The meeting will take place virtually on July 21, 2020, from 12:00 to 3:00 p.m. EDT. The general meeting is open to the public, and time will be permitted for public comment from 2:45-3:00 p.m. EDT. Members of the public seeking to attend the meeting are required to register in advance. Those interested in attending must provide notification by Friday, July 10, 2020, at 5:00 p.m. EDT, via the contact information provided above.

Written comments concerning ETTAC affairs are welcome any time before or after the meeting. To be considered during the meeting, written comments must be received by Friday, July 10, 2020, at 5:00 p.m. EDT to ensure transmission to the members before the meeting. Minutes will be available within 30 days of this meeting.

Topics to be considered: At this final meeting of the current (2018-2020) ETTAC charter, the ETTAC will present its recommendations to senior officials from the U.S. Department of Commerce, then interagency representatives of the Trade Promotion Coordinating Committee's Environmental Trade Working Group (TPCC ETWG) will respond to the recommendations that the ETTAC presented. The meeting will be co-chaired by senior officials from the International Trade Administration and the U.S. Environmental Protection Agency. The ETTAC's recommendation letters can be found atwww.export.gov/ettac. The recommendations were developed by the ETTAC's three subcommittees: Trade Policy and Trade Negotiations, Trade Promotion and Export Market Development, and Cooperation on Standards, Certifications and Regulations. OEEI will make the final agenda available to the public one week prior to the meeting. Please email Adam.OMalley@trade.gov for a copy.

Background: The ETTAC is mandated by Section 2313(c) of the Export Enhancement Act of 1988, as amended, 15 U.S.C. 4728(c), to advise the Environmental Trade Working Group of the Trade Promotion Coordinating Committee, through the Secretary of Commerce, on the development and administration of programs to expand U.S. exports of environmental technologies, goods, services, and products. The ETTAC was most recently re-chartered through August 16, 2020.

NOAA's Office of National Marine Sanctuaries administers the Dr. Nancy Foster Scholarship Program which recognizes outstanding achievement in master's and doctoral degrees in oceanography, marine biology, or maritime archaeology—this can include but is not limited to ocean and/or coastal: Engineering, social science, marine education, marine stewardship, resource management disciplines—and particularly to encourage women and members of minority groups to apply. The scholarship supports independent graduate level research through financial support of graduate degrees in such fields. Gender and minority status are not considered when selecting award recipients. However, special outreach efforts are employed to solicit applications from women and members of minority groups. Scholarships are distributed by disciplines, institutions, and geography, and by degree sought, with selections within distributions based on financial need, the potential for success in a graduate level studies program (academic achievement), and the potential for achieving research and career goals. Data collection in the form of a full application, letters of recommendation, grade point average documents, research outline, a letter of financial need statement, and a declaration statement are all required to apply for the scholarship.

Information is collected through an application submission, either electronically through the Grants.gov platform or if internet is not available, applicants may submit applications via mail.

OMB Control Number: 0648-0432.

Form Number(s): SF-424

Type of Review: Regular (extension of an approved collection).

Affected Public: Individuals.

Estimated Number of Respondents: 190.

Estimated Time per Response: Application and transcripts: 8 hours; Letters of recommendation: 45 minutes; Biographical sketch and photograph of awardees: 1 hour; Annual progress reports: 4 hours; Pre- and post-evaluations and exit interview: 10 minutes each.

Estimated Total Annual Burden Hours: 570 burden hours

Estimated Total Annual Cost to Public: $3,800.

Respondent's Obligation: Voluntary

Legal Authority: 16 U.S.C. 1445c-1 and 16 U.S.C. 1445c.

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 information collection request (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.

The purpose of this meeting is to make multi-year acceptable biological catch (ABC) recommendations for Atlantic surfclam, ocean quahog, longfin squid, and butterfish based on the results of the recently completed management track stock assessment updates. The SSC will recommend 2021-26 ABC specifications for Atlantic surfclam and ocean quahog; 2021-23 ABC specifications for longfin squid; and 2021-22 ABC specifications for butterfish. The SSC will also review the most recent survey and fishery data and the previously recommended 2021 ABC for Atlantic mackerel, bluefish, summer flounder, scup, and black sea bass. For summer flounder, scup, and black sea bass, the SSC will consider revising the 2021 ABC recommendation utilizing the new risk policy recently approved by the Council. The SSC will also review and provide feedback on ongoing Council actions, including the Summer Flounder, Scup, and Black Sea Bass Commercial/Recreational Allocation Amendment and the Bluefish Allocation and Rebuilding Amendment. In addition, the SSC may take up any other business as necessary.

A detailed agenda and background documents will be made available on the Council's website ( www.mafmc.org ) prior to the meeting.

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.

The meeting will begin with Introductions, Adoption of Agenda, Approval of Minutes from the June 29 and July 8-9, 2020 webinar meetings. Council staff will review the Scope of Work; and, the Committees will select a SSC Representative for the August 24-27, 2020 Gulf Council meeting. Florida Fish and Wildlife Conservation Commission (FWC) staff will review Southeast Data, Assessment, and Review (SEDAR) 64—Southeastern US Yellowtail Snapper Stock Assessment; with Current and Marine Recreational Information Program (MRIP)-adjusted Stock Apportionment between the Gulf of Mexico Fishery Management Council (GMFMC) and South Atlantic Fishery Management Council (SAFMC); and, Current and MRIP-adjusted Stock Allocations for the SAFMC. The Committees will also receive a Stock Assessment Executive Summary.

Committees will review an update of SEDAR 28—Gulf of Mexico Migratory Group Cobia Stock Assessment; including Assessment Presentation and Stock Status Determination, Projections and the Stock Assessment Executive Summary.

The Committees will review the July 13, 2020 MRIP Private Recreational Red Snapper Data Calibrations Workshop. The Committees will discuss the NOAA Office of Science and Technology (OST) Calibrations and Southeast Regional Office (SERO) Adjustments to Calibrations, Next Steps for Data Availability and Data Adjusting; Review of State-generated Calibrations; and, SSC Discussion.

The Committees will conclude their review the July 13, 2020 MRIP Private Recreational Red Snapper Data Calibrations Workshop. The Southeast Fisheries Science Center (SEFSC) will review Individual Fishing Quota (IFQ) Capacity and Technical Efficiency study. SEDAR will update the Committees on the Operational Assessment Process, and Council staff will review the proposed Timelines and Stock Identifications Process for SEDAR 74—Gulf of Mexico Red Snapper. Council and SEFSC staff will then review the Shrimp Stock Assessment Terms of Reference with the Committees.

Lastly, the Committees will discuss any other business items and receive public comments.

The meeting will be broadcast via webinar. You may register for the webinar by visiting www.gulfcouncil.org and clicking on the SSC meeting on the calendar.

The Agenda is subject to change, and the latest version along with other meeting materials will be posted on www.gulfcouncil.org as they become available.

Although other non-emergency issues not on the agenda may come before the Scientific and Statistical Committees for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Scientific and Statistical Committee will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.

This notice announces our review of the dusky sea snake ( Aipysurus fuscus ) listed as endangered under the ESA. Section 4(c)(2)(A) of the ESA requires that we conduct a review of listed species at least once every 5 years. This will be the first review of this species since it was listed in 2015. The regulations in 50 CFR 424.21 require that we publish a notice in the Federal Register announcing species currently under active review. On the basis of such reviews under section 4(c)(2)(B), we determine whether any species should be removed from the list ( i.e., delisted) or reclassified from endangered to threatened or from threatened to endangered (16 U.S.C. 1533(c)(2)(B)). As described by the regulations in 50 CFR 424.11(e), the Secretary shall delist a species if the Secretary finds that, after conducting a status review based on the best scientific and commercial data available: (1) The species is extinct; (2) the species does not meet the definition of an endangered species or a threatened species; and/or (3) the listed entity does not meet the statutory definition of a species. Any change in Federal classification would require a separate rulemaking process.

Background information on the species is available on the NMFS website at: https://www.fisheries.noaa.gov/species/dusky-sea-snake.

To ensure that the reviews are complete and based on the best available scientific and commercial information, we are soliciting new information from the public, governmental agencies, Tribes, the scientific community, industry, environmental entities, and any other interested parties concerning the status of Aipysurus fuscus. Categories of requested information include: (1) Species biology including, but not limited to, population trends, distribution, abundance, demographics, and genetics; (2) habitat conditions including, but not limited to, amount, distribution, and important features for conservation; (3) status and trends of threats to the species and its habitats; (4) conservation measures that have been implemented that benefit the species, including monitoring data demonstrating effectiveness of such measures; and (5) other new information, data, or corrections including, but not limited to, taxonomic or nomenclatural changes and improved analytical methods for evaluating extinction risk. If you wish to provide information for the review, you may submit your information and materials electronically or via mail (see ADDRESSES section). We request that all information be accompanied by supporting documentation such as maps, bibliographic references, or reprints of pertinent publications. We also would appreciate the submitter's name, address, and any association, institution, or business that the person represents; however, anonymous submissions will also be accepted.

This request is for extension of a currently approved information collection. Under the Magnuson-Stevens Fishery Conservation and Management Act, the Secretary of Commerce (Secretary) has the responsibility for the conservation and management of marine fishery resources. Much of this responsibility has been delegated to the National Oceanic and Atmospheric Administration (NOAA)/National Marine Fisheries Service (NMFS). Under this stewardship role, the Secretary was given certain regulatory authorities to ensure the most beneficial uses of these resources. One of the regulatory steps taken to carry out the conservation and management objectives is to collect data from users of the resources.

Regulations at 50 CFR 648.11(g) require observer service providers to comply with specific requirements in order to operate as an approved provider in the Atlantic sea scallop (scallop) fishery. Observer service providers must comply with the following requirements: Submit applications for approval as an observer service provider; formally request observer training by the Northeast Fisheries Observer Program (NEFOP); submit observer deployment reports and biological samples; give notification of whether a vessel must carry an observer within 24 hours of the vessel owner's notification of a prospective trip; maintain an updated contact list of all observers that includes the observer identification number; observer's name mailing address, email address, phone numbers, homeports or fisheries/trip types assigned, and whether or not the observer is “in service.” The regulations also require observer service providers submit any outreach materials, such as informational pamphlets, payment notification, and descriptions of observer duties as well as all contracts between the service provider and entities requiring observer services for review to NMFS/NEFOP. Observer service providers also have the option to respond to application denials and submit a rebuttal in response to a pending removal from the list of approved observer providers. These requirements allow NMFS/NEFOP to effectively administer the scallop observer program.

The approved observer service providers submit information to NMFS/NEFOP via email, fax, or postal service.

OMB Control Number: 0648-0546.

Form Number: None.

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

Affected Public: Business or other for-profit organization.

Estimated Number of Respondents: 515.

Estimated Time per Response: Application for approval of observer service provider, 10 hours; applicant response to denial of application for approval of observer service provider, 10 hours; observer service provider request for observer training, 30 minutes; observer deployment report, 10 minutes; observer availability report, 10 minutes; safety refusal report, 30 minutes; submission of raw observer data, 5 minutes; observer debriefing, 2 hours; biological samples, 5 minutes; rebuttal of pending removal from list of approved observer service providers, 8 hours; vessel request to observer service provider for procurement of a certified observer, 25 minutes; vessel request for waiver of observer coverage requirement, 5 minutes; observer contact list updates, 5 minutes; observer availability updates, 1 minute; service provider material submissions, 30 minutes; service provider contracts, 30 minutes.

Estimated Total Annual Burden Hours: 5,675.

Estimated Total Annual Cost to Public: $46,600.

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 information collection request (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.

NTIA seeks renewed approval under the Paperwork Reduction Act (PRA) to add 66 questions to a future edition of the U.S. Census Bureau's Current Population Survey (CPS). This collection of questions is known as the NTIA internet Use Survey, and is also referred to as the CPS Computer and internet Use Supplement. NTIA has sponsored fifteen such surveys since 1994, and previously used the current iteration of the survey instrument in 2017 and 2019.

As the digital economy's accelerating growth reinforces the internet's importance to the nation's economic prosperity, policymakers, businesses, non-profits, communities, and other stakeholders increasingly rely on data about whether and how Americans use broadband in their routine activities. Digitally-connected Americans provide the modern workforce, creative innovation, and growing customer base to help sustain our nation's global competitiveness; the NTIA internet Use Survey will yield data that can inform investment decisions and resource allocations to advance full participation in the digital economy. The research and policy analysis enabled by this data collection are particularly important as the nation recovers from a pandemic that has further highlighted the importance of the internet in daily life.

NTIA is working with Congress, the Federal Communications Commission (FCC), other federal agencies, state and local governments, as well as with industry and nonprofits to develop and promote policies that foster broadband deployment and adoption. These policies help to ensure that the nation's businesses and consumers can obtain competitively priced high-speed internet access and that everyone is able to gain the skills necessary to use the technology. Collecting current, systematic, and comprehensive information on broadband use and non-use by U.S. households is critical to enabling policymakers to gauge progress made to date, and also to identify specific areas and demographic groups in which broadband adoption is a concern with a specificity that permits carefully targeted and cost-effective responses.

The U.S. Census Bureau is widely regarded as a premier data collector based on centuries of experience and rigorous scientific methods. Collection of NTIA's requested broadband usage data will occur in conjunction with a future edition of the U.S. Census Bureau's CPS, thereby significantly reducing the potential burdens on the U.S. Census Bureau and on surveyed households.

The U.S. government has an increasingly pressing need for comprehensive broadband data. The U.S. Government Accountability Office (GAO), NTIA, and the FCC have issued reports noting the importance of useful broadband adoption data for policymakers. Moreover, Congress passed legislation—the Broadband Data Improvement Act in 2008 and the American Recovery and Reinvestment Act in 2009—wholly or in part to address this deficiency. Modifying the CPS to include NTIA's requested broadband questions will enable the Commerce Department and NTIA to respond to congressional concerns and directives.

NTIA has made a copy of the proposed information collection instrument available at https://www.ntia.gov/files/ntia/blogimages/november_2019_cps_supplement_-_final.pdf.

The NTIA internet Use Survey will be administered by the U.S. Census Bureau as a supplement to the CPS. Data will be collected through personal visits and live telephone interviews using computer-assisted telephone interviewing and computer-assisted personal interviewing.

OMB Control Number: 0660-0021.

Form Number(s): None.

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

Affected Public: Individuals and households.

Estimated Number of Respondents: 54,000 households.

Estimated Time per Response: 10 minutes.

Estimated Total Annual Burden Hours: 9,000.

Estimated Total Annual Cost to Public: $0.

Respondent's Obligation: Voluntary.

Legal Authority: 47 U.S.C. 902(b)(2)(M), (P).

We are soliciting public comments to permit NTIA 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.

Section 8 of the Secure and Trusted Communications Network Act of 2019 (Act) directs NTIA, in cooperation with the Office of the Director of National Intelligence, the Department of Homeland Security (DHS), the Federal Bureau of Investigation, and the Federal Communications Commission (FCC), to establish a program to share “supply chain security risk” information with trusted providers of “advanced communications service” and suppliers of communications equipment or services. As part of that program, NTIA must “conduct regular briefings and other events” to share information with trusted providers and suppliers and “engage” with such providers and suppliers, particularly those that are small businesses or that primarily serve rural areas. NTIA must also develop, and submit to Congress, a plan for declassifying material, when feasible, and expediting and expanding the provision of security clearances to facilitate information sharing from the Federal government to trusted providers and suppliers. On June 12, 2020, NTIA published a Notice and Request for public comments seeking public comment on several key terms in the Act, as well as on steps that should be taken to best achieve the purposes of the Act. See NTIA, Notice; Request for public comments, Promoting the Sharing of Supply Chain Security Risk Information Between Government and Communications Providers and Suppliers, 85 FR 35919 (June 12, 2020), available at: https://www.ntia.gov/files/ntia/publications/fr-rfc-promoting-sharing-supply-chain-security-risk-information.pdf. The original deadline for submission of comments was July 13, 2020. With today's Notice, NTIA extends the comment deadline by 15 days until July 28, 2020. All other information in the June 12, 2020, Notice and Request for public comments remain unchanged.

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: Education Stabilization Fund—Reimagine Workforce Preparation Grants.

OMB Control Number: 1830-NEW.

Type of Review: New information collection.

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

Total Estimated Number of Annual Responses: 40.

Total Estimated Number of Annual Burden Hours: 1,600.

Abstract: This is a request for approval of an information collection which solicits applications for Education Stabilization Fund—Reimagine Workforce Preparation Grants (ESF-RWP), which is authorized by section 18001(a)(3) of Division B of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The collection request includes a notice inviting applications and an accompanying application package. These documents set out the selection criteria used to assess the quality of applications and establish application requirements and the performance indicators on which grantees must report. This discretionary grant falls under the Streamlined Clearance Process for Discretionary Grant Information Collections, 1894-0001.

Since this collection was approved through emergency processing, the Department is providing the public with an opportunity to comment through the regular clearance process. This information collection will be transferred to the information collection requests, 1810-0741 and 1810-0743, to complete the comment period process. 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: CARES Act Programs; Equitable Services to Students and Teachers in Non-Public Schools.

OMB Control Number: 1810-NEW.

Type of Review: New information collection.

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

Total Estimated Number of Annual Responses: 1,900.

Total Estimated Number of Annual Burden Hours: 76,393.

Abstract: The U.S. Department of Education (Department) is issuing an interim final rule to clarify the requirement in section 18005 of Division B of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that local educational agencies (LEAs) provide equitable services to students and teachers in non-public schools under the Governor's Emergency Education Relief Fund (GEER Fund) and the Elementary and Secondary School Emergency Relief Fund (ESSER Fund) (collectively, the CARES Act programs). Section 18005(a) of the CARES Act requires an LEA that receives funds under the GEER Fund or the ESSER Fund to provide equitable services in the same manner as provided under section 1117 of the Elementary and Secondary Education Act of 1965 (ESEA) to students and teachers in non-public schools, as determined in consultation with representatives of non-public schools. This is a request for an emergency paperwork clearance from OMB on the data collections associated with the interim final rule.

Additional Information: An emergency clearance approval for the use of the system is described below due to the following conditions:

Pursuant to the Office of Management and Budget (OMB) procedures established at 5 CFR part 1320, the U.S. Department of Education (Department) requests that the following collection of information, non-public school poverty count and enrollment data to be collected by local educational agencies (LEAs) that receive funds under the Governor's Emergency Education Relief Fund (GEER Fund) and the Elementary and Secondary School Emergency Relief Fund (ESSER Fund) (collectively, the CARES Act programs), be processed in accordance with § 1320.13 Emergency Processing. The Department is issuing an interim final rule, Equitable Services to Students and Teachers in Non-Public Schools, to clarify the requirement in section 18005 of Division B of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that LEAs provide equitable services to students and teachers in non-public schools under the CARES Act programs. The Department has determined that LEAs must collect this information prior to the expiration of the time periods established under part 1320, and that approval of this information collection is essential for LEAs to effectively implement the interim final rule. Therefore, the Department is requesting emergency approval to provide LEAs the means to carry out the CARES Act programs as intended.

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: Mandatory Civil Rights Data Collection.

OMB Control Number: 1870-0504.

Type of Review: Revision of an existing information collection.

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

Total Estimated Number of Annual Responses: 17,621.

Total Estimated Number of Annual Burden Hours: 1,487,068.

Abstract: The collection, use, and reporting of education data is an integral component of the mission of the U.S. Department of Education (ED). EDFacts, an ED initiative to put performance data at the center of ED's policy, management, and budget decision-making processes for all K-12 education programs, has transformed the way in which ED collects and uses data. For school years 2009-10 and 2011-12, the Civil Rights Data Collection (CRDC) was approved by OMB as part of the EDFacts information collection (1875-0240). For school years 2013-14, 2015-16, and 2017-18, the Office for Civil Rights (OCR) cleared the CRDC as a separate collection from EDFacts. The currently proposed revised CRDC information collection for school year 2020-21 is modeled after the most recent OMB-approved EDFacts information collection (1850-0925). For the 2020-21 CRDC, OCR is proposing some changes, and those changes will have the net effect of reducing burden on school districts. As with previous CRDC collections, the purpose of the 2020-21 CRDC is to obtain vital data related to the civil rights laws' requirement that public local educational agencies (LEAs) and elementary and secondary schools provide equal educational opportunity. ED has analyzed the uses of many data elements collected in the 2013-14 and 2015-16 CRDCs and sought advice from experts across ED to refine, improve, and where appropriate, add or remove data elements from the collection. ED also made the CRDC data definitions and metrics consistent with other mandatory collections across ED wherever possible. ED seeks OMB approval under the Paperwork Reduction Act to collect from LEAs, the elementary and secondary education data described in the sections of Attachment A. In addition, ED requests that LEAs and other stakeholders respond to the directed questions found in Attachment A-5.

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 the U.S. Presidential Scholars Program.

OMB Control Number: 1860-0504.

Type of Review: Change to an existing information collection.

Respondents/Affected Public: Individuals or households.

Total Estimated Number of Annual Responses: 3,300.

Total Estimated Number of Annual Burden Hours: 52,800.

Abstract: The United States Presidential Scholars Program is a national recognition program to honor outstanding graduating high school seniors. Candidates are invited to apply based on academic achievements on the SAT or ACT assessments, through nomination from Chief State School Officers, other recognition program partner organizations, on artistic merits based on participation in a national talent program and achievement in career and technical education programs. This program was established by Presidential Executive Orders 11155, 12158 and 13697. The proposed change to the candidate portion of the Presidential Scholars application is to give the applicants a choice between two questions for a short answer essay. Question A is currently on the application. Question B is a new question and will provide the candidate with an option which was not available before.

Title: FERC-725N, Mandatory Reliability Standards TPL-007-4, Transmission System Planned Performance for Geomagnetic Disturbance Events.

OMB Control No.: 1902-0264.

Type of Request: Revisions to the information collection, as discussed in Docket No. RD20-3-000.

Abstract: The proposed Reliability Standard TPL-007-4 requires owners and operators of the Bulk-Power System to conduct initial and on-going vulnerability assessments of the potential impact of defined geomagnetic disturbance events on Bulk- Power System equipment and the Bulk-Power System as a whole. Specifically, the Reliability Standard requires entities to develop corrective action plans for vulnerabilities identified through supplemental geomagnetic disturbance vulnerability assessments and requires entities to seek approval from the Electric Reliability Organization of any extensions of time for the completion of corrective action plan items.

On August 8, 2005, Congress enacted into law the Electricity Modernization Act of 2005, which is Title XII, Subtitle A, of the Energy Policy Act of 2005 (EPAct 2005). 1 EPAct 2005 added a new section 215 to the FPA, which required a Commission-certified Electric Reliability Organization (ERO) to develop mandatory and enforceable Reliability Standards, which are subject to Commission review and approval. Once approved, the Reliability Standards may be enforced by the ERO subject to Commission oversight, or the Commission can independently enforce Reliability Standards. 2

On February 3, 2006, the Commission issued Order No. 672, implementing section 215 of the FPA. 3 Pursuant to Order No. 672, the Commission certified one organization, North American Electric Reliability Corporation (NERC), as the ERO. 4 The Reliability Standards developed by the ERO and approved by the Commission apply to users, owners and operators of the Bulk-Power System as set forth in each Reliability Standard.

On February 7, 2020, the North American Electric Reliability Corporation filed a petition seeking approval of proposed Reliability Standard TPL-007-4 (Transmission System Planned Performance for Geomagnetic Disturbance Events).

NERC's filed petition was noticed on February 11, 2020, with interventions, comments and protests due on or before March 9, 2020. No interventions or comments were received.

The DLO was issued on March 19, 2020. The standard goes in effect at NERC on October 1, 2020.

On April 16, 2020, the Commission published a Notice in the Federal Register in Docket No. RD20-3-000 requesting public comments. The Commission received no public comment(s) which is addressed here and in the related submittal to OMB.

Type of Respondents: Generator Owner, Planning Coordinator, Distribution Provider and Transmission Owners.

Estimate of Annual Burden:   5 Our estimates are based on the NERC Compliance Registry Summary of Entities as of January 31, 2020.

The individual burden estimates include the time needed to gather data, run studies, and analyze study results. These are consistent with estimates for similar tasks in other Commission-approved standards. Estimates for the additional average annual burden and cost  6 as proposed in Docket No. RD20-3-000 follow:

Comments: Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Section 108(a) of the Clean Air Act directs the Administrator to identify certain air pollutants which, among other things, “cause or contribute to air pollution which may reasonably be anticipated to endanger public health or welfare”;  1 and to issue air quality criteria for them. The air quality criteria are to “accurately reflect the latest scientific knowledge useful in indicating the kind and extent of all identifiable effects on public health or welfare which may be expected from the presence of [a] pollutant in the ambient air. . . .”. Under section 109 of the Act, EPA is then to establish NAAQS for each pollutant for which EPA has issued criteria. Section 109(d)(1) of the Act subsequently requires periodic review and, if appropriate, revision of existing air quality criteria to reflect advances in scientific knowledge on the effects of the pollutant on public health or welfare. EPA is also required to review and, if appropriate, revise the NAAQS, based on the revised air quality criteria (for more information on the NAAQS review process, see https://www.epa.gov/naaqs ).

EPA has established NAAQS for six criteria pollutants, including for lead (Pb). Periodically, EPA reviews the scientific basis for these standards by preparing an ISA (formerly called an Air Quality Criteria Document). The ISA provides the scientific basis for EPA's decisions, in conjunction with additional technical and policy assessments, on the adequacy of the current NAAQS and the appropriateness of possible alternative standards. Early steps in this process include announcing the beginning of this periodic NAAQS review and the development of the ISA, and EPA requesting that the public submit scientific literature that they want to bring to the attention of the Agency as it begins this process. The Clean Air Scientific Advisory Committee (CASAC), whose review and advisory functions are mandated by section 109(d)(2) of the Clean Air Act, is charged (among other things) with independent scientific review of the Agency's air quality criteria.

The ISA will build on the scientific assessment for the last review, 2 focusing on assessing the information newly available since that considered in the 2013 ISA. With regard to development of the ISA, the public is encouraged to assist in identifying relevant scientific information for the review by submitting research studies that were not part of the prior review, and have been published or accepted for publication in a peer-reviewed journal. The Agency is interested in obtaining information from new and emerging studies showing effects or no effects from Pb exposure. For example, the Agency is interested in information about studies of effects of controlled exposure to Pb, including in laboratory animals and in vitro systems; epidemiologic (observational) studies of associations of health outcomes with population exposures to Pb; and studies of ecological effects of Pb exposure. With regard to health effect studies, of particular interest are those studies that address or provide new information on health outcomes for which the scientific evidence presented in the 2013 ISA supported a “causal relationship” or “likely to be causal relationship” with Pb, e.g., cognitive effects in children, cardiovascular effects, and immune system effects; endpoints with less overall evidence and/or notable uncertainties at the time of the 2013 Pb ISA, such as attention deficit hyperactivity disorder, neurodegenerative effects, and adult obesity; endpoints not previously identified in the 2013 Pb ISA; relationships between Pb exposure concentrations and occurrence of health-related endpoints; health effects associated with blood lead levels below 10 µg/dL and/or with near current exposure concentrations; Pb toxicokinetics and toxicokinetic modeling; information and data useful for assessing biological plausibility for Pb-related health effects; and identification of populations and life stages at increased risk of Pb-related health effects. For ecological effects of Pb, studies that address or provide new information on terrestrial and aquatic biota are of particular interest including, but not necessarily limited to, effects of Pb on vegetation, soil and aquatic fauna, communities and populations of microorganisms, plants, and animals, as well as research on fate and transport of Pb in environmental media, and exposure-response relationships between Pb in ambient air or other media and ecological endpoints.

Information particular to air-related pathways of human and ecological exposure, including those involving deposition, are also of interest to the Agency. Air-related pathways are those that include air and may also involve media other than air, including indoor and outdoor dust, soil, surface water and sediments, vegetation and biota. Air-related Pb pathways of human exposure include inhalation of ambient air or ingestion of food, water or other materials, including dust and soil, containing Pb that has deposited from ambient air.

EPA also seeks recent information in other areas of Pb research such as human and ecological exposure assessment and exposure assessment methodologies, sources and emissions, chemistry and physics, sampling and analytical methodology, ambient concentrations and size distributions, including environmental media concentration changes in response to changes in Pb deposition, and other effects on public welfare or the environment not listed above.

The Agency also seeks information regarding the design and scope of the review of the air quality criteria and the primary (health-based) and secondary (welfare-based) Pb standards to ensure that it addresses key policy-relevant issues and considers the new science that is relevant to informing our understanding of these issues. The Agency also seeks new scientific information that may address key uncertainties identified in the last Pb NAAQS review, which are provided in the Policy Assessment (EPA-452/R-14, May 2014). 3 Other opportunities for submission of new peer-reviewed, published (or in-press) papers will be possible as part of public comment on the draft ISAs that will be reviewed by the CASAC.

Submit your materials identified by Docket ID No. EPA-HQ-OAR-2020-0312 by one of the following methods:

• www.regulations.gov: Follow the on-line instructions for submitting comments.

• Email: a-and-r-Docket@epa.gov.

• Fax: 202-566-9744. Due to COVID-19, there may be a delay in processing comments submitted by fax.

• Mail: Office of Air and Radiation (OAR) Docket (Mail Code: 28221T), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460. The phone number is 202-566-1752. Due to COVID-19, there may be a delay in processing comments submitted by mail.

Note: The EPA Docket Center and Reading Room is currently in the reopening process. Visitors may be considered on an exception basis. Visitors must complete docket material requests in advance and then make an appointment to retrieve the material. Visitors will be allowed entrance to the Reading Room by appointment only, and no walk-ins will be allowed.

Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-2020-0312. Please ensure that your comments are submitted within the specified comment period. Comments received after the closing date will be marked “late,” and may only be considered if time permits. It is EPA's policy to include all materials it receives in the public docket without change and to make the materials available online at www.regulations.gov, including any personal information provided, unless materials includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through www.regulations.gov or email. The www.regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email directly to EPA without going through www.regulations.gov, your email address will be automatically captured and included as part of the materials that are placed in the public docket and made available on the internet. If you submit electronic materials, EPA recommends that you include your name and other contact information in the body of your materials and with any disk or CD-ROM you submit. If EPA cannot read your materials due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider the materials you submit. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit EPA's Docket Center homepage at www.epa.gov/epahome/dockets.htm.

Docket: Documents in the docket are listed in the www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other materials, such as copyrighted material, are publicly available only in hard copy. Publicly available docket materials are available either electronically in www.regulations.gov or in hard copy at the OAR Docket in EPA's Headquarters Docket Center.

This public workshop is primarily directed to the TPCs, panel producers, and fabricators or laminated product producers who contract with TPCs to certify composite wood products under the formaldehyde emission standards for composite wood products final rule codified in 2016 at 40 CFR part 770. EPA is hosting the workshop to help inform potential development of future guidance to assist those seeking to petition the Agency through the provisions at 40 CFR 770.4(b), which ask EPA to initiate a rulemaking for additional exemptions for laminated products from the definition of hardwood plywood in the formaldehyde emission standards for composite wood products final rule. While the issue is of most relevance to laminated product producers, in general, importers, distributors and retailers who are affected by the formaldehyde emission standards for composite wood products final rule may also be interested in this workshop. Since other stakeholders may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in the issues to be discussed at the public workshop.

The docket for this action, identified by docket ID number EPA-HQ-OPPT-2019-0470, is available at http://www.regulations.gov. For assistance with the docket, and additional information about commenting, please go to http://www.epa.gov/dockets.

The final rule, entitled “Formaldehyde Emission Standards for Composite Wood Products” and codified at 40 CFR part 770, published in the Federal Register of December 12, 2016 (81 FR 89674) (FRL-9949-90) and became effective on May 22, 2017 (82 FR 14324, March 21, 2017) (FRL-9960-28-OP). Since publication of the final rule, EPA received feedback from regulated stakeholders requesting guidance on the process at 40 CFR 770.4(b) for the laminated product rulemaking petition for exemption from the definition of hardwood plywood. In the Federal Register of May 24, 2018, EPA announced a public related to Technical Issues—Formaldehyde Emission Standards for Composite Wood Products (83 FR 24104) (FRL-9978-21), where the Agency stated its intent to address the issue of working with stakeholders, through an additional workshop, to inform potential development of future guidance on how one can petition the Agency for this exemption. Thus, EPA will host this public workshop to discuss what types of information a petitioner should consider providing the Agency to support a determination on a petition submitted under 40 CFR 770.4(b). The workshop will also discuss what a typical submittal process may look like.

The Agency's intent is for participants to actively engage in an open dialogue with EPA and other participants on the agenda topics and to provide supporting documentation (in advance or after the workshop) as appropriate for EPA's consideration. The Agency plans to record the workshop and will post a written transcript in the docket for this workshop during the comment period that follows the workshop.

The Agency is allowing the comment period on this public workshop to remain open until after the workshop to provide stakeholders and interested parties ample time to develop additional comments, compile data, studies, and/or reports that can aid EPA in considering the development of guidance for submitting and supporting a laminated product rulemaking petition under 40 CFR 770.4(b) for exemption from the definition of hardwood plywood. Should the Agency develop guidance related to the rulemaking petitions for exemption under 40 CFR 770.4(b), EPA will provide a draft for public comment and post such guidance on the Agency's website.

An agenda for the public workshop has been included in the docket for this workshop.

The workshop will only be accessible remotely ( i.e., web conferencing) for registered participants. Participants will be provided information on how to connect to the workshop prior to its start that is sent to the email address participants provided when they registered for this workshop.

To register to attend the workshop and receive remote access, you must register online as described under ADDRESSES and by the date specified under DATES .

Attendees and participants will be offered the opportunity to speak and provide feedback during the workshop. To register for the workshop online, you must provide your full name, organization or affiliation, and contact information.

The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

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: 3060-0906.

Title: Annual DTV Ancillary/Supplemental Services Report for DTV Stations, FCC Form 2100, Schedule G; 47 CFR 73.624(g).

Form Number: FCC Form 2100, Schedule G (formerly FCC Form 317).

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit entities; Not-for-profit institutions.

Number of Respondents and Responses: 7,652 respondents, 15,304 responses.

Frequency of Response: Recordkeeping requirement, annual reporting requirement.

Obligation to Respond: Required to obtain benefits—Statutory authority for this collection of information is contained in Sections 154(i), 303, 336 and 403 of the Communications Act of 1934, as amended.

Estimated Time per Response: 2-4 hours.

Total Annual Burden: 45,912 hours.

Total Annual Cost: $1,147,800.

Nature and Extent of Confidentiality: There is no need for confidentiality required with this collection of information.

Privacy Impact Assessment: No impact(s).

Needs and Uses: In 2018, the Commission revised section 73.624(g) of its rules to require only those DTV stations that provided “feeable” ancillary or supplementary services during the relevant reporting period to submit Form 2100, Schedule G to the Commission. See Amendment of Section 73.624(g) of the Commission's Rules Regarding Submission of FCC Form 2100, Schedule G, Used to Report TV Stations' Ancillary or Supplementary Services, MB Docket Nos. 17-264, 17-105, FCC 18-41, Report and Order. Each licensee/permittee of a digital television (DTV) station that provides feeable ancillary or supplementary services during the relevant reporting period must file on an annual basis FCC Form 2100, Schedule G. Specifically, required filers include the following (but we generally refer to all such entities herein as a “DTV licensee/permittee”):

A licensee of a digital commercial or noncommercial educational (NCE) full power television (TV) station, low power television (LPTV) station, TV translator or Class A TV station.

A permittee operating pursuant to digital special temporary authority (STA) of a commercial or NCE full power TV station, LPTV station, TV translator or Class A TV station.

Each DTV licensee/permittee must report the feeable ancillary or supplementary services that were provided during the reporting cycle.

Each DTV licensee/permittee is required to retain the records supporting the calculation of the fees due for three years from the date of remittance of fees. Each NCE licensee/permittee must also retain for eight years documentation sufficient to show that its entire bitstream was used “primarily” for NCE broadcast services on a weekly basis.

On June 15, 1984, OMB delegated to the Board authority under the PRA to approve and assign OMB control numbers to collections of information conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies. Pursuant to its delegated authority, the Board may temporarily approve a revision to a collection of information, without providing opportunity for public comment, if the Board determines that a change in an existing collection must be instituted quickly and that public participation in the approval process would defeat the purpose of the collection or substantially interfere with the Board's ability to perform its statutory obligations.

As discussed below, the Board has made certain temporary revisions to the FR Y-9C information collection. The Board's delegated authority requires that the Board, after temporarily approving a collection, publish a notice soliciting public comment. Therefore, the Board is also inviting comment on a proposal to extend the FR Y-9 family of reports for three years, with these revisions to the FR Y-9C.

The Board invites public comment on the following information collection, which is being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:

a. Whether the proposed collection of information is necessary for the proper performance of the Board's functions, including whether the information has practical utility;

b. The accuracy of the Board's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

c. Ways to enhance the quality, utility, and clarity of the information to be collected;

d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and

e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.

At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Board should modify the proposal.

Report title: Financial Statements for Holding Companies.

Agency form number: FR Y-9C; FR Y-9LP; FR Y-9SP; FR Y-9ES; FR Y-9CS.

OMB control number: 7100-0128.

Frequency: Quarterly, semiannually, and annually.

Respondents: Bank holding companies (BHCs), savings and loan holding companies (SLHCs), securities holding companies (SHCs), and U.S. intermediate holding companies (IHCs) (collectively, holding companies (HCs)). 1

Estimated number of respondents:

FR Y-9C (non-advanced approaches (AA) HCs community bank leverage ratio (CBLR)) with less than $5 billion in total assets—71, FR Y-9C (non AA HCs CBLR) with $5 billion or more in total assets—35, FR Y-9C (non AA HCs non-CBLR) with less than $5 billion in total assets—84, FR Y-9C (non AA HCs non-CBLR) with $5 billion or more in total assets—154, FR Y-9C (AA HCs)—19, FR Y-9LP—434, FR Y-9SP—3,960, FR Y-9ES—83, FR Y-9CS—236.

Estimated average hours per response:

FR Y-9C (non AA HCs CBLR) with less than $5 billion in total assets—29.17, FR Y-9C (non AA HCs CBLR) with $5 billion or more in total assets—35.14, FR Y-9C (non AA HCs non-CBLR) with less than $5 billion in total assets—41.01, FR Y-9C (non AA HCs non-CBLR) with $5 billion or more in total assets—46.98, FR Y-9C (AA HCs)—48.80, FR Y-9LP—5.27, FR Y-9SP—5.40, FR Y-9ES—0.50, FR Y-9CS—0.50.

FR Y-9C—1, FR Y-9LP—1, FR Y-9SP—0.50, FR Y-9ES—0.50, FR Y-9CS—0.50.

Estimated annual burden hours:

FR Y-9C (non AA HCs CBLR) with less than $5 billion in total assets—8,284, FR Y-9C (non AA HCs CBLR) with $5 billion or more in total assets—4,920, FR Y-9C (non AA HCs non-CBLR) with less than $5 billion in total assets—13,779, FR Y-9C (non AA HCs non-CBLR) with $5 billion or more in total assets—28,940, FR Y-9C (AA HCs)—3,709, FR Y-9LP—9,149, FR Y-9SP—42,768, FR Y-9ES—42, FR Y-9CS—472.

FR Y-9C—1,452, FR Y-9LP—1,736, FR Y-9SP—3,960, FR Y-9ES—42, FR Y-9CS—472.

General description of report: The FR Y-9 family of reporting forms continues to be the primary source of financial data on holding companies that examiners rely on in the intervals between on-site inspections. The Board requires HCs to provide standardized financial statements to fulfill the Board's statutory obligation to supervise these organizations. Financial data from these reporting forms are used to detect emerging financial problems, to review performance and conduct pre-inspection analysis, to monitor and evaluate capital adequacy, to evaluate holding company mergers and acquisitions, and to analyze a holding company's overall financial condition to ensure the safety and soundness of its operations. The FR Y-9C report serves as standardized financial statements for the consolidated holding company. The FR Y-9LP and FR Y-9SP are parent-company only financial statements submitted primarily based on the HC's total consolidated assets. The FR Y-9ES is a financial statement for HCs that are Employee Stock Ownership Plans. The Board uses the voluntary FR Y-9CS (a free-form supplement) to collect additional information deemed to be critical and needed in an expedited manner. HCs file the FR Y-9C on a quarterly basis, the FR Y-9LP quarterly, the FR Y-9SP semiannually, and the FR Y-9ES annually, as applicable, and the FR Y-9CS on a schedule that is determined when this supplement is used.

The Board has temporarily revised the FR Y-9C to collect four new data items related to the Paycheck Protection Payment (PPP) loans and the Paycheck Protection Program Liquidity Facility (PPPLF). 2

In addition, the Board temporarily revised the FR Y-9C to collect two new items related to Section 4013 of the CARES Act. Section 4013 of the CARES Act permits holding companies flexibility in modifying loans related to the coronavirus disease 2019 (COVID-19).

Section 1102 of the CARES Act allows for banking organizations to make loans under a program of the Small Business Administration (SBA) in connection with COVID-19 disruptions to small businesses (referred to as PPP loans or PPP covered loans). While the loans are funded by the banking organizations, they receive a guarantee from the SBA. The Federal Reserve subsequently established a liquidity facility to permit banking organizations to obtain non-recourse loans, for which PPP loans are pledged to the facility, to provide additional liquidity.

The Board needs to collect information on the number and outstanding balance of PPP loans, as well as the outstanding balance and quarterly average of PPP loans pledged to the liquidity facility, for use in supervising holding companies. These items also would enable Federal Reserve supervision staff to monitor credit and liquidity risk, aggregate industry trends, and individual institutions' use of the PPPLF. Therefore, the Board temporarily approved the addition of four new data items to collect this information, with the collection of these items expected to be time-limited. The Board would collect these items through the December 31, 2021, as-of date. If the Board subsequently determines that there is a supervisory need for this information beyond December 31, 2021, an extension of these items would be published for comment in a separate Federal Register notice.

Starting with the June 30, 2020, reporting period, a holding company will be required to report the total number of PPP loans outstanding, the outstanding balance of PPP loans, the outstanding balance of PPP loans pledged to the Federal Reserve's liquidity facility, and the quarterly average amount of PPP loans pledged to the Federal Reserve's liquidity facility and excluded from average total assets in the calculation of the leverage ratio. These items have been added to Schedule HC-M, as items 25.a, 25.b, 25.c, and 25.d.

Section 4013 of the CARES Act suspends the requirements under United States generally accepted accounting principles for eligible loan modifications related to the COVID-19 pandemic that would otherwise be categorized as troubled debt restructurings (TDRs). The CARES Act defines an eligible loan under section 4013 (section 4013 loan) as a loan modification that is (1) related to COVID-19, (2) executed on a loan that was not more than 30 days past due as of December 31, 2019, and (3) executed between March 1, 2020, and the earlier of (A) 60 days after the date of termination of the National Emergency concerning the COVID-19 outbreak or (B) December 31, 2020. Section 4013(d)(2) of the CARES Act provides that federal banking agencies may collect data about section 4013 loans for supervisory purposes.

Holding companies accounting for eligible loans under Section 4013 are not required to apply ASC Subtopic 310-40 to the Section 4013 loans for the term of the loan modification. In addition, HCs do not have to report Section 4013 loans as TDRs in regulatory reports. However, as provided for under Section 4013, HCs should maintain records of the volume of section 4013 loans and the collection of data about such loans may be required for supervisory purposes.

Consistent with section 4013(d)(2) of the CARES Act, the Board has added two new data items for section 4013 loans to the FR Y-9C, which would be collected quarterly beginning with the June 30, 2020, report date. These confidential items would enable Federal Reserve supervision staff to monitor credit risk, aggregate industry trends, and individual institutions' use of the temporary relief provided by section 4013. These new items, Memorandum item 16.a, “Number of Section 4013 loans outstanding,” and Memorandum item 16.b, “Outstanding balance of Section 4013 loans,” have been added to Schedule HC-C, Part I, Loans and Leases. These items will enable the Board to monitor individual HCs' use of the temporary relief provided by Section 4013 as well as the volume of loans modified in accordance with section 4013. The Board would collect these items through the December 31, 2021, as-of date. If the Board subsequently determines that there is a supervisory need for this information beyond December 31, 2021, an extension of these items would be published for comment in a separate Federal Register notice.

The Board will collect institution-level section 4013 loan information on a confidential basis. The Board has encouraged financial institutions to work with their borrowers during the National Emergency related to COVID-19, including use of the relief under Section 4013. 3 However, public disclosure of supervisory information on Section 4013 loans could have a detrimental impact on holding companies offering modifications under this provision to borrowers that need relief due to COVID-19.

The Board has determined that these temporary revisions to the FR Y-9C must be instituted quickly and that public participation in the approval process would defeat the purpose of the collection of information, as delaying the revisions would result in the collection of inaccurate information, would interfere with the Board's ability to perform its statutory duties and to properly supervise holding companies.

Additionally, the Board proposes to extend the FR Y-9 family of reports for three years, with the revisions to the FR Y-9C discussed above, in order to permit continued accurate reporting of related data.

Legal authorization and confidentiality: The Board has the authority to impose the reporting and recordkeeping requirements associated with the FR Y-9 family of reports on BHCs pursuant to section 5 of the Bank Holding Company Act of 1956 (BHC Act) (12 U.S.C. 1844); on SLHCs pursuant to section 10(b)(2) and (3) of the Home Owners' Loan Act (12 U.S.C. 1467a(b)(2) and (3)), as amended by sections 369(8) and 604(h)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act); on U.S. IHCs pursuant to section 5 of the BHC Act (12 U.S.C 1844), as well as pursuant to sections 102(a)(1) and 165 of the Dodd-Frank Act (12 U.S.C. 511(a)(1) and 5365); and on securities holding companies pursuant to section 618 of the Dodd-Frank Act (12 U.S.C. 1850a(c)(1)(A)). The obligation to submit the FR Y-9 series of reports, and the recordkeeping requirements set forth in the respective instructions to each report, are mandatory.

With respect to the FR Y-9C report, Schedule HI's memoranda data item 7(g) “FDIC deposit insurance assessments,” Schedule HC-P's data item 7(a) “Representation and warranty reserves for 1-4 family residential mortgage loans sold to U.S. government agencies and government sponsored agencies,” and Schedule HC-P's data item 7(b) “Representation and warranty reserves for 1-4 family residential mortgage loans sold to other parties” are considered confidential commercial and financial information. Such treatment is appropriate under exemption 4 of the Freedom of Information Act (FOIA) (5 U.S.C. 552(b)(4)) because these data items reflect commercial and financial information that is both customarily and actually treated as private by the submitter, and which the Board has previously assured submitters will be treated as confidential. It also appears that disclosing these data items may reveal confidential examination and supervisory information, and in such instances, this information would also be withheld pursuant to exemption 8 of the FOIA (5 U.S.C. 552(b)(8)), which protects information related to the supervision or examination of a regulated financial institution.

For both the FR Y-9C report and the FR Y-9SP report, Schedule HC's memorandum item 2.b., the name and email address of the external auditing firm's engagement partner, is considered confidential commercial information and protected by exemption 4 of the FOIA (5 U.S.C. 552(b)(4)) if the identity of the engagement partner is treated as private information by HCs. The Board has assured respondents that this information will be treated as confidential since the collection of this data item was proposed in 2004.

Additionally, items on the FR Y-9C, Schedule HC-C for loans modified under section 4013, data items Memorandum items 16.a, “Number of Section 4013 loans outstanding” and Memorandum items 16.b, “Outstanding balance of Section 4013 loans” are considered confidential. While the Board generally makes institution-level FR Y-9C report data publicly available, the Board is collecting section 4013 loan information as part of condition reports for the impacted HCs and the Board considers disclosure of these items at the HC level would not be in the public interest. 4 Such information is permitted to be collected on a confidential basis, consistent with 5 U.S.C. 552(b)(8). 5 In addition, holding companies may be reluctant to offer modifications under section 4013 if information on these modifications made by each holding company is publicly available, as analysts, investors, and other users of public FR Y-9C report information may penalize an institution for using the relief provided by the CARES Act. The Board may disclose section 4013 loan data on an aggregated basis, consistent with confidentiality or as otherwise required by law.

Aside from the data items described above, the remaining data items on the FR Y-9C report and the FR Y-9SP report are generally not accorded confidential treatment. The data items collected on FR Y-9LP, FR Y-9ES, and FR Y-9CS reports are also generally not accorded confidential treatment. As provided in the Board's Rules Regarding Availability of Information (12 CFR part 261), however, a respondent may request confidential treatment for any data items the respondent believes should be withheld pursuant to a FOIA exemption. The Board will review any such request to determine if confidential treatment is appropriate, and will inform the respondent if the request for confidential treatment has been denied.

To the extent the instructions to the FR Y-9C, FR Y-9LP, FR Y-9SP, and FR Y-9ES reports each respectively direct the financial institution to retain the workpapers and related materials used in preparation of each report, such material would only be obtained by the Board as part of the examination or supervision of the financial institution. Accordingly, such information is considered confidential pursuant to exemption 8 of the FOIA (5 U.S.C. 552(b)(8)). In addition, the workpapers and related materials may also be protected by exemption 4 of the FOIA, to the extent such financial information is treated as confidential by the respondent (5 U.S.C. 552(b)(4)).

Consultation outside the agency: The Federal Reserve consulted with the Office of the Comptroller of the Currency and the Federal Deposit Insurance Corporation in the development of this proposal.

Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis of Agreement Containing Consent Orders to Aid Public Comment describes the terms of the consent agreement and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC website (for June 26, 2020), at this web address: https://www.ftc.gov/news-events/commission-actions.

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before August 6, 2020. Write “Eldorado and Caesars; File No. 191 0158” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the https://www.regulations.gov website.

Due to the public health emergency in response to the COVID-19 outbreak and the agency's heightened security screening, postal mail addressed to the Commission will be subject to delay. We strongly encourage you to submit your comments online through the https://www.regulations.gov website.

If you prefer to file your comment on paper, write “Eldorado and Caesars; File No. 191 0158” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D), Washington, DC 20580; or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

Because your comment will be placed on the publicly accessible website at https://www.regulations.gov, you are solely responsible for making sure that your comment does not include any sensitive or confidential information. In particular, your comment should not include any sensitive personal information, such as your or anyone else's Social Security number; date of birth; driver's license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any “trade secret or any commercial or financial information which . . . is privileged or confidential”—as provided by Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—including in particular competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted on the public FTC website—as legally required by FTC Rule 4.9(b)—we cannot redact or remove your comment from the FTC website, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request.

Visit the FTC website at http://www.ftc.gov to read this Notice and the news release describing this matter. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding, as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before August 6, 2020. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

The Federal Trade Commission (“Commission”) has accepted for public comment, subject to final approval, an Agreement Containing Consent Orders (“Consent Agreement”) from Eldorado Resorts, Inc. (“Eldorado”) and Caesars Entertainment Corporation (“Caesars”). The purpose of the proposed Consent Agreement is to remedy the anticompetitive effects that would likely result from Eldorado's acquisition of Caesars (“the Acquisition”). Under the terms of the proposed Decision and Order (“Order”) contained in the Consent Agreement, Eldorado is required to divest to Twin River Worldwide Holdings, Inc. (“Twin River”): (1) Eldorado's only casino in the South Lake Tahoe area, the MontBleu Resort Casino and Spa (“MontBleu”) in Stateline, Nevada; and (2) Eldorado's only casino in the Bossier City-Shreveport, Louisiana, area, the Eldorado Casino Resort (“Eldorado Shreveport”). The divestitures must be completed by the earlier of (i) 12 months from the closing of the Acquisition; or (ii) 30 days from the date that Twin River receives all regulatory approvals. Additionally, if Eldorado does not consummate its sale of the Isle of Capri casino (“Isle of Capri”) in Kansas City, Missouri, within 60 days from the closing of the Acquisition, the proposed Consent Agreement provides the Commission with the option (at its discretion) to require Eldorado to divest the Isle of Capri casino to a Commission-approved acquirer within 12 months. The Isle of Capri sale is independent from the Acquisition.

The proposed Consent Agreement has been placed on the public record for 30 days for receipt of comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will review the comments received and decide whether it should withdraw, modify, or make the Consent Agreement final.

On June 24, 2019, Eldorado agreed to acquire Caesars for approximately $17.3 billion. By a vote of 3-1-1 on June 25, 2020, the Commission issued an administrative complaint alleging that the Acquisition, if consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 45, by eliminating meaningful and substantial competition between Eldorado and Caesars for casino services in the South Lake Tahoe, Bossier City-Shreveport, and Kansas City area markets. The elimination of this competition would likely have caused significant competitive harm, specifically higher prices and diminished quality and service levels in each of these markets. The proposed Consent Agreement would remedy the alleged violations by requiring a divestiture in the affected markets. The divestitures will establish a new independent competitor to Eldorado in each relevant area, replacing the competition that otherwise would be lost as a result of the Acquisition.

Eldorado is a publicly traded casino entertainment and hospitality services provider headquartered in Reno, Nevada. Founded in 1973, Eldorado operates 23 casino gaming properties in 11 states. Eldorado operates casinos under several brands, including Eldorado, Isle of Capri, and Tropicana. In the aggregate, Eldorado's properties feature approximately 23,900 slot machines, 660 table games, and more than 11,300 hotel rooms. In the South Lake Tahoe area market, Eldorado operates the MontBleu casino in Stateline, Nevada. In the Bossier City-Shreveport area market, Eldorado operates the Eldorado Shreveport casino in Shreveport, Louisiana. In the Kansas City area market, Eldorado operates the Isle of Capri casino in Kansas City, Missouri. Eldorado had approximately $2.5 billion in revenue in 2019.

Caesars is a publicly traded casino entertainment and hospitality services provider headquartered in Las Vegas, Nevada. It operates 53 properties in 14 states and five countries outside of the United States. Caesars' properties offer approximately 38,000 slot machines, 2,700 table games, and more than 36,000 hotel rooms. Caesars' gaming properties operate primarily under the Harrah's, Caesars, and Horseshoe brand names. In the South Lake Tahoe area, Caesars operates two facilities offering casino services: Harrah's Lake Tahoe Hotel and Casino, and Harveys Lake Tahoe Hotel and Casino, both in Stateline, Nevada. In the Bossier City-Shreveport area, Caesars operates two facilities offering casino services: Horseshoe Bossier City Hotel and Casino in Bossier City, Louisiana, and Harrah's Louisiana Downs, a gaming and racetrack facility located eight miles east in Shreveport, Louisiana. In the Kansas City area market, Caesars operates Harrah's Kansas City Hotel and Casino in Kansas City, Missouri. Caesars had approximately $8.7 billion in revenue in 2019.

Twin River is a publicly traded casino entertainment and hospitality services provider headquartered in Providence, Rhode Island. It operates eight properties in four states, including the Twin River Casino Hotel in Lincoln, Rhode Island. Twin River's properties feature approximately 9,130 slot machines, 267 table games, and 1,200 hotel rooms. The company had approximately $524 million in revenue in 2019.

Eldorado's proposed acquisition of Caesars would likely result in substantial competitive harm in the markets for casino services in South Lake Tahoe, Bossier City-Shreveport and Kansas City. The relevant product market in which to assess the competitive effects of the proposed Acquisition is casino services. The casino services market consists of casino-based gaming services ( e.g., slots and table games), as well as other amenities such as lodging, entertainment, and food and beverage services. Casino operators typically generate the vast majority of their revenues from gaming. Casino services differ significantly from other entertainment and leisure activities in a number of respects. For example, casinos are highly regulated, with a limited number of casinos licensed to operate in any given state and age restrictions on who can gamble. Consistent with prior Commission precedent, the evidence here supports a distinct relevant market consisting of casino services.

Local geographic markets are appropriate to assess the competitive effects of the proposed Acquisition. There are three relevant geographic markets in which to analyze the merger's effects: (1) The South Lake Tahoe area, which approximately corresponds to the area in and around the cities of Stateline, Nevada, and South Lake Tahoe, California; (2) the Bossier City-Shreveport, Louisiana area, which approximately corresponds to the Bossier City-Shreveport, Louisiana metropolitan statistical area; and (3) the Kansas City area, which approximately corresponds to the Kansas City, Missouri metropolitan statistical area.

Absent relief, the Acquisition would result in significant increases in concentration and lead to highly concentrated markets in all three markets, resulting in a presumption of the enhancement of market power under the Horizontal Merger Guidelines. Further, Eldorado and Caesars are close and vigorous competitors in the South Lake Tahoe, Bossier City-Shreveport, and Kansas City area markets. Absent relief, the Acquisition would substantially lessen the significant head-to-head competition between Eldorado and Caesars and would likely increase Eldorado's ability and incentive to raise prices post-Acquisition in the form of hold rates, rake rates, and table game rules and odds that are less favorable to customers, and lower player reinvestments. The proposed Acquisition also would likely diminish Eldorado's incentive to maintain or improve the quality of services and amenities to the detriment of casino customers in each of these markets.

New entry or expansion is unlikely to deter or counteract the likely anticompetitive effects of the Acquisition in the South Lake Tahoe, Bossier City-Shreveport, and Kansas City area markets. The affected markets are insulated from new entry or expansion by significant regulatory barriers, including limitations on the number of casino licenses available and the ability to expand existing gaming operations. In the South Lake Tahoe area market, entry or expansion is unlikely to occur in a timely manner because of, among other things, the time and cost associated with acquiring the necessary state, county, and city approvals. In the Bossier City-Shreveport area market, Louisiana law limits the number of casino licenses and it has already issued all available licenses. Louisiana also has statutory restrictions that make significant expansion by current market participants unlikely absent legislative action. Similarly, in the Kansas City area market, Missouri and Kansas law limit the total number of casino licenses available and both states have already issued all available licenses. Expansion in Missouri is unlikely and only limited expansion in Kansas is possible. Entry or repositioning would be unlikely to be sufficient to deter or counteract the anticompetitive effects of the Acquisition.

The proposed Consent Agreement remedies the likely anticompetitive effects in the South Lake Tahoe and Bossier City-Shreveport area markets by requiring divestitures of the MontBleu and Eldorado Shreveport casinos to Twin River by the earlier of (i) 12 months from the closing of the Acquisition; or (ii) 30 days from the date Twin River receives all regulatory approvals. Until the completion of each divestiture, the parties are required to abide by the Order to Hold Separate and Maintain Assets, which requires them to maintain the viability, marketability, and competitiveness of the divestiture assets until the divestitures are completed. The proposed Consent Agreement appoints a Monitor to ensure the parties' compliance with the Order to Hold Separate and Maintain Assets, Consent Agreement, and divestiture agreements between Eldorado and Twin River following the divestiture. The proposed Consent Agreement also remedies the likely anticompetitive effects in the Kansas City area market in the event that Eldorado's independent sale of the Isle of Capri casino does not close within 60 days from the closing of the Acquisition. In the event the Isle of Capri sale does not timely close as required, the proposed Consent Agreement provides the Commission with the option (at its discretion) to require Eldorado to divest the Isle of Capri casino to a Commission-approved acquirer within 12 months. Although these divestiture deadlines are longer than typically ordered by the Commission, they are appropriate in this matter to accommodate the lengthy state regulatory approval process, which may be subject to continued disruption from the COVID-19 pandemic.

Additionally, the proposed Consent Agreement requires the parties to provide transitional services to the approved acquirer for up to 12 months after the divestiture, as needed, to assist the acquirer with the transfer and operation of the divested assets. Finally, the proposed Consent Agreement contains standard terms regarding the acquirer's access to employees, protection of material confidential information, and compliance reporting requirements, among other things, to ensure the viability of the divested business.

The proposed Consent Agreement remedies the likely anticompetitive effects of the proposed Acquisition in the South Lake Tahoe area market by requiring the divestiture of Eldorado's MontBleu. This remedy would preserve the status quo in the South Lake Tahoe area casino services market, maintaining three independent casino operators and resulting in no change in market concentration.

The proposed Consent Agreement remedies the likely anticompetitive effects of the proposed Acquisition in the Bossier City-Shreveport area market by requiring Eldorado to divest the Eldorado Shreveport. This remedy would preserve four independent casino operators and result in no change in market concentration.

In the Kansas City area market, the proposed Consent Agreement provides the Commission with the option (at its discretion) to require Eldorado to divest its Isle of Capri casino to a Commission-approved buyer within 12 months if its independent sale of the Isle of Capri fails to consummate within 60 days of closing the Acquisition. If a divestiture is required, the proposed Consent Agreement remedies the likely anticompetitive effects of the Acquisition by requiring Eldorado to divest the Isle of Capri. The proposed Consent Agreement would preserve four independent casino operators and result in no change in market concentration.

The purpose of this analysis is to facilitate public comment on the proposed Consent Agreement to aid the Commission in determining whether it should make the proposed Consent Agreement final. This analysis is not an official interpretation of the proposed Consent Agreement and does not modify its terms in any way.

• The Commission should not agree to merger settlements unless divestitures are completed promptly to a qualified buyer ready and willing to compete on day one.

• It is risky and makes little sense to propose a complex settlement with a prolonged divestiture period and unorthodox terms to justify a merger that has no meaningful benefits, particularly given the financial uncertainties stemming from the COVID-19 crisis.

• I am concerned that the Commission's standard process for vetting divestiture buyers minimizes or ignores major financial red flags. We should revamp our approach.

Caesars Entertainment (NASDAQ: CZR) is selling itself to one of its smaller competitors, Eldorado Resorts (NASDAQ: ERI). The transaction has no noteworthy benefits to customers, workers, suppliers, or competition. If anything, the transaction is risky for everyone involved.

The enormous amount of debt financing could materially increase the likelihood of financial distress of the combined casino conglomerate, and rating agencies have already started to downgrade Eldorado's debt. 1 Given the major financial uncertainties looming over the gaming industry stemming from the pandemic, as well as the industry's past experiences with leveraged buyouts, the proposed transaction might make conditions even more fragile and precarious.

The agreement is subject to review by state gaming regulators and the Federal Trade Commission. In comparison to state regulators, who must weigh a number of public interest factors, the Federal Trade Commission's mandate is more specific: To determine whether the transaction violates U.S. antitrust laws. Based on the Commission's investigation, I agree that the transaction is illegal and I support the complaint.

However, I have serious reservations about the terms of the settlement. As a policy matter, I disagree that the Commission should enter into risky, complicated settlements with delayed divestitures—like the resolution proposed here.

To remedy an illegal transaction, the FTC should only agree to settlements when divestitures will quickly restore the competitive intensity killed off from a merger. It is not enough to have some of the competition restored; it must be fully restored. A new competitor should be able to step in on day one to compete.

For example, in 2015, the FTC prevailed in its challenge of the merger of Sysco and US Foods, the nation's two largest food distributors, when divestitures could not cure the harmful merger on “day one.” The companies proposed to divest a lengthy list of US Foods' assets to an entity controlled by the Blackstone Group. The FTC argued this was insufficient, and the court agreed that the new competitor could not replicate the same level of competitive intensity of US Foods. 2

The Commission's proposed remedy will definitely not cure this harmful casino merger on day one. Under the terms of the Commission's proposed settlement, Eldorado is required to divest one property in Nevada and another in Louisiana to Twin River Worldwide Holdings (NYSE: TRWH)—but after a prolonged period of time. 3 Allowing a lengthy divestiture only compounds the problems with this settlement, as it necessitates the addition of other risky settlement provisions.

To mitigate the anticompetitive harm from the prolonged divestiture schedule, the FTC's proposed settlement sets up a complex arrangement where some casinos will be operated separately by Commission-appointed casino property managers until a buyer is ready to take over the assets. I do not believe that the Commission should be in the business of appointing casino property managers here. 4

The Commission will also appoint a monitor. It is particularly unclear how the Commission and the appointed monitor can remove or discipline the casino property managers. In addition, the casino property managers will operate under a similar compensation and bonus plan as provided by the prior owner, which could easily lead to anticompetitive distortions. The anticompetitive harms could grow if Twin River is rejected as a suitable buyer by state regulators.

There may be rare circumstances where unusual settlement terms are warranted, but this isn't one of them. The proposed remedy is also a gamble on several other fronts.

First, the Commission's due diligence on Twin River did not adequately analyze the role of new investors exerting enormous control. The FTC must always consider the incentives and plans for those in control of a divestiture buyer. Sometimes, new investors can help a stagnant company change strategic direction. But too often, new investors find ways to buy, strip, and flip, rather than create a strong, long-term competitor. This is particularly true for certain private equity and hedge fund investors, so careful due diligence is critical.

In 2019, a Wall Street hedge fund, Standard General, accumulated a major ownership stake in Twin River. Standard General now has significant control over the company and is, by far, its largest shareholder. Its stake is roughly equivalent to the maximum amount allowable under state law. 5 Another hedge fund, HG Vora, has also emerged as a major holder of Twin River. 6 Standard General and similar funds often seek to accumulate board seats to implement their desired investment strategy. Indeed, just a few months ago, Twin River's longtime chairman “reluctantly” stepped down and was replaced by Standard General's managing partner, Soohyung Kim. 7

By approving Twin River as the divestiture buyer, I am concerned that the Commission is relying on Twin River's past track record, rather than analyzing how changes in ownership and control of the company will impact their future business strategy.

Second, buyers of divested assets need to prioritize competing on day one, but they cannot if other high-priority mergers and acquisitions distract them. In this matter, Twin River is in the midst of a string of other takeovers.

In 2019, it completed an acquisition of Dover Downs Hotel and Casino in Delaware, 8 and then in January of this year, Twin River acquired three casinos in Colorado. 9 Several other acquisitions are pending: in the last twelve months, it has inked deals to purchase casinos in Missouri and Mississippi. 10 Outside of this settlement, it has also struck a deal to purchase Bally's, its first foray into the large Atlantic City market. 11 These acquisitions will require significant management attention, and I did not find any compelling evidence that Twin River will prioritize the divested assets to fully restore competitive intensity in the markets that the Commission believes would suffer from killed-off competition.

Finally, the Commission should avoid acting without the benefit of a full review by the state gaming regulators. State regulatory agencies have unique insights and expertise into the industries they regulate; their findings inform the issues the Commission takes into consideration, and not just relating to the appointment of casino managers. Some states have a specific mandate to look at the ownership and financial conditions of the transacting firms, and we would benefit from that expertise. Their analysis is particularly important during this period of uncertainty, as the industry is roiling from closures due to the current COVID-19 pandemic. It is important that we consider all of the information and work across government bodies to protect competition. While the Commission does work with some of these authorities, I am not convinced that acting before state regulators have completed their analysis is the right approach.

The proposed resolution in this transaction offers a unique window into the assumptions and philosophy of the Federal Trade Commission. The merger is clearly anticompetitive in the markets where the Commission alleged a violation, and offers no meaningful benefits to the public. Since the Commission would not need to go to trial to block the transaction because the state regulators have yet to act, there is no immediate concern about limiting FTC resources or weighing the litigation risk. Given these facts, why would the Commission put the public at risk with delayed divestitures to a questionable buyer that has no guarantee of obtaining a license?

I am concerned that the Commission is rolling the dice with this complex settlement that will clearly not lead to an immediate restoration of lost competition. It is also clear that we must revamp our approach when it comes to vetting proposed divestiture buyers, particularly when a new financial investor is in charge in the boardroom.

Our state partners will obviously need to scrutinize the financial aspects of the proposed transaction between Caesars and Eldorado, given the harms inflicted on the public and regional economies from past leveraged buyouts—and resulting bankruptcies—in the industry. 12 They will also need to carefully assess whether the restoration of competition will come too late, and whether Twin River can guarantee that it will actually accomplish this goal. The stakes are high right now. For these reasons, I dissent.

Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis of Agreement Containing Consent Orders to Aid Public Comment describes the terms of the consent agreement and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC website (for June 24, 2020), at this web address: https://www.ftc.gov/news-events/commission-actions.

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before August 6, 2020. Write “Tri Star Energy, LLC; File No. 201-0074” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the https://www.regulations.gov website.

Due to the public health emergency in response to the COVID-19 outbreak and the agency's heightened security screening, postal mail addressed to the Commission will be subject to delay. We strongly encourage you to submit your comments online through the https://www.regulations.gov website.

If you prefer to file your comment on paper, write “Tri Star Energy, LLC; File No. 201-0074” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D), Washington, DC 20580; or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

Because your comment will be placed on the publicly accessible website at https://www.regulations.gov, you are solely responsible for making sure that your comment does not include any sensitive or confidential information. In particular, your comment should not include any sensitive personal information, such as your or anyone else's Social Security number; date of birth; driver's license number or other state identification number, or foreign country equivalent; passport number; financial account number; or credit or debit card number. You are also solely responsible for making sure your comment does not include any sensitive health information, such as medical records or other individually identifiable health information. In addition, your comment should not include any “trade secret or any commercial or financial information which . . . is privileged or confidential”—as provided by Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)—including in particular competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c). Your comment will be kept confidential only if the General Counsel grants your request in accordance with the law and the public interest. Once your comment has been posted on the public FTC website—as legally required by FTC Rule 4.9(b)—we cannot redact or remove your comment from the FTC website, unless you submit a confidentiality request that meets the requirements for such treatment under FTC Rule 4.9(c), and the General Counsel grants that request.

Visit the FTC website at http://www.ftc.gov to read this Notice and the news release describing this matter. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding, as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before August 6, 2020. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

The Federal Trade Commission (“Commission”) has accepted for public comment, subject to final approval, an Agreement Containing Consent Orders (“Consent Agreement”) from Tri Star Energy, LLC (“Tri Star”) and Hollingsworth Oil Company, Inc., C & H Properties, and Ronald L. Hollingsworth (“Hollingsworth” and collectively, the “Respondents”). The Consent Agreement is designed to remedy the anticompetitive effects that likely would result from Tri Star's proposed acquisition of retail fuel assets from Hollingsworth.

Under the terms of the proposed Consent Agreement, Tri Star must divest to the upfront buyer, Cox Oil Company, Inc. (“Cox”), retail fuel assets in two local markets in Tennessee. Tri Star must complete the divestiture within 10 days after the closing of Tri Star's acquisition of Hollingsworth. The Commission and Respondents have agreed to an Order to Maintain Assets that requires Respondents to operate and maintain each divestiture outlet in the normal course of business through the date Cox acquires the outlet.

The Commission has placed the proposed Consent Agreement on the public record for 30 days to solicit comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will again review the proposed Consent Agreement and the comments received, and will decide whether it should withdraw from the Consent Agreement, modify it, or make it final.

Respondent Tri Star, a company headquartered in Nashville, Tennessee, owns and operates convenience stores and retail fuel outlets throughout Tennessee, Alabama, Georgia, and Kentucky. Tri Star operates 89 convenience stores with attached retail fuel outlets, including 82 in Tennessee. Tri Star's convenience stores operate under the Twice Daily, Hightail, and t-Fuel names, and its retail fuel outlets sell under a variety of third-party branded and unbranded fuel banners. Tri Star also supplies fuel to a network of 285 dealer locations.

Respondent Mr. Ronald L. Hollingsworth, a resident of the state of Tennessee, controls both Hollingsworth Oil Company, Inc. and C & H Properties, entities operating in Tennessee. Hollingsworth operates a network of 54 convenience stores under the Sudden Service name with attached retail fuel outlets throughout middle Tennessee. Hollingsworth provides a variety of third-party branded and unbranded fuels at its Sudden Service outlets and to 172 wholesale fuel locations.

On March 6, 2020, Tri Star entered into an agreement to acquire certain retail fuel outlets and other interests, from Hollingsworth and related entities (the “Acquisition”). The Acquisition would expand Tri Star's presence throughout middle Tennessee.

The Commission's Complaint alleges that the Acquisition, if consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and that the Acquisition agreement constitutes a violation of Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 45, by substantially lessening competition for the retail sale of gasoline and the retail sale of diesel in each of two local markets in Tennessee.

The Commission's Complaint alleges that the relevant product markets in which to analyze the Acquisition are the retail sale of gasoline and the retail sale of diesel fuel. Consumers require gasoline for their gasoline-powered vehicles and can purchase gasoline only at retail fuel outlets. Likewise, consumers require diesel for their diesel-powered vehicles and can purchase diesel only at retail fuel outlets. The retail sale of gasoline and the retail sale of diesel fuel constitute separate relevant markets because the two are not interchangeable—vehicles that run on gasoline cannot run on diesel and vehicles that run on diesel cannot run on gasoline.

The Commission's Complaint alleges the relevant geographic markets in which to assess the competitive effects of the Acquisition are two local markets in and around Whites Creek, Tennessee, and Greenbrier, Tennessee.

The geographic markets for retail gasoline and retail diesel are highly localized, ranging up to a few miles, depending on local circumstances. Each relevant market is distinct and fact-dependent, reflecting a number of considerations, including commuting patterns, traffic flows, and outlet characteristics. Consumers typically choose between nearby retail fuel outlets with similar characteristics along their planned routes. The geographic markets for the retail sale of diesel are likely similar to the corresponding geographic markets for retail gasoline as many diesel consumers exhibit the same preferences and behaviors as gasoline consumers.

The Acquisition would eliminate competition in these local markets, resulting in a merger to monopoly in each market for the retail sale of gasoline and the retail sale of diesel fuel. Retail fuel outlets compete on price, store format, product offerings, and location, and pay close attention to competitors in close proximity, on similar traffic flows, and with similar store characteristics. The combined entity would be able to raise prices unilaterally in the two local markets. Absent the Acquisition, Tri Star and Hollingsworth would continue to compete head to head in these local markets.

Entry into each relevant market would not be timely, likely, or sufficient to deter or counteract the anticompetitive effects arising from the Acquisition. Significant entry barriers include the availability of attractive real estate, the time and cost associated with constructing a new retail fuel outlet, and the time associated with obtaining necessary permits and approvals.

The proposed Consent Agreement would remedy the Acquisition's likely anticompetitive effects by requiring Tri Star to divest certain Tri Star and Hollingsworth retail fuel assets to Cox in each local market.

The proposed Consent Agreement requires that the divestiture be completed no later than 10 days after Tri Star consummates the Acquisition. The proposed Consent Agreement further requires Tri Star and Hollingsworth to maintain the economic viability, marketability, and competitiveness of each divestiture asset until the divestiture to Cox is complete. For up to twelve months following the divestiture, Tri Star and Hollingsworth must make available transitional services, as needed, to assist Cox with the divestiture assets.

In addition to requiring outlet divestitures, the proposed Consent Agreement also requires Respondents to provide the Commission notice before re-acquiring the divested outlets for ten years. The prior notice provision is necessary because an acquisition of either or both divested assets would likely raise the same competitive concerns and may fall below the HSR Act premerger notification thresholds.

The proposed Consent Agreement contains additional provisions designed to ensure the effectiveness of the proposed relief. For example, Respondents have agreed to an Order to Maintain Assets that will issue at the time the proposed Consent Agreement is accepted for public comment. The Order to Maintain Assets requires Respondents to operate and maintain each divestiture outlet in the normal course of business, through the date the Respondents complete the divestiture. The Commission may appoint an independent third party as a Monitor to oversee the Respondents' compliance with the requirements of the proposed Consent Agreement.

The purpose of this analysis is to facilitate public comment on the proposed Consent agreement, and the Commission does not intend this analysis to constitute an official interpretation of the proposed Consent Agreement or to modify its terms in any way.

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 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.

FDA is seeking to conduct qualitative and quantitative research studies to better understand consumers', patients', caregivers', academic/scientific experts', and public health professionals' perceptions and behaviors regarding various issues and outcomes associated with disease prevention, treatment, and the safety and efficacy off all FDA-regulated products. These studies may consist of small groups, focus groups, individual indepth interviews, and surveys relating to the evaluation of disease prevention and treatment and the safety, efficacy, and usage of FDA-regulated products and communication messages and strategies, and other materials directed to consumers, patients, caregivers, and public health professionals ( e.g., evaluate the effectiveness of communication messages, educational materials, and interventions directed toward promoting and protecting human and animal health).

Among the general provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is charged with promoting the public health through regulatory oversight as well as clinical research. Specifically, section 1003 of the FD&C Act (21 U.S.C. 393(d)(2)(C) and (D)) provides that the Commissioner of Food and Drugs shall be responsible for research. Accordingly, FDA is seeking to conduct qualitative and quantitative research studies. These studies may consist of small groups, focus groups, individual in-depth interviews, and surveys relating to the evaluation of disease prevention and treatment and the safety, efficacy, and usage of FDA-regulated products and communication messages and strategies, and other materials directed to consumers, patients, caregivers, and public health professionals ( e.g., evaluate the effectiveness of communication messages, educational materials, and interventions directed toward promoting and protecting human and animal health).

The information collection is intended to support research conducted by, or on behalf of, FDA. Understanding consumers, patients, caregivers, academic/scientific experts, and public health professionals' perceptions and behaviors plays an important role in improving FDA's decision-making processes and communications impacting various stakeholders. To better understand consumers, patient, caregivers, academic/scientific experts, and public health professionals' perceptions and behaviors regarding various issues and outcomes associated the disease prevention, treatment, and the safety, efficacy, and usage of products overseen by the Agency, FDA is requesting approval of this generic information collection request.

The qualitative and quantitative research anticipated by FDA aligns with Agency objectives. For example, among eight scientific priorities is the goal to support social and behavioral sciences. Such research helps the Agency meet this goal by:

• Identifying gaps in the target audience's knowledge regarding FDA-regulated products, and outcomes associated the disease prevention, treatment;

• reaching diverse audiences;

• assessing target audiences' knowledge, perceptions, and behaviors about FDA-regulated products;

• evaluating the effectiveness of FDA's communications;

• exploring ways to incorporate patient input into decision-making;

• leveraging real-world data;

• evaluating outcomes; and

• integrating the knowledge gained from the research into Agency communications, activities, interventions, and programs.

FDA will only submit a collection for approval under this generic clearance if it meets the following conditions: information provided by respondents will be kept private and anonymous, except as otherwise required by law. This will be communicated to respondents by means of introductory letters, explanatory texts on the cover pages of questionnaires, scripts read prior to focus groups or telephone interviews, and consent forms as appropriate. Respondents also will be advised of the following: (1) The nature of the activity; (2) the intended purpose and use of the data collected; (3) FDA sponsorship (when appropriate); and (4) the fact that participation is voluntary at all times. Because responses are voluntary, respondents will be assured that there will be no penalties if they decide not to respond, either to the information collection as a whole or to any individual questions.

Only Agency or Agency-sponsored personnel will have access to individual-level surveys, interviews, or focus group data. All project staff from a contractor or cooperative agreement grantee conducting the information collection must take required measures to ensure respondent privacy and confidentiality of data. Personally identifiable information (PII) shall be limited to data that may be required in the process of respondent enrollment. PII will be accessible to only those contractors or cooperative agreement grantee who need it and will not be linked to interview data. Neither FDA employees nor any Federal employee of any other agency will have access to PII. All PII will be destroyed by contractors as soon as feasible following data collected during interviews.

All electronic and hard-copy data will be maintained securely throughout the information collection and data processing phases. While under review, electronic data will be stored in locked files on secured computers; hard-copy data will be maintained in secure building facilities in locked filing cabinets. As a further guarantee of privacy and anonymity, all data will be reported to FDA in aggregate form, with no links to individuals preserved. Reports generated by this information collection will be used only for research purposes and for the development of communication messages.

Social and behavioral testing efforts described in this proposal are typically considered exempt from the “Regulations for the Protection of Human Subjects” in accordance with 45 CFR 46.101(b)(3). Before data are collected, FDA researchers must obtain either an exemption or an expedited or full approval for all research from FDA's institutional review board (IRB).

When FDA's IRB determines that minors are capable of giving assent, the IRB shall determine whether adequate provisions are made for soliciting assent. Generally, assent requires securing the signature of a minor potentially participating in the research in a separate assent form, in addition to the consent form the parent or legal guardian signs. An assent document should: (1) Contain an explanation of the study; (2) a description of what is required of the subject ( e.g., what he or she will experience (whether the minor will be in the hospital, whether the minor's parents will be with him or her, etc.)); (3) an explanation of any risks and pain associated with the study; (4) an explanation of any anticipated change in the minor's appearance; and (5) an explanation of the benefits to the minor or others.

FDA plans to use the data collected under this generic clearance to inform its FDA-regulated products educational, interventions, outcomes, and regulatory science programs, materials and resources and disease prevention and treatment. FDA expects the data to guide the formulation of the Agency's educational and public health objectives on FDA-regulated products and support development of subsequent research efforts. The data will not be used to make policy or regulatory decisions. Rather, these data will: (1) Inform FDA's public education campaigns and other educational/interventional materials directed to informing consumers, patients, caregivers, and public health professionals about human and animal health issues and (2) provide information on the safety, efficacy, and usage of FDA-regulated products.

If these conditions are not met, FDA will submit an information collection request to OMB for approval through the normal PRA process.

To obtain approval for a collection that meets the conditions of this generic clearance, an abbreviated supporting statement will be submitted to OMB along with supporting documentation ( e.g., a copy of the interview or moderator guide, screening questionnaire).

FDA will submit individual qualitative and quantitative collections under this generic clearance to the OMB. Individual collections will also undergo review by FDA's IRB, senior leadership in the for the primary investigator's respective offices, and PRA specialists.

Description of Respondents: The respondents to this collection of information are all FDA stakeholders including, general population individuals, as well as consumers of certain products, patients and their caregivers, academic/scientific experts, individuals from specific target labor groups such as physicians, medical specialists, pharmacists, dentists, nurses, veterinarians, dietitians, and other public health professionals.

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

On December 17, 2014, FDA published a final guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Standardized Study Data” (eStudy Data guidance), posted on FDA's Study Data Standards Resources web page at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The eStudy Data guidance implements the electronic submission requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379k-1(a)) for study data contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and certain investigational new drug applications (INDs) submitted to CDER or CBER by specifying the format for electronic submissions. The eStudy Data guidance states that a Federal Register notice will specify any new standards and version updates, when the support begins or ends, and when the requirement begins or ends, that will be added to the Catalog. Support for version 1.7 of the CDISC SDTM IG 3.3 and version 2.1 of the Define-XML will begin on March 15, 2021, and the date that the requirement begins will be on March 15, 2022, for NDAs, ANDAs, and certain BLAs. For noncommercial INDs, the date that requirement begins will be March 15, 2023. Support and requirement ended for version 1.3 of the CDISC SDTM IG 3.1.3 will end on March 15, 2021.

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 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.

Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act.

The Office of Prescription Drug Promotion's (OPDP) mission is to protect the public health by helping to ensure that prescription drug promotional material is truthful, balanced, and accurately communicated, so that patients and health care providers can make informed decisions about treatment options. OPDP's research program provides scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to our mission. Our research focuses in particular on three main topic areas: Advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features, we assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits. Focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience, and our focus on research quality aims at maximizing the quality of our research data through analytical methodology development and investigation of sampling and response issues. This study will inform the first two topic areas: Advertising features, including content and format, and target populations.

Because we recognize that the strength of data and the confidence in the robust nature of the findings is improved by utilizing the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our homepage, which can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website includes links to the latest Federal Register notices and peer-reviewed publications produced by our office. The website maintains information on studies we have conducted, dating back to a survey on direct-to-consumer (DTC) advertisements conducted in 1999.

The purpose of this research is to build on prior FDA research on the topic of disclosures by examining the impact of disclosures of two different types of information, detailed later in this notice. The literature on disclosures suggests their effectiveness is subject to format, design, and audience factors, among other things (Ref. 1). For example, research on consumer attitudes have found some people believe that FDA evaluates certain dietary supplement claims despite the presence and consumer awareness of language required by the Dietary Supplement Health and Education Act, which clearly states that FDA has not evaluated those claims (Refs. 2 and 3). In the context of prescription drug promotion, there is initial evidence that—when noticed—disclosures may effectively convey important information (Refs. 4 to 6); however, what role disclosures may play in educating or correcting misunderstanding warrants further investigation.

In the new study proposed here, the first type of disclosed information we will examine is clinical benefit information based on a secondary endpoint reported in a product's approved labeling (a secondary claim). In some cases, truthful and non-misleading presentations about secondary endpoints in well-designed clinical studies can provide reliable information about treatment effects that may be distinct from the treatment effects described in the product's indication statement. For example, a product may be indicated to treat a specific type of cancer based on a primary endpoint of survival. However, a secondary endpoint in the study of that product may provide data about an additional distinct benefit, such as functional status.

Phase 1 of the proposed research will examine the impact of adding a disclosure about a secondary claim in DTC and healthcare professional (HCP)-directed promotion in the context of a prescription drug website. We will also examine the effect of the presence of a comparative claim about the secondary claim. Our proposed main outcome measures are perceptions of and attitudes toward the product, the secondary claim, and the disclosure. The pretest and main studies for Phase 1 will have the same design, will be conducted online, and will follow the same procedure. We will examine four levels of secondary claim disclosure to explore the effects of disclosing that the secondary benefit is not one of the indicated uses of the product ( e.g., not a treatment for [the secondary benefit claim], quantitative information about claim, not a treatment for [claim] and quantitative information about claim, or no disclosure), and two levels (presence or absence) of a comparative element regarding the secondary claim, for a total of eight experimental conditions (see table 1). Participants will be randomly assigned to one of these conditions; they will view one version of a website. This 4 × 2 design will be replicated across two target populations (HCPs and consumers).

The second, independent phase of the proposed research will examine disclosures about a biosimilar product. In both consumer and HCP audiences, we will assess the impact of a disclosure designating the product as a biosimilar as well as varying basic factual statements about biosimilars. Phase 2 will examine the impact of: (1) Adding a disclosure designating the product as a biosimilar; (2) adding general informational statements about biosimilars; and (3) naming a reference product. This approach allows us to examine the effect of disclosing biosimilar status, examines the additive effect of including one, two, or three additional basic statements of information about biosimilars, and measures the effect of naming the reference product. Our proposed main outcome measures are perceptions of and attitudes toward the biosimilar product and the disclosure.

We propose to examine seven different disclosure conditions plus a control with no disclosure for a total of eight test conditions. As a baseline, each of the seven disclosure conditions will include a statement that the drug is a biosimilar. Six of the seven disclosure conditions will include this baseline statement and will vary the amount of additional basic factual information about biosimilar products in the following way: (1) Two of the six conditions have the baseline + statement A; (2) two of the six conditions have the baseline + statement A + statement B; and (3) two of the six conditions have the baseline + statement A + statement B + statement C. Moreover, three of the six disclosure conditions will name the specific reference product while the other three will refer to a reference product generally (for example, “This biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product”). The wording of the disclosure will be tailored to the audience; for example, the disclosures for the consumer audience will avoid technical terms. A control condition will also be included in which no biosimilar statement or additional information disclosure is presented.

The pretest and main studies for Phase 2 will have the same design, will be conducted online, and will follow the same procedure. Both phases will be conducted concurrently. Sample sizes were determined on the basis of power analysis that will allow us to detect medium effect sizes.

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

FDA is requesting that public stakeholders—including patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts—notify the Agency of their intent to participate in periodic stakeholder consultation meetings on the reauthorization of PDUFA. PDUFA authorizes FDA to collect user fees from the regulated industry for the process for the review of human drugs. The authorization for the current program (PDUFA VI) expires in September 2022. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to fund the human drug review process.

Section 736B(f)(1) of the FD&C Act (21 U.S.C. 379h-2(f)(1)) requires that FDA consult with a range of stakeholders, including representatives from patient and consumer groups, healthcare professionals, and scientific and academic experts, in developing recommendations for the next PDUFA program. FDA will initiate the reauthorization process by holding a public meeting on July 23, 2020, where stakeholders and other members of the public will be given an opportunity to present their views on the reauthorization. The FD&C Act further requires that FDA continue meeting with these stakeholders at least once every month during negotiations with the regulated industry to continue discussions of stakeholder views on the reauthorization. It is anticipated that these monthly stakeholder consultation meetings will commence in September 2020.

FDA is issuing this Federal Register notice to request that stakeholder representatives from patient and consumer groups, healthcare professional associations, as well as scientific and academic experts, notify FDA of their intent to participate in the periodic stakeholder consultation meetings on PDUFA reauthorization. FDA believes that consistent stakeholder representation at these meetings will be important to ensure progress in these discussions. If you wish to participate in the stakeholder consultation meetings, please designate one or more representatives from your organization who will commit to attending these meetings and preparing for the discussions. Stakeholders who identify themselves through this notice will be included in all stakeholder consultation discussions while FDA negotiates with the regulated industry. If a stakeholder decides to participate in these monthly meetings at a later time, that stakeholder may join the remaining monthly stakeholder consultation meetings after notifying FDA of this intention (see ADDRESSES ). These stakeholder discussions will satisfy the consultation requirement in section 736B(f)(3) of the FD&C Act.

If you intend to participate in continued periodic stakeholder consultation meetings regarding PDUFA reauthorization, please provide notification by email to PDUFAReauthorization@fda.hhs.gov by August 17, 2020. Your email should contain complete contact information, including name, title, affiliation, address, email address, phone number, and notice of any special accommodations required because of disability. Stakeholders will receive confirmation and additional information about the first meeting after FDA receives this notification.

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

Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA-regulated products in carrying out the provisions of the FD&C Act.

Prescription opioids play a significant role in the opioid misuse and abuse epidemic in the United States. Opioid analgesics with properties designed to deter abuse, commonly known as abuse deterrent formulations (ADFs), may play a role in helping to curb this epidemic. Currently available ADFs have been demonstrated to deter some forms of abuse (injection, snorting, or, in some cases, chewing and swallowing). FDA's own research and other evidence suggests considerable variability in health care providers' (HCPs) knowledge of and attitudes toward prescription opioid products and practices (Ref. 1), including understanding of ADFs. ADF prescription practices may present opportunities for HCPs to reduce opioid abuse. Conducting a comprehensive evaluation of opioid prescribers' knowledge, attitudes, perceptions, experiences, and behaviors related to ADFs will help to inform FDA's approaches to ADFs.

Given the significance and far-reaching nature of the opioid crisis, along with FDA concerns about potential misunderstanding among HCPs about ADF terminology and capabilities, FDA determined that systematic research was necessary to provide the detailed and comprehensive evidence on which to base the Agency's ADF-related policy, regulatory, and communication decisions, including potential alternative language that may be necessary to describe and explain these products. This work aligns with Priority 1 of the FDA's Strategic Policy Roadmap ( https://www.fda.gov/about-fda/reports/healthy-innovation-safer-families-fdas-2018-strategic-policy-roadmap ), and the Department of Health and Human Services (HHS) and the Administration have similarly placed high priorities on addressing the epidemic of misuse and abuse of opioid drugs harming U.S. families.

The study's purpose is to explore and assess the ADF-related knowledge, attitudes, and behaviors among opioid prescribers (physicians, nurse practitioners and physician assistants) and dispensers/pharmacists, including the related terms addiction and abuse deterrence, and to explore possible alternative language for describing these products. Phase 1 consisted of focus groups (OMB approval under control number 0910-0695). The research described in this notice represents Phases 2 and 3 of the overall project.

Phase 2 will consist of a survey based on the Phase 1 focus group findings related to: (1) Health care provider understanding of addiction, abuse, and abuse deterrent formulations; (2) attitudes toward, perceptions about, and experiences with abuse-deterrent opioid analgesics and abuse deterrence, including prescribing decisions and practices, potential barriers to using ADFs, the quality and understandability of the ADF nomenclature, and the underlying reasons for these perceptions; and (3) HCPs' ideas for minimizing confusion about ADFs, the kinds of ADF training needed, and suggested language/terms they believe would best convey the concept of abuse deterrence to HCPs. The objective of the survey will be to determine the prevalence of HCP knowledge, attitudes, behaviors, and perceptions identified through the qualitative discussion occurring in the Phase 1 focus groups and to uncover any subgroup differences among opioid prescribers and dispensers. We will conduct one pretest, averaging not longer than 20 minutes, to pilot the main survey procedures among the target HCP populations. The main survey will also average 20 minutes.

Phase 3 will build on findings from the Phase 1 focus groups and Phase 2 survey and will consist of an experimental study examining variations in descriptive terminology for abuse deterrent formulation products. We will conduct two pretests, each averaging not longer than 20 minutes, to test the experimental manipulations and pilot the main study procedures. The main study procedure will also average 20 minutes in length. Participants will be randomly assigned to read a description of abuse deterrent formulation opioids that contains one of four terms that could be used to refer to these products (ADF will function as the control term) and then complete a questionnaire that assesses their comprehension and perceptions of the information, including terminology, as well as their attitudes, behavioral intentions, and experience related to these types of opioid products.

For all phases of this research, we will recruit adult health care professional volunteers 18 years of age or older. We will exclude individuals who work for HHS or work in the health care, marketing, or pharmaceutical industries. The sample will consist of 10 percent pharmacists, at least half of whom dispense ADF opioids. The other 90 percent will be prescribers who, at the time they are recruited, spend at least 50 percent of their time seeing patients and who have prescribed opioids to at least five different patients in the last 30 days, with at least half of the opioids they prescribe being for chronic non-cancer pain. The prescriber sample will be segmented to include 70 percent primary care providers ( i.e., those practicing in family practice, or internal or general medicine) and 30 percent a mix of specialists practicing in a variety of fields such as rheumatology, neurology, anesthesiology, pain management, emergency medicine, surgery, orthopedics, and physical medicine and rehabilitation. In each of these groups, 60 to 70 percent will consist of physicians, 15 percent nurse practitioners, and 15 percent physician assistants. A minimum of 30 percent must have experience prescribing an ADF opioid.

We will use soft quotas to ensure that our sample includes a diversity of participants, including related to age, race/ethnicity, gender, years and location of practice, and opioid prescribing levels. We will also exclude pretest participants from the main studies, and participants will not be able to participate in more than one phase of the project. With the sample sizes described below, we will have sufficient power to detect primarily small-sized effects for Phases 2 and 3.

In the Federal Register of February 5, 2020 (85 FR 6562), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received three submissions that were PRA-related. Within those submissions, FDA received multiple comments, which the Agency has addressed below.

(Comment 1) I believe Phase 2 should include more pharmacists than 10 percent ratio.

(Response 1) We have carefully planned the sample for the study to ensure sufficient numbers of prescribers, including primary care providers and several types of specialists (including neurologists, pain management specialists, rheumatologists, neurologists, surgeons, orthopedists, physical medicine and rehabilitation specialists), physician assistants and nurse practitioners, as well as including a group of pharmacists for analysis. Expanding the sample further is beyond the scope of what we have planned for the project. Our power analysis suggests we will have sufficient power to ensure comparisons between groups in the sample. In addition, in the earlier focus group phase, pharmacists said they rarely talk with patients about ADFs and never talk with health care professionals about them, suggesting the feedback we would receive from them would likely be limited.

(Comment 2) Practitioners chosen should be based on greater prescribing habits. Those practitioners who are the larger rate of treating chronic non-cancer pain with ADF opioid should be the target of information gathering.

(Response 2) One of our screening criteria is that at least half of a provider's prescriptions must be for chronic, non-cancer pain. We plan to include approximately equal numbers of low, medium, and high prescribers across each prescriber type and field of practice so that comparisons can be made between groups. In addition, in the earlier focus group phase, current prescribers of ADFs were already aware of and had significant knowledge about ADFs, so their feedback likely would not provide the kind of insight needed about the misunderstanding and confusion we previously observed among other prescribers.

(Comment 3) We support FDA's decision to conduct a comprehensive evaluation of opioid prescribers' knowledge, attitudes, perceptions, experiences, and behaviors related to ADFs and agree with the FDA that new language is needed to better describe and explain ADFs.

(Response 3) Thank you for this comment.

(Comment 4) We strongly encourage testing the impact of terminology that more accurately describes the product's abuse-deterrent properties. For example, if a pill is formulated to be difficult to crush, it should be labeled “crush-resistant.”

(Response 4) The survey, in part, will provide HCPs an opportunity to propose terms they think best describe these opioids and will test both objectively and subjectively numerous alternative terms that were commonly cited as appropriate by HCP participants in the earlier focus group phase of this study. This includes terms that relate to physical manipulation such as “alteration-resistant opioids” and “tamper-resistant opioids.”

(Comment 5) We support FDA's efforts to ensure the diversity of the sample populations for the three proposed studies. It is important to study health care providers with varying opioid prescribing levels, and years and locations of practice. We particularly commend the efforts to additionally account for diverse ages, ethnicities, and gender of the health care providers, as all of these factors can affect knowledge, attitudes, and the patients they serve.

(Response 5) Thank you for this comment.

(Comment 6) The proposed study plans to include a wide range of health care providers, including primary care providers; specialists from various fields such as rheumatology, neurology, anesthesiology, pain management, emergency medicine, surgery, orthopedics, and physical medicine and rehabilitation; nurse practitioners; physician assistants; as well as dispensers/pharmacists. However, there is clear evidence that dentists, periodontists, and oral surgeons should also be included, since research has shown that they often overprescribe opioids.

(Response 6) While the reviewers raises an important consideration, the inclusion of dentists and oral surgeons is beyond the scope of the current study. Dentists do not typically prescribe for long-term pain and are therefore less likely to prescribe an abuse-deterrent formulation opioid or ADF, which is the main focus of this study. For a similar reason, based on what we heard in the earlier focus group phase of this study, we chose to exclude emergency medicine physicians from the sample survey populations.

(Comment 7) The proposed study should explore providers' knowledge of how ADF opioids are used and abused once they are on the market. Opioids considered to be abuse-deterrent are still widely abused through the most common oral route.

(Response 7) Our survey questions will include items about provider knowledge of ADFs, including specific questions to test whether they are aware that ADFs can still be abused, as well as related to their experiences with use, misuse, and abuse of opioids.

(Comment 8) We applaud the effort to gather information about HCPs' understanding of these products. This effort is consistent with the Agency's history of extensive and diverse efforts to balance the needs of people seeking relief from severe acute and chronic pain and the simultaneous need to avoid worsening of the abuse, addiction, and diversion of opioid medications in these times of the opioid overdose epidemic.

(Response 8) Thank you for this comment.

(Comment 9) We believe that the proposed sample design adequately accounts for current ADF product prescribers for chronic non-cancer pain. It is not clear, however, whether the proposed sample design would adequately capture the second relevant population, i.e. appropriate potential prescribers of ADF products for chronic non-cancer pain. Commenter recommends that FDA focus on those HCPs who specialize in chronic non-cancer pain management, because these relatively few HCPs manage a disproportionate volume of patients with chronic non-cancer pain and, therefore, manage a disproportionate volume of current and appropriate potential prescriptions of ADF products for chronic non-cancer pain.

Suggestions:

• The proposed threshold of 5 patients treated with opioids for chronic non-cancer pain in a typical month is too low. A low threshold does not ensure that pain specialists will be included, and evidence has shown that the treatment of chronic non-cancer pain with opioids has consolidated under such pain specialists in recent years.

• Study should focus on HCPs who specialize in chronic non-cancer pain management. This small subset of HCPs manage a disproportionate volume of patients with chronic non-cancer pain, and therefore, they manage a disproportionate volume of current and appropriate potential ADF prescriptions.

• Study can capture both intended populations (current and “appropriate potential” prescribers) by recruiting only pain specialists and imposing a threshold for experience prescribing ADF products.

(Response 9) Pain management is one of the specialties included on our recruitment screener (in addition to rheumatology, neurology, anesthesiology, surgery, orthopedics, and physical medicine and rehabilitation). Our screening criteria will ensure an approximately equal number of low, medium, and high-volume prescribers across each provider group. We also have included a requirement that at least 50 percent of prescriptions must be for chronic, non-cancer pain. A key objective of this study is to gain insight into misunderstandings about ADF opioids and the terminology and how to best address the confusion and misunderstandings that we found in the earlier focus group phase of the study as well as in prior research FDA conducted. These data indicated pain management specialists already tend to have considerable knowledge about and experience with ADFs, suggesting their feedback would likely be of limited usefulness with respect to the study's key objectives. This is similarly the case for ADF prescribers, which is the reason the study populations were purposely inclusive of a broad cross-section of opioid prescribers.

(Comment 10) Include a screening question with a list of ADF products to account for respondents' lack of knowledge about which products are and are not ADF.

(Response 10) Thank you for the suggestion. Our recruitment screener includes such a question, which asks respondents to identify which of 17 different listed opioids they have prescribed, including six abuse-deterrent formulations that will not be identified as such. The survey questionnaire itself also asks prescribers to specifically cite in an open-ended question the ADF opioids they have prescribed, which will be used, in part, to asses ADF knowledge.

(Comment 11) Set quotas to ensure recruitment of representative sample sizes for both non-specialists and pain specialists.

(Response 11) Early in the protocol development we identified the need for samples of prescribers working in primary care fields and among those in specific specialties, which research has shown generally prescribe the most opioids overall, and the sample populations included in the study will reflect this necessary diversity.

(Comment 12) Lower Ns for Phase 2 and 3 to ensure timely completion. In the company's experience, a survey of 200 HCPs takes 5 weeks to complete.

(Response 12) We identified current sample sizes based on power calculations. Any reduction in sample size would reduce our power to find effects. We have planned a timeline for the project to complete both phases 2 and 3 based experience collecting data using these methods but will be adjusting as necessary given the COVID-19 pandemic and any other unforeseen factors. This project is an FDA priority, and we will prioritize rigorous methodology that ensures representativeness and robust data and evidence even if it means taking a little more time.

(Comment 13) Implement appropriate honoraria to ensure feasibility and timely results.

(Response 13) The financial incentive rates were based on going rates for incentives in provider panel surveys and on recent research on incentives for physician surveys. These will also comport with those allowable by OMB. In addition, our experience has shown that the topic of this study—opioids and the national crisis—and the fact that the research is being undertaken by FDA, the Federal agency responsible for regulating these products, are additional incentives for participation.

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

The following reference is on display with the Dockets Management Staff (see ADDRESSES ) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is not available electronically at https://www.regulations.gov as this reference is copyright protected.