begin on August 12, 2019. Analysis of available data shows that adjustment of the LCS commercial retention limit upward to 55 would result in minimal risks of exceeding the blacktip shark, aggregated LCS and hammerhead shark quotas in the Gulf of Mexico region based on our consideration of previous years' data. With quota available and with no measurable impacts to the stocks expected, it would be contrary to the public interest to require vessels to wait to harvest the sharks otherwise allowable through this action. Therefore, the AA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment. Adjustment of the LCS commercial retention limit in the Gulf of Mexico region is effective August 12, 2019, to minimize any unnecessary disruption in fishing patterns and to allow the impacted fishermen to benefit from the adjustment. Foregoing opportunities to harvest the respective quotas could have negative social and economic impacts for U.S. fishermen that depend upon catching the available quotas. Therefore, the AA finds there is also good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effectiveness.

This action is being taken under § 635.24(a)(2) and is exempt from review under Executive Order 12866.