This Notice seeks input from stakeholders on upcoming standards development activities by AMS NOP, including feedback about specific recommendations from the NOSB. The NOP's mission is to protect the integrity of USDA organic products and the organic seal and to develop and grow the organic market by supporting organic farms, businesses, and those exploring the organic market. NOP develops the market and protects organic integrity by establishing clear standards that create a level playing field, providing oversight of third-party certifying agents, and enforcing the regulations. The NOSB is a Federal advisory committee established by the Organic Foods Production Act (OFPA). The NOSB's mission is “to assist in the development of standards for substances to be used in organic production and to advise the Secretary on any other aspects of the implementation of [OFPA].” (7 U.S.C. 6518(a))

The USDA is committed to transparently sharing the status, priorities, decision criteria, and current positions on NOSB recommendations. As such, in response to stakeholder interest in organic standards development and in the status of outstanding NOSB recommendations, AMS is hosting a listening session with request for public comment. AMS intends to use information received from public comments to guide the prioritization of organic standards development. Stakeholders that may be affected by future actions on this topic includes certified organic operations, certifying agents, operations transitioning (or seeking to transition) to organic, consumers, and other interested parties.

The listening session will be recorded, and a transcript will be posted following the session on the NOP website at https://www.ams.usda.gov/event/national-organic-program-priorities-listening-session.

Oral Comments: Individuals that want to present oral comments during the virtual listening session must pre-register by 11:59 p.m. ET, February 28, 2022. Each commenter will be allotted one 3-minute speaking slot during the virtual listening session. Instructions for registering to present oral comments can be found at https://www.ams.usda.gov/event/national-organic-program-priorities-listening-session.

Written Comments: Interested persons are invited to submit written comments on NOP rulemaking priorities and development activities. Written comments must be submitted on or before March 30, 2022, via http://www.regulations.gov. All written comments should reference the document number and the date and page number of this issue of the Federal Register . All comments submitted in response to this Notice will be included in the record and the identity of the individuals or entities submitting the comments will be made public on the internet at the address provided above. AMS, Specialty Crops Program, strongly prefers that comments be submitted electronically. However, written comments may also be submitted ( i.e., postmarked) via mail to the person listed in the FOR FURTHER INFORMATION CONTACT section by or before the deadline.

Meeting Accommodations: If you are a person requiring a reasonable accommodation, please make requests in advance for sign language interpretation or other reasonable accommodation to the person listed under FOR FURTHER INFORMATION CONTACT . Determinations for a reasonable accommodation will be made on a case-by-case basis.

The NOP's mission is to protect the integrity of USDA organic products and the organic seal. AMS protects organic integrity by establishing clear standards that create a level playing field and then enforcing those standards. AMS also develops and grows the organic market by supporting organic farms and businesses and those exploring the organic market. The program also oversees third-party certifying agents in their implementation of the organic standards with organic operations and develops training to support standards implementation and oversight.

AMS also supports the work of the NOSB, an Advisory Board with a mission to assist USDA in the development of standards for substances used in organic production and to advise the Secretary on other aspects of implementation of OFPA. The NOSB has specific statutory authorities with respect to the National List, found in the OFPA and the USDA organic regulations. The Board's activities include analyzing petitions, Technical Reports, and other documents to make recommendations for certain materials to be included in or excluded from the National List. Beyond its National List responsibilities, the Board also has and exercises authority to make recommendations on other topics related to organic agriculture and food production, including new standards, clarification of existing standards, or the role of organic in broader policy issues such as climate-smart agriculture or creating a more resilient and equitable agriculture system. Some of these work agenda topics are AMS-initiated (import oversight, human capital); others are proposed by NOSB members and approved by AMS. NOP and NOSB members collaborate to develop work plan items and meeting agendas.

For all of its work, the Board develops and reviews discussion papers and proposals, and also considers stakeholder input through oral and written comment. If a NOSB proposal passes with a “decisive vote” ( 2/3 of the vote), it becomes a recommendation to the USDA for consideration. An NOSB recommendation is not USDA policy. USDA reviews the recommendation to determine whether to advance it through the standards development process.

The NOSB and the NOP both operate under the authority of the OFPA, and standards developed by the program must align with OFPA provisions. In addition to the OFPA, the NOSB is also governed by the Federal Advisory Committee Act (FACA). The NOP establishes standards, including conducting rulemaking and developing policies, in accordance with the Administrative Procedure Act (APA), 5 U.S.C. 551 et seq., and the Office of Management and Budget (OMB) rules and policies. The NOSB and NOP evaluate policy using overlapping, but distinct regulatory criteria. For example, where the NOSB focuses on the OFPA criteria and stakeholder input to develop its proposals and recommendations, the NOP must also consider other factors including the regulatory impact, including costs and benefits, to regulated entities.

As of October 2021, the NOSB has made 678 recommendations to USDA AMS related to organic production and substances since the NOSB was first chartered in 1992. USDA AMS has reviewed and implemented 87 percent (592) of the Board's total recommendations and 80 percent of the NOSB's recommendations specific to practice (non-materials-related) standards. Not all recommendations have required rulemaking; AMS has implemented many NOSB recommendations through guidance, instructions and letters to certifiers, training, and policy statements.

AMS has a number of rulemaking priorities in progress. This section summarizes these rules; however, AMS is not accepting comments on these rules in this listening session. Rather, they are included here to provide the status of ongoing regulatory priorities. AMS will be accepting comments on these four rules once they are published in the Federal Register .

In August 2020, AMS published the Strengthening Organic Enforcement (SOE) proposed rule to strengthen the oversight and enforcement of organic control systems. This was needed to respond to the increasing complexity of organic supply chains and market growth. The proposed rule includes provisions related to handler certifications, import certificates, and certifier oversight. The proposed rule would implement the requirements from the 2018 Farm Bill, other provisions informed by program experience, and several recommendations from the NOSB, including:

• Calculating Percentage Organic in Multi-ingredient Products (April 2013);

• Establishing Criteria for Certification of Grower Groups (October 2002);

• Certifying Operations with Multiple Production Units, Sites and Facilities Under the National Organic Program (November 2008);

• Clarifying the Limitations of Uncertified Handlers under § 205.101(b) (October 2010);

• Strengthening Inspector Qualifications and Training (May 2018);

• Publishing Guidance on Unannounced Inspections (December 2011);

• Information on Certificates of Organic Operation (March 2005);

• Using Expiration Dates on Certificates of Organic Operation (November 2006); and

• Standardized Certificates (November 2007).

AMS has written the SOE final rule and it is under review. We expect the final rule to be published in 2022.

In 2015, the NOP published the Origin of Livestock (OOL) proposed rule to clarify requirements for the transition of dairy animals into organic production. The OOL rulemaking is to implement previous NOSB recommendations. The final rule has been written and, as of December 2021, was under review at the Office of Management and Budget (OMB).

The Organic Livestock and Poultry Practices (OLPP) final rule was originally published under Secretary Vilsack in 2017 and withdrawn under Secretary Perdue in 2018. A new proposed rule—Organic Livestock and Poultry Standards (OLPS)—has been written and, as of December 2021, was under review at OMB.

Materials and ingredients that support organic crop and livestock production and organic processors are vital for the day-to-day work of organic farms and businesses. In addition to periodic rules and notices (2-6 per year) to maintain and change the National List to respond to NOSB recommendations, AMS is finalizing an Advanced Notice of Proposed Rulemaking to address the use in organic production of “inert” substances, which is currently based on Environmental Protection Agency (EPA) regulatory reference lists that have expired. Future rulemaking is needed to update the National List to resolve the references to the expired EPA reference lists, to provide market certainty, and to maintain industry confidence in the National List process.

Standards development is one of many activities conducted by the NOP. The NOP is made up of six groups: Accreditation Division, Compliance and Enforcement Division, International Activities Division, Trade Systems Division, Standards Division, and the Office of the Deputy Administrator. The Accreditation Division and Compliance and Enforcement Division conducts audits of certifying agents and their satellite offices, prepares noncompliance and evaluates corrective actions; considers reinstatement requests from suspended operations; reviews certifier records and reports; investigates complaints; conducts surveillance of operations and regions or countries based on market growth and risk; conducts the program's livestock compliance program; conducts focused import oversight investigations; and develops and delivers training for certifiers and operations.

The International Activities Division monitors existing organic trade arrangements and leads technical negotiations for new arrangements. The Trade Systems Division is responsible for all technology development and data dashboard development for the program, including leading the development of the import certificate reporting system required by the 2018 Farm Bill. The team also leads the Interagency Organic Import Oversight Working Group. The Office of the Deputy Administrator houses the NOP appeals function, quality management, communications, Organic Integrity Learning Center development, the human capital initiative, special projects, and general customer service and organizational management.

The Standards Division develops organic rules and policies; provides technical and administrative support to the NOSB; and evaluates materials conflicts from certifiers. The Division also serves as USDA's authority on interpreting the organic standards and provides critical input to NOP and other USDA officials concerning USDA policy positions on organic production, handling, processing, and labeling.

AMS believes that the current structure of the Program appropriately supports the Program's mission. AMS invites public comments on this structure.

Experience has shown that organic rulemaking is most successful when it addresses the needs with the most cross-community support, when the economic benefits are clear, and when rulemaking resolves known market inconsistencies. Below, AMS outlines what it believes to be the current outstanding NOSB recommendations, focusing on practice standards. Some NOSB recommendations were passed very early in the life of the program, before there was an active NOP Standards Division. Some recommendations have been addressed through training, guidance, or instructions for certifiers. NOSB recommendations referenced above as being addressed by current rulemaking priorities are not repeated here.

NOP drafted a proposed rule that would establish organic apiculture standards during the Obama Administration; however, the rule was not published. AMS invites comments on whether to prioritize this rulemaking.

NOP drafted a proposed rule that would establish organic pet food product standards during the Obama Administration; however, the rule was not published. AMS invites comments on whether to prioritize this rulemaking.

NOP has completed preliminary research for this standards development work. Producers are currently certifying mushrooms under the organic crop standard. AMS invites comments on whether to prioritize this rulemaking.

NOP drafted a proposed rule that would establish organic aquaculture standards during the Obama Administration. The rule was placed on hold at the end of the Administration due to interagency concerns during OMB review; agencies with interest in the rule included the National Oceanic and Atmospheric Administration (NOAA), Small Business Administration (SBA), and Office of the United States Trade Representative (USTR). The rule would require interagency coordination to advance. The NOP currently permits the sale of organic aquaculture products that are certified under other government organic standards ( e.g., European Union). AMS invites comments on whether to prioritize this rulemaking.

The certification of hydroponic production systems as organic is currently allowed by AMS if the producer can demonstrate compliance with the USDA organic regulations; there are certified organic hydroponic operations in the U.S. at this time. While the NOSB recommended a rulemaking that would prohibit organic certification for those operations, AMS does not to intend to propose the prohibition of these production systems. However, AMS agrees that there are currently inconsistencies among certifiers with respect to the certification of greenhouses and container systems. AMS invites comments as to whether standards should be established for these specific production environments.

NOP has not made this recommendation a regulatory priority and believes it should continue to be a low regulatory priority, as there has not yet been a demonstrated need or justification for advancing this recommendation. There are no known situations where parasiticides have been used in a manner inconsistent with the National List, nor have certifiers reported having issues determining what is considered “emergency use.” AMS invites comments on this prioritization.

NOP has not made this recommendation a regulatory priority. Provisions within this recommendation appear to contradict the wild crop standard which allows product harvested from unmanaged land to be certified as organic. Before proceeding with this recommendation, NOP would like to see significant support by the organic industry and Congressional action may be needed. AMS invites comments on this prioritization, including whether increased utilization of existing USDA programs could help meet some of the goals of this recommendation.

NOP has not made this recommendation a regulatory priority because the Accredited Certifiers Association (ACA) has issued Best Practices documents for commercial availability that are currently in use among the industry. Certifiers have not communicated a strong need for this recommendation to move forward. AMS invites comments on this prioritization.

NOP has not made this recommendation a regulatory priority because NOP believes the recommendation is already addressed by USDA organic regulations for commercial availability related to seeds and planting stock. Therefore, additional rulemaking is not needed. The NOP has completed training on organic seed sourcing as a practical, high-impact step; the training is available in the Organic Integrity Learning Center. The ACA has also published a Best Practice Document for certifiers to increase consistency. AMS invites comments on this prioritization.

NOSB has made a number of recommendations related to genetic engineering and included methods. For example, “ Require Genetic Integrity for Transparency of Seed Grown on Organic Land—Instructions to Certifiers” (October 2019) and “Guidance of GMO Prevention Strategies” (October 2015) both recommend establishing thresholds for addressing the presence of genetic material contamination, with significant cost implications for testing and monitoring. The NOP has not prioritized these two recommendations given the significant implementation requirements and likely costs involved. AMS invites comments on this prioritization.

The NOSB has also recommended developing “Guidance for Determining which New Technologies are Considered Excluded Methods” (October 2019). NOP has not made this recommendation a priority because it believes the current definition of Excluded Methods in the USDA organic regulations is sufficiently broad to cover a large range of new technologies. Augmenting this regulatory definition with a long list of prohibited technologies may cause confusion and could lead to an implied “allowance by omission” for technologies not listed. We believe the intent of this recommendation could be achieved by communicating the program's position on excluded methods (that they are not allowed) more directly and investing resources into communicating with certifiers about NOP's expectations for oversight. AMS invites comments on this prioritization.

NOP has not made this recommendation a regulatory priority. This rulemaking would be very complex and would require a significant expansion of existing regulations. NOP has published two items: “Policy Memo: “Organic Personal Care/Cosmetics” and “Fact Sheet—Personal Care Products” that have allowed certifiers and operations to find a path to certification for these products within the existing rules and standards. Other private standards have been developed that are specific to organic cosmetic certification. Regulatory action in this area would require significant interagency cooperation and review, as it would need to harmonize with current Food and Drug Administration (FDA) regulations regarding ingredient statements on cosmetics and personal care products. AMS invites comments on this prioritization.

NOP has not made this recommendation a regulatory priority. There has not been a strong justification or demonstrated need for this rulemaking. The organic livestock industry is not large enough to support the development, testing, and deployment of non-genetically modified (GMO) vaccines. Rulemaking would involve adding the non-GMO commercial availability as an annotation to § 205.603(a)(4). AMS invites comments on this prioritization.

Along with the OFPA and the USDA organic regulations, the NOP Handbook, titled, The Program Handbook: Guidance and Instructions for Accredited Certifying Agents and Certified Operations provides those who own, manage, or certify organic operations with guidance, instructions, and policy memos that can assist them in complying with the USDA organic regulations. The Handbook is consistent with OMB's Bulletin on Agency Good Guidance Practices (GGPs) published January 25, 2007 (72 FR 3432-3440). The purpose of the OMB's GGPs is to help ensure that program guidance documents are developed with adequate public participation, are readily available to the public, and are not applied as binding requirements.

The NOP Handbook is an important tool for organic operations and for certifying agents. There are a number of guidance, instructions, and policy memos that are part of the NOP Handbook that will need to be updated as a result of SOE; several also need updates to align with current NOP policy ( e.g., label use-ups when certifiers exit the organic program; accreditation process updates based on NOP's increased staffing and capabilities; and references to conservation tools administered by other USDA agencies). AMS invites public comments with respect to which NOP Handbook documents need updates from the organic community's perspective.

AMS seeks comments on the prioritization of outstanding NOSB recommendations and NOP Handbook updates (specifically, comments on whether issues not currently included should be considered for regulatory action) as it considers future rulemaking and policy development activities. AMS welcomes input about whether current resources should be allocated in a different manner to support standards development, or other program priorities. Comments received in response to this notice will inform future regulatory and policy development activities.

On August 5, 2021, Commerce published the Preliminary Results of this review. 1 On November 2, 2021, Commerce extended the deadline for the final results of this review to no later than February 1, 2022. 2 Subsequently, on December 2, 2021, Commerce issued its post-preliminary analysis. 3 For a complete description of the events that followed the Preliminary Results, see the Issues and Decision Memorandum. 4

The merchandise covered by the Order is CTL plate. For a complete description of the scope of the Order, see the Issues and Decision Memorandum.

All issues raised in interested parties' briefs are addressed in the Issues and Decision Memorandum. A list of the issues addressed is attached to this notice at Appendix I. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

Based on our analysis of the case and rebuttal briefs and the evidence on the record, we made one change from the Preliminary Results and post-preliminary analysis. This change is explained in the Issues and Decision Memorandum.

As noted in the Preliminary Results, Commerce timely received a no-shipment certification from Hyundai Steel Company (Hyundai). We inquired with U.S. Customs and Border Protection (CBP) whether Hyundai had shipped merchandise to the United States during the POR, and CBP provided no evidence to contradict the claims of no shipment made by Hyundai. Accordingly, in the Preliminary Results, Commerce stated its intention to rescind the review with respect to Hyundai in the final results. No party commented on this aspect of the Preliminary Results. Because there is no evidence on the record to indicate that Hyundai had shipments of subject merchandise to the United States during the POR, we are rescinding the administrative review of Hyundai, pursuant to 19 CFR 351.213(d)(3). 6

The statute and Commerce's regulations do not directly address the establishment of rates to be applied to companies not selected for individual examination where Commerce limits in examination in an administrative review pursuant to section 777(A)(e)(2) of the Act. However, Commerce normally determines the rates for non-selected companies in reviews in a manner that is consistent with section 705(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation. We also note that section 777A(e)(2) of the Act provides that “the individual countervailable subsidy rates determined under subparagraph (A) shall be used to determine the all-others rate under section 705(c)(5) {of the Act}.” Section 705(c)(5)(A)(i) of the Act states that, in general, for companies not investigated, we will determine an all-others rate by using the weighted-average countervailable subsidy rates established for exporters and producers individually investigated, excluding zero and de minimis rates or any rates based solely on the facts available. Additionally, section 705(c)(5)(A)(ii) provides that when the countervailable subsidy rates established for all exporters and producers individually investigated are zero or de minimis rates, or based solely on facts available, Commerce may use any reasonable method to establish a rate for the companies not individually investigated, including averaging the weighted-average countervailable subsidy rates determined for the exporters and producers individually investigated.

In the final results of this review, we calculated a de minimis net countervailable subsidy rate for POSCO, the sole mandatory respondent. As a result, for the reasons discussed in the Issues and Decision Memorandum, we have determined that it is appropriate to assign to the companies subject to the review, but not selected for individual examination, the de minimis net countervailable subsidy rate calculated for POSCO in this review. For a list of the 40 companies for which a review was requested and not rescinded, and which were not selected as mandatory respondents or found to be cross-owned with a mandatory respondent, see Appendix II to this notice.

In accordance with 19 CFR 351.221(b)(5), we calculated an individual net countervailable subsidy rate for POSCO. Commerce determines that, during the POR, the net countervailable subsidy rates for the producers/exporters under review are as follows:

Commerce intends to disclose the calculations performed for these final results of review within five days of the date of publication of this notice in the Federal Register . 9

Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication). Because we have calculated a de minimis countervailable subsidy rate for the companies under review, we will instruct CBP to liquidate shipments of subject merchandise produced and/or exported by the companies listed above, entered, or withdrawn from warehouse for consumption, from January 1, 2019, through December 31, 2019, without regard to countervailing duties in accordance with 19 CFR 351.212(b)(2) and 19 CFR 351.106(c). For the company for which this review is rescinded, countervailing duties will be assessed at a rate equal to the cash deposit of estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption, during the period January 1, 2019, through December 31, 2019.

In accordance with section 751(a)(2)(C) of the Act, Commerce intends to instruct CBP to continue to suspend liquidation but not to collect cash deposits of estimated countervailing duties on shipments of subject merchandise by the companies under review entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review. For all non-reviewed firms subject to the Order, we will instruct CBP to continue to collect cash deposits of estimated countervailing duties at the most recent company-specific rate or the all-others rate (4.31 percent), as appropriate. 10 These cash deposit requirements, effective upon publication of these final results, shall remain in effect until further notice.

This notice also serves as a reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

We are issuing and publishing these final results in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.221(b)(5).

On April 17, 2018, Cambria Company LLC filed petitions seeking the imposition of AD and CVD duties on imports of QSP from China. 1 Following Commerce's affirmative determinations of dumping and countervailable subsidies, 2 and the U.S. International Trade Commission (ITC)'s finding of material injury, 3 Commerce issued the Orders. 4

The products covered by the Orders are certain QSP from China, whether finished or unfinished. Such products “consist of slabs and other surfaces created from a mixture of materials that includes predominately silica ( e.g., quartz, quartz powder, cristobalite) as well as a resin binder ( e.g., an unsaturated polyester). The incorporation of other materials, including, but not limited to, pigments, cement, or other additives does not remove the merchandise from the scope of the Orders. However, the scope of the Orders only includes products where the silica content is greater than any other single material, by actual weight.” For a full description of the scope of the Orders, see the “Scope of the Orders,” in the appendix to this notice.

Pursuant to 19 CFR 351.225(b), if Commerce “determines from available information that an inquiry is warranted to determine whether a product is covered by the scope of an order,” then Commerce “may initiate a scope inquiry and publish a notice of initiation in the Federal Register .”

Furthermore, section 351.226(b) of Commerce's regulations states that if Commerce “determines from available information that an inquiry is warranted into the question of whether the elements necessary for a circumvention determination under section 781 of the Act exist,” Commerce “may initiate a circumvention inquiry and publish a notice of initiation in the Federal Register .” Section 781(b)(1) of the Act provides that Commerce may find circumvention of an AD or CVD order when merchandise of the same class or kind subject to the order is completed or assembled in a foreign country other than the country to which the order applies. In conducting circumvention inquiries, under section 781(b)(1) of the Act, Commerce relies on the following criteria: (A) Merchandise imported into the United States is of the same class or kind as any merchandise produced in a foreign country that is the subject of an antidumping or countervailing duty order or finding, (B) before importation into the United States, such imported merchandise is completed or assembled in another foreign country from merchandise which is subject to the order or merchandise which is produced in the foreign country that is subject to the order, (C) the process of assembly or completion in the foreign country referred to in section (B) is minor or insignificant, (D) the value of the merchandise produced in the foreign country to which the AD or CVD order applies is a significant portion of the total value of the merchandise exported to the United States, and (E) the administering authority determines that action is appropriate to prevent evasion of such order or finding.

In determining whether or not the process of assembly or completion in a third country is minor or insignificant under section 781(b)(1)(C) of the Act, section 781(b)(2) of the Act directs Commerce to consider: (A) The level of investment in the foreign country, (B) the level of research and development in the foreign country, (C) the nature of the production process in the foreign country, (D) the extent of production facilities in the foreign country, and (E) whether or not the value of processing performed in the foreign country represents a small proportion of the value of the merchandise imported into the United States. However, no single factor, by itself, controls Commerce's determination of whether the process of assembly or completion in a third country is minor or insignificant. 5 Accordingly, it is Commerce's practice to evaluate each of these five factors as they exist in the third country, depending on the totality of the circumstances of the particular circumvention inquiry. 6

In addition, section 781(b)(3) of the Act sets forth additional factors to consider in determining whether to include merchandise assembled or completed in a third country within the scope of an antidumping and/or countervailing duty order. Specifically, Commerce shall take into account such factors as: (A) The pattern of trade, including sourcing patterns; (B) whether the manufacturer or exporter of the merchandise is affiliated with the person who, in the third country, uses the merchandise to complete or assemble the merchandise which is subsequently imported into the United States; and (C) whether imports of the merchandise into the third country have increased after the initiation of the investigation that resulted in the issuance of such order or finding.

As described below, Commerce is self-initiating concurrent scope and circumvention inquiries.

Commerce has placed information on the administrative record, as attachments to its Initiation Memo, that indicates that certain QSP or QSP inputs produced in China undergo further processing in Malaysia before being exported to the United States. 7 That QSP exported from Malaysia to the United States is the merchandise at issue in both the scope and circumvention inquiry initiations.

The scope covers merchandise which “has been finished, packaged, or otherwise fabricated in a third country, including by cutting, polishing, curing, edging, thermoforming, attaching to, or packaging with another product, or any other finishing, packaging, or fabrication that would not otherwise remove the merchandise from the scope of the orders if performed in the country of manufacture of the quartz surface products.” Accordingly, Commerce is self-initiating this scope inquiry to determine if QSP or QSP inputs produced in China and further processed in Malaysia before being exported to the United States meet this description. We are seeking to determine whether in-scope QSP or QSP inputs leave China and undergo minor processing in Malaysia before being exported to the United States. If the Chinese-origin, in-scope merchandise that undergoes minor processing in Malaysia results in merchandise that still corresponds to the description of in-scope merchandise outlined in the Orders, Commerce will find that the merchandise meeting the scope description is covered by the Orders. For those products for which Commerce finds that the merchandise is covered by the Orders, Commerce may rescind the circumvention inquiry, pursuant to 19 CFR 351.226(f)(6).

Based on available information, we also determine the initiation of a circumvention inquiry is warranted to determine whether certain imports of QSP, completed in Malaysia using certain QSP inputs manufactured in China, are circumventing the Orders. 8 Commerce has made this determination in accordance with its analysis of the factors set forth in section 781(b) of the Act and 19 CFR 351.226(i). 9

Commerce has determined that it is appropriate to first determine whether the merchandise is covered by the scope of the Orders through a scope inquiry, before considering whether the merchandise is circumventing the Orders. Accordingly, Commerce will initially conduct its scope inquiry of the merchandise at issue, and then once it has made a determination as to the scope coverage status of the merchandise, it will determine whether to continue with the circumvention inquiry. If Commerce determines QSP or QSP inputs leaving China that are not covered by the scope of the Orders undergo further processing in Malaysia and this further processing consequently results in the production of in-scope merchandise, this merchandise would be subject to the scope of the Orders. Under that scenario, Commerce may apply its scope determination, in accordance with 19 CFR 351.225(m)(1), on a producer-specific, exporter-specific, or importer-specific basis, or on country-wide basis, regardless of the producer, exporter or importer of the products being exported from Malaysia to the United States.

If Commerce determines that QSP or QSP inputs completed in Malaysia and exported to the United States are not covered by the scope of the Orders, in whole or in part, Commerce may then determine to immediately continue with the circumvention inquiry of that merchandise. If as a result of a circumvention inquiry Commerce determines that the products subject to the inquiry are circumventing the Orders, then in accordance with 19 CFR 351.226(m)(1), Commerce may apply its determination on a producer-specific, exporter-specific, or importer specific basis, or on a country-wide basis, regardless of the producer, exporter or importer of the products being exported from Malaysia to the United States.

Pursuant to 19 CFR 351.226(f)(7), Commerce may “alter or extend” time limits under the circumvention inquiry as necessary to make certain all parties to each or both segments of the proceeding are able to file comments and factual information, as necessary.

Pursuant to 19 CFR 351.225(l)(1), when Commerce self-initiates a scope inquiry under 19 CFR 351.225(b), Commerce will notify CBP of the initiation and direct CBP to continue the suspension of liquidation of entries of products subject to the scope inquiry that were already subject to the suspension of liquidation, and to apply the cash deposit rate that would be applicable if the product were determined to be covered by the scope of the order. Accordingly, Commerce will notify CBP of the initiation of the scope inquiry and direct CBP to continue to suspend (unliquidated) entries of the products subject to the scope inquiry that were already subject to the suspension of liquidation. In addition, Commerce will direct CBP to apply the cash deposit rate that would be applicable if the products were determined to be covered by the scope of the Orders.

Should Commerce issue preliminary or final scope rulings, Commerce will follow the suspension of liquidation rules under 19 CFR 351.225(l)(2)-(4). In the event that Commerce issues preliminary or final scope rulings that the products are covered by the scope of the Orders, Commerce will instruct CBP to continue the suspension of liquidation of previously suspended entries and to apply the applicable cash deposit rate. Commerce will also instruct CBP to begin the suspension of liquidation and application of cash deposits for any unliquidated entries not yet suspended, entered, or withdrawn from warehouse, for consumption, on or after the date of initiation of the scope inquiry pursuant to paragraphs (l)(2)(ii) and (l)(3)(ii). In addition, pursuant to paragraphs (l)(2)(iii)(A) and (l)(3)(iii)(A), Commerce normally will instruct CBP to begin the suspension of liquidation and application of cash deposits for any unliquidated entries not yet suspended, entered, or withdrawn from warehouse, for consumption, prior to the date of initiation of the scope inquiry, but not for such entries prior to November 4, 2021, the effective date of these provisions in the Final Rule. 10 These rules will not affect CBP's authority to take any additional action with respect to the suspension of liquidation or related measures for these entries, as stated in 19 CFR 351.225(l)(5).

Pursuant to 19 CFR 351.226(l)(1), when Commerce self-initiates a circumvention inquiry under 19 CFR 351.226(b), Commerce will notify CBP of the initiation and direct CBP to continue the suspension of liquidation of entries of products subject to the circumvention inquiry that were already subject to the suspension of liquidation, and to apply the cash deposit rate that would be applicable if the product were determined to be circumventing the order. Accordingly, Commerce will notify CBP of the initiation of the circumvention inquiry and direct CBP to continue to suspend (unliquidated) entries of the products subject to the circumvention inquiry that were already subject to the suspension of liquidation. In addition, Commerce will direct CBP to apply the cash deposit rate that would be applicable if the products were determined to be circumventing the Orders.

Should Commerce issue preliminary or final circumvention determinations, Commerce will follow the suspension of liquidation rules under 19 CFR 351.226(l)(2)-(4). In the event that Commerce issues affirmative preliminary or final circumvention determinations that the products are circumventing the Orders, Commerce will instruct CBP to continue the suspension of liquidation of previously suspended entries and to apply the applicable cash deposit rate. Commerce will also instruct CBP to begin the suspension of liquidation and application of cash deposits for any unliquidated entries not yet suspended, entered, or withdrawn from warehouse, for consumption, on or after the date of publication of the notice of initiation of the circumvention inquiry pursuant to paragraphs (l)(2)(ii) and (l)(3)(ii). In addition, pursuant to paragraphs (l)(2)(iii)(A) and (l)(3)(iii)(A), Commerce may instruct CBP to begin the suspension of liquidation and application of cash deposits for any unliquidated entries not yet suspended, entered, or withdrawn from warehouse, for consumption, prior to the date of initiation of the circumvention inquiry, but not for such entries prior to November 4, 2021, the effective date of these provisions in the Final Rule. 11 These rules will not affect CBP's authority to take any additional action with respect to the suspension of liquidation or related measures for these entries, as stated in 19 CFR 351.226(l)(5).

In accordance with sections 19 CFR 351.225(b) and 351.226(b), and 781(b) of the Act, Commerce determines that available information supports initiating both scope and circumvention inquiries to determine whether certain imports of QSP, completed in and exported from Malaysia using certain QSP inputs manufactured in China, are subject to or circumventing the Orders. Accordingly, Commerce is notifying all interested parties of the initiation of scope and circumvention inquiries. In addition, we have included a description of the products that are the subject of these inquiries, and an explanation of the reasons for Commerce's decision to initiate these inquiries as provided above and in the accompanying Initiation Memo. Pursuant to 19 CFR 351.225(e)(3) and 351.226(e)(3), due to the interrelated nature of the scope and circumvention inquiries, Commerce is aligning the deadlines for the scope inquiry with the circumvention inquiry and will conduct the scope inquiry first for the reasons explained above.

Pursuant to 19 CFR 351.225(f)(1), interested parties have until March 2, 2022, to submit one set of comments and factual information addressing the self-initiation of the scope inquiry. Under 19 CFR 351.225(l)(2)(iii)(B) and (l)(3)(iii)(B), interested parties may timely request that Commerce adopt an alternative date to begin the suspension of liquidation and application of cash deposits under paragraphs (l)(2)(ii)(A) and (l)(3)(iii)(A). A request for Commerce to adopt an alternative date must be based on a specific argument supported by evidence establishing the appropriateness of that alternative date. 12 If parties wish to make such a request, that request must be included with the set of comments and factual information submitted to Commerce pursuant to 19 CFR 351.225(f)(1).

Interested parties will then have until March 16, 2022 to submit comments and factual information to rebut, clarify, or correct factual information submitted by the other interested parties (including rebuttal in response to any requests made under 19 CFR 351.225(l)(2)(iii)(B) and (l)(3)(iii)(B)). At this time, we are not soliciting or accepting comments on the self-initiation of the circumvention inquiry. Should Commerce determine to proceed with the circumvention inquiry after finalizing its scope determination, Commerce will notify interested parties on the segment-specific service list of an opportunity to comment.

In accordance with section 19 CFR 351.225(e), unless the scope inquiry is rescinded, in whole or in part, Commerce intends to issue its final scope ruling within 120 days after the date on which the scope inquiry was initiated. Furthermore, in accordance with section 781(f) of the Act and 19 CFR 351.226(e)(2), unless the circumvention inquiry is rescinded, in whole or in part, Commerce intends to issue its final circumvention determination within 300 days from the date of publication of the notice of initiation of a circumvention inquiry in the Federal Register .

This notice is published in accordance with 19 CFR 351.225(b) and 351.226(b) and section 781(b) of the Act.

On August 6, 2021, Commerce published the preliminary results of the 2019-2020 administrative review of the antidumping duty order on certain steel nails from the UAE. 1 On November 30, 2021, Commerce extended the deadline for the final results by 60 days, until February 2, 2022. 2 A full description of the events since the Preliminary Results is contained in the Issues and Decision Memorandum. 3

Commerce conducted this review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act).

The products covered by this order are steel nails from the UAE. For a full description of the scope, see the Issues and Decision Memorandum.

In the Issues and Decision Memorandum, we address the sole issue raised in case and rebuttal briefs submitted by interested parties as reflected in the list of topics provided in the appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

Based on a review of the record and comments received from interested parties, and for the reasons explained in the Issues and Decision Memorandum, we made certain changes to the Preliminary Results.

Commerce determines that the following weighted-average dumping margins exist for the period May 1, 2019, through April 30, 2020.

Commerce intends to disclose to interested parties the calculations performed in connection with the final results within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of the notice of final results in the Federal Register , in accordance with 19 CFR 351.224(b).

Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise covered by this review. We calculated importer-specific ad valorem antidumping duty assessment rates based on the ratio of the total amount of antidumping duties calculated for the importer's examined sales to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). If an importer-specific assessment rate is de minimis ( i.e., less than 0.50 percent), Commerce will instruct CBP to liquidate that importer's entries of subject merchandise without regard to antidumping duties.

For entries of subject merchandise during the POR produced by Middle East Manufacturing Steel LLC and Rich Well Steel Industries LLC for which they did not know the merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate companies involved in the transaction. 4

Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rates for each company listed above will be equal to the weighted-average dumping margins established in the final results of this administrative review; (2) for merchandise exported by producers or exporters not covered in this review, but covered in a prior segment of this proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently-completed segment of this proceeding in which they were examined; (3) if the exporter is not a firm covered in this review, a prior review, or the original less-than-fair-value (LTFV) investigation but the producer is, then the cash deposit rate will be the rate established for the most recently-completed segment for the producer of the merchandise; and (4) the cash deposit rate for all other producers or exporters will continue to be 4.30 percent, the all-others rate established in the LTFV investigation. 5 These cash deposit requirements, when imposed, shall remain in effect until further notice.

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.

This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

We are issuing and publishing these results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(5).

This request is for extension of a currently approved information collection.

Marine recreational anglers are surveyed to collect catch and effort data, fish biology data, and angler socioeconomic characteristics. These data are required to carry out provisions of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq. ), as amended, regarding conservation and management of fishery resources.

Marine recreational fishing catch and effort data are collected through a combination of mail surveys, telephone surveys and on-site intercept surveys with recreational anglers. Amendments to the Magnuson-Stevens Fishery Conservation and Management Act (MSA) require the development of an improved data collection program for recreational fisheries. To partially meet these requirements, NOAA Fisheries designed and implemented a new Access-Point Angler Intercept Survey (APAIS) in 2013 to ensure better coverage and representation of recreational fishing activity.

The APAIS intercepts marine recreational fishers at public-access sites in coastal counties from Maine to Mississippi, Hawaii, and Puerto Rico to obtain information about the just-completed day's fishing activity. Respondents are asked about the time and type of fishing, the angler's avidity and residence location, and details of any catch of finfish. Species identification, number, and size are collected for any available landed catch. Data collected from the APAIS are used to estimate the catch per angler of recreational saltwater fishers. These APAIS estimates are combined with estimates derived from independent but complementary surveys of fishing effort, the Fishing Effort Survey and the For-Hire Survey, to estimate total, state-level fishing catch, by species, and participation. These estimates are used in the development, implementation, and monitoring of fishery management programs by the NMFS, regional fishery management councils, interstate marine fisheries commissions, and state fishery agencies.

Information will be collected through onsite in-person interviews.

OMB Control Number: 0648-0659.

Form Number(s): None.

Type of Review: Regular submission (extension of a current information collection).

Affected Public: Individuals or households.

Estimated Number of Respondents: 100,000.

Estimated Time per Response: 5 minutes for intercepted anglers.

Estimated Total Annual Burden Hours: 8,333.

Estimated Total Annual Cost to Public: $0 in recordkeeping/reporting costs.

Respondent's Obligation: Voluntary.

Legal Authority: Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq. ).

We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

In 2014, NOAA issued a final rule establishing the sanctuary nomination process (SNP), a process by which communities may submit nominations of areas of the marine and Great Lakes environment for NOAA to consider for designation as a national marine sanctuary (79 FR 33851). The final rule establishing the SNP included a five-year limit on any nomination added to the inventory that NOAA does not advance for designation. The nomination for St. George Unangan Heritage NMS was accepted to the national inventory on January 27, 2017, and was scheduled to expire in January 2022.

In November 2019, NOAA issued a notice (84 FR 61546) to clarify procedures for evaluating and updating a nomination as it approaches the five-year mark on the inventory of areas that could be considered for national marine sanctuary designation. This notice explained that if a nomination remains responsive to the 11 evaluation criteria for inclusion on the inventory, it may be appropriate to allow the nomination to remain on the inventory for another five years. The notice also established a process for NOAA to consider the continuing viability of nominations nearing the five-year expiration mark. The 11 evaluation criteria can be found at https://nominate.noaa.gov.

On November 17, 2021, NOAA issued a request for public comments on this nomination (86 FR 64190). NOAA requested relevant information pertaining to the 11 evaluation criteria that NOAA applied to evaluate the St. George Unangan Heritage NMS nomination for inclusion in the national inventory of areas that NOAA may consider for future designation as a national marine sanctuary. During the comment period, 32 public comments were received, and the nominator provided additional information as well, which NOAA has used in evaluating the nomination. Comments can be found at regulations.gov (search for Docket Number NOAA-NOS-2021-0094). In analyzing this material, particular attention was given to new scientific information about the national significance of natural and cultural resources, as well as increases or decreases in the threats to resources originally proposed for protection, and changes to the management framework of the area. NOAA also assessed the level of community-based support for the nomination from a broad range of interests.

Following NOAA's review of information provided regarding the nomination's merit for remaining on the inventory after five years, it was determined that new information shows: There are still significant threats to the area; it is still an area of national significance; and, there is still broad community support for the nomination remaining on the inventory of possible designations, among other criteria that the nomination still continues to meet. Therefore, the ONMS Director has determined the nomination for the St. George Unangan Heritage NMS should remain on the inventory. NOAA is not proposing to designate St. George Unangan Heritage NMS or any other new national marine sanctuary with this action. This notice serves to inform the public of this decision to extend the nomination on the inventory.

Authority: 16 U.S.C. 1431 et seq.

Title of Collection: Certification of Vaccination.

OMB Control Number: 3170-0075.

Type of Review: Extension of a currently approved information collection.

Affected Public: Individuals.

Estimated Number of Respondents: 1,500.

Estimated Total Annual Burden Hours: 125.

Abstract: This information collection ( i.e., the Certification of Vaccination form) will ascertain individuals' vaccination statuses to the Bureau to comply with Executive Order 13991 titled “Protecting the Federal Workforce and Requiring Mask-Wearing.” In compliance with guidance from the Centers for Disease Control and Prevention (CDC) and the Safer Federal Workforce Task Force, the Bureau is collecting this information from fully vaccinated individuals so that they can comply with Bureau safety guidelines. The Bureau is also collecting this information from partially or unvaccinated individuals so that that other measures can be implemented to enforce Bureau safety guidelines ( e.g., wearing masks, physical/social distancing, regular testing, adherence to applicable travel requirements). The Bureau collects these data to promote the safety of Federal buildings, the Federal workforce, and others on site at agency facilities consistent with the COVID-19 Workplace Safety: Agency Model Safety Principles established by the Safer Federal Workforce Task Force and guidance from the CDC and the Occupational Safety and Health Administration. Specifically, Bureau staff will use these data for implementing and enforcing workplace safety protocols.

Request for Comments: The Bureau is publishing this notice and soliciting comments on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be submitted to OMB as part of its review of this request. All comments will become a matter of public record.

The OMB is particularly interested in comments which:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions;

• Propose ways to enhance the quality, utility, and clarity of the information to be collected; and

• Propose ways to 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.

A 60-day Notice requesting public comment was published in the Federal Register on December 2, 2021 at Vol. 86 FR 68487. This comment period ended January 31, 2022. Zero (0) public comments were received from this Notice.

Title of Collection: AmeriCorps Member Application, Enrollment and Exit Form.

OMB Control Number: 3045-0054. Type of Review: Renewal.

Respondents/Affected Public: Businesses and Organizations and State, Local or Tribal Governments.

Total Estimated Number of Annual Responses: 521,000.

Total Estimated Number of Annual Burden Hours: 386,833.

Abstract: AmeriCorps is soliciting comments concerning its proposed new AmeriCorps Member Application, Enrollment, and Exit Form. Applicants will respond to the questions included in this information collection tool to apply to serve as AmeriCorps members, enroll in the National Service Trust, and exit their term of service. AmeriCorps also seeks to continue using a currently approved information collection until the new information collection is approved by OMB. The currently approved information collections are due to expire on February 28, 2022 and July 31, 2024.

This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) (5 U.S.C., Appendix), the Government in the Sunshine Act (5 U.S.C. 552b), and 41 CFR 102-3.140 and 102-3.150.

Purpose of the Meeting: The mission of the Board is to examine and advise the Secretary of Defense on overall DoD management and governance. The Board provides independent advice reflecting an outside private sector perspective on proven and effective best business practices that can be applied to DoD.

Agenda: The Board meeting will begin February 22, 2022 at 11:00 a.m. Eastern time with opening remarks by Jennifer Hill, the Designated Federal Officer. The Board will then receive remarks by the Board Chair. The Board will then receive a presentation on the DBB Assessment of DoD Mentor Protégé Program. The Board members will deliberate and vote on the proposed findings, observations, and recommendations from the study. If time permits, the Chair may receive comments from the public. The meeting will conclude with closing remarks by the Board Chair and Designated Federal Officer. The latest version of the agenda will be available upon publication of the Federal Register on the Board's website at: https://dbb.defense.gov/Meetings/Meeting-February22-2022/.

Meeting Accessibility: Pursuant to the FACA and 41 CFR 102-3.140, the meeting on February 22, 2022 from 11:00 a.m. to 1:00 p.m. is open to the public. Persons desiring to participate in the public session are required to register. Public attendance will be by teleconference only. To attend the public session, submit your name, affiliation/organization, telephone number, and email contact information to the Board at osd.pentagon.odam.mbx.defense-business-board@mail.mil.

Requests to attend the public meeting must be received no later than 3:00 p.m. Eastern time, on Friday, February 18, 2022. Upon receipt of this information, a teleconference line number will be sent to the email address provided which will allow teleconference attendance to the event. (The DBB will be unable to provide technical assistance to any user experiencing technical difficulties during the meeting.)

Written Comments and Statements: Pursuant to 41 CFR 102-3.105(j) and 102-3.140 and section 10(a)(3) of the FACA, the public or interested organizations may submit written comments or statements to the Board in response to the stated agenda of the meeting or in regard to the Board's mission in general. Written comments or statements should be submitted to Ms. Jennifer Hill, the Designated Federal Officer, via electronic mail (the preferred mode of submission) at the address listed in the FOR FURTHER INFORMATION CONTACT section. Each page of the comment or statement must include the author's name, title or affiliation, address, and daytime phone number. The Designated Federal Officer must receive written comments or statements being submitted in response to the agenda set forth in this notice by February 15, 2022 to be considered by the Board. The Designated Federal Officer will review all timely submitted written comments or statements with the Board Chair, and ensure the comments are provided to all members of the Board before the meeting. Written comments or statements received after this date may not be provided to the Board until its next scheduled meeting. Pursuant to 41 CFR 102-3.140d, the Board is not obligated to allow any member of the public to speak or otherwise address the Board during the meeting. Members of the public will be permitted to make verbal comments during the meeting only at the time and in the manner described below. If a member of the public is interested in making a verbal comment at the meeting, that individual must submit a request, with a brief statement of the subject matter to be addressed by the comment, at least three (3) business days in advance to the Designated Federal Officer, via electronic mail (the preferred mode of submission) at the addresses listed in the FOR FURTHER INFORMATION CONTACT section. The Designated Federal Officer will log each request, in the order received, and in consultation with the Board Chair determine whether the subject matter of each comment is relevant to the Board's mission and/or the topics to be addressed in the public meeting. Members of the public who have requested to make a comment and whose comments have been deemed relevant under the process described above will be invited to speak in the order in which the Designated Federal Officer received their requests. The Board Chair may allot a specific amount of time for comments. Please note that all submitted comments and statements will be treated as public documents and will be made available for public inspection, including, but not limited to, being posted on the Board's website.

Title; Associated Form; and OMB Number: Non-combatant Tracking System and Evacuation Tracking and Accountability System; OMB Control Number 0704-NCTS.

Type of Request: New.

Number of Respondents: 50,000.

Responses per Respondent: 1.

Annual Responses: 50,000.

Average Burden per Response: 5 minutes.

Annual Burden Hours: 4,167 hours.

Needs and Uses: This information collection is necessary to document the movement of an evacuee from a foreign country to an announced safe haven and to assist the evacuee in meeting their needs. In addition, this information collection is needed to ensure that federal and state agencies receive the proper reimbursement for costs incurred during these expensive operations. The primary purpose of this information collection is personnel accountability of evacuees who have been repatriated through designated processing sites. By identifying what services have been provided to respective evacuees during initial processing and where they have gone, federal agencies may ensure that their personnel receive safe haven entitlements and notification of change in status.

Affected Public: Individuals or households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Jasmeet Seehra.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DoD Clearance Officer: Ms. Angela Duncan.

Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Title; Associated Form; and OMB Number: Enlisted Retention and Promotion Barrier Analysis; OMB Control Number 0704-ERPB.

Needs and Uses: The Fiscal Year 2021 National Defense Authorization Act (NDAA) (Section 551) requires DoD to conduct a barrier analysis to review demographic diversity patterns across the military life cycle, starting with enlistment or accession into the Armed Forces in order to: (i) Identify barriers to increasing diversity; (ii) develop and implement plans and processes to resolve or eliminate any barriers to diversity; and (iii) review the progress of the Armed Forces in implementing previous plans and processes to resolve or eliminate barriers to diversity. DoD's Office for Diversity, Equity, and Inclusion will carry out the NDAA requirement by completing the information collection ( i.e., Enlisted Retention and Promotion Barrier Analysis Study). Additionally, the DoD Board on Diversity and Inclusion, in its December 2020 report, recommended DoD address barriers confronted by minority members in the workplace.

Affected Public: Individuals or households.

Annual Burden Hours: 499 hours.

Number of Respondents: 340.

Responses per Respondent: 1.

Annual Responses: 340.

Average Burden per Response: 88 minutes.

Frequency: On occasion.

Title; Associated Form; and OMB Number: Military OneSource Case Management System—Intake; OMB Control Number 0704-0528.

Type of Request: Revision.

Number of Respondents: 219,723.

Responses per Respondent: 1.

Annual Responses: 219,723.

Average Burden per Response: 1 hour.

Annual Burden Hours: 219,723 hours.

Needs and Uses: The Military OneSource program fulfills the requirement established in 10 U.S.C. 1781 “Establishment of Online Resources to provide Information About Benefits and Services Available to Members of the Armed Forces and Their Families”, and establishes an internet outreach website for the purpose of providing comprehensive information to members of the Armed Forces and their families about the benefits and services available to them. The Military OneSource Business Operations Information System drives the technological capabilities that deliver the full ecosystem of Military OneSource web-based services and capabilities that supports service members and families throughout their military life.

Affected Public: Individuals or households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Jasmeet Seehra.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DoD Clearance Officer: Ms. Angela Duncan.

Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Application for Grants under the Upward Bound Math and Science Program.

OMB Control Number: 1840-0824.

Type of Review: Reinstatement with change of a previously approved collection.

Respondents/Affected Public: State, Local, and Tribal Governments; Private Sector.

Total Estimated Number of Annual Responses: 620.

Total Estimated Number of Annual Burden Hours: 20,440.

Abstract: The Department of Education is requesting a reinstatement with change of the application for grants under the Upward Bound Math and Science (UBMS) Program. The Department is requesting a reinstatement with change because the previous UBMS application expired in December 2019 and the application will be needed for a Fiscal Year (FY) 2022 competition for new awards. The Department expects an increase in respondents for the FY 2022 competition. The FY 2022 application incorporates three competitive preference priorities.

This collection is being submitted under the Streamlined Clearance Process for Discretionary Grant Information Collections (1894-0001). Therefore, the 30-day public comment period notice will be the only public comment notice published for this information collection.

On December 16, 2021, we published in the Federal Register the Eligibility NIA (86 FR 71470). Under the Eligibility NIA, applications were due on January 21, 2022. This notice reopens the deadline for transmittal of applications until February 18, 2022. All other requirements and conditions in the notice remain the same.

Accessible Format: On request to the program contact person listed under FOR FURTHER INFORMATION CONTACT , individuals with disabilities can obtain this document and a copy of the application package in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, braille, large print, audiotape, or compact disc, or other accessible format.

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

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

Title: FERC-519, Application under Federal Power Act Section 203. 1

OMB Control No.: 1902-0082.

Type of Request: Three-year extension of the FERC-519 information collection requirements with no changes to the current reporting requirements. The Commission issued a 60-day notice on November 15, 2021 (86 FR 63010) requesting public comments; no comments were received.

Abstract: The Commission requires that public utility officers must seek authorization under amended section 203(a)(1)(B) of the Federal Power Act (FPA) to merge or consolidate, directly or indirectly, its facilities subject to the jurisdiction of the Commission, or any part thereof, with the facilities of any other person, or any part thereof, that are subject to the jurisdiction of the Commission and have a value in excess of $10 million, by any means whatsoever. In addition, as required by the Act, the Commission establishes a requirement to submit a notification filing for mergers or consolidations by a public utility if the facilities to be acquired have a value in excess of $1 million and such public utility is not required to secure Commission authorization under amended section 203(a)(1)(B). The information collected under the FERC-519 enables the Commission to meet its statutory responsibilities regarding public utility disposition, merger, consolidation of facilities, purchase, or acquisition oversight and enforcement in accordance with the FPA as referenced above. The required information includes descriptions of corporate attributes of the party or parties to the proposed transaction ( e.g., a sale, lease, or other disposition, merger, or consolidation of facilities, or purchase of other acquisition of the securities of a public utility and the facilities or other property involved in the transaction), statements about effect of the transaction, and the applicant's proof that the transaction will be consistent with the public interest. It will enable the Commission to meet its statutory responsibilities regarding its FPA section 203 oversight of public utility dispositions, mergers, or consolidation of facilities, and associated oversight and enforcement responsibilities under the FPA as referenced above. The required information to be collected in the notification filing (established by the addition of 18 CFR part 33.12) for certain transactions includes descriptions of corporate attributes of the party or parties to the transaction and the facilities involved. FPA section 203 requires a filing on the occasion that a public utility proposes to dispose of jurisdictional facilities, merge such facilities, or acquire the securities of another public utility. Public Utilities consist of:

• Corporate;

• Information Technology Management;

• General Accounting;

• Personnel and Payroll;

• Transportation;

• Tariffs and Rates;

• Insurance;

• Operations and Maintenance;

• Plant and Depreciation;

• Purchase and Stores;

• Revenue Accounting and Collection;

• Tax;

• Treasury; and

• Miscellaneous.

Type of Respondents: Public utility officers regulated by the FPA.

Estimate of Annual Burden:   2 The Commission estimates the total annual burden and cost  3 for this information collection as follows:

OMB Control Number: 3060-0718.

Title: Part 101 Rule Sections Governing the Terrestrial Microwave Fixed Radio Service.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities, not-for-profit institutions, and state, local, or tribal government.

Number of Respondents: 9,500 respondents; 33,914 responses.

Estimated Time per Response: 0.25-2.85 hours.

Frequency of Response: On occasion and every 10 year reporting requirements, third party disclosure requirement, and recordkeeping requirement.

Obligation to Respond: Required to obtain or retain benefits or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 151, 154(i), 301, 303(f), 303(g), 303(r), 307, 308, 309, 310, and 316.

Total Annual Burden: 39,096 hours.

Total Annual Cost: $3,884,100.

Needs and Uses: The Commission will submit this information collection to the Office of Management and Budget for a three-year extension of OMB Control Number 3060-0718. Part 101 rule sections require respondents to report or disclose information to the Commission or third parties, respectively, and to maintain records. These requirements are necessary for the Commission staff to carry out its duties to determine technical, legal and other qualifications of applicants to operate and remain licensed to operate a station(s) in the common carrier and/or private fixed microwave services. In addition, the information is used to determine whether the public interest, convenience, and necessity are being served as required by 47 U.S.C. 309 and to ensure that applicants and licenses comply with ownership and transfer restrictions imposed by 47 US.C. 310. Without this information, the Commission would not be able to carry out its statutory responsibilities.

OMB Control Number: 3060-0084.

Title: Ownership Report for Noncommercial Educational Broadcast Stations, FCC Form 323-E; Section 73.3615, Ownership Reports.

Form Number: FCC Form 323-E.

Type of Review: Extension of a currently approved collection.

Respondents: Not-for-profit institutions.

Number of Respondents: 2,636 respondents; 2,636 responses.

Estimated Time per Response: 1 to 1.5 hours.

Frequency of Response: On occasion reporting requirement; biennial reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for these collections are contained in 47 U.S.C. 151, 152(a), 154(i), 257, 303(r), 307, 308, 309, and 310.

Total Annual Burden: 3,867 hours.

Total Annual Cost: $2,319,900.

Needs and Uses: Licensees of noncommercial educational AM, FM, and television broadcast stations must file FCC Form 323-E every two years. Biennial Ownership Reports shall provide information accurate as of October 1 of the year in which the Report is filed. Form 323-E shall be filed by December 1 in all odd-numbered years.

In addition, Licensees and Permittees of noncommercial educational AM, FM, and television broadcast stations must file Form 323-E following the consummation of a transfer of control or an assignment of a noncommercial educational AM, FM, or television broadcast station license or construction permit; a Permittee of a new noncommercial educational AM, FM, or television broadcast station must file Form 323-E within 30 days after the grant of the construction permit; and a Permittee of a new noncommercial educational AM, FM, or television broadcast station must file Form 323-E to update the initial report or to certify the continuing accuracy and completeness of the previously filed report on the date that the Permittee applies for a license to cover the construction permit.

In the case of organizational structures that include holding companies or other forms of indirect ownership, a separate Form 323-E must be filed for each entity in the organizational structure that has an attributable interest in the Licensee or Permittee.

OMB Control Number: 3060-0995.

Title: Section 1.2105(c), Bidding Application and Certification Procedures; Sections 1.2105(c) and 1.2205, Prohibition of Certain Communications.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

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

Estimated Number of Respondents and Responses: 10 respondents and 10 responses.

Estimated Time per Response: 1.5 hours to 2 hours.

Frequency of Response: On occasion reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in sections 154(i), 309(j), and 1452(a)(3) of the Communications Act, as amended, 47 U.S.C. 4(i), 309(j)(5), 1452(a)(3), and sections 1.2105(c) and 1.2205 of the Commission's rules, 47 CFR 1.2105(c), 1.2205.

Estimated Total Annual Burden: 50 hours.

Total Annual Costs: $9,000.

Needs and Uses: A request for extension of this information collection (no change in requirements) will be submitted to the Office of Management and Budget (OMB) after this 60-day comment period in order to obtain the full three year clearance from OMB.

The Commission's rules prohibiting certain communications in Commission auctions are designed to reinforce existing antitrust laws, facilitate detection of collusive conduct, and deter anticompetitive behavior, without being so strict as to discourage pro-competitive arrangements between auction participants. They also help assure participants that the auction process will be fair and objective, and not subject to collusion. The information collected under this information collection allows the Commission to enforce the prohibition on auction applicants and other covered parties by making clear the responsibility of parties who receive information that potentially violates the rules to promptly report to the Commission. It also enables the Commission to ensure that no bidder gains an unfair advantage over other bidders in its auctions, thereby enhancing the competitiveness and fairness of Commission spectrum auctions. The information collected will be reviewed and, if warranted, referred to the Commission's Enforcement Bureau for possible investigation and administrative action. The Commission may also refer allegations of anticompetitive auction conduct to the Department of Justice for investigation.

This is a summary of the Potential Safeguards in Connection with NORS-DIRS Information Sharing Public Notice, PS Docket Nos. 15-80; DA 21-62, released January 19, 2022.

The complete text of the Potential Safeguards in Connection with NORS-DIRS Information Sharing Public Notice is also available electronically at: https://www.fcc.gov/document/pshsb-seeks-comments-nors-dirs-information-sharing-safeguards.

On March 17, 2021, the Commission adopted a framework to allow sharing certain communications network outage information submitted to the FCC's NORS and DIRS systems with state, federal, and Tribal nation agencies to improve situational awareness, enhance their ability to response more rapidly to outages, and to help save lives. Information submitted in NORS and DIRS “is sensitive for reasons concerning national security and commercial competitiveness, and the Commission this treats it as presumptively confidential.”  2

To protect the confidentiality and integrity of this sensitive information, the Second Report and Order adopted four specific safeguards: “(1) providing read-only access to the NORS and DIRS filings; (2) limiting the number of users with access to NORS and DIRS filings at participating agencies; (3) requiring special training for participating agencies regarding their privileges and obligations under the program; and (4) potentially terminating access to agencies that misuse or improperly disclose NORS and DIRS data.”  3

Acknowledging the utility of proposals raised by commenters earlier in this proceeding, the Commission directed the Bureau to “to seek, via Public Notice, further information on the cost, manner and technical feasibility” of including confidential notifications, headers, or watermarks on the read-only outage reports. 4 The Bureau seeks specific comments on the usefulness and effectiveness of these specific safeguards as well as information on costs and feasibility of these proposals.

The Bureau was further directed to “implement in NORS and DIRS any measures and safeguards that it determines suitable and in the public interest based on the record developed in response to the Public Notice.”  5 Keeping in mind that proposed safeguards “should not impose new regulatory requirements on service providers or additional conditions on agencies seeking access to outage data,” the Bureau invites comments proposing additional technical measures to preserve the confidentiality and integrity of the newly shared NORS and DIRS data. 6

Following the receipt of comments, the Bureau will release a Public Notice specifying any technical safeguards implemented in response to this Public Notice. To the extent necessary, these changes may be made without prior notice-and-comment under the Administrative Procedure Act as “rules of agency organization, procedure, or practice,” 5 U.S.C. 553(b)(A). The Bureau will then seek Office of Management and Budget (OMB) approval of the modifications to the extent required under the Paperwork Reduction Act. Upon receipt of OMB approval, and the Bureau's completion of all necessary changes to the systems, the Bureau will announce that the modifications are effective.

Interested parties may file comments in response to this Public Notice on or before the date indicated on the first page of this document. See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998). Comments may be filed using the Commission's Electronic Comment Filing System (ECFS).

Electronic Filers: Comments may be filed electronically using the internet by accessing the ECFS: http://apps.fcc.gov/ecfs/.

Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing.

Filings can be sent by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701. U.S. Postal Service first-class, Express, and Priority mail must be addressed to 45 L Street NE, Washington, DC 20554.

Effective March 19, 2020, and until further notice, the Commission no longer accepts any hand or messenger delivered filings. This is a temporary measure taken to help protect the health and safety of individuals, and to mitigate the transmission of COVID-19. See FCC Announces Closure of FCC Headquarters Open Window and Change in Hand-Delivery Policy, Public Notice, DA 20-304 (March 19, 2020).

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

This proceeding has been designated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. See 47 CFR 1.1200(a), 1.1206. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with rule 1.1206(b). In proceedings governed by rule 1.49(f) or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format ( e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”

OMB Control Number: 3060-0292.

Title: Part 69—Access Charges (Section 69.605, Reporting and Distribution of Pool Access Revenues).

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents and Responses: 732 respondents; 8,773 responses.

Estimated Time per Response: 0.75 hours-1 hour.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained 47 U.S.C. 154, 201, 202, 203, 205, 218 and 403 of the Communications Act of 1934, as amended.

Frequency of Response: Annual and monthly reporting requirements and third party disclosure requirement.

Total Annual Burden: 6,580 hours.

Total Annual Cost: No cost.

Privacy Act Impact Assessment: No impact(s).

Nature of Extent of Confidentiality: The Commission is not requesting that the respondents submit confidential information to the FCC. Respondents may, however, request confidential treatment for information they believe to be confidential under 47 CFR Section 0.459 of the Commission's rules.

Needs and Uses: Section 69.605 requires that access revenues and cost data shall be reported by participants in association tariffs to the association for computation of monthly pool revenues distributions. The association shall submit a report on or before February 1 of each calendar year describing the association's cost study review process for the preceding calendar year as well as the results of that process. For any revisions to the cost study results made or recommended by the association that would change the respective carrier's calculated annual common line or traffic sensitive revenue requirement by ten percent or more, the report shall include the following information:

(1) Name of the carrier;

(2) A detailed description of the revisions;

(3) The amount of the revisions;

(4) The impact of the revisions on the carrier's calculated common line and traffic sensitive revenue requirements; and

(5) The carrier's total annual common line and traffic sensitive revenue requirement.

The information is used by the Commission to compute charges in tariffs for access service (or origination and termination) and to compute revenue pool distributions. Neither process could be implemented without this information.

OMB Control Number: 3060-0743.

Title: Implementation of the Pay Telephone Reclassification and Compensation Provisions of the Telecommunications Act of 1996, CC Docket No. 96-128.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents and Responses: 4,471 respondents; 10,071 responses.

Estimated Time per Response: 0.50-100 hours.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority is contained in 47 U.S.C. 276 of the Telecommunications Act of 1996, as amended.

Frequency of Response: On occasion, quarterly and monthly reporting requirements, recordkeeping requirement and third-party disclosure requirement.

Total Annual Burden: 118,137 hours.

Total Annual Cost: No cost.

Privacy Act Impact Assessment: No impact(s).

Nature of Extent of Confidentiality: The Commission is not requesting that the respondents submit confidential information to the FCC. Respondents may, however, request confidential treatment for information they believe to be confidential under 47 CFR Section 0.459 of the Commission's rules.

Needs and Uses: This collection will be submitted as an extension of a currently approved collection to the Office of Management and Budget (OMB) in order to obtain the full three-year clearance. The Commission promulgated rules and reporting requirements implementing section 276 of the Telecommunications Act of 1996. Among other things, the rules: (1) Establish fair compensation for every completed intrastate and interstate payphone calls; (2) discontinue intrastate and interstate access charge payphone service elements and payments, and intrastate and interstate payphone subsidies from basic exchange services; and (3) adopt guidelines for use by the states in establishing public interest payphones to be located where there would otherwise not be a payphone. The information collected is provided to third parties and to ensure that interexchange carriers, payphone service providers (“PSP”) LECs, and the states comply with their obligations under the 1996 Act.

OMB Control Number: 3060-0214.

Title: Sections 73.3526 and 73.3527, Local Public Inspection Files; Sections 73.1212, 76.1701 and 73.1943, Political Files.

Form Number: N/A.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for profit entities; Not for profit institutions; State, Local or Tribal government; Individuals or households.

Number of Respondents: 23,805 respondents; 66,364 responses.

Estimated Time per Response: 1-52 hours.

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

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for these collections is contained in Sections 151, 152, 154(i), 303, 307, 308, and 315 of the Communications Act of 1934, as amended.

Total Annual Burden: 2,064,483 hours.

Total Annual Cost: No cost.

Needs and Uses: On January 25, 2022, the Commission adopted a Report and Order in MB Docket No. 21-293, FCC 22-5, Revisions to Political Programming and Record-Keeping Rule, which updates the political file rules for broadcast licensees and cable television system operators to bring them into conformity with the Bipartisan Campaign Reform Act of 2002. The Report and Order revises the following information collection requirements:

Pursuant to 47 CFR 73.1943 and 76.1701, each broadcast station licensee and each cable television system is required to maintain in its online political file a complete record of any request to purchase broadcast and cablecast time that is made by or on behalf of a candidate for public office, or that communicates a message relating to any political matter of national importance, including a legally qualified candidate, any election to Federal office, or a national legislative issue of public importance. Such records must include information regarding:

(1) Whether the request to purchase broadcast or cablecast time is accepted or rejected by the broadcast licensee or cable television system operator;

(2) the rate charged for the broadcast or cablecast time;

(3) the date and time on which the communication is aired;

(4) the class of time that is purchased;

(5) the name of the candidate to which the communication refers and the office to which the candidate is seeking election, the election to which the communication refers, or the issue to which the communication refers (as applicable);

(6) in the case of a request made by, or on behalf of, a candidate, the name of the candidate, the authorized committee of the candidate, and the treasurer of such committee; and

(7) in the case of any other request, the name of the person purchasing the time, the name, address, and phone number of a contact person for such person, and a list of the chief executive officers or members of the executive committee or of the board of directors of such person.

In addition, when free time is provided for use by or on behalf of candidates, a record of the free time provided must be placed in the political file. These records must be placed in the political file as soon as possible and retained for a period of two years.

All other information collection requirements contained under 47 CFR 73.1212, 73.3526, 73.3527, 73.1943, and 76.1701 are still a part of the information collection and remain unchanged since last approved by OMB.

OMB Control Number: 3060-1207.

Title: Section 25.701, Other DBS Public Interest Obligations, and Section 25.702, Other SDARS Public Interest Obligations.

Form Number: N/A.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents: 3 respondents; 11 responses.

Estimated Time per Response: 1-11 hours.

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

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this information collection is contained in sections 154, 301, 302, 303, 307, 309, 310, 332, and 335 of the Communications Act of 1934, as amended.

Total Annual Burden: 75 hours.

Total Annual Cost: No cost.

Needs and Uses: On January 25, 2022, the Commission adopted a Report and Order in MB Docket No. 21-293, FCC 22-5, Revisions to Political Programming and Record-Keeping Rule, which updates the political file rules for Direct Broadcast Satellite (DBS) providers and Satellite Digital Audio Radio Service (SDARS) licensees to bring them into conformity with the Bipartisan Campaign Reform Act of 2002. The Report and Order revises the following information collection requirements:

Pursuant to 47 CFR 25.701(d) and 25.702(b), each DBS provider and each SDARS licensee is required to maintain in its online political file a complete record of any request to purchase airtime that is made by or on behalf of a candidate for public office, or that communicates a message relating to any political matter of national importance, including a legally qualified candidate, any election to Federal office, or a national legislative issue of public importance. Such records must include information regarding:

(1) Whether the request to purchase airtime is accepted or rejected by the DBS provider or SDARS licensee;

(2) the rate charged for the airtime;

(3) the date and time on which the communication is aired;

(4) the class of time that is purchased;

(5) the name of the candidate to which the communication refers and the office to which the candidate is seeking election, the election to which the communication refers, or the issue to which the communication refers (as applicable);

(6) in the case of a request made by, or on behalf of, a candidate, the name of the candidate, the authorized committee of the candidate, and the treasurer of such committee; and

(7) in the case of any other request, the name of the person purchasing the time, the name, address, and phone number of a contact person for such person, and a list of the chief executive officers or members of the executive committee or of the board of directors of such person.

In addition, when free time is provided for use by or on behalf of candidates, a record of the free time provided must be placed in the political file. These records must be placed in the political file as soon as possible and retained for a period of two years.

All other information collection requirements contained under 47 CFR 25.701 and 25.702 are still a part of the information collection and remain unchanged since last approved by OMB.

This information collection (OMB 3060-1207) also consolidates the information collections in OMB 3060-1065, OMB 3060-1212, and the portion of OMB 3060-0214 which related to SDARS licensees to eliminate duplication and inconsistencies between these information collections. OMB 3060-1065 and OMB 3060-1212 will be discontinued.

Description: ACF/ORR requests information from the ORR-6 Performance Report to determine effectiveness of state Cash and Medical Assistance (CMA) and Refugee Support Services programs. ORR uses state-by-state CMA utilization rates, derived from the ORR-6 Performance Report, to formulate program initiatives, priorities, standards, budget requests, and assistance policies. Federal regulations require state Refugee Resettlement, Replacement Designee agencies, and local governments submit statistical or programmatic information that the ORR Director determines to be required to fulfill their responsibility under the Immigration and Nationality Act (INA). ORR will submit a revision request prior to 8/12/2022 for the revisions described in 86 FR 44370 ( https://www.federalregister.gov/d/2021-17246 ). An additional request for comments will publish in the Federal Register at the time of the revision request.

Respondents: State governments and Replacement Designees.

Estimated Total Annual Burden Hours: 1,920.

Authority: 8 U.S.C 1522 of the Immigration and Nationality Act (the Act) (title IV, sec. 412 of the Act), and 45 CFR 400.28(b).

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed 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) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control Act), enacted on June 22, 2009, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and provided FDA with the authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own (RYO) tobacco, and smokeless tobacco products to protect the public health and to reduce tobacco use by minors. The Tobacco Control Act also gave FDA the authority to issue regulations deeming other products that meet the statutory definition of a tobacco product to be subject to chapter IX of the FD&C Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))).

In accordance with that authority, on May 10, 2016, FDA issued a final rule deeming all products that meet the statutory definition of tobacco product, except accessories of newly deemed tobacco products, to be subject to FDA's tobacco product authority (final deeming rule) (81 FR 28974).

Chapter IX of the FD&C Act now applies to newly regulated products, including sections 904(a)(3) and (c)(1) (21 U.S.C. 387d(a)(3) and (c)(1)). Section 904(a)(3) of the FD&C Act requires the submission of an initial report from each tobacco product manufacturer or importer, or agents thereof, listing all constituents, including smoke constituents as applicable, identified as a harmful and potentially harmful constituent (HPHC) to health by FDA. Reports must be by brand and by quantity in each brand and subbrand. We note that for cigarettes, smokeless tobacco, cigarette filler, and RYO tobacco products, this initial reporting was completed in 2012.

Section 904(c)(1) of the FD&C Act provides that manufacturers of tobacco products not on the market as of June 22, 2009, must also provide the information reportable under section 904(a)(3) at least 90 days prior to introducing the product into interstate commerce. 1

FDA has taken several steps to identify HPHCs to be reported under section 904 of the FD&C Act, including issuing a guidance discussing FDA's current thinking on the meaning of the term “harmful and potentially harmful constituent” in the context of implementing the HPHC list requirement under section 904(e) of the FD&C Act (76 FR 5387, January 31, 2011, revised guidance issued August 2016). The guidance is available on the internet at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/harmful-and-potentially-harmful-constituents-tobacco-products-used-section-904e-federal-food-drug. The current established list of HPHCs also is available on the internet at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-established-list (77 FR 20034, April 3, 2012).

The purpose of the information collection is to collect statutorily mandated information regarding HPHCs in certain tobacco products and tobacco smoke, by brand and by quantity in each brand and subbrand.

To facilitate the submission of HPHC information, Forms FDA 3787a-j, for cigarettes, smokeless tobacco products, and RYO tobacco products, respectively, in both paper and electronic formats, are available. Additionally, FDA is developing forms to facilitate the submission of HPHC information for the deemed tobacco products. We intend to model these forms on the current HPHC reporting forms ( i.e., Forms FDA 3787a-j). A proposed information collection for deemed products will be published in a separate Federal Register notice, and we will solicit comments on that collection at that time.

Manufacturers or importers, or their agents, may submit HPHC information either electronically or in paper format. The FDA eSubmitter tool, available at https://www.fda.gov/industry/fda-esubmitter/using-esubmitter-prepare-tobacco-product-submissions, provides electronic forms to streamline the data entry and submission process for reporting HPHCs for cigarettes, smokeless tobacco products, and RYO tobacco products. Users of eSubmitter may populate an FDA-created Excel file and import data into eSubmitter. Whether respondents decide to submit reports electronically or on paper, each form provides instructions for completing and submitting HPHC information to FDA. The forms contain fields for company information, product information, and HPHC information.

FDA estimates the burden of this collection of information as follows:

The burden for this collection of information is estimated to be 19,193 hours. The burden estimate for this collection of information includes the time it will take to read the instructions, test the products, and prepare the HPHC report. In arriving at this burden estimate, FDA estimated the number of tobacco products to be reported under the requirements of section 904(c)(1) of the FD&C Act annually to FDA.

Section 1 of table 1 estimates that 424 respondents (380 cigarettes receiving authorizations, 19 RYO tobacco receiving authorizations, 25 smokeless receiving authorizations) will submit 424 HPHC reports annually. Each respondent represents a statutory tobacco product that receives authorization from FDA for which manufacturers and importers (or their agents), must report their product information to FDA under section 904(c)(1) of the FD&C Act at least 90 days prior to delivery for introduction into interstate commerce for all new products. This section addresses the time required to report their company information to FDA through the use of the electronic portal or paper forms.

The company information reported includes company name; mailing address; telephone and Fax numbers; FDA Establishment Identifier number; Data Universal Numbering System number; and point of contact name, mailing address, and telephone and Fax numbers, as applicable. It also addresses the time required for manufacturers and importers to report their product information by entering certain testing information into the electronic or paper forms.

The product information includes brand and subbrand name; unique product identification number; type of product identification number; product category and subcategory; and mean weight and standard deviation of tobacco in product.

We estimate that the burden to enter both the company and product information is no more than 1.82 hours per response for cigarettes, 0.43 hours per response for RYO, and 0.63 hours per response for smokeless tobacco products regardless of whether the paper or electronic Form FDA series 3787 is used. The time to report per tobacco product types varies because the number of HPHCs varies by tobacco product category. The total hours estimated for this section is 716.

The estimated number of responses under section 904(c)(1) of the FD&C Act is based on FDA's experience, the past 4 years of tobacco products receiving marketing authorizations from FDA, and actual responses to FDA under this provision of the FD&C Act for statutorily regulated products.

Section 2 of table 1 estimates that 44 respondents (19 cigarette filler and RYO tobacco receiving authorizations and 25 smokeless receiving authorizations) will test quantities of HPHCs in an average of 44 products annually. This section addresses the time required for manufacturers and importers (or their agents) who must test HPHC quantities in products. The burden estimates include the burden to test the tobacco products, draft testing reports, and submit the report to FDA. The total expected burden for this section is 481 hours.

Section 3 of table 1 addresses the time required for manufacturers and importers to test quantities for HPHCs in cigarette smoke. The burden estimates include: The burden to test the number of replicate measurements; test date range; manufacture date range; extraction method; separation method; detection method; and mean quantity and standard deviation of HPHCs and includes the burden to test the tobacco products, draft testing reports, and submit the report to FDA. The annual burden reflects our estimate of the time it takes to test the tobacco products ( i.e., carry out laboratory work). The burden estimate assumes that manufacturers and importers report HPHC quantities in cigarette mainstream smoke according to the two smoking regimens. The total expected burden is 17,996 hours for this section.

The total estimated burden for this information collection is 19,193 hours and 424 respondents. Our estimated burden for the information collection reflects an overall increase of 269 respondents and a corresponding increase of 16,677 hours. We attribute this adjustment to updated methodology in which the current estimates are derived from historical statutory tobacco product applications submitted and authorized by FDA in the past 4 years as (1) manufacturers and importers (or their agents) of authorized products are required to submit HPHC reports at least 90 days prior to delivery for introduction into interstate commerce for all new products and (2) initial reporting under section 904(a)(3) of the FD&C Act for statutory products was completed in 2012.

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

FDA is requesting OMB approval for the reporting requirements contained in the FDA collection of information “Environmental Impact Considerations.” The National Environmental Policy Act (NEPA) (42 U.S.C. 4321-4347) states national environmental objectives and imposes upon each Federal Agency the duty to consider the environmental effects of its actions. Section 102(2)(C) of NEPA requires the preparation of an environmental impact statement (EIS) for every major Federal action that will significantly affect the quality of the human environment.

FDA's NEPA regulations are in part 25 (21 CFR part 25). All applications or petitions requesting Agency action require the submission of a claim for categorical exclusion or an environmental assessment (EA). A categorical exclusion applies to certain classes of FDA-regulated actions that usually have little or no potential to cause significant environmental effects and are excluded from the requirements to prepare an EA or EIS. Section 25.15(a) and (d) (21 CFR 25.15(a) and (d)) specifies the procedures for submitting to FDA a claim for a categorical exclusion. Extraordinary circumstances (21 CFR 25.21), which may result in significant environmental impacts, may exist for some actions that are usually categorically excluded. An EA provides information that is used to determine whether an FDA action could result in a significant environmental impact. Section 25.40(a) and (c) (21 CFR 25.40(a) and (c)) specifies the content requirements for EAs for non-excluded actions.

This collection of information is used by FDA to assess the environmental impact of Agency actions and to ensure that the public is informed of environmental analyses. Firms wishing to manufacture and market substances regulated under statutes for which FDA is responsible must, in most instances, submit applications requesting approval. Environmental information must be included in such applications for the purpose of determining whether the proposed action may have a significant impact on the environment. Where significant adverse events cannot be avoided, the Agency uses the submitted information as the basis for preparing and circulating to the public an EIS, made available through a Federal Register document also filed for comment at the Environmental Protection Agency. The final EIS, including the comments received, is reviewed by the Agency to weigh environmental costs and benefits in determining whether to pursue the proposed action or some alternative that would reduce expected environmental impact.

Any final EIS would contain additional information gathered by the Agency after the publication of the draft EIS, a copy or a summary of the comments received on the draft EIS, and the Agency's responses to the comments, including any revisions resulting from the comments or other information. When the Agency finds that no significant environmental effects are expected, the Agency prepares a finding of no significant impact.

In the Federal Register of August 25, 2021 (86 FR 47501), FDA published a 60-day notice requesting public comment on the proposed collection of information. Although one comment was received, it was not responsive to the four collection of information topics solicited.

FDA estimates the burden of this collection of information as follows:

Under §§ 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and 314.94(a)(9)(i) (21 CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and 314.94(a)(9)(i)), each investigational new drug application (IND), new drug application (NDA), and abbreviated new drug application (ANDA) must contain a claim for categorical exclusion under § 25.30 (21 CFR 25.30) or § 25.31 (21 CFR 25.31), or an EA under § 25.40. Annually, FDA receives approximately 5,503 INDs from 3,717 sponsors; 142 NDAs from 111 applicants; 3,285 supplements to NDAs from 516 applicants; 35 biologic license applications (BLAs) from 32 applicants; 777 supplements to BLAs from 89 applicants; 743 ANDAs from 239 applicants; and 11,438 supplements to ANDAs from 482 applicants. FDA estimates that it receives approximately 21,923 claims for categorical exclusions as required under § 25.15(a) and (d) and 13 EAs as required under § 25.40(a) and (c). Based on information provided by the pharmaceutical industry, FDA estimates that it takes sponsors or applicants approximately 8 hours to prepare a claim for a categorical exclusion and approximately 3,400 hours to prepare an EA. Based on recent numbers, we now estimate a total of 21,936 annual responses and 219,584 hours for human drugs (an increase of 6,489 responses and 62,088 hours).

In the Federal Register of January 11, 2022, FDA published a notice of availability with a 60-day comment period to request comments on draft guidance for industry and FDA staff entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act.”

The Agency has received a request for an extension of the comment period. The request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response.

FDA has considered the request and is extending the comment period for the notice of availability for 30 days, until April 11, 2022. The Agency believes that a 30-day extension allows adequate time for interested persons to submit comments without significantly delaying guidance on these important issues.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This draft guidance document is also available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic copy of “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 21003 and complete title to identify the guidance you are requesting.

FDA is announcing the availability of a draft guidance for industry entitled “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs.” This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or requestors of nonprescription drugs without approved new drug applications that are governed by section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h) (hereafter referred to as OTC monograph drugs ).

Section 505G of the FD&C Act was added by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136), which was enacted on March 27, 2020. As required by section 505G(l) of the FD&C Act, this draft guidance, when finalized, will discuss the procedures and principles for formal meetings between FDA and sponsors or requestors for an OTC monograph drug (hereafter referred to collectively as meeting requesters ). In doing so, and as required by section 505G(h) of the FD&C Act, this draft guidance, when finalized, will describe procedures under which meeting requesters can meet with appropriate FDA officials to obtain recommendations on the studies and other information necessary to support submissions under section 505G of the FD&C Act, to obtain information on other matters relevant to the regulation of nonprescription drugs, and to obtain recommendations on the development of new OTC monograph drugs. As required by section 505G(i) of the FD&C Act, this draft guidance, when finalized, will also describe procedures to facilitate efficient participation in joint meetings by multiple meeting requestors and/or organizations nominated by them to represent their interests.

This draft guidance does not apply to meetings for the development of nonprescription drug products intended for submission in new drug applications or abbreviated new drug applications under section 505 of the FD&C Act. This draft guidance does not apply to meetings between FDA and pre-investigational new drug or investigational new drug sponsors. For the purposes of this draft guidance, a formal meeting includes any meeting that is requested by a meeting requester following the procedures provided in this draft guidance and includes meetings conducted in any format ( i.e., face to face, teleconference/videoconference, or written response only).

In support of the CARES Act, FDA agreed to specific performance goals and procedures described in the document “Over-the-Counter Monograph User Fee Program Performance Goals and Procedures—Fiscal Years 2018-2022,” commonly referred to as the OMUFA Commitment Letter (the document can be accessed at https://www.fda.gov/media/106407/download and the document with updated goal dates for fiscal years 2021-2025 can be accessed at https://www.fda.gov/media/146283/download ). The OMUFA Commitment Letter includes meeting management goals for formal meetings that occur between FDA and meeting requesters. In the OMUFA Commitment Letter, FDA committed to issuing this draft guidance under specific timelines.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs; Draft Guidance for Industry.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act of 1995 does not apply to collections of information made under section 505G of the FD&C Act. The information collections made in this guidance implement the provisions of three subsections of section 505G: (1) Section 505G(l)(1), which requires FDA to issue guidance that specifies the procedures and principles for formal meetings between FDA and sponsors or requestors for drugs subject to section 505G; (2) section 505G(h), which requires FDA to establish procedures under which meeting requestors can meet with appropriate FDA officials to obtain advice on the studies and other information necessary to support submissions under section 505G, other matters relevant to the regulation of nonprescription drugs, and the development of new nonprescription drugs under section 505G; and (3) section 505G(i), which requires FDA to, among other things, establish procedures to facilitate efficient participation in joint meetings by multiple meeting requesters and/or organizations nominated by them to represent their interests. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required for these collections of information.

Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

Technology description follows:

The ongoing COVID-19 pandemic, caused by severe respiratory syndrome coronavirus 2 (SARS-CoV-2), has created an immense public health, social, and economic burden. Variants of concern continue to emerge that have increased transmissibility, pathogenicity, or both and that reduce the effectiveness of current therapeutics and vaccines. Thus, there is a great need for broadly protective therapeutics.

This technology relates to two monoclonal antibodies targeting the spike protein of SARS-CoV-2 that between the two have picomolar activity against wild-type SARS-CoV-2 and the Alpha, Beta, Delta, and Omicron variants of concern. Additionally, one of the antibodies recognizes a highly-conserved epitope of the spike protein. Treatment with either monoclonal antibody before or after challenge with SARS-CoV-2 reduced symptoms and viral load in nasal turbinate and lung tissue in the golden Syrian hamster model. This monoclonal antibody technology has great potential to treat SARS-CoV-2 infections and may provide protection against future variants of concern.

This technology is available for licensing for commercial development in accordance with 35 U.S.C. 209 and 37 CFR part 404.

• In vivo data assessment (animal)

Inventors: Zhaochun Chen (NIAID); Patrizia Farci (NIAID); Kamille West (CC); Peng Zhang (NIAID); Paolo Lusso (NIAID); Ulla Buchholz (NIAID); Yumiko Matsuoka (NIAID).

Intellectual Property: HHS Reference No. E-132-2021- U.S. Provisional Application No. 63/296,380, filed January 4, 2022.

Licensing Contact: To license this technology, please contact Elizabeth Pitts, Ph.D., 240-669-5299; elizabeth.pitts@nih.gov, and reference E-132-2021.

Collaborative Research Opportunity: The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize this technology. For collaboration opportunities, please contact Elizabeth Pitts, Ph.D., 240-669-5299; elizabeth.pitts@nih.gov.

The Defense Production Act (DPA), 50 U.S.C. 4501 et seq., authorizes the making of “voluntary agreements and plans of action” with, among others, representatives of industry and business to help provide for the national defense. 1 The President's authority to facilitate voluntary agreements was delegated to the Secretary of Homeland Security with respect to responding to the spread of COVID-19 within the United States in Executive Order 13911. 2 The Secretary of Homeland Security has further delegated this authority to the FEMA Administrator. 3

On August 17, 2020, after the appropriate consultations with the Attorney General and the Chairman of the Federal Trade Commission, FEMA completed and published in the Federal Register a “Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic” (Voluntary Agreement). 4 Unless terminated prior to that date, the Voluntary Agreement is effective until August 17, 2025, and may be extended subject to additional approval by the Attorney General after consultation with the Chairman of the Federal Trade Commission. The Voluntary Agreement may be used to prepare for or respond to any pandemic, including COVID-19, during that time.

Previously, FEMA has announced the activation of five Plans of Action under the Voluntary Agreement:

(1) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Personal Protective Equipment (PPE) to Respond to COVID-19.

(2) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Diagnostic Test Kits and other Testing Components to Respond to COVID-19.

(3) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Drug Products, Drug Substances, and Associated Medical Devices to Respond to COVID-19.

(4) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Devices to Respond to COVID-19.

(5) Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Gases to Respond to COVID-19.

FEMA has now activated a sixth Plan of Action under the Voluntary Agreement:

(6) Plan of Action to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to COVID-19.

This Plan is necessitated by continued transportation-related concerns and shortfalls that interfere with the movement of critical resources for our nation's COVID-19 response. Appropriate members of the private sector have been invited to join the Plan of Action as Sub-Committee Participants. Provided that a Sub-Committee Participant acts in accordance with the terms of the Plan, the DPA affords the Participant an affirmative defense to certain civil and criminal actions brought under the antitrust laws (or any similar law of any state) for appropriate actions taken to carry out the Plan. The Plan is designed to foster a close working relationship among FEMA, Department of Health and Human Services, and Sub-Committee Participants to address national defense needs through cooperative action under the direction and active supervision of FEMA.

The Attorney General, in consultation with the Chairman of the Federal Trade Commission, has made the required finding for the Plan of Action that the purposes of section 708(c)(1) of the DPA cannot reasonably be achieved without the Plan of Action, or by a Plan of Action having less anticompetitive effects than the proposed Plan of Action. Pursuant to section 708(f)(1)(B) of the DPA, the Department of Justice separately published the finding for this Plan of Action in the Federal Register . 5 The FEMA Administrator has certified in writing that the Plan of Action is necessary to help provide for the national defense.

Pursuant to section 708 of the Defense Production Act of 1950 (DPA), as amended (50 U.S.C. 4558), the Federal Emergency Management Agency (FEMA) Administrator (Administrator), after consultation with the Secretary of the Department of Health and Human Services (HHS), the Attorney General of the United States (Attorney General), and the Chair of the Federal Trade Commission (FTC), developed a Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic (Voluntary Agreement), 85 FR 50035 (August 17, 2020). The Voluntary Agreement, which operates through a series of Plans of Action, maximizes the manufacture and efficient distribution of Critical Healthcare Resources nationwide to respond to a pandemic by establishing unity of effort between Participants and the Federal Government for integrated coordination, planning, information sharing with FEMA, as authorized by FEMA, and distribution of Critical Healthcare Resources.

This document establishes a Plan of Action (Plan) to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to COVID-19. This Plan will be implemented under the Voluntary Agreement by one or more Sub-Committees, beginning with a Sub-Committee to Define Requirements for COVID-19 National Multimodal Healthcare Supply Chains and may also include:

(1) Sub-Committee to Define Requirements for COVID-19 National Multimodal Healthcare Supply Chains,

(2) Sub-Committee for Aviation,

(3) Sub-Committee for Surface Transportation (including Highway, Motor Carriers, and Freight Rail), and

(4) Sub-Committee for Maritime Transportation.

FEMA may combine these Sub-Committees or establish additional Sub-Committees under this Plan, so long as:

(1) The Sub-Committee addresses one specific and well-defined component of the National Multimodal Healthcare Supply Chains System; and

(2) The Sub-Committee is recommended by the Sub-Committee to Define Requirements for COVID-19 National Multimodal Healthcare Supply Chains.

The purpose of the Plan and Sub-Committees is to evaluate and optimize coordination of National Multimodal Healthcare Supply Chains System resources related to the COVID-19 response. The primary goal of the Plan is to create a mechanism to immediately address exigent needs within the National Multimodal Healthcare Supply Chains System and to ensure actions to address such needs do not come with unacceptable risks or interfere with other efforts to meet critical End-User requirements. When the requirements of the Plan are met, it affords Sub-Committee Participants defenses to civil and criminal actions brought under the antitrust laws (or any similar law of any state) for actions taken within the scope of the Plan. The Plan is designed to foster a close working relationship among FEMA, HHS, and Sub-Committee Participants to address national defense needs through cooperative action under the direction and active supervision of FEMA.

A pandemic may present conditions that pose a direct threat to the national defense of the United States or its preparedness programs such that, pursuant to DPA section 708(c)(1), it becomes necessary to establish an agreement and plan to collaboratively evaluate and coordinate resources within the National Multimodal Healthcare Supply Chains System. This Plan of Action to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to COVID-19 is established under the Voluntary Agreement and initially establishes up to four Sub-Committees responsible for the Plan's oversight and implementation. The Plan and Sub-Committees will optimize the coordination of National Multimodal Healthcare Supply Chains and create a prioritization protocol based upon End-Users' demonstrated or projected requirements.

Section 708, Defense Production Act (50 U.S.C. 4558); sections 402(2) & 501(b), Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121-5207); sections 503(b)(2)(B) & 504(a)(10) & (16) of the Homeland Security Act of 2002 (6 U.S.C. 313(b)(2)(B), 314(a)(10) & (16)); sections 201, 301, National Emergencies Act (50 U.S.C. 1601 et seq. ); section 319, Public Health Service Act (42 U.S.C. 247d); Executive Order (E.O.) 13911, 85 FR 18403 (March 27, 2020). Pursuant to DPA section 708(f)(1)(A), the Administrator certifies that this Plan is necessary for the national defense.

The FEMA Administrator is the Sponsor of the Voluntary Agreement. Pursuant to a delegation or redelegation of the functions given to the President by DPA section 708, the Administrator proposes and provides for the development and carrying out of the Voluntary Agreement, including through the development and implementation of Plans of Action. The Administrator is responsible for carrying out all duties and responsibilities required by 50 U.S.C. 4558 and 44 CFR part 332 and for appointing one or more Chairpersons to manage and administer the Committee and all Sub-Committees formed to carry out the Voluntary Agreement.

The process of analyzing and determining the relative distribution among one or more competing requests from End-Users utilizing the same National Multimodal Healthcare Supply Chains. Through the allotment process, FEMA—with participation from Sub-Committee Participants—will assess the actual needs of End-Users and determine how to divide the available and projected capabilities of National Multimodal Healthcare Supply Chains to minimize impacts to life, safety, and economic disruption associated with shortages. Allotment will take place only under Exigent Circumstances. With the exception of all forms of civil transportation resources under the jurisdiction of the Department of Transportation, which are excluded from this Plan, FEMA retains decision-making authority for allotment under this Plan.

Subject matter experts, invited by the Chairperson or a Sub-Committee Chairperson to attend meetings authorized under the Voluntary Agreement or this Plan, to provide technical advice or to represent other government agencies or interested parties. Invitations to attendees will be extended as required for Committee or Sub-Committee meetings and deliberations.

FEMA senior executive(s), appointed by the Administrator, to chair the Committee for the Distribution of Healthcare Resources Necessary to Respond to a Pandemic (Committee). The Chairperson shall be responsible for the overall management and administration of the Committee, the Voluntary Agreement, and Plans of Action developed under the Voluntary Agreement while remaining under the supervision of the Administrator; shall initiate, or approve in advance, each meeting held to discuss problems, determine policies, recommend actions, and make decisions necessary to carry out the Voluntary Agreement; appoint one or more co-Chairpersons to chair the Committee, and otherwise shall carry out all duties and responsibilities assigned to him. With the approval of the Administrator, the Chairperson may create one or more Sub-Committees, and may appoint one or more Sub-Committee Chairpersons to chair the Sub-Committees, as appropriate.

Committee for the Distribution of Healthcare Resources Necessary to Respond to a Pandemic established under the Voluntary Agreement.

Competitively Sensitive Information that is shared pursuant to this Plan may include any Document or other tangible thing or oral transmission that contains financial, business, commercial, scientific, technical, economic, or engineering information or data, including, but not limited to

All Competitively Sensitive Information provided by a Sub-Committee Participant as described herein is deemed Competitively Sensitive Information, except for Information that:

a. Is published or has been made publicly available at the time of disclosure by the Sub-Committee Participant;

b. was in the possession of, or was lawfully and readily available to, FEMA from another source at the time of disclosure without breaching any obligation of confidentiality applicable to the other source; or

c. was independently developed or acquired without reference to or reliance upon the Sub-Committee Participant's Competitively Sensitive Information;

Where information deemed Competitively Sensitive Information is required to be disclosed by law, regulation, or court order, the “Competitively Sensitive” (or substantially similar) label will continue to attach to all information and portion(s) of documents that are not made public through the required disclosure.

Any information, on paper or in electronic/audio/visual format, including written, recorded, and graphic materials of every kind, in the possession, custody, or control of the Participant and used or shared in the course of participation in the Voluntary Agreement or a subsequent Plan of Action.

This includes all direct and ancillary medical support including, but not limited to, hospitals, independent healthcare providers, nursing homes, medical laboratories, dental care providers, independent physician offices, first responders, alternate care facilities, distributors, wholesalers, and the general public that reasonably represents the totality of the nation's response to COVID-19.

As determined by the Chairperson, the actual or forecasted shortage of resources and their impact on the National Multimodal Healthcare Supply Chains which likely cannot be fulfilled via usual market mechanisms for an acute, critical time period, and where immediate and substantial harm is projected to occur from lack of intervention.

Any or all of the necessary resources and processes contributing to the supply, production, and distribution of critical healthcare resources necessary to respond to COVID-19.

This Plan focuses on resources, entities, and processes within the Transportation Systems Sector, identified under Presidential Policy Directive (PPD)-21, Critical Infrastructure Security and Resilience, that support National Multimodal Healthcare Supply Chains.

A Pandemic is defined as an epidemic that has spread to human populations across a large geographic area that is subject to one or more declarations under the National Emergencies Act, the Public Health Service Act, or the Robert T. Stafford Disaster Relief and Emergency Assistance Act, or if the Administrator determines that one or more declarations is likely to occur and the epidemic poses a direct threat to the national defense or its preparedness programs. For example, Coronavirus Disease 2019 (COVID-19) meets the definition of a Pandemic.

An individual, partnership, corporation, association, or private organization, other than a federal agency, that has substantive capabilities, resources or expertise to carry out the purpose of the Voluntary Agreement, that has been specifically invited to participate in the Voluntary Agreement by the Chairperson, and that has applied and agreed to the terms of the Voluntary Agreement. “Participant” includes a corporate or non-corporate entity entering into the Voluntary Agreement and all subsidiaries and affiliates of that entity in which that entity has 50 percent or more control either by stock ownership, board majority, or otherwise. The Administrator may invite Participants to join the Voluntary Agreement at any time during its effective period.

This document. A documented method, pursuant to 50 U.S.C. 4558(b)(2), proposed by FEMA to implement a particular set of activities under the Voluntary Agreement, through a Sub-Committee focused on a particular Critical Healthcare Resource, or pandemic response workstream or functional area necessary for the national defense.

A separate commitment made by Participants upon invitation and agreement to participate in a Plan of Action as part of one or more Sub-Committees. Completing the Plan of Action Agreement confers responsibilities on the Participant consistent with those articulated in the Plan of Action and affords Participants a defense against antitrust claims under section 708 for actions taken to develop or carry out the Plan and the appropriate Sub-Committee(s), as described in Section IV below.

The representatives the Administrator identifies and invites to the Committee from FEMA, HHS, and other federal agencies with equities in this Plan, and empowered to speak on behalf of their agencies' interests. The Attorney General and the Chair of the FTC, or their delegates, may also attend any meeting as a Representative.

A body formed by the Administrator from select Participants to implement a Plan of Action.

FEMA executive, appointed by the Chairperson, to chair a Sub-Committee to implement a Plan of Action. The Sub-Committee Chairperson shall be responsible for the overall management and administration of the Sub-Committee in furtherance of this Plan while remaining under the supervision of the Administrator and the Chairperson.

Collectively the Sub-Committee Chairperson(s), Representatives, and Sub-Committee Participants. Jointly responsible for developing and executing this Plan.

A subset of Participants of the Committee, that have been specifically invited to participate in a Sub-Committee by the Sub-Committee Chairperson, and that have applied and agreed to the terms of this Plan and signed the Plan of Action Agreement. The Sub-Committee Chairperson may invite Participants in the Committee to join a Sub-Committee as a Sub-Committee Participant at any time during the Plan's effective period.

This Plan will be carried out by a subset of the Participants in the Voluntary Agreement through several Sub-Committees, which may include:

(1) Sub-Committee to Define Requirements for COVID-19 National Multimodal Healthcare Supply Chains,

(2) Sub-Committee for Aviation,

(3) Sub-Committee for Surface Transportation (including Highway, Motor Carriers, and Freight Rail), and

(4) Sub-Committee for Maritime Transportation.

FEMA may combine these Sub-Committees or establish additional Sub-Committees under this Plan, so long as:

(1) The Sub-Committee addresses one specific and well-defined component of the National Multimodal Healthcare Supply Chains System; and

(2) The Sub-Committee is recommended by the Sub-Committee to Define Requirements for COVID-19 National Multimodal Healthcare Supply Chains.

Each Sub-Committee will consist of the (1) Sub-Committee Chairperson(s), (2) Representatives from FEMA, HHS, the Department of Justice (DOJ), and other federal agencies with equities in this Plan, and (3) Sub-Committee Participants that have substantive capabilities, resources or expertise to carry out the purpose of this Plan and have signed the Plan of Action Agreement. The Chairperson shall invite Sub-Committee Participants who, in his or her determination, are reasonably representative of the appropriate industry or segment of such industry. Other Attendees—invited by the Sub-Committee Chairperson as subject matter experts to provide technical advice or to represent the interests of other government agencies or interested parties—may also participate in Sub-Committee meetings. The naming of these Sub-Committees does not commit the Administrator to creating them unless and until circumstances dictate.

This Plan is effective immediately upon satisfaction of the requirements of DPA section 708(f)(1). This Plan shall remain in effect until terminated in accordance with 44 CFR 332.4. It shall be effective for no more than five (5) years from August 17, 2020, when the requirements of DPA section 708(f)(1) were satisfied for the Voluntary Agreement, unless otherwise terminated pursuant to DPA section 708(h)(9) and 44 CFR 332.4 or extended as set forth in DPA section 708(f)(2). No action may take place under this Plan until it is activated, as described in Section III(E), below.

Participation in the Plan is voluntary, as is the acceptance of most obligations under the Plan. Sub-Committee Participants may withdraw from this Plan or from an individual Sub-Committee at any point, subject to the fulfillment of obligations previously agreed upon by the Participant prior to the date of withdrawal. Note that the obligations outlined in V.B regarding information management and associated responsibilities apply once a party has shared or received information through a Sub-Committee and remain in place after the party's withdrawal from the Sub-Committee or Plan. If a Sub-Committee Participant indicates an intent to withdraw from the Plan due to a modification or amendment of the Plan (described below), the Sub-Committee Participant will not be required to perform actions directed by that modification or amendment. Withdrawal from the Plan will automatically trigger withdrawal from all Sub-Committees; however, a Participant may withdraw from a Sub-Committee without also withdrawing from the Plan or other Sub-Committees. To withdraw from the Plan or from an individual Sub-Committee, a Participant must provide written notice to the Administrator at least fifteen (15) calendar days prior to the effective date of that Sub-Committee Participant's withdrawal specifying the scope of withdrawal. Following receipt of such notice, the Administrator will inform the other Sub-Committee Participants of the date and the scope of the withdrawal.

Upon the effective date of the withdrawal from the Plan, the Sub-Committee Participant must cease all activities under the Plan. Upon the effective date of the withdrawal from one or more Sub-Committee(s), the Sub-Committee Participant must cease all activities under the Plan that pertain to the withdrawn Sub-Committee(s).

The Administrator, in consultation with the Chairperson and Sub-Committee Chairperson, will invite a select group of Participants in the Voluntary Agreement to form at least one of the following Sub-Committees, beginning with the Sub-Committee to Define Requirements for COVID-19 National Multimodal Healthcare Supply Chains, which will be responsible for implementing this Plan.

(1) Sub-Committee to Define Requirements for COVID-19 National Multimodal Healthcare Supply Chains,

(2) Sub-Committee for Aviation,

(3) Sub-Committee for Surface Transportation (including Highway, Motor Carriers, and Freight Rail), and

(4) Sub-Committee for Maritime Transportation.

(1) The Sub-Committee addresses one specific and well-defined component of the National Multimodal Healthcare Supply Chains System; and

(2) The Sub-Committee is recommended by the Sub-Committee to Define Requirements for COVID-19 National Multimodal Healthcare Supply Chains.

This Plan will be activated for each invited Participant when the Participant executes a Plan of Action Agreement, and a Participant may not participate in a Sub-Committee until the Plan of Action Agreement is executed. Participants will be invited to join this Plan at the discretion of the Chairperson or the Sponsor to the Voluntary Agreement. Participants will be further invited to attend specific meetings of one or more Sub-Committees at the discretion of the Chairperson.

Sub-Committee Participants acknowledge and agree to comply with all provisions of DPA section 708, as amended, and regulations related thereto which are promulgated by FEMA, the Department of Homeland Security, HHS, the Attorney General, and the FTC. FEMA has promulgated standards and procedures pertaining to voluntary agreements in 44 CFR part 332. The Administrator shall inform Participants of new rules and regulations as they are issued.

The Administrator, after consultation with the Attorney General and the Chair of the FTC, may terminate or modify, in writing, this Plan at any time. The Attorney General, after consultation with the Chair of the FTC and the Administrator, may terminate or modify, in writing, this Plan at any time. Sub-Committee Participants may propose modifications or amendments to the Plan or to the Sub-Committees at any time.

Where possible, material modifications to the Plan or a Sub-Committee will be subject to a 30-calendar day delayed implementation and opportunity for notice and comment by Sub-Committee Participants to the Chairperson. This delayed implementation period may be shortened or eliminated if the Administrator deems it necessary. The Administrator shall inform Sub-Committee Participants of modifications or amendments to the Plan or to the Sub-Committees as they are proposed and issued.

The Administrator, after consultation with the Attorney General and the Chair of the FTC, may remove Sub-Committee Participants from the Plan or from a Sub-Committee at any time. The Attorney General, after consultation with the Chair of the FTC and the Administrator, may remove Sub-Committee Participants from this Plan or from a Sub-Committee at any time. If a Participant is removed from the Plan or from a Sub-Committee, the Participant may request written notice of the reasons for removal from the Chairperson, who shall provide such notice in a reasonable time period.

Participation in this Plan or in a Sub-Committee does not confer funds to Sub-Committee Participants, nor does it limit or prohibit any pre-existing source of funds. Unless otherwise specified, all expenses, administrative or otherwise, incurred by Sub-Committee Participants associated with participation in this Plan or a Sub-Committee shall be borne exclusively by the Sub-Committee Participants.

Each Sub-Committee Chairperson shall have primary responsibility for maintaining records in accordance with 44 CFR part 332 and shall be the official custodian of records related to carrying out this Plan. Each Sub-Committee Participant shall maintain for five years all minutes of meetings, transcripts, records, documents, and other data, including any communications with other Sub-Committee Participants or with any other member of the Sub-Committee, including drafts, related to the carrying out of this Plan or incorporating data or information received in the course of carrying out this Plan. Each Sub-Committee Participant agrees to produce to the Administrator, the Attorney General, and the Chair of the FTC upon request any item that this section requires the Participant to maintain. Any record maintained in accordance with 44 CFR part 332 shall be available for public inspection and copying, unless exempted on the grounds specified in 5 U.S.C. 552(b)(1), (3) or (4) or identified as privileged and confidential information in accordance with DPA section 705(d), and 44 CFR 332.5.

Under the provisions of DPA subsection 708(j), each Sub-Committee Participant in this Plan shall have available as a defense to any civil or criminal action brought for violation of the antitrust laws (or any similar law of any State) with respect to any action to develop or carry out this Plan, that such action was taken by the Sub-Committee Participant in the course of developing or carrying out this Plan, that the Sub-Committee Participant complied with the provisions of DPA section 708 and the rules promulgated thereunder, and that the Sub-Committee Participant acted in accordance with the terms of the Voluntary Agreement and this Plan. Except in the case of actions taken to develop this Plan, this defense shall be available only to the extent the Sub-Committee Participant asserting the defense demonstrates that the action was specified in, or was within the scope of, this Plan and within the scope of the appropriate Sub-Committee(s), including being taken at the direction and under the active supervision of FEMA.

This defense shall not apply to any actions taken after the termination of this Plan. Immediately upon modification of this Plan, no defense to antitrust claims under Section 708 shall be available to any subsequent action that is beyond the scope of the modified Plan. The Sub-Committee Participant asserting the defense bears the burden of proof to establish the elements of the defense. The defense shall not be available if the person against whom the defense is asserted shows that the action was taken for the purpose of violating the antitrust laws.

As the sponsoring agency, FEMA will maintain oversight over Sub-Committee activities and direct and supervise actions taken to carry out this Plan, including by retaining decision-making authority over actions taken pursuant to the Plan to ensure such actions are necessary to address a direct threat to the national defense. The Attorney General and the Chair of the FTC will monitor activities of the Sub-Committees to ensure they execute their responsibilities in a manner consistent with this Plan and their actions have the least anticompetitive effects possible.

This Plan will be used to support Pandemic response by maximizing the coordination for selected National Multimodal Healthcare Supply Chains and creating a prioritization protocol for End-Users. Each Sub-Committee will support the following objectives to mitigate the loss of life and public health threats associated with COVID-19.

(1) Identify capabilities to effectively support National Multimodal Healthcare Supply Chains.

(2) Ensure effective coordination of National Multimodal Healthcare Supply Chains System resources that may be required for the Response to COVID-19.

(3) Ensure ongoing competition continues within the National Multimodal Healthcare Supply Chains System to the greatest extent possible under the DPA.

Sub-Committee Participants may be asked to support these objectives by taking the following specific actions:

(1) Assist the Chairperson in identifying priorities and challenges within the National Multimodal Healthcare Supply Chains System that should be addressed within the Plan's Sub-Committees because of their importance to the national response to COVID-19. Using the best evidence available, Participants should consider whether current and projected National Multimodal Healthcare Supply Chains System resources are sufficient to meet essential needs of End-Users and geographic areas, and if there are any critical shortfalls of such resources that may be of concern for the response to COVID-19.

(2) Create a collaborative process for evaluating and addressing competing National Multimodal Healthcare Supply Chains System claims, as directed and decided by the Chairperson.

(3) Develop a mechanism to inform prioritization of the distribution of healthcare products through National Multimodal Healthcare Supply Chains, as directed and decided by the Chairperson.

(4) Prepare a general strategy to accomplish the activities listed in V(A)(2) and V(A)(5) regarding activities in Exigent Circumstances consistent with the decisions made by the Chairperson.

(5) In Exigent Circumstances, with review and concurrence in all possible instances by DOJ in consultation with FTC:

• Facilitate maximum use of the National Multimodal Healthcare Supply Chains System to meet requirements of the nation or particular geographic areas by deconflicting overlapping demands from the collective Participants' End-Users, as directed and decided by the Chairperson.

• Facilitate maximum availability of resources provided within the National Multimodal Healthcare Supply Chains System to meet requirements of the nation or particular geographic areas, as directed and decided by the Chairperson.

• Facilitate the efficient distribution of resources through the National Multimodal Healthcare Supply Chains System by deconflicting overlapping distribution chain activities of Sub-Committee Members, as directed and decided by the Chairperson.

• Establish a process and means of collaboration to address exigent End-User requirements in a manner aligned with the objectives of this Plan, as directed and decided by the Chairperson.

(6) Provide data and information necessary to validate the efforts of the Sub-Committee including the actual and planned COVID-19 response activities that may foreseeably impact National Multimodal Healthcare Supply Chains throughout the nation, as determined by the Chairperson.

(7) Provide feedback to the Chairperson and Sub-Committee Members on outcomes, accomplishments, and impediments of collective efforts to accomplish objectives and actions outlined in this Plan.

(8) Advise the Chairperson whether additional Participants or Attendees should be invited to join this Plan and its Sub-Committees.

(9) Carry out other activities that the Sub-Committees under this Plan determine to be necessary for the coordination of National Multimodal Healthcare Supply Chains System resources to address the COVID-19 Pandemic's direct threat to the national defense, as determined and directed by the Chairperson, where such activities have been reviewed and approved by DOJ and FTC and received concurrence from Sub-Committee members.

FEMA will request only the data and information from Sub-Committee Participants that is necessary to meet the objectives of the Plan and consistent with the scope of the relevant Sub-Committees. Upon signing a Plan of Action Agreement for this Plan, FEMA requests that Participants endeavor to cooperate with diligence and speed, and to the extent permissible under this Plan, and to share with FEMA any data and information necessary to meet the objectives of this Plan.

Sub-Committee Participants agree to share with FEMA the following data with diligence and speed to the extent permissible under this Plan, and to abide by the following guidelines where feasible and consistent with the data that is owned by each Sub-Committee Participant:

(1) In general, Participants will not be asked to share Competitively Sensitive Information directly with other Participants.

(2) FEMA will only request direct sharing of Competitively Sensitive Information among Participants during Exigent Circumstances where there is a mission critical need or timeline such that sharing only through FEMA is impractical or threatens the outcome of the Plan or Sub-Committee action. Such requests, if made, will be only among Participants whose participation is necessary to meet the objectives of the Plan, will be limited in scope to the greatest extent possible, and will be shared only pursuant to safeguards subject to prior review and audit by DOJ and FTC. Direct sharing of Competitively Sensitive Information with other Participants will be limited in scope and circumstances to the greatest extent possible. Participants may not share Competitively Sensitive Information directly with other Participants unless specifically requested by FEMA, in consultation with DOJ and FTC. All Competitively Sensitive Information delivered to FEMA or to another Sub-Committee Participant shall be delivered by secure means, for example, password-protected or encrypted electronic files or drives with the password/key delivered by separate communication or method or via upload to an appropriately secure web portal as directed by FEMA. All data delivered to the web portal designated by FEMA is deemed to be Competitively Sensitive Information.

(3) To allow FEMA to identify and appropriately protect documents containing Competitively Sensitive Information by the Sub-Committee Participant providing the documents, the Sub-Committee Participant will make good faith efforts to designate any Competitively Sensitive Information by placing restrictive markings on documents and things considered to be competitively sensitive, the restrictive markings being sufficiently clear in wording and visibility to indicate the restricted nature of the data. The Sub-Committee Participant will identify Competitively Sensitive Information that is disclosed verbally by oral warning. Information designated as competitively sensitive will, to the extent allowed by law, be presumed to constitute trade secrets, or commercial or financial information, and be provided by the Sub-Committee Participant to FEMA with the expectation that it will be kept confidential by both parties, as such terms are understood in accordance with 5 U.S.C. 552(b)(4) of the Freedom of Information Act and federal judicial interpretations of this statute. FEMA agrees that to the extent any information designated as competitively sensitive by a Sub-Committee Participant is responsive to a request for disclosure under the Freedom of Information Act, FEMA will consult with the Sub-Committee Participant and afford the Participant ten (10) working days to object to any disclosure by FEMA.

(4) FEMA will make good faith efforts to appropriately recognize unmarked Documents containing Competitively Sensitive Information as Competitively Sensitive Information. However, FEMA cannot guarantee that all unmarked Documents will be recognized as being Competitively Sensitive Information and protected from disclosure to third parties. If the unmarked Documents have not been disclosed without restriction outside of FEMA, the Sub-Committee Participant may retroactively request to have appropriate designations placed on the Documents. If the unmarked Documents have been disclosed without restriction outside of FEMA, FEMA will, to the extent practicable, remove any requested information from public forums controlled by FEMA and will work promptly to request that a receiving party return or destroy disclosed unmarked Documents if requested by the Sub-Committee Participant.

(5) Competitively Sensitive Information may be used by FEMA, alone or in combination with additional information, including Documents and Competitively Sensitive Information received from third parties, to support FEMA's implementation of this Plan as determined by the Chairperson. In all situations, FEMA will aggregate and anonymize Competitively Sensitive Information to the greatest extent possible to protect the interests retained by the owners of the data while still allowing the objectives of the Plan and Sub-Committee to be achieved. To the greatest extent possible, such aggregation will render the competitively sensitive nature of the Competitively Sensitive Information of the Sub-Committee Participant no longer recognizable in a commercially sensitive manner, and without sufficient information to enable, by inference or otherwise, attribution to Sub-Committee Participant or its affiliates (as clearly identified and disclosed to FEMA). Any disclosure of Competitively Sensitive Information by FEMA, within or outside a Sub-Committee, will be subject to review and approval by DOJ and FTC.

(6) Except as otherwise expressly permitted by applicable federal law, FEMA shall not disclose any Competitively Sensitive Information or use any Competitively Sensitive Information for any purpose other than in connection with the purposes of this Plan, and FEMA will not sell any Competitively Sensitive Information of any Sub-Committee Participant.

(7) Except as described below, FEMA may disclose Competitively Sensitive Information only to its employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors). Any individual with access to Competitively Sensitive Information will be expected to comply with the terms of this Plan.

a. Information Sharing within the Sub-Committee: FEMA may share Competitively Sensitive Information with Sub-Committee Participants and Federal Representatives of the Plan, and their respective employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors) where there is a need to know and where disclosure is reasonably necessary in furtherance of implementing the Plan. FEMA will aggregate and anonymize data prior to sharing with the Sub-Committee Participants to the greatest extent possible while still allowing the objectives of the Plan to be achieved, and will not share data—particularly to competitors of the submitter—prior to consultation with and approval by the DOJ and FTC.

i. Sub-Committee Participants, when providing Competitively Sensitive Information to FEMA, may request that this Information not be shared with other Sub-Committee Participants. Where these requests are made in good faith and are reasonable in nature, FEMA will respect these requests to the greatest extent possible and will consult the owner of the data prior to any release made to Sub-Committee Participants.

b. Restricted Reports. FEMA may communicate Competitively Sensitive Information to appropriate government officials through Restricted Reports. The information contained in Restricted Reports shall be aggregated and anonymized to the greatest extent possible, while recognizing that these officials may need a certain amount of granularity and specificity of information to appropriately respond to COVID-19. FEMA will aim to aggregate data to the County level, and will not share Restricted Reports prior to consultation and approval from the DOJ and FTC. FEMA may disclose Restricted Reports to relevant White House and Administration officials and State Governors, and their respective employees, officers, directors, contractors, agents, and advisors (including attorneys, accountants, consultants, and financial advisors) who have a need to know and to whom such disclosure is reasonably necessary solely in furtherance of the implementation of this Plan. FEMA shall take appropriate action (by instructions, agreement, or otherwise) to ensure that receiving parties comply with all data-sharing confidentiality and obligations under this Plan as if such persons or entities had been parties to this Plan.

c. Public Reports. FEMA may share information with the public through Public Reports. Data contained in Public Reports shall be fully aggregated and anonymized. Public Reports shall be aggregated to at least a state level and may be publicly disclosed after consultation and approval from the DOJ and FTC.

(8) Where possible and not obviated by Exigent Circumstances, FEMA will notify Sub-Committee Participants prior to the release of any Competitively Sensitive Information that has not been fully aggregated and anonymized. In consultation with DOJ and FTC, FEMA will consider any good-faith requests made by Sub-Committee members to hold the release of data or requests for further aggregation or anonymization. In general, FEMA will not provide notification prior to the release of Public Reports, under the presumption that the data in these reports has already been fully anonymized and de-identified.

(9) Any party receiving Competitively Sensitive Information through this Plan shall use such information solely for the purposes outlined in the Plan and take steps, such as imposing previously approved firewalls or tracking usage, to prevent misuse of the information. Disclosure and use of Competitively Sensitive Information will be limited to the greatest extent possible, and any party receiving Competitively Sensitive Information shall follow the procedures outlined in paragraph 7 above.

(10) At the conclusion of a Participant's involvement in a Plan—due to the deactivation of the Plan or due to the Participant's withdrawal or removal—each Participant will be requested to sequester any and all Competitively Sensitive Information received through participation in the Plan. This sequestration shall include the deletion of all Competitively Sensitive Information unless required to be kept pursuant to the Record Keeping requirements as described supra, Section I, 44 CFR part 332, or any other provision of law.

Each Sub-Committee Chairperson is responsible for ensuring that the Attorney General, or suitable delegate(s) from the DOJ, and the FTC Chair, or suitable delegate(s) from the FTC, have awareness of activities under this Plan, including activation, deactivation, and scheduling of meetings. The Attorney General, the FTC Chair, or their delegates may attend Sub-Committee meetings and request to be apprised of any activities taken in accordance with activities under this Plan. DOJ or FTC Representatives may request and review any proposed action by the Sub-Committee or Sub-Committee Participants undertaken pursuant to this Plan, including the provision of data. If any DOJ or FTC Representative believes any actions proposed or taken are not consistent with relevant antitrust protections provided by the DPA, he or she shall provide warning and guidance to the Sub-Committee as soon as the potential issue is identified. If questions arise about the antitrust protections applicable to any particular action, FEMA may request DOJ, in consultation with the FTC, provide an opinion on the legality of the action under relevant DPA antitrust protections.

This Plan establishes Sub-Committees to implement the Plan of Action to Establish a National Strategy for the Coordination of National Multimodal Healthcare Supply Chains to Respond to COVID-19 to provide the Federal Government and the Participants a forum to maximize the coordination of selected National Multimodal Healthcare Supply Chain resources and to create a prioritization protocol based upon existing or projected needs of End-Users and geographic areas within the National Multimodal Healthcare Supply Chains System. The outcome should include a framework to expeditiously meet critical needs within the National Multimodal Healthcare Supply Chains System that may arise in Exigent Circumstances, and to ensure actions to address such needs do not come with unacceptable risks to End-Users or interfere with other efforts to meet critical End-User requirements. A Sub-Committee Chairperson designated by the Chairperson will convene and preside over each Sub-Committee. Sub-Committees will not be used for contract negotiations or contract discussions between the Participants and the Federal Government; such negotiations or discussions will be in accordance with applicable federal contracting policies and procedures. However, this shall not limit any discussion within a Sub-Committee about the operational utilization of existing and potential contracts between the Participants and Representatives when seeking to align their use with overall manufacturing and distribution efforts consistent with this Plan.

Each Sub-Committee will consist of designated Representatives from FEMA, HHS, other federal agencies with equities in this Plan, and each Sub-Committee Participant. The Attorney General and Chair of the FTC, or their delegates, may also join each Sub-Committee and attend meetings at their discretion. Attendees may also be invited at the discretion of a Sub-Committee Chairperson as subject matter experts, to provide technical advice, or to represent other government agencies, but will not be considered part of the Sub-Committee.