The purpose of the meeting is for project planning. The public is invited to the meeting and encouraged to address the committee following the meeting.

If other persons who plan to attend the meeting require other accommodations, please contact Evelyn Bohor at ebohor@usccr.gov at the Eastern Regional Office at least ten (10) working days before the scheduled date of the meeting.

Persons interested in the issue are also invited to submit written comments; the comments must be received in the regional office by Thursday, May 7, 2020. Written comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, faxed to (202) 376-7548, or emailed to Evelyn Bohor at ebohor@usccr.gov. Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.

Records and documents discussed during the meeting will be available for public viewing as they become available at https://www.facadatabase.gov/FACA/FACAPublicViewCommitteeDetails?id=a10t0000001gzloAAA, and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Eastern Regional Office at the above phone number, email or street address.

Background

On December 13, 2019, Commerce published the Preliminary Results of the administrative review of the antidumping duty (AD) order on steel wire garment hangers from the People's Republic of China (China). 1 We invited interested parties to comment on these Preliminary Results. We received no comments from interested parties. As such, these final results are unchanged from the Preliminary Results.

The merchandise subject to the order is steel wire garment hangers. 2 The products are currently classifiable under the Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 7326.20.0020, 7323.99.9060, and 7323.99.9080. Although the HTSUS subheadings are provided for convenience and customs purposes, the written product description of the scope of the order remains dispositive. For a full description of the scope of the order, see the Preliminary Decision Memorandum. 3

Commerce conducted this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act). As noted in the Preliminary Results, Shanghai Wells did not permit Commerce to verify its questionnaire responses. 4 Therefore, Commerce preliminarily determined that Shanghai Wells is not eligible for a separate rate and is therefore part of the China-wide entity. We received no comments on the Preliminary Results, and, thus, we have no basis for reconsidering this determination. Because there are no changes for these final results from the Preliminary Results, there is no accompanying Issues and Decision Memorandum.

We continue to find that Shanghai Wells is not eligible for a separate rate, and therefore it is part of the China-wide entity. The rate previously established for the China-wide entity is 187.25 percent  5 and is not subject to change as a result of this review because no party requested a review of the China-wide entity. 6

Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review.

Commerce intends to issue assessment instructions to CBP 15 days after the date of publication of the final results of this review in the Federal Register .

We will instruct CBP to assess antidumping duties at a rate of 187.25 percent for all entries of subject merchandise during the POR which was exported by Shanghai Wells.

The following cash deposit requirements will be effective upon publication of the final results of this administrative review for shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date of this notice, as provided by section 751(a)(2)(C) of the Act: (1) For previously investigated or reviewed Chinese and non-Chinese exporters of subject merchandise that have received a separate rate in a prior segment of this proceeding, the cash deposit rate will continue to be the existing exporter-specific cash deposit rate published for the most recently completed period; (2) for all Chinese exporters of subject merchandise that have not been found to be entitled to a separate rate, including Shanghai Wells, the cash deposit rate will be the existing cash deposit rate for the China-wide entity, i.e., 187.25 percent; and (3) for all non-Chinese exporters of subject merchandise which have not received their own separate rate, the cash deposit rate will be the rate applicable to the Chinese exporter that supplied that non-Chinese exporter.

These cash deposit requirements, when imposed, shall remain in effect until further notice.

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

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

We are issuing and publishing these final results of administrative review in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(5) and 19 CFR 351.213(h)(1).

I. Abstract

This is a request for renewal of a current information collection.

This notice is for the extension of Paperwork Reduction Act requirements regarding Greater Atlantic Region fishing gear marking requirements. Regulations at 50 CFR 648.84(a),(b), and (d), 648.123(b)(3), 648.144(b)(1), 648.264(a)(5), and 697.21(a) and (b) require that Federal permit holders using certain types of fishing gear mark the gear with specified information for the purposes of vessel and gear identification ( e.g., hull identification number, Federal fishing permit number, etc.). The regulations also specify how the gear is to be marked for the purposes of visibility ( e.g., buoys, radar reflectors, etc.).

The success of fisheries management programs depends on regulatory compliance. The ability to link fishing gear to the vessel owner or operator is crucial to the enforcement of regulations under the authority of the Magnuson-Stevens Fishery Conservation and Management Act. The ability to identify gear allows state and federal enforcement personnel to identify permit holders that are using unapproved gear configuration, using the gear during a time restriction, or using gear in a restricted area. In the Greater Atlantic Region, gear marking is required of permit holders in the Northeast multispecies longline and gillnet fisheries, American lobster trap fishery, scup trap/pot fishery, the deep-sea red crab fishery, the tilefish longline fishery, and the black sea bass trap/pot fishery.

The marking of gear is also a valuable tool in ascertaining ownership of lost or damaged gear, as well as gear involved in civil proceedings. Gear can be lost or damaged as the result of interactions between mobile and fixed gears. Gear identification is an important tool in identifying the parties involved in these conflicts. Proper marking also makes gear more visible to other vessels in the water to aid in navigation and increase safety at sea.

The quantity of gear in this collection is distinguished by the number of attached end lines associated with each string of hooks, pots, or traps. As such, a single Federal permit holder may be responsible for marking several strings of a given gear type, or may use multiple different gear types that require marking.

No information is submitted to NMFS as a result of this collection. The vessel's hull identification number or other means of identification specified in the regulations must be affixed to the buoy or other part of the gear as specified in the regulations.

OMB Control Number: 0648-0351.

Form Number(s): None.

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

Affected Public: Individuals and households; business or other for-profit organizations.

Estimated Number of Respondents: 4,789.

Estimated Time per Response: 1 minute per string of gear.

Estimated Total Annual Burden Hours: 16,886.

Estimated Total Annual Cost to Public: $47,890.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

This is a request for extension, without change, of a currently approved collection. The National Marine Sanctuaries Act (NMSA) authorizes the Secretary of Commerce to designate and protect areas of the marine environment with special national significance due to their conservation, recreational, ecological, historical, scientific, cultural, archeological, educational or esthetic qualities as national marine sanctuaries. Day-to-day management of national marine sanctuaries has been delegated by the Secretary of Commerce to NOAA's Office of National Marine Sanctuaries, which serves as the trustee for a network of underwater parks encompassing more than 600,000 square miles of marine and Great Lakes waters. The network includes a system of 14 national marine sanctuaries and Papahānaumokuākea and Rose Atoll marine national monuments. The primary objective of the NMSA is to protect marine resources, such as coral reefs, sunken historical vessels or unique habitats.

National marine sanctuary regulations provide that the public may nominate special places of the marine environment to become a national marine sanctuary through the sanctuary nomination process (15 CFR part 922). Through this nomination process, NOAA is seeking to give communities an opportunity to identify special marine and Great Lakes areas they believe would benefit from designation as a national marine sanctuary. There is no requirement for who may nominate an area for consideration; however, nominations should demonstrate broad support from a variety of stakeholders and interested parties. Persons wanting to submit nominations for consideration should submit information on the qualifying criteria and management considerations for the site to be nominated. The Office of National Marine Sanctuaries reviews the submissions, which could result in the nomination being added to an inventory of areas that NOAA may consider for sanctuary designation at some point in the future. Sanctuary designation is a separate public process that would be conducted pursuant to the requirements of the National Marine Sanctuaries Act, and all other applicable laws.

Electronic applications submitted via email and paper nominations submitted via regular mail.

OMB Control Number: 0648-0682.

Form Number(s): None.

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

Affected Public: Individuals or households; Business or other for-profit organizations; Not-for-profit institutions; State, Local, or Tribal government; Federal government.

Estimated Number of Respondents: 5.

Estimated Time per Response: 84 hours.

Estimated Total Annual Burden Hours: 591.

Estimated Total Annual Cost to Public: $120.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

I. Abstract

This request is for extension of a current information collection. The National Estuarine Research Reserve System (NERRS) is a partnership between the National Oceanic and Atmospheric Administration (NOAA) and 22 states and Puerto Rico that protects more than 1.3 million coastal and estuarine acres in 28 Reserves for long-term research, monitoring, education, and stewardship, established under Section 315 of the Coastal Zone Management Act (CZMA) of 1972 (16 U.S.C. 1451), 16 U.S.C. 1461. The NERRS consists of carefully selected estuarine areas of the United States that are designated, preserved, and managed for research and educational purposes. The Reserves are chosen to reflect regional differences and to include a variety of ecosystem types according to the classification scheme of the national program as presented in 15 CFR part 921. As part of a national system, the Reserves collectively provide a unique opportunity to address research questions and estuarine management issues of national significance. The Reserves also serve to enhance public awareness and understanding of estuarine areas and provide suitable opportunities for public education and interpretation. Regulations provide guidance for delineating Reserve boundaries and additional guidance for arriving at the most effective and least costly approach to establishing adequate state control of key land and water areas. Any qualified public or private persons, organizations or institutions may compete for research funding to work in research Reserves. In fact, applicants are almost always states.

Subsection 3l5(e)(1)(B) of the CZMA authorizes the National Ocean Service (NOS) to make grants to, or cooperative agreements with, any coastal state or public or private institution or person for purposes of supporting research within the NERRS. This program is listed in the Catalog of Federal Domestic Assistance under “Coastal Zone Management Estuarine Research Reserve, Number 11.420”. Applications for such grants follow the provisions of 2 CFR 200. During the site selection and designation process, information is collected from states in order to prepare a management plan and environmental impact statement. Designated Reserves apply annually for operations funds by submitting a work plan; subsequently, progress reports are required every six months for the duration of the award. Each Reserve compiles an ecological characterization or site profile to describe the biological and physical environment of the Reserve, research to date and research gaps. Reserves revise their management plans every five years. A competitive fellowship program supports opportunities for graduate students to conduct research at each Reserve. This information is required to ensure that Reserves are adhering to regulations and that the Reserves are in keeping with the purpose for which they were designated.

Respondents have a choice of either electronic or paper submissions. Methods of submittal include email of electronic forms, and mail and facsimile transmission of paper forms.

OMB Control Number: 0648-0121.

Form Number(s): None.

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

Affected Public: Non-profit institutions; state, local, or tribal government.

Estimated Number of Respondents: 75.

Estimated Time per Response: Management plan, 1800 hours; site profile, 1800 hours; site nomination documents, 2500 hours; award application, 8 hours; award reports, 5 hours; NEPA documentation, 40 hours.

Estimated Total Annual Burden Hours: 8,216.

Estimated Total Annual Cost to Public: $0.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.

The Committee's charter is being renewed in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix) and 41 CFR 102-3.50(d). The charter and contact information for the Committee's Designated Federal Officer (DFO) are found at https://www.facadatabase.gov/FACA/apex/FACAPublicAgencyNavigation .

Pursuant to section 546(c)(1) of the Carl Levin and Howard P. “Buck” McKeon National Defense Authorization Act for Fiscal Year 2015 (“FY 2015 NDAA”), the Committee will advise the Secretary of Defense and the Deputy Secretary of Defense on the investigation, prosecution, and defense of allegations of rape, forcible sodomy, sexual assault, and other sexual misconduct involving members of the Armed Forces.

Pursuant to section 546(b) of the FY 2015 NDAA, the Committee will be composed of no more than 20 members. Committee members selected will have experience with the investigation, prosecution, and defense of allegations of sexual assault offenses. Members of the Committee may include Federal and State prosecutors, judges, law professors, and private attorneys. Members of the Armed Forces serving on active duty may not serve as members of the Committee.

Members of the Committee who are not full-time or permanent part-time Federal officers, employees, or members of the Armed Forces will be appointed as experts or consultants, pursuant to 5 U.S.C. 3109, to serve as special government employee members. Committee members who are full-time or permanent part-time Federal officers, employees, or members of the Armed Forces will be appointed pursuant to 41 CFR 102-3.130(a), to serve as regular government employee members.

All members of the Committee are appointed to provide advice on the basis of their best judgment without representing any particular point of view and in a manner that is free from conflict of interest. Except for reimbursement of official Committee-related travel and per diem, members serve without compensation.

The public or interested organizations may submit written statements to the Committee membership about the Committee's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the Committee. All written statements shall be submitted to the DFO for the Committee, and this individual will ensure that the written statements are provided to the membership for their consideration.

On February 24, 2020, the U.S. Department of Energy (DOE) published a request for information (RFI) in the Federal Register (85 FR 10424). DOE issued this RFI to invite public input on key challenges in reconstituting uranium mining and conversion capabilities in the United States. This invitation is in recognition of the importance of nuclear fuel supply chain capabilities in the United States. The Joint Explanatory Statement of the Energy and Water Development Committees on H.R. 1865, the Fiscal Year 2020 Energy and Water Appropriations Act, requests the Department to contract not later than 60 days after enactment of the Act with a Federally-Funded Research and Development Center (FFRDC) or other independent organization to work with industry to identify key challenges in reconstituting mining and conversion capabilities in the United States. The responses received from this RFI will be provided to the FFRDC or the independent organization. The RFI established a March 16, 2020, deadline for the submission of written comments. DOE has received requests from the public for extension of the public comment period. In response to those requests, DOE is extending the comment period to March 30, 2020 to provide the public additional time for comment.

Title: FERC-725G (Mandatory Reliability Standards for the Bulk-Power System: Regional Reliability Standard PRC-006-NPCC-2, Automatic Underfrequency Load-Shedding (UFLS).

OMB Control No.: 1902-0252.

Type of Request: Revisions to the information collection, as discussed in Docket No. RD20-1-000.

Abstract: The proposed regional Reliability Standard applies to generator owners, planning coordinators, distribution providers, and transmission owners in the Northeast Power Coordinating Council Region and is designed to ensure the development of an effective automatic underfrequency load shedding (UFLS) program to preserve the security and integrity of the Bulk-Power System during declining system frequency events in coordination with the NERC continent-wide UFLS Reliability Standard PRC-006-1. The Commission also proposes to approve the related violation risk factors, violation severity levels, implementation plan, and effective date proposed by NERC.

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 December 23, 2019, the North American Electric Reliability Corporation (NERC) and Northeast Power Coordinating Council, Inc. (NPCC) filed a joint petition seeking approval of proposed regional Reliability Standard PRC-006-NPCC-2 (NPCC Automatic Underfrequency Load Shedding). NERC and NPCC state that regional Reliability Standard PRC-006-NPCC-2 establishes consistent and coordinated requirements for the design, implementation, and analysis of automatic underfrequency load shedding (UFLS) programs among all NPCC applicable entities. These requirements are more stringent and specific than the NERC continent-wide UFLS Reliability Standard, PRC-006-3, and were established such that the declining frequency is arrested and recovered in accordance with NPCC performance requirements. NPCC revised currently effective Regional Reliability Standard PRC-006-NPCC-1 to remove redundancies with the Reliability Standard PRC-006-3, clarify obligations for registered entities, improve communication of island boundaries to affected registered entities, and provide entities with the flexibility to calculate net load shed for UFLS in certain situations.

On February 19, 2020, the Commission issued a Delegated Letter Order, Docket No. RD20-1-000, approving proposed Reliability Standard PRC-006-NPCC-2, the associated VRFs and VSLs, the Effective Date, and the retirement of the currently effective Regional Reliability Standard PRC-006-NPCC-1. The effective date for Reliability Standard PRC-006-NPCC-2 is as of the date of this order, January 18, 2020.

Type of Respondents: Generator owners, planning coordinators, distribution providers, and transmission owners in the Northeast Power Coordinating Council (NPCC) Region.

Estimate of Annual Burden:   5 Our estimates are based on the NERC Compliance Registry Summary of Entities as of January 31, 2019. According to the NERC compliance registry, and Functions as of, which indicates there are registered as GO, PC, DP and TO entities.

The individual burden estimates are based on the time needed to gather data, run studies, and analyze study results to design or update the underfrequency load shedding programs. Additionally, documentation and the review of underfrequency load shedding program results by supervisors and management is included in the administrative estimations. These are consistent with estimates for similar tasks in other Commission approved standards.

Estimates for the additional burden and cost imposed by the order in Docket No. RD20-1-000 follow:

Commission estimates the annual burden and cost  6 as follows. Burden and cost for the information collection as follows:

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.

The delineation of the proposed no-discharge zone of Sarah Creek from York River will begin at 37°14′58.34″ N, 76°29′39.17″ W and extend to 37°15′00.81″ N, 76°28′37.84″ W. From there it will continue north throughout any navigable waters including all tributaries and bays. The delineation of the proposed no-discharge zone of Perrin River from York River will begin at 37°15′47.18″ N, 76°25′20.73″ W and extend to 37°15′50.63″ N, 76°25′11.84″ W. From there it will continue north throughout any navigable waters including all tributaries and bays.

Based on the boater population in Sarah Creek and Perrin River, EPA guidance recommends one pumpout facility for each waterbody. The Commonwealth of Virginia has certified that there are three stationary and one mobile pumpout facilities at two locations on Sarah Creek and one stationary pumpout facility on Perrin River. Two of the three locations also have a method to empty portable toilets. Furthermore, the Hampton Roads Sanitation District (HRSD) provides free portable pumpout service in Gloucester County on Fridays, Saturdays and Sundays during summer months and on Saturdays the rest of the year. HRSD prefers to service marinas but will provide the portable pumpout at a private residence when requested. The Virginia Department of Health (VDH) ensures that proper sanitary facilities are present at marinas, and marina facilities are inspected annually by VDH for compliance with regulations. A list of the facilities, phone numbers, locations and hours of operation follows.

OMB Control No.: 3060-0850.

Title: Quick-Form Application for Authorization in the Ship, Aircraft, Amateur, Restricted and Commercial Operator, and General Mobile Radio Services, FCC Form 605.

Form No.: FCC Form 605.

Type of Review: Extension of a currently approved collection.

Respondents: Individuals or households; business or other for-profit; not-for-profit institutions; state, local or tribal government.

Number of Respondents/Responses: 130,000 respondents; 130,000 responses.

Estimated Time per Response: 0.17 hours-0.44 hours.

Frequency of Response: On occasion reporting requirement; third party disclosure requirement, recordkeeping and other (5 and 10 years).

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in 47 CFR 1.913(a)(4).

Total Annual Burden: 57,218 hours.

Total Respondent Cost: $2,676,700.

Privacy Act Impact Assessment: Yes.

Nature and Extent of Confidentiality: In general, there is no need for confidentiality. The Commission is required to withhold from disclosure certain information about the individual such as date of birth or telephone number.

Needs and Uses: FCC Form 605 application is a consolidated application form for Ship, Aircraft, Amateur, Restricted and Commercial Radio Operators, and General Mobile Radio Services and is used to collect licensing data for the Universal Licensing System. The Commission is requesting OMB approval for an extension (no change in the reporting, recordkeeping and/or third party disclosure requirements). The Commission is making minor clarifications to the instructions on the main form and schedule B as well as a clarification to Item 3 on the main form.

The data collected on this form includes the Date of Birth for Commercial Operator licensees however this information will be redacted from public view.

The FCC uses the information in FCC Form 605 to determine whether the applicant is legally, technically, and financially qualified to obtain a license. Without such information, the Commission cannot determine whether to issue the licenses to the applicants that provide telecommunication services to the public, and therefore, to fulfill its statutory responsibilities in accordance with the C communications Act of 1934, as amended. Information provided on this form will also be used to update the database and to provide for proper use of the frequency spectrum as well as enforcement purposes.

OMB Approval Number: 3060-0896.

Title: Broadcast Auction Form Exhibits.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

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

Number of Respondents and Responses: 2,000 respondents and 5,350 responses.

Estimated Hours per Response: 0.5 hours-2 hours.

Frequency of Response: On occasion reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in Sections 154(i) and 309 of the Communications Act of 1934, as amended.

Annual Hour Burden: 6,663 hours.

Annual Cost Burden: $12,332,500.

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

Privacy Impact Assessment(s): No impact(s).

Needs and Uses: The Commission's rules require that broadcast auction participants submit exhibits disclosing ownership, bidding agreements, bidding credit eligibility and engineering data. These data are used by Commission staff to ensure that applicants are qualified to participate in Commission auctions and to ensure that license winners are entitled to receive the new entrant bidding credit, if applicable. Exhibits regarding joint bidding agreements are designed to prevent collusion. Submission of engineering exhibits for non-table services enables the Commission to determine which applications are mutually exclusive.

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: 3060-0787.

Title: Implementation of the Subscriber Carrier Selection Changes Provisions of the Telecommunications Act of 1996, Policies and Rules Concerning Unauthorized Changes of Consumers' Long Distance Carriers, CC Docket No. 94-129, CG Docket 17-169.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Individuals or household; Business or other for-profit; State, Local or Tribal Government.

Number of Respondents and Responses: 4,160 respondents; 20,920 responses.

Estimated Time per Response: 30 minutes (.50 hours) to 10 hours.

Frequency of Response: Recordkeeping requirement; Biennial, on occasion and one-time reporting requirements; Third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for the information collection requirements is found at Sec. 258 [47 U.S.C. 258] Illegal Changes In Subscriber Carrier Selections, Public Law 104-104, 110 Stat. 56.

Total Annual Burden: 87,173 hours.

Total Annual Cost: 26,300,00.

Nature and Extent of Confidentiality: Confidentiality is an issue to the extent that individuals and households provide personally identifiable information, which is covered under the FCC's system of records notice (SORN), FCC/CGB-1, “Informal Complaints, Inquiries, and Requests for Dispute Assistance.” As required by the Privacy Act, 5 U.S.C. 552a, the Commission also published a SORN, FCC/CGB-1 “Informal Complaints, Inquiries, and Requests for Dispute Assistance”, in the Federal Register on August 15, 2014 (79 FR 48152) which became effective on September 24, 2014.

Privacy Impact Assessment: The FCC completed a Privacy Impact Assessment (PIA) on June 28, 2007. It may be reviewed at http://www.fcc.gov/omd/privacyact/Privacy-Impact-Assessment.html. The Commission is in the process of updating the PIA to incorporate various revisions to it as a result of revisions to the SORN.

Needs and Uses: Section 258 of the Telecommunications Act of 1996 (1996 Act) directed the Commission to prescribe rules to prevent the unauthorized change by telecommunications carriers of consumers' selections of telecommunications service providers (slamming). On March 17, 2003, the FCC released the Third Order on Reconsideration and Second Further Notice of Proposed Rulemaking, CC Docket No. 94-129, FCC 03-42 (Third Order on Reconsideration), in which the Commission revised and clarified certain rules to implement section 258 of the 1996 Act. On May 23, 2003, the Commission released an Order (CC Docket No. 94-129, FCC 03-116) clarifying certain aspects of the Third Order on Reconsideration. On January 9, 2008, the Commission released the Fourth Report and Order, CC Docket No. 94-129, FCC 07-223, revising its requirements concerning verification of a consumer's intent to switch carriers.

The Fourth Report and Order modified the information collection requirements contained in § 64.1120(c)(3)(iii) of the Commission's rules to provide for verifications to elicit “confirmation that the person on the call understands that a carrier change, not an upgrade to existing service, bill consolidation, or any other misleading description of the transaction, is being authorized.”

OMB Control Number: 3060-XXXX.

Title: Application for the Uniendo a Puerto Rico Fund and the Connect USVI Fund Stage 2 Fixed Support.

Form Number: FCC Form 5634.

Type of Review: New information collection.

Respondents: Business or other for-profit entities.

Number of Respondents and Responses: 20 unique respondents; 30 responses.

Estimated Time per Response: 2-80 hours.

Frequency of Response: One-time and annual reporting requirements.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 151-154, 214, and 254.

Total Annual Burden: 1,620 hours.

Total Annual Cost: No Cost.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: Although some information collected in FCC Form 5634 will be made available for routine public inspection, the Commission will withhold certain information collected in FCC Form 5634 from routine public inspection. Specifically, the Commission will treat certain financial and technical information submitted in FCC Form 5634 as confidential. However, if a request for public inspection for this technical or financial information is made under 47 CFR 0.461, and the applicant has any objections to disclosure, the applicant will be notified and will be required to justify continued confidential treatment. To the extent that an applicant seeks to have other information collected in FCC Form 5634 or during the post-selection review process withheld from public inspection, the applicant may request confidential treatment pursuant to 47 CFR 0.459.

Needs and Uses: The Commission is requesting the Office of Management and Budget (OMB) approval for this new information collection. In the Uniendo a Puerto Rico Fund and Connect USVI Fund Order, the Commission comprehensively reformed the high-cost program within the universal service fund to focus support on networks capable of providing advanced, hardened voice and broadband services in Puerto Rico and the U.S. Virgin Islands (collectively, the Territories). Uniendo a Puerto Rico Fund and the Connect USVI Fund, WC Dockets Nos. 18-143 et al., Report and Order and Order on Reconsideration, 34 FCC Rcd 9109 ( PR-USVI Order ). As part of the PR-USVI Order, the Commission adopted a single-round competitive proposal process to award Stage 2 support for fixed telecommunications networks in the Territories (Stage 2 Competition).

For the Stage 2 Competition, service providers will compete to receive high-cost support of up to $504.7 million in Puerto Rico and $186.5 million in the U.S. Virgin Islands over 10 years to offer fixed voice and broadband services to all locations in the Territories in accordance with the framework adopted in the PR-USVI Order. The information collection requirements reported under this new collection are the result of the competitive proposal process adopted by the PR-USVI Order to award support to winning applicants. The Commission adopted various rules regarding the eligibility of service providers and the term of support. In addition, the Commission adopted rules to govern the competitive proposal process, which includes information to be submitted by parties as part of their competitive proposals and information that must be submitted by winning bidders seeking to become authorized to receive Stage 2 fixed support. The Commission concluded, based on its experience with awarding high-cost support and consistent with the record, that this single-stage competitive proposal process balances the need to collect information essential to awarding support and authorizing Stage 2 fixed support with administrative efficiency.

The Commission estimates that approximately 20 parties will apply and approximately 10 will be selected as winning applicants. The Commission is therefore seeking approval from the OMB for the collection on FCC Form 5634 of the information, disclosures, and certifications adopted by the Commission. This information collection addresses the burdens associated with these requirements.

OMB Control Number: 3060-0055.

Title: Application for Cable Television Relay Service Station License, FCC Form 327.

Form Number: FCC Form 327.

Type of Review: Extension of a currently approved collection.

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

Number of Respondents and Responses: 400 respondents; 400 responses.

Estimated Time per Response: 3.166 hours.

Frequency of Response: On occasion reporting requirement; Every 5 years reporting requirement.

Total Annual Burden: 1,266 hours.

Total Annual Costs: $98,000.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in Sections 154(i), 308 and 309 of the Communications Act of 1934, as amended.

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

Privacy Impact Assessment(s): No impact(s).

Needs and Uses: This filing is the application for a Cable Television Relay Service (CARS) microwave radio license. Franchised cable systems and other eligible services use the 2, 7, 12 and 18 GHz CARS bands for microwave relays pursuant to part 78 of the Commission's Rules. CARS is principally a video transmission service used for intermediate links in a distribution network. CARS stations relay signals for and supply program material to cable television systems and other eligible entities using point-to-point and point-to-multipoint transmissions. These relay stations enable cable systems and other CARS licensees to transmit television broadcast and low power television and related audio signals, AM and FM broadcast stations, and cablecasting from one point ( e.g., on one side of a river or mountain) to another point ( e.g., the other side of the river or mountain) or many points (“multipoint”) via microwave. The filing is done for an initial license, for modification of an existing license, for transfer or assignment of an existing license, and for renewal of a license after five years from initial issuance or from renewal of a license. Filing is done in accordance with Sections 78.11 to 78.40 of the Commission's Rules. The form consists of multiple schedules and exhibits, depending on the specific action for which it is filed. Initial applications are the most complete, and renewal applications are the most brief. The data collected is used by Commission staff to determine whether grant of a license is in accordance with Commission requirements on eligibility, permissible use, efficient use of spectrum, and prevention of interference to existing stations.

OMB Control Number: 3060-0310.

Title: Section 76.1801, Registration Statement; Community Cable Registration, FCC Form 322.

Form Number: FCC Form 322.

Type of Review: Extension of a currently approved collection.

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

Number of Respondents and Responses: 601 respondents and 601 responses.

Estimated Time per Response: 0.5 hours.

Frequency of Response: One time and on occasion reporting requirements.

Total Annual Burden: 301 hours.

Total Annual Costs: $36,060.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in Sections 154(i), 303, 308, 309 and 621 of the Communications Act of 1934, as amended.

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

Privacy Impact Assessment(s): No impacts.

Needs and Uses: Cable operators are required to file FCC Form 322 with the Commission prior to commencing operation of a community unit. FCC Form 322 identifies biographical information about the operator and system as well as a list of broadcast channels carried on the system. This form replaces the requirement that cable operators send a letter containing the same information.

OMB Control Number: 3060-0607.

Title: Section 76.922, Rates for Basic Service Tiers and Cable Programming Services Tiers.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities and State, Local or Tribal Government.

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

Number of Respondents and Responses: 1 respondent; 1 response.

Estimated Time per Response: 12 hours.

Total Annual Burden: 12 hours.

Total Annual Cost: No cost.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in Sections 4(i) and 623 of the Communications Act of 1934, as amended.

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

Privacy Impact Assessment(s): No impact(s).

Needs and Uses: The information collection requirements contained in 47 CFR 76.922(b)(5) provides that an eligible small system that elects to use the streamlined rate reduction process must implement the required rate reductions and provide written notice of such reductions to local subscribers, the local franchising authority (“LFA”), and the Commission.

OMB Control Number: 3060-0938.

Title: Application for a Low Power FM Broadcast Station License, FCC Form 319.

Form Number: FCC Form 319.

Type of Review: Extension of a currently approved collection.

Respondents: Not-for-profit institutions, State, local or Tribal Government.

Number of Respondents and Responses: 200 respondents and 200 responses.

Estimated Time per Response: 1 hour.

Frequency of Response: On occasion reporting requirement.

Total Annual Burden: 200 hours.

Total Annual Cost: $27,500.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in Sections 154(i), 303 and 308 of the Communications Act of 1934, as amended.

Privacy Impact Assessment(s): No impacts.

Needs and Uses: On January 20, 2000, the Commission adopted a Report and Order (R&O) in MM Docket No. 99-25, In the Matter of Creation of Low Power Radio Service. With the adoption of this R&O, the Commission authorized the licensing of two new classes of FM radio stations, generally referred to as low power FM stations (LPFM): A LP100 class for stations operating at 50-100 watts effective radiated power (ERP) at an antenna height above average terrain (HAAT) of 30 meters; and a LP10 class for stations operating at 1-10 watts ERP and an antenna height of 30 meters HAAT. These stations will be operated on a noncommercial educational basis by entities that do not hold attributable interests in any other broadcast station or other media subject to the Commission's ownership rules. The LPFM service authorized in this Report and Order provides significant opportunities for new radio services. The LPFM service creates a class of radio stations designed to serve very localized communities or underrepresented groups within communities.

In connection with this new service, the Commission developed a new FCC Form 319, Application for a Low Power FM Broadcast Station License. FCC Form 319 is required to apply for a license for a new or modified Low Power FM (LPFM) station.

OMB Control No.: 3060-0997.

Title: Section 52.15(k), Numbering Utilization and Compliance Audit.

Form No.: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Businesses or other for-profit.

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

Estimated Time Per Response: 33 hours.

Frequency of Response: Third party disclosure requirement.

Obligation to Respond: Mandatory. Statutory authority for this information collection is contained in 47 U.S.C. Section 251.

Total Annual Burden: 330 hours.

Total Annual Cost: No cost.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: Commission employees and the independent auditor are prohibited by 47 U.S.C. 220(f) from divulging any fact or information that may come to their knowledge in the course of performing the audit, except as directed by the Commission or a court.

Needs and Uses: The audit program, consisting of audit procedures and guidelines, is developed to conduct random audits. The random audits are conducted on the carriers that use numbering resources in order to verify the accuracy of numbering data reported on FCC Form 502, and to monitor compliance with FCC rules, orders and applicable industry guidelines. Failure of the audited carriers to respond to the audits can result in penalties. Based on the final audit report, evidence of potential violations may result in enforcement action.

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Providing Regulatory Submissions in Alternate Electronic Format.” This draft guidance provides recommendations on an alternate electronic format for submissions that are covered under an exemption from or granted a waiver of the requirements of section 745A(a) of the FD&C Act (21 U.S.C. 379k-1). These recommendations pertain to the electronic format of content in NDAs, ANDAs, DMFs, certain BLAs, and certain INDs submitted to the Center for Drug Evaluation and Research or to the Center for Biologics Evaluation and Research.

This draft guidance includes information on: (1) How to submit in alternate electronic format (without xml backbone), (2) submission of FDA forms, (3) pre-submission considerations, (4) submission structure, (5) file formats and versions, (6) datasets and study information, (7) transmitting electronic submissions, and (8) receipt dates.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Providing Regulatory Submissions in Alternate Electronic Format.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001; and the collections of information in 21 CFR part 601 have been approved under OMB control number 0910-0338.

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

I. Background

In recent years, regulatory authorities and industry associations from around the world have participated in many important initiatives to promote international harmonization of regulatory requirements under the ICH. FDA has participated in several ICH meetings designed to enhance harmonization, and FDA is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and reduce differences in technical requirements for drug development among regulatory agencies.

ICH was established to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products for human use among regulators around the world. The six founding members of the ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; FDA; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; and the Pharmaceutical Research and Manufacturers of America. The Standing Members of the ICH Association include Health Canada and Swissmedic. Any party eligible as a Member in accordance with the ICH Articles of Association can apply for membership in writing to the ICH Secretariat. The ICH Secretariat, which coordinates the preparation of documentation, operates as an international nonprofit organization and is funded by the Members of the ICH Association.

The ICH Assembly is the overarching body of the Association and includes representatives from each of the ICH members and observers. The Assembly is responsible for the endorsement of draft guidelines and adoption of final guidelines. FDA publishes ICH guidelines as FDA guidance.

In the Federal Register of July 13, 2018 (83 FR 32669), FDA published a notice announcing the availability of a draft guidance entitled “Q3D Elemental Impurities.” The notice gave interested persons an opportunity to submit comments by August 13, 2018.

After consideration of the comments received, a final draft of the guideline was submitted to the ICH Assembly and endorsed by the regulatory agencies in March 2019.

The guidance revises the existing guidance for industry “Q3D Elemental Impurities” and provides an updated permitted daily exposure (PDE) for the cadmium inhalation route of exposure. The revision was initiated following identification of a calculation error in the original text. The updated PDE of 3 µg/day is based on a modifying factor approach that is consistent with the method used for calculating the PDEs for the oral and parenteral routes of exposure.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Q3D(R1) Elemental Impurities.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

Persons with access to the internet may obtain the guidance at https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances.

On December 17, 2014, FDA published 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, abbreviated new drug applications, biologics license applications, and investigational new drug applications submitted to CDER or the Center for Biologics Evaluation and Research by specifying the format for electronic submissions. The eStudy Data guidance states that a Federal Register notice will specify any new standard version updates that will be added to the Catalog and will specify when support for the new standard begins or ends, and when the requirement to submit data using the new standard begins or ends. FDA will begin supporting SDTM v1.8 and SENDIG-AR v1.0 on March 15, 2020, and such Animal Rule  1 submissions will be required to use the new standard effective March 15, 2022.

In the Federal Register of April 3, 2019, FDA published a notice announcing a public hearing to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. In addition, we notified the public that FDA was establishing a docket for public comment on this hearing. The information from the hearing and comments provided to the docket were solicited to help inform our regulatory oversight of these products and as an important step in our continued evaluation of cannabis and cannabis-derived compounds in FDA-regulated products. We asked that comments be submitted by July 2, 2019.

In response to requests for an extension of the comment period to provide additional time to develop meaningful and thoughtful responses to questions, on June 20, 2019, we published a notice that appeared in the Federal Register that extended the comment period for 14 days, until July 16, 2019.

In light of the continued interest and increased research activity in this space, as well as the need for additional scientific data on this topic, we have decided to reopen the comment period and extend it indefinitely to allow interested parties to continue to comment and to provide relevant data to the Agency on this subject. If, in the future, we decide to close the comment period, we will publish a Federal Register notice to that effect. This extension will allow stakeholders to continue to provide new and emerging information, in as close to real time as possible, as research in this area evolves.

We are particularly interested in data that may help to address uncertainties and data gaps related to the CBD. Studies that may help to address such uncertainties and data gaps may include, but are not limited to:

• The risk of liver injury from CBD, e.g., clinical studies to evaluate potential liver injury following long-term exposure of CBD in healthy populations and in people who may be more susceptible to CBD-induced liver injury ( e.g., due to preexisting liver disease), long-term (chronic), repeated dose studies in an appropriate animal model to determine the most sensitive liver toxicity endpoint, and to establish a no observed effect level (NOAEL), as well as studies to investigate the mechanism of liver injury;

• Toxicities of some of the active metabolites of CBD, e.g., animal toxicology studies of the major human metabolites such as 7-COOH-CBD, as well as pharmacology studies to fully characterize the binding profile and activity of major metabolites of CBD ( e.g., 7-OH-CBD, 7-COOH-CBD);

• Impact of CBD on the male reproductive system, e.g., long-term (chronic), repeated dose studies in an appropriate animal model to determine the most sensitive male reproductive toxicity endpoint and to establish a NOAEL, and studies to characterize the mechanism mediating CBD effects on the male reproductive system for the purpose of assessing human relevance;

• Effect of CBD co-administration with other medicines, alcohol, dietary supplements, tobacco products, and herbal products;

• Impact on neurological development, e.g., neurodevelopmental toxicology studies of CBD and 7-COOH-CBD to characterize the long-term functional impact of these compounds on the developing brain; addition of long-term neurodevelopment adverse outcomes in ongoing or future clinical trials of CBD to assess learning, cognition, and behavior;

• Sedative effects of CBD, e.g., studies to characterize the effect on driving performance and ability to operate heavy machinery due to CBD's sedative effects;

• Transdermal penetration and pharmacokinetics of CBD, e.g., methods development for the evaluation and assessment of dermal penetration of CBD;

• Clinical studies (including real world data/evidence) to address safety questions related to long-term sustained or cumulative exposure to CBD, including in vulnerable populations such as children, the elderly, and women who are pregnant or breastfeeding;

• Long-term (chronic) repeated dose toxicity studies in appropriate animal models, evaluating the most relevant toxicological end points ( e.g., male reproductive toxicity and liver toxicity), to better characterize the potential long-term effects of CBD, with systematic reporting of relevant parameters including, but not limited to, histopathology, hematology and clinical chemistry analyses, testosterone and other hormone levels, and urinalysis;

• Clinical studies on the effect of different routes of CBD administration ( e.g., oral, topical, inhaled) on its safety profile;

• Effect of CBD on pets and food-producing animals, e.g., animal studies that demonstrate the effect of CBD exposure in different target animal species, breeds, or classes, including information on the formation of residues in edible tissues of food-producing animals and safety of chronic exposure;

• Studies to characterize the potential for bioaccumulation of CBD over long-term exposure, e.g., appropriately designed absorption, distribution, metabolism, and elimination studies in appropriate animal models; and

• Effect of CBD on the eye, e.g., studies to determine if CBD is distributed into the eye following various routes of exposure, studies to characterize CBD's potential effect on intraocular pressure, and assessment of potential impacts in potentially sensitive populations such as patients with glaucoma.

I. Background

FDA endorses an informed and balanced approach to gathering data informing the safe and effective use of drugs and biological products in pregnancy through judicious inclusion of pregnant women in clinical trials and careful attention to potential fetal risk. Input from this meeting will help provide such information on the development of therapies for pregnancy-specific conditions and for general medical conditions that occur in women of childbearing age and require treatment during pregnancy. This meeting supports the objectives of The Task Force on Research Specific to Pregnant Women and Lactating Women (“Task Force” or “PRGLAC”) which was established by section 2041 of the 21st Century Cures Act, Public Law 114-255, to provide advice and guidance on activities related to identifying and addressing gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women, including the development of such therapies and the collaboration on and coordination of such activities. 1 Input from this meeting may also help further inform FDA's work toward the finalization of the Agency's draft guidance: Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials (83 FR 15161, April 6, 2018).

The meeting will allow participants (including industry, clinicians, patients, researchers, institutional review boards, ethicists, professional societies and other stakeholders) to provide input on key topics, including:

• Key areas of unmet needs for therapeutic development or clinical data in obstetrics

• The regulatory, scientific, and ethical considerations and challenges in the enrollment of pregnant women in clinical research

For more information on the meeting topics and discussion questions, visit https://healthpolicy.duke.edu/events/scientific-and-ethical-considerations-inclusion-pregnant-women-clinical-trials. FDA will publish a discussion guide outlining background information on the topic areas to this website approximately 2 weeks before the meeting date. FDA will also post the agenda and other meeting materials to this website approximately 5 business days before the meeting.

The format of the public meeting will consist of a series of presentations, panel discussions, and open discussion.

Registration: To register for the public meeting, please visit the following website: https://healthpolicy.duke.edu/events/scientific-and-ethical-considerations-inclusion-pregnant-women-clinical-trials. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.

Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting must register. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation once they have been accepted. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 8 a.m. We will let registrants know if registration closes before the day of the public meeting.

If you need special accommodations due to a disability, please contact Jasmine Smith, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, at ONDPublicMTGSupport@fda.hhs.gov or 301-796-0621; or Catherine Sewell, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5360, Silver Spring, MD 20993-0002, Fax: 301-796-9897.

Persons attending FDA's meetings are advised that FDA is not responsible for providing access to electrical outlets.

Streaming Webcast of the Public Meeting: This public meeting will also be webcast and archived video footage will be available at the event website. If you are unable to attend the meeting in person, you can register to view a live webcast of the meeting. Persons interested in viewing the live webcast are encouraged to register in advance. You will be asked to indicate in your registration if you plan to attend in person or via the webcast. Please register for the webcast by visiting https://healthpolicy.duke.edu/events/scientific-and-ethical-considerations-inclusion-pregnant-women-clinical-trials.

Registered webcast participants will be sent technical system requirements in advance of the event. It is recommended that you review these technical system requirements prior to joining the streaming webcast of the public meeting.

FDA has verified the website addresses in this document as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Transcripts: Please be advised that transcripts of the public meeting will not be available.

In accordance with 42 U.S.C. 285, of the Public Health Service Act, as amended. Similar to NCI-MATCH, NCI-ComboMATCH is conceived as a signal-seeking study. The NCI-ComboMATCH team will determine whether patients with tumor mutations, amplifications or translocations in the genetic pathway(s) of interest are likely to derive clinical benefit if treated with a combination of precision medicine agents targeting those specific pathway(s). This recruitment is for labs that can specifically screen 200 patients seen at NCTN sites per month.

Patients with histologically documented solid tumors and lymphomas whose disease has progressed following at least one line of standard systemic therapy or for whom no standard therapy exists are eligible if they meet the eligibility criteria for the trial.

The selected collaborating outside laboratories may only act ( i.e., refer patients) on any of the variant arms for which their assay reports actionable mutations of interest (aMOIs). The assay must also report all exclusionary variants for the arm unless these occur at a frequency of <1% in cancer patients.

Only CLIA accredited/certified laboratories located in the United States may be considered for addition to the laboratory network.

Candidate laboratories should submit a letter of interest to NCICOMBOMATCHLabApps@nih.gov stating:

Following an acceptable eligibility review to the NCI-ComboMATCH screening committee, the laboratory would execute a confidentiality agreement with the NCI and will be provided with a detailed list of eligibility and exclusion variants for arms (approved at that time). The lab would then be required to submit an application within 6 weeks for review by the NCI-Combo MATCH review committee. Candidate laboratories will be required to meet the following general requirements:

• Testing must be performed in a CLIA-certified or -accredited laboratory located in the United States.

• Assays can be on tumor tissue (including lymphoma) or circulating tumor DNA (ctDNA).

• Laboratory NGS panels must be analytically and clinically validated on DNA from human tumor tissue, with performance characteristics as follows:

Laboratories must supply the following information in their application:

• Laboratory NGS test panels must interrogate actionable mutations of interest (aMOIs) required for enrollment into the available variant arms.

• Academic laboratories must be located at a center that participates in NCI-Combo MATCH.

• The designated lab should be willing to provide residual nucleic acid from the sample they tested if the patient enrolls on NCI-ComboMATCH.

• Laboratories shall NOT advertise that they are screening laboratories for ComboMATCH eligibility without prior review by NCI and ECOG-ACRIN. Any press release or public disclosure requires clearance by NCI and the NCI-ComboMATCH team.

• Laboratories must agree to use the existing workflow established by the NCI NCI-ComboMATCH trial team to identify patients for the variant arms.

○ Laboratory results of NGS assays done for clinical care will be the subject of this initiative. There is no funding for “screening” a patient for NCI-ComboMATCH.

○ Laboratories must notify NCI-ComboMATCH sites that the laboratory results would potentially allow the patient to be eligible for NCI-ComboMATCH.

○ Laboratories must track how many assays per month detect variants that could make a patient eligible for NCI-ComboMATCH.

○ If the clinician presents the NCI-ComboMATCH study and the patient is eligible and desires to enter the study, the laboratory must agree to enter the results into the informatics system that assigns treatment in NCI-ComboMATCH (MATCHbox).

○ Laboratories must have a way to answer questions from NCI-ComboMATCH sites about their assay and must have a contact person for optimal communication with the NCI-ComboMATCH team.

• Prior to participation, laboratories must enter into a collaboration agreement with NCI. A sample agreement is available upon request. As part of such a collaboration agreement, laboratories must agree to provide the licensing rights described in the CTEP IP Option to the Pharmaceutical Collaborators who provided agents for the NCI-ComboMATCH trial ( https://ctep.cancer.gov/branches/rab/intellectual_property_option_to_collaborators.htm ) as well as agree to the data sharing and publication rights consistent with those agreements.

• No reimbursement for these activities (testing or notification of sites of NCI-ComboMATCH eligibility) exists.

1. Submit letter of interest (LOI) as described above under “Letter of Interest and Confidentiality Agreement” to NCICOMBOMATCHLabApps@nih.gov .

2. LOIs will be accepted for 3 months from the date of this notice. LOIs will be reviewed immediately upon receipt.

3. Notification of acceptance, non-acceptance or questions from Steering Committee will be sent to the designated contact person as soon as the LOI has been reviewed. This notification will include further instructions if a full application is invited.

4. Applications that have not been submitted within 6 weeks of notification of acceptance of the LOI will be de-activated and not further considered.

5. DO NOT send a full application until you are invited to do so.

Review criteria for LOI:

Laboratory is a CLIA-certified laboratory within the United States.

Academic laboratories must have NCI-ComboMATCH open at their site.

Laboratory NGS assay has adequate sensitivity and specificity.

Laboratory tests tumor tissue for variants as described in NCI-ComboMATCH.

Laboratory agrees to provide needed information for evaluation of the analytical validity of the test.

Laboratory is likely to screen at least 200 patients at NCTN sites per month for NCI-ComboMATCH.

Laboratory agrees to contact sites regarding NCI-ComboMATCH eligibility.

Laboratory agrees to a collaboration with NCI as detailed above.

Review criteria for full application:

Laboratory supplies evidence that the assay meets analytical requirements as detailed above.

Laboratories are capable of contacting clinical sites, tracking activity, and screening at least 200 patients at NCTN sites per month to the study based on detection of potential variants.

Laboratories agree to execute a collaboration agreement with NCI, as well as to data sharing and sharing publication rights.

Laboratories agree to abide by the procedures in place for the NCI-ComboMATCH study and to collaborate fully with the NCI-ComboMATCH team.

For more information, contact NCICOMBOMATCHLabApps@nih.gov.

In accordance with 42 U.S.C. 285, of the Public Health Service Act, as amended. Similar to NCI-MATCH, NCI-ComboMATCH is conceived as a signal-seeking study. The NCI-ComboMATCH team will determine whether pediatric patients with tumor mutations, amplifications or translocations in the genetic pathway(s) of interest are likely to derive clinical benefit if treated with a combination of precision medicine agents targeting those specific pathway(s). This recruitment is for pediatric focused labs that can specifically screen 250 pediatric patients seen at NCTN sites per month.

Patients with histologically documented solid tumors and lymphomas whose disease has progressed following at least one line of standard systemic therapy or for whom no standard therapy exists are eligible if they meet the eligibility criteria for the trial.

The selected collaborating outside laboratories may only act ( i.e. refer patients) on any of the variant arms for which their assay reports actionable mutations of interest (aMOIs). The assay must also report all exclusionary variants for the arm unless these occur at a frequency of <1% in cancer patients.

Only CLIA accredited/certified laboratories located in the United States may be considered for addition to the laboratory network.

Candidate laboratories should submit a letter of interest to NCICOMBOMATCHLabApps@nih.gov stating:

Following an acceptable eligibility review to the NCI-ComboMATCH screening committee, the laboratory would execute a confidentiality agreement with the NCI and will be provided with a detailed list of eligibility and exclusion variants for arms (approved at that time). The lab would then be required to submit an application within 6 weeks for review by the NCI-ComboMATCH review committee. Candidate laboratories will be required to meet the following general requirements:

• Testing must be performed in a CLIA-certified or -accredited laboratory located in the United States.

• Assays can be on tumor tissue (including lymphoma) or circulating tumor DNA (ctDNA).

• Laboratory NGS panels must be analytically and clinically validated on DNA from human tumor tissues, with performance characteristics as follows:

Laboratories must supply the following information in their application:

• Laboratory NGS test panels must interrogate actionable mutations of interest (aMOIs) required for enrollment into the available variant arms. Applicant laboratories must state which NCI-ComboMATCH arms they would like to participate in.

• Academic laboratories must be located at a center that participates in NCI-ComboMATCH.

• The designated lab should be willing to provide residual nucleic acid from the sample they tested if the patient enrolls on NCI-ComboMATCH.

• Laboratories shall NOT advertise that they are screening laboratories for ComboMATCH eligibility without prior review by NCI and ECOG-ACRIN. Any press release or public disclosure requires clearance by NCI and the NCI-ComboMATCH team.

• Laboratories must agree to use the existing workflow established by the NCI NCI-ComboMATCH trial team to identify patients for the variant arms.

○ Laboratory results of NGS assays done for clinical care will be the subject of this initiative. There is no funding for “screening” a patient for NCI-ComboMATCH.

○ Laboratories must notify NCI-ComboMATCH sites that the laboratory results would potentially allow the patient to be eligible for NCI Combo MATCH.

○ Laboratories must track how many assays per month detect variants that could make a pediatric patient eligible for NCI-ComboMATCH.

○ If the clinician presents the NCI-ComboMATCH study and the pediatric patient is eligible and desires to enter the study, the laboratory must agree to enter results into the informatics system that assigns treatment in Combo MATCH (MATCHbox).

○ Laboratories must have a way to answer questions from Combo MATCH sites about their assay and must have a contact person for optimal communication with the NCI-ComboMATCH team.

• Prior to participation, laboratories must enter into a collaboration agreement with NCI. A sample agreement is available upon request. As part of such a collaboration agreement, laboratories must agree to provide the licensing rights described in the CTEP IP Option to the Pharmaceutical Collaborators who provided agents for the NCI-ComboMATCH trial ( https://ctep.cancer.gov/branches/rab/intellectual_property_option_to_collaborators.htm ) as well as agree to the data sharing and publication rights consistent with those agreements.

• No reimbursement for these activities (testing or notification of sites of NCI-ComboMATCH eligibility) exists.

Qualified laboratories serving underserved populations are encouraged to participate.

How to apply:

1. Submit letter of interest (LOI) as described above under “Letter of Interest and Confidentiality Agreement” to NCICOMBOMATCHLabApps@nih.gov.

2. LOIs will be accepted for 3 months from the date of this notice. LOIs will be reviewed immediately upon receipt.

3. Notification of acceptance, non-acceptance or questions from Steering Committee will be sent to the designated contact person as soon as the LOI has been reviewed. This notification will include further instructions if a full application is invited.

4. Applications that have not been submitted within 6 weeks of notification of acceptance of the LOI will be de-activated and not further considered.

5. DO NOT send a full application until you are invited to do so.

Review criteria for LOI:

Laboratory is a CLIA certified laboratory within the United States.

Academic laboratories must have NCI-ComboMATCH open at their site.

Laboratory NGS assay has adequate sensitivity and specificity.

Laboratory tests tumor tissue for variants as described in NCI-ComboMATCH.

Laboratory agrees to provide needed information for evaluation of the analytical validity of the test.

Laboratory is likely to screen at least 250 pediatric patients at NCTN sites for NCI-ComboMATCH per month.

Laboratory agrees to contact sites regarding NCI-ComboMATCH eligibility.

Laboratory agrees to a collaboration with NCI as detailed above.

Review criteria for full application:

Laboratory supplies evidence that the assay meets analytical requirements as detailed above.

Laboratories are capable of contacting clinical sites, tracking activity, and of screening at least 250 pediatric patients at NCTN sites per month to the study based on detection of potential variants.

Laboratories agree to execute a collaboration agreement with NCI, as well as to data sharing and sharing publication rights.

Laboratories agree to abide by the procedures in place for the NCI-ComboMATCH study and to collaborate fully with the NCI-ComboMATCH team.

For more information, contact NCICOMBOMATCHLabApps@nih.gov.

The Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act), Public Law 93-288, as amended, is the legal basis for the Federal Emergency Management Agency (FEMA) to provide financial assistance and services to individuals applying for disaster assistance benefits in the event of a federally declared disaster. Regulations in 44 CFR, 206.110—Federal Assistance to Individuals and Households implements the policy and procedures set forth in Section 408 of the Stafford Act, 42 U.S.C. 5174, as amended. This program provides financial assistance and, if necessary, direct assistance to eligible individuals and households who, as a direct result of a major disaster or emergency, have uninsured or under-insured, necessary expenses and serious needs, and are unable to meet such expenses or needs through other means.

This collection provides applicants the ability to request approval of late applications, request continued temporary housing assistance, appeal program decisions, request advance disaster assistance, request assistance checks not received be stopped and reissued, and to authorize the release of information third parties. This collection also allows for the establishment of an annual agreement between FEMA and States, territories, or Tribal governments regarding how the Other Needs provision of IHP will be administered: By FEMA, by the State, territory, or Tribal government, or jointly.

Title: Federal Assistance to Individuals and Households Program.

Type of Information Collection: Revision of a currently approved information collection.

OMB Number: 1660-0061.

FEMA Forms: FEMA Form 010-0-11, Individuals and Households Program (IHP)—Other Needs Assistance Administrative Option Selection; Development of State/Tribal Administrative Plan (SAP) for Other Needs Provision of IHP; FEMA Form 010-0-12 (English), Individuals and Households Program Application for Continued Temporary Housing Assistance; FEMA Form 010-0-12S (Spanish), Programa de Individuos y Familias Solicitud Para Continuar La Asistencia de Vivienda Temporera; Request for Approval of Late Registration; Appeal of Program Decision; FEMA Form 009-0-95 (English), Request for Advance Disaster Assistance; FEMA Form 009-0-95S (Spanish), Solicitud de Adelanto de la Asistencia por Desastre; FEMA Form 009-0-96 (English), Request to Stop Payment and Reissue Disaster Assistance Check; FEMA Form 009-0-96S (Spanish), Solicitud para Detener el Pago y Reemitir el Cheque de Asistencia por Desastre; FEMA Form 140-003d-1—(English), Authorization for the Release of Information Under the Privacy Act; FEMA Form 140-003d-1S—(Spanish), Autorización para la Divulgación de Información bajo el Acta de Privacidad.

Abstract: This collection provides applicants the ability to request approval of late applications, request continued temporary housing assistance, appeal program decisions, request advance disaster assistance, request assistance checks not received be stopped and reissued, and to authorize the release of information third parties. It also establishes an agreement between FEMA and States, territories, and Tribal governments regarding the administration of the Other Needs provision of IHP.

Affected Public: Individuals or Households; State, local, or Tribal Government.

Estimated Number of Respondents: 140,753.

Estimated Number of Responses: 185,057.

Estimated Total Annual Burden Hours: 150,828.

Estimated Total Annual Respondent Cost: $5,530,313.

Estimated Respondents' Operation and Maintenance Costs: NA.

Estimated Respondents' Capital and Start-Up Costs: NA.

Estimated Total Annual Cost to the Federal Government: $1,089,213.

Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

Pursuant to the provisions of the Privacy Act of 1974, 5 U.S.C. 552a, and as part of its ongoing integration and management efforts, the Department of Homeland Security (DHS) is rescinding the following system of records notice (SORN), “Department of Homeland Security(DHS)/U.S. Customs and Border Protection(CBP)-017 Analytical Framework for Intelligence (AFI)” System of Records, and replace it, and rely upon for records collected and maintained to support CBP's law enforcement intelligence mission, with “Department of Homeland Security(DHS)/U.S. Customs and Border Protection(CBP)-024 CBP Intelligence Records System (CIRS) System of Records” (82 FR 44198, September 21, 2017). Eliminating this notice will have no adverse impacts on individuals, but will promote the overall streamlining and management of DHS Privacy Act record systems.

I. Background

In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, DHS/CBP proposes to update, rename, and reissue a current DHS system of records newly titled, “DHS/CBP-002 Trusted and Registered Traveler Programs (TRTP).” Formerly titled the “Global Enrollment System,” this system of records allows CBP to collect and maintain records on individuals who voluntarily provide personally identifiable information to CBP in return for enrollment in a program that will make them eligible for dedicated CBP processing at designated U.S. border ports of entry. This system of records includes information on individuals who participate in trusted traveler and registered traveler programs. This system of records notice is being re-published under the new name, with a more comprehensive description of these programs, and the removal of references to the CBP Trusted Worker Programs, which are covered under the DHS/CBP-010 Persons Engaged in International Trade in Customs and Border Protection Licensed/Regulated Activities System of Records Notice (December 19, 2008, 73 FR 77753).

Trusted traveler programs facilitate processing for pre-approved members, permitting more efficient inspections, and helping move participants through the lines at the port of entry or other designated locations more expeditiously. CBP's trusted traveler programs include:

• Global Entry, 1 which enables CBP to provide U.S. citizens, lawful permanent residents (LPRs), and citizens of certain foreign countries dedicated processing when arriving at airports with designated Global Entry kiosks.

• NEXUS, which allows pre-screened travelers dedicated processing when entering the United States and Canada. Program members use specific processing lanes at designated U.S.-Canada border ports of entry, NEXUS kiosks when entering Canada by air, and Global Entry kiosks when entering the United States via Canadian Preclearance airports. NEXUS members also receive dedicated processing at marine reporting locations.

• Secure Electronic Network for Travelers Rapid Inspection (SENTRI), which provides dedicated processing clearance for pre-approved travelers using designated primary lanes entering the United States at land border ports of entry along the U.S.-Mexico border.

• The Free and Secure Trade (FAST) program, which provides dedicated processing for pre-approved commercial truck drivers from the United States, Canada, and Mexico. Members may use dedicated FAST lanes at both northern and southern border ports.

• The U.S.-Asia Economic Cooperation (APEC) Business Travel Card (ABTC) Program, which allows for U.S. business travelers or government officials engaged in business in the APEC region dedicated screening at participating airports.

Individuals who apply for enrollment in a trusted traveler program must provide biographic and certain biometric information to CBP, as described below. CBP screens this information against databases to verify eligibility for trusted traveler program participation. Once an applicant is approved and enrolls in the trusted traveler program, his or her information is vetted by CBP on a recurrent basis to ensure continued eligibility.

CBP also sponsors registered traveler programs that, like trusted traveler programs, allow individuals to provide their information to CBP voluntarily prior to travel in order to qualify for dedicated processing. Unlike trusted travelers, registered travelers are not subject to vetting, but rather maintain information on file with CBP to better facilitate their arrival at ports of entry.

Registered traveler programs include:

• Decal and Transponder Online Procurement System (DTOPS), which allows individuals registered to eligible commercial vehicles to pay their annual user fees in advance online and cross the border using decals or transponders that facilitate CBP inspection.

• Pleasure boat reporting options, which allow operators of small vessels arriving in the United States from a foreign location to report their arrival to CBP remotely instead of in person as required under 19 U.S.C. 1433. Travelers who are members of another CBP trusted traveler program, who hold an I-68 Canadian Border boat landing permit, or who participate in the Local Border Option (LBO) may be eligible for remote arrival reporting.

CBP has signed a number of joint statements with foreign partners to permit citizens of certain foreign countries to apply for Global Entry. Some of these joint statements also permit Global Entry members to apply for trusted traveler programs operated by foreign partners. CBP continues to work with government border authorities in various countries to create this growing international network. As part of the procedure for implementing a joint statement, and adding foreign partners to Global Entry, CBP and each foreign partner execute parallel procedures that incorporate privacy protections. A more in-depth discussion of the arrangements by country is made available in DHS/CBP/PIA-002(b) GES Privacy Impact Assessment and Appendix A “CBP Global Entry Expansion: Joint Statements.”

The authority for TRTP derives from CBP's mandate to secure the borders of the United States, and to facilitate legitimate trade and travel. The statutes that permit and define these programs include:

• Section 7208 of the Intelligence Reform and Terrorism Prevention Act of 2004 (IRTPA), as amended, 8 U.S.C. 1365b(k);

• Section 215 of the Immigration and Nationality Act, as amended, 8 U.S.C. 1185;

• Section 402 of the Homeland Security Act of 2002, as amended, 6 U.S.C. 202;

• Section 404 of the Enhanced Border Security and Visa Reform Act of 2002, 8 U.S.C. 1753; and

• Section 433 of the Tariff Act of 1930, as amended, 19 U.S.C. 1433.

The Regulations that permit and define TRTP include Parts 103 and 235 of Title 8 of the Code of Federal Regulations. See, especially, 8 CFR 103.2, 103.7, 103.16, 235.1, 235.2, 235.7, and 235.12. Pursuant to the Independent Offices Appropriations Act of 1952, 31 U.S.C. 9701, individuals seeking to enroll in trusted traveler or registered traveler programs must pay a fee when they apply or renew their membership. See 8 CFR 103.7(b)(1)(ii)(M).

Participation in these programs is entirely voluntary. Joint Statements with foreign partners establish that each country's use of GES information for vetting will be consistent with applicable domestic laws and policies. Participants should be aware that when they submit their information to a foreign country or agree to share their information with a foreign partner, the foreign country uses, maintains, retains, or disseminates their information in accordance with that foreign country's laws and privacy protections.

Consistent with DHS's information sharing mission, GES information may be shared with other DHS components whose personnel have a need to know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions. In addition, information may be shared with appropriate federal, state, local, tribal, territorial, foreign, or international government agencies consistent with the routine uses set forth in this system of records notice.

DHS/CBP is simultaneously issuing a notice of proposed rulemaking to exempt portions of the DHS/CBP-002 TRTP SORN from the Privacy Act requirements. Pursuant to 5 U.S.C. 552a(j)(2) of the Privacy Act, law enforcement related records, including the information from other law enforcement databases that support the DHS/CBP membership decision, and the law enforcement risk assessment worksheet that have been created during the background check and vetting process, are exempt from 5 U.S.C. 552a(c)(3) and (4); (d); (e)(1), (e)(2), (e)(3), (e)(4)(G), (e)(4)(H), (e)(4)(I), (e)(5), and (e)(8); (f); and (g)(1). Pursuant to 5 U.S.C. 552a(k)(2), records created during the background check and vetting process are exempt from the following provisions of the Privacy Act: 5 U.S.C. 552a(c)(3); (d); (e)(1), (e)(4)(G), (e)(4)(H), (e)(4)(I); and (f). In addition, when a record contains information from other exempt systems of records, DHS/CBP will claim the same exemptions for that record as are claimed for the original systems of records and will claim any additional exemptions that this notice delineates.

CBP will not assert any exemptions with regard to accessing or amending an individual's application data in a trusted or registered traveler program and/or final membership determination in the trusted traveler programs. However, this data may be shared with law enforcement and/or intelligence agencies pursuant to the routine uses identified in the TRTP SORN. The Privacy Act requires that DHS maintain an accounting of such disclosures made pursuant to all routine uses. Disclosing the fact that a law enforcement and/or intelligence agency has sought particular records may affect ongoing law enforcement activity. As such, pursuant to 5 U.S.C. 552a(j)(2) and (k)(2), DHS will claim an exemption from (c)(3), (e)(8), and (g)(1) of the Privacy Act, as is necessary and appropriate to protect this information. This updated system will be included in DHS's inventory of record systems.

The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which Federal Government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. Additionally, the Judicial Redress Act (JRA) provides a statutory right to covered persons to make requests for access and amendment to covered records, as defined by the JRA, along with judicial review for denials of such requests. In addition, the JRA prohibits disclosures of covered records, except as otherwise permitted by the Privacy Act.

Below is the description of the DHS/CBP-002 TRTP System of Records.

In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.

In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, DHS/CBP proposes to establish a new DHS system of records titled, “DHS/CBP-026 Explorer Program System of Records.”

The CBP Explorer Program allows youth between the ages of 14 and 18 to learn about law enforcement careers and serves as a stepping-stone for a career in law enforcement. The Explorer Program is chartered by Learning for Life/Boy Scouts of America (LFL/BSA) as an educational resource program and sponsored by CBP as a personnel recruitment program. All members of the CBP Explorer Program are members of the LFL/BSA. In order to participate, applicants must submit information to CBP related to their eligibility for the program. A variety of forms are required as part of the application package, including general application forms, consent forms and waivers, medical releases, and background check authorizations. For applicants under the age of 18, a parent or legal guardian is required to provide information about him or herself as part of the application process. Parents and legal guardians are also subject to background checks during the application process to obtain and verify information provided by applicants. Candidates accepted to the program attend a 10-week training academy and are then posted with the Office of Field Operations at Ports of Entry and/or with U.S. Border Patrol at Border Patrol stations. Explorers participate in regular meetings, activities, and trainings at their post until they “age out” or resign from the Program.

Consistent with DHS's information sharing mission, information stored in the DHS/CBP-026 Explorer Program System of Records may be shared with other DHS Components that have a need to know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions. In addition, DHS/CBP may share information with appropriate federal, state, local, tribal, territorial, foreign, or international government agencies consistent with the routine uses set forth in this system of records notice.

This newly established system will be included in DHS's inventory of record systems.

The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which Federal Government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. Additionally, the Judicial Redress Act (JRA) provides a statutory right to covered persons to make requests for access and amendment to covered records, as defined by the JRA, along with judicial review for denials of such requests. In addition, the JRA prohibits disclosures of covered records, except as otherwise permitted by the Privacy Act.

Below is the description of the DHS/CBP-026 Explorer Program System of Records.

In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.

Pursuant to the provisions of the Privacy Act of 1974, 5 U.S.C. 552a, and as part of its ongoing integration and management efforts, the Department of Homeland Security (DHS) is rescinding the system of records notices, “DHS/U.S. Citizenship and Immigration Services (USCIS)-002 Background Check Service System of Records,” (June 5, 2007, 72 FR 31082) and “DHS/USCIS-003 Biometric Storage System,” (April 6, 2007, 72 FR 17172), and has consolidated both system of records notices into “DHS/USCIS-018 Immigration Biometric and Background Check Records System of Records,” (July 31, 2018, 83 FR 36950).

USCIS will continue to collect and maintain biometric and associated biographic information to assist USCIS with determining an individual's eligibility for an immigration request. USCIS captures biographic and biometric data from applicants, petitioners, sponsors, beneficiaries, or other individuals making immigration requests, to facilitate three key operational functions: (1) Enroll, verify, and manage an individual's identity; (2) conduct criminal and national security background checks; and (3) produce benefit cards/documents as a proof of benefit. USCIS also uses the information to support data sharing initiatives between DHS components, other U.S. Government agencies and foreign partners in order to prevent terrorism, including terrorist travel; prevent serious crime and other threats to national security and public safety; and assist in the administration and enforcement of immigration laws.

DHS/USCIS-002 covered the collection, use, maintenance, and dissemination of information derived from background check requests and results of individuals seeking USCIS benefits, including individuals over the age of 18 residing in a prospective adoptive parent's household. DHS/USCIS-003 covered the collection, use, maintenance, and dissemination of all biometric and associated biographic data used by USCIS to conduct background checks, facilitate card production, and accurately identify individuals who submit an immigration request. USCIS uses these records to assist it with making eligibility determinations, which will result in the approval or denial of an immigration request.

As such, DHS will continue to collect and maintain biometric and associated biographic information to assist USCIS with determining an individual's eligibility for an immigration request, and will rely upon DHS/USCIS-018.

Rescinding DHS/USCIS-002 and DHS/USCIS-003 and consolidating into the new system of records notice will have no adverse impacts on individuals, but will provide transparency and promote the overall streamlining and management of DHS Privacy Act record systems.

I. Background

In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the Department of Homeland Security (DHS) proposes to establish a new DHS system of records titled, “Department of Homeland Security/ALL-045 Statistical Immigration Data Production and Reporting System of Records.” Federal statutes, including the Immigration and Nationality Act of 1965, as amended, and the Homeland Security Act of 2002, as amended, as well as Executive Orders and congressional mandates, require DHS's Office of Immigration Statistics (OIS) to regularly prepare an extensive series of analytical and statistical reports on border security, immigration enforcement activities, refugee and asylum claims, and other immigration events. For instance, in December 2015, Congress's explanatory statement accompanying DHS's 2016 appropriations legislation specifically directed the DHS Office of Strategy, Policy, and Plans (which includes OIS), to report on the “enforcement lifecycle,” defined as “the full scope of immigration enforcement activities, from encounter to final disposition, including the use of prosecutorial discretion.” Further, Congress directed that “[a]ll data necessary to support a better picture of this lifecycle and the Department's effectiveness in enforcing immigration laws shall be considered and prioritized, including appropriate data collected by the [Executive Office for Immigration Review (EOIR)] at the Department of Justice [DOJ].”

Fulfilling these mandates requires OIS to collect data related to the granting of immigration requests, such as nonimmigrant admissions, grants of lawful permanent residence, changes in legal status, naturalizations, and information related to the enforcement of immigration law, from across DHS and other federal immigration agencies. These data contain both personally identifiable information (PII) and sensitive PII (SPII). OIS is establishing this system of records notice (SORN) to inform the public of its collection and use of PII to create its statistical products.

DHS's immigration Components and other federal immigration agencies initially collect this data for operational purposes in accordance to their own mission and authorities. While the data that are first collected for operations purposes are covered by their respective SORNs, OIS is developing its own SORN to cover the records it creates and has aggregated as they enter OIS's analytical environment. Once in this environment, OIS processes the records in preparation for use in statistical analysis. Analyses may include merging of records from these distinct data systems to create new records.

Data within this system of records are intended only for analytical and statistical purposes, and are not intended for operational uses. This is reflected in the routine uses, which allow for the use of and sharing of data in this system of records solely for these purposes.

Consistent with DHS's information sharing mission, information stored in the DHS/ALL-045 Statistical Immigration Data Production and Reporting System of Records may be shared with other DHS Components that have a need to know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions, except for data that the DHS Information Sharing and Safeguarding Governance Board (ISSGB) has granted a waiver from this requirement on behalf of the Secretary of Homeland Security. In addition, DHS/OIS may share information with appropriate federal, state, local, tribal, territorial, foreign, or international government agencies consistent with the routine uses set forth in this system of records notice.

This newly established system will be included in DHS's inventory of record systems.

The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which Federal Government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. Additionally, the Judicial Redress Act (JRA) provides covered persons with a statutory right to make requests for access and amendment to covered records, as defined by the JRA, along with judicial review for denials of such requests. In addition, the JRA prohibits disclosures of covered records, except as otherwise permitted by the Privacy Act.

Below is the description of the DHS/ALL-045 Statistical Immigration Data Production and Reporting System of Records.

In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.

In October 2002, the eRulemaking Program was established as a cross-agency initiative under Section 206 of the E-Government Act of 2002. The eRulemaking system, managed by the General Services Administration, effective as of October 1, 2019, is a centralized repository for all Federal rulemaking dockets, including Notices of Proposed Rulemaking, Interim Rules, supporting materials such as scientific or economic analyses, and public comments, as well as for non-rulemaking dockets, such as Notices. It consists of a public facing interface, www.regulations.gov, and a portal visible to DHS, called the Federal Docket Management System (FDMS). The Federal Docket Management System is a Federal-wide document management system. DHS employees may self-register to use FDMS.gov and will only see dockets belonging to their Component.

Persons who use eRulemaking to submit a comment on a DHS or a DHS component Federal rulemaking may be asked to provide name and contact information (email or mailing address). If that submission meets all requirements, as determined by DHS, it will be posted on the public eRulemaking website— http://www.regulations.gov —for public viewing, and all the contents of the posted comment will be searchable. eRulemaking provides a full text search capability, including any name and identifying information submitted in the body of the comment. Names of individuals and organizations submitting comments using the eRulemaking system, if names are provided, will be posted on the http://www.regulations.gov site with their respective comments for public viewing. Contact information (such as email or mailing address) will not be available for public viewing, unless the submitter includes that information in the body of the docket submission. DHS does retain submitted contact information as part of this system in FDMS.

DHS may choose not to post certain types of information contained in a docket submission yet preserve the entire submission to be reviewed and considered as part of the rulemaking docket by the Component. For example, comments containing material restricted from disclosure by Federal statute may not be publicly posted or viewable on http://www.regulations.gov, but will be retained and considered by DHS. Similarly, if a person chooses to submit a comment on a rulemaking through the mail rather than through http://www.regulations.gov, or if a person submits a comment through mail after being directed to do so by DHS instructions because of sensitive contents of that individual's comment ( e.g., if it constitutes Chemical-terrorism Vulnerability Information, Protected Critical Infrastructure Information, or Sensitive Security Information), that comment may not appear on the public website, but will be retained and considered by DHS as part of the rulemaking process.

Consistent with DHS's information sharing mission, information stored in the DHS/ALL-044 DHS eRulemaking may be shared with other DHS Components that have a need to know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions. In addition, DHS may share information with appropriate Federal, state, local, tribal, territorial, foreign, or international government agencies consistent with the routine uses set forth in this system of records notice. This newly established system will be included in DHS's inventory of record systems.

The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which Federal Government agencies collect, maintain, use, and disseminate individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. Additionally, the Judicial Redress Act (JRA) provides covered persons with a statutory right to make requests for access and amendment to covered records, as defined by the JRA, along with judicial review for denials of such requests. In addition, the JRA prohibits disclosures of covered records, except as otherwise permitted by the Privacy Act.

Below is the description of the DHS/ALL-044 eRulemaking System of Records.

In accordance with 5 U.S.C. 552a(r), DHS has provided a report of this system of records to the Office of Management and Budget and to Congress.

Table of Abbreviations BIA—Board of Immigration Appeals CFR—Code of Federal Regulations DHS—U.S. Department of Homeland Security DOS—U.S. Department of State EAD—Employment Authorization Document FNC—Final Nonconfirmation Form I-765—Application for Employment Authorization Form I-797—Notice of Action Form I-821—Application for Temporary Protected Status Form I-9—Employment Eligibility Verification Form I-912—Request for Fee Waiver Form I-94—Arrival/Departure Record FR—Federal Register Government—U.S. Government IJ—Immigration Judge INA—Immigration and Nationality Act IER—U.S. Department of Justice Civil Rights Division, Immigrant and Employee Rights Section SAVE—USCIS Systematic Alien Verification for Entitlements Program Secretary—Secretary of Homeland Security TNC—Tentative Nonconfirmation TPS—Temporary Protected Status TTY—Text Telephone USCIS—U.S. Citizenship and Immigration Services U.S.C.—United States Code

Through this notice, DHS sets forth procedures necessary for eligible nationals of Somalia (or aliens having no nationality who last habitually resided in Somalia) to re-register for TPS and to apply for renewal of their EADs with USCIS. Re-registration is limited to aliens who have previously registered for TPS under the designation of Somalia and whose applications have been granted.

For aliens who have already been granted TPS under Somalia's designation, the 60-day re-registration period runs from March 11, 2020 through May 11, 2020. USCIS will issue new EADs with a September 17, 2021, expiration date to eligible Somali TPS beneficiaries who timely re-register and apply for EADs. Given the timeframes involved with processing TPS re-registration applications, DHS recognizes that all re-registrants may not receive new EADs before their current EADs expire on March 17, 2020. Accordingly, through this Federal Register notice, DHS automatically extends the validity of these EADs previously issued under the TPS designation of Somalia for 180 days, through September 13, 2020. Therefore, TPS beneficiaries who have EADs with: (1) A March 17, 2020 expiration date and (2) an A-12 or C-19 category code, can show these EADs as proof of continued employment authorization through September 13, 2020. This notice explains how TPS beneficiaries and their employers may determine which EADs are automatically extended and how this affects the Employment Eligibility Verification (Form I-9), E-Verify, and USCIS Systematic Alien Verification for Entitlements (SAVE) processes.

Aliens who have a Somalia-based Application for Temporary Protected Status (Form I-821) and/or Application for Employment Authorization (Form I-765) that was still pending as of March 11, 2020 do not need to file either application again. If USCIS approves an alien's Form I-821, USCIS will grant the alien TPS through September 17, 2021. Similarly, if USCIS approves a pending TPS-related Form I-765, USCIS will issue the alien a new EAD that will be valid through the same date. There are currently approximately 454 beneficiaries under Somalia's TPS designation.

• TPS is a temporary immigration status granted to eligible nationals of a country designated for TPS under the Immigration and Nationality Act (INA), or to eligible aliens without nationality who last habitually resided in the designated country.

• During the TPS designation period, TPS beneficiaries are eligible to remain in the United States, may not be removed, and are authorized to obtain EADs so long as they continue to meet the requirements of TPS.

• TPS beneficiaries may also apply for and be granted travel authorization as a matter of discretion.

• The granting of TPS does not result in or lead to lawful permanent resident status.

• To qualify for TPS, beneficiaries must meet the eligibility standards at INA section 244(c)(1)-(2), 8 U.S.C. 1254a(c)(1)-(2).

• When the Secretary terminates a country's TPS designation, beneficiaries return to one of the following:

○ The same immigration status or category that they maintained before TPS, if any (unless that status or category has since expired or been terminated); or

○ Any other lawfully obtained immigration status or category they received while registered for TPS, as long as it is still valid beyond the date TPS terminates.

Somalia was initially designated on September 16, 1991, on the basis of extraordinary and temporary conditions in Somalia that prevented nationals of Somalia from safely returning. See Designation of Nationals of Somalia for Temporary Protected Status, 56 FR 46804 (Sept. 16, 1991). Somalia's designation for TPS has been consecutively extended by multiple Administrations since its initial designation in 1991. Additionally, Somalia was newly designated for TPS in 2001, based on new extraordinary and temporary conditions. See Extension and Redesignation of Somalia under Temporary Protected Status Program, 66 FR 46288 (Sept. 4, 2001). In 2012, Somalia was again newly designated for TPS on the basis of extraordinary and temporary conditions and under the separate basis of ongoing armed conflict. See Extension and Redesignation of Somalia for Temporary Protected Status, 77 FR 25723 (May 1, 2012). Somalia's 2012 TPS designation was subsequently extended in 2013, 2015, 2107, and 2018. See Extension of the Designation of Somalia for Temporary Protected Status, 83 FR 43695 (Aug. 27, 2018).

Section 244(b)(1) of the INA, 8 U.S.C. 1254a(b)(1), authorizes the Secretary, after consultation with appropriate agencies of the U.S. Government (Government), to designate a foreign state (or part thereof) for TPS if the Secretary determines that certain country conditions exist. 1 The decision to designate any foreign state (or part thereof) is a discretionary decision, and there is no judicial review of any determination with respect to the designation, or termination of, or extension of, a designation. The Secretary, in his discretion, may then grant TPS to eligible nationals of that foreign state (or eligible aliens having no nationality who last habitually resided in the designated country). See INA section 244(a)(1)(A), 8 U.S.C. 1254a(a)(1)(A).

At least 60 days before the expiration of a country's TPS designation or extension, the Secretary, after consultation with appropriate Government agencies, must review the conditions in the foreign state designated for TPS to determine whether the conditions for the TPS designation continue to be met. See INA section 244(b)(3)(A), 8 U.S.C. 1254a(b)(3)(A). If the Secretary does not determine that the foreign state no longer meets the conditions for TPS designation, the designation will be extended for an additional period of 6 months or, in the Secretary's discretion, 12 or 18 months. See INA section 244(b)(3)(A), (C), 8 U.S.C. 1254a(b)(3)(A), (C). If the Secretary determines that the foreign state no longer meets the conditions for TPS designation, the Secretary must terminate the designation. See INA section 244(b)(3)(B), 8 U.S.C. 1254a(b)(3)(B).

DHS has reviewed conditions in Somalia. Based on the review, the Secretary has determined that an 18-month extension is warranted because the ongoing armed conflict and extraordinary and temporary conditions supporting Somalia's TPS designation remain.

Despite Somalia's peaceful political transition in 2017, the country is currently a terrorist safe haven, and the security situation remains volatile, with armed conflict continuing in 2018 and 2019. Civilians in Somalia continue to be displaced, injured, and killed as a result of conflicts involving government forces, clan militias, the African Union Mission in Somalia (AMISOM), al Shabaab, and a splinter group of the self-described Islamic State (IS-Somalia). The United States has provided significant support for AMISOM and Somali efforts to counter al Shabaab, and U.S. military personnel advise, assist, and accompany regional forces during counterterrorism operations. U.S. air strikes in Somalia against members of al Qaeda and al Shabaab continued in 2018 and 2019 as well. Al Shabaab currently controls many rural areas in Somalia. IS-Somalia expanded activities in 2018 from its primary base in Somalia's Puntland region, establishing influence in Mogadishu. Both al Shabaab and IS-Somalia used a range of asymmetric tactics against AMISOM and Somali security forces, members of parliament, and other government personnel, as well as soft targets such as hotels, restaurants, and cafes. Al Shabaab launched multiple, often coordinated attacks on a regular basis throughout the country, using suicide bombers, Vehicle Borne Improvised Explosive Devices, ambush-style raids, targeted killings, and mortar attacks. On December 28, 2019, al Shabaab launched a suicide car bomb attack in Mogadishu. At least 79 civilians, including many students, were killed and at least 90 were wounded. It was reportedly the worst terrorist attack in Mogadishu since 2017. IS-Somalia carried out a number of roadside Improvised Explosive Device and small arms attacks, suicide bombings, and targeted killings, primarily in Bosasso in Puntland and the Bakara Market area of Mogadishu, as well as in smaller towns. The United Nations Assistance Mission in Somalia reported 982 civilian casualties from January-October 2018, over half from al Shabaab attacks.

Civilians continue to suffer human rights abuses and violations, including those involving unlawful or arbitrary killings by security forces, clan militias, and unknown assailants; forced disappearances; torture; arbitrary and politically motivated arrests and detentions; forced evictions; sexual abuse; and the forced recruitment of children. Civilian movements are severely limited in many areas of the country due to regular and active hostilities or military operations, and al Shabaab restrictions on civilians leaving territory under its control.

According to a needs assessment conducted by the United Nations Office for the Coordination of Humanitarian Affairs (UNOCHA), approximately 4.2 million Somalis—37 percent of the country's estimated population of 11.3 million—required humanitarian assistance in 2019. UNOCHA reported that this represents a reduction as compared to previously reported figures, which UNOCHA attributed to improvements in the humanitarian situation, a more focused definition of humanitarian needs, and a change in how humanitarian needs are calculated.

As of December 2019, more than 2.6 million people in Somalia were displaced, representing an increase of more than 500,000 from the 2.1 million reported displaced as of April 2018, according to the United Nations High Commissioner for Refugees (UNHCR). Forced evictions, fed by growing population density and rising property prices, as well as weak land tenure protections, continue to negatively affect displaced populations in Somalia. According to the U.S. Department of State (DOS) 2018 Human Rights Report for Somalia, more than 204,000 displaced individuals were forced from their places of shelter in 2018, further undermining humanitarian efforts. 173,255 people were evicted from January-August 2019, with the majority of evictions taking place in Mogadishu.

According to UNHCR, there were 752,038 Somali refugees in neighboring countries as of December 2019. This is a decrease of more than 66,000 from the 819,000 reported refugees in neighboring countries as of May 2018. Since December 2014, more than 91,000 Somali refugees have voluntarily returned to Somalia with the assistance of UNHCR from countries including Djibouti, Eritrea, Kenya, Libya, Sudan, and Yemen. In addition, some 38,000 Somali nationals who had been in Yemen have returned to Somalia since March 2015. According to UNHCR, Somalia hosted 35,523 refugees and asylum seekers, mainly from Ethiopia (21,707) and Yemen (13,259).

Access to medical care continued to worsen in 2018 due to widespread violence, and Somalia's health system remains fragmented, under-resourced, and ill-equipped to provide lifesaving and preventative services. Three million people in Somalia require urgent and essential healthcare services, according to UNOCHA. Women and children are particularly exposed to elevated health risks—Somalia has the world's highest child mortality rate and faces the sixth highest lifetime maternal death risk in the world, also according to UNOCHA.

Somalia experienced signs of economic recovery in 2018. Both the World Bank and the International Monetary Fund reported Gross Domestic Product growth of 2.8 percent. The World Bank projects further growth of 3.0 to 3.5 percent in 2019 and 2020. Nevertheless, an estimated 69 percent of Somalia's population lives in poverty, the sixth highest poverty rate of all countries in the world. In 2018, average per capita income was $332 U.S. dollars per year, according to the World Bank.

Based upon this review, and after consultation with appropriate Government agencies, the Secretary has determined that:

• The conditions supporting Somalia's designation for TPS continue to be met. See INA section 244(b)(3)(A) and (C), 8 U.S.C. 1254a(b)(3)(A) and (C).

• There continues to be an ongoing armed conflict in Somalia and, due to such conflict, requiring the return to Somalia of Somali nationals (or aliens having no nationality who last habitually resided in Somalia) would pose a serious threat to their personal safety. See INA section 244(b)(1)(A), 8 U.S.C. 1254a(b)(1)(A).

• There continue to be extraordinary and temporary conditions in Somalia that prevent Somali nationals (or aliens having no nationality who last habitually resided in Somalia) from returning to Somalia in safety, and it is not contrary to the national interest of the United States to permit Somali TPS beneficiaries to remain in the United States temporarily. See INA section 244(b)(1)(C), 8 U.S.C. 1254a(b)(1)(C).

• The designation of Somalia for TPS should be extended for an 18-month period, from March 18, 2020, through September 17, 2021. See INA section 244(b)(3)(C), 8 U.S.C. 1254a(b)(3)(C).

By the authority vested in me as Secretary under INA section 244, 8 U.S.C. 1254a, I have determined, after consultation with the appropriate Government agencies, the conditions supporting Somalia's designation for TPS continue to be met. See INA section 244(b)(3)(A), 8 U.S.C. 1254a(b)(3)(A). On the basis of this determination, I am extending the existing designation of TPS for Somalia for 18 months, from March 18, 2020, through September 17, 2021. See INA section 244(b)(1)(A), (b)(1)(C); 8 U.S.C. 1254a(b)(1)(A), (b)(1)(C).

To re-register for TPS based on the designation of Somalia, you must submit an Application for Temporary Protected Status (Form I-821). There is no Form I-821 fee for re-registration. See 8 CFR 244.17. You may be required to pay the biometric services fee. Please see additional information under the “Biometric Services Fee” section of this notice.

Through this Federal Register notice, your existing EAD issued under the TPS designation of Somalia with the expiration date of March 17, 2020, is automatically extended for 180 days, through September 13, 2020. Although not required to do so, if you want to obtain a new EAD valid through September 17, 2021, you must file an Application for Employment Authorization (Form I-765) and pay the Form I-765 fee (or submit a Request for a Fee Waiver (Form I-912)). If you do not want a new EAD, you do not have to file Form I-765 and pay the Form I-765 fee. If you do not want to request a new EAD now, you may also file Form I-765 at a later date and pay the fee (or request a fee waiver), provided that you still have TPS or a pending TPS application.

If you have a Form I-821 and/or Form I-765 that was still pending as of March 11, 2020, then you do not need to file either application again. If USCIS approves your pending TPS application, USCIS will grant you TPS through September 17, 2021. Similarly, if USCIS approves your pending TPS-related Form I-765, it will be valid through the same date.

You may file the application for a new EAD either prior to or after your current EAD has expired. However, you are strongly encouraged to file your application for a new EAD as early as possible to avoid gaps in the validity of your employment authorization documentation and to ensure that you receive your new EAD by September 13, 2020.

For more information on the application forms and fees for TPS, please visit the USCIS TPS web page at www.uscis.gov/tps. Fees for the Form I-821, the Form I-765, and biometric services are also described in 8 CFR 103.7(b)(1)(i).

Biometrics (such as fingerprints) are required for all applicants 14 years of age and older. Those applicants must submit a biometric services fee. As previously stated, if you are unable to pay the biometric services fee, you may complete a Request for Fee Waiver (Form I-912). For more information on the application forms and fees for TPS, please visit the USCIS TPS web page at www.uscis.gov/tps. If necessary, you may be required to visit an Application Support Center to have your biometrics captured. For additional information on the USCIS biometrics screening process, please see the USCIS Customer Profile Management Service Privacy Impact Assessment, available at www.dhs.gov/privacy.

You should file as soon as possible within the 60-day re-registration period so USCIS can process your application and issue any EAD promptly. Properly filing early will also allow you to have time to refile your application before the deadline, should USCIS deny your fee waiver request. If, however, you receive a denial of your fee waiver request and are unable to refile by the re-registration deadline, you may still refile your Form I-821 with the biometrics fee. USCIS will review this situation to determine whether you established good cause for late TPS re-registration. However, you are urged to refile within 45 days of the date on any USCIS fee waiver denial notice, if possible. See INA section 244(c)(3)(C); 8 U.S.C. 1254a(c)(3)(C); 8 CFR 244.17(b). For more information on good cause for late re-registration, visit the USCIS TPS web page at www.uscis.gov/tps. Following denial of your fee waiver request, you may also refile your Form I-765 with fee either with your Form I-821 or at a later time, if you choose.

Note: Although a re-registering TPS beneficiary age 14 and older must pay the biometric services fee (but not the Form I-821 fee) when filing a TPS re-registration application, you may decide to wait to request an EAD. Therefore, you do not have to file the Form I-765 or pay the associated Form I-765 fee (or request a fee waiver) at the time of re-registration, and can wait to seek an EAD until after USCIS has approved your TPS re-registration application. If you choose to do this, to re-register for TPS you would only need to file the Form I-821 with the biometrics services fee, if applicable, (or request a fee waiver).

Mail your application for TPS to the proper address in Table 1.

If you were granted TPS by an Immigration Judge (IJ) or the Board of Immigration Appeals (BIA) and you wish to request an EAD or are re-registering for the first time following a grant of TPS by an IJ or the BIA, please mail your application to the appropriate mailing address in Table 1. When re-registering and requesting an EAD based on an IJ/BIA grant of TPS, please include a copy of the IJ or BIA order granting you TPS with your application. This will help us to verify your grant of TPS and process your application.

The filing instructions on the Form I-821 list all the documents needed to establish eligibility for TPS. You may also find information on the acceptable documentation and other requirements for applying or registering for TPS on the USCIS website at www.uscis.gov/tps under “Somalia.”

To get case status information about your TPS application, including the status of an EAD request, you can check Case Status Online at www.uscis.gov, or call the USCIS Contact Center at 800-375-5283 (TTY 800-767-1833). If your Form I-765 has been pending for more than 90 days, and you still need assistance, you may request an EAD inquiry appointment with USCIS at my.uscis.gov/en/appointment/v2. However, we strongly encourage you first to check Case Status Online or call the USCIS Contact Center for assistance before requesting an appointment online.

Yes. Provided that you currently have a Somalia TPS-based EAD with a marked expiration date of March 17, 2020, bearing the notation A-12 or C-19 on the face of the card under Category, this notice automatically extends your EAD through September 13, 2020. Although this Federal Register notice automatically extends your EAD through September 13, 2020, you must re-register timely for TPS in accordance with the procedures described in this Federal Register notice to maintain your TPS.

You can find the Lists of Acceptable Documents on the third page of Form I-9 as well as the Acceptable Documents web page at www.uscis.gov/i-9-central/acceptable-documents. Employers must complete Form I-9 to verify the identity and employment authorization of all new employees. Within 3 days of hire, employees must present acceptable documents to their employers as evidence of identity and employment authorization to satisfy Form I-9 requirements.

You may present any document from List A (which provides evidence of both identity and employment authorization), or one document from List B (which provides evidence of your identity) together with one document from List C (which provides evidence of employment authorization), or you may present an acceptable receipt as described in the Form I-9 instructions. Employers may not reject a document based on a future expiration date. You can find additional information about Form I-9 on the I-9 Central web page at www.uscis.gov/I-9Central.

An EAD is an acceptable document under List A. See the section “How do my employer and I complete Form I-9 using my automatically extended employment authorization for a new job?” of this Federal Register notice for further information. If your EAD has an expiration date of March 17, 2020, and states A-12 or C-19 under Category, it has been extended automatically by virtue of this Federal Register notice and you may choose to present your EAD to your employer as proof of identity and employment eligibility for Form I-9 through September 13, 2020, unless your TPS has been withdrawn or your request for TPS has been denied. If you have an EAD with a marked expiration date of March 17, 2020, that states A-12 or C-19 under Category, and you received a Notice of Action (Form I-797C) that states your EAD is automatically extended for 180 days, you may choose to present your EAD to your employer together with this Form I-797C as a List A document that provides evidence of your identity and employment authorization for Form I-9 through September 13, 2020, unless your TPS has been withdrawn or your request for TPS has been denied. See the subsection titled, “How do my employer and I complete the Employment Eligibility Verification (Form I-9) using my automatically extended employment authorization for a new job?” for further information.

As an alternative to presenting evidence of your automatically extended EAD, you may choose to present any other acceptable document from List A, a combination of one selection from List B and one selection from List C, or an acceptable receipt.

Even though your EAD has been automatically extended, your employer is required by law to ask you about your continued employment authorization, and you will need to present your employer with evidence that you are still authorized to work. Once presented, your employer should update the EAD expiration date in Section 2 of Form I-9. See the section “What corrections should my current employer make to Form I-9 if my employment authorization has been automatically extended?” of this Federal Register notice for further information. You may show this Federal Register notice to your employer to explain what to do for Form I-9 and to show that your EAD has been automatically extended through September 13, 2020. Your employer may need to re-inspect your automatically extended EAD to check the Card Expires date and Category code if your employer did not keep a copy of your EAD when you initially presented it.

The last day of the automatic extension for your EAD is September 13, 2020. Before you start work on September 14, 2020, your employer is required by law to reverify your employment authorization in Section 3 of Form I-9. At that time, you must present any document from List A or any document from List C on Form I-9, Lists of Acceptable Documents, or an acceptable List A or List C receipt described in the Form I-9 instructions to reverify employment authorization.

If your original Form I-9 was a previous version, your employer must complete Section 3 of the current version of Form I-9, and attach it to your previously completed Form I-9. Your employer can check the I-9 Central web page at www.uscis.gov/I-9Central for the most current version of Form I-9.

Your employer may not specify which List A or List C document you must present and cannot reject an acceptable receipt.

No. When completing Form I-9, including reverifying employment authorization, employers must accept any documentation that appears on the Form I-9 Lists of Acceptable Documents that reasonably appears to be genuine and that relates to you, or an acceptable List A, List B, or List C receipt. Employers need not reverify List B identity documents. Employers may not request documentation that does not appear on the Lists of Acceptable Documents. Therefore, employers may not request proof of Somali citizenship or proof of re-registration for TPS when completing Form I-9 for new hires or reverifying the employment authorization of current employees. If presented with an EAD that has been automatically extended, employers should accept such a document as a valid List A document, so long as the EAD reasonably appears to be genuine and relates to the employee. Refer to the “Note to Employees” section of this Federal Register notice for important information about your rights if your employer rejects lawful documentation, requires additional documentation, or otherwise discriminates against you based on your citizenship or immigration status, or your national origin.

When using an automatically extended EAD to complete Form I-9 for a new job before September 14, 2020, for Section 1, you should:

a. Check “An alien authorized to work until” and enter September 13, 2020 as the expiration date; and

b. Enter your USCIS number or A-Number where indicated (your EAD or other document from DHS will have your USCIS number or A-Number printed on it; the USCIS number is the same as your A-Number without the A prefix).

For Section 2, your employer should:

a. Determine if the EAD is auto-extended by ensuring it is in Category A-12 or C-19 and has a Card Expires date of March 17, 2020;

b. Write in the document title;

c. Enter the issuing authority;

d. Enter either the employee's A-Number or USCIS number from Section 1 in the Document Number field on Form I-9; and

e. Write September 13, 2020, as the expiration date.

Before the start of work on September 14, 2020, employers must reverify the employee's employment authorization in Section 3 of Form I-9.

If you presented a TPS-related EAD that was valid when you first started your job and your EAD has now been automatically extended, your employer may need to re-inspect your current EAD if the employer does not have a copy of the EAD on file. Your employer should determine if your EAD is automatically extended by ensuring that it contains Category A-12 or C-19 and has a Card Expires date of March 17, 2020. If your employer determines that your EAD has been automatically extended, your employer should update Section 2 of your previously completed Form I-9 as follows:

a. Write EAD EXT and September 13, 2020, as the last day of the automatic extension in the Additional Information field; and

b. Initial and date the correction.

Note: This is not considered a reverification. Employers do not need to complete Section 3 until either the 180-day automatic extension has ended or the employee presents a new document to show continued employment authorization, whichever is sooner. By September 14, 2020, when the employee's automatically extended EAD has expired, employers are required by law to reverify the employee's employment authorization in Section 3. If your original Form I-9 was a previous version, your employer must complete Section 3 of the current version of Form I-9 and attach it to your previously completed Form I-9. Your employer can check the I-9 Central web page at www.uscis.gov/I-9Central for the most current version of Form I-9.

Employers may create a case in E-Verify for a new employee by providing the employee's A-Number or USCIS number from Form I-9 in the Document Number field in E-Verify.

E-Verify has automated the verification process for TPS-related EADs that are automatically extended. If you have employees who provided a TPS-related EAD when they first started working for you, you will receive a “Work Authorization Documents Expiring” case alert when the auto-extension period for this EAD is about to expire. Before this employee starts work on September 14, 2020, you must reverify his or her employment authorization in Section 3 of Form I-9. Employers should not use E-Verify for reverification.

Employers are reminded that the laws requiring proper employment eligibility verification and prohibiting unfair immigration-related employment practices remain in full force. This Federal Register notice does not supersede or in any way limit applicable employment verification rules and policy guidance, including those rules setting forth reverification requirements. For general questions about the employment eligibility verification process, employers may call USCIS at 888-464-4218 (TTY 877-875-6028) or email USCIS at I9Central@dhs.gov. USCIS accepts calls and emails in English and many other languages. For questions about avoiding discrimination during the employment eligibility verification process (Form I-9 and E-Verify), employers may call the U.S. Department of Justice's Civil Rights Division, Immigrant and Employee Rights Section (IER) Employer Hotline at 800-255-8155 (TTY 800-237-2515). IER offers language interpretation in numerous languages. Employers may also email IER at IER@usdoj.gov.

For general questions about the employment eligibility verification process, employees may call USCIS at 888-897-7781 (TTY 877-875-6028) or email USCIS at I-9Central@dhs.gov. USCIS accepts calls in English, Spanish, and many other languages. Employees or applicants may also call the IER Worker Hotline at 800-255-7688 (TTY 800-237-2515) for information regarding employment discrimination based upon citizenship, immigration status, or national origin, including discrimination related to Employment Eligibility Verification (Form I-9) and E-Verify. The IER Worker Hotline provides language interpretation in numerous languages.

To comply with the law, employers must accept any document or combination of documents from the Lists of Acceptable Documents if the documentation reasonably appears to be genuine and to relate to the employee, or an acceptable List A, List B, or List C receipt as described in the Form I-9 Instructions. Employers may not require extra or additional documentation beyond what is required for Form I-9 completion. Further, employers participating in E-Verify who receive an E-Verify case result of “Tentative Nonconfirmation” (TNC) must promptly inform employees of the TNC and give such employees an opportunity to contest the TNC. A TNC case result means that the information entered into E-Verify from an employee's Form I-9 differs from records available to DHS.

Employers may not terminate, suspend, delay training, withhold pay, lower pay, or take any adverse action against an employee because of the TNC while the case is still pending with E-Verify. A “Final Nonconfirmation” (FNC) case result is received when E-Verify cannot verify an employee's employment eligibility. An employer may terminate employment based on a case result of FNC. Work-authorized employees who receive an FNC may call USCIS for assistance at 888-897-7781 (TTY 877-875-6028). For more information about E-Verify-related discrimination or to report an employer for discrimination in the E-Verify process based on citizenship, immigration status, or national origin, contact IER's Worker Hotline at 800-255-7688 (TTY 800-237-2515). Additional information about proper nondiscriminatory Form I-9 and E-Verify procedures is available on the IER website at www.justice.gov/ier and on the USCIS and E-Verify websites at www.uscis.gov/i-9-central and www.e-verify.gov.

For Federal purposes, TPS beneficiaries presenting an EAD referenced in this Federal Register Notice do not need to show any other document, such as an I-797C Notice of Action, to prove that they qualify for this extension. However, while Federal Government agencies must follow the guidelines laid out by the Federal Government, state and local government agencies establish their own rules and guidelines when granting certain benefits. Each state may have different laws, requirements, and determinations about what documents you need to provide to prove eligibility for certain benefits. Whether you are applying for a Federal, state, or local government benefit, you may need to provide the government agency with documents that show you are a TPS beneficiary, show you are authorized to work based on TPS or other status, and/or that may be used by DHS to determine whether you have TPS or other immigration status. Examples of such documents are:

• Your current EAD;

• A copy of your Form I-797C, Notice of Action, for your Form I-765 providing an automatic extension of your currently expired or expiring EAD;

• A copy of your Form I-797C, Notice of Action, for your Form I-821 for this re-registration;

• A copy of your Form I-797, the notice of approval, for a past or current Form I-821, if you received one from USCIS; and

• Any other relevant DHS-issued document that indicates your immigration status or authorization to be in the United States, or that may be used by DHS to determine whether you have such status or authorization to remain in the United States.

Check with the government agency regarding which document(s) the agency will accept. Some benefit-granting agencies use the USCIS Systematic Alien Verification for Entitlements (SAVE) program to confirm the current immigration status of applicants for public benefits. While SAVE can verify when an alien has TPS, each agency's procedures govern whether they will accept an unexpired EAD, I-797, or I-94. You should:

a. Present the agency with a copy of the relevant Federal Register notice showing the extension of TPS-related documentation in addition to your recent TPS-related document with your alien or I-94 number;

b. Explain that SAVE will be able to verify the continuation of your TPS using this information; and

c. Ask the agency to initiate a SAVE query with your information and follow through with additional verification steps, if necessary, to get a final SAVE response showing the validity of your TPS.

You can also ask the agency to look for SAVE notices or contact SAVE if they have any questions about your immigration status or auto-extension of TPS-related documentation. In most cases, SAVE provides an automated electronic response to benefit-granting agencies within seconds, but, occasionally, verification can be delayed. You can check the status of your SAVE verification by using CaseCheck at save.uscis.gov/casecheck/, then by clicking the “Check Your Case” button. CaseCheck is a free service that lets you follow the progress of your SAVE verification using your date of birth and one immigration identifier number. If an agency has denied your application based solely or in part on a SAVE response, the agency must offer you the opportunity to appeal the decision in accordance with the agency's procedures. If the agency has received and acted upon or will act upon a SAVE verification and you do not believe the response is correct, you may make an appointment for an in-person interview at a local USCIS office. Detailed information on how to make corrections or update your immigration record, make an appointment, or submit a written request to correct records under the Freedom of Information Act can be found on the SAVE website at www.uscis.gov/save.

On August 30, 2019 HUD published the FY 2020 FMRs, requesting comments on the FY 2020 FMRs, and outlining procedures for requesting a reevaluation of an area's FY 2020 FMRs (84 FR 45789). This notice revises FY 2020 FMRs for six areas based on data provided to HUD. In addition to providing revised FY 2020 FMRs, this notice also provides responses to the public comments HUD received on the notice referenced above.

The FMRs appearing in the following table supersede the use of the FY 2019 FMRs for the five areas requesting reevaluation and for Guam, which has been using FY 2020 FMRs. The updated FY 2020 FMRs are based on surveys conducted by the area public housing agencies (PHAs) and reflect the estimated 40th percentile rent levels trended to April 1, 2020.

The FMRs for the affected area are revised as follows:

The FY 2020 FMRs are amended and are available on the HUD USER website: http://www.huduser.gov/portal/datasets/fmr.html. The FY 2020 Small Area FMRs (SAFMRs) for metropolitan areas with revised FMRs have also been updated commensurate with the metropolitan area revisions and may be found at https://www.huduser.gov/portal/datasets/fmr/smallarea/index.html.

A total of 20 comments were received and posted on regulations.gov, https://www.regulations.gov/docket?D=HUD-2019-0070. Of the 20 comments received, nine were reevaluation requests for nine FMR areas. HUD granted requests for reevaluation for 8 FMR areas, and rejected one request submitted by a tenant looking for affordable housing in Memphis, TN. HUD could not approve this request because the request was not made by housing agencies administering more than half of the vouchers in the FMR area as required by item 1 in the request for reevaluation procedures in the August 30, 2019 Federal Register notice. HUD discussed these requests for reevaluation in a posting available at https://www.huduser.gov/portal/datasets/fmr/fmr2020/Areas-where-FY2019-;FMRs-Remain-in-Effect.pdf.

Public housing agencies in the eight areas where HUD agreed to reevaluate the FY 2020 FMRs continued to use FY 2019 FMRs during the reevaluation period as mandated by the Housing Opportunities Through Modernization Act. Five of these eight areas have continued to use FY 2019 FMRs since January 10, 2020 because they provided valid survey data to revise the FY 2020 FMRs. FY 2020 FMRs became effective on January 13, 2020 for the three areas where local survey data was not submitted by the January 10, 2020 cut-off date. HUD published a list of the three FMR areas not providing data on January 13, 2020 stating that the FY 2020 FMRs become effective on January 13, 2020 ( https://www.huduser.gov/portal/datasets/fmr/fmr2020/FMR-Areas-Requesting-Re-evaluation-and-No-Data-Submission.pdf ). This notice provides the reevaluated FY 2020 FMRs for the five areas requesting reevaluation and for Guam.

Most of the comments not related to specific areas requesting a reevaluation discussed inaccuracies of the FMRs and a need for more current and local data. These comments and their responses are discussed in greater detail below.

Comment: Several commenters suggested that HUD should provide additional funding to PHAs who undertake local area surveys. One comment noted that the cost for address-based mail surveys is in the $5,000 to $10,000 range.

HUD Response: HUD reminds PHAs that paying for local area rent surveys is an eligible expense to be paid from on-going administrative fees or their administrative fee reserve account. The estimate of $5,000 to $10,000 per survey is incorrect. This value is apparently based on a study conducted in 2012 for very small metropolitan areas with fewer than 20,000 rental units. Far fewer than 100 survey cases were acceptable at this time, but no longer because over time HUD has imposed a minimum 100 observation requirement to reduce year to year fluctuations in FMRs. The cost of the survey increases with the size of the FMR, the size of the rental market and the availability and cost of good rental market lists.

Comment: HUD's reliance on setting FMRs at the 40th percentile is flawed because this only works if there is a normal distribution of rental units. Sub-standard housing should be removed from the distribution when calculating a 40th percentile rent.

HUD Response: The purpose of using a percentile instead of an average is to account for abnormal distributions. HUD removes responses from the American Community Survey (ACS) when the respondent reports the unit does not have a complete kitchen or complete plumbing to address sub-standard units. In addition, HUD determines a “public housing cut-off rent” to eliminate the bottom end of the distribution of rental units from the ACS before the 40th percentile rent is calculated as a proxy to remove units with low rents that are likely in non-market transactions ( e.g., rented from relatives), subsidized (ACS does not ask whether households receive rental subsidies), or are otherwise inadequate in some manner not measured by the ACS. HUD uses a consistent method to calculate this distribution cut off for each HUD region. HUD continues to explore alternatives for removing assisted units from the ACS responses before the 40th percentile rent is calculated for the purpose of calculating FMRs.

Comment: HUD needs to conduct its own analysis or research to address market anomalies and account for erratic fluctuations in FMRs between years and by bedroom size.

HUD Response: HUD did conduct research into different methods of calculating the trend factor and implemented metropolitan and regional forecasting into the calculation of the trend factor in the FY 2020 FMRs.

To correct erratic fluctuations in FMRs year over year, HUD has implemented steps to attenuate the fluctuations found in the annually updated survey data. HUD has made methodology changes that call for averaging bedroom ratios over three years of data and averaging base rents over the same period when the data is limited. The statutory directive to use the most recent data available compels HUD to update the data behind each area's FMR calculation when new data is released. Consequently, FMRs will change from year to year in accordance with changes in the underlying survey data. HUD emphasizes that the primary data source for FMRs is a survey (ACS) and while surveyors do their best to select unbiased random samples of the population, sampling error persists within survey statistics.

Comment: Along with inadequate administrative fees, inadequate FMRs result in voucher underutilization nationwide. HUD's methodology for setting FMRs also often results in a reduction of choice and in many places relegates voucher holders to the poorest areas.

HUD Response: HUD's methodology for calculating FMRs has been revised to improve choice in metropolitan areas through the use of Small Area FMRs and in all FMR areas by the use of local or regional trend factors as opposed to one national trend factor. Outside the voucher program, however, especially for programs that only allow for the use of area-wide FMRs, the FMR may cover the cost of units with rent above the 40th percentile found in the poorest of areas.

Comment: HUD should create new administrative mechanisms to cope with inaccurate FMRs.

HUD Response: HUD does have procedures that provide flexibility in the voucher program that allow PHAs to keep payment standards constant when FMRs decline. For areas where rents increase more rapidly than what is captured by the most recent data available to HUD in calculating FMRs, the department provides a mechanism for more recent data collected in a survey to be supplied to HUD. Lastly, HUD has eased the exception payment standard regulations in metropolitan areas to allow for the use of up to 110 percent of the Small Area FMR as an exception payment standard with no approval needed from HUD. The only requirement is for PHAs to notify HUD of their use of Small Area FMRs in this manner. New administrative procedures would have to be developed by the programs other than the Housing Choice Voucher program to allow for use of payment standards to provide additional flexibility. Each program required to use FMRs without similar flexibility to payment standards would have to amend its regulations to allow for flexible application of FMRs if statute permits.

Comment: Adjustments to FMRs must be followed by the commensurate adjustments in the Renewal Funding Inflation Factors (RFIF), particularly in the years following rapid growth and increase in the FMR.

HUD Response: HUD includes revised FMRs in that year's RFIFs. This gives those areas that provided new survey data with an increase in their RFIF in the first year over what they would have had under the FMRs without the revision. In subsequent years, while the survey is still effective, their FMRs will only increase by normal factors, and the RFIFs change accordingly.

Comment: Proper consideration is not being paid by HUD to rapidly escalating market rents; HUD should tie FMR calculations to the qualifier provided in Comprehensive Housing Market Analysis (CMHA) and other such publications. The qualifiers include economy, sales market and rental market and include categorical ranking and description that give more insight into local market conditions than older census survey data.

HUD Response: HUD's Comprehensive Housing Market Analysis (CHMA) and other such publications are undertaken primarily to assess the demand for construction of new housing units over a three-year market horizon. Moreover, CHMAs are not conducted in all areas and are typically not annually updated. Finally, the area over which a CHMA is conducted is at the discretion of HUD's Field Economist organization and may not align with FMR area boundaries. This is to ensure the construction demand estimates provided in the CHMAs are targeted appropriately. These reasons make CHMAs a poor source of data for calculating FMRs. Finally, the FY 2020 appropriations statute directs HUD to undertake a research study to determine alternative methods for calculating FMRs in markets with rapidly rising rents. HUD is in the initial stages of beginning this research effort and expects to have the research completed sometime in 2021.

Comment: HUD should increase transparency of the FMR calculation, especially for FMR areas that are based on local rent surveys. Unless full transparency is provided into the calculations and methodology used in determining FMRs, the argument that HUD cannot use private data is invalid. HUD should publish a forecast at 6 months into the year of the trend factor, so agencies are given plenty of time to plan a rent survey or deal with other negative impacts to funding.

HUD Response: For the FY 2020 FMRs, HUD modified its Documentation System to provide better information for areas that receive an FMR based on current or past surveys.

Comment: HUD should continue to refine its methodology for calculating FMRs. A high priority should be placed on improving the data that is used to derive more accurate FMRs. HUD should explore “scraping” local rent data or purchase this data for access to rents in newer Class A properties. HUD should use more timely data when calculating FMRs. In addition, HUD needs to use data to exclude rent controlled units from FMR calculations. Other than various private data sources, HUD could enter into an interagency agreement with the IRS to get information on monthly rent and size of units from landlord tax filings.

HUD Response: There is no other data on gross rents paid that is consistently collected on a nationwide basis, available to HUD, that is more current than the data we receive through the ACS. Proprietary rental data cannot be used as the basis for the FMR calculations because it is not consistently available for all areas and is not collected in such a way that it is statistically representative of the rental markets it covers. Some of these sources focus on rents for major apartment projects only. Additionally, rents for single family homes, which are at least 30 percent of the rental market in major metropolitan areas and a greater portion in rural areas, are typically compiled from internet-based ads, or the small subset of professionally managed single-family rental units and generally are not representative of the entire rental stock of single family homes. Online listings of rents are similar to newspaper ads which have been excluded as a source of rent data for FMRs since the mid-1980s due to a directive issued by HUD's Inspector General because they do not constitute a statistically representative sample of the rental market for an area.

HUD can only exclude rent control units if it has some basis for determining the scope of rents in an area that are governed by rent control.

The Federal Government invests a substantial amount of resources in collecting socio-economic data through the American Community Survey (ACS). Furthermore, the Census Bureau has statutory advantages in compelling responses to the ACS and receives significantly higher response rates than HUD could achieve if it was to undertake its own survey program. The IRS is prohibited by law from releasing taxpayer information such as rental income, even to other Federal agencies.

Comment: HUD should use the 2017 American Community Survey data to compare the gross rent by FMR area to the FY 2017 FMRs to determine accuracy of FMRs and report back to the industry.

HUD Response: HUD undertook an analysis such as this and reported the results in a recent report to Congress. Please see the section labeled “Accuracy of FMRs” in HUD's report “Proposals To Update the Fair Market Rent Formula”, page 3, available at https://www.huduser.gov/portal/sites/default/files/pdf/Proposals-To-Update-the-Fair-Market-Rent-Formula.pdf. Between 2009 and 2016 for areas with sufficiently large ACS recent mover rental unit samples, the ACS-measured 40th percentile gross rents were within 90 to 110 percent of the published FMRs in 83.4 to 94.3 percent of cases. These results do not adjust for more recent improvements in the FMR estimation method.

This Notice involves establishment of a rate and does not constitute a development decision affecting the physical condition of specific project areas or building sites. Accordingly, under 24 CFR 50.19(c)(6), this Notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).

We, the Fish and Wildlife Service, announce receipt of an application from Michael McKoy (applicant) for an incidental take permit (ITP) under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ). The applicant requests to take the federally listed Alabama beach mouse ( Peromyscus polionotus ammobates; ABM) incidental to the construction of a single-family home (project) in Baldwin County, Alabama. We request public comment on the application, which includes the applicant's proposed habitat conservation plan (HCP) and the Service's preliminary determination that this HCP qualifies as “low-effect,” categorically excluded, under the National Environmental Policy Act (NEPA; 42 U.S.C. 4231 et seq. ) To make this determination, we used our environmental action statement and low-effect screening form, both of which are also available for public review.

The applicant requests a 50-year ITP to take Alabama beach mice incidental to the conversion of approximately 0.18 acres of occupied Alabama beach mouse habitat to construct a single-family home on a 0.74-acre lot in Baldwin County, Alabama. The applicant proposes to implement standard ABM minimization and mitigation measures to mitigate for take of the species. The standard mitigation and minimization measures include reducing the construction footprint to the maximum extent possible, installing sea turtle-friendly exterior lighting and tinted windows, planting landscaping with native vegetation, and constructing a driveway with materials that will not disperse in a storm surge. The applicant will utilize refuse control measures during construction, as well as restore ABM habitat after tropical storms, and future residents also would be required implement such measures. Free-roaming cats and the use of exterior rodenticide also would be prohibited on the parcel. Prior to engaging in any project activities, the applicant will contribute an in-lieu fee of $2.30-per-square-foot of impacts to the Alabama Coastal Heritage Trust. The fee will be utilized by the Bon Secour National Wildlife Refuge to monitor the ABM or enhance the species' habitat within the refuge.

Before including your address, phone number, email address, or other personal identifying information in your comment, be aware that your entire comment, including your personal identifying information may be made available to the public. While you may request that we withhold your information, we cannot guarantee that we will be able to do so.

The Service has made a preliminary determination that the applicant's project, including land clearing, infrastructure building, landscaping, and proposed mitigation and minimization measures, would individually and cumulatively have a minor or negligible effect on the Alabama beach mouse and the environment. Therefore, we have preliminarily concluded that the ITP for this project would qualify for categorical exclusion as well as that the HCP is low effect under our NEPA regulations at 43 CFR 46.205 and 46.210. A low-effect HCP is one that would result in (1) minor or negligible effects on federally listed, proposed, and candidate species and their habitats; (2) minor or negligible effects on other environmental values or resources; and, (3) impacts that, when considered together with the impacts of other past, present, and reasonably foreseeable similarly situated projects, would not over time result in significant cumulative effects to environmental values or resources.

The Service will evaluate the application and the comments received to determine whether to issue the requested permit. We will also conduct an intra-Service consultation pursuant to section 7 of the ESA to evaluate the effects of the proposed take. After considering the preceding findings, we will determine whether the permit issuance criteria of section 10(a)(l)(B) of the ESA have been met. If met, the Service will issue ITP number TE46613D-0 to the applicant Michael McKoy.

The Service provides this notice under section 10(c) (16 U.S.C. 1539(c)) of the ESA and NEPA regulation 40 CFR 1506.6.

We, the Fish and Wildlife Service, announce receipt of an application from the City of Gulf Shores, Alabama (applicant), to modify an existing 50-year incidental take permit (ITP) under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ). The applicant requests to take the federally listed Alabama beach mouse ( Peromyscus polionotus ammobates ) incidental to the construction of a parking lot with associated facilities (project) in Gulf Shores, Alabama. The ITP modification would reduce the amount of take from 0.89 to 0.86 acres of occupied ABM habitat. We request public comment on the application, which includes the proposed modified habitat conservation plan (HCP) and the Service's preliminary determination that the HCP qualifies as “low-effect,” categorically excluded, under the National Environmental Policy Act (NEPA; 42 U.S.C. 4231 et seq. ). To make this determination, we used our environmental action statement and low-effect screening form, both of which are also available for public review.

The applicant requests to modify its ITP to authorize take of the ABM via conversion of approximately 0.86 acres of the species' occupied associated with construction of a parking lot with amenities on 1.37 acres of a 5.1-acre parcel in Baldwin County, Alabama. The applicant proposes to implement standard ABM minimization and mitigation measures to mitigate for take of the species. The standard minimization and mitigation measures include, but are not limited to, reducing the construction footprint, shifting the project to the west and north to increase habitat continuity for the species, installing sea turtle-friendly exterior lighting and tinted windows, planting landscaping with native vegetation, and constructing a driveway with materials that will not disperse in a storm surge. The applicant will utilize refuse control measures during construction, as well as restore species' habitat after tropical storms. Free-roaming cats and use of exterior rodenticide also would be prohibited on the parcel. The applicant will conduct on-site monitoring of the Alabama beach mouse population via fall and spring trapping surveys (twice a year) over the remaining term of the ITP. Other minimization and mitigation measures include trapping and relocating ABM, dune enhancement, and restoration and installation of sand fencing. The applicant also would create and contribute to a dune enhancement fund to which future developers could also contribute. The applicant would make an annual contribution to the fund over the span of the ITP. The proceeds from the fund would be used to enhance habitat elsewhere within the city limits where ABM might be found.

Before including your address, phone number, email address, or other personal identifying information in your comment, be aware that your entire comment including your personal identifying information may be made available to the public. While you may request that we withhold your information, we cannot guarantee that we will be able to do so.

The Service has made a preliminary determination that the applicant's project, including the proposed minimization and mitigation measures, would have a minor or negligible effect on the Alabama beach mouse and the environment. Therefore, we have preliminarily determined that modification of the incidental take permit would qualify for categorical exclusion and the modified HCP would be “low effect” and categorically excluded under our NEPA regulations at 43 CFR 46.205 and 46.210. A low-effect HCP is one that would result in (1) minor or negligible effects on federally listed, proposed, and candidate species and their habitats; (2) minor or negligible effects on other environmental values or resources; and, (3) impacts that, when considered together with those of other past, present, and reasonably foreseeable similarly situated projects, would not over time result in significant individual or cumulative effects to environmental values or resources.

The Service will evaluate the application and comments to determine whether to issue the requested modified permit. We will also conduct an intra-Service consultation pursuant to section 7 of the ESA to evaluate the effects of the proposed take. After considering the preceding findings, we will determine whether to modify the ITP and issue ITP number TE84363C-1 to the City of Gulf Shores.

The Service provides this notice under section 10(c) (16 U.S.C. 1539(c)) of the ESA and NEPA regulation 40 CFR 1506.6.

Under the Endangered Species Act of 1973, as amended (Act; 16 U.S.C. 1531, et seq. ), we maintain lists of endangered and threatened wildlife and plant species (referred to as the List) in the Code of Federal Regulations (CFR) at 50 CFR 17.11 (for wildlife) and 17.12 (for plants). Section 4(c)(2) of the Act requires us to review each listed species' status at least once every 5 years. For additional information about 5-year status reviews, refer to our factsheet at http://www.fws.gov/endangered/what-we-do/recovery-overview.html.

A 5-year status review considers all new information available at the time of the review. In conducting these reviews, we consider the best scientific and commercial data that have become available since the listing determination or most recent status reviews, such as:

A. Species biology, including but not limited to population trends, distribution, abundance, demographics, and genetics;

B. Habitat conditions, including but not limited to amount, distribution, and suitability;

C. Conservation measures that have been implemented that benefit the species;

D. Threat status and trends in relation to the five listing factors (as defined in section 4(a)(1) of the Act); and

E. Other new information, data, or corrections, including but not limited to taxonomic or nomenclatural changes, identification of erroneous information contained in the List, and improved analytical methods.

Any new information will be considered during the 5-year status review and will also be useful in evaluating the ongoing recovery programs for these species.

This notice announces our active review of the 129 species listed in the table below.

To ensure that a 5-year status review is complete and based on the best available scientific and commercial information, we request new information from all sources. See What Information Do We Consider in Our Review? for specific criteria. If you submit information, please support it with documentation such as maps, references, methods used to gather and analyze the data, and/or copies of any pertinent publications, reports, or letters by knowledgeable sources.

If you wish to provide information for any species listed in the table, please submit your comments and materials to the appropriate contact in ADDRESSES .

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 can 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.

Comments and materials received will be available for public inspection, by appointment, during normal business hours at the offices to which the comments are submitted.

A list of all completed and currently active 5-year status reviews addressing species for which our Regional Office has lead responsibility is available at http://www.fws.gov/pacific/ecoservices/endangered/recovery/5year.html.

This document is published under the authority of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531, et seq. ).

New Mexico Principal Meridian, New Mexico

The plat, representing the dependent resurvey of a portion of the south boundary of the Picuris Pueblo Grant, certain private claim boundaries, Townships 22 and 23 North, Range 12, East, and a portion of the north boundary and the subdivisional lines of Township 22 North, Range 12 East, accepted October 7, 2019, for Group 1125, New Mexico.

The remonumentation of the corner of sections 10, 11, 14 and 15, Township 16 North, Range 19 West, approved March 5, 2020.

This plat and remonumentation were prepared at the request of the Bureau of Indian Affairs.

The remonumentation of certain corners along the Chickasaw and Choctaw Boundary, Townships 2, 3, and 5 North, and 1 and 3 South, Range 8 East.

This remonumentation was prepared at the request of the Chickasaw Nation.

A person or party who wishes to protest against any of these surveys must file a written notice of protest within 30 calendar days from the date of this publication with the New Mexico Director, Bureau of Land Management, stating that they wish to protest.

A statement of reasons for a protest may be filed with the notice of protest to the State Director, or the statement of reasons must be filed with the State Director within 30 days after the protest is filed. Before including your address, or other personal information in your protest, please be aware that your entire protest, including your personal identifying information, may be made publicly available at any time. While you can 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.

On June 27, 2018, the United States Court of Appeals for the Federal Circuit found that a portion of the consolidated appeal in Ajinomoto Co., Inc. v. International Trade Commission, Appeal Nos. 2018-1590, -1629, was moot by reason of the expiration of the '373 patent and remanded the investigation to the Commission to determine whether to vacate the portion of the underlying final determination relating to the `373 patent.

The Federal Circuit appeal at issue stemmed from Certain L-Tryptophan, L-Tryptophan Products, and Their Methods of Production, Investigation No. 337-TA-1005. This investigation was instituted based on a complaint filed by Complainants Ajinomoto Co., Inc. of Tokyo, Japan and Ajinomoto Heartland Inc. of Chicago, Illinois (collectively, “Complainants”). See 81 FR 38735-36 (June 14, 2016). The complaint, as supplemented, alleged violations of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain L-tryptophan, L-tryptophan products, and their methods of production by reason of infringement of certain claims of U.S. Patent No. 7,666,655 (“the '655 patent”) and U.S. Patent No. 6,180,373 (“the '373 patent”). See id. The notice of investigation identified CJ CheilJedang Corp. of Seoul, Republic of Korea, CJ America, Inc. of Downers Grove, Illinois, and PT CheilJedang Indonesia of Jakarta, Indonesia (collectively, “Respondents”) as respondents in this investigation. See id. The Office of Unfair Import Investigations was not a party to the investigation. See id.

On August 11, 2017, the Administrative Law Judge issued his final initial determination finding no violation of section 337. On December 18, 2017, the Commission reversed and found a section 337 violation with respect to both the '655 and the '373 patents. The '373 patent expired on January 30, 2018.

On February 27, 2018, Respondents filed a notice of appeal of the Commission's final determination with the Court of Appeals for the Federal Circuit. Their appeal was consolidated with Complainant's appeal filed on February 16, 2018. In addition, on May 25, 2018, Respondents filed a corrected motion that sought partial dismissal of the appeal with respect to the now-expired '373 patent, vacatur of the related portions of the Commission's final determination, and remand to the Commission with an instruction to dismiss the related portion of the complaint. The Commission did not file a response to Respondents' motion. On June 4, 2018, Complainants filed a response to Respondents' motion and indicated that while it agreed to the partial dismissal of the appeal, it objected to the vacatur of the portion of the Commission's final determination.

On June 27, 2018, the Federal Circuit granted Respondents' motion “to the extent that this matter is remanded for the limited purposes of allowing the Commission to address whether to vacate its final determinations relating to the '373 patent.” Ajinomoto Co., Inc. v. Int'l Trade Comm'n, Consolidated Appeal Nos. 18-1590, -1629, Order at 3 (ECF No. 38) (Fed. Cir. June 27, 2018). The Federal Circuit retained jurisdiction over the remainder of the appeal, which it affirmed on August 6, 2019. Ajinomoto Co., Inc. v. Int'l Trade Comm'n, 932 F.3d 1342 (Fed. Cir. 2019). A petition for writ of certiorari was filed with the Supreme Court on February 24, 2020. CJ CheilJedang Corp. v. Int'l Trade Comm'n, No. 19-1062 (filed Feb. 24, 2020).

The Commission has determined to vacate the portion of its final determination relating to the '373 patent and its limited exclusion order based thereon. The Commission's opinion is being issued concurrently herewith. The Commission hereby terminates this investigation.

The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

The Commission instituted this investigation on November 20, 2017, based on a complaint filed on behalf of Kyocera Senco Brands Inc. (“Kyocera”) of Cincinnati, Ohio. 82 FR 55118-19 (Nov. 20, 2017). The complaint, as amended and supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (“section 337”), based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain gas spring nailer products and components thereof by reason of infringement of certain claims of U.S. Patent Nos. 8,011,547 (“the '547 patent”); 8,267,296 (“the '296 patent”); 8,27,297 (“the '297 patent”); 8,387,718 (“the '718 patent”); 8,286,722 (“the '722 patent”); and 8,602,282 (“the '282 patent”). The complaint further alleges the existence of a domestic industry. The Commission's notice of investigation named Hitachi as a respondent. The Office of Unfair Import Investigations is not participating in the investigation. The '547 patent has been terminated from the investigation and the notice of investigation was amended to add claim 30 of the '297 patent to the investigation. Order No. 13 (June 4, 2018), unreviewed by Comm'n Notice (June 22, 2018); Order No. 15 (June 19, 2018), unreviewed by Comm'n Notice (July 9, 2018), 83 FR 32685-66 (July 15, 2018). Prior to the evidentiary hearing, the parties stipulated that the '718 patent is the only remaining patent at issue because no violation could be shown as to the '296, '297, '722, and '282 patents based on an evidentiary ruling limiting the Kyocera's expert's testimony. See ID at 1-2. At the hearing, Kyocera asserted claims 1, 10, and 16 (the “asserted claims”) of the '718 patent. Id. at 2, 21.

On June 7, 2019, the ALJ issued a final ID finding no violation of section 337 as to the '718 patent based on non-infringement and the failure of Kyocera to establish the existence of a domestic industry (“DI”) that practices the '718 patent. Specifically, the ID finds that Kyocera failed to show that the accused products or the domestic industry products practice the asserted claims. The ID also finds that Kyocera satisfied the economic prong of the DI requirement under section 337(a)(3)(B). The ID also includes a recommended determination on remedy and bonding (“RD”) during the period of Presidential review. The RD recommends an LEO directed to gas spring nailer products and components thereof that infringe the asserted claims of the '718 patent, and recommends a CDO directed against Hitachi. The RD does not recommend imposing a bond.

On August 14, 2019, the Commission determined to review the ID in part and remand in part. See Comm'n Notice (Aug. 14, 2019). Specifically, the Commission determined to review the ID's finding that Kyocera did not establish: (1) Either direct or induced infringement of the asserted claims of the '718 patent, and (2) practice of the asserted claims by the DI products to satisfy the DI requirement. The Commission also determined to review the ID's finding that Kyocera has satisfied the economic prong of the DI requirement. Id. The Commission remanded the issues of whether Kyocera has established, by a preponderance of the evidence, that: (1) The remaining limitations (irrespective of the “system controller” limitation, i.e., “a circuit configured to control operation based on received input signals”) of the asserted claims of the '718 patent are met by the accused products; (2) the remaining limitations of the asserted claims are practiced by the DI products (“the DI products”); and (3) Hitachi induced infringement of the asserted claims. Id.

On October 28, 2019, the ALJ issued an RID finding no violation of section 337 as to the '718 patent based on non-infringement and the failure of Kyocera to establish the existence of a domestic industry that practices the '718 patent. Specifically, the RID finds that: (1) Neither the accused products nor the DI products satisfy the “displacement volume” limitation ( i.e., “(A) a hollow cylinder comprising a cylindrical wall with a movable piston therewith, said hollow cylinder containing a displacement volume created by a stroke of said piston”) and the “initiating a driving cycle” limitation ( i.e., “initiating a driving cycle by pressing said exit end against a workpiece and actuating said trigger, thereby causing said fastener driving mechanism to force the driver member to move toward said exit end and drive a fastener into said workpiece”) of the asserted claims; and (2) Kyocera failed to establish that Hitachi possesses the requisite specific intent to induce infringement of the claims.

On November 12, 2019, Kyocera petitioned, and Hitachi contingently petitioned, for review of the RID. On November 20, 2019, Kyocera and Hitachi each filed a response in opposition to the other party's petition for review.

On December 12, 2019, the Commission determined to review the RID in part. Specifically, the Commission determined to review the RID's finding that Kyocera did not establish: (1) Direct infringement of the asserted claims with respect to the “displacement volume” and “initiating a driving cycle” limitations; (2) practice of the asserted claims by the DI products with respect to these limitations; and (3) induced infringement of the asserted claims. 84 FR 69391-92 (Dec. 18, 2019). The Commission determined not to review the remainder of the RID. Id. The Commission also requested the parties to respond to certain questions concerning the issues under review with respect to the ID and RID, and requested written submissions on the issues of remedy, the public interest, and bonding from the parties and interested non-parties. Id.

On January 3 and 10, 2020, Kyocera and Hitachi each filed a brief and a reply brief, respectively, on all issues for which the Commission requested written submissions. Having reviewed the record in this investigation, including the final ID, the RID, and the parties' written submissions, the Commission has determined to find a violation of section 337. Specifically, the Commission has determined that: (1) The accused and DI products meet the “system controller,” “displacement volume,” and “initiating a driving cycle” limitations of the asserted claims 1, 10, and 16 of the '718 patent, and therefore the accused products infringe these claims; (2) the DI products practice these claims and therefore Kyocera has satisfied the technical prong of the DI requirement; (3) Hitachi has induced infringement of the asserted claims; and (4) Kyocera has satisfied the economic prong of the DI requirement under section 337(a)(3)(C). The Commission reverses the ID's and RID's findings to the contrary and takes no position on the ID's finding that Kyocera has satisfied the economic prong of the DI requirement under section 337(a)(3)(B). Accordingly, the Commission finds a violation based on Hitachi's induced infringement of the asserted claims. The Commission has issued an opinion explaining the basis for the Commission's determination.

Having found a violation of section 337 as to the '718 patent, the Commission has determined that the appropriate form of relief is an LEO prohibiting the entry of unlicensed gas spring nailer products and components thereof that infringe one or more of claims 1, 10, and 16 of the '718 patent, and that are manufactured abroad by or on behalf of, or imported by or on behalf of Hitachi, or any of its affiliated companies, parents, subsidiaries, or other related business entities, or their successors or assigns. Appropriate relief also includes a CDO prohibiting Hitachi from conducting any of the following activities in the United States: Importing, selling, marketing, advertising, distributing, offering for sale, transferring (except for exportation), and soliciting U.S. agents or distributors for gas spring nailer products and components thereof that infringe one or more of claims 1, 10, and 16 of the '718 patent.

The Commission has further determined that the public interest factors enumerated in sections 337(d)(1) and 337(f)(1) (19 U.S.C. 1337(d)(1) and 1337(f)(1)) do not warrant denying relief. Finally, the Commission has determined that no bond is required during the period of Presidential review (19 U.S.C. 1337(j)). The Commission's order was delivered to the President and to the United States Trade Representative on the day of its issuance.

The Commission has terminated this investigation. The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in part 210 of the Commission's Rules of Practice and Procedure, 19 CFR part 210.

The Commission instituted this investigation on May 29, 2019, based on a complaint filed on behalf of Style Pantry LLC (“Style Pantry”) of Beverly Hills, California. 84 FR 24816 (May 29, 2019). The complaint, as amended, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain female fashion dresses, jumpsuits, maxi skirts, and accoutrements by reason of false designation, false description, dilution, and obtaining sales by false claim of association, the threat or effect of which is to destroy or substantially injure an industry in the United States. The notice of investigation named Amazon.com Inc. (“Amazon”) of Seattle, Washington; Xunyun, Jiaxing Xunyung Imp & Exp Co. Ltd of Zhejiang, China; and Jianzhang Liao, Pinkqueen Apparel Inc. of Xiamen, China as respondents. The Office of Unfair Import Investigations (“OUII”) was also named as a party in this investigation.

Respondents Xunyun, Jiaxing Xunyung Imp & Exp Co. Ltd and Jianzhang Liao, Pinkqueen Apparel Inc. were found in default pursuant to 19 CFR 210.16, for failure to respond to the complaint and notice of investigation. See Order No. 7 (Dec. 3, 2019), not rev'd by Comm'n Notice (Dec. 26, 2019).

On January 22, 2020, Style Pantry and Amazon filed a joint motion to terminate the investigation based on a settlement agreement. On February 3, 2020, OUII filed a response in support of the motion.

On February 4, 2020, the ALJ issued the subject ID granting the joint motion to terminate pursuant to Commission Rule 210.21(b)(1) (19 CFR 210.21(b)(1)). See Order No. 9 at 1-2 (Feb. 4, 2020). The ALJ found that the motion to terminate complies with the Commission's rules, and there is no evidence that terminating this investigation by settlement would be contrary to the public interest. Id. at 2. No petitions for review were filed.

The Commission has determined not to review the subject ID. The investigation is terminated in its entirety.

The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

Notice is hereby given that the NRC has issued Subsequent Renewed Facility Operating Licenses Nos. DPR-44 and DPR-56 to Exelon Generation Company, LLC and PSEG Nuclear, LLC (Exelon, PSEG, or the licensees), for Peach Bottom Atomic Power Station, Units 2 and 3, respectively. Exelon is the operator of the facility. Subsequent Renewed Facility Operating Licenses Nos. DPR-44 and DPR-56 authorize operation of Unit 2 and Unit 3, respectively, by Exelon at reactor core power levels not in excess of 4,016 megawatts thermal for each unit, in accordance with the provisions of the Peach Bottom, Units 2 and 3 renewed licenses and technical specifications. Notice is also given that the ROD that supports the NRC's decision to issue Subsequent Renewed Facility Operating Licenses Nos. DPR-44 and DPR-56 is available in ADAMS under Accession No. ML20024G429.

As discussed in the ROD and the final supplemental environmental impact statement (FSEIS) for Peach Bottom, Units 2 and 3, Supplement 10, Second Renewal, to NUREG-1437, “Generic Environmental Impact Statement for License Renewal of Nuclear Plants, Regarding Subseqent License Renewal for Peach Bottom Atomic Power Station, Unit 2 and Unit 3, Final Report,” dated January 2020 (ADAMS Accession No. ML20023A937), the NRC staff considered a range of reasonable alternatives that included a new nuclear power alternative, a supercritical pulverized coal alternative, a natural gas combined-cycle alternative, and a combination alternative of natural gas combined-cycle, wind, solar, and purchased power. The FSEIS documents the environmental review, including the determination that the adverse environmental impacts of subsequent license renewal for Peach Bottom Units 2 and 3 are not so great that preserving the option of subsequent license renewal for energy planning decisionmakers would be unreasonable. In addition to the NRC staff's independent environmental review, the FSEIS conclusion is based on (1) the analysis and findings in the Generic Environmental Impact Statement for License Renewal of Nuclear Plants, (2) information provided in the environmental report submitted by Exelon, and (3) consultation with Federal, State, local, and Tribal agencies.

Peach Bottom Units 2 and 3 are single-cycle, forced-circulation boiling water reactors located in Peach Bottom Township, near Delta, York County, Pennsylvania. The application for the subsquent renewed licenses, “Subsequent License Renewal Application, Peach Bottom Atomic Power Station Units 2 and 3,” dated July 10, 2018 (ADAMS Package Accession No. ML18193A689), as supplemented by letters dated through October 9, 2019, complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the NRC's regulations. As required by the Act and NRC regulations in chapter 1 of title 10 of the Code of Federal Regulations (10 CFR), the NRC has made appropriate findings, which are set forth in the licenses.

A public notice of the proposed issuance of the renewed licenses and an opportunity for a hearing was published in the Federal Register on September 6, 2018 (83 FR 45285). An NRC Atomic Safety and Licensing Board denied an intervention petition and terminated the adjudicatory proceeding. An appeal and motions related to a request to file a new contention are pending before the Commission. Because the termination of the proceeding has not been stayed pending Commission review, and the NRC staff has determined that issuance of the subsequent renewed licenses prior to Commission action on the pending appeal and motions would not foreclose or prejudice any Commission action, issuance of the subsequent renewed licenses is permissible.

For further details with respect to this action, see: (1) Exelon Generation Company's subsequent license renewal application for Peach Bottom Units 2 and 3, dated July 10, 2018 (ADAMS Package Accession No. ML18193A689), as supplemented by letters dated through October 9, 2019; (2) the NRC's safety evaluation report, dated Februrary 2020 (ADAMS Package Accession No. ML20044D902); (3) the NRC's final environmental impact statement (NUREG-1437, Supplement 10, Second Renewal) for Peach Bottom Units 2 and 3, dated January 2020 (ADAMS Accession No. ML20023A937); and (4) the NRC's ROD (ADAMS Accession No. ML20024G429).

The following is a summary of the application. The complete application may be obtained via the Commission's website by searching for the file number, or for an applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling (202) 551-8090.

1. Two Sigma Investments (together with its “affiliates,” as defined in rule 12b-2 under the Securities Exchange Act of 1934 (the “Exchange Act”), “Two Sigma,” and each, a “Two Sigma Entity”) is a Delaware limited partnership. Two Sigma Investments has organized Two Sigma Luna, LLC, a Delaware limited liability company (the “Initial LLC”) and will in the future organize limited liability companies, limited partnerships, corporations, business trusts or other entities (each a “Future Fund” and, collectively with the Initial LLC, the “Funds”) as “employees' securities companies,” as defined in section 2(a)(13) of the Act. The Funds are intended to provide investment opportunities that are competitive with those at other investment management and financial services firms and to facilitate the recruitment and retention of high caliber professionals.

2. The Initial LLC was formed on May 3, 2013 as a Delaware limited liability company. Two Sigma Principals, LLC, a Delaware limited liability company, acts as managing member to the Initial LLC. Two Sigma Investments serves as investment adviser to the Initial LLC. The Initial LLC seeks to achieve absolute U.S. dollar-denominated returns by investing all or substantially all of its assets in various private investment vehicles that are managed by Two Sigma (the “Initial LLC's Underlying Funds”). The investment objective and strategies of the Initial LLC's Underlying Funds are set forth in the offering and/or governing documents of the applicable Initial LLC's Underlying Fund.

3. A Future Fund may be structured as a domestic or offshore limited or general partnership, limited liability company, corporation, business trust or other entity. Two Sigma may also form parallel funds organized under the laws of various jurisdictions in order to create similar investment opportunities for Eligible Employees (defined below) in other jurisdictions. Interests in a Fund may be issued in one or more series, each of which corresponds to particular Fund investments (each, a “Series”). Each Series will be an “employees' securities company” within the meaning of section 2(a)(13) of the Act. Each Fund will operate as a closed-end management investment company, and a particular Fund may operate as a “diversified” or “non-diversified” vehicle within the meaning of the Act.

4. Two Sigma will control each Fund within the meaning of section 2(a)(9) of the Act. Each Fund has, or will have, a general partner, managing member or other such similar entity that manages, operates and controls such Fund (a “Managing Member”). The Managing Member will be responsible for the overall management of each Fund, and will appoint a Two Sigma Entity to serve as investment adviser (“Investment Adviser”) to a Fund and delegate to the Investment Adviser the authority to make all decisions regarding the acquisition, management and disposition of Fund investments.

5. Each Managing Member and Investment Adviser is an investment adviser within the meaning of section 9 and 36 of the Act and is subject to those sections. The Managing Member or Investment Adviser may receive a performance-based fee or allocation (an “Incentive Allocation”) based on the net gains of the Fund's investments, in addition to any amount allocable to the Managing Member's or Investment Adviser's capital contribution. 1

6. If the Managing Member elects to recommend that a Fund enter into any side-by-side investment with an unaffiliated entity, the Managing Member will be permitted to engage as a sub-investment adviser the unaffiliated entity (an “Unaffiliated Subadviser”), which will be responsible for the management of such side-by-side investment.

7. Interests in the Funds will be offered in a transaction exempt from registration under section 4(a)(2) of the Securities Act of 1933, as amended (the “1933 Act”), or Regulation D or Regulation S promulgated thereunder, and will be sold only to “Qualified Participants,” which term refers to: (i) Eligible Employees (as defined below); (ii) Eligible Family Members (as defined below); (iii) Eligible Investment Vehicles (as defined below); and (iv) Two Sigma. Prior to offering interests in a Fund to a Qualified Participant, Two Sigma must reasonably believe that the Eligible Employee or Eligible Family Member will be capable of understanding and evaluating the merits and risks of participation in a Fund and that each such individual is able to bear the economic risk of such participation and afford a complete loss of his or her investments in the Fund.

8. The term “Eligible Employees” is defined as current and former employees, officers and directors of Two Sigma (including people in administration, marketing, and operations) and current consultants engaged on retainer to provide services and professional expertise on an ongoing basis to Two Sigma. 2 The term “Eligible Family Members” is defined as spouses, parents, children, spouses of children, brothers, sisters and grandchildren of Eligible Employees, including step and adoptive relationships. 3 The term “Eligible Investment Vehicles” is defined as: (i) A trust of which a trustee, grantor and/or beneficiary is an Eligible Employee; (ii) a partnership, corporation or other entity created or controlled  4 by an Eligible Employee;  5 and (iii) a trust or other entity established solely for the benefit of Eligible Employees and/or Eligible Family Members. Each Eligible Employee and Eligible Family Member will be an Accredited Investor under rule 501(a)(5) or rule 501(a)(6) of Regulation D under the 1933 Act, except that a maximum of 35 Eligible Employees who are sophisticated investors but who are not Accredited Investors may become investors in a Fund, if each of them falls into one of the following categories: (i) An Eligible Employee who (a) has a graduate degree in business, law or accounting, (b) has a minimum of five years of consulting, investment management, investment banking, legal or similar business experience, and (c) had reportable income from all sources (including any profit shares or bonus) of $100,000 in each of the two most recent years immediately preceding the Eligible Employee's admission as an investor of the Fund and has a reasonable expectation of income from all sources of at least $140,000 in each year in which the Eligible Employee will be committed to make investments in the Fund;  6 or (ii) Eligible Employees who are “knowledgeable employees” (as defined in rule 3c-5 under the Act) of the Fund (with the Fund treated as though it were a “covered company” for purposes of the rule).

9. A Qualified Participant may purchase an interest through an Eligible Investment Vehicle only if either (i) the investment vehicle is an Accredited Investor, as defined in rule 501(a) of Regulation D under the 1933 Act or (ii) the Eligible Employee is a settlor  7 and principal investment decision-maker with respect to the investment vehicle. Eligible Investment Vehicles that are not Accredited Investors will be counted in accordance with Regulation D toward the 35 non-Accredited Investor limit discussed above.

10. The terms of each Fund will be fully disclosed to each Qualified Participant (or person making the investment on behalf of the Qualified Participant) at the time the Qualified Participant is invited to participate in the Fund. A Fund will send its investors an annual financial statement with respect to those investments in which the investor had an interest within 120 days after the end of each fiscal year of the Fund, or as soon as practicable after the end of the Fund's fiscal year. The financial statement will be audited  8 by independent certified public accountants. In addition, as soon as practicable after the end of each calendar year, a report will be sent to each investor setting forth the information with respect such investor's share of income, gains, losses, credits, and other items for U.S. federal and state income tax purposes resulting from the operation of the Fund during that year.

11. Interests in a Fund will not be transferable except with the express consent of the Managing Member, and then only to a Qualified Participant. No sales load or similar fee of any kind will be charged in connection with the sale of interests in a Future Fund.

12. A Managing Member may have the right, but not the obligation, to repurchase, cancel, or transfer to another Qualified Participant the interest of (i) an Eligible Employee who ceases to be an employee, officer, director or current consultant of any Two Sigma Entity for any reason or (ii) any Eligible Family Member of any person described in clause (i). The governing documents for each Fund will describe, if applicable, the amount that an investor would receive upon repurchase, cancellation or transfer of its interest. The investor will, at a minimum, be paid the lesser of (i) the amount actually paid by or on behalf of the investor to acquire the interest (plus interest, as reasonably determined by the Managing Member) less any amounts paid to the investor as distributions, and (ii) the fair value, determined at the time of repurchase in good faith by the Managing Member, of such interest.

13. A Future Fund may invest in one or more pooled investment vehicles (including private funds relying on sections 3(c)(1) and 3(c)(7) under the Act and funds relying on section 3(c)(5) under the Act) and/or registered investment companies sponsored by Two Sigma or by third parties (each, an “Underlying Fund”). 9 One Fund may also invest in another Fund in a “master-feeder” or similar structure. A Fund may also be operated as a parallel fund making investments on a side-by-side basis with Two Sigma Entities.

14. A Fund may co-invest in a portfolio company (or a pooled investment vehicle) with a Two Sigma Entity or with an investment fund or separate account organized primarily for the benefit of investors who are not affiliated with Two Sigma (“Third Party Investors”) over which a Two Sigma Entity exercises investment discretion or which is sponsored by a Two Sigma Entity (an “Two Sigma Third Party Fund”). Co-investments with a Two Sigma Entity or with a Two Sigma Third Party Fund in a transaction in which Two Sigma's investment was made pursuant to a contractual obligation to a Two Sigma Third Party Fund will not be subject to Condition 3 below. All other side-by-side investments held by Two Sigma Entities involving a joint enterprise or other joint arrangement will be subject to Condition 3.

15. If Two Sigma makes loans to a Fund, the lender will be entitled to receive interest, provided that the interest rate will be no less favorable to the borrower than the rate obtainable on an arm's length basis. The possibility of any such borrowings, as well as the terms thereof, would be disclosed to Qualified Participants prior to their investment in a Fund. Any indebtedness of the Fund will be the debt of the Fund and without recourse to the investors. A Fund will not borrow from any person if the borrowing would cause any person not named in section 2(a)(13) of the Act to own securities of the Fund (other than short-term paper). A Fund will not lend any funds to a Two Sigma Entity.

16. A Fund will not acquire any security issued by a registered investment company if immediately after such acquisition such Fund will own more than 3% of the outstanding voting stock of the registered investment company.

1. Section 6(b) of the Act provides that the Commission shall exempt employees' securities companies from the provisions of the Act if and to the extent that such exemption is consistent with the protection of investors. Section 6(b) provides that the Commission will consider, in determining the provisions of the Act from which the company should be exempt, the company's form of organization and capital structure, the persons owning and controlling its securities, the price of the company's securities and the amount of any sales load, how the company's funds are invested, and the relationship between the company and the issuers of the securities in which it invests. Section 2(a)(13) defines an employees' securities company, in relevant part, as any investment company all of whose securities (other than short-term paper) are beneficially owned (a) by current or former employees, or persons on retainer, of one or more affiliated employers, (b) by immediate family members of such persons, or (c) by such employer or employers together with any of the persons in (a) or (b).

2. Section 7 of the Act generally prohibits investment companies that are not registered under section 8 of the Act from selling or redeeming their securities. Section 6(e) of the Act provides that in connection with any order exempting an investment company from any provision of section 7, certain specified provisions of the Act shall be applicable to such company, and to other persons in their transactions and relations with such company, as though such company were registered under the Act, if the Commission deems it necessary and appropriate in the public interest or for the protection of investors. Applicants submit that it would be appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policies and provisions of the Act for the Commission to issue an order under sections 6(b) and 6(e) of the Act exempting the Funds from all provisions of the Act and the rules and regulations thereunder, except sections 9, 17, 30, and 36 through 53 of the Act, and the Rules and Regulations. With respect to sections 17(a), (d), (e), (f), (g) and (j) and 30(a), (b), (e), and (h) of the Act, and the Rules and Regulations, and rule 38a-1 under the Act, Applicants request a limited exemption as set forth in the application.

3. Section 17(a) of the Act generally prohibits any affiliated person of a registered investment company, or any affiliated person of such a person, acting as principal, from knowingly selling or purchasing any security or other property to or from the investment company. Applicants request an exemption from section 17(a) to the extent necessary to (a) permit a Two Sigma Entity or a Two Sigma Third Party Fund (or any affiliated person of such Two Sigma Entity or Two Sigma Third Party Fund), or any affiliated person of a Fund (or affiliated persons of such persons), acting as principal, to engage in any transaction directly or indirectly with any Fund or any company controlled by such Fund; and (b) permit a Fund to invest in or engage in any transaction with any Two Sigma Entity, acting as principal, (i) in which such Fund, any company controlled by such Fund or any Two Sigma Entity or any Two Sigma Third Party Fund has invested or will invest, or (ii) with which such Fund, any company controlled by such Fund or any Two Sigma Entity or Two Sigma Third Party Fund is or will become otherwise affiliated; and (c) permit a Third Party Investor, acting as a principal, to engage in any transaction directly or indirectly with a Fund or any company controlled by such Fund. The transactions to which any Fund is a party will be effected only after a determination by the Managing Member that the requirements of Conditions 1, 2 and 6 (set forth below) have been satisfied. Applicants, on behalf of the Funds, represent that any transactions otherwise subject to section 17(a) of the Act, for which exemptive relief has not been requested, would require approval of the Commission.

4. Applicants submit that an exemption from section 17(a) is consistent with the policy of each Fund and the protection of investors. Applicants state that the investors in each Fund will have been fully informed of the possible extent of such Fund's dealings with Two Sigma and of the potential conflicts of interest that may exist. Applicants also state that, as professionals employed in the investment management and securities businesses, or in administrative, financial, accounting, legal, sales, marketing, risk management or operational activities related thereto, the investors will be able to understand and evaluate the attendant risks. Applicants assert that the community of interest among the investors in each Fund, on the one hand, and Two Sigma, on the other hand, is the best insurance against any risk of abuse. Applicants acknowledge that the requested relief will not extend to any transactions between a Fund and an Unaffiliated Subadviser or any affiliated person of the Unaffiliated Subadviser, or between a Fund and any person who is not an employee, officer or director of Two Sigma or is an entity outside of Two Sigma and, in each case, is an affiliated person of the Fund as defined in section 2(a)(3)(E) of the Act (“Advisory Person”) or any affiliated person of such person.

5. Section 17(d) of the Act and rule 17d-1 under the Act prohibit any affiliated person or principal underwriter of a registered investment company, or any affiliated person of such a person or principal underwriter, acting as principal, from participating in any joint arrangement with the company unless authorized by the Commission. Applicants request an exemption from section 17(d) and rule 17d-1 to the extent necessary to permit affiliated persons of each Fund, or affiliated persons of any of such persons to participate in, or effect any transaction in connection with, any joint enterprise or other joint arrangement or profit-sharing plan in which such Fund or a company controlled by such Fund is a participant. The exemption would permit, among other things, co-investments by each Fund, Two Sigma Third Party Fund and individual members or employees, officers, directors or consultants of Two Sigma making their own individual investment decisions apart from Two Sigma. Applicants acknowledge that the requested relief will not extend to any transaction in which an Unaffiliated Subadviser or Advisory Person or an affiliated person of either has an interest.

6. Applicants assert that compliance with section 17(d) would prevent each Fund from achieving a principal purpose, which is to provide a vehicle for Eligible Employees (and other permitted investors) to co-invest with Two Sigma or, to the extent permitted by the terms of the Fund, with other employees, officers, directors or consultants of Two Sigma or Two Sigma Entities or with a Two Sigma Third Party Fund. Applicants further contend that compliance with section 17(d) would cause a Fund to forego investment opportunities simply because an investor in such Fund or other affiliated person of such Fund (or any affiliated person of such a person) also had, or contemplated making, a similar investment. Applicants submit that it is likely that suitable investments will be brought to the attention of a Fund because of its affiliation with Two Sigma's large capital resources and investment management experience, and that attractive investment opportunities of the types considered by a Fund often require each participant in the transaction to make funds available in an amount that may be substantially greater than those the Fund would independently be able to provide. Applicants contend that, as a result, a Fund's access to such opportunities may have to be through co-investment with other persons, including its affiliates. Applicants assert that the flexibility to structure co-investments and joint investments will not involve abuses of the type section 17(d) and rule 17d-1 were designed to prevent. In addition, Applicants represent that any transactions otherwise subject to section 17(d) of the Act and rule 17d-1 thereunder, for which exemptive relief has not been requested, would require approval by the Commission.

7. Co-investments with a Two Sigma Entity or with a Two Sigma Third Party Fund in a transaction in which Two Sigma's investment was made pursuant to a contractual obligation to a Two Sigma Third Party Fund will not be subject to Condition 3 below. Applicants believe that the interests of the Eligible Employees participating in a Fund will be adequately protected in such situations because Two Sigma is likely to invest a portion of its own capital in Two Sigma Third Party Fund investments, either through such Two Sigma Third Party Fund or on a side-by-side basis (which Two Sigma investments will be subject to substantially the same terms as those applicable to such Two Sigma Third Party Fund, except as otherwise disclosed in the governing documents of the relevant Fund). Applicants assert that if Condition 3 were to apply to Two Sigma's investment in these situations, the Two Sigma Third Party Fund would be indirectly burdened. Applicants further assert that the relationship of a Fund to a Two Sigma Third Party Fund is fundamentally different from such Fund's relationship to Two Sigma. Applicants contend that the focus of, and the rationale for, the protections contained in the requested relief are to protect the Funds from any overreaching by Two Sigma in the employer/employee context, whereas the same concerns are not present with respect to the Funds vis-à-vis the investors in a Two Sigma Third Party Fund.

8. Section 17(e) of the Act and rule 17e-1 thereunder limit the compensation an affiliated person may receive when acting as agent or broker for a registered investment company. Applicants request an exemption from section 17(e) to permit a Two Sigma Entity (including the Managing Member and the Investment Adviser) that acts as an agent or broker to receive placement fees, advisory fees, or other compensation from a Fund in connection with the purchase or sale by the Fund of securities, provided that the fees or other compensation are deemed “usual and customary.” Applicants state that for purposes of the application, fees or other compensation that are charged or received by a Two Sigma Entity will be deemed to be “usual and customary” only if (i) the Fund is purchasing or selling securities alongside other unaffiliated third parties, Two Sigma Third Party Funds or Third Party Investors who are also similarly purchasing or selling securities, (ii) the fees or other compensation being charged to the Fund are also being charged to the unaffiliated third parties, Two Sigma Third Party Funds or Third Party Investors and (iii) the amount of securities being purchased or sold by the Fund does not exceed 50% of the total amount of securities being purchased or sold by the Fund and the unaffiliated third parties, Two Sigma Third Party Funds or Third Party Investors. Applicants state that compliance with section 17(e) would prevent a Fund from participating in a transaction in which Two Sigma, for other business reasons, does not wish to appear as if the Fund is being treated in a more favorable manner (by being charged lower fees) than other third parties also participating in the transaction. Applicants assert that the concerns of overreaching and abuse that section 17(e) and rule 17e-1 were designed to prevent are alleviated by the conditions that ensure that (i) the fees or other compensation paid by a Fund to a Two Sigma Entity are those negotiated at arm's length with unaffiliated third parties and (ii) the unaffiliated third parties have as great or greater interest as the Fund in the transaction as a whole.

9. Rule 17e-1(b) under the Act requires that a majority of directors who are not “interested persons” (as defined in section 2(a)(19) of the Act) take actions and make approvals regarding commissions, fees, or other remuneration. Rule 17e-1(c) under the Act requires each Fund to comply with the fund governance standards defined in rule 0-1(a)(7) under the Act. Applicants request an exemption from rule 17e-1(b) to the extent necessary to permit each Fund to comply with rule 17e-1(b) without the necessity of having a majority of the directors (or members of a comparable body) of the Fund who are not “interested persons” take such actions and make such approvals as are set forth in rule 17e-1(b). Applicants note that in the event that all the directors of the Managing Member or other governing body of the Managing Member will be affiliated persons, a Fund could not comply with rule 17e-1(b) without the relief requested. Applicants represent that in such event, the Fund will comply with rule 17e-1(b) by having a majority of the directors (or members of a comparable body) of the Fund or its Managing Member take such actions and make such approvals as are set forth in rule 17e-1(b), and that each Fund will otherwise comply with all other requirements of rule 17e-1(b). Applicants further request an exemption from rule 17(e)-1(c) to the extent necessary to permit each Fund to comply with rule 17e-1 without the necessity of having a majority of the directors (or members of a comparable body) of the Fund or its Managing Member be “disinterested persons” as is set forth in rule 17e-1(c). Applicants note that in the event that all the directors (or members of a comparable governing body) of the Fund or its Managing Member will be affiliated persons, a Fund could not comply with rule 17e-1 without the relief requested. Applicants represent that each Fund will otherwise comply with all other requirements of rule 17e-1(c).

10. Section 17(f) of the Act provides that the securities and similar investments of a registered management investment company must be placed in the custody of a bank, a member of a national securities exchange or the company itself in accordance with Commission rules. Rule 17f-2 under the Act specifies the requirements that must be satisfied for a registered management investment company to act as a custodian of its own investments. Applicants request relief from section 17(f) and rule 17f-2 to permit the following exceptions from the requirements of rule 17f-2: (a) A Fund's investments may be kept in the locked files of the Managing Member or the Investment Adviser for purposes of paragraph (b) of the rule; (b) for purposes of paragraph (d) of the rule, (i) employees of Two Sigma or its affiliates (including the Managing Member) will be deemed to be employees of the Funds, (ii) officers or managers of the Managing Member of a Fund will be deemed to be officers of the Fund and (iii) the Managing Member of a Fund or its board of directors will be deemed to be the board of directors of the Fund; and (c) in place of the verification procedure under rule 17f-2(f), verification will be effected quarterly by two employees of the Investment Adviser who are also employees of Two Sigma responsible for the administrative, legal and/or compliance functions for funds managed or sponsored by Two Sigma and who have specific knowledge of custody requirements, policies and procedures of the Funds. Applicants expect that, with respect to certain Funds, many of their investments will be evidenced only by partnership agreements, participation agreements or similar documents, rather than by negotiable certificates that could be misappropriated. Applicants assert that, for such a Fund, these instruments are most suitably kept in the files of the Managing Member or its Investment Adviser, where they can be referred to as necessary. Applicants represent that they will comply with all other provisions of rule 17f-2, including the recordkeeping requirements of paragraph (e).

11. Section 17(g) of the Act and rule 17g-1 thereunder generally require the bonding of officers and employees of a registered investment company who have access to its securities or funds. Rule 17g-1 requires that a majority of directors who are not “interested persons” of a registered investment company take certain actions and give certain approvals relating to fidelity bonding. Among other things, the rule also requires that the board of directors of an investment company relying on the rule satisfy the fund governance standards defined in rule 0-1(a)(7). Applicants request an exemption from rule 17g-1 to the extent necessary to permit a Fund to comply with rule 17g-1 by having the Managing Member of the Fund take such actions and make such approvals as are set forth in rule 17g-1. Applicants state that in the event all the directors of the Managing Member or other governing body of the Managing Member will be affiliated persons, a Fund could not comply with rule 17g-1 without the requested relief. Applicants also request an exemption from the requirements of rule 17g-1(g) and (h) relating to the filing of copies of fidelity bonds and related information with the Commission and the provision of notices to the board of directors and from the requirements of rule 17g-1(j)(3). Applicants contend that the filing requirements are burdensome and unnecessary as applied to the Funds and represent that the Managing Member of each Fund will designate a person to maintain the records otherwise required to be filed with the Commission under rule 17g-1(g). Applicants further contend that the notices otherwise required to be given to the board of directors will be unnecessary as the Funds will not have boards of directors. Applicants represent that each Fund will comply with all other requirements of rule 17g-1.

12. Section 17(j) of the Act and paragraph (b) of rule 17j-1 under the Act make it unlawful for certain enumerated persons to engage in fraudulent or deceptive practices in connection with the purchase or sale of a security held or to be acquired by a registered investment company. Rule 17j-1 also requires that every registered investment company adopt a written code of ethics and that every access person of a registered investment company report personal securities transactions. Applicants request an exemption from section 17(j) and the provisions of rule 17j-1 (except for the anti-fraud provisions of rule 17j-1(b)) because they assert that these requirements are burdensome and unnecessary as applied to the Funds. The relief requested will extend only to entities within Two Sigma and is not requested with respect to any Unaffiliated Subadviser or Advisory Person.

13. Sections 30(a), (b) and (e) of the Act and the rules thereunder generally require that registered investment companies prepare and file with the Commission and mail to their shareholders certain periodic reports and financial statements. Applicants contend that the forms prescribed by the Commission for periodic reports have little relevance to a Fund and would entail administrative and legal costs that outweigh any benefit to the investors in such Fund. Applicants request relief under sections 30(a), (b) and (e) to the extent necessary to permit each Fund to report annually to its investors in the manner described in the application. Section 30(h) of the Act requires that every officer, director, member of an advisory board, investment adviser or affiliated person of an investment adviser of a closed-end investment company be subject to the same duties and liabilities as those imposed upon similar classes of persons under section 16(a) of the Exchange Act. Applicants request an exemption from section 30(h) of the Act to the extent necessary to exempt the Managing Member of each Fund, directors, and officers of the Managing Member and any other persons who may be deemed members of an advisory board or investment adviser (and affiliated persons thereof) of such Fund from filing Forms 3, 4, and 5 under section 16(a) of the Exchange Act with respect to their ownership of interests in such Fund under section 16 of the Exchange Act. Applicants assert that, because there will be no trading market and the transfers of interests are severely restricted, these filings are unnecessary for the protection of investors and burdensome to those required to make them.

14. Rule 38a-1 requires registered investment companies to adopt, implement and periodically review written policies reasonably designed to prevent violation of the federal securities laws and to appoint a chief compliance officer. Each Fund will comply will rule 38a-1(a), (c) and (d), except that: (i) To the extent the Fund does not have a board of directors, the board of directors of the Managing Member or other governing body of the Managing Member will fulfill the responsibilities assigned to the Fund's board of directors under the rule; (ii) to the extent the board of directors or other governing body of the Managing Member does not have any disinterested members, approval by a majority of the disinterested board members required by rule 38a-1 will not be obtained; and (iii) to the extent the board of directors or other governing body of the Managing Member does not have any independent members, the Funds will comply with the requirement in rule 38a-1(a)(4)(iv) that the chief compliance officer meet with the independent directors by having the chief compliance officer meet with the board of directors or other governing body of the Managing Member as constituted. Applicants represent that each Fund has adopted written policies and procedures reasonably designed to prevent violations of the terms and conditions of the application, has appointed a chief compliance officer and is otherwise in compliance with the terms and conditions of the application.

Applicants agree that any order granting the requested relief will be subject to the following conditions:

1. Each proposed transaction otherwise prohibited by section 17(a) or section 17(d) of the Act and rule 17d-1 thereunder to which a Fund is a party (the “Section 17 Transactions”) will be effected only if the Managing Member determines that: (a) The terms of the Section 17 Transaction, including the consideration to be paid or received, are fair and reasonable to the Fund and the investors and do not involve overreaching of such Fund or its investors on the part of any person concerned; and (b) the Section 17 Transaction is consistent with the interests of the Fund and the investors, such Fund's organizational documents and such Fund's reports to its investors.

In addition, the Managing Member will record and preserve a description of all Section 17 Transactions, the Managing Member's findings, the information or materials upon which the Managing Member's findings are based and the basis for such findings. All such records will be maintained for the life of the Fund and at least six years thereafter, and will be subject to examination by the Commission and its staff. 10

2. The Managing Member will adopt, and periodically review and update, procedures designed to ensure that reasonable inquiry is made, prior to the consummation of any Section 17 Transaction, with respect to the possible involvement in the transaction of any affiliated person or promoter of or principal underwriter for such Fund, or any affiliated person of such a person, promoter or principal underwriter.

3. The Managing Member will not cause the funds of any Fund to be invested in any investment in which a “Co-Investor” (as defined below) has acquired or proposes to acquire the same class of securities of the same issuer, where the investment involves a joint enterprise or other joint arrangement within the meaning of rule 17d-1 in which the Fund and a Co-Investor are participants, unless prior to such investment any such Co-Investor agrees, prior to disposing of all or part of its investment, to: (a) Give the Managing Member sufficient, but not less than one day's, notice of its intent to dispose of its investment; and (b) refrain from disposing of its investment unless the Fund has the opportunity to dispose of the Fund's investment prior to or concurrently with, on the same terms as, and on a pro rata basis with, the Co-Investor. The term “Co-Investor” with respect to any Fund means any person who is: (a) An “affiliated person” (as defined in section 2(a)(3) of the Act) of the Fund (other than a Two Sigma Third Party Fund); (b) Two Sigma (except when a Two Sigma Entity co-invests with a Fund and a Two Sigma Third Party Fund pursuant to a contractual obligation to the Two Sigma Third Party Fund); (c) an officer or director of a Two Sigma Entity; or (d) an entity (other than a Two Sigma Third Party Fund) in which Two Sigma acts as a managing member or has a similar capacity to control the sale or other disposition of the entity's securities. The restrictions contained in this condition, however, shall not be deemed to limit or prevent the disposition of an investment by a Co-Investor: (a) To its direct or indirect wholly-owned subsidiary, to any company (a “parent”) of which the Co-Investor is a direct or indirect wholly-owned subsidiary or to a direct or indirect wholly-owned subsidiary of its parent; (b) to immediate family members of the Co-Investor, including step or adoptive relationships, or a trust or other investment vehicle established for any Co-Investor or any such family member; or (c) when the investment is comprised of securities that are (i) listed on a national securities exchange registered under section 6 of the Exchange Act; (ii) NMS stocks, pursuant to section 11A(a)(2) of the Exchange Act and rule 600(b) of Regulation NMS thereunder; (iii) government securities as defined in section 2(a)(16) of the Act; (iv) “Eligible Securities” as defined in rule 2a-7 under the Act; or (v) listed or traded on any foreign securities exchange or board of trade that satisfies regulatory requirements under the law of the jurisdiction in which such foreign securities exchange or board of trade is organized similar to those that apply to a national securities exchange or a national market system for securities.

4. Each Fund and its Managing Member will maintain and preserve, for the life of such Fund and at least six years thereafter, such accounts, books, and other documents as constitute the record forming the basis for the audited financial statements that are to be provided to the investors in such Fund, and each annual report of such Fund required to be sent to such investors, and agree that all such records will be subject to examination by the Commission and its staff. 11

5. Within 120 days after the end of the fiscal year of each Fund, or as soon as practicable thereafter, the Managing Member of each Fund will send to each investor in such Fund who had an interest in any capital account of the Fund, at any time during the fiscal year then ended, Fund financial statements audited by the Fund's independent accountants, except in the case of a Fund formed to make a single portfolio investment. In such cases, financial statements will be unaudited, but each investor will receive financial statements of the single portfolio investment audited by such entity's independent accountants. At the end of each fiscal year and at other times as necessary in accordance with customary practice, the Managing Member will make a valuation or cause a valuation to be made of all of the assets of the Fund as of the fiscal year end. In addition, as soon as practicable after the end of each tax year of a Fund, the Managing Member of such Fund will send a report to each person who was an investor in such Fund at any time during the fiscal year then ended, setting forth such tax information as shall be necessary for the preparation by the investor of his, her or its U.S. federal and state income tax returns and a report of the investment activities of the Fund during that fiscal year.

6. If a Fund makes purchases or sales from or to an entity affiliated with the Fund by reason of an officer, director or employee of Two Sigma (a) serving as an officer, director, managing member or investment adviser of the entity, or (b) having a 5% or more investment in the entity, such individual will not participate in the Fund's determination of whether or not to effect the purchase or sale.