This action, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This rule is issued under Marketing Agreement and Order No. 930, both as amended (7 CFR part 930), regulating the handling of tart cherries produced in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin. Part 930 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Board locally administers the Order and is comprised of producers and handlers of tart cherries operating within the production area, and a public member.

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 13563 and 13175. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the Order now in effect, tart cherry handlers are subject to assessments. Funds to administer the Order are derived from such assessments. It is intended that the assessment rate will be applicable to all assessable tart cherries for the 2020-21 crop year and continue until amended, suspended, or terminated.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. Such handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This rule decreases the portion of the assessment rate allocated to research and promotion activities from $0.005 to $0.00275 per pound of tart cherries and increases the portion allocated to administrative expenses from $0.00075 to $0.003 per pound of tart cherries. The overall assessment rate established for the Board for the 2020-21 and subsequent fiscal periods remains unchanged at $0.00575 per pound of tart cherries.

The Order provides authority for the Board, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members are familiar with the Board's needs and with the costs of goods and services in their local areas and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 2019-20 fiscal period, the Board recommended, and USDA approved, an assessment rate of $0.00575 per pound of tart cherries that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.

During the September 10, 2020, meeting, the Board recommended 2020-21 expenditures of $795,000 and an assessment rate of $0.00575 per pound of tart cherries. In comparison, last year's budgeted expenditures were $1,956,500. The total assessment rate remains unchanged by this action. However, this rule decreases the portion of the assessment rate allocated to research and promotion activities from $0.005 to $0.00275 per pound of tart cherries and increases the portion allocated to administrative expenses from $0.00075 to $0.003 per pound of tart cherries. This shift in allocation will allow the Board to fund its administrative obligations while continuing limited research and promotion activities to help market this season's below-average crop. The revised allocation should ensure the availability of adequate administrative funds despite a significant draw-down in reserves resulting from the 2019-20 crop year assessment rate reduction.

The major expenditures recommended by the Board for the 2020-21 year include $350,000 for research and promotion, $255,000 for salaries and wages, and $130,000 for other administrative expenses. Budgeted expenses for these items in 2019-2020 were $1,514,500, $250,000, and $130,000, respectively.

The Board derived the recommended assessment rate by considering anticipated administrative expenses, an estimated crop of 141.46 million pounds of tart cherries (down from last year's production of 236.3 million pounds), the current status of reserves, and the needs of the industry with regards to research and promotion activities. Income derived from handler assessments is calculated at $813,395 (141.46 million pounds × $0.00575/pound). The Board anticipates that due to approved exemptions and loss adjustments the actual income from assessments will be closer to $783,992. Assessment income, along with interest income and funds from the Board's authorized reserve, should be adequate to cover budgeted expenses of $795,000. Funds in the reserve are estimated to be $75,096 at the end of the 2020-21 fiscal year.

The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Board or other available information.

Although this assessment rate will be in effect for an indefinite period, the Board will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Board meetings are available from the Board or USDA. Board meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Board recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Board's 2020-21 budget and those for subsequent fiscal periods will be reviewed and, as appropriate, approved by USDA.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 400 producers of tart cherries in the regulated area and approximately 40 handlers of tart cherries who are subject to regulation under the Order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $1,000,000 and small agricultural service firms have been defined as those whose annual receipts are less than $30,000,000 (13 CFR 121.201).

According to the National Agricultural Statistics Service (NASS) and Board data, the average annual grower price for tart cherries during the 2019-20 season was approximately $0.15 per pound. With total utilization at 236.3 million pounds, the total 2019-20 crop value is estimated at $35.45 million. Dividing the crop value by the estimated number of producers (400) yields an estimated average receipt per producer of $88,613. This is well below the SBA threshold for small producers.

A free on board (FOB) price of $0.82 per pound for processed tart cherries was derived from USDA's 2020 purchases of dried tart cherries at an average price of $4.11 per pound. The dried cherry price was converted to a raw product equivalent price at an industry recognized ratio of five to one. Based on utilization, this price represents a good estimate of the price for processed cherries. Multiplying this FOB price by total utilization of 236.3 million pounds results in an estimated handler-level tart cherry value of $193.8 million. Dividing this figure by the number of handlers (40) yields estimated average annual handler receipts of $4.8 million, which is below the SBA threshold for small agricultural service firms. Assuming a normal distribution, the majority of producers and handlers of tart cherries may be classified as small entities.

This final rule decreases the portion of the assessment rate allocated to research and promotion activities from $0.005 to $0.00275 per pound of tart cherries and increases the portion allocated to administrative expenses from $0.00075 to $0.003 per pound of tart cherries. The overall assessment rate established for the Board for the 2019-20 and subsequent fiscal periods remains unchanged at $0.00575 per pound of tart cherries. The volume of assessable tart cherries for the 2020-21 season is estimated at 141.46 million pounds. Thus, the $0.00575 rate should provide $813,395 in assessment income (141.46 million pounds × $0.00575/pound). The Board anticipates that due to approved exemptions and loss adjustments the total income from assessments will be $783,992. Income derived from handler assessments, along with interest income and funds from the Board's authorized reserve, should be adequate to cover budgeted expenses.

The major expenditures recommended by the Board for the 2020-21 year include $350,000 for research and promotion, $255,000 for salaries and wages, and $130,000 for other administrative expenses. Budgeted expenses for these items in 2019-20 were $1,514,500, $250,000, and $130,000, respectively.

This rule shifts the allocation of the assessment rate to decrease the portion allotted for research and promotion, while increasing the amount allocated for administrative costs. This adjustment should provide enough funds for the Board's administrative obligations and decrease the funding for research and promotion activities to reflect the significant reduction in the 2020-21 crop.

Prior to arriving at this budget and assessment rate, the Board considered production history, crop estimates, its financial statements, and the need to meet its administrative obligations and maintain some marketing efforts to increase demand for tart cherries. The Board discussed alternatives, including raising the assessment rate and borrowing funds; however, they were rejected due to the burden of increasing assessments on handlers and the cost of debt due to financing. The Board determined that 2020-21 expenditures of $795,000 were appropriate, and the recommended assessment rate and allocation, along with funds from interest income, and funds from reserves, would be adequate to cover the budgeted expenses.

A review of historical information and preliminary information pertaining to the upcoming fiscal year indicates that the average grower price for the 2020-21 season should be approximately $0.19 per pound of tart cherries. According to NASS statistics, this price is the average of the past three years. Therefore, the estimated assessment revenue for the 2020-21 crop year as a percentage of total grower revenue will be approximately 3.0 percent.

This action will not increase the assessment obligation imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, these costs will be offset by the benefits derived by the operation of the marketing order.

The Board's meeting was widely publicized throughout the tart cherry industry. All interested persons were invited to attend the meeting and participate in Board deliberations on all issues. Like all Board meetings, the September 10, 2020, meeting was a public meeting, and all entities, both large and small, were able to express views on this issue.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by the OMB and assigned OMB No. 0581-0177, Tart Cherries Grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin. No changes in those requirements will be necessary as a result of this rule. Should any changes become necessary, they would be submitted to OMB for approval.

This rule imposes no additional reporting or recordkeeping requirements on either small or large tart cherry handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

A proposed rule concerning this action was published in the Federal Register on December 16, 2020 (85 FR 81425). Copies of the proposed rule were also mailed or sent via email to all tart cherry handlers. The proposed rule was made available through the internet by USDA and the Office of the Federal Register. A 30-day comment period ending January 15, 2021, was provided for interested persons to respond to the proposal.

One comment was received that opposed any increase to the assessment rate and expressed concern that small growers suffered an unfair financial burden with respect to assessments. While this action does increase the portion of the assessment rate dedicated to administrative expenses, it decreases the portion dedicated to research and promotion. This action does not change the overall assessment rate currently in effect and will not increase the assessment cost on small or large handlers. The assessment rate is also calculated on a per pound basis so the cost to small and large handlers is shared proportionally based on their production volume. Accordingly, no changes will be made to the rule as proposed, based on the comment received.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: https://www.ams.usda.gov/rules-regulations/moa/small-businesses . Any questions about the compliance guide should be sent to Richard Lower at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant material presented, including the information and recommendation submitted by the Board and other available information, it is hereby found that this rule will tend to effectuate the declared policy of the Act.

For the reasons set forth in the preamble, 7 CFR part 930 is amended as follows:

The 1991 amendments to the Cotton Research and Promotion Order (7 CFR part 1205) were implemented following the July 1991 referendum. The amendments were provided for in the Cotton Research and Promotion Act (7 U.S.C. 2101-2118) amendments of 1990. These amendments provided for: (1) Importer representation on the Cotton Board by an appropriate number of persons, to be determined by USDA, who import cotton or cotton products into the U.S., and whom USDA selects from nominations submitted by importer organizations certified by USDA; (2) assessments levied on imported cotton and cotton products at a rate determined in the same manner as for U.S. cotton; (3) increasing the amount USDA can be reimbursed for the conduct of a referendum from $200,000 to $300,000; (4) reimbursing government agencies that assist in administering the collection of assessments on imported cotton and cotton products; and (5) terminating the right of producers to demand a refund of assessments.

On December 18, 2020, USDA issued a determination based on its review (85 FR 82426) not to conduct a referendum regarding the 1991 amendments to the Order; however, the Act provides that USDA shall nevertheless conduct a referendum at the request of 10 percent or more of the total number of eligible producers and importers that voted in the most recent referendum. Furthermore, the Act provides for a sign-up period during which eligible cotton producers and importers may request that USDA conduct a referendum on continuation of the 1991 amendments to the Order.

Pursuant to section 8(c) of the Act, USDA will provide all eligible Upland cotton producers and importers of cotton and cotton-containing products an opportunity to sign up and request a continuance referendum regarding the 1991 amendments to the Order. Eligible cotton producers would be provided the opportunity to sign-up to request a continuance referendum in person at the county Farm Service Agency (FSA) office where their farm is located. If a producer's land is in more than one county, the producer shall sign-up at the county office where FSA administratively maintains and processes the producer's farm records. Producers may alternatively request a sign-up form in the mail from the same office or through the USDA, AMS website: http://www.ams.usda.gov/Cotton and return it to their FSA office or return their signed request forms to USDA, Agricultural Marketing Service, Cotton and Tobacco Program, Attention: Cotton Sign-Up, P.O. Box 23181, Washington, DC 20077-8249.

Eligible importers would be provided the opportunity to sign up to request a continuance referendum by downloading a form from the AMS website, or request a sign-up form by contacting CottonRP@usda.gov or (540) 361-2726, and return their signed request forms to USDA, Agricultural Marketing Service, Cotton and Tobacco Program, Attention: Cotton Sign-Up, P.O. Box 23181, Washington, DC 20077-8249.

Such request must be accompanied by a copy of the U.S. Customs and Border Protection form 7501 showing payment of a cotton assessment (also known as the “cotton fee”) for calendar year 2020. Requests and supporting documentation should be mailed to USDA, AMS, Cotton and Tobacco Program, Attention: Cotton Sign-Up, P.O. Box 23181, Washington, DC 20077-8249.

The sign-up period will be from June 21, 2021, until July 2, 2021. Producer and importer forms shall only be counted if received by USDA before July 2, 2021.

Section 8(c)(2) of the Act provides that if USDA determines, based on the results of the sign-up, that 10 percent ( i.e., 4,622) or more of the total number of eligible producers and importers that voted in the most recent 1991 referendum request a continuance referendum on the 1991 amendments, a referendum will be held within 12 months after the end of the sign-up period. In counting such requests, however, not more than 20 percent may be from producers from any one state or from importers of cotton. For example, when counting the requests, the Agricultural Marketing Service's (AMS) Cotton and Tobacco Program would determine the total number of valid requests from all cotton-producing states and from importers. Not more than 20 percent of the total requests will be counted from any one state or from importers toward reaching the 10 percent or 4,622 total signatures required to call for a referendum. If USDA determines that 10 percent or more of the number of producers and importers who voted in the most recent referendum favor a continuance referendum, a referendum will be held.

This direct final rule amends the procedures for the conduct of the current sign-up period. The current rules and regulations provide for sections on definitions, supervision of the sign-up period, eligibility, participation in the sign-up period, counting requests, reporting results, and instructions and forms.

In §§ 1205.20, 1205.26, and 1205.27, references to “calendar year 2014” are revised to read “calendar year 2020.” Also, in § 1205.26, eligible persons are further defined to ensure that all producers that planted cotton during 2020 will be eligible to participate in the sign-up period, and in § 1205.26(2), the rule updates and reflects the elimination of the $2.00 per line item importer de minimis (81 FR 38893; June 15, 2016) and that any importer of cotton and cotton-containing products during the representative period may participate. In §§ 1205.27, 1205.28, and 1205.29 sign-up period conduct dates, FSA reporting dates, and mailing addresses have been updated.

A 30-day comment period is determined to be appropriate because these eligibility and participation requirements are substantially the same as the eligibility and participation requirements that were used in previous referenda and sign-up periods; participation is voluntary; and this rule, if adopted, should be made effective as soon as possible in order to conduct the sign-up at the earliest possible dates.

This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation would not have substantial and direct effects on Tribal governments and would not have significant Tribal implications.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 12 of the Act, any person subject to an order may file with the Secretary of Agriculture (Secretary) a petition stating that the order, any provision of the plan, or any obligation imposed in connection with the order is not in accordance with law and requesting a modification of the order or to be exempted therefrom. Such person is afforded the opportunity for a hearing on the petition. After the hearing, the Secretary would rule on the petition. The Act provides that the District Court of the United States in any district in which the person is an inhabitant, or has his principal place of business, has jurisdiction to review the Secretary's ruling, provided a complaint is filed within 20 days from the date of the entry of the Secretary's ruling.

In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has examined the economic impact of this rule on small entities. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such action so that small businesses will not be unduly or disproportionately burdened. The Small Business Administration (SBA) defines, in 13 CFR 121.201, small agricultural producers as those having annual receipts of no more than $1,000,000, and small “Other Farm Product Raw Material Merchant Wholesalers” (cotton merchants/importers) as having no more than 100 employees. The Cotton Board estimates 12,000 producers and 40,000 importers are subject to the rules and regulations issued pursuant to the Cotton Research and Promotion Order. According to the United States Census Bureau's “2016 Survey of SUSB Annual Data Tables by Establishment Industry,” most importers are considered small entities as defined by the SBA. The majority of these producers and importers are small businesses under the criteria established by the SBA.

There are no Federal rules that duplicate, overlap, or conflict with this rule.

This rule is voluntary and only affects producers and importers wishing to participate in the sign-up under the Cotton Research and Promotion Order. Only those eligible persons who are in favor of conducting a referendum would need to participate in the sign-up period. Of the 46,220 total valid ballots received in the 1991 referendum, 27,879, or 60 percent, favored the amendments to the Order, and 18,341, or 40 percent, opposed the amendments to the Order. This rule provides those persons who are not in favor of the continuance of the Order amendments an opportunity to request a continuance referendum.

The eligibility and participation requirements for producers and importers are substantially the same as the rules that established the eligibility and participation requirements for the 1991 referendum and previous sign-up periods. In the most recent sign-up in 2015, USDA announced its determination not to conduct a continuance referendum because it received only 46 requests, an insufficient number of signatures to hold another referendum (80 FR 76654; December 10, 2015).

The amendments in this action update various dates, name changes, and addresses, and make other miscellaneous administrative changes.

The sign-up procedures do not impose a substantial burden or have a significant impact on persons subject to the Order because participation is not mandatory, not all persons subject to the Order are expected to participate, and USDA will determine producer and importer eligibility. The information collection requirements under the Paperwork Reduction Act are minimal.

The information collections in this rule will be carried out under the OMB Control Number 0581-0093. This rule does not add to the overall burden currently approved by OMB and assigned OMB Control Number 0581-0093 under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). This OMB Control Number is referenced in § 1205.541 of the regulations.

A 30-day comment period is provided to comment on the changes to the Cotton Board Rules and Regulations herein.

For the reasons stated in the preamble, AMS amends 7 CFR part 1205 as follows:

The Board is issuing this interim final rule pursuant to its authority under the Federal Credit Union Act. 1 The Act grants the Board a broad mandate to issue regulations that govern both federal credit unions and, more generally, all FICUs. For example, section 120 of the Act is a general grant of regulatory authority, and authorizes the Board to prescribe rules and regulations for the administration of the Act. 2 Section 209 of the Act is a plenary grant of regulatory authority to issue rules and regulations necessary or appropriate for the Board to carry out its role as share insurer for all FICUs. 3 Other provisions of the Act confer specific rulemaking authority to address prescribed issues or circumstances. 4 Such specific rulemaking authority is set forth in section 216(b) with respect to PCA. 5

In 1998, Congress enacted the Credit Union Membership Access Act (“CUMAA”). 6 The CUMAA amended the Federal Credit Union Act (“the Act”) to require the NCUA to adopt, by regulation, a system of PCA consisting of minimum capital standards and corresponding remedies to improve the net worth of federally insured “natural person” credit unions. 7 The purpose of PCA is to “resolve the problems of insured credit unions at the least possible long-term loss to the [National Credit Union Share Insurance Fund (`NCUSIF')].”  8

The statute designated three principal components of PCA: (1) A framework combining mandatory actions prescribed by statute with discretionary actions developed by the NCUA; (2) an alternative system of PCA to be developed by the NCUA for FICUs which CUMAA defines as “new;” and (3) a risk-based net worth requirement to apply to FICUs which the NCUA defines as “complex.”

For FICUs other than those that meet the statutory definition of a “new” FICU, the CUMAA mandated a framework of mandatory and discretionary supervisory actions indexed to five statutory net worth categories:

The mandatory actions and conditions that trigger conservatorship and liquidation are expressly prescribed by statute. 9 To supplement the mandatory actions, the statute directed the NCUA to develop discretionary actions which are “comparable” to the “discretionary safeguards” available under section 38 of the Federal Deposit Insurance Act, which is the statute that applies PCA to other federally insured depository institutions. 10

The Act addresses the earnings-retention requirement applicable to FICUs that are not well capitalized. 11 Such FICUs are required to annually set aside as net worth an amount equal to not less than 0.4% of their total assets. 12 The Board has the authority to decrease the earnings-retention requirement. 13 To accomplish this, the Board may issue an order if it determines the decrease is necessary to avoid a significant redemption of shares and further the purpose of PCA—to resolve the problems of insured credit unions at the least possible long-term cost to the NCUSIF. The Act also requires the Board to periodically review any order that it issues to decrease a FICU's earnings-retention requirement. 14

Separately, 12 U.S.C. 1790d(f) sets forth requirements related to NWRPs, which FICUs must submit to the NCUA and which the NCUA must review when a FICU becomes undercapitalized. The regulatory provisions that address the procedures and documentation requirements for NWRPs are codified at 12 CFR 702.206 and are detailed below.

In February 2000, the NCUA Board adopted part 702 and subpart L of part 747, establishing a comprehensive system of PCA that combines mandatory supervisory actions prescribed by the statute with discretionary supervisory actions developed by the NCUA (2000 final rule). 15 Each of these supervisory actions index to the five statutory net worth categories (well capitalized, adequately capitalized, undercapitalized, significantly undercapitalized, and critically undercapitalized).

In addition, the 2000 final rule permits the NCUA to impose other action to carry out PCA beyond any discretionary supervisory action available for a particular net worth category. 16 In the proposal that provided the basis for the 2000 final rule, the Board noted that part 702 also amplifies the terms of the statutory exception to the 0.4% minimum set aside. Specifically, the Board stated that it interpreted the phrase by order to indicate that exceptions to the 0.4% statutory minimum are to be granted on a case-by-case basis. 17 The Board had historically interpreted these orders on a case-by-case basis. However, given the current economic conditions associated with the COVID-19 pandemic—during which many FICUs broadly face similar circumstances that affect net worth—the Board has determined it is appropriate to implement the changes in this rule to authorize a broadly applicable order to decrease the earnings-retention requirements for multiple FICUs and to allow a streamlined NWRP in certain circumstances.

On May 21, 2020, the Board approved an interim final rule that temporarily amended two provisions in the PCA regulations in part 702. 18 The first amendment addressed the earnings-retention requirement in § 702.201 for FICUs classified as adequately capitalized. The second amendment addressed the NWRPs in § 702.206(c) that have become undercapitalized.

The May 2020 interim final rule was issued in response to the COVID-19 pandemic. It sought to ensure that FICUs continued to operate efficiently, to ensure that FICUs maintained sufficient liquidity, and to account for the potential temporary increase in shares that FICUs may experience during the COVID-19 pandemic. Specifically, the Board believed the temporary amendments in the interim final rule would allow FICUs to better utilize resources by reducing the administrative burden associated with a temporary increase in shares.

The Board concluded that the amendments would provide FICUs with necessary additional flexibility in a manner consistent with the NCUA's responsibility to maintain the safety and soundness of the credit union system. The Board made the temporary amendments effective upon publication and specified that they would remain in place through the end of calendar year 2020. The Board sought comment on the interim final rule.

On June 5, 2020, pursuant to the changes made by the May 2020 interim final rule, the Board issued a temporary order decreasing the earnings-retention requirement. 19 Specifically, the Board determined that, in light of the economic circumstances caused by the COVID-19 pandemic, decreasing the earnings-retention requirements set forth in the NCUA's regulations was necessary to avoid a significant redemption of shares and would further the purposes of the PCA regulations. Accordingly, the Board ordered that any natural-person FICU that had a net worth classification, as defined in part 702 of the NCUA's regulations, of adequately capitalized between March 31, 2020, and December 31, 2020, could decrease its earnings-retention requirement to zero as set forth in part 702. The order was effective through, and including, December 31, 2020.

As noted, the Board solicited comment on the May 2020 interim final rule. The Board received comments from a credit union trade association, two state credit union leagues, and an organization of state credit union supervisors. All commenters supported the interim final rule, and no commenter opposed it. All commenters stated that the changes were appropriate, noting that they provided regulatory relief and flexibility to credit unions to manage their liquidity and address financial hardships caused by the COVID-19 pandemic.

The interim final rule's two provisions expired on December 31, 2020. All commenters requested that the temporary amendments be extended or made permanent. One commenter stated that if the economic dislocation caused by the pandemic lingered, the regulatory relief contemplated in the interim final rule could be necessary beyond December 31, 2020. Among the recommendations to extend the effective date were (1) make the rule permanent, (2) extend the applicability until the COVID-19 pandemic was declared over by the Center for Disease Control or other Federal agency, or (3) make the end date December 31, 2021.

Based on limited utilization of the previous relief as of December 2020, the Board did not extend these provisions but continued to consider this issue. Considering information available following the expiration of the 2020 interim final rule, the Board has determined it is appropriate to readopt these amendments to the PCA regulations in part 702 on a temporary basis. Specifically, based on the recent congressional action (the American Rescue Plan Act of 2021)  20 to provide direct financial relief to individual taxpayers, the Board anticipates that credit unions will receive a significant increase in deposits due to stimulus checks. Accordingly, the Board has determined it is appropriate to reinstitute the changes to the PCA provisions previously adopted in May 2020.

In 2020, the credit union industry experienced significant asset growth as a result of the COVID-19 pandemic. The Board believes this growth will be temporary. This growth strained the net worth position of credit unions, and negatively impacted many credit unions' PCA classification. Specifically, the credit union industry experienced asset growth—predominantly from share growth—at a rate of 17.73 percent from December 31, 2019, to December 31, 2020. During this same period, the number of FICUs with a PCA classification of adequately capitalized increased by 274 percent, and those classified as undercapitalized increased by 123 percent. 21

The American Rescue Plan Act is the third in a series of congressional actions to provide taxpayers monetary relief. 22 This action, approved in March 2021, provides relief to individual taxpayers in the form of stimulus payments (referred to as “recovery rebates” in the American Rescue Plan Act). At the time of this action, the previous stimulus payments approved by Congress in December 2020 as part of the Consolidated Appropriations Act of 2021 were still being distributed to qualified individuals in the form of stimulus payments. 23 Looking forward, the combination of both stimulus payments will place a continued strain on FICUs' PCA classifications.

With respect to earnings retention, a FICU that is classified as adequately capitalized or lower must increase the dollar amount of its net worth quarterly by an amount equivalent to at least 1/10th of a percent of its total assets and must quarterly transfer at least that amount (for a total of 0.4% annually) from undivided earnings to its regular reserve account every quarter until it is well capitalized. 24 The purpose of this provision is to restore a FICU that is less than well capitalized to a well-capitalized position in an incremental manner.

As discussed previously, § 702.201 currently provides that the Board may waive this requirement on a case-by-case basis when an affected FICU submits a waiver application to the NCUA. The Act provides broader authority for the Board to issue an order to waive this requirement and does not require an application or individual orders. 25 In response to the COVID-19 pandemic and resulting economic conditions, the Board has determined that it is appropriate to temporarily amend § 702.201 to provide the Board express regulatory authority to issue a single order waiving the earnings-retention requirement for all FICUs classified as adequately capitalized while this temporary rule is in effect. The Board intends, as it did in its June 2020 order, to authorize the applicable Regional Director to require an application for an earnings transfer waiver if a particular FICU poses undue risk to the NCUSIF or exhibits material safety and soundness concerns.

Amending the regulation in this manner will allow the Board to respond to circumstances that broadly affect many FICUs with a single issuance rather than numerous individual waiver approvals. This provision will be effective on the date the interim final rule is published in the Federal Register and will expire on March 31, 2022.

This interim final rule will impact the processing of earnings transfer waiver submissions listed in the following table. It will not impact the earnings transfer waiver submissions that were due March 16, 2021, as a result of a credit union's PCA classification of adequately capitalized (or lower), based on the Call Report for the quarter ending of December 31, 2020.

Once this regulatory amendment is in effect, the Board intends to issue the order described above following the publication of this rule in the Federal Register . The order will be applicable to adequately capitalized FICUs and will grant relief from the earnings-retention requirement without requiring those FICUs to submit applications and receive individual waiver approvals, subject to the qualification previously noted in this section.

The Board is exercising this authority under 12 U.S.C. 1790d(e)(2) to enhance flexibility in the application of the earnings-retention requirement. This relief is necessary to avoid a reduction of shares and thus retain system liquidity and capital adequacy, thereby furthering the purpose of PCA. As previously noted, the COVID-19 pandemic resulted in significant asset growth in the credit union industry. This growth may impact many credit unions' PCA classification, resulting in an increased number of credit unions being subject to the earnings retention requirement. Based on the December 31, 2020 Call Report data, 155 credit unions are classified as less than well capitalized and are subject to mandatory action under PCA. An estimated 107 credit unions were classified as adequately capitalized. These credit unions may experience relief from this rulemaking. The potential for the impact of additional issuance of COVID-19 pandemic relief in the form of stimulus payments could result in further reported asset growth and result in more credit unions qualifying for earnings retention relief. Specifically, 465 credit unions had net worth ratios between seven and eight percent at December 31, 2020. If these credit unions experienced substantial asset growth caused by increased share growth, there is a potential that some of these credit unions may also qualify for earnings retention relief during the next twelve months.

The Board further notes that FICU operations continue to be significantly disrupted as a result of social distancing practices, remote work, and related complications. This regulatory relief will lessen the administrative burden on both FICUs and the NCUA by avoiding the effort associated with preparing a waiver application and (for the NCUA) evaluating and responding to such applications. The Board notes qualifications in the planned order regarding FICUs that pose undue risk or material safety and soundness concerns will help ensure the purpose of PCA—namely, to resolve the problems of insured credit unions at the least possible long-term cost to the NCUSIF—is maintained while this temporary rule is in effect.

This approach affords the agency the flexibility to address potential difficulties FICUs face during this unprecedented period. The Board also notes that the current, specific requirements on earnings transfer waivers are based on a regulatory provision rather than a specific statutory directive. 26 Accordingly, the Board has flexibility to modify the regulatory provision to address the financial circumstances of individual FICUs as well as the broader credit union system. This is consistent with the overall statutory structure of PCA, which combines both mandatory and discretionary provisions.

Expansionary monetary and fiscal policies, combined with precautionary savings, are placing a strain on FICU net worth. The ongoing economic impact of the COVID-19 pandemic may result in an increase in the volatility of share balances, loan demand, and loan losses. The resulting stress on credit union balance sheets could potentially require an increased level of liquidity management throughout 2021. The NCUA continues to encourage credit unions to work with their members who are affected by the COVID-19 pandemic. Allowing for a broad order relieving adequately capitalized FICUs from this requirement is consistent with the statutory criteria for issuing such an order—namely, avoiding a significant redemption of shares and furthering the purpose of 12 U.S.C. 1790d to “resolve the problems of insured credit unions at the least possible long-term loss to the Fund.”  27

Accordingly, the Board is amending § 702.201 to adopt the temporary provision to issue a broadly applicable order. The Board plans to issue through a separate action an order consistent with this re-adopted provision to set forth the terms of relief from the earnings-retention requirement.

With respect to NWRPs, the Act provides a broad directive that a FICU that is less than adequately capitalized must submit an applicable NWRP to the NCUA. The NCUA, by regulation, has provided additional details to flesh out this statutory provision. Section 702.206(a) of the NCUA's regulations specifies the schedule for filing an NWRP, and § 702.206(c) of the NCUA's regulations outlines the contents of an NWRP. 28

The FAA has determined, in accordance with 5 U.S.C. 553(b)(3)(B) and 553(d)(3), that notice and opportunity for prior public comment hereon are unnecessary because substantially identical special conditions have been previously subject to the public comment process in several prior instances, such that the FAA is satisfied that new comments are unlikely. For the same reason, the FAA finds that good cause exists for adopting these special conditions upon issuance. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment.

While the FAA did not precede these special conditions with a notice of proposed special conditions, the FAA invites you to send any written relevant data, views, or arguments about this final special condition. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0241; Special Conditions No. 29-053-SC” at the beginning of your comments. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

The FAA will consider all comments received by the closing date for comments. The FAA may change these special conditions based on the comments received.

On November 7, 2014, Airbus applied for FAA type certification validation of the Model H160B helicopter. Airbus applied for an extension on November 1, 2016, which is also the date of the updated type certification basis.

The Airbus Model H160B is a 14 CFR part 29 transport category, twin turboshaft engine helicopter. The Airbus Model H160B helicopter has a maximum takeoff weight of 13,436 lbs. It can hold a maximum of 12 passengers and 2 crew on board. The Airbus Model H160B helicopter is a new part 29 helicopter characterized by the integration of composite materials in its airframe construction, five main rotor blades ( i.e., blue edge technology), a Fenestron tail rotor, and a Helionix flight deck.

Airbus proposes that the Model H160B helicopter include the use of a novel and unusual design feature, which is a 30-minute AEO power rating. The 30-minute AEO power rating is generally intended to be used for hovering at increased power for search and rescue missions. Title 14 CFR 1.1 defines “rated takeoff power” as limited in use to no more than 5 minutes for takeoff operation. The use of takeoff power for 30 minutes will require special airworthiness standards, known as special conditions, to address the use of this 30-minute AEO rating and its effects on the rotorcraft. These special conditions will add requirements to the existing airworthiness standards in 14 CFR 29.1049 (Hovering cooling test procedures), 29.1305 (Powerplant instruments), and 29.1521 (Powerplant limitations).

Under the provisions of 14 CFR 21.17, Airbus must show that the Model H160B helicopter meets applicable provisions of the regulations as listed below. The Airbus Model H160B type certification basis date is November 1, 2016.

1. 14 CFR part 29, Amendments 29-1 through 29-55, dated January 31, 2012.

2. Equivalent Safety Findings:

(a) Sections 29.1305, 29.1309, 29.1549, Engine Training Mode.

(b) Sections 29.1305, 29.1321(a), 29.135l(d)(l), and 29.1435, Part Time Display of Vehicle Parameters.

(c) Sections 29.1301, 29.1305, 29.1309, 29.1321, 29.1549, Substitution of Power Index Indicator for required powerplant instruments.

(d) Sections 29.l545(b)(4), 29.l549(b), Airspeed and Powerplant indication green marking.

(e) Section 29.1555(c)(l), Usable fuel capacity marking.

(f) Section 29.807(c), Passenger emergency exits—other than side of fuselage.

In addition, the certification basis includes certain equivalent safety findings that are not relevant to these proposed special conditions.

In addition to the applicable airworthiness regulations and special conditions, the Airbus Model H160B helicopter must comply with the noise certification requirements of 14 CFR part 36, and the FAA must issue a finding of regulatory adequacy under section 611 of Public Law 92-574, the “Noise Control Act of 1972.”

The Administrator has determined that the applicable airworthiness regulations (that is, 14 CFR part 29) do not contain adequate or appropriate safety standards for the Airbus Model H160B helicopter because of a novel or unusual design feature. Therefore, special conditions are prescribed under the provisions of § 21.16.

The FAA issues special conditions, as defined in § 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.17(a)(2).

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.

The Airbus Model H160B helicopter will incorporate the following novel or unusual design feature:

A 30-minute AEO power rating.

The following is a summary of the final special conditions:

(a) In addition to the requirements of § 29.1049, the aircraft cooling effects due to the use of the 30-minute AEO power rating versus the Takeoff (five-minute) rating must be accounted for in the testing.

(b) In addition to the requirements of § 29.1305, since this new 30-minute AEO power rating has a time limit associated with its use, the pilot must have the means to identify:

(1) When the rated engine power level is achieved,

(2) when the event begins,

(3) when the time interval expires, and

(4) when the cumulative time in one flight is reached.

(c) In addition to the requirements of § 29.1521, this new 30-minute AEO power rating must be limited to not more than 30 minutes per use and not more than a 50 minute cumulative time per flight. This new rating will allow the use of power above maximum continuous power (MCP) up to 30 minutes.

(d) Furthermore, the rotorcraft flight manual for the Airbus Model H160B helicopter must include limitations on the use of the 30-minute AEO power rating, which state that continuous use above MCP up to take-off power is limited to 30 minutes.

As discussed above, these special conditions are applicable to the Airbus Model H160B helicopter. Should Airbus apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only a certain novel or unusual design feature on the Airbus Model H160B helicopter. It is not a rule of general applicability.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Airbus Helicopters Model H160B helicopter. Unless stated otherwise, all requirements in §§ 29.1049, 29.1305, and 29.1521 remain unchanged.

1. Section 29.1049, Hovering cooling test procedures. In addition to the requirements of this section, for rotorcraft with a 30-minute all engines operating (AEO) power rating, the hovering cooling provisions at the 30-minute AEO power rating must be shown—

a. At maximum weight or at the greatest weight at which the rotorcraft can hover (if less), at sea level, with the power required to hover but not more than the 30-minute power, in the ground effect in still air, until at least five minutes after the occurrence of the highest temperature recorded, or until the continuous time limit of the 30-minute AEO power rating if the highest temperature recorded is not stabilized before.

b. At maximum weight and at the altitude resulting in zero rate of climb for this configuration, until at least five minutes after the occurrence of the highest temperature recorded, or until the continuous time limit of the 30-minute AEO power rating if the highest temperature recorded is not stabilized before.

2. Section 29.1305 Powerplant instruments, at Amendment 29-40. In addition to the requirements of this section, for rotorcraft with a 30-minute AEO power rating, a means must be provided to alert the pilot when the engine is at the 30-minute power level, when the event begins, when the time interval expires, and when the cumulative time in one flight is reached.

3. Section 29.1521 Powerplant limitations, at Amendment 29-41. In addition to the requirements of this section, the use of the 30-minute AEO power rating must be limited to not more than 30 minutes per use and not more than a 50 minute cumulative time per flight. The use of the 30-minute power must also be limited by:

a. The maximum rotational speed which may not be greater than—

(1) The maximum value determined by the rotor design; or

(2) The maximum value shown during the type tests;

b. The maximum allowable turbine inlet or turbine outlet gas temperature.

c. The maximum allowable power or torque for each engine, considering the power input limitations of the transmission with all engines operating;

d. The time limit for the use of the power corresponding to the limitations established in this section, sub-paragraphs a. through c. of this section; and

e. The maximum allowable engine and transmission oil temperatures.

TCCA, which is the aviation authority for Canada, has issued TCCA AD CF-2021-10, dated March 18, 2021 (TCCA AD CF-2021-10) (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for certain Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes.

This AD was prompted by reports of the failure of ELT antennas, including one case where the antenna departed the airplane. The FAA has determined that these ELT antenna failures were caused by vibration loads induced by air vortices shed by the Gogo 2Ku antenna radome installed on the airplane. The FAA is issuing this AD to address ELT antenna failure, which can lead to the loss of the ELT antenna and the development of fuselage cracks that can result in an inability to maintain cabin pressure. See the MCAI for additional background information.

TCCA AD CF-2021-10 describes procedures for repetitive replacements of the ELT antenna with a new ELT antenna and repetitive inspections of the exterior fuselage skin around the ELT antenna attachment area for damage (including cracking). This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the MCAI referenced above. The FAA is issuing this AD because the FAA evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

This AD requires accomplishing the actions specified in TCCA AD CF-2021-10 described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA initially worked with Airbus and the European Union Aviation Safety Agency (EASA) to develop a process to use certain EASA ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has since coordinated with other manufacturers and civil aviation authorities (CAAs) to use this process. As a result, TCCA AD CF-2021-10 is incorporated by reference in this final rule. This AD, therefore, requires compliance with TCCA AD CF-2021-10 in its entirety, through that incorporation, except for any differences identified as exceptions in the regulatory text of this AD. Service information specified in TCCA AD CF-2021-10 that is required for compliance with TCCA AD CF-2021-10 is available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-0313.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because ELT antenna failure can lead to the possible loss of the ELT antenna and the development of fuselage cracks that can result in an inability to maintain cabin pressure. In addition, the compliance time for the required action is shorter than the time necessary for the public to comment and for publication of the final rule. Therefore, the FAA finds good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reasons stated above, the FAA finds that good cause exists for making this amendment effective in less than 30 days.

The FAA invites you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-0313; Project Identifier MCAI-2021-00348-T” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this final rule.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Deep Gaurav, Aerospace Engineer, Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7300; fax 516-794-5531; email 9-avs-nyaco-cos@faa.gov . Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The requirements of the RFA do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 49 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

The FAA determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866, and

(2) Will not affect intrastate aviation in Alaska.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies Class E airspace at Mc Elroy Airfield Airport, Kremmling, CO, to ensure the safety and management of IFR operations at the airport.

The FAA published a notice of proposed rulemaking in the Federal Register (85 FR 85568; December 29. 2020) for Docket No. FAA-2020-1097 to modify the Class E airspace at Mc Elroy Airfield Airport, Kremmling, CO. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E5 airspace designations are published in paragraph 6005 of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to 14 CFR part 71 modifies the Class E airspace extending upward from 700 feet above the surface at Mc Elroy Airfield Airport, Kremmling, CO. This airspace is designed to contain IFR departures to 1,200 feet above the surface and IFR arrivals descending below 1,500 feet above the surface. The circular radius of the airport is larger than required and is reduced from 10.1 miles to 4.6 miles. An area is also added east of the airport to contain IFR aircraft departing toward/over rising terrain and IFR aircraft arriving via the RNAV Runway 27 approach. A second area is also added southwest of the airport to contain IFR aircraft arriving via the VOR/DME-A and the RNAV (GPS)-B approaches. A third area is added west of the airport to contain IFR aircraft departing toward/over rising terrain.

This action also implements administrative updates to the airport's name and geographic coordinates. To match the FAA database, “Kremmling” has been removed from the second line of the text header and the airport name is updated to Mc Elroy Airfield Airport. Further, to match the FAA database, the airport's geographic coordinates are updated to lat. 40°03′12″ N, long. 106°22′08″ W.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial, and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant the preparation of an environmental assessment.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies Class E airspace at Meeker Coulter Field Airport, Meeker, CO, to ensure the safety and management of IFR operations at the airport.

The FAA published a notice of proposed rulemaking in the Federal Register (85 FR 85564; December 29, 2020) for Docket No. FAA-2020-1098 to modify the Class E airspace at Meeker Coulter Field Airport, Meeker, CO. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Subsequent to the publication of the NPRM, the FAA determined that the proposed description of the airspace created a small gap between the circular radius of the airport and the airspace on either side of the 220° bearing from the airport. The final rule removes the small gap by adjusting the 220° bearing to the 221° bearing from the airport, and changes the distance on either side of the 221° bearing from 1.0 mile to 1.1 miles. This adjustment will not impact the external boundaries of the airspace. Further, the final rule removes excess verbiage from the airspace's description. The corrected airspace description reads: That airspace extending upward from 700 feet above the surface within a 3.5-mile radius of the airport, and within 1.1 miles each side of the 221° bearing from the airport, extending from the 3.5-mile radius to 9 mile southwest of the airport, and within 4 miles north and 8 miles south of the 292° bearing from the airport, extending from 2.1 miles west of the airport to 18.1 miles west of Meeker Coulter Field Airport.

Class E5 airspace designations are published in paragraph 6005 of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11E lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to 14 CFR part 71 modifies the Class E airspace extending upward from 700 feet above the surface at Meeker Coulter Field Airport, Meeker, CO. This airspace is designed to contain IFR departures to 1,200 feet above the surface and IFR arrivals descending below 1,500 feet above the surface. The airspace area was larger than required and has been reduced to properly contain IFR aircraft departing and arriving at the airport.

Additionally, this action implements an administrative update to the airport's name. To match the FAA database, the airport name is updated to Meeker Coulter Field Airport.

FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial, and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant the preparation of an environmental assessment.

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

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

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

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

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

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

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

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

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

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

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

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

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

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

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

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

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

On December 13, 2016, the Cures Act was enacted (Pub. L. 114-255). The Cures Act amended the FD&C Act to include descriptions of software functions that are excluded from the definition of device in the FD&C Act. The Cures Act amended the FD&C Act to state that the term device does not include the software functions excluded pursuant to section 520(o)(1) of the FD&C Act.

Among the software functions excluded from the definition of device by this provision, most relevant to this rule are the software functions intended to transfer, store, convert formats, or display clinical laboratory test or other device data, results, and findings and that do not interpret or analyze such clinical laboratory test or other device data, results, and findings. Because the provision only excludes certain software functions from the device definition, the regulatory status of device hardware remains unchanged. With this final rule, FDA is amending the “identification” description of eight classification regulations so that the regulations no longer include software functions that the Cures Act excluded from the device definition in the FD&C Act. In other words, in this action, FDA is amending eight classification regulations so that the regulations conform to the medical software provisions of the Cures Act and reflect FDA's current statutory authority.

This rule updates eight classification regulations by amending these regulations to exclude software functions that no longer fall within the device definition under 201(h) of the FD&C Act. Specifically, FDA is amending the following classification regulations:

• Amend the calculator/data processing module for clinical use “identification” description to remove non-device software functions that maintain and retrieve laboratory data;

• amend the continuous glucose monitor (CGM) secondary display “identification” description to remove receive and display software functions, and amend the title of the CGM secondary display regulation to “Continuous Glucose Monitor (CGM) Secondary Alarm System;”

• amend the automated indirect immunofluorescence microscope and software-assisted system device “identification” description by replacing the first use of the word “software” with “device” because both hardware and software functions that use fluorescent signal acquisition and processing software, data storage, and transferring mechanisms, or assay specific algorithms to interpret or analyze results, are devices;

• amend the medical device data systems (MDDS) “identification” description to remove non-device software functions intended for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results;

• amend the home uterine activity monitor (HUAM) “identification” description to remove non-device software functions intended for transmitting, receiving, and displaying data;

• amend medical image storage device “identification” description to remove non-device software functions intended for storing and retrieving so that a medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images;

• amend medical image communications device “identification” description to include software functions intended for medical image processing and manipulation; and

• amend picture archiving and communications system “identification” description to remove non-device software functions intended for storing and displaying medical images, revise the “identification” description to clarify that the regulation includes software and hardware functions intended for medical image management and processing, and revise the title of the classification regulation to “Medical Image Management and Processing System.”

This final rule does not change the classification of the device types for which FDA is amending the title and/or identification statements. This rule will ensure that the specific classification regulations conform to changes the Cures Act made to the FD&C Act and reflect current FDA statutory authority.

This final rule is being issued under sections 201(h), 520(o), and 701 of the FD&C Act (21 U.S.C. 321, 360j, and 371) and the device and general administrative provisions of the FD&C Act sections 501, 510, 513, 515, 520, 522, and 701 (21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, and 371).

On December 13, 2016, the Cures Act was enacted. The Cures Act amended, among other things, FDA's authority to regulate medical software, including certain clinical decision support software. The provision of the Cures Act entitled “Clarifying Medical Software Regulation,” amended section 520 of the FD&C Act by adding subsection (o), which describes specific software functions that are excluded from the definition of device in the FD&C Act (section 201(h) of FD&C Act).

Section 520(o)(1) of the FD&C Act excludes from the definition of device software functions that are intended for:

1. Administrative support of a healthcare facility (section 520(o)(1)(A));

2. Maintaining or encouraging a healthy lifestyle and unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition (section 520(o)(1)(B));

3. Serving as electronic patient records, including patient-provided information, to the extent that such records are intended to transfer, store, convert formats, or display the equivalent of a paper medical chart, so long as such records were created, stored, transferred, or reviewed by healthcare professionals or by individuals working under supervision of such professionals; such records are part of health information technology that is certified under section 3001(c)(5) of the Public Health Service Act (42 U.S.C. 300jj-11(c)(5)); and such function is not intended to interpret or analyze patient records, including medical image data, for the purpose of diagnosis, cure, mitigation, prevention, or treatment of a disease or condition (section 520(o)(1)(C)); or

4. Transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a healthcare professional with respect to such data and results, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, or findings (section 520(o)(1)(D)); or

5. Unless the function is intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system, for the purpose of—(section 520(o)(1)(E));

a. Displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines) (section 520(o)(1)(E)(i));

b. Supporting or providing recommendations to a healthcare professional about prevention, diagnosis, or treatment of a disease or condition (section 520(o)(1)(E)(ii)); and

c. Enabling such healthcare professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such healthcare professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient (section 520(o)(1)(E)(iii)).

The Cures Act also provides that a software function described in section 520(o)(1)(C), (D), or (E) of the FD&C Act will not be excluded from the device definition under section 201(h) of the FD&C Act if FDA makes a finding that the software function would be reasonably likely to have serious adverse health consequences and certain substantive and procedural criteria are met (section 520(o)(3) of the FD&C Act). Also, nothing in section 520(o)(1) should exclude regulated software used in the manufacture and transfusion of blood and blood components to assist in the prevention of disease in humans (section 520(o)(4) of the FD&C Act).

A device, as defined in section 201(h) of the FD&C Act, may be comprised of one or more functions that are subject to FDA oversight. FDA defines the term “function” as a distinct purpose of a product, which could be the intended use or a subset of the intended use of the product and is not synonymous with the term “device.” For example, a device with an intended use to analyze data has one function: Analysis. A device with an intended use to store, transfer, and analyze data has three functions: (1) Storage, (2) transfer, and (3) analysis. Devices with “multiple functions” may contain functions that are software functions excluded from the device definition as described in section 520(o) of the FD&C Act.

FDA is issuing this final rule because the FD&C Act was amended by the Cures Act to remove certain software functions from the device definition, including software functions that are solely intended to transfer, store, convert formats, or display medical device data and results, including medical images or other clinical information, unless such functions are intended to interpret or analyze clinical laboratory test or other device data, results, and findings (sections 201(h) and 520(o)(1)(D) of the FD&C Act).

FDA is making its regulations consistent with the FD&C Act as amended by the Cures Act by amending the “identification” descriptions in eight regulations so that the descriptions do not include software functions that no longer fall within the definition of a device. The Agency has conducted a detailed review of all device classification regulations to determine whether the classification regulations contain software functions identified under section 520(o)(1)(A)-(E) of the FD&C Act (see 21 CFR parts 862-892), and therefore should be amended to reflect changes the Cures Act made to FDA's device statutory authority. As a result of this review, FDA identified eight classification regulations to amend (see Table 1 below).

Because of changes made to the FD&C Act by the Cures Act, the “identification” description of certain classification regulations that predated the Cures Act are no longer consistent with the FD&C Act. FDA finds good cause for issuing this amendment as a final rule without notice and comment because this rule only updates the “identification” description of those classification regulations so they reflect changes made to the FD&C Act by the Cures Act (see section 520(o)(1) of the FD&C Act) (5 U.S.C. 553(b)(3)(B)). In addition, FDA also finds good cause for this amendment to become effective on the date of publication of this action. The Administrative Procedure Act (APA) allows an effective date less than 30 days after publication as “provided by the agency for good cause found and published with the rule” (5 U.S.C. 553(d)(3)). A delayed effective date is unnecessary in this case because these amendments reflect the state of the law in section 520(o)(1) of the FD&C Act as amended by section 3060 of the Cures Act. This rule does not impose any new regulatory requirements on affected parties. As a result, affected parties do not need time to prepare before the rule takes effect. Therefore, FDA finds good cause for these amendments to become effective on the date of publication of this action.

This final rule is being issued under sections 201(h), 520(o), and 701 of the FD&C Act and the device and general administrative provisions of the FD&C Act sections 501, 510, 513, 515, 520, 522, and 701.

FDA is amending the “identification” description in eight classification regulations, so that they no longer include software functions that are excluded from the device definition by section 520(o)(1) of the FD&C Act and thus are not subject to FDA's device statutory authority. Among the software functions excluded from the definition of device in the FD&C Act, most relevant to this rule are the software functions excluded by section 520(o)(1)(D) of the FD&C Act. This provision excludes software functions that are solely intended to transfer, store, convert formats, or display, unless such functions are intended to interpret or analyze clinical laboratory test or other device data, results, and findings. This includes functions that are intended for data retrieval, receipt, or transmission because these are forms of information “transfer,” and functions that are intended for data maintenance, which is a form of “storage” (section 520(o)(1)(D) of the FD&C Act; see also FDA guidance “Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act” (Ref. 1)). However, software functions that analyze or interpret medical device data in addition to transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results remain subject to FDA's regulatory oversight, unless they fall within section 520(o)(1)(E) of the FD&C Act, which excludes certain clinical decision support software functions from the device definition.

Section 520(o)(1) of the FD&C Act describes software functions, not hardware functions, that are excluded from the definition of a device. Therefore, device hardware that is specifically intended to transfer, store, convert formats, and display medical device data and results (such as electrical hardware, magnetic and optical discs, physical communications medium, etc.) remains a device.

In Table 1, we list the regulations that FDA is amending to conform the “identification” description with the device definition under the FD&C Act. The amendments to the “identification” description of these regulations do not affect the classification of the devices in this final rule ( i.e., the device types remain class I, class II, etc.).

A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data (21 CFR 862.2100). Because “storing and retrieving data” are software functions that no longer fall within the definition of a device, FDA is amending the classification regulation to remove the language “store, retrieve, and” so that the regulation will state: “a calculator/data processing module for clinical use is an electronic device intended to process laboratory data.”

A CGM secondary display is identified as a device intended to be used for passive real-time monitoring of continuous glucose monitoring data § 862.1350 (21 CFR 862.1350). The identification further describes that the primary display device, which is not a part of the CGM secondary display, directly receives the glucose data (for example, it communicates directly with transmitter) from the continuous glucose meter, which is not a part of the continuous glucose monitor secondary display, and is the primary means of viewing the continuous glucose monitor data and alerting the patient to a low or high glucose value. A continuous glucose monitor secondary display can be used by caregivers of people with diabetes to monitor a person's continuous glucose monitoring data.

The intended use of the device, as explained in FDA's 2015 Dexcom Share Direct Secondary Displays (DEN140038) order, includes the functions to receive and display medical device data ( i.e., real-time glucose values and glucose trend information), in addition to functions to receive and deliver notifications and alarms. Because of changes made to the FD&C Act by the Cures Act, receiving and displaying device data software functions are no longer device functions. To make this regulation consistent with the FD&C Act, therefore, FDA is amending the title of the classification in § 862.1350 to “continuous glucose monitor secondary alarm system” and is amending the “identification” description to state that “a continuous glucose monitor (CGM) secondary alarm system is identified as a device intended to be used as a secondary alarm for a CGM to enable immediate awareness for potential clinical intervention to help assure patient safety.” With these amendments, the regulation no longer includes software functions excluded by the Cures Act, i.e., functions to receive and display medical device data.

An automated indirect immunofluorescence microscope and software-assisted system is a device that acquires, analyzes, stores, and displays digital images of indirect immunofluorescent slides (21 CFR 866.4750). FDA is replacing the first occurrence of the word “software” with “device” in the identification section, so that the identification will state that the device may use fluorescent signal acquisition and processing software, data storage and transferring mechanisms, or assay specific algorithms to suggest results. Because some of the software functions included in the regulation remain within the device definition ( e.g., assay specific algorithms to suggest results), the “identification” description will not be limited to hardware functions only. Instead, FDA is using the term “device,” which includes software functions that continue to fall within the device definition and hardware functions.

An MDDS is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (1) The electronic transfer of medical device data; (2) the electronic storage of medical device data; (3) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (4) the electronic display of medical device data (§ 880.6310 (21 CFR 880.6310)). An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. Each MDDS function ((1)-(4)) describes a software function that is excluded from the device definition under section 520(o)(1)(D) of the FD&C Act. Thus, FDA is amending the regulation to state that only hardware that performs these functions remain within the definition of devices by adding the term “hardware” to the “identification” description so that the regulation (§ 880.6310(a)(1)) states that an MDDS is a “hardware device that is intended to provide one or more of the following uses . . .”.

In addition, FDA is amending § 880.6310(a)(2) to remove the term “software,” because the software functions described in the identification of § 880.6310(a)(2) no longer fall within the definition of a device. Further, FDA is removing the phrase “a communications protocol” from § 880.6310(a)(2), because the term “communications protocol” refers to software functions associated with the transfer of data, and this function does not fall within the definition of a device. FDA is also amending the identification of § 880.6310(a)(2) to include the term “hardware,” such that the “identification” description states that MDDS “does not include hardware devices intended to be used in connection with active patient monitoring.” FDA is revising this identification because hardware devices for active patient monitoring are classified under other regulations for software- and hardware-based devices, and are not included in this regulation. The identification of § 880.6310(a)(2) will be amended to include the following: “Hardware devices for active patient monitoring are classified under other regulations and are not included in this regulation.”

A HUAM is an electronic system for at home antepartum measurement of uterine contractions, data transmission by telephone to a clinical setting, and for receipt and display of the uterine contraction data at the clinic (21 CFR 884.2730). The HUAM system comprises a tocotransducer, an at-home recorder, a modem, and a computer and monitor that receive, process, and display data. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor. The identification in the classification regulation for this device includes software functions intended to transmit, receive, and display data, which no longer fall within the statutory definition of a device. Therefore, FDA is removing these software functions from the “identification” description in this classification regulation.

A medical image storage device is a device that provides electronic storage and retrieval functions for medical images and may employ software, electronic, or electrical hardware such as magnetic and optical discs, magnetic tape, and digital memory (§ 892.2010 (21 CFR 892.2010)). Medical image storage includes software functions, specifically storage and retrieval functions, which are excluded from the device definition by section 520(o)(1)(D) of the FD&C Act. Thus, FDA is amending the regulation to state that only hardware that performs these functions remains within the device definition so that the regulation (§ 892.2010(a)(1)) states that a medical image storage device is a “hardware device that is intended to provide for the electronic storage and retrieval functions for medical images.”

A medical image communications device provides electronic transfer of medical image data between medical devices (21 CFR 892.2020). The device may include a physical communications medium, modems, or interfaces. In reviewing this classification regulation, FDA has determined that products with specific software functions for medical image processing and manipulation should be mentioned in the “identification” description of the classification regulation because such functions have always been included in the regulation and are not excluded under section 520(o)(1)(D) of the FD&C Act. Therefore, FDA is amending this regulation to include the following clarifying language to the “identification” description: “It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.”

The Picture Archiving and Communications Systems (PACS) device includes both software and hardware image storage and display functions and software image processing functions (21 CFR 892.2050). FDA has determined that software functions in the PACS classification regulation for storage and display of medical images no longer fall within the definition of a device under section 520(o)(1)(D) of the FD&C Act. However, FDA recognizes that some software functions in the PACS regulation, which are for complex image processing, including those for image manipulation, enhancement, or quantification, remain device functions. Therefore, FDA is amending this regulation to change the title of the classification regulation from “Picture Archiving and Communications Systems” to “Medical Image Management and Processing System” and is amending the “identification” description to exclude software functions for the “storage and display” of medical images. In addition, the amendment to the PACS classification regulation clarifies specific functions and the device's intended use with examples in the “identification” description.

This final rule is effective on the date of publication in the Federal Register .

We have examined the impacts of the final rule under E.O. 12866, E.O. 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). E.O.s 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Because this final rule merely amends certain classification regulations to remove provisions that are now obsolete in order to conform to the medical software provisions in the Cures Act, it does not impose any additional regulatory burdens. Therefore, we believe that this final rule is not economically significant and not a significant regulatory action as defined by E.O. 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this regulation does not change requirements, and amends certain classification regulations to conform to the medical software provisions in the Cures Act, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $158 million, using the most current (2020) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.

Because this direct final rule does not impose any additional regulatory burdens, this regulation is not anticipated to result in any compliance costs.

We have determined under 21 CFR 25.30(i) and 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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

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

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

The following reference is on display in the Dockets Management Staff (see ADDRESSES ) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. FDA has verified the website address, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act, 21 CFR parts 862, 866, 880, 884, and 892 are amended as follows:

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

Pursuant to 21 U.S.C. 811(a)(2), the Attorney General may, by rule, “remove any drug or other substance from the schedules if he finds that the drug or other substance does not meet the requirements for inclusion in any schedule.” The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Acting Administrator of the Drug Enforcement Administration (DEA). 28 CFR 0.100.

The CSA provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General on the petition of any interested party. 21 U.S.C. 811(a)(3). This action was initiated by one petition to remove samidorphan from the list of scheduled controlled substances of the CSA, and is supported by, inter alia, a recommendation from the Assistant Secretary of the HHS and an evaluation of all relevant data by DEA. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle or propose to handle samidorphan.

Samidorphan (3-carboxamido-4-hydroxy naltrexone), is a chemical entity that is structurally similar to naltrexone, a mu (µ)-opioid receptor antagonist. Samidorphan (other developmental code names: RDC-0313 or ALKS 33) is a mu-opioid receptor antagonist with a weak partial agonist activity at the kappa- and delta-opioid receptors. According to HHS, products containing samidorphan are currently being developed for medical use. Samidorphan is currently controlled in schedule II of the CSA, as defined in 21 CFR 1308.12(b)(l), because it can be derived from opium alkaloids. On April 14, 2014, DEA received a petition to initiate proceedings to amend 21 CFR 1308.12(b)(1) so as to decontrol samidorphan from schedule II of the CSA. The petition complied with the requirements of 21 CFR 1308.43(b) and was accepted for filing. The petitioner contended that samidorphan has been characterized as an opioid receptor antagonist, a class of drugs with no abuse potential.

Pursuant to 21 U.S.C. 811(b), DEA gathered the necessary data on samidorphan and forwarded the data, the sponsor's petition, and a request for scheduling recommendation on samidorphan to HHS on April 24, 2015.

On January 9, 2020, DEA received from HHS a scientific and medical evaluation (dated December 19, 2019) conducted by the Food and Drug Administration (FDA)  1 entitled “Basis for the Recommendation to Remove Samidorphan (3-Carboxamido-4-Hydroxy Naltrexone) and its Salts from All Schedules of Control Under the Controlled Substances Act” and a scheduling recommendation. Following consideration of the eight factors and findings related to the substance's abuse potential, legitimate medical use, and dependence liability, HHS recommended that samidorphan and its salts be removed from all schedules of control of the CSA. In response, DEA conducted its own eight factor analysis of samidorphan pursuant to 21 U.S.C. 811(c). Both DEA and HHS analyses are available in their entirety in the public docket of this rule (Docket Number DEA-665) at http://www.regulations.gov under “Supporting and Related Material.”

After a review of the available data, including the scientific and medical evaluation and the recommendation to decontrol samidorphan from HHS, the Acting Administrator of DEA published in the Federal Register a notice of proposed rulemaking (NPRM) entitled “Schedules of Controlled Substances: Removal of Samidorphan from Control” which proposed removal of samidorphan and its salts from the schedules of the CSA. 85 FR 79450, December 10, 2020. The proposed rule provided an opportunity for interested persons to file a request for a hearing in accordance with DEA regulations by January 11, 2021. No requests for such a hearing were received by DEA. The NPRM also provided an opportunity for interested persons to submit written comments on the proposal on or before January 11, 2021.

DEA received two comments on the proposed rule to remove samidorphan from control. Both commenters supported decontrol of samidorphan.

One commenter, a psychiatrist, clinical investigator and pain management expert, who participated as a principal investigator in clinical trials that examined the safety and efficacy of samidorphan and olanzapine combination product, stated that samidorphan counters weight gain associated with clinical use of olanzapine as antipsychotic medication and this combination product offers significant advancement relative to olanzapine alone, and thus supported this scheduling action.

Another commenter, on behalf of the sponsor of a samidorphan and olanzapine combination drug product currently under review by FDA for marketing approval, stated that samidorphan when combined with olanzapine has the potential to improve the safety profile of olanzapine by mitigating the weight gain associated with olanzapine treatment without altering its antipsychotic efficacy. This commenter agreed with DEA's conclusion that samidorphan lacks abuse or dependence potential and stated that samidorphan and its salts should be removed from the CSA schedules. This commenter further mentioned that the samidorphan and olanzapine combination product, which is currently under review by FDA for marketing approval, is an important new therapeutic option for patients and any delay in its availability for therapeutic use would negatively affect stakeholders, and therefore this final rule should be made effective immediately.

DEA Response: DEA appreciates the comments in support of this rulemaking.

Based on the consideration of all comments, the scientific and medical evaluation and accompanying recommendation of HHS, and based on DEA's consideration of its own eight-factor analysis, the Acting Administrator finds that these facts and all relevant data demonstrate that samidorphan does not meet the requirements for inclusion in any schedule, and will be removed from control under the CSA.

In accordance with 21 U.S.C. 811(a), this scheduling action is subject to formal rulemaking procedures done “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order (E.O.) 12866 and the principles reaffirmed in E.O. 13563.

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

This rulemaking does not have federalism implications warranting the application of E.O. 13132. The rule does not have substantial direct effects on the States, on the relationship between the Federal government and the States, or the distribution of power and responsibilities among the various levels of government.

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

The Acting Administrator, in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612) (RFA), has reviewed this rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities. The purpose of this rule is to remove samidorphan from the list of schedules of the CSA. This action removes regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances for handlers and proposed handlers of samidorphan. Accordingly, it has the potential for some economic impact in the form of cost savings.

This rule will affect all persons who would handle, or propose to handle, samidorphan. Samidorphan is not currently available or marketed in any country. Due to the wide variety of unidentifiable and unquantifiable variables that potentially could influence the distribution and dispensing rates, if any, of samidorphan, DEA is unable to determine the number of entities and small entities which might handle samidorphan. In some instances where a controlled pharmaceutical drug is removed from the schedules of the CSA, DEA is able to quantify the estimated number of affected entities and small entities because the handling of the drug is expected to be limited to DEA registrants even after removal from the schedules. In such instances, DEA's knowledge of its registrant population forms the basis for estimating the number of affected entities and small entities. However, DEA does not have a basis to estimate whether samidorphan is expected to be handled by persons who hold DEA registrations, by persons who are not currently registered with DEA to handle controlled substances, or both. Therefore, DEA is unable to estimate the number of entities and small entities who plan to handle samidorphan.

Although DEA does not have a reliable basis to estimate the number of affected entities and quantify the economic impact of this final rule, a qualitative analysis indicates that this rule is likely to result in some cost savings. Any person planning to handle samidorphan will realize cost savings in the form of saved DEA registration fees, and the elimination of physical security, recordkeeping, and reporting requirements. Because of these factors, DEA projects that this rule will not result in a significant economic impact on a substantial number of small entities.

DEA finds that good cause exists for adopting this rule as a final rule with an immediate effective date under 5 U.S.C. 553(d) because this final rule relieves a restriction.

On the basis of information contained in the RFA section above, DEA has determined and certifies pursuant to the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501 et seq., that this action would not result in any federal mandate that may result “in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted for inflation) in any one year. . . .” Therefore, neither a Small Government Agency Plan nor any other action is required under provisions of UMRA.

This action does not impose a new collection of information requirement under the Paperwork Reduction Act, 44 U.S.C. 3501-3521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will not result in: an annual effect on the economy of $100 million or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets. However, pursuant to the CRA, DEA is submitting a copy of this final rule to both Houses of Congress and to the Comptroller General.

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

In 22 CFR 62.27(e)(1) and (e)(4)(i), there is a reference to the “American Board of Medical Specialties” (ABMS). These provisions, last amended in 1993, state that ABMS will perform certain certification functions for the Secretary of State.

ABMS no longer produces the publication, Marquis Who's Who, referenced in 22 CFR part 62. Furthermore, ABMS has confirmed that it is also no longer the appropriate organization to comment on programs of graduate medical education. The Department has confirmed that the Accreditation Council for Graduate Medical Education (ACGME) has responsibility to accredit and recognize institutions offering programs of graduate medical education, and is replacing the reference to the ABMS with the ACGME in § 62.27.

The Department of State is publishing this rulemaking as a final rule, pursuant to 5 U.S.C. 553(b). This rulemaking is a rule of agency organization, procedure, or practice. The effective date of the rule is 30 days after publication, as provided in the Administrative Procedure Act.

The Department further finds that this is not a major rule; is not subject to the Unfunded Mandates Reform Act of 1995; will not have tribal implications as defined by Executive Order 13175; and will not have an impact on a substantial number of small entities under the Regulatory Flexibility Act. This rule is not an economically significant rule under Executive Order 12866, and the Department certifies that the benefits of this rulemaking outweigh any costs, which are minimal for the public. The Office of Information and Regulatory Affairs designated this rule as “non-significant,” as defined by Executive Order 12866.

The Department of State has reviewed this rule in light of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden. This rule will not have substantial direct effect on the states, on the relationships between the National Government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement.

This rulemaking does not create or modify any collections of information subject to the Paperwork Reduction Act.

For the reasons set forth above, the Department of State amends part 62 of title 22 of the Code of Federal Regulations as follows:

On February 19, 2021 (86 FR 10218), the Postal Service published a notice of proposed rulemaking to amend Publication 52, Hazardous, Restricted, and Perishable Mail, which is incorporated by reference into 39 CFR part 113. The text of the proposed edits to Publication 52 is available at https://pe.usps.com/FederalRegisterNotice/2021/E-Cigarettes%20Proposed%20Rule.pdf. The proposed edits would implement the Preventing Online Sales of E-Cigarettes to Children Act (“Act”), Public Law 116-160, div. FF, title VI (2020), which adds “electronic nicotine delivery systems” (“ENDS”) to the definition of “cigarettes” subject to regulation under the Jenkins Act, 15 U.S.C. 375 et seq. Consequently, ENDS will also become subject to the mailability restrictions and exceptions in 18 U.S.C. 1716E (“PACT Act”), which rely on the Jenkins Act definition of “cigarettes.” 18 U.S.C. 1716E(a)(1).

Certain such exceptions currently require application to and approval by the Postal Service's Pricing and Classification Service Center. See Publication 52 sections 472.221 (business/regulatory purposes), 472.241 (consumer testing/public health). The Postal Service proposed to apply the business/regulatory purposes exception to ENDS, but not the consumer testing and public health exceptions, and invited comments on that proposed approach. Those comments will be considered in developing the final rule. The final rule will contain the Postal Service's determination as to whether any of those exceptions will be made available for nonmailable ENDS.

Until the final rule is issued, ENDS are not subject to the PACT Act, although they may be nonmailable for other reasons. See, e.g., 18 U.S.C. 1716(a), (h) (poisonous, explosive, and other dangerous materials, and advertising, promotional, or sales matter relating to the same); 21 U.S.C. 843(b)-(c), 863 (controlled substances, drug paraphernalia, and advertisements relating to the same); 39 U.S.C. 3018 (hazardous materials); Publication 52 sections 31-349, 453 & appx. A, C. Regardless of the legal status of any products under state or local laws, violations of these Federal mailability laws can result in civil and/or criminal penalties.

The Postal Service has received numerous inquiries and comments about the possibility of submitting exception applications for ENDS products in advance of the final rule. Several commenters express the ENDS industry's concerns about the continuity of supply chains and regulatory compliance activities that rely on the mails, to the extent that such reliance may permissibly continue under the PACT Act. The Postal Service understands that those concerns are heightened by Congress's decision to make ENDS nonmailable immediately upon publication of the final rule, rather than applying the 30-day notice period that typically follows a final rule under the Administrative Procedure Act. Therefore, this document is intended to clarify the state of the exception application process in advance of the final rule and to provide guidance to mailers interested in availing themselves of any exceptions that may ultimately be made available.

The Postal Service cannot accept early applications for PACT Act exceptions relating to ENDS products at this time. The Postal Service has not yet determined whether and to what extent those exceptions will be extended to ENDS. Early acceptance of applications would pose significant administrative challenges for the very Postal Service personnel who are developing the final rule amid substantial public comment under a tight timeframe.

If any of the relevant exceptions are ultimately made available for ENDS, then, given the highly decentralized nature of the ENDS industry relative to the industries historically covered by the PACT Act, the Postal Service anticipates receiving ENDS-related exception applications at a rate several orders of magnitude above the historic norm. Moreover, those applications are expected to involve numbers of parties and products far greater than past PACT Act applications. These factors translate into a load on Postal Service resources that would massively outstrip historically allocated levels. The Postal Service is contemplating reforms to its application process to contend with this manifold near-term increase in complexity that would result from extending the exceptions to ENDS, as well as studying how to improve the process's efficiency and accessibility in the longer term.

Whether any ENDS mailers may ultimately be allowed to use the exceptions remains to be determined. The Postal Service is not in an administrative position to begin accepting ENDS-related exception applications at this time, and it may not be in such a position until issuance of the final rule. If, contrary to expectation, circumstances permit earlier acceptance of ENDS-related exception applications on a provisional basis, the Postal Service will issue further notice to that effect.

If the final rule does make the business/regulatory purposes and/or consumer testing/public health exceptions available for ENDS and applications are accepted through a reorganized process, applicants should expect review of their applications to require potentially substantial processing time, in light of the statutory requirements for Postal Service verification of mailers' and recipients' eligibility. 18 U.S.C. 1716E(b)(3)(B)(ii)(I)-(II), (b)(5)(C)(ii)(I). The duration of any review would be determined by the number and complexity of the applications that the Postal Service receives and the amount of engagement with applicants during processing.

The following guidance is aimed at facilitating Postal Service review and potentially reducing processing times for any potential exception applications relating to ENDS, should they be permitted under the final rule.

Documentation. With respect to the relevant exceptions, the PACT Act requires the Postal Service to verify mailers' and recipients' eligibility, which includes whether they are “legally operating”, “have all applicable State and Federal Government licenses or permits and are engaged in tobacco product manufacturing, distribution, wholesale, export, import, testing, investigation, or research.” 18 U.S.C. 1716E(b)(3)(A)(i), (b)(3)(B)(ii)(I)-(II), (b)(5)(A), (b)(5)(C)(ii)(I). Applicants for the consumer testing exception must also be (or be legally authorized agents of) legally operating cigarette manufacturers with “a permit, in good standing, issued under section 5713 of the Internal Revenue Code of 1986.” Id. at (b)(5)(A)(i).

To the extent that the final rule may make any of these exceptions available for shipments of ENDS, prospective applicants may wish to prepare by compiling electronic copies of all relevant license and permit documentation for themselves and, with respect to the business/regulatory purposes exception, each addressee that they intend to identify in their exception application.

For intended business/regulatory purposes exception applications by organizations engaged in testing, investigation, or research and those listing such organizations as addressees, relevant documentation may include such materials that would demonstrate the organizations' authorization to engage in the relevant activities ( e.g., grant or contract approval documents showing the scope and duration of a relevant research project).

Indexing. Prospective applicants for the business/regulatory purposes exception should prepare a spreadsheet that contains the following data elements with respect to each sender and recipient address that they intend to identify in their exception application:

a. Business or governmental entity name.

b. Address.

c. The Postal Service retail or business mail acceptance office(s) where each intended sender would tender shipments.

d. The Postal Service retail office(s) where each intended recipient would retrieve shipments.

e. A description of the business or governmental entity ( e.g., battery manufacturer, retail store, wholesale distributor, testing laboratory).

f. For each permit or license, the issuing jurisdiction; the permit or license number; the expiration date (if any); and the activity covered by each current permit or license ( e.g., general business operations; sale or manufacture of tobacco products or ENDS).

g. For each sender or addressee engaged in testing, investigation, or research, the entities authorizing the conduct of such activities; the expiration date (if any) of such authorization; and a brief statement of the subject of each authorization ( e.g., health effects of flavor substances, medical effects of cannabidiol (“CBD”), battery safety testing).

h. The brand name and a description of each product intended to be shipped by each sender or to each addressee.

i. Whether any identified products or other intended shipments from each sender or to each addressee contain lithium batteries, nicotine, CBD, or tetrahydrocannabinol (“THC”).

j. For products containing nicotine or THC, the intended quantity of the product per shipment and the concentration of nicotine or THC.

k. For products containing CBD with a THC concentration not exceeding 0.3 percent, whether the CBD derives from hemp.

ENDS implicate mailability statutes and regulations beyond the PACT Act. These statutes and regulations already render certain substances and components nonmailable, and they will continue to do so with respect to any ENDS shipments that remain mailable pursuant to exceptions or exclusions under the impending final rule. ENDS that become nonmailable under the PACT Act can additionally violate other mailability statutes and regulations. These restrictions and requirements govern the use of the federal mail system, regardless of the legal status of any items under state or local law. Violations of these mailability laws can result in civil or criminal penalties. Therefore, all persons currently or prospectively engaged in the mailing of ENDS—including, in particular, those who intend to continue mailing ENDS under any potentially available PACT Act exceptions—are advised to review Publication 52 carefully. Certain pertinent issues are highlighted below, but this list is not necessarily exhaustive.

CBD products. For hemp-based products containing CBD with a THC concentration not exceeding 0.3 percent, mailers must retain, and prepare to make available upon request, records establishing compliance with all applicable federal, state, and local laws pertaining to hemp production, processing, distribution, and sales, including the Agricultural Act of 2014 and the Agricultural Improvement Act of 2018. Such records may include laboratory test results, licenses, and compliance reports. See Publication 52 section 453.37.

Controlled substances and drug paraphernalia. All other substances that contain THC are Schedule I controlled substances for purposes of federal law, 21 CFR 1308.11(d)(31), and are therefore nonmailable in most instances. 21 U.S.C. 843(b); Publication 52 section 453. Products used with such substances may qualify as nonmailable drug paraphernalia. See 21 U.S.C. 863; Publication 52 section 453. This federal mailing prohibition is unaffected by whether the mailing of THC-containing substances violates state or local law and by the restriction of Department of Justice appropriations relating to medical marijuana. See Public Law 116-260, div. B, title V, section 531 (2020).

Advertisements for controlled substances and drug paraphernalia. It is unlawful to mail advertisements for, or to advertise the mailing of, federally controlled substances or drug paraphernalia. 21 U.S.C. 843(b), (c)(1); Mailing Standards of the United States Postal Service, Domestic Mail Manual (“DMM”) section 601.9.4.1.

Hazardous materials: Solutions. Toxic and flammable substances are nonmailable except subject to requirements designed to render them nonhazardous in the mails and/or in air transportation. 18 U.S.C. 1716(a)-(b); 39 U.S.C. 3018; Publication 52 sections 31-349, 711-728 & appx. A, C. Mailers of ENDS solutions should carefully review the chemical constituents of those products and ascertain the flashpoint of each constituent substance, its toxicological profile, and its concentration in the relevant solution. Nicotine is a toxic substance, for example. In addition, ENDS liquids—including non-nicotine-containing liquids—may contain acetals, acetoin (acetyl methyl carbinol), aldehydes, butanol, diacetyl (butanedione), propanol, and other compounds that qualify as flammable or toxic substances. Compare 49 CFR 172.101; Publication 52, appx. A, with Hanno C. Erythropel et al., Formation of Flavorant-Propylene Glycol Adducts with Novel Toxicological Properties in Chemically Unstable E-Cigarette Liquids, 21 Nicotine & Tobacco Research 1248 (2018); Joseph G. Allen et al., Flavoring Chemicals in E-Cigarettes: Diacetyl, 2,3-Pentanedione, and Acetoin in a Sample of 51 Products, Including Fruit-, Candy-, and Cocktail-Flavored E-Cigarettes, 124 Enviro. Health Perspectives 733 (2016).

Depending on a substance's flashpoint or lethal dose (LD 50 ) and its concentration in a solution, the substance may or may not be prohibited or subject to special Department of Transportation requirements as a hazardous material. See generally Publication 52 sections 343, 346 & appx. A, C. Such items may be prohibited from or restricted in air transportation and may not be eligible for shipping via Priority Mail Express, Priority Mail, First-Class Mail, or First-Class Package Service. Id. sections 327, 711-728. Even nonregulated toxic liquids and solids may be subject to quantity restrictions, packaging requirements, and restrictions on the availability of Postal Service shipping options. See Publication 52 sections 346.232.

Hazardous materials: Lithium batteries. Mailers of lithium metal or lithium-ion batteries should be aware of applicable restrictions and requirements, which may determine mailability, packaging, product design, shipping quantities, and the availability of relevant Postal Service products. See Publication 52 section 349.221-.222, 711-728.

Non-hazardous liquids. Mailers of liquids that are not regulated as hazardous materials (whether or not such liquids contain nicotine) should be aware of applicable packaging requirements. See Publication 52 section 451.3 and DMM section 601.3.4.

Hazardous and restricted materials: Advertising, promotional, or sales matter. To the extent that ENDS may be subject to special requirements as hazardous or otherwise restricted materials, then matter that solicits or induces the mailing of such items is mailable only if it contains all pertinent packaging instructions and any other mailing limitations. 18 U.S.C. 1716(h); DMM section 601.9.4.1.

Again, it is emphasized that the Postal Service has yet to determine whether and to what extent any PACT Act exceptions may be made available for ENDS. Nevertheless, mailers of ENDS products may find the preparatory information above useful in preparing for the potential availability of such exceptions following a final rule. In addition, all persons currently or prospectively engaged in the mailing of ENDS products should carefully review non-PACT-Act-related mailing prohibitions, restrictions, and other requirements that may apply to ENDS products, to ensure that their use of the mail system is safe and compliant with Federal law.

On March 22, 2021 (86 FR 15104), EPA published a final rule action, “Air Plan Approval; Arkansas; Arkansas Regional Haze and Visibility Transport State Implementation Plan Revisions.” The final rule approved revisions to the State Implementation Plan (SIP) for the State of Arkansas concerning requirements of the Clean Air Act and the Regional Haze Rule for visibility protection in mandatory Class I Federal areas for the first implementation period and pertain specifically to the Domtar Ashdown Mill. The final rule also approved revisions concerning Arkansas' interstate visibility transport obligations for the following national ambient air quality standards (NAAQS): The 2006 24-hour fine particulate matter (PM 2.5 ) NAAQS; the 2012 annual PM 2.5 NAAQS; the 2008 and 2015 eight-hour ozone (O 3 ) NAAQS; the 2010 one-hour nitrogen dioxide (NO 2 ) NAAQS; and the 2010 one-hour SO 2 NAAQS. For more information, please see the EPA's rulemaking action at https://www.regulations.gov under Docket ID No. EPA-R06-OAR-2015-0189.

As published, the regulatory text in the final rule contains an error that omits the amendatory instruction for adding two entries to the table entitled “EPA-Approved Non-Regulatory Provisions and Quasi-Regulatory Measures in the Arkansas SIP” in 40 CFR 52.170(e). The EPA finds that there is good cause to make this correction without providing for notice and comment because neither notice nor comment is necessary and would not be in the public interest due to the nature of the correction which is minor, technical and does not change the obligations already existing in the rule. While the “Identification of Plan” section of the regulatory text accurately includes the three new entries added to the “EPA-Approved Non-Regulatory Provisions and Quasi-Regulatory Measures in the Arkansas SIP” table, the amendatory instruction erroneously states that one entry rather than three are being added to the table. Therefore, the EPA finds that the corrections are merely correcting the amendatory instruction without changing any final action taken by the EPA on March 22, 2021.

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 Publishing 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(g), 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-2019-0385 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 June 18, 2021. 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-2019-0385, 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 August 30, 2019 (84 FR 45702) (FRL-9998-15), 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 8E8707) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709. That document stated that BASF's petition (summarized by BASF Corporation in docket ID EPA-HQ-OPP-2019-0385) requested that 40 CFR 180.657 be amended by establishing tolerances for residues of the insecticide metaflumizone (2-[2-(4-cyanophenyl)-1-[3-(trifluoromethyl)phenyl]ethylidene]- N -[4-(trifluoromethoxy)phenyl]hydrazinecarboxamide; E and Z isomers), in or on apple at 1.0 parts per million (ppm), apple, wet pomace at 3.0 ppm, coffee at 0.15 ppm, fruit, small, vine climbing, except fuzzy kiwi fruit, subgroup 13-07F at 5.0 ppm, grape, raisin at 10 ppm, lemon/lime subgroup 10-10B at 3.0 ppm, lemon/lime subgroup 10-10B, oil at 42 ppm, melon subgroup 9A at 1.0 ppm, orange subgroup 10-10A at 3.0 ppm, orange subgroup 10-10A, oil at 42 ppm, cattle, fat at 0.05 ppm, goat, fat at 0.05 ppm, horse, fat at 0.05 ppm, sheep, fat at 0.05 ppm, and milk, fat at 0.1 ppm. Although the petition summary did not request a tolerance on apple, wet pomace, the petition itself requested a tolerance on apple, wet pomace, so EPA included that commodity in the document published in the Federal Register . There were no substantive comments received in response to the notice of filing for this pesticide petition.

Based upon review of the data supporting the referenced petition, and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA has revised the tolerance levels and commodity definitions for several of the proposed commodities, established additional necessary tolerances, and deleted a number of established tolerances superseded by the newly established import tolerances. The reasons for these changes are explained in full detail 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 metaflumizone including exposure resulting from the tolerances established by this action. A summary of EPA's assessment of exposures and risks associated with metaflumizone follows.

In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings and republishing the same sections is unnecessary; EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.

EPA has previously published a number of tolerance rulemakings for metaflumizone, in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to metaflumizone and established tolerances for residues of that chemical. EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged.

Toxicological Profile. For a discussion of the Toxicological Profile of metaflumizone, see Unit III.A. of the October 30, 2015 rulemaking (80 FR 66795) (FRL-9934-88).

Toxicological Points of Departure/Levels of Concern. For a summary of the Toxicological Points of Departure/Levels of Concern used for the safety assessment, see Unit III.B. of the October 30, 2015 rulemaking.

Exposure Assessment. Much of the exposure assessment remains unchanged from the previous rulemaking, although some updates have occurred to accommodate exposures from the petitioned-for tolerances. The updates are discussed in this section; for a description of the rest of the EPA approach to and assumptions for the exposure assessment, see Unit III.C. of the October 30, 2015 rulemaking.

EPA's exposure assessments have been updated to include the additional exposure from imported apple, coffee, melon subgroup 9A, orange subgroup 10-10A, lemon/lime subgroup 10-10B, small vine climbing fruit subgroup 13-07F (except fuzzy kiwifruit), milk fat, and ruminant fat for the combined residues of metaflumizone (E-Z isomer ratio of >9:1). The acute and chronic dietary analyses for metaflumizone for this action assumed tolerance-level residues, 100% crop treated, and 2018 default processing factors when necessary, except for citrus juice, which used empirical processing factor for citrus juice. The modeled estimates of drinking water concentrations and the Agency's assessment of residential, or non-occupational exposure remain the same as in the October 30, 2015 rulemaking, as the residues on imported commodities do not impact the drinking water exposures or residential exposures. The Agency's position regarding cumulative risk also remains the same.

Safety Factor for Infants and Children. EPA continues to retain the Food Quality Protection Act (FQPA) safety factor of 10× for inhalation exposure scenarios, while continuing to conclude that there is reliable data showing that the safety of infants and children would be adequately protected if the FQPA SF were reduced from 10× to 3× for all oral exposure scenarios and reduced to 1× for dermal exposures. The reasons for that decision are articulated in Unit III.D. of the October 30, 2015 rulemaking.

Aggregate Risks and Determination of Safety. 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). 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. For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure.

The acute and chronic dietary estimates for metaflumizone were found not to be of concern for the U.S. general population and all population subgroups and are below the Agency's level of concern (LOC) (<100% of the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD), respectively). An acute endpoint of concern was not identified in the toxicological database for the general U.S. population including infants and children. Acute dietary risks for metaflumizone are below the Agency's LOC: 5.3% of the aPAD at the 95th percentile for females 13-49 years of age, the population group with the highest exposure; and chronic risks are below the Agency's LOC: 65% of the cPAD for children 1-2 years old, the most highly exposed population subgroup. Metaflumizone is classified as “Not Likely to be Carcinogenic to Humans.” Therefore, EPA does not expect exposure to metaflumizone to pose a cancer risk.

Since metaflumizone is registered for uses that could result in short-term residential exposure, EPA evaluated the potential for short-term risk by aggregating chronic exposure through food and water with short-term residential exposures to metaflumizone. Since the LOC for the various routes of exposure differ, the aggregate risk estimates were calculated using the Aggregate Risk Index (ARI) approach (LOC for ARI <1). The short-term aggregate assessment combined food + drinking water exposure with the highest potential residential post-application exposure (high-contact activity on turf). The aggregate ARIs are greater than 1; therefore, EPA concludes there is no short-term risk of concern. Although only short-term residential exposure is anticipated, the short-term assessment is protective of intermediate-term exposure since the short- and intermediate-term PODs/LOCs are identical.

Determination of Safety. Based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the U.S. general population, or to infants and children, from aggregate exposure to metaflumizone residues. More detailed information on the subject action can be found at http://www.regulations.gov in the documents entitled “Metaflumizone: Human Health Risk Assessment in Support of Section 3 Registrations for Application of Metaflumizone to Pome Fruit (crop group (CG) 11-10) and Stone Fruit (CG 12-12); Updating the CG Designation for Citrus to 10-10 and Tree Nuts to 14-12; and Permitting Aerial Application to Citrus Fruits, Grapes, Tree Nuts, and Nurseries Containing Field-/Container-Grown Nonbearing Stone and Pome Fruit Trees,” dated September 29, 2015 (docket ID EPA-HQ-OPP-2014-0607), and “Metaflumizone: Human Health Risk Assessment in Support of Tolerances Without a U.S. Registration in/on Apple, Coffee, Melon Subgroup 9A, Orange Subgroup 10-10A, Lemon/Lime Subgroup 10-10B, Grape, Milk Fat, and Ruminant Fat,” dated December 7, 2020 (docket ID EPA-HQ-OPP-2019-0385).

For a discussion of the available analytical enforcement method, see Unit IV.A. of the October 30, 2015 rulemaking.

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). Codex 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. Although EPA may establish a tolerance that is different from a Codex MRL, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

While Codex has not yet established MRLs on the commodities mentioned in this document, it has proposed MRLs in/on most of the relevant commodities. EPA notes that the U.S. and Codex residue definitions differ in that the U.S. tolerance expression includes metaflumizone (E- and Z-isomers) and M320I04 while Codex includes only metaflumizone (E- and Z-isomers). EPA is harmonizing its U.S. tolerances with most of the proposed Codex MRLs for apple, coffee, grape, melon subgroup 9A, orange subgroup 10-10A, orange oil, raisin, milk fat, and fat (cattle, goat, horse, and sheep). EPA is not harmonizing the U.S. tolerance on lemon/lime subgroup 10-10B with the Codex MRL since the Codex MRL is less than that calculated by EPA using the submitted residue data and the OECD tolerance calculation procedure.

Based upon review of data and supporting materials for this petition, EPA is establishing tolerances for the following commodities requested using the Agency's preferred commodity terminology: Instead of establishing a tolerance for coffee, as requested, the Agency is establishing a tolerance for coffee, green bean. In addition, based upon supporting data and harmonization with proposed Codex MRLs, the Agency is establishing a tolerance level lower than requested for Apple at 0.9 ppm, and tolerance levels higher than requested for grape, raisin at 13 ppm; lemon/lime subgroup 10-10B, oil at 100 ppm; and orange subgroup 10-10A, oil at 100 ppm. Further, since importation of ruminant commodities is also a probability and based on the livestock dietary burdens, EPA is also establishing tolerances for milk fat and ruminant fat tolerances in or on cattle, fat at 0.15 ppm; goat, fat at 0.15 ppm; horse, fat at 0.15 ppm; sheep, fat at 0.15 ppm; and milk, fat at 0.6 ppm.

Therefore, tolerances are established for residues of the insecticide metaflumizone (2-[2-(4-cyanophenyl)-1-[3-(trifluoromethyl)phenyl]ethylidene]- N -[4-(trifluoromethoxy)phenyl]hydrazinecarboxamide; E and Z isomers), in or on apple at 0.9 parts per million (ppm); apple, wet pomace at 3 ppm; coffee, green bean at 0.15 ppm; grape, raisin at 13 ppm; grapefruit subgroup 10-10C at 0.04 ppm; lemon/lime subgroup 10-10B at 3 ppm; lemon/lime subgroup 10-10B, oil at 100 ppm; melon subgroup 9A at 1 ppm; orange subgroup 10-10A at 3 ppm; orange subgroup 10-10A, oil at 100 ppm; cattle, fat at 0.15 ppm; goat, fat at 0.15 ppm; horse, fat at 0.15 ppm; milk, fat at 0.6 ppm; and sheep, fat at 0.15 ppm. In addition, the existing tolerance for “fruit, pome, group 11-10,” is amended to clarify that that entry now excludes apple, due to the establishment of a separate apple tolerance in this rulemaking and the existing tolerance for grape is amended to raise the tolerance level from 0.04 ppm to 5 ppm. Finally, EPA is removing the tolerance for “fruit, citrus, group 10-10” because it is superseded by the newly established tolerances for each of the fruit, citrus, group 10-10 subgroups.

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) or 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:

This is a summary of the Auction 109 Procedures Public Notice, released on April 1, 2021. The complete text of the Auction 109 Procedures Public Notice, including attachments and any related document, are available on the Commission's website at www.fcc.gov/auction/109 or by using the search function for AU Docket No. 21-39, DA 21-361, on the Commission's Electronic Comment Filing System (ECFS) web page at www.fcc.gov/ecfs. Alternative formats are available to persons with disabilities by sending an email to FCC504@fcc.gov or by calling the Consumer & Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

1. Introduction. By the Auction 109 Procedures Public Notice, the Office of Economics and Analytics (OEA), in conjunction with the Media Bureau (MB), establishes the procedures and minimum opening bid amounts for the upcoming auction of certain AM and FM broadcast construction permits.

2. On February 8, 2021, OEA, in conjunction with MB, released a public notice seeking comment on competitive bidding procedures and minimum opening bid amounts to be used in Auction 109. Three parties submitted comments in response to the Auction 109 Comment Public Notice, 86 FR 12556, March 4, 2021.

3. Construction Permits Offered in Auction 109. Auction 109 will offer four AM construction permits and 136 FM construction permits. The construction permits to be auctioned are listed in Attachment A to the Auction 109 Procedures Public Notice.

4. AM Construction Permits. Auction 109 will offer four construction permits in the AM broadcast service. Attachment A to the Auction 109 Procedures Public Notice lists the community of license, channel, class, and coordinates for each AM permit being offered.

5. The construction permits to be auctioned are for four previously licensed AM stations: KFTK(AM), East St. Louis, IL, former Facility ID No. 72815; WQQW(AM), Highland, IL, former Facility ID No. 90598; KZQZ(AM), St. Louis, MO, former Facility ID No. 72391; and KQQZ(AM), Fairview Heights, IL, former Facility ID No. 5281. The license renewals of each of these former AM stations were dismissed with prejudice in a hearing before the Commission's Administrative Law Judge and the call signs deleted.

6. To facilitate the auction of the four AM permits, the four AM facilities will be treated as existing allotments, using the coordinates, AM station frequency and class, and community of license of the respective AM facility as listed in Attachment A to the Auction 109 Procedures Public Notice. The Media Bureau has protected these four AM stations by freezing the filing of any minor modification applications that would be mutually exclusive with the facilities of the four AM stations. Pursuant to that freeze, any AM minor change application that conflicts with the most recently licensed facilities of these four AM stations may not be filed during a period that started on March 20, 2020, and ends the day after the filing deadline for long-form applications by Auction 109 winning bidders. Because protections only extend to the previously licensed facility parameters, any winning bidder or permittee will be limited in its opportunities to modify these AM permits. Due to the existence of these technical limitations, preferred site coordinates cannot be specified for any of these AM construction permits.

7. FM Construction Permits. Auction 109 will also offer 136 construction permits in the FM broadcast service. The construction permits to be auctioned include all of the 130 FM permits that had previously been listed in the inventory for Auction 106, as well as six additional permits. The FM construction permits offered in Auction 109 include 34 construction permits that were offered but not sold or were defaulted upon in prior auctions.

8. Attachment A to the Auction 109 Procedures Public Notice lists the specific vacant FM allotments for which the Commission will offer construction permits in this auction, along with the reference coordinates for each vacant FM allotment. These construction permits are for vacant FM allotments reflecting FM channels added to the Table of FM Allotments, 47 CFR 73.202(b), pursuant to the Commission's established rulemaking procedures, and assigned at the indicated communities.

9. Each applicant in the FM service may submit a set of preferred site coordinates on its short-form application (FCC Form 175) as an alternative to the reference coordinates for the vacant FM allotment upon which the applicant intends to bid. In order to avoid potential conflicts between, on the one hand, FM commercial and noncommercial educational (NCE) minor change applications, which can typically be filed on a first-come first-served basis, and, on the other hand, any alternative reference coordinates submitted on an applicant's short form application, MB will not accept any FM commercial or NCE minor change application during the Auction 109 short-form application filing window from April 28, 2021, to May 11, 2021. FM commercial and NCE minor change applications filed during the Auction 109 short-form application filing window will be dismissed. In addition, MB has announced that, in order to promote a more certain and speedy auction process, during a period that started on February 8, 2021 and ending the day after the filing deadline for post-Auction 109, long-form applications, it will not accept any application proposing to modify any FM allotments that will be offered in Auction 109; any petition or counterproposal that proposes a change in channel, class, community, or reference coordinates for any FM allotments that will be offered in Auction 109; nor any application, petition, or counterproposal that fails to fully protect any FM allotment that will be offered in Auction 109. Any such application filed between February 8, 2021 and the day after the filing deadline for post-auction 109, long-form applications will be dismissed.

10. OEA and MB declined to adopt commenters' suggestions to add certain AM facilities and FM allotments to the Auction 109 inventory.

11. An applicant may apply for any AM or FM construction permit listed in Attachment A to the Auction 109 Procedures Public Notice. Consistent with our approach in previous broadcast service auctions, when two or more short-form applications (FCC Form 175) are submitted specifying the same permit, mutual exclusivity exists for auction purposes, and that construction permit must be awarded by competitive bidding procedures. As explained in the Auction 109 Comment Public Notice, once mutual exclusivity exists for auction purposes, even if only one applicant is qualified to bid for a particular construction permit, that applicant is required to submit a bid in order to obtain the construction permit.

12. Relevant Authority. Auction 109 applicants must familiarize themselves thoroughly with the Commission's general competitive bidding rules, including Commission decisions in proceedings regarding competitive bidding procedures, application requirements, and obligations of Commission licensees. Broadcasters should also familiarize themselves with the Commission's AM and FM broadcast service and competitive bidding requirements contained in part 73 of the Commission's rules, as well as Commission orders concerning competitive bidding for broadcast construction permits. Applicants must also be thoroughly familiar with the procedures, terms, and conditions contained in the Auction 109 Procedures Public Notice and any future public notices that may be released in this proceeding or that relate to the construction permits being offered in Auction 109 or the AM and FM broadcast services.

13. The terms contained in the Commission's rules, relevant orders, and public notices are not negotiable. The Commission may amend or supplement the information contained in its public notices at any time, and will issue public notices to convey any new or supplemental information to applicants. It is the responsibility of all applicants to remain current with all Commission rules and with all public notices pertaining to this auction. Copies of most auctions-related Commission documents, including public notices, can be retrieved from the FCC Auctions internet site at www.fcc.gov/auctions.

14. An applicant should consult the Commission's rules to ensure that, in addition to the materials described below, all required information is included in its short-form application. To the extent the information in the Auction 109 Procedures Public Notice does not address a potential applicant's specific operating structure, or if the applicant needs additional information or guidance concerning the following disclosure requirements, the applicant should review the educational materials for Auction 109 and/or use the contact information provided in the Auction 109 Procedures Public Notice to consult with Commission staff to better understand the information it must submit in its short-form application.

15. General Information Regarding Short-Form Applications. An application to participate in Auction 109, referred to as a short-form application or FCC Form 175, provides information that the Commission uses to determine whether the applicant is legally, technically, and financially qualified to participate in Commission auctions for licenses or permits. The short-form application is the first part of the Commission's two-phased auction application process. In the first phase, parties desiring to participate in the auction must file a streamlined, short-form application in which they certify under penalty of perjury as to their qualifications. Eligibility to participate in bidding is based on the applicant's short-form application and certifications, and on its upfront payment, as explained below.

16. A party seeking to participate in Auction 109 must file a short-form application electronically via the FCC's Auction Application System prior to 6:00 p.m. ET on May 11, 2021, following the FCC Form 175 Filing Instructions for this auction in Attachment B to the Auction 109 Procedures Public Notice. All those wishing to participate in Auction 109, regardless of whether they may have previously filed a short-form application for Auction 106, will be required to file a new application to participate in Auction 109.

17. An applicant bears full responsibility for submitting an accurate, complete, and timely short-form application. An applicant must certify on its short-form application under penalty of perjury that it is legally, technically, financially, and otherwise qualified to hold a license. Each applicant should read carefully the instructions set forth in Attachment B to the Auction 109 Procedures Public Notice and should consult the Commission's rules to ensure that, in addition to the materials described below, all the information required is included within its short-form application.

18. Submission of a short-form application (and any amendments thereto) constitutes a representation by the certifying official that he or she is an authorized representative of the applicant, that he or she has read the form's instructions and certifications, and that the contents of the application, its certifications, and any attachments are true and correct. Submission of a false certification to the Commission may result in penalties, including monetary forfeitures, license forfeitures, ineligibility to participate in future auctions, and/or criminal prosecution.

19. No individual or entity may file more than one short-form application or have a controlling interest in more than one short-form application. If a party submits multiple short-form applications for an auction, then only one application may be the basis for that party to become qualified to bid in that auction.

20. Consistent with the Commission's general prohibition of joint bidding agreements, a party is generally permitted to participate in a Commission auction only through a single bidding entity. Accordingly, the filing of applications in Auction 109 by multiple entities controlled by the same individual or set of individuals is not permitted. This restriction applies across all applications, without regard to the construction permits selected. Consistent with this requirement, a broadcaster interested in bidding on more than one construction permit cannot use two or more subsidiary entities to bid separately on construction permits in separate markets, regardless of whether each subsidiary were to select different construction permits on its short-form application. Likewise, if an entity, individual, or set of individuals hold controlling interests in multiple entities that are interested in participating in Auction 109, regardless of whether those entities have other, non-shared controlling or non-controlling interests, those entities must participate in the auction through a single bidding entity and only that bidding entity may file an auction application. In that regard, the bidding entity must disclose in its short-form application any joint ventures or other agreements or arrangements with any commonly controlled, non-applicant entities related to bidding in Auction 109. As noted by the Commission in adopting the prohibition of applications by commonly controlled entities, this rule, in conjunction with the prohibition against joint bidding agreements, protects the competitiveness of our auctions.

21. Authorized Bidders. An applicant must designate at least one authorized bidder, and no more than three, in its FCC Form 175. The Commission's rules prohibit an individual from serving as an authorized bidder for more than one auction applicant or being listed as an authorized bidder in more than one FCC Form 175 application.

22. Permit Selection. An applicant must select on its FCC Form 175 the construction permit or permits, from the list of available permits, on which it wants to bid. An applicant must carefully review and verify its construction permit selections before the deadline for submitting the FCC Form 175, because those selections cannot be changed after the initial auction application filing deadline. The FCC auction bidding system will not accept bids on construction permits that were not selected on the applicant's FCC Form 175.

23. Disclosure of Agreements and Bidding Arrangements. An applicant must provide in its FCC Form 175 a brief description of, and identify each party to, any partnership, joint venture, consortium, or agreement, arrangement, or understanding of any kind relating to the AM and FM construction permits being auctioned, including any agreement that addresses or communicates directly or indirectly bids (including specific prices), bidding strategies (including the specific construction permit(s) or license(s) on which to bid or not to bid), or the post-auction market structure, to which the applicant, or any party that controls or is controlled by the applicant, is a party. In connection with the agreement disclosure requirements, the applicant must certify under penalty of perjury in its FCC Form 175 that it has described, and identified each party to, any such agreement, arrangement, or understanding into which it has entered. An auction applicant that enters into any agreement during an auction that relates to the permits or licenses being auctioned is subject to the same disclosure obligations it would have for agreements existing at the FCC Form 175 filing deadline, and it must maintain the accuracy and completeness of the information in its pending auction application.

24. The Commission's rules generally prohibit joint bidding and other arrangements involving auction applicants (including any party that controls, or is controlled by, such applicants). For purposes of this prohibition, joint bidding arrangements include arrangements relating to the permits being auctioned that address or communicate, directly or indirectly, bidding at the auction, bidding strategies, including arrangements regarding price or the specific permits on which to bid, and any such arrangements relating to the post-auction market structure.

25. To implement the prohibition on joint bidding arrangements, the Commission's rules require each auction applicant to certify in its short-form application that it has disclosed any arrangements or understandings of any kind relating to the permits or licenses being auctioned to which it (or any party that controls or is controlled by it) is a party. The applicant must also certify that it (or any party that controls or is controlled by it) has not entered and will not enter into any arrangement or understanding of any kind relating directly or indirectly to bidding at auction with, among others, any other applicant.

26. Although the Commission's rules do not prohibit auction applicants from communicating about matters that are within the scope of an excepted agreement that has been disclosed in an FCC Form 175, the Commission reminds applicants that certain discussions or exchanges could nonetheless touch upon impermissible subject matters, and that compliance with the Commission's rules will not insulate a party from enforcement of the antitrust laws.

27. Applicants should bear in mind that a winning bidder will be required to disclose in its long-form application following the close of the auction the specific terms, conditions, and parties involved in any agreement relating to the permits or licenses being auctioned into which it had entered prior to the time bidding closed. This applies to any joint venture, partnership, or other agreement, arrangement, or understanding of any kind entered into relating to the competitive bidding process, including any agreements relating to the permits being auctioned that address or communicate directly or indirectly bids (including specific prices), bidding strategies (including the specific permits on which to bid or not to bid), or the post-auction market structure, to which the applicant, or any party that controls or is controlled by the applicant, is a party.

28. Ownership Disclosure Requirements. Each applicant must comply with the ownership disclosure requirements and provide information required by §§ 1.2105 and 1.2112 and, where applicable, 1.2110 of the Commission's rules. Specifically, in completing the FCC Form 175, an applicant will be required to fully disclose information on the real party(ies)-in-interest and the ownership structure of the applicant, including both direct and indirect ownership interests of 10% or more, as prescribed in §§ 1.2105 and 1.2112 and, where applicable, 1.2110 of the Commission's rules. Each applicant is responsible for ensuring that information submitted in its short-form application is complete and accurate.

29. Foreign Ownership Disclosure Requirements. Section 310 of the Communications Act of 1934, as amended (the Act), 47 U.S.C. 310, requires the Commission to review foreign investment in radio station licenses and imposes specific restrictions on who may hold certain types of radio licenses. In its FCC Form 175, an applicant must report citizenship or jurisdiction of formation for the applicant and for each disclosable interest holder (DIH). In completing the FCC Form 175, an applicant also will be required to certify that it is in compliance with the foreign ownership provisions contained in section 310 of the Act. Section 1.2105(a)(2)(vi) specifies that the Commission will accept an auction application certifying that a request for waiver or declaratory ruling from the requirements of section 310 is pending. If an applicant has foreign ownership interests in excess of the applicable limit or benchmark specified in section 310(b), it may seek to participate in Auction 109 if it has filed with the Media Bureau prior to the FCC Form 175 filing deadline a petition for declaratory ruling requesting Commission approval to exceed the applicable foreign ownership limit or benchmark in section 310(b) that is pending before, or has been granted by, the Commission.

30. Prohibited Communication and Compliance with Antitrust Laws. The rules prohibiting certain communications set forth in §§ 1.2105(c) and 73.5002(d) and (e) of the rules apply to each applicant that files an FCC Form 175 in Auction 109. Section 1.2105(c)(1) of the Commission's rules provides that, subject to specified exceptions, after the deadline for filing a short-form application all applicants are prohibited from cooperating or collaborating with respect to, communicating with or disclosing, to each other in any manner the substance of their own, or each other's, or any other applicant's bids or bidding strategies (including post-auction market structure), or discussing or negotiating settlement agreements, until after the down payment deadline.

31. Entities Subject to § 1.2105(c). An applicant for purposes of this rule includes the officers and directors of the applicant, all controlling interests in the entity submitting the FCC Form 175, as well as all holders of interests amounting to 10% or more of that entity. A party that submits an application becomes an applicant under the rule at the application filing deadline, and that status does not change based on later developments, including failure to become a qualified bidder.

32. Scope of Prohibition on Communications; Prohibition on Joint Bidding Agreements. Section 1.2105 of the Commission's rules prohibits certain communications between applicants for an auction, regardless of whether the applicants seek permits in the same geographic area or market. The Commission's rules also prohibit any joint bidding arrangement, including arrangements relating to the permits being auctioned, that address or communicate, directly or indirectly, bidding at the auction, bidding strategies, including arrangements regarding price or the specific permits on which to bid, and any such arrangements relating to the post-auction market structure. The rule provides limited exceptions for a communication within the scope of any arrangement consistent with the exclusion from the Commission's rule prohibiting joint bidding, provided such arrangement is disclosed on the applicant's auction application. An applicant may continue to communicate pursuant to any pre-existing agreements, arrangements, or understandings that are solely operational or that provide for transfer or assignment of licenses, provided that such agreements, arrangements, or understandings are disclosed on its application and do not both relate to the permits at auction and address or communicate bids (including amounts), bidding strategies, or the particular permits or licenses on which to bid or the post-auction market structure.

33. In addition to express statements of bids and bidding strategies, the prohibition against communicating in any manner includes public disclosures as well as private communications and indirect or implicit communications. Consequently, an applicant must take care to determine whether its auction-related communications may reach another applicant.

34. Parties subject to § 1.2105(c) should take special care in circumstances where their officers, directors, and employees may receive information directly or indirectly relating to any applicant's bids or bidding strategies. Such information may be deemed to have been received by the applicant under certain circumstances. For example, Commission staff have determined that, where an individual serves as an officer or director for two or more applicants, the bids and bidding strategies of one applicant are presumed conveyed to the other applicant through the shared officer or director, which creates an apparent violation of the rule.

35. Subject to the exception described above, § 1.2105(c)(1) prohibits applicants from communicating with specified other parties only with respect to their own, or each other's, or any other applicant's bids or bidding strategies. Moreover, a communication conveying bids or bidding strategies (including post-auction market structure) must also relate to the licenses being auctioned in order to be covered by the prohibition. Thus, the prohibition is limited in scope and does not apply to all communications between or among the specified parties. The Commission consistently has made clear that application of the rule prohibiting communications has never required total suspension of essential ongoing business. Entities subject to the prohibition may negotiate agreements during the prohibition period, provided that the communications involved do not relate both (1) to the licenses or permits being auctioned and (2) to bids or bidding strategies or post-auction market structure.

36. Accordingly, business discussions and negotiations that are unrelated to bidding in Auction 109 and that do not convey information about the bids or bidding strategies of an applicant, including the post-auction market structure, are not prohibited by the rule. While § 1.2105(c) does not prohibit business discussions and negotiations among auction applicants that are not auction related, each applicant must remain vigilant not to communicate, directly or indirectly, information that affects, or could affect, bids or bidding strategies. Certain discussions might touch upon subject matters that could convey price or geographic information related to bidding strategies. Such subject areas include, but are not limited to, management, sales, local marketing agreements, and other transactional agreements.

37. Communicating with Third Parties. Section 1.2105(c) does not prohibit an applicant from communicating bids or bidding strategies to a third-party, such as a consultant or consulting firm, counsel, or lender. The applicant should take appropriate steps, however, to ensure that any third party it employs for advice pertaining to its bids or bidding strategies does not become a conduit for prohibited communications to other specified parties, as that would violate the rule. For example, an applicant might require a third party, such as a lender, to sign a non-disclosure agreement before the applicant communicates any information regarding bids or bidding strategy to the third party. Within third-party firms, separate individual employees, such as attorneys or auction consultants, may advise individual applicants on bids or bidding strategies, so long as such firms implement firewalls and other compliance procedures that prevent such individuals from communicating the bids or bidding strategies of one applicant to other individuals representing separate applicants. Although firewalls and/or other procedures should be used, their existence is not an absolute defense to liability if a violation of the rule has occurred.

38. Applicants may discuss the short-form application or bids for specific permits with their counsel, consultant, or expert of their choice before the short-form application deadline. Furthermore, the same third-party individual could continue to give advice to multiple applicants regarding their applications after the short-form application deadline, provided that no information pertaining to bids or bidding strategies is conveyed to that individual from any of the applicants the individual advises. No person may serve as an authorized bidder for more than one applicant in Auction 109.

39. Applicants also should use caution in their dealings with other parties, such as members of the press, financial analysts, or others who might become conduits for the communication of prohibited bidding information. For example, even though communicating that it has applied to participate in this auction will not violate the rule, an applicant's statement to the press that it intends to stop bidding in an auction could give rise to a finding of a § 1.2105 violation. Similarly, an FCC Form 175 applicant's public statement of intent not to place bids during bidding in Auction 109 could also violate the rule.

40. Section 1.2105(c) Certification. By electronically submitting its FCC Form 175, each applicant in Auction 109 certifies its compliance with §§ 1.2105(c) and 73.5002(d) of the rules. However, the mere filing of a certifying statement as part of an application will not outweigh specific evidence that a prohibited communication has occurred, nor will it preclude the initiation of an investigation when warranted. Any applicant found to have violated these communication prohibitions may be subject to sanctions.

41. Duty to Report Prohibited Communications. Section 1.2105(c)(4) requires that any applicant that makes or receives a communication that appears to violate § 1.2105(c) must report such communication in writing to the Commission immediately, and in no case later than five business days after the communication occurs. Each applicant's obligation to report any such communication continues beyond the five-day period after the communication is made, even if the report is not made within the five-day period.

42. Procedures for Reporting Prohibited Communications. Section 1.2105(c) requires parties to file only a single report concerning a prohibited communication and to file that report with Commission personnel expressly charged with administering the Commission's auctions. This rule is designed to minimize the risk of inadvertent dissemination of information in such reports. Any reports required by § 1.2105(c) must be filed consistent with the instructions set forth in the Auction 109 Procedures Public Notice. For Auction 109, such reports must be filed with the Chief of the Auctions Division, OEA, by the most expeditious means available. Any such report should be submitted by email to the Auctions Division Chief at the following email address: auction109@fcc.gov. If you choose instead to submit a report in hard copy, contact Auctions Division staff for guidance at auction109@fcc.gov or (202) 418-0660.

43. A party reporting any communication pursuant to § 1.65 or § 1.2105(a)(2) or (c)(4) must take care to ensure that any report of a prohibited communication does not itself give rise to a violation of § 1.2105(c). For example, a party's report of a prohibited communication could violate the rule by communicating prohibited information to other applicants through the use of Commission filing procedures that would allow such materials to be made available for public inspection. A party seeking to report such a prohibited communication should consider submitting its report with a request that the report or portions of the submission be withheld from public inspection by following the procedures specified in 47 CFR 0.459. Such parties also are encouraged to coordinate with the Auctions Division staff about the procedures for submitting such reports.

44. Winning Bidders Must Disclose Terms of Agreements. Each applicant that is a winning bidder will be required to disclose in its long-form application the specific terms, conditions, and parties involved in any agreement relating to the competitive bidding process it has entered into. Such agreements must have been entered into prior to the filing deadline for short-form applications. This disclosure requirement applies to any bidding consortia, joint venture, partnership, or agreement, understanding, or other arrangement entered into relating to the competitive bidding process, including any agreement relating to the post-auction market structure. Failure to comply with the Commission's rules can result in enforcement action.

45. Antitrust Laws. Regardless of compliance with the Commission's rules, applicants remain subject to the antitrust laws, which are designed to prevent anticompetitive behavior in the marketplace. Compliance with the disclosure requirements of § 1.2105(c) will not insulate a party from enforcement of the antitrust laws. To the extent the Commission becomes aware of specific allegations that suggest that violations of the Federal antitrust laws may have occurred, the Commission may refer such allegations to the United States Department of Justice for investigation. If an applicant is found to have violated the antitrust laws or the Commission's rules in connection with its participation in the competitive bidding process, it may be subject to forfeiture of its upfront payment, down payment, or full bid amount, and may be prohibited from participating in future auctions, among other sanctions.

46. New Entrant Bidding Credits. To promote the objectives of section 309(j) of the Act and further its long-standing commitment to the diversification of broadcast facility ownership, the Commission provides a tiered new entrant bidding credit for broadcast auction applicants with no, or very few, other media interests.

47. The Auction 109 Procedures Public Notice explains why OEA and MB are unable to establish for Auction 109 a bidding credit for a party that had successfully petitioned for a vacant FM channel to be added to the FM Table of Allotments, as suggested by a commenter.

48. Applicants that qualify for the new entrant bidding credit are eligible for a bidding credit in this auction that represents the amount by which a bidder's winning bid is discounted. The size of a new entrant bidding credit depends on the number of ownership interests in other media of mass communications that are attributable to the bidder-entity and its attributable interest-holders. A 35% bidding credit will be given to a winning bidder if it, and/or any individual or entity with an attributable interest in the winning bidder, has no attributable interest in any other media of mass communications, as defined in 47 CFR 73.5008. A 25% bidding credit will be given to a winning bidder if it, and/or any individual or entity with an attributable interest in the winning bidder, has an attributable interest in no more than three mass media facilities, as defined in 47 CFR 73.5008. No bidding credit will be given if any of the commonly owned mass media facilities serve the same area as the broadcast permit proposed in the auction, as defined in 47 CFR 73.5007(b), or if the winning bidder, and/or any individual or entity with an attributable interest in the winning bidder, has attributable interests in more than three mass media facilities. For purposes of determining whether a broadcast permit offered in this auction is in the same area as an applicant's existing mass media facilities, the coverage area of the to-be-auctioned facility is calculated using maximum class facilities at the AM construction permit coordinates or the FM allotment reference coordinates specified in Attachment A to the Auction 109 Procedures Public Notice, not, based on any applicant-specified preferred site coordinates for FM allotments.

49. Bidding credits are not cumulative; qualifying applicants receive either the 25% or the 35% bidding credit, but not both.

50. The interests of the applicant, and of any individuals or entities with an attributable interest in the applicant, in other media of mass communications are considered when determining an applicant's eligibility for the New Entrant Bidding Credit. Attributable interests are defined in 47 CFR 73.3555 and note 2 of that section. In Auction 109, the bidder's attributable interests, and thus, its maximum new entrant bidding credit eligibility, are determined as of the short-form application filing deadline. An applicant intending to divest a media interest or make any other ownership change, such as resignation of positional interests (officer or director) in order to avoid attribution for purposes of qualifying for the New Entrant Bidding Credit, must have consummated such divestment transactions or have completed such ownership changes by no later than the FCC Form 175 filing deadline. However, events occurring after the short-form application filing deadline, such as the acquisition of attributable interests in media of mass communications, may cause diminishment or loss of the bidding credit and, must be reported immediately.

51. Under broadcast attribution rules, those entities or individuals with an attributable interest in a bidder include: (1) All officers and directors of a corporate bidder; (2) any owner of 5% or more of the voting stock of a corporate bidder; (3) all general partners and limited partners of a partnership bidder, unless the limited partners are sufficiently insulated; and (4) all members of a limited liability company, unless sufficiently insulated.

52. In cases where an applicant's spouse or close family member holds other media interests, such interests are not automatically attributable to the bidder. The Commission decides attribution issues in this context based on certain factors traditionally considered relevant.

53. The eligibility standards for the New Entrant Bidding Credit include attribution of the media interests held by very substantial investors in, or creditors of, an applicant claiming new entrant status. Specifically, the attributable mass media interests held by an individual or entity with an equity and/or debt interest in an applicant shall be attributed to that bidder for purposes of determining its eligibility for the New Entrant Bidding Credit, if the equity and debt interests, in the aggregate, exceed 33% of the total asset value of the applicant, even if such an interest is non-voting.

54. Generally, media interests will be attributable for purposes of the New Entrant Bidding Credit to the same extent that such other media interests are considered attributable for purposes of the broadcast multiple ownership rules. However, attributable interests held by a winning bidder in existing low power television, television translator or FM translator facilities will not be counted among the applicant's other mass media interests in determining its eligibility for a New Entrant Bidding Credit. A medium of mass communications is defined in 47 CFR 73.5008(b). Full service noncommercial educational stations, on both reserved and non-reserved channels, are included among media of mass communications as defined in § 73.5008(b).

55. Application Requirements. If an applicant claims eligibility for a bidding credit, the information provided in its FCC Form 175 will be used to determine whether the applicant is eligible for the claimed bidding credit. In addition to the ownership information required pursuant to §§ 1.2105 and 1.2112, applicants seeking a New Entrant Bidding Credit are required to establish on their short-form applications that they satisfy the eligibility requirements to qualify for the bidding credit. In those cases, a certification under penalty of perjury must be provided in completing the short-form application. An applicant claiming that it qualifies for a 35% New Entrant Bidding Credit must certify that neither it nor any of its attributable interest holders has any attributable interests in any other media of mass communications. An applicant claiming that it qualifies for a 25% New Entrant Bidding Credit must certify that neither it nor any of its attributable interest holders has any attributable interests in more than three media of mass communications, and must identify and describe such media of mass communications.

56. Unjust Enrichment. Unjust enrichment provisions apply to a winning bidder that utilizes a bidding credit and subsequently seeks to assign or transfer control of its license or construction permit to an entity not qualifying for the same level of bidding credit.

57. Former and Current Defaulters. Pursuant to the rules governing competitive bidding, each applicant must make certifications regarding whether it is a current or former defaulter or delinquent. A current defaulter or delinquent is not eligible to participate in Auction 109. Accordingly, each applicant must certify under penalty of perjury on its FCC Form 175 that, as of the filing deadline, the applicant, any of its affiliates, any of its controlling interests, and any of the affiliates of its controlling interests are not in default on any payment for a Commission construction permit or license (including down payments), and that they are not delinquent on any non-tax debt owed to any Federal agency.

58. An applicant is considered a former defaulter or a former delinquent when it or any of its controlling interests has defaulted on any Commission construction permit or license or has been delinquent on any non-tax debt owed to any Federal agency, but has since remedied all such defaults and cured all of the outstanding non-tax delinquencies, as of the FCC Form 175 filing deadline. A former defaulter or delinquent who has remedied all such defaults and cured all of the outstanding non-tax delinquencies prior to the FCC Form 175 filing deadline in this auction may participate so long as it is otherwise qualified, if the applicant makes an upfront payment that is 50% more than would otherwise be required. For this reason, an applicant must certify under penalty of perjury whether it (along with any of its controlling interests) has ever been in default on any payment for a Commission construction permit or license (including a down payment) or has ever been delinquent on any non-tax debt owed to any Federal agency, subject to the exclusions described in 47 CFR 1.2105(a)(2)(xii).

59. Applicants should review previous guidance provided on default and delinquency disclosure requirements in the context of the auction short-form application process. Applicants also may consult with Auctions Division staff if they have questions about delinquency or default disclosure requirements.

60. The Commission considers outstanding debts owed to the United States Government, in any amount, to be a serious matter. The Commission adopted rules, including a provision referred to as the red light rule, that implement its obligations under the Debt Collection Improvement Act of 1996, which governs the collection of debts owed to the United States. Under the red light rule, applications and other requests for benefits filed by parties that have outstanding debts owed to the Commission will not be processed. When adopting that rule, the Commission explicitly declared, however, that its competitive bidding rules are not affected by the red light rule. As a consequence, the Commission's adoption of the red light rule does not alter the applicability of any of its competitive bidding rules, including the provisions and certifications of §§ 1.2105 and 1.2106, with regard to current and former defaults or delinquencies.

61. The Commission's Red Light Display System, which provides information regarding debts currently owed to the Commission, may not be determinative of an auction applicant's ability to comply with the default and delinquency disclosure requirements of § 1.2105. Thus, while the red light rule ultimately may prevent the processing of long-form applications by auction winners, an auction applicant's lack of current red light status is not necessarily determinative of its eligibility to participate in an auction (or whether it may be subject to an increased upfront payment obligation). Moreover, any long-form applications filed after the close of bidding will be reviewed for compliance with the Commission's red light rule, and such review may result in the dismissal of a winning bidder's long-form application. Each applicant should carefully review all records and other available Federal agency databases and information sources to determine whether the applicant, or any of its affiliates, or any of its controlling interests, or any of the affiliates of its controlling interests, currently owes or was ever delinquent in the payment of non-tax debt owed to any Federal agency.

62. Optional Applicant Status Identification. An applicant owned by members of minority groups and/or women, as defined in § 1.2110(c)(3), or that is a rural telephone company, as defined in § 1.2110(c)(4), may identify itself as such in filling out its FCC Form 175. This applicant status information is optional and collected for statistical purposes only because it assists the Commission in monitoring the participation of various groups in its auctions.

63. Noncommercial Educational Status Election. If an FCC Form 175 filed during the Auction 109 filing window identifying the application's proposed station as noncommercial educational (NCE) is mutually exclusive with any application filed during that window for a commercial station, the NCE application will be returned as unacceptable for filing and the applicant will not be provided with any further opportunity to become eligible to bid in this auction. Short-form applications that do not identify the facilities proposed in the FCC Form 175 as NCE will be considered, as a matter of law, applications for commercial broadcast stations. For this reason, each prospective applicant in this auction should consider carefully whether it wishes to propose NCE operation for any AM or FM station acquired in this auction. This NCE election cannot be reversed after the initial application filing deadline.

64. Only Minor Modifications to FCC Form 175 Allowed. After the initial application filing deadline, an applicant will be permitted to make only minor modifications to its short-form application. Examples of minor changes include the deletion or addition of authorized bidders (to a maximum of three), revision of addresses and telephone numbers of the applicant, its responsible party, and its contact person, or change in the applicant's selected bidding option (electronic or telephonic). A major modification to an FCC Form 175 ( e.g., change of construction permit selection, change in the required certifications, change in control of the applicant such as any change in ownership or control that would constitute an assignment or transfer of control of the applicant) will not be permitted after the initial FCC Form 175 filing deadline. If an applicant makes a major amendment, as defined by § 1.2105(b)(2), the major amendment may result in the disqualification of the applicant from participating in bidding. Questions about FCC Form 175 amendments should be directed to the Auctions Division at (202) 418-0660.

65. Duty to Maintain Accuracy and Completeness of FCC Form 175. Each applicant has a continuing obligation to maintain the accuracy and completeness of information furnished in its pending application in a competitive bidding proceeding. An auction applicant must furnish additional or corrected information to the Commission within five days after a significant occurrence, or amend its FCC Form 175 no more than five days after the applicant becomes aware of the need for the amendment. In accordance with the Commission's rules, an applicant's obligation to make modifications to a pending auction application in order to provide additional or corrected information continues beyond the five-day period, even if the report is not made within the five-day period. An applicant is obligated to amend its pending application even if a reported change is considered to be a major modification that may result in the dismissal of its application.

66. Modifying an FCC Form 175. During the initial filing window, an applicant will be able to make any necessary modifications to its FCC Form 175 in the Auction Application System. An applicant that has certified and submitted its FCC Form 175 before the close of the initial filing window may continue to make modifications as often as necessary until the close of that window; however, the applicant must re-certify and re-submit its FCC Form 175 before the close of the initial filing window to confirm and effect its latest application changes. After each submission, a confirmation page will be displayed stating the submission time and submission date. Additional information on the procedures for modifying an FCC Form 175 appear in Attachment B to the Auction 109 Procedures Public Notice.

67. As with filing the FCC Form 175, any amendment(s) to the application and related statements of fact must be certified by an authorized representative of the applicant with authority to bind the applicant. Submission of any such amendment or related statement of fact constitutes a representation by the person certifying that he or she is an authorized representative with such authority and that the contents of the amendment or statement of fact are true and correct.

68. Due Diligence. Each potential bidder is solely responsible for investigating and evaluating all technical and marketplace factors that may have a bearing on the value of the construction permit(s) it is seeking in this auction. The FCC makes no representations or warranties about the use of this spectrum or these construction permits for particular services. Applicants should be aware that an FCC auction represents an opportunity to become an FCC permittee in a broadcast service, subject to certain conditions and regulations. This includes the established authority of the Commission to alter the terms of existing licenses by rulemaking, which is equally applicable to licenses awarded by auction. An FCC auction does not constitute an endorsement by the FCC of any particular service, technology, or product, nor does an FCC construction permit or license constitute a guarantee of business success.

69. An applicant should perform its due diligence research and analysis before proceeding, as it would with any new business venture. In particular, each potential bidder should perform technical analyses and/or refresh its previous analyses to assure itself that, should it become a winning bidder for any Auction 109 construction permit, it will be able to build and operate facilities that will fully comply with all applicable technical and legal requirements. For example, potential applicants should note the short-spacing restrictions for FM allotment MM-FM1192-B, Channel 300B, at Sacramento, California. Each applicant should inspect any prospective transmitter sites located in, or near, the service area for which it plans to bid, to confirm the availability of such sites, and to familiarize itself with the Commission's rules regarding any applicable Federal, state, and local requirements.

70. The Media Bureau has protected the parameters of the four previously-licensed AM stations that were on the relevant frequencies in the St. Louis area. Because protections only extend to those previously licensed station parameters, the winning bidders will be limited in their opportunities to modify these AM construction permits. For example, to the extent that any of these four previously licensed stations had contour overlap with nearby stations in violation of § 73.37 or § 73.187 of the rules, the winning bidder for that AM construction permit will be limited to the parameters of the previously licensed station on that frequency, and will not be permitted to make such overlap worse. Furthermore, to the extent that any of the four previously licensed AM stations exceeded the root-sum-square (RSS) contribution limits in § 73.182 of the rules, a winning bidder will be limited to the nighttime RSS contributions of the previously-licensed St. Louis area AM station. Generally, a winning bidder may avail itself of any grandfathered situation involving the relevant previously licensed St. Louis area AM station.

71. Each applicant should continue to conduct its own research throughout Auction 109 in order to determine the existence of pending or future administrative or judicial proceedings that might affect its decision to continue participating in the auction. Each Auction 109 applicant is responsible for assessing the likelihood of the various possible outcomes and for considering the potential impact on construction permits available in this auction. The due diligence considerations mentioned in the Auction 109 Procedures Public Notice do not comprise an exhaustive list of steps that should be undertaken prior to participating in this auction. As always, the burden is on the potential bidder to determine how much research to undertake, depending upon specific facts and circumstances related to its interests.

72. Applicants are solely responsible for identifying associated risks and for investigating and evaluating the degree to which such matters may affect their ability to bid on, otherwise acquire, or make use of the construction permits available in Auction 109. Each potential bidder is responsible for undertaking research to ensure that any permits won in this auction will be suitable for its business plans and needs. Each potential bidder must undertake its own assessment of the relevance and importance of information gathered as part of its due diligence efforts.

73. The Commission makes no representations or guarantees regarding the accuracy or completeness of information in its databases or any third-party databases, including, for example, court docketing systems. To the extent the Commission's databases may not include all information deemed necessary or desirable by an applicant, it must obtain or verify such information from independent sources or assume the risk of any incompleteness or inaccuracy in said databases. Furthermore, the Commission makes no representations or guarantees regarding the accuracy or completeness of information that has been provided by incumbent licensees and incorporated into its databases.

74. Bidder Education—Online Tutorial on Auction Process. An educational auction tutorial is available on the Auction 109 web page. This online tutorial provides information about pre-auction procedures, the FCC auction application system, completing short-form applications, auction conduct, the FCC auction bidding system, auction rules, and broadcast services rules. The online auction tutorial is accessible on the Education tab of the Auction 109 website at www.fcc.gov/auction/109. This tutorial will remain available and accessible anytime for reference in connection with the procedures outlined in the Auction 109 Procedures Public Notice.

75. Short-Form Application Filing Deadline. In order to be eligible to bid in Auction 109, in addition to other requirements, an applicant must first follow the procedures to submit a short-form application (FCC Form 175) for the relevant auction electronically via the FCC Auction Application System, following the instructions set forth in Attachment B to the Auction 109 Procedures Public Notice. The short-form application will become available with the opening of the initial filing window and must be submitted prior to 6:00 p.m. ET on May 11, 2021. Late applications will not be accepted. No filing fee is required to be paid at the time of filing a short-form application.

76. Applications may be filed at any time beginning at noon ET on April 28, 2021, until the filing window closes at 6:00 p.m. ET on May 11, 2021. Applicants are strongly encouraged to file early and are responsible for allowing adequate time to file their applications. There are no limits or restrictions on the number of times an application can be updated or amended until the initial filing deadline on May 11, 2021.

77. An applicant must always click on the CERTIFY & SUBMIT button on the Certify & Submit screen to successfully submit its FCC Form 175 and any modifications; otherwise the application or changes to the application will not be received or reviewed by Commission staff. Additional information about accessing, completing, and viewing the FCC Form 175 is included in Attachment B to the Auction 109 Procedures Public Notice. Applicants requiring technical assistance should contact FCC Auctions Technical Support at (877) 480-3201, option nine; (202) 4141250; or (202) 414-1255 (text telephony (TTY)). Hours of service are Monday through Friday, from 8:00 a.m. to 6:00 p.m. ET. In order to provide better service to the public, all calls to Technical Support are recorded.

78. Correction of Application Deficiencies by Minor Modifications. After the deadline for filing auction applications, Commission staff will review all timely submitted applications for Auction 109 to determine whether each applicant has complied with the application requirements and whether it has provided all required information concerning its qualifications for bidding. After this review is completed, OEA and MB will issue a public notice announcing applicants' initial application status by identifying (1) those that are complete; (2) those that are rejected; and (3) those that are incomplete or deficient because of minor defects that may be corrected. This public notice also will establish an application resubmission filing window, during which an applicant may make permissible minor modifications to its application to address identified deficiencies. The public notice will include the deadline for resubmitting corrected applications, and a paper copy will be sent by overnight delivery to the contact address listed in the FCC Form 175 for each applicant. In addition, each applicant with an incomplete application will be sent information on the nature of the deficiencies in its application, along with the name and phone number of a Commission staff member who can answer questions specific to the application. To become a qualified bidder, an applicant must have a complete application ( i.e., have timely corrected any identified deficiencies) and make a timely and sufficient upfront payment. Qualified bidders will be identified by public notice at least 10 days prior to the mock auction.

79. After the application filing deadline on May 11, 2021, applicants can make only minor corrections or updates to their applications. They will not be permitted to make major modifications.

80. Commission staff will communicate only with an applicant's contact person or certifying official, as designated on the short-form application, unless the applicant's certifying official or contact representative notifies the Commission in writing that applicant's counsel or other representative is authorized to speak on behalf of the applicant. Authorizations may be sent by email to auction109@fcc.gov.

81. Public Notice of Final Application Status After Upfront Payment Deadline. After Commission staff review resubmitted applications for Auction 109 and evaluate upfront payment submissions, Commission staff will release a public notice identifying applicants that have become qualified bidders. A public notice announcing qualified bidders will be issued before bidding in the auction begins. Qualified bidders are those applicants with submitted FCC Forms 175 that are deemed timely filed and complete, and which have made a timely and sufficient upfront payment (as described below).

82. Upfront Payments. In order to be eligible to bid in this auction, a sufficient upfront payment and a complete and accurate FCC Remittance Advice Form (FCC Form 159, February 2003 edition) must be submitted before 6:00 p.m. ET on June 16, 2021, following the procedures outlined below and the instructions in Attachment C to the Auction 109 Procedures Public Notice. After completing its short-form application, an applicant will have access to an electronic version of the FCC Form 159. This FCC Form 159 can be printed and the completed form must be sent by fax to the FCC at (202) 418-2843, or by email to RROGWireFaxes@fcc.gov.

83. Making Upfront Payments by Wire Transfer. All upfront payments must be made by wire transfer. No other payment method is acceptable. All payments must be made in U.S. dollars. Upfront payments for Auction 109 go to a U.S. Treasury account number specific to Auction 109 and different from the accounts used in previous FCC auctions. Do not use a beneficiary account number from a previous auction. Wire transfer information is specified in the Making Upfront Payments by Wire Transfer section of the Auction 109 Procedures Public Notice.

84. Each applicant is responsible for ensuring timely submission of its upfront payment and for timely filing of an accurate and complete Form 159. To avoid untimely payments, an applicant should discuss arrangements and deadlines with its financial institution (including that financial institution's specific wire transfer requirements) several days before they plan to make the wire transfer, and well ahead of the due date, as well as allowing sufficient time for the wire transfer to be initiated and completed prior to the deadline. The Commission repeatedly has cautioned auction participants about the importance of planning ahead to prepare for unforeseen last-minute difficulties in making payments by wire transfer. Each applicant is responsible for obtaining confirmation from its financial institution that its wire transfer to the U.S. Treasury was successful and from Commission staff that its upfront payment was timely received and that it was deposited into the proper account. As a regulatory requirement, the U.S. Treasury screens all payments from all financial institutions before deposits are made available to specified accounts. If wires are suspended, the U.S. Treasury may direct questions regarding any transfer to the financial institution initiating the wire. Each applicant must take care to assure that any questions directed to its financial institution(s) are addressed promptly. To receive confirmation from Commission staff requesting receipt and deposit of wire transfers, contact Scott Radcliffe of the Office of Managing Director's Revenue & Receivables Operations Group/Auctions at (202) 418-7518, or Theresa Meeks at (202) 418-2945.

85. Failure to deliver a sufficient upfront payment as instructed in the Auction 109 Procedures Public Notice by the 6:00 p.m. deadline on June 16, 2021, will result in dismissal of the short-form application and disqualification from participation in the auction.

86. Completing and Submitting FCC Form 159. An accurate and complete FCC Form 159 (February 2003 edition) must be sent to the FCC to accompany each upfront payment. At least one hour before placing the order for the wire transfer (but on the same business day), applicants must fax a completed Form 159 to the FCC at (202) 418-2843. Alternatively, the completed form can be scanned and sent as an attachment to an email to RROGWireFaxes@fcc.gov. On the fax cover sheet, write: Wire Transfer—Auction Payment for Auction 109.

87. Upfront Payments and Bidding Eligibility. OEA and MB adopted the upfront payment amount proposed for each construction permit in Attachment A of the Auction 109 Comment Public Notice, except that the upfront payment amount for Allotment MM-FM1237-C1, Big Lake, Texas is reduced because the minimum opening bid for that permit should be lower than the amount initially proposed, as discussed below. The specific upfront payment amounts and bidding units for each construction permit in Auction 109 are specified in Attachment A to the Auction 109 Procedures Public Notice.

88. An applicant must make an upfront payment sufficient to obtain bidding eligibility on the construction permits on which it will bid. OEA and MB proposed in the Auction 109 Comment Public Notice that the amount of the upfront payment would determine a bidder's initial bidding eligibility, the maximum number of bidding units on which a bidder may place bids in any single round. Under that proposal, in order to bid on a particular construction permit, a qualified bidder must have selected the construction permit on its FCC Form 175 and must have a current eligibility level that meets or exceeds the number of bidding units assigned to that construction permit. At a minimum, therefore, an applicant's total upfront payment must be enough to establish eligibility to bid on at least one of the construction permits selected on its FCC Form 175, or else the applicant will not be qualified to participate in the auction. An applicant does not have to make an upfront payment to cover all construction permits the applicant selected on its FCC Form 175, but only enough to cover the maximum number of bidding units that are associated with construction permits on which they wish to place bids and hold provisionally winning bids in any given round. The total upfront payment does not affect the total dollar amount the bidder may bid on any given construction permit.

89. OEA and MB received no comments on the proposal that the upfront payment amount would determine a bidder's initial eligibility. Therefore, OEA and MB adopted this proposal. Each applicant's upfront payment amount will determine that bidder's initial bidding eligibility.

90. In calculating its upfront payment amount, an applicant should determine the maximum number of bidding units on which it may wish to be active (bid on or hold provisionally winning bids on) in any single round, and submit an upfront payment amount covering that number of bidding units. In order to make this calculation, an applicant should add together the bidding units for all construction permits on which it seeks to be active in any given round. Applicants should check their calculations carefully, as there is no provision for increasing a bidder's eligibility after the upfront payment deadline.

91. An applicant that is a former defaulter, as described above, must pay an upfront payment 50% greater than that required of an applicant that is not a former defaulter. For purposes of this rule, defaults and delinquencies of the applicant itself and its controlling interests are included. If an applicant is a former defaulter, it must calculate its upfront payment for all of its selected construction permits by multiplying the number of bidding units on which it wishes to be active (bid on or hold provisionally winning bids on) during a given round by 1.5. In order to calculate the number of bidding units to assign to former defaulters, the Commission will divide the upfront payment received by 1.5 and round the result up to the nearest bidding unit. If an applicant fails to submit a sufficient upfront payment to establish eligibility to bid on at least one of the construction permits selected on its FCC Form 175, the applicant will not be eligible to participate in bidding in the auction. This applicant will retain its status as an applicant in Auction 109 and will remain subject to 47 CFR 1.2105(c), 73.5002(d).

92. Auction Registration. All qualified bidders for Auction 109 are automatically registered for the auction. Registration materials will be distributed prior to the auction by overnight mail. The mailing will be sent only to the contact person at the contact address listed in the FCC Form 175 and will include the SecurID® tokens that will be required to place bids, the web address and instructions for accessing and logging in to the auction bidding system, FCC assigned username (User ID) for each authorized bidder, and the Auction Bidder Line phone number.

93. Qualified bidders that do not receive this registration mailing will not be able to submit bids. Therefore, if this mailing is not received by the contact representative for a qualified bidder by noon on Tuesday, July 20, 2021, call the Auctions Hotline at (717) 338-2868. In no event, however, will the FCC send auction registration materials to anyone other than the contact person listed on the applicant's FCC Form 175 or respond to a request for replacement registration materials from anyone other than the authorized bidder, contact person, or certifying official listed on the applicant's FCC Form 175. Receipt of this registration mailing is critical to participating in the auction, and each qualified bidder is responsible for ensuring it has received all of the registration materials.

94. In the event that SecurID® tokens are lost or damaged, only a person who has been designated as an authorized bidder, the contact person, or the certifying official on the applicant's short-form application may request replacements. To request replacement of these items, call the Auction Bidder Line at the telephone number provided in the registration materials or the Auctions Hotline at (717) 338-2868.

95. The SecurID® tokens can be recycled, and bidders should return the tokens to the FCC. Pre-addressed envelopes will be provided to return the tokens once bidding in the auction has ended.

96. Remote Electronic Bidding via the FCC Auction Bidding System. The Commission will conduct this auction over the internet, and telephonic bidding will be available as well. Only qualified bidders are permitted to bid. Each applicant should indicate its bidding preference—electronic or telephonic—on its FCC Form 175. In either case, each authorized bidder must have its own SecurID® token, which the Commission will provide at no charge. Each qualified bidder will be issued three SecurID® tokens. For security purposes, the SecurID® tokens, bidding system web address, FCC assigned username, and the telephonic bidding telephone number are only mailed to the contact person at the contact address listed on the FCC Form 175. Each SecurID® token is tailored to a specific auction. SecurID® tokens issued for other auctions or obtained from a source other than the FCC will not work for Auction 109.

97. The Commission makes no warranties whatsoever, and shall not be deemed to have made any warranties, with respect to the FCC Auction Application System and the auction bidding system, including any implied warranties of merchantability or fitness for a particular purpose. In no event shall the Commission, or any of its officers, employees, or agents, be liable for any damages whatsoever (including, but not limited to, loss of business profits, business interruption, loss of use, loss of revenue, loss of business information, or any other loss) arising out of or relating to the existence, furnishing, functioning, or use of the FCC Auction Application System or the FCC auction bidding systems that are accessible to qualified bidders in connection with this auction. Moreover, no obligation or liability will arise out of the Commission's technical, programming, or other advice or service provided in connection with the FCC auction systems.

98. To the extent an issue arises with the auction bidding system itself, the Commission will take all appropriate measures to resolve such issues quickly and equitably. Should an issue arise that is outside the auction bidding system or attributable to a bidder, including, but not limited to, a bidder's hardware, software, or internet access problem that prevents the bidder from submitting a bid prior to the end of a round, the Commission shall have no obligation to resolve or remedy such an issue on behalf of the bidder. Similarly, if an issue arises due to bidder error using the auction bidding system, the Commission shall have no obligation to resolve or remedy such an issue on behalf of the bidder. Accordingly, after the close of a bidding round, the results of bid processing will not be altered absent evidence of any failure in the auction bidding system.

99. Mock Auction. All qualified bidders will be eligible to participate in a mock auction on Friday, July 23, 2021. The mock auction will enable bidders to become familiar with the FCC auction bidding system prior to the auction. All bidders should participate in the mock auction. Details will be announced by public notice.

100. Fraud Alert. As is the case with many business investment opportunities, some unscrupulous entrepreneurs may attempt to use Auction 109 to deceive and defraud unsuspecting investors. Information about deceptive telemarketing investment schemes is available from the FCC as well as the Federal Trade Commission (FTC), Securities and Exchange Commission (SEC) and the National Fraud Information Center. Additional sources of information for potential bidders and investors are described in the Auction 109 Procedures Public Notice.

101. Environmental Review Requirements. Permittees or licensees must comply with the Commission's rules for environmental review under the National Environmental Policy Act, the National Historic Preservation Act, and other Federal environmental statutes. The construction of a broadcast facility is a Federal action, and the permittee or licensee must comply with the Commission's environmental rules for each such facility. These environmental rules require, among other things, that the permittee or licensee consult with expert agencies having environmental responsibilities, including the U.S. Fish and Wildlife Service, the State Historic Preservation Office, the U.S. Army Corps of Engineers, and the Federal Emergency Management Agency (through the local authority with jurisdiction over floodplains). In assessing the effect of facility construction on historic properties, the permittee or licensee must follow the provisions of the FCC's Nationwide Programmatic Agreement Regarding the Section 106 National Historic Preservation Act Review Process. The permittee or licensee must prepare environmental assessments for any facility that may have a significant impact in or on wilderness areas, wildlife preserves, threatened or endangered species, or designated critical habitats, historical or archaeological sites, Indian religious sites, floodplains, and surface features. In addition, the permittee or licensee must prepare environmental assessments for facilities that include high intensity white lights in residential neighborhoods or excessive radio frequency emission.

102. The first round of bidding for Auction 109 will begin on Tuesday, July 27, 2021. Unless otherwise announced, bidding on all construction permits will be conducted on each business day until bidding has stopped on all construction permits. The initial bidding schedule will be announced in a public notice listing the qualified bidders, which is released at least one week before the start of bidding in the auction.

103. Simultaneous Multiple Round Auction. In the Auction 109 Comment Public Notice, OEA and MB proposed to auction all construction permits listed in Attachment A of this Auction 109 Procedures Public Notice in a single auction using the Commission's standard simultaneous multiple-round auction format. This type of auction offers every construction permit for bid at the same time and consists of successive bidding rounds in which qualified bidders may place bids on individual construction permits. OEA and MB received no comment on this proposal, and this proposal was adopted. Unless otherwise announced, bids will be accepted on all construction permits in each round of the auction until bidding stops on every construction permit.

104. FCC Auction Bidding System. All bidding will take place remotely either over the internet through the FCC auction bidding system or by telephone using the telephonic bidding option. Please note that telephonic bid assistants are required to use a script when entering bids placed by telephone. Telephonic bidders are therefore reminded to allow sufficient time to bid by placing their calls well in advance of the close of a round. The length of a call to place a telephonic bid may vary; please allow a minimum of ten minutes. All telephone calls are recorded.

105. An Auction 109 bidder's ability to bid on specific construction permits is determined by two factors: (1) The construction permits selected by that applicant in its FCC Form 175 and (2) the bidder's bidding eligibility measured in bidding units. The FCC auction bidding system will allow bidders to submit bids on only those construction permits the bidder selected on its FCC Form 175.

106. In order to access the bidding function of the FCC auction bidding system, bidders must be logged in during a bidding round using the passcode generated by the SecurID® token and a personal identification number (PIN) created by the bidder. Bidders are strongly encouraged to print a round summary for each round after they have completed all of their activity for that round.

107. Round Structure. The initial schedule of bidding rounds will be announced in the public notice listing the qualified bidders in the auction. Each bidding round is followed by the release of round results. Multiple bidding rounds may be conducted each day.

108. In the Auction 109 Comment Public Notice, OEA and MB proposed to retain the discretion to change the bidding schedule in order to foster an auction pace that reasonably balances speed with the bidders' need to study round results and adjust their bidding strategies. OEA and MB received no comment on these proposals and adopted them for Auction 109. OEA and MB may change the amount of time for the bidding rounds, the amount of time between rounds, or the number of rounds per day, depending upon bidding activity and other factors, by prior announcement.

109. Eligibility and Activity Rules. In Auction 109, upfront payments will be used to determine initial (maximum) bidding eligibility (as measured in bidding units) for Auction 109. The amount of the upfront payment submitted by a bidder determines initial bidding eligibility, the maximum number of bidding units on which a bidder may be active (bid or hold provisionally winning bids) in a given round. Each construction permit is assigned a specific number of bidding units as listed in Attachment A to the Auction 109 Procedures Public Notice. Bidding units assigned to each construction permit do not change as prices rise during the auction. Upfront payments are not attributed to specific construction permits. Rather, a bidder may place bids on any of the construction permits selected on its FCC Form 175 as long as the total number of bidding units associated with those construction permits does not exceed the bidder's current eligibility. Eligibility cannot be increased during the auction; it can only remain the same or decrease. Thus, in calculating its upfront payment amount, an applicant must determine the maximum number of bidding units on which it may wish to bid or hold provisionally winning bids in any single round, and submit an upfront payment amount covering that total number of bidding units. At a minimum, an applicant's upfront payment must cover the bidding units for at least one of the construction permits it selected on its short-form application. The total upfront payment does not affect the total dollar amount a bidder may bid on any given construction permit. OEA and MB received no comments on the bidding eligibility proposals, and these proposals are adopted.

110. To ensure that an auction closes within a reasonable period of time, an activity rule requires bidders to bid actively throughout the auction, rather than wait until late in the auction before participating. Bidders are required to be active (bid or hold provisionally winning bids) on a specified percentage of their current bidding eligibility during each round of the auction. A bidder's activity level in a round is the sum of the bidding units associated with construction permits covered by the bidder's new bids in the current round and provisionally winning bids from the previous round.

111. The minimum required activity is expressed as a percentage of the bidder's current eligibility, and it increases by stage as the auction progresses. Failure to maintain the requisite activity level will result in the use of an activity rule waiver, if any remain, or a reduction in the bidder's eligibility, possibly curtailing or eliminating the bidder's ability to place additional bids in the auction.

112. In response to a commenter's suggestion that the auction should begin with an activity requirement lower than that proposed in the Auction 109 Comment Public Notice, OEA and MB adopted a more flexible activity requirement in the Auction 109 Procedures Public Notice. Accordingly, OEA and MB initially adopt two activity requirements: An 80% requirement for the beginning of the auction and a 95% requirement that will be used later in the auction. These requirements will be implemented using auction stages, as described below.

113. Auction Stages. OEA and MB will conduct the auction in at least two stages as described below. Under this approach, a bidder desiring to maintain its current bidding eligibility will be required to be active on construction permits representing at least 80% of its current eligibility during each round of Stage One, and on at least 95% of its current bidding eligibility in Stage Two.

114. Stage One: During the first stage of the auction, a bidder desiring to maintain its current bidding eligibility will be required to be active on construction permits representing at least 80% of its current bidding eligibility in each bidding round. Failure to maintain the required activity level will result in the use of an activity rule waiver or, if the bidder has no activity rule waivers remaining, a reduction in the bidder's bidding eligibility in the next round. During Stage One, reduced eligibility for the next round will be calculated by multiplying the bidder's current round activity (the sum of bidding units of the bidder's provisionally winning bids and bids during the current round) by five-fourths ( 5/4 ).

115. Stage Two: During the second stage of the auction, a bidder desiring to maintain its current bidding eligibility is required to be active on 95% of its current bidding eligibility. Failure to maintain the required activity level will result in the use of an activity rule waiver or, if the bidder has no activity rule waivers remaining, a reduction in the bidder's bidding eligibility in the next round. During Stage Two, reduced eligibility for the next round will be calculated by multiplying the bidder's current round activity (the sum of bidding units of the bidder's provisionally winning bids and bids during the current round) by twenty-nineteenths (20/19).

116. Stage Transitions. OEA and MB intend to advance the auction from Stage One to Stage Two after considering a variety of measures of auction activity including, but not limited to, the percentages of construction permits (as measured in bidding units) on which there are new bids, the number of new bids, and the increase in revenue.

117. The auction will start in Stage One. Prior to moving from Stage One to Stage Two or to any subsequent stages, OEA and MB will alert bidders by announcement in the bidding system. Because activity requirements increase in Stage Two, bidders must carefully check their activity during the first round following a stage transition to ensure that they are meeting the increased activity requirement. In past auctions, some bidders have inadvertently lost bidding eligibility or used an activity rule waiver because they did not re-verify their activity at stage transitions.

118. OEA and MB have the discretion to further alter the activity requirements before and/or during the auction as circumstances warrant. In addition to transitioning to Stage Two, OEA and MB retain the discretion to change the activity requirements during the auction by other means, including adding an additional stage with a higher activity requirement, not transitioning to Stage Two, and transitioning to Stage Two with an activity requirement that is higher or lower than 95%. This determination will be based on a variety of measures of auction activity, including, but not limited to, the number of new bids and the percentages of construction permits (as measured in bidding units) on which there are new bids.

119. Activity Rule Waivers. For Auction 109, OEA and MB adopted the proposal to provide each bidder in the auction with three activity rule waivers, which are principally a mechanism for a bidder to avoid the loss of bidding eligibility in the event that exigent circumstances prevent it from bidding in a particular round.

120. Use of an activity rule waiver preserves the bidder's eligibility despite its activity in the current round being below the required minimum activity level. An activity rule waiver applies to an entire round of bidding and not to a particular construction permit. A bidder may use an activity rule waiver in any round of the auction as long as the bidder has not used all of its waivers.

121. The FCC auction bidding system will assume that a bidder that does not meet the activity requirement would prefer to use an activity rule waiver (if available) rather than lose bidding eligibility. Therefore, the system will automatically apply a waiver at the end of any bidding round in which a bidder's activity level is below the minimum required unless (1) the bidder has no activity rule waiver remaining, or (2) the bidder overrides the automatic application of a waiver by reducing eligibility, therefore meeting the activity requirement. If the bidder has no waivers remaining and does not satisfy the required activity level, the bidder's current eligibility will be permanently reduced, possibly curtailing or eliminating the ability to place additional bids in the auction.

122. A bidder with insufficient activity may wish to reduce its bidding eligibility rather than use an activity rule waiver. If so, the bidder must affirmatively override the automatic waiver mechanism during the bidding round by using the reduce eligibility function in the FCC auction bidding system. In this case, the bidder's eligibility would be permanently reduced to bring it into compliance with the activity rule described above. Reducing eligibility is an irreversible action once the round has closed, and a bidder cannot regain its lost bidding eligibility.

123. Finally, a bidder may apply an activity rule waiver proactively as a means to keep the auction open without placing a bid. If a bidder proactively applies an activity rule waiver (using the proactive waiver function in the FCC auction bidding system) during a bidding round in which no bids are placed, the auction will remain open and the bidder's eligibility will be preserved. An automatic waiver applied by the FCC auction bidding system in a round in which there is no new bid or a proactive waiver will not keep the auction open.

124. Auction Stopping Rule. For Auction 109, OEA and MB proposed to employ a simultaneous stopping rule approach, which means all construction permits remain available for bidding until bidding stops on every construction permit. Specifically, bidding will close on all construction permits after the first round in which no bidder submits any new bid or applies a proactive waiver.

125. OEA and MB also sought comment on alternative versions of the simultaneous stopping rule for Auction 109:

Option 1. The auction would close for all construction permits after the first round in which no bidder applies a proactive waiver or places any new bid on any construction permit on which it is not the provisionally winning bidder. Thus, absent any other bidding activity, a bidder placing a new bid on a construction permit for which it is the provisionally winning bidder would not keep the auction open under this modified stopping rule.

Option 2. The auction would close for all construction permits after the first round in which no bidder applies a waiver or places any new bid on any construction permit that already has a provisionally winning bid. Thus, absent any other bidding activity, a bidder placing a new bid on an FCC-held construction permit (a construction permit that does not have a provisionally winning bid) would not keep the auction open under this modified stopping rule.

Option 3. The auction would close using a modified version of the simultaneous stopping rule that combines Option 1 and Option 2 above.

Option 4. The auction would close after a specified number of additional rounds (special stopping rule) to be announced in advance in the FCC auction bidding system. If OEA and MB invoke this special stopping rule, bids will be accepted in the specified final round(s), after which the auction will close.

Option 5. The auction would remain open even if no bidder places any new bid or applies a waiver. In this event, the effect will be the same as if a bidder had applied a waiver. Thus, the activity rule will apply as usual, and a bidder with insufficient activity will either lose bidding eligibility or use a waiver.

126. OEA and MB proposed to exercise these options only in certain circumstances, for example, where the auction is proceeding unusually slowly or quickly, there is minimal overall bidding activity, or it appears likely that the auction will not close within a reasonable period of time or will close prematurely. Before exercising these options, OEA and MB are likely to attempt to change the pace of the auction. For example, OEA and MB may adjust the pace of bidding by changing the number of bidding rounds per day and/or the minimum acceptable bids. OEA and MB proposed to retain the discretion to exercise any of these options with or without prior announcement during the auction. OEA and MB received one comment regarding stopping rule Option 2. The commenter cautioned against the use of Option 2, but indicated that this option should remain available. OEA and MB adopted these approaches for Auction 109.

127. Auction Delay, Suspension, or Cancellation. By public notice or by announcement through the FCC auction bidding system, OEA and MB may delay, suspend, or cancel bidding in the auction in the event of natural disaster, technical obstacle, network interruption, administrative or weather necessity, evidence of an auction security breach or unlawful bidding activity, or for any other reason that affects the fair and efficient conduct of competitive bidding. In such cases, OEA and MB, in their sole discretion, may elect to resume the auction starting from the beginning of the current round or from some previous round, or cancel the auction in its entirety. This authority will be exercised solely at the discretion of OEA and MB, and not as a substitute for situations in which bidders may wish to apply their activity rule waivers.

128. Minimum Opening Bids and Acceptable Bid Amounts. Consistent with the mandate of section 309(j) of the Act, the Commission directed OEA and MB to seek comment on the use of a minimum opening bid and/or reserve price prior to the start of each auction.

129. In the Auction 109 Comment Public Notice, OEA and MB did not propose to establish separate reserve prices for the construction permits in Auction 109, and OEA and MB found no basis for establishing any separate reserve price in the Auction 109 Procedures Public Notice. This is consistent with policy applied in earlier broadcast spectrum auctions. OEA and MB, however, proposed to establish minimum opening bids for each construction permit in Auction 109, reasoning that a minimum opening bid, which has been used in other auctions, is an effective tool for accelerating the competitive bidding process. The bidding system will not accept bids lower than the minimum opening bids for each construction permit. Based on experience in past auctions, setting minimum opening bid amounts judiciously is an effective tool for accelerating the competitive bidding process.

130. OEA and MB adopted the minimum opening bid amounts proposed in the Auction 109 Comment Public Notice., except that the minimum opening bid for Allotment MM-FM1237-C1, Big Lake, Texas is lowered to $35,000 after further analysis in response to one commenter's filing. The specific minimum opening bid and upfront payment amounts for each construction permit are set forth in Attachment A to the Auction 109 Procedures Public Notice.

131. In each round of Auction 109 a qualified bidder will be able to place a bid on a given construction permit in any of up to nine different amounts. The FCC auction bidding system interface will list the nine acceptable bid amounts for each construction permit.

132. In the Auction 109 Comment Public Notice, to calculate the first of the acceptable bid amounts, OEA and MB proposed to use a minimum acceptable bid increment percentage of 10%. This means that the minimum acceptable bid amount for a construction permit will be approximately 10% greater than the provisionally winning bid amount for the construction permit. To calculate the eight additional acceptable bid amounts, OEA and MB proposed in the Auction 109 Comment Public Notice to use an additional bid increment percentage of 5%. The Commission did not receive any comments on these proposals to use 10% and 5% respectively in the calculation of nine acceptable bid amounts for each construction permit. Based on OEA and MB experience in previous broadcast auctions, a minimum acceptable bid increment percentage of 10% and an additional bid increment percentage of 5% are sufficient to ensure active bidding. Therefore, OEA and MB will begin the auction with a minimum acceptable bid increment percentage of 10% and an additional bid increment percentage of 5%.

133. In Auction 109, the minimum acceptable bid amount for a construction permit will be equal to its minimum opening bid amount until there is a provisionally winning bid for the construction permit. After there is a provisionally winning bid for a construction permit, the minimum acceptable bid amount will be calculated by multiplying the provisionally winning bid amount by one plus the minimum acceptable bid percentage— i.e., provisionally winning bid amount * 1.10, rounded. In accordance with the Commission's standard rounding procedure for auctions, results of this calculation above $10,000 will be rounded to the nearest $1,000; results below $10,000 but above $1,000 will be rounded to the nearest $100; and results below $1000 will be rounded to the nearest $10.

134. In Auction 109, the FCC auction bidding system will calculate the eight additional bid amounts by multiplying the minimum acceptable bid amount by the additional bid increment percentage of 5%, and that result (rounded) is the additional increment amount. The first additional acceptable bid amount equals the minimum acceptable bid amount plus the additional increment amount. The second additional acceptable bid amount equals the minimum acceptable bid amount plus two times the additional increment amount; the third additional acceptable bid amount is the minimum acceptable bid amount plus three times the additional increment amount; etc. Because the additional bid increment percentage is 5%, the calculation of the additional increment amount is (minimum acceptable bid amount) * (0.05), rounded. The first additional acceptable bid amount equals (minimum acceptable bid amount) + (additional increment amount); the second additional acceptable bid amount equals (minimum acceptable bid amount) + (2 * (additional increment amount)); the third additional acceptable bid amount equals (minimum acceptable bid amount) + (3 * (additional increment amount)); etc.

135. OEA and MB proposed to retain the discretion to change the minimum acceptable bid amounts, the minimum acceptable bid increment percentage, the additional bid increment percentage, and the number of acceptable bid amounts if circumstances so dictate, consistent with past practice. OEA and MB also proposed to retain the discretion to do so on a construction permit-by-construction permit basis. OEA and MB also proposed to retain the discretion to limit (a) the amount by which a minimum acceptable bid for a construction permit may increase compared with the corresponding provisionally winning bid, and (b) the amount by which an additional bid amount may increase compared with the immediately preceding acceptable bid amount. For example, OEA and MB could set a $1,000 limit on increases in minimum acceptable bid amounts over provisionally winning bids. Thus, if calculating a minimum acceptable bid using the minimum acceptable bid increment percentage results in a minimum acceptable bid amount that is $1,200 higher than the provisionally winning bid on a construction permit, the minimum acceptable bid amount would instead be capped at $1,000 above the provisionally winning bid.

136. The sole commenter to address this issue expressed support for the proposal to retain discretion to change the minimum acceptable bid amounts, yet suggested that OEA and MB should not exercise this discretion until several bidding rounds have concluded when more price information is available. OEA and MB did not receive any other comments on these proposals concerning changes of bid amounts. OEA and MB typically exercise this discretion based on monitoring of ongoing bidding and reserved such discretion in the Auction 109 Procedures Public Notice. If OEA and MB exercise this discretion, bidders will be alerted by announcement in the FCC auction bidding system during the auction.

137. Provisionally Winning Bids. Consistent with practice in past auctions, the FCC auction bidding system at the end of each bidding round will determine a provisionally winning bid for each construction permit based on the highest bid amount received for that permit. A provisionally winning bid will remain the provisionally winning bid until there is a higher bid on the same construction permit at the close of a subsequent round. Provisionally winning bids at the end of the auction become the winning bids.

138. OEA and MB will use a pseudo-random number generator to select a single provisionally winning bid in the event of identical high bid amounts being submitted on a construction permit in a given round ( i.e., tied bids). Accordingly, the FCC auction bidding system will assign a pseudo-random number to each bid upon submission. The tied bid with the highest pseudo-random number wins the tiebreaker and becomes the provisionally winning bid. The remaining bidders, as well as the provisionally winning bidder, can submit higher bids in subsequent rounds. However, if the auction were to close with no other bids being placed, the winning bidder would be the one that placed the provisionally winning bid. If the construction permit receives any bids in a subsequent round, the provisionally winning bid again will be determined by the highest bid amount received for the construction permit. As a reminder, provisionally winning bids count toward activity for purposes of the activity rule.

139. Bid Removal and Bid Withdrawal. In the Auction 109 Comment Public Notice, OEA and MB explained bid removal procedures in the FCC auction bidding system. Each qualified bidder has the option of removing any bids placed in a round provided that such bids are removed before the close of that bidding round. By removing a bid within a round, a bidder effectively unsubmits the bid. A bidder removing a bid placed in the same round is not subject to withdrawal payments. Removing a bid will affect a bidder's activity because a removed bid no longer counts toward bidding activity for the round. Once a round closes, a bidder may no longer remove a bid.

140. Bidders in Auction 109 are prohibited from withdrawing any bid after close of the round in which that bid was placed. OEA and MB adopted the prohibition in recognition of the site-specific nature and wide geographic dispersion of the permits available in this auction, as well as experience with past auctions of broadcast construction permits. Bidders are cautioned to select bid amounts carefully because no bid withdrawals will be allowed in Auction 109, even if a bid was mistakenly or erroneously made.

141. Bidding Results. Bids placed during a round will not be made public until the conclusion of that round. After a round closes, OEA and MB will compile reports of all bids placed, current provisionally winning bids, new minimum acceptable bid amounts for the following round, whether the construction permit is FCC-held, and bidder eligibility status (bidding eligibility and activity rule waiver), and post the reports for public access.

142. Auction Announcements. The Commission staff will use auction announcements to report necessary information to bidders, such as schedule changes. All auction announcements will be available by clicking a link in the FCC auction bidding system.

143. Shortly after bidding has closed, the Commission will issue a public notice declaring the auction closed, identifying the winning bidders, and establishing the deadlines for submitting down payments, final payments, and the long-form applications.

144. Down Payments. Within ten business days after release of the auction closing public notice, each winning bidder must submit sufficient funds (in addition to its upfront payment) to bring its total amount of money on deposit with the Commission for Auction 109 to 20% of the net amount of its winning bid(s) (gross bid(s) less any applicable new entrant bidding credit(s)).

145. Final Payments. Each winning bidder will be required to submit the balance of the net amount of its winning bid(s) within ten business days after the applicable deadline for submitting down payments.

146. Long-Form Applications. The Commission's rules currently provide that within thirty days following the close of bidding and notification to the winning bidders, unless a longer period is specified by public notice, each winning bidder must electronically submit a separate, properly completed long-form application for each permit won, and required exhibits, along with the applicable application filing fee. Winning bidders for FM construction permits will electronically file FCC Form 2100, Schedule 301-FM, in the Media Bureau's Licensing and Management System (LMS). Winning bidders for AM construction permits will electronically file FCC Form 301 in the Media Bureau's Consolidated Data Base System (CDBS).

147. A winning bidder is required to submit an application filing fee with each long-form application. 47 CFR 1.1104. The application filing fee must be paid in addition to the winning bid amount. The Commission recently adopted a new long-form application filing fee that includes an amount to recover costs for processing the short-form application. The amended § 1.1104, which specifies filing fees for AM and FM long-form applications, is not yet in effect. The long-form application filing fee that is in effect when such form is filed will be the applicable fee.

148. Winning bidders claiming new entrant status must include an exhibit demonstrating their eligibility for the bidding credit. Further instructions on these and other filing requirements will be provided to winning bidders in the auction closing public notice.

149. Default and Disqualification. Any winning bidder that defaults or is disqualified after the close of the auction ( i.e., fails to remit the required down payment within the prescribed period of time, fails to submit a timely long-form application, fails to make full and timely final payment, or is otherwise disqualified) is liable for a default payment as described in 47 CFR 1.2104(g)(2). This default payment consists of a deficiency payment, equal to the difference between the amount of the Auction 109 bidder's winning bid and the amount of the winning bid the next time a construction permit covering the same spectrum is won in an auction, plus an additional payment equal to a percentage of the defaulter's bid or of the subsequent winning bid, whichever is less.

150. The percentage of the applicable bid to be assessed as an additional payment for defaults in a particular auction is established in advance of the auction. The additional default payment for Auction 109 is 20% of the applicable bid.

151. Finally, in the event of a default, the Commission has the discretion to re-auction the construction permit or offer it to the next highest bidder (in descending order) at its final bid amount. In addition, if a default or disqualification involves gross misconduct, misrepresentation, or bad faith by an applicant, the Commission may declare the applicant and its principals ineligible to bid in future auctions, and may take any other action that it deems necessary, including institution of proceedings to revoke any existing authorizations held by the applicant.

152. Refund of Remaining Upfront Payment Balance. All refunds of upfront payment balances will be returned to the payer of record as identified on the FCC Form 159 unless the payer submits written authorization instructing otherwise. This written authorization must comply with the refund instructions provided in the Auction 109 Procedures Public Notice.

153. Paperwork Reduction Act. The Office of Management and Budget (OMB) has approved the information collections in the Application to Participate in an FCC Auction, FCC Form 175, OMB Control No. 3060-0600. The Auction 109 Procedures Public Notice does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. Therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198.

154. Congressional Review Act. The Commission will submit the Auction 109 Procedures Public Notice to the Administrator of the Office of Management and Budget Office of Information and Regulatory Affairs for concurrence as to whether these procedures are major or non-major under the Congressional Review Act, 5 U.S.C. 804(2). The Commission will send a copy of the Auction 109 Procedures Public Notice in a report to Congress and the Government Accountability Office pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A).

155. Supplemental Final Regulatory Flexibility Analysis. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission prepared Initial Regulatory Flexibility Analyses (IRFAs) in connection with the Broadcast Competitive Bidding Notice of Proposed Rulemaking (NPRM), 62 FR 65392, December 12, 1997, and other Commission NPRMs (collectively, Competitive Bidding NPRMs ) pursuant to which Auction 109 will be conducted. Final Regulatory Flexibility Analyses (FRFAs) likewise were prepared in the Broadcast Competitive Bidding Order, 63 FR 48615, September 11, 1998, and other Commission rulemaking orders (collectively, Competitive Bidding Orders ) pursuant to which Auction 109 will be conducted. In this proceeding, a Supplemental Initial Regulatory Flexibility Analysis (Supplemental IRFA) was incorporated in the Auction 109 Comment Public Notice, 86 FR 12556, March 4, 2021. The Commission sought written public comment on the proposals in the Auction 109 Comment Public Notice, including comments on the Supplemental IRFA. This Supplemental Final Regulatory Flexibility Analysis (Supplemental FRFA) supplements the FRFAs in the Competitive Bidding Orders to reflect the actions taken in the Auction 109 Procedure Public Notice and conforms to the RFA.

156. Need for, and Objectives of, the Public Notice. The procedures for the conduct of Auction 109 as described in the Auction 109 Procedures Public Notice implement the Commission's competitive bidding rules, which have been adopted by the Commission in multiple notice-and-comment rulemaking proceedings. More specifically, the Auction 109 Procedures Public Notice provides an overview of the procedures, terms, and conditions governing Auction 109, and the post-auction application and payment processes, as well as setting the minimum opening bid amount for each of the AM and FM broadcast construction permits that are subject to being assigned by competitive bidding.

157. To promote the efficient and fair administration of the competitive bidding process for all Auction 109 participants, including small businesses, in the Auction 109 Procedures Public Notice OEA and MB announced the following procedures: (1) Use of a simultaneous multiple-round auction format, consisting of sequential bidding rounds with a simultaneous stopping procedure; (2) a specific upfront payment amount for each construction permit; (3) a specific minimum opening bid amount for each construction permit; (4) a specific number of bidding units for each construction permit; (5) a bidder's initial bidding eligibility will be based on the amount of that bidder's upfront payment; (6) a two-stage auction with an activity requirement in which a bidder is required to be active on 80% of its bidding eligibility in stage one and 95% of its bidding eligibility in stage two; (7) provision of three activity waivers for each qualified bidder to allow it to preserve bidding eligibility during the course of the auction; (8) use of minimum acceptable bid amounts and additional acceptable increments, along with the methodology for calculating such amounts; (9) a procedure for breaking ties if identical high bid amounts are submitted on one permit in a given round; (10) a prohibition on bid withdrawals; and (11) establishment of an additional default payment percentage of 20% of the applicable bid in the event that a winning bidder defaults or is disqualified after the auction.

158. Summary of Significant Issues Raised by Public Comments in Response to the IRFA. There were no comments filed that specifically addressed the Supplemental IRFA.

159. Response to Comments by the Chief Counsel for Advocacy of the Small Business Administration. Pursuant to the Small Business Jobs Act of 2010, which amended the RFA, the Commission is required to respond to any comment filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA), and to provide a detailed statement of any change made to the proposed procedures as a result of those comments. The Chief Counsel did not file any comments in response to the procedures that were proposed in the Auction 109 Comment Public Notice.

160. Description and Estimate of the Number of Small Entities to Which the Procedures Will Apply. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the rules adopted in the Auction 109 Procedures Public Notice. The RFA generally defines the term small entity as having the same meaning as the terms small business, small organization, and small governmental jurisdiction. In addition, the term small business has the same meaning as the term small business concern under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.

161. The specific competitive bidding procedures and minimum opening bid amounts described in the Auction 109 Procedures Public Notice will affect all applicants participating in Auction 109. The number of entities that may apply to participate in Auction 109 is unknown. Based on the number of applicants in prior FM auctions, OEA and MB estimate that the number of applicants for Auction 109 may range from approximately 130 to 260. This estimate is based on the number of applicants who filed short-form applications to participate in previous auctions of FM construction permits held to date, an average of 1.8 short-form applications were filed per construction permit offered, with a median of 1.2 applications per permit. The actual number of applicants for Auction 109 could vary significantly as any individual's or entity's decision to participate may be affected by a number of factors beyond the Commission's knowledge.

162. Radio Stations. This Economic Census category comprises establishments primarily engaged in broadcasting aural programs by radio to the public. Programming may originate in their own studio, from an affiliated network, or from external sources. According to the most recent rulemaking order to assess annual regulatory fees, Commission staff identified from the Media Bureau's licensing databases 9,636 licensed radio facilities subject to annual regulatory fees as of October 1, 2019, excluding from this count radio stations exempt from required annual regulatory fees.

163. The SBA has established a small business size standard for this category as firms having $41.5 million or less in annual receipts. Economic Census data for 2012 shows that 2,849 radio station firms operated during that year. Of that number, 2,806 firms operated with annual receipts of less than $25 million per year, 17 with annual receipts between $25 million and $49,999,999, and 26 with annual receipts of $50 million or more. Therefore, based on the SBA's size standard the majority of such entities are small entities.

164. According to Commission staff review of the BIA/Kelsey, LLC's Media Access Pro Radio Database (BIA) as of January 26, 2021, nearly all AM and FM full-service radio stations (approximately 15,478 of 15,483 total stations, or 99.97%) had revenues of $41.5 million or less and thus qualify as small entities under the SBA definition. The SBA size standard data, however, does not enable a meaningful estimate of the number of small entities who may participate in Auction 109.

165. Also, in assessing whether a business entity qualifies as small under the SBA definition, business control affiliations must be included. This estimate therefore likely overstates the number of small entities that might be affected by this auction because the revenue figure on which it is based does not include or aggregate revenues from affiliated companies. Moreover, the definition of small business also requires that an entity not be dominant in its field of operation and that the entity be independently owned and operated. The estimate of small businesses to which Auction 109 competitive bidding procedures may apply does not exclude any radio station from the definition of a small business on these bases and is therefore over-inclusive to that extent. Furthermore, OEA and MB are unable at this time to define or quantify the criteria that would establish whether a specific radio station is dominant in its field of operation. It is difficult to assess these criteria in the context of media entities and therefore estimates of small businesses to which they apply may be over-inclusive to this extent.

166. OEA and MB are unable to accurately develop an estimate of how many of the entities in this auction would be small businesses based on the number of small entities that applied to participate in prior broadcast auctions because that information is not collected from applicants for broadcast auctions in which bidding credits are not based on an applicant's size (as is the case in auctions of licenses for wireless services).

167. In 2013, the Commission estimated that 97% of radio broadcasters met the SBA's prior definition of small business concern, based on annual revenues of $7 million. The SBA has since increased that revenue threshold to $41.5 million, which suggests that an even greater percentage of radio broadcasters would fall within the SBA's definition. The Commission has estimated the number of licensed commercial AM radio stations to be 4,347 and the number of commercial FM radio stations to be 6,699, for a total number of 11,046 radio stations. As of January 2021, 4,347 AM stations and 6,694 FM stations had revenues of $41.5 million or less, according to Commission staff review of the BIA Database. Accordingly, based on this data, OEA and MB that the majority of Auction 109 applicants would likely meet the SBA's definition of a small business concern.

168. Description of Projected Reporting, Recordkeeping, and Other Compliance Requirements for Small Entities. For Auction 109, no new reporting, recordkeeping, or other compliance requirements for small entities or other auction applicants were proposed. The Commission designed the auction application process itself to minimize reporting and compliance requirements for applicants, including small business applicants. For all spectrum auctions, in the first part of the Commission's two-phased auction application process, parties desiring to participate in an auction file streamlined, short-form applications in which they certify under penalty of perjury as to their qualifications. Eligibility to participate in bidding is based on an applicant's short-form application and certifications, as well as its upfront payment. In the second phase of the auction application process, there are additional compliance requirements for winning bidders. Thus, a small business that fails to become a winning bidder does not need to file a long-form application and provide the additional showings and more detailed demonstrations required of a winning bidder.

169. Auction 109 applicants, including small entities, will become qualified to bid in Auction 109 only if they comply with the following: (1) Submission of a short-form application that is timely and is found to be substantially complete, and (2) timely submission of a sufficient upfront payment for at least one of the construction permits that the applicant selected on its FCC Form 175. In accordance with the terms of 47 CFR 1.2105(b)(2), an applicant whose application is found to contain deficiencies will have a limited opportunity to bring its application into compliance with the Commission's competitive bidding rules during a resubmission window. In addition, each Auction 109 applicant must maintain the accuracy of its previously filed short-form application electronically using the FCC auction application system.

170. In the second phase of the process, there are additional compliance requirements only applicable to winning bidders. As with other winning bidders, any small entity that is a winning bidder will be required to comply with the terms of the following rules, among others: (1) 47 CFR 1.2107(b), by submitting as a down payment within 10 business days after release of the auction closing public notice sufficient funds (in addition to its upfront payment) to bring its total amount of money on deposit with the Commission for Auction 109 to 20% of the amount of its winning bid or bids; (2) 47 CFR 1.2109(a), by submitting within 10 business days after the down payment deadline the balance of the amount for each of its winning bids; and (3) 47 CFR 73.5005(a), by electronically filing a properly completed long-form application and required exhibits for each construction permit won through Auction 109.

171. Further, as required by 47 CFR 1.2105(c), reports concerning prohibited communications must be filed with the Chief of the Auctions Division, as detailed in the Auctions 109 Procedures Public Notice.

172. Steps Taken to Minimize the Significant Economic Impact on Small Entities, and Significant Alternatives Considered. The RFA requires an agency to describe any significant, specifically small business, alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities. See 5 U.S.C. 603(c)(1)-(4).

173. OEA and MB intend that the procedures adopted in the Auctions 109 Procedures Public Notice to facilitate participation in Auction 109 will result in both operational and administrative cost savings for small entities and other auction participants. In light of the numerous resources that will be available from the Commission to small entities and other auction participants at no cost, the processes and procedures announced in the Auctions 109 Procedures Public Notice should minimize any economic impact of the auction processes and procedures on small entities and should result in both operational and administrative cost savings for small entities and other auction participants. For example, prior to the beginning of bidding in this auction, the Commission will hold a mock auction to allow qualified bidders the opportunity to familiarize themselves with both the processes and systems that will be used in Auction 109. During the auction, participants will be able to access and participate in bidding via the internet using a web-based system, or telephonically, providing two cost-effective methods of participation and avoiding the cost of travel for in-person participation. Further, small entities as well as other auction participants will be able to avail themselves of a telephone hotline for assistance with auction processes and procedures as well as a technical support telephone hotline to assist with issues such as access to or navigation within the electronic FCC Form 175 and use of the FCC's auction bidding system. In addition, all auction participants, including small business entities, will have access to various other sources of information and databases through the Commission that will aid in both their understanding and participation in the process. These mechanisms are made available to facilitate participation by all qualified bidders and may result in significant cost savings for small business entities that utilize these mechanisms. These resources, coupled with the description and communication of the bidding procedures before bidding begins in Auction 109, should ensure that the auction will be administered predictably, efficiently and fairly, thus providing certainty for small entities as well as other auction participants.

174. Notice to SBA. The Commission will send a copy of the Auctions 109 Procedures Public Notice, including the Supplemental FRFA, to the Chief Counsel for Advocacy of the SBA.

The Migratory Bird Treaty Act of 1918 (MBTA, 16 U.S.C. 703 et seq. ) was enacted to conserve certain species of migratory birds and gives the Secretary of the Interior the authority to regulate the harvest of these birds. The law further authorizes the Secretary to issue regulations to ensure that the indigenous inhabitants of the State of Alaska may take migratory birds and collect their eggs for nutritional and other essential needs during seasons established by the Secretary “so as to provide for the preservation and maintenance of stocks of migratory birds” (16 U.S.C. 712(1)).

The take of migratory birds for subsistence uses in Alaska occurs during the spring and summer, during which timeframe the sport harvest of migratory birds is not allowed. Regulations governing the subsistence harvest of migratory birds in Alaska are located in title 50 of the Code of Federal Regulations (CFR) in part 92. These regulations allow for the continuation of customary and traditional subsistence uses of migratory birds and prescribe regional information on when and where the harvesting of birds in Alaska may occur.

The migratory bird subsistence harvest regulations are developed cooperatively by the Alaska Migratory Bird Co-Management Council (AMBCC or the Council), which consists of the U.S. Fish and Wildlife Service, the Alaska Department of Fish and Game (ADFG), and representatives of Alaska's Native population. The Council's primary purpose is to develop recommendations pertaining to the subsistence harvest of migratory birds.

This rule incorporates changes to the subsistence harvest regulations that were recommended by the Council in 2020 as described below. This rule also sets forth an updated list of migratory bird species open to subsistence harvest.

Per the collaborative process described above, we published a proposed rule to update the regulations for the taking of migratory birds for subsistence uses in Alaska during the spring and summer (86 FR 11707, February 26, 2021). By the end of the comment period on the proposed rule, we received five comments. While one comment pertained to an issue that is outside the scope of this rulemaking action, we hereby respond to the relevant issues that were raised in the public input. We made no changes to the proposed rule as a result of the input we received via the public comments (see Final Regulations, below, for more information).

Issue: One commenter expressed the following concerns: (i) Migratory bird populations cannot sustain hunting pressure; (ii) migratory birds are resources belonging to all residents of the United States; (iii) the proposed Kodiak Island Roaded Area permit hunt did not undergo sufficient public review; (iv) the Service's treatment of common and Wilson's snipe in Alaska is incorrect by conflating them together; and (v) the Service's enforcement of prohibitions on the use of lead shot to hunt waterfowl is insufficient.

Response: The Service conducts migratory bird population and harvest surveys to monitor potential effects of hunting on abundance, distribution, and trend; further, we use an adaptive harvest strategy to ensure harvest does not impact sustainable and healthy waterfowl populations. The Service agrees that migratory birds should be managed on a flyway or continental basis for the enjoyment of all U.S. residents.

The proposed 3-year experimental Kodiak Roaded Area Permit hunt underwent a rigorous review over a multiyear period involving Council, Flyway, and national public review periods. We explain the process establishing the experimental hunt in our May 11, 2020, proposed rule (85 FR 27698) in the preamble under “(5) Kodiak Archipelago Region Kodiak Island Roaded Area Closure,” and our response to comments on this topic is found in our November 17, 2020, final rule (85 FR 73233).

Snipe in Alaska are recognized primarily as Wilson's snipe, but common snipe are known to occur on the Aleutian Islands of Alaska. Thus, for administrative purposes, we clarify that snipe includes both recognized species in Alaska: Wilson's snipe and common snipe. The separation of these species in the list of migratory birds open to subsistence harvest will not result in differential harvest effects on either species.

The Service agrees with the commenter's concern about detrimental effects of lead shot on migratory birds. The nationwide ban on the use of lead shot for hunting waterfowl occurred in 1991. The Service's Office of Law Enforcement and law enforcement officers of the National Wildlife Refuge System work with State law enforcement personnel to check waterfowl hunters during the Alaska spring-summer subsistence and fall-winter seasons for use of nontoxic ammunition. The Service has also worked with vendors in rural Alaska to remove lead shot from being available and sold during the migratory bird hunting seasons.

Issue: A commenter recommended: (i) Support for establishing regulations to support the cultural and traditional importance of spring-summer subsistence harvest of migratory birds in Alaska; (ii) that important areas where protected species congregate be closed to hunting; and (iii) that closed areas of hunting could allow assessment of hunting mortality versus other forms of mortality. The commenter also inquired if violations of the MBTA are enforced by the Service.

Response: The Service appreciates support for the traditional, cultural, and nutritional benefits attained by the spring-summer harvest of migratory birds in rural Alaska. Breeding, staging, molting, and wintering habitats of protected species, including spectacled and Steller's eiders, are important to other hunted migratory birds; therefore, it is not possible to close specific areas to all hunting. The Service appreciates the comment regarding the need to understand sources of mortality and their respective impacts to population abundance and trends. However, the closure of a specific area to hunting will not allow a greater understanding of hunting as a source of mortality due to the migratory nature of most species. In regard to the comment if violations of the MBTA are enforced by the Service, to decrease risk of illegal harvest of protected species, the Service relies on public education and outreach to describe species closed to harvest. Please see page 28 of Regulations for the 2021 Alaska Subsistence Spring/Summer Migratory Bird Harvest (available in the docket on www.regulations.gov ) as an example of public outreach to protect threatened spectacled and Steller's eiders. The Service also monitors and enforces hunting regulations through its Office of Law Enforcement.

Issue: A commenter requested the Service protect migratory birds from hunting.

Response: The MBTA allows for the lawful and sustainable harvest of migratory birds per annual hunting regulations. Spring-summer subsistence and fall-winter hunting regulations are established each year, the impacts of which are monitored by annual population and harvest surveys.

Issue: A commenter expressed interest in and support for establishing State-specific migratory bird harvest regulations.

Response: The Service appreciates the commenter's support for establishing Alaska spring-summer migratory bird subsistence harvest regulations.

The proposed rule (86 FR 11707, February 26, 2021) set forth the same subsistence harvest regulations in subpart D, Annual Regulations Governing Subsistence Harvest, as those from the 2020 subsistence harvest seasons (see 85 FR 18455, April 2, 2020; 85 FR 27698, May 11, 2020; 85 FR 49601, August 14, 2020; and 85 FR 73233, November 17, 2020) with the following two exceptions and three clarifications from the 2020 seasons:

This change to the regulations in part 92, subpart A (general provisions) would add another method (a permit) to invite a hunter from an excluded area to participate in the spring-summer subsistence hunt in the Upper Copper River region.

Current regulations in 50 CFR 92.5(d) allow immediate family members (children, parents, grandparents, and siblings) living in excluded areas to participate in the customary spring-summer subsistence harvest of migratory birds in a village's subsistence area, if invited via letter by the respective Village Council, to assist permanent residents of the village in meeting their nutritional and other essential needs or for teaching cultural knowledge. A letter of invitation is sent to the hunter with a copy provided to the Executive Director of the Council, who then informs the Service's Alaska Regional Office of Law Enforcement within 2 business days. In addition to the letter of invitation, this new permit system adds another method to invite a hunter from an excluded area to participate in the spring-summer subsistence hunt in the Upper Copper River region. The permit will certify that the prospective hunter is an immediate family member as defined in 50 CFR 92.4 and is thereby authorized to assist family members in hunting migratory birds in the subsistence harvest area of the region.

To date, the Council Executive Director has received two letters of invitation to hunt in the State of Alaska since the last revision of 50 CFR 92.5(d) in 2014 (79 FR 19454, April 8, 2014). The letter of invitation requirement is viewed by the Upper Copper River Region as burdensome and administratively inefficient due in large part to high turnover in Tribal administrative staff. In the Upper Copper River Region, an invitation to hunt by permit is considered less onerous and a more practical approach for eligible hunters to invite participation by family members living in excluded areas. This regulatory revision adds the invitation by permit as an option for Tribal Councils or their authorized Tribal representatives in the Upper Copper River Region to administer the invitation to hunt in their subsistence harvest area. Invited hunters will be required to carry the permit while hunting as proof of eligibility. The permit will be valid for 2 years from the date of issuance. A list of permittees will be forwarded to the Council Executive Director, who will then forward the list to the Service's Alaska Regional Office of Law Enforcement.

This change to the regulations in subpart A is not anticipated to result in a significant increase in harvest of birds and eggs in the Upper Copper River Region because invited hunters are authorized only to assist in fulfilling the needs of immediate family members in villages or teaching cultural knowledge.

This change to the regulations in part 92, subpart C (general regulations governing the subsistence harvest general provisions) closes the harvest of emperor goose eggs statewide.

The abundance (index) of emperor geese (Anser canagicus) is estimated annually via the Service's (Alaska Region) Yukon-Kuskokwim Delta Coastal Zone (Coastal Zone) survey. This information is used to inform harvest management decisions for emperor geese based on harvest strategies in the Council Emperor Goose Management Plan (Plan) and the Pacific Flyway Council Management Plan. The harvest strategy in the Plan prescribes an open emperor geese subsistence season if the Coastal Zone index from the previous year is greater than 23,000 geese, and a closed season if the index is below 23,000 geese. If the Coastal Zone index is between 23,000 and 28,000 geese, the Council will consider implementing regulatory or nonregulatory conservation measures to help avoid a closed season in subsequent seasons. In 2019, the Coastal Zone index (26,585; 95% Confidence Limit = 24,161-29,008 geese) dropped below the 28,000-bird threshold that triggers consideration of conservation measures. For the 2020 spring-summer hunting season, the Council agreed to develop and distribute outreach and educational materials to help limit emperor goose harvest. The coronavirus pandemic forced the cancellation of the Coastal Zone survey in 2020. Consequently, no Coastal Zone index was available to inform regulatory decisions for the 2021 season.

The harvest strategy in the Plan does not include guidance on making regulatory decisions in the absence of previous year's survey data; thus, the Council's Emperor Goose Subcommittee convened on June 2, 2020, to consider available emperor goose population status information in the absence of the 2020 Coastal Zone index. Subcommittee members considered results from a number of approaches to infer emperor goose population status in 2020 including prediction from a demographic model (Osnas 2020). Results from the different approaches were in general agreement, and indicated that abundance of emperor geese in 2020 likely remains between the 23,000- and 28,000-population thresholds with low probability that abundance was below the closure threshold.

Because the predicted abundance of emperor geese remains between the population thresholds requiring consideration of conservation measures, the Council's Emperor Goose Subcommittee and Council recommended the emperor goose season remain open in 2021. This recommendation includes outreach and educational efforts and closure of emperor goose egg gathering in Alaska to help limit harvest of emperor geese, considering the uncertainty in emperor goose population status in 2020 and the desire to reduce the probability of having a closed season in the future. This regulatory change affects the list of subsistence migratory bird species in § 92.22, which is in subpart C.

Current regulations in 50 CFR 92.5(b)(1) define the geographic boundaries of the Central Interior Excluded Area but mistakenly fail to include the Fairbanks North Star Borough. In 2007, the Service enacted the ADFG's request to expand the Fairbanks North Star Borough Excluded Area (72 FR 18317 April 11, 2007). This regulatory change appears in 50 CFR 92.5(b)(3). The expanded Fairbanks North Star Borough Excluded Area was renamed the Central Interior Excluded Area, but the description of the area defined in 50 CFR 92.5(b)(3) failed to specifically include the Fairbanks North Star Borough. This rule clarifies this regulatory text by including the words “Fairbanks North Star Borough” in the description of the Central Interior Excluded Area.

In 2020, the Service approved a 3-year experimental season for migratory bird hunting and egg gathering by registration permit only within the Kodiak Island Roaded Area in the Kodiak Archipelago Region of Alaska, as recommended by the Council in 2019 (85 FR 73233, November 17, 2020). This regulatory change appears in 50 CFR 92.31. The Roaded Area was to remain closed to hunting and egg gathering for Arctic terns, Aleutian terns, mew gulls, and emperor geese. The regulation allows residents of the Kodiak Archipelago Region the opportunity to participate in subsistence hunting activities without the need for a boat in an area that otherwise restricts hunting to 500 feet offshore and offshore islands.

Initially, we and the Council expected that the 3-year experimental season would begin in 2020 and continue through 2022. In the supplementary information of the 2020 proposed and final rules, we associated those years (2020-2022) with the 3-year experimental season, although years were not specified in the regulations allowing the season. Delay in publishing the proposed and final rules in 2020 prevented the 3-year experimental season from beginning in 2020 as initially expected. Therefore, we clarify here that our intent remains the same—to allow a 3-year experimental season for migratory bird hunting and egg gathering by registration permit along the Kodiak Island Roaded Area in the Kodiak Archipelago Region of Alaska—but that this season is now expected to occur during the 2021-2023 subsistence seasons. The experimental season will terminate at the completion of the third year, now expected to be in 2023. Reopening the Roaded Area after the 3-year experimental period will require a subsequent proposal from the Council for continuation of the season under either operational or experimental status.

As described above, in 2020 the Service approved a 3-year experimental season for migratory bird hunting and egg gathering by registration permit within the Kodiak Island Roaded Area in the Kodiak Archipelago Region of Alaska, as recommended by the Council in 2019 (85 FR 73233, November 17, 2020). This regulatory change appears in 50 CFR 92.31. Prior to this change, the Kodiak Island Roaded Area was closed to hunting. Following approval of a hunt within the previously closed area, the current boundary description of the Kodiak Island Roaded Area in 50 CFR 92.31(e) includes the term “closed area.” We now clarify the language by replacing the words “closed area” with “Kodiak Island Roaded Area” in 50 CFR 92.31(e) and by improving the clarity of the boundary description.

On April 16, 2020, we published in the Federal Register (85 FR 21282) a revised List of Migratory Birds protected under the Migratory Bird Treaty Act (MBTA) by both adding to and removing species from the list, which appears in 50 CFR 10.13. Reasons for the changes to the list included adding species based on revised taxonomy and new evidence of natural occurrence in the United States or U.S. territories, removing species no longer known to occur within the United States or U.S. territories, and changing names to conform to accepted use. This rule went into effect on May 18, 2020. The revised List of Migratory Birds updated nomenclature (family or scientific name) for 17 species on the list of birds open to subsistence harvest (50 CFR 92.22) and separated Canada goose into two separate species: Cackling goose (Branta hutchinsii) and Canada goose (Branta canadensis) . Therefore, to be consistent with the taxonomy on the List of Migratory Birds, we are updating the taxonomy of the list of migratory birds open to subsistence harvest at 50 CFR 92.22 and correcting 11 typographical errors in species common names.

We are also taking this opportunity to reorganize the list of migratory birds open to subsistence harvest to follow the order of bird families as they appear in 50 CFR 10.13, and we are adding the common snipe ( Gallinago gallinago ) to the list of migratory birds open to subsistence harvest. On April 1, 2016, we published in the Federal Register (81 FR 18787) a revised list of migratory bird subsistence species in which we replaced the common snipe with Wilson's snipe ( Gallinago delicata ) to account for taxonomic changes; Wilson's snipe was previously considered a subspecies under common snipe. Snipe in Alaska are recognized primarily as Wilson's snipe, but common snipe are known to occur on the Aleutian Islands of Alaska. Thus, for administrative purposes, we clarify that snipe includes both recognized species in Alaska: Wilson's snipe and common snipe. Because, historically, common snipe applied to both species of snipe, the separation of these species in the list of migratory birds open to subsistence harvest will not result in differential harvest effects on either species.

We are making no changes to the regulatory revisions in our February 26, 2021 (86 FR 11707), proposed rule as a result of the input we received via the public comments.

The Service has dual objectives and responsibilities for authorizing a subsistence harvest while protecting migratory birds and endangered and threatened species. Although these objectives continue to be challenging, they are not irreconcilable, provided that: (1) Regulations continue to protect endangered and threatened species; (2) measures to address documented threats are implemented; and (3) the subsistence community and other conservation partners commit to working together.

Mortality, sickness, and poisoning from lead exposure have been documented in many waterfowl species. The Service will work with partners to increase our education, outreach, and enforcement efforts to ensure that subsistence waterfowl hunting is conducted using nontoxic shot.

We have monitored subsistence harvest for more than 25 years through the use of household surveys in the most heavily used subsistence harvest areas, such as the Yukon-Kuskokwim Delta. Based on our monitoring of the migratory bird species and populations taken for subsistence, we find that this rule will provide for the preservation and maintenance of migratory bird stocks as required by the MBTA. Communication and coordination between the Service, the Council, and the Pacific Flyway Council have allowed us to set harvest regulations to ensure the long-term viability of the migratory bird stocks.

Section 7 of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ) requires the Secretary of the Interior to review other programs administered by the Department of the Interior and utilize such programs in furtherance of the purposes of the ESA. The Secretary is further required to insure that any action authorized, funded, or carried out by the Department of the Interior is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of critical habitat.

Spectacled eiders (Somateria fischeri) and the Alaska-breeding population of Steller's eiders (Polysticta stelleri) are listed as threatened species under the ESA. Their migration and breeding distribution overlap with areas where the spring and summer migratory bird subsistence hunt is open in Alaska. Neither species is included in the list of subsistence migratory bird species at 50 CFR 92.22; therefore, both species are closed to subsistence harvest.

The Alaska Division of Migratory Bird Management conducted an intra-agency consultation with the Service's Anchorage Fish and Wildlife Field Office on the proposed rule (86 FR 11707, February 26, 2021). The consultation was completed with a biological opinion that concluded these rulemaking actions are not likely to jeopardize the continued existence of endangered or threatened species or result in the destruction or adverse modification of designated critical habitat. Therefore, we have determined that this rule complies with the ESA.

This rule takes effect on the date set forth above in DATES . Delaying the effective date for 30 days would have detrimental effects on Alaskans seeking to conduct subsistence harvest of migratory birds. To respect the subsistence hunt of many rural Alaskans, either for their cultural or religious exercise, sustenance, and/or materials for cultural use ( e.g., handicrafts), the Department of the Interior finds that it is in the public interest to make this rule effective as soon as possible. For these reasons, we find that “good cause” exists within the terms of 5 U.S.C. 553(d)(3) of the Administrative Procedure Act and under the authority of the Migratory Bird Treaty Act (July 3, 1918), as amended (16 U.S.C. 703 et seq. ), to make this rule take effect immediately upon publication in the Federal Register .

Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) 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 Department of the Interior certifies that this rule will not have a significant economic impact on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). A regulatory flexibility analysis is not required. Accordingly, a Small Entity Compliance Guide is not required. This rule would legalize a preexisting subsistence activity, and the resources harvested will be consumed.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

(a) Would not have an annual effect on the economy of $100 million or more. It legalizes and regulates a traditional subsistence activity. It will not result in a substantial increase in subsistence harvest or a significant change in harvesting patterns. The commodities that will be regulated under this rule are migratory birds. This rule deals with legalizing the subsistence harvest of migratory birds and, as such, does not involve commodities traded in the marketplace. A small economic benefit from this rule derives from the sale of equipment and ammunition to carry out subsistence hunting. Most, if not all, businesses that sell hunting equipment in rural Alaska qualify as small businesses. We have no reason to believe that this rule would lead to a disproportionate distribution of benefits.

(b) Would not cause a major increase in costs or prices for consumers; individual industries; Federal, State, or local government agencies; or geographic regions. This rule does not deal with traded commodities and, therefore, would not have an impact on prices for consumers.

(c) Would 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. This rule deals with the harvesting of wildlife for personal consumption. It would not regulate the marketplace in any way to generate substantial effects on the economy or the ability of businesses to compete.

We have determined and certified under the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ) that this rule will not impose a cost of $100 million or more in any given year on local, State, or Tribal governments or private entities. The rule would not have a significant or unique effect on State, local, or Tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act is not required.

Participation on regional management bodies and the Council requires travel expenses for some Alaska Native organizations and local governments. In addition, they assume some expenses related to coordinating involvement of village councils in the regulatory process. Total coordination and travel expenses for all Alaska Native organizations are estimated to be less than $300,000 per year. In a notice of decision (65 FR 16405, March 28, 2000), we identified 7 to 12 partner organizations (Alaska Native nonprofits and local governments) to administer the regional programs. The ADFG also incurs expenses for travel to Council and regional management body meetings. In addition, the State of Alaska is required to provide technical staff support to each of the regional management bodies and to the Council. Expenses for the State's involvement may exceed $100,000 per year, but should not exceed $150,000 per year. When funding permits, we make annual grant agreements available to the partner organizations and the ADFG to help offset their expenses.

Under the criteria in Executive Order 12630, this rule does not have significant takings implications. This rule is not specific to particular land ownership, but applies to the harvesting of migratory bird resources throughout Alaska. A takings implication assessment is not required.

Under the criteria in Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. We discuss effects of this rule on the State of Alaska in the Unfunded Mandates Reform Act section, above. We worked with the State of Alaska to develop these regulations. Therefore, a federalism summary impact statement is not required.

The Department, in promulgating this rule, has determined that it would not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of Executive Order 12988.

Consistent with Executive Order 13175 (65 FR 67249; November 6, 2000), “Consultation and Coordination with Indian Tribal Governments,” and Department of the Interior policy on Consultation with Indian Tribes (December 1, 2011), we consulted with Alaska Federally recognized Indian Tribes affected by these regulations to solicit their input.

We implemented the amended treaty with Canada with a focus on local involvement. The treaty calls for the creation of management bodies to ensure an effective and meaningful role for Alaska's indigenous inhabitants in the conservation of migratory birds. According to the Letter of Submittal, management bodies are to include Alaska Native, Federal, and State of Alaska representatives as equals. They develop recommendations for, among other things: Seasons and bag limits, methods and means of take, law enforcement policies, population and harvest monitoring, education programs, research and use of traditional knowledge, and habitat protection. The management bodies involve village councils to the maximum extent possible in all aspects of management. To ensure maximum input at the village level, we require each of the 11 participating regions to create regional management bodies consisting of at least one representative from the participating villages. The regional management bodies meet at least one time each year to review and/or submit proposals to the statewide body.

This rule contains existing, revised, and new information collections. All information collections require approval under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number. OMB has previously approved the information collection requirements associated with subsistence harvest reporting and assigned OMB Control Number 1018-0124. We will submit a revision to 1018-0124 to incorporate the new harvest reporting requirements contained in this rule. Additionally, we will request a new OMB control number for the permit and information letter requirements contained in this rule.

The existing information collection requirements identified below are currently approved by OMB under Control Number 1018-0124:

The harvest surveys collect information on the subsistence harvest in Alaska of ~60 species categories of birds and their eggs (geese, ducks, swans, crane, ptarmigan and grouse, seabirds, shorebirds, loons and grebes). Survey data includes species category and amounts of birds and eggs taken for subsistence use in each harvest season (spring, summer, fall, winter). The surveys rely on collaboration among the FWS, the ADFG, and many Alaska Native organizations. Contracts and cooperative agreements are in place to facilitate the collection of data with Alaska Native organizations and other regional and local partners. Surveyors contact local residents. The ADFG Division of Subsistence coordinates the surveys on behalf of the Council via a cooperative agreement with the FWS.

The FWS uses the survey data to:

(1) Inform harvest regulations for migratory birds and their eggs so they are consistent with the long-term sustainability of bird populations;

(2) Document subsistence harvest trends and track changes in harvest;

(3) Document the importance of birds as food and cultural resources for subsistence communities in Alaska;

(4) Protect sustainable harvest opportunities; and

(5) Assist in the development of management plans by State and Federal agencies.

Federal and State agencies use the data collected to develop harvest regulations and protect sustainable harvest opportunities. The FWS adjusts harvest regulations as needed to provide maximum and sustainable subsistence harvest opportunities while accounting for current bird population status and population goals established in species' management plans. The Council uses this information to make regulation recommendations to the Service Regulations Committee. Nongovernmental organizations use survey data to monitor the status of uses of migratory bird resources in Alaska and internationally. The survey also became a main line of communication between wildlife management agencies and the local communities and harvesters.

Participation in the surveys is voluntary for communities and households. In selected communities that agree to participate, surveyors compile a list of all permanent households or addresses, provide information about the survey, and assist households to complete the harvest report form (hardcopy) in in-person interviews. Households may offer comments on their harvest, on the availability of birds, on the survey, or any other topic related to bird harvest. The survey uses the following forms:

(1) Tracking Sheet & Household Consent (FWS Form 3-2380): The surveyor invites each selected household to participate and completes FWS Form 3-2380 documenting whether each selected household agreed to participate, did not agree, or could not be contacted. The surveyor also uses this form to keep track of survey work.

(2) Harvest Report (FWS Forms 3-2381-1, 3-2381-2, 3-2381-3, 3-2381-4, and 3-2381-5: The forms have up to four sheets, one for each surveyed season. The Western and Interior forms (3-2381-1 and 3-2381-3; ~394 households surveyed per year) have 3 sheets (spring, summer, and fall). The Bristol Bay form has 4 sheets (spring, summer, fall, winter; ~110 households surveyed per year). The North Slope form has 2 sheets (spring and summer; ~150 households surveyed per year). The Cordova form has only 1 sheet (spring; ~27 households surveyed per year). The weighted average for the whole survey is 2.96 seasonal sheets (rounded as 3 for calculation of burden estimates). Each seasonal sheet has drawings of bird species, next to which are fields to record the number of birds and eggs harvested. Because bird species available for harvest vary in different regions of Alaska, there are five versions of the harvest report form with different sets of species. This helps to prevent erroneously recording bird species as harvested in areas where they do not usually occur.

The revised and new information collection requirements identified below require approval by OMB in conjunction with the revision to OMB Control Number 1018-0124:

(1) Splitting burden estimates for 3-2381-5, Cordova survey (REVISED): We realized the previous submission to OMB incorrectly reported 3 submissions of the Cordova survey rather than a single submission for the spring season. We are separating the burden for this survey out separately from FWS Form 3-2381-1, Form 3-2381-2, Form 3-2381-3, and Form 3-2381-4 to more accurately report harvest data reporting burden.

(2) Harvest Report (FWS Forms 3-2381-6 (new) and 3-2381-7 (NEW): Starting in 2021, a mail survey akin to that conducted for the Cordova harvest will be implemented for the Kodiak roaded area harvest as required by updated Federal regulations for the Kodiak Archipelago region. To participate in the Kodiak roaded area harvest, harvesters are required to obtain a permit and to complete a harvest report form, even if they did not harvest. (We will request OMB approval of this permit requirement in a separate request for a new OMB control number explained below). Staff from the ADFG Division of Subsistence worked in close collaboration with the Sun'aq Tribe of Kodiak to develop the permit and harvest reporting system. The Sun'aq Tribe requested in-season harvest reporting. Permits will be issued by the Sun'aq Tribe.

The Kodiak Roaded Area In-Season Harvest Report (FWS Form 3-2381-6) will be provided to permit holders at the time the permit is issued. Harvesters are required to record their harvest using this form during the season. At the end of the season (early Sept.), all permit holders are required to submit the completed Kodiak Roaded Area In-Season Harvest Report (FWS Form 3-2381-7) indicating whether they harvested birds and eggs, and if so, the kinds and amounts of birds and eggs harvested. Permit holders submit the completed form by mail to the ADFG for data analysis (the form includes the return address and is postage-paid). To ensure a more complete harvest reporting, the ADFG will mail a post-season harvest survey to permit holders who did not submit a completed in-season harvest log. The post-season mail survey includes two reminders. Reported harvests will be extrapolated to represent all permit holders based on statistical methods. Forms 3-2381-6 and 3-2381-7 are only completed twice per year (spring and summer seasons).

Title of Collection: Alaska Migratory Bird Subsistence Harvest Household Surveys.

OMB Control Numbers: 1018-0124.

Form Numbers: FWS Form 3-2381-1, Form 3-2381-2, Form 3-2381-3, Form 3-2381-4, Form 3-2381-5, Form 3-2381-6 (New), and Form 3-2381-7 (New).

Type of Review: Revision to a previously approved information collection.

Respondents/Affected Public: Individuals and Tribal governments.

Total Estimated Number of Annual Respondents: 2,351.

Total Estimated Number of Annual Responses: 4,551.

Estimated Completion Time per Response: 5 minutes.

Total Estimated Number of Annual Burden Hours: 379.

Respondent's Obligation: Required to obtain or retain a benefit.

Frequency of Collection: On occasion.

Total Estimated Annual Nonhour Burden Cost: None.

The additional information collection requirements associated with permits and invitation letters contained in this rule identified below require approval by OMB and assignment of a new OMB control number:

(1) Tribal or Village Council Invitation Letter: Regulations at 50 CFR 92.5(d) allow immediate family members (children, parents, grandparents, and siblings) living in excluded areas to participate in the customary spring-summer subsistence harvest of migratory birds in a village's subsistence area. This letter of invitation is intended to assist permanent residents of the village in meeting their nutritional and other essential needs or for teaching cultural knowledge. The regulations specify that participation of residents of excluded areas in the spring-summer harvest of migratory birds in an eligible area must be pre-authorized by a letter of invitation issued by a local Tribal or Village Council within the harvest area.

(2) Tribal Council Invitation Permit : This rulemaking action establishes a permit as another method to invite an immediate family member residing in an excluded area to participate in the spring-summer subsistence hunt in the Upper Copper Region. The permit, issued by the Tribal Council or their authorized Tribal representative, certifies that the prospective hunter is an immediate family member as defined in 50 CFR 92.4 and is thereby authorized to assist family members in hunting migratory birds in the Upper Copper River Region. The permit is valid for 2 years from the date of issuance.

(3) Tribal Council Notifications to AMBCC: Tribal Councils will provide a list of permittees to the Executive Director of the AMBCC.

(4) AMBCC Notification to Alaska Regional Office of Law Enforcement: Upon receiving copies of the letters of invitation and issued permits from Tribal and Village Councils, the AMBCC Executive Director will inform the Service's Alaska Regional Office of Law Enforcement (AK-OLE) within 2 business days. To date, only two letters have been received.

(5) Kodiak Island Roaded Area Experimental Season Permit: The Service's 2020 final rule (RIN 1018-BF12, 85 FR 73233, November 17, 2020) approved a 3-year experimental season for migratory bird hunting and egg gathering in the Kodiak Island Roaded Area in the Kodiak Archipelago Region (50 CFR 92.31). Harvesting in the Kodiak roaded area requires a mandatory permit and harvest reporting. The Sun'aq Tribe of Kodiak worked in close collaboration with the ADFG Division of Subsistence to develop a permit and harvest monitoring system. Permits are issued by the Sun'aq Tribe of Kodiak to individual harvesters. The Sun'aq Tribe provide copies of issued permits to the ADFG Division of Subsistence, which uses this information to manage the harvest reporting system. The permit includes fields to write the permit holder's name and mailing address as well as a field for the permit holder to sign acknowledging the terms of the permit. The permit also includes a map of the harvest area and description of the harvest regulations including the list of species open to harvest. Permit data are securely disposed of after completion of the annual harvest data collection and analysis.

The regulation allows a 3-year experimental season (this rule updates the seasons from 2020-2022 to 2021-2023) for migratory bird hunting and egg gathering by registration permit along the Kodiak Island Roaded Area in the Kodiak Archipelago Region of Alaska. The experimental season will terminate at the completion of the third year in 2023. Reopening the Roaded Area after the 3-year experimental period will require a subsequent proposal for continuation of the season under either operational or experimental status.

(6) Cordova Harvest Household Registration: The Service's final rule that published on April 8, 2014 (79 FR 19454), authorized spring-summer harvest of migratory birds by residents of the community of Cordova in the Gulf of Alaska region. In 2017, the regulations were updated to allow residents of the neighboring communities of Tatitlek and Chenega to harvest in the area defined for the Cordova harvest (82 FR 16298, April 4, 2017). Local partners including the Eyak Tribe and the U.S. Forest Service Chugach Subsistence Program in Cordova worked in close collaboration with the ADFG Division of Subsistence to develop a household registration and harvest monitoring system using a post-season mail survey. Household registrations are issued by the Tribal councils of the communities of Cordova, Tatitlek, and Chenega as well as by the U.S. Forest Service Chugach Subsistence Program in Cordova. The registration form includes fields to write the permit holder's name and mailing address as well as a field for the permit holder to sign acknowledging the terms of the permit. The permit also includes fields to write the names of other household members authorized to harvest under the registration. Registration data are securely disposed of after completion of the annual harvest data collection and analysis.

Title of Collection: Regulations for the Taking of Migratory Birds for Subsistence Uses in Alaska, 50 CFR part 92.

OMB Control Numbers: 1018-0178.

Form Numbers: None.

Type of Review: New.

Respondents/Affected Public: Individuals and Tribal governments.

Total Estimated Number of Annual Respondents: 234.

Total Estimated Number of Annual Responses: 234.

Estimated Completion Time per Response: Varies from 15 minutes to 30 minutes, depending on activity.

Total Estimated Number of Annual Burden Hours: 62.

Respondent's Obligation: Required to obtain or retain a benefit.

Frequency of Collection: On occasion.

Total Estimated Annual Nonhour Burden Cost: None.

As part of our continuing effort to reduce paperwork and respondent burdens, we invite the public and other Federal agencies to comment on any aspect of this information collection, including:

(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;

(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;

(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and

(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of response.

This final rule is effective immediately upon publication, for the reasons set forth above under Immediate Effective Date. We will, however, accept and consider all public comments concerning the information collection requirements received in response to this final rule. Send your written comments and suggestions on this information collection to the Service Information Collection Clearance Officer, U.S. Fish and Wildlife Service, 5275 Leesburg Pike, MS: PRB (JAO/3W), Falls Church, VA 22041-3803 (mail); or Info_Coll@fws.gov (email). Please reference “OMB Control Number 1018-BF08” in the subject line of your comments. National Environmental Policy Act Consideration (42 U.S.C. 4321 et seq. )

Implementation of the Service's 2013 supplemental environmental impact statement on the hunting of migratory birds resulted in changes to the overall timing of the annual regulatory schedule for the establishment of migratory bird hunting regulations and the Alaska migratory bird subsistence harvest regulations. The programmatic document, “Second Final Supplemental Environmental Impact Statement: Issuance of Annual Regulations Permitting the Sport Hunting of Migratory Birds (EIS 20130139),” addresses compliance with the National Environmental Policy Act by the Service for issuance of the annual framework regulations for hunting of migratory game bird species. We published a notice of availability in the Federal Register on May 31, 2013 (78 FR 32686), and our Record of Decision on July 26, 2013 (78 FR 45376).

The annual regulations and options are considered in a January 2021 environmental assessment, “Managing Migratory Bird Subsistence Hunting in Alaska: Hunting Regulations for the 2021 Spring/Summer Harvest.” Copies are available from the person listed under FOR FURTHER INFORMATION CONTACT or at http://www.regulations.gov .

Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. This is not a significant regulatory action under this Executive Order; it allows only for traditional subsistence harvest and improves conservation of migratory birds by allowing effective regulation of this harvest. Further, this rule is not expected to significantly affect energy supplies, distribution, or use. Therefore, a Statement of Energy Effects is not required.

Osnas, E. 2020. A simple state space model framework to predict harvest management survey observations in 2020. USFWS, publ. analyses: https://github.com/USFWS/StateSpace-Prediction-2020 .

For the reasons set out in the preamble, we amend title 50, chapter I, subchapter G, of the Code of Federal Regulations as follows: