Under the regulations in “Subpart L-Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-12, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into or disseminated within the United States.

Section 319.56-4 of the regulations provides the requirements for authorizing the importation of fruits and vegetables into the United States, as well as revising existing requirements for the importation of fruits and vegetables. Paragraph (c) of that section provides that the name and origin of all fruits and vegetables authorized importation into the United States, as well as the requirements for their importation, are listed on the internet in APHIS' Fruits and Vegetables Import Requirements database, or FAVIR ( https://epermits.aphis.usda.gov/manual ). It also provides that, if the Administrator of APHIS determines that any of the phytosanitary measures required for the importation of a particular fruit or vegetable are no longer necessary to reasonably mitigate the plant pest risk posed by the fruit or vegetable, APHIS will publish a notice in the Federal Register making its pest risk analysis and determination available for public comment.

Currently, fragrant pear from China is listed in FAVIR as a fruit authorized importation into the United States, subject to phytosanitary measures. In summary, these measures require that:

• Fragrant pears may only be imported from China if they are grown in the Korla region of Xinjiang Province at a production site that is registered with the national plant protection organization (NPPO) of China.

• The fragrant pears must be produced from propagative material that has been certified as free of quarantine pests.

• Registered places of production are subject to pre- and post-harvest inspections.

• Fragrant pears must be packed in labeled cartons.

• Fragrant pears must be held in a cold storage facility while awaiting export.

• If the cold storage facility also stores fruit from unregistered production sites, the pears must be isolated from such fruit.

• Fragrant pears must be shipped in insect-proof containers.

• Each consignment must be accompanied by a phytosanitary certificate stating that the requirements listed above have been met and that the consignment has been inspected and found free of quarantine pests.

• Fragrant pears are subject to inspection at the port of entry into the United States.

• Fragrant pears must be imported under permit.

APHIS received a request from the NPPO of China to allow imports of fragrant pears from an expanded production area that would include the Akesu region as well as the currently approved Korla region of Xinjiang Province. The request was for market access to the entire United States, comprising all 50 States and U.S. territories. In response to the request, APHIS prepared a pest list to evaluate the pests of quarantine significance that could follow the pathway of importation of fragrant pears from the Akesu and Korla regions of Xinjiang Province in China into the United States.

In preparing the pest list, we discovered that our existing requirements for fragrant pear from China were based on a 1997 pest risk assessment (PRA) for all pear species from all of China, rather than limiting the assessment to fragrant pears from Xinjiang Province. In that same 1997 PRA, we also misidentified the fragrant pears as belonging to the species Pyrus sp. nr. communis, rather than the species Pyrus x sinkiangensis Yu. Our new pest list corrects these errors. The pest list identifies two pests of quarantine significance that could follow the pathway of importation of fragrant pears from the Akesu and Korla regions of Xinjiang Province in China into the United States: Eulecanium circumfluum Borchsenius, a soft scale, and Euzophera pyriella Yang, the pyralid moth.

Based on the pest list, a risk management document (RMD) was prepared to identify the phytosanitary measures that could be applied to the importation of fragrant pears from the Akesu and Korla regions of Xinjiang Province to mitigate the pest risk.

We have determined that fragrant pears can safely be imported from the Akesu and Korla regions of Xinjiang Province subject to the following phytosanitary measures:

• The fragrant pears must be grown in the Akesu or Korla region at a production site that is registered with the NPPO of China.

• Registered production sites must have in place a production site control program approved by APHIS and the NPPO of China.

• The NPPO of China is responsible for ensuring that registered production sites are subject to field sanitation and that growers are aware of quarantine pests and control measures to be taken for their control. Such measures must be described in detail in an operational workplan approved by the NPPO of China and APHIS.

• Only intact fruits may be harvested for export and the harvested fruit must be safeguarded against quarantine pests from the production site until the consignment is shipped.

• Fragrant pears must be packed in a packinghouse registered with the NPPO of China.

• The packinghouses must have a tracking system in place that will allow for traceback of the fruit to individual production sites.

• Registered packinghouses are prohibited from packing fragrant pears destined for other countries while packing fruit destined for the United States.

• Packinghouse procedures must be in accordance with the operational workplan.

• Each shipping box must be marked with the identity of the packinghouse and grower.

• Each consignment of fragrant pears must be accompanied by a phytosanitary certificate issued by the NPPO of China attesting to place of origin (production site and region) and stating that all APHIS phytosanitary requirements have been met and that the consignment was inspected and found free of quarantine pests.

• Fragrant pears may be imported as commercial consignments only.

• Fragrant pears are subject to inspection at the port of entry into the United States.

• Fragrant pears must be imported under permit.

Therefore, in accordance with § 319.56-4(c)(3), we are announcing the availability of our pest list and RMD for public review and comment. Those documents, as well as a description of the economic considerations associated with the importation of fresh fragrant pears from the Akesu and Korla regions of Xinjiang Province in China, may be viewed on the Regulations.gov website or in our reading room (see ADDRESSES above for a link to Regulations.gov and information on the location and hours of the reading room). You may request paper copies of these documents by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT . Please refer to the subject of the analysis you wish to review when requesting copies.

After reviewing any comments we receive, we will announce our decision regarding whether to revise the requirements for the importation of fragrant pears from China in a subsequent notice. If the overall conclusions of our analysis and the Administrator's determination of risk remain unchanged following our consideration of the comments, then we will revise the requirements for the importation of fragrant pears from China in accordance with this notice.

The purpose of these meetings is to:

(1) Review funding,

(2) review proposals, and

(3) possibly vote to recommend proposals.

These meetings are open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by April 23, 2019, to be scheduled on the agenda for the May 7, 2019 meeting; April 30, 2019, to be scheduled on the agenda for the May 14, 2019 meeting; May 7, 2019, to be scheduled on the agenda for the May 21, 2019 meeting; and May 14, 2019, to be scheduled on the agenda for the May 28, 2019 meeting. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Julie Roberts, RAC Coordinator, Sierra National Forest, 1600 Tollhouse Road, Clovis, California 93611; or by email to jaroberts@usda.gov, or via facsimile to 559-294-4809.

Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled For Further Information Contact. All reasonable accommodation requests are managed on a case by case basis.

The purpose of the meeting is to:

1. Introduce all the RAC members to one another;

2. Update all RAC members on the status of the SRS program, and the pending nomination package for new RAC members; and

3. Review and make recommendations on 27 new or modified recreation fee proposals submitted by the Columbia River Gorge National Scenic Area (1 proposal) and the Willamette National Forest (26 proposals).

The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by June 25, 2019, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Jennifer Sorensen, RAC Coordinator, 3106 Pierce Parkway, Suite D, Springfield, Oregon 97477; or by email to Jennifer.Sorensen@usda.gov.

Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled For Further Information Contact . All reasonable accommodation requests are managed on a case by case basis.

The purpose of the meeting is to:

1. Review progress of previously funded projects;

2. Review new project proposals; and

3. Conclude any business that may be remaining concerning recommendations for allocation of Title II funding to projects.

The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by Friday, May 3, 2019, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments may be sent to Linda Slaght, RAC Coordinator, Post Office Box 1328, Petersburg, Alaska 99833; by email to lslaght@fs.fed.us or via facsimile to 907-772-5995.

Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled For Further Information Contact . All reasonable accommodation requests are managed on a case by case basis.

The purpose of the meeting is to discuss, recommend, and approve new Title II projects.

The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by Friday, May 1, 2019, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Susan Garner, RAC Coordinator, 1835 Black Lake Boulevard, Southwest, Olympia, Washington 98512; by email to scgarner@fs.fed.us or via facsimile at 360-965-2320.

Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

The purpose of the meeting is to:

1. Review project proposals, and

2. Make project funding recommendations for Title II funds.

The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by April 29, 2019, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Lee Anne Schramel, Plumas County RAC Coordinator, Plumas National Forest Headquarters, 159 Lawrence Street, Quincy, California 95971; by email at easchramel@fs.fed.us, or via facismile at (530) 283-7746.

Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled For Further Information Contact. All reasonable accommodation requests are managed on a case by case basis.

The purpose of the meeting is to discuss the following:

(1) Welcome and Introductions;

(2) Overview of Secure Rural Schools Act, RAC Overview, and Discussion of the Roles of the Designated Federal Officer and Committee Members;

(3) Review RAC Charter and Operating Guidelines;

(4) RAC Project Overview;

(5) Selection of RAC Chairperson; and

(6) Questions, Answers, and Next Steps

These meetings are open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by May 24, 2019, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meetings.

Written comments and requests for time for oral comments must be sent to Debbie Maneely, RAC Coordinator, Prescott National Forest, 2971 Willow Creek Road, Building 4, Prescott, Arizona 86301; by telephone at (928) 443-8130 or via email at dmaneely@fs.fed.us.

Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

The purpose of the meetings is to:

1. Provide status updates regarding Secure Rural Schools Program and Title II funding; and

2. Review and recommend projects for Title II funding for Okanogan, Chelan, Kittitas and Yakima Counties.

These meetings are open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by May 6, 2019, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meetings.

Written comments and requests for time for oral comments must be sent to Robin DeMario, RAC Coordinator, 215 Melody Lane, Wenatchee, Washington 98801; by email to robin.demario@usda.gov or via facsimile to 509-664-9286.

Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled FOR FURTHER INFORMATION CONTACT. All reasonable accommodation requests are managed on a case by case basis.

Title: Vegetable Surveys Program.

OMB Number: 0535-0037.

Expiration Date of Approval: August 31, 2019.

Type of Request: Intent to Seek Approval to Revise and Extend an Information Collection for 3 years.

Abstract: The primary objective of the National Agricultural Statistics Service (NASS) is to collect, prepare, and issue State and national estimates of crop and livestock production, prices, and disposition; as well as economic statistics, environmental statistics related to agriculture and also to conduct the Census of Agriculture. The Vegetable Surveys Program obtains basic agricultural statistics for fresh market and processing vegetables in major producing States. Vegetable statistics are used by the U.S. Department of Agriculture to help administer programs and by growers, processors, and marketers in making production and marketing decisions. The Federal vegetable estimation program now consists of 26 selected crops.

Every 5 years NASS conducts a program review following the completion of the Census of Agriculture. The primary purpose is to ensure that the NASS annual estimating program targets commodities and states most relevant based on the latest available information. Last fall NASS announced the program review and requested stakeholder input. The primary source of information for the program review is the Census of Agriculture, since it is the most comprehensive source of data; however we also take into consideration estimates from the current annual estimating program and administrative data. The detailed listing of program changes can be found at the following link: https://www.nass.usda.gov/Surveys/Program_Review/2019/Vegetable-Program.pdf. All questionnaires included in this information collection will be voluntary.

Authority: These data will be collected under authority of 7 U.S.C. 2204(a). Individually identifiable data collected under this authority are governed by Section 1770 of the Food Security Act of 1985 as amended, 7 U.S.C. 2276, which requires USDA to afford strict confidentiality to non-aggregated data provided by respondents. This Notice is submitted in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-113) and Office of Management and Budget regulations at 5 CFR part 1320. NASS also complies with OMB Implementation Guidance, “Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),” Federal Register , Vol. 72, No. 115, June 15, 2007, p. 33362.

Estimate of Burden: Public reporting burden for this collection of information is estimated to be between 5 and 20 minutes per respondent per survey.

Respondents: Farms and businesses.

Estimated Number of Respondents: 14,000.

Estimated Total Annual Burden on Respondents: 5,000 hours.

Comments: 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 will have practical utility; (b) 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) 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 those who are to respond, through the use of appropriate automated, electronic, mechanical, technological or other forms of information technology collection methods.

All responses to this notice will become a matter of public record and be summarized in the request for OMB approval.

Correction

In the Federal Register of Tuesday, April 9, 2019, in FR Doc. 2019-06989, on page 14085, third column; and on page 14086, first and second column, correct the “Dates” caption to read:

I. Abstract

As in previous censuses, the Post-Enumeration Survey (PES) for the 2020 Census will be conducted to provide estimates of census net coverage and components of census coverage (such as correct enumerations, omissions, erroneous enumerations [including duplicates], and whole-person imputations) for housing units and people living in housing units for the United States and Puerto Rico, excluding remote Alaska. (See Definition of Terms.) Group quarters (such as college dormitories and correctional facilities) are out of scope because populations can change significantly between census enumeration and PES enumeration operations. Similarly, remote Alaska is out of scope for the PES because the seasonal nature of addresses and the population throughout the year make it infeasible to accurately conduct the matching and follow-up operations necessary for dual-system estimation. For this reason, the Census Bureau's past post-enumeration surveys have never included remote Alaska. These coverage estimates provide insight into the quality and coverage of census results and operations. As in the past, including in the 2010 Census Coverage Measurement program, the 2020 PES operations and activities must be conducted separate from, and independent of, the other 2020 Census operations.

The 2020 PES will use the dual-system estimation procedure, which depends on two independent systems of measurement. The independence between the PES and census operations is a fundamental necessity for dual-system estimation. The PES will comprise two independent enumerations of housing units and the household population within the same sample areas. These two enumerations are called the enumeration sample (E sample) and the population sample (P sample). The primary sampling unit is the basic collection unit (BCU), which is the smallest unit of collection geography for 2020 Census operations. The E sample contains the list of housing units and people enumerated in the 2020 Census within a sample of BCUs. The P sample contains housing units and people in the sample set of sample BCUs, but obtained independently from the census. The independent roster of housing units is obtained during the PES Independent Listing, while the independent roster of people is obtained during the PES Person Interview. The P sample housing units and people will be matched to all census housing units in the sample BCUs and surrounding BCUs.

During the Independent Listing operation, field staff, referred to as “listers,” will canvass every street, road, or other place where people might live in their assigned BCUs and construct a list of housing units from scratch. Following the completion of listing for each BCU, the addresses are computer and clerically matched in the Initial Housing Unit Matching operation. Addresses that remain unmatched or have unresolved address status after matching will be sent to the Initial Housing Unit Follow-up operation, during which listers collect additional information that might allow a resolution of any differences between the Independent Listing and the preliminary census address list results. Matching to a preliminary census file of housing units allows the PES to conduct person interviews close to census day (April 1, 2020), rather than waiting until the final census list is available. In the Final Housing Unit Matching operation addresses collected in the Independent Listing operation are matched to the final census list of housing units. The Initial Housing Unit Follow-up field operation seeks to answer questions needed to resolve the match or enumeration status of addresses identified in the Initial Housing Unit matching operation, while the Final Housing Unit Follow-up field operation seeks to answer similar questions identified in the Final Housing Unit matching operation. A Federal Register Notice has been issued for the PES Independent Listing operation (Federal Register Notice Vol. 83 FR 53849, pages 53849-53850). Federal Register Notices for the Person Interview and Person Follow-up operations will be issued at a later date.

Addresses identified for both Initial and Final Housing Unit Follow-ups will generally need additional information to determine housing unit status (for example, to clarify if the addresses refer to a housing unit or commercial building and to identify duplicate addresses) or to resolve inconsistencies between the PES and census addresses. Using paper questionnaires tailored to capture information needed to resolve each specific status question or discrepancy, listers will contact a member of each housing unit and ask questions to resolve housing unit status or to clarify discrepancies. If the listers do not find anyone at home after several attempts, they will try to collect the information from a proxy or by observation as a last resort. Proxies are respondents who are not members of the household.

The Initial and Final Housing Unit Follow-up operations will also have separate quality control operations. The first quality control operation is the Initial Housing Unit Follow-up Quality Control, which contains 15 percent of the Initial Housing Unit Follow-up workload. The second quality control operation is the Final Housing Unit Follow-up Quality Control, which contains 15 percent of the Final Housing Unit Follow-up workload. These operations are implemented to ensure that the work performed is of acceptable quality.

The Housing Unit Follow-up and Housing Unit Follow-up Quality Control operations will be conducted through personal visits using paper questionnaires. Listers will receive work assignments grouped by geography and in close proximity to the lister's residence whenever possible. The PES Initial Housing Unit Follow-up and Initial Housing Unit Follow-up Quality Control operations will occur May 6, 2020 through June 19, 2020. The PES Final Housing Unit Follow-up and Final Housing Unit Follow-up Quality Control operations will occur starting May 19, 2021 through June 18, 2021.

A sample of approximately 180,000 housing units will be selected for the Initial Housing Unit Follow-up operation and approximately 8,000 housing units will be selected for the Final Housing Unit Follow-up operation. Housing Unit Follow-up listers are expected to knock on every door that requires additional information over several spaced visits in their assigned BCUs to try to find a resident or proxy to ask about the units. The Initial Housing Unit Follow-up Quality Control operation will contain about 27,000 housing units and the Final Housing Unit Follow-up Quality Control operation will contain about 1,200 housing units.

Components of Census Coverage— The components of census coverage include correct enumerations, erroneous enumerations, whole-person imputations, and omissions. Correct enumerations are people or housing units that were correctly enumerated in the census. Erroneous enumerations are people or housing units that were enumerated in the census but should not have been. Examples of erroneous enumerations are duplicates, nonexistent housing units or people, and people or housing units that were enumerated in the wrong place. Omissions are people and housing units that were not enumerated in the census but should have been. Lastly, whole-person imputations are census records for which all of the demographic characteristics were imputed. Many of these imputations represent people in housing units where we knew the household count but did not obtain sufficient information about the people residing at the housing unit.

Net Coverage —Reflects the difference between the true population (which is estimated by the Post-Enumeration Survey) and the census count. If the census count was less than the actual number of people or housing units in the population, then we say there was an undercount. If the census count was more than the actual number of people or housing units in the population, then we say there was an overcount.

For more information about the Post-Enumeration Survey, please visit the following page of the Census Bureau's website: https://www.census.gov/coverage_measurement/post-enumeration_surveys/.

OMB Control Number: 0607-XXXX.

Form Numbers: D-1303, D-1303PR, D-1340, D-1340PR, D-1380, D-1380PR, D-1325, and D-1325PR.

Type of Review: Regular submission.

Affected Public: Individuals or Households.

Estimated Total Annual Burden Hours: 18,017 hours.

Estimated Total Annual Cost: $0. (This is not the cost of respondents' time, but the indirect costs respondents may incur for such things as purchases of specialized software or hardware needed to report, or expenditures for accounting or records maintenance services required specifically by the collection.)

Respondent's Obligation: Mandatory.

Legal Authority: Title 13, U.S. Code, Sections 141 and 193.

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.

On August 1, 2018, Commerce published the notice of initiation of the fourth sunset reviews of the Orders   1 on pasta from Italy and Turkey, pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). 2 As a result of its reviews, Commerce determined that revocation of the Orders on pasta from Italy and Turkey would likely lead to the continuation or recurrence of dumping and countervailable subsidies. 3 Commerce, therefore, notified the ITC of the magnitude of the margins of dumping and the net countervailable subsidy rates likely to prevail were the Orders revoked. 4

On April 10, 2019, the ITC published its determinations, pursuant to sections 751(c) and 752 of the Act, that revocation of the Orders on pasta from Italy and Turkey would likely lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time. 5

The merchandise subject to the order is pasta. The product is currently classified under items 1901.90.90.95 and 1902.19.20 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS numbers are provided for convenience and customs purposes, the written product description available in Italy AD Order and Italy CVD Order remains dispositive. 6

The merchandise subject to the order is pasta. The product is currently classified under items 1902.19.20 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS numbers are provided for convenience and customs purposes, the written product description available in Turkey AD Order and Turkey CVD Order remains dispositive. 7

As a result of the determinations by Commerce and the ITC that revocation of the Orders would likely lead to a continuation or a recurrence of dumping, a continuation or recurrence of countervailable subsidies, and a continuation or recurrence of material injury to an industry in the United States, pursuant to section 751(d)(2) of the Act and 19 CFR 351.218(a), Commerce hereby orders the continuation of the Orders on pasta from Italy and Turkey. U.S. Customs and Border Protection will continue to collect AD and CVD cash deposits at the rates in effect at the time of entry for all imports of subject merchandise.

The effective date of the continuation of the Orders will be the date of publication in the Federal Register of this notice of continuation. Pursuant to section 751(c)(2) of the Act, Commerce intends to initiate the next five-year reviews of these orders not later than 30 days prior to the fifth anniversary of the effective date of continuation.

This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return/destruction or conversion to judicial protective order of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Failure to comply is a violation of the APO which may be subject to sanctions.

These sunset reviews and notice are in accordance with sections 751(c), 752, and published pursuant to 777(i)(1) of the Act and 19 CFR 351.218(f)(4).

Background: The Board advises the Secretary of Commerce on matters relating to the U.S. travel and tourism industry.

Public Participation: The meeting will be open to the public and will be accessible to people with disabilities. Any member of the public requesting to join the meeting is asked to register in advance by the deadline identified under the DATES caption. Requests for auxiliary aids must be submitted by the registration deadline. Last minute requests will be accepted but may not be possible to fill. There will be fifteen (15) minutes allotted for oral comments from members of the public joining the meeting. To accommodate as many speakers as possible, the time for public comments may be limited to three (3) minutes per person. Members of the public wishing to reserve speaking time during the meeting must submit a request at the time of registration, as well as the name and address of the proposed speaker. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, the International Trade Administration may conduct a lottery to determine the speakers. Speakers are requested to submit a written copy of their prepared remarks by 5 p.m. EDT on Monday, April 22, 2019 for inclusion in the meeting records and for circulation to the members of the Board.

In addition, any member of the public may submit pertinent written comments concerning the Board's affairs at any time before or after the meeting. Comments may be submitted to Brian Beall at the contact information indicated above. To be considered during the meeting, comments must be received no later than 5 p.m. EDT on Monday, April 22, 2019 to ensure transmission to the Board prior to the meeting. Comments received after that date and time will be distributed to the members but may not be considered during the meeting. Copies of Board meeting minutes will be available within 90 days of the meeting.

I. Background

The NMSA authorizes the Secretary of Commerce (Secretary) to designate and protect as national marine sanctuaries areas of the marine environment that are of special national significance due to their conservation, recreational, ecological, historical, scientific, cultural, archeological, educational, or esthetic qualities. Day-to-day management of national marine sanctuaries has been delegated by the Secretary to ONMS. The primary objective of the NMSA is to protect the resources of the sanctuary system.

The area being considered for designation as a national marine sanctuary is a region in eastern Lake Ontario that includes approximately 1,700 square miles of lake waters and bottomlands adjacent to Jefferson, Wayne, Oswego, and Cayuga counties in the State of New York. The area is adjacent to approximately 200 miles of United States shoreline and extends north to the mid-lake international border with Canada. The area features a diverse collection of historic shipwrecks dating back to the 1700s, as well as a historic aircraft.

Eastern Lake Ontario represents a diverse array of important events in our nation's history, including military conflicts, maritime innovation, and American expansion to the west. The eastern corridor is one of the most historically significant regions in the Great Lakes and the country. Lake Ontario has dominated maritime trade and transportation for centuries, beginning with the canoes and boats of early indigenous peoples. During the colonial period, Lake Ontario was a strategic theater of conflict among European powers and the young American republic. Military actions occurred in the region during the French and Indian War, Revolutionary War, and the War of 1812. Later, this region was critical to the development of the American West and the nation's industrial core.

Vessels that historically plied Lake Ontario's waters often met with treacherous conditions, which resulted in numerous shipwrecks. The lake's cold, fresh water has preserved these wrecks, making these “submerged museums” ripe for protection, study, and interpretation. The area contains 21 known shipwrecks, 47 additional reported vessel losses, several reported aircraft losses, numerous other historic maritime-related features, and is adjacent to communities that have embraced their centuries-long relationship with Lake Ontario. The collection also includes HMS Ontario, the oldest confirmed shipwreck and the only fully intact British warship to have ever been found in the Great Lakes; at least one submerged shipwreck that has been listed, and several evaluated for listing, on the National Register of Historic Places; and a 19th Century Great Lakes cargo vessel that is recognized as the only New York State Submerged Cultural Preserve and Dive Site in Lake Ontario and Lake Erie.

On January 17, 2017, Governor Andrew Cuomo, acting on behalf of the State of New York and the Counties of Jefferson, Wayne, Cayuga, and Oswego submitted a nomination to NOAA through the Sanctuary Nomination Process (SNP) (79 FR 33851), asking NOAA to consider designating an area in eastern Lake Ontario waters as a national marine sanctuary. The nomination asks NOAA to supplement and complement work by the State of New York to enhance protection of this collection of nationally significant shipwrecks and other underwater cultural resources ( e.g., aircraft, inundated prehistoric sites) in the face of evolving and expanding human use. The nomination also identifies opportunities for NOAA to expand upon existing local, county, and state efforts to study, interpret, and manage the area's unique submerged cultural resources. The nomination does not propose that the sanctuary regulate fishing, water quality, or other natural resource attributes of the area.

NOAA is initiating the process to designate this area as a national marine sanctuary based on the information included in the nomination. NOAA's review of the nomination against the criteria and considerations of the SNP indicated strong merit in proposing this area as a national marine sanctuary to protect cultural resources. The nomination was endorsed by a diverse coalition of organizations and individuals at local, state, regional, and national levels including elected officials, businesses, a federally recognized tribe, recreational users, conservation groups, fishing associations, tourism companies, museums, historical societies, and education groups. NOAA completed its review of the nomination on March 21, 2017 and added the area to the inventory of nominations that are eligible for designation. NOAA encourages the public to review the full nomination at https://nominate.noaa.gov/nominations/.

NOAA's goal in considering the designation is to protect, research, interpret, and improve public access to shipwrecks and other maritime heritage resources. Designation under the NMSA would allow NOAA to complement the State of New York's efforts to preserve this collection of nationally significant historic shipwrecks and other underwater cultural resources. Through a research and monitoring program, NOAA could use its assets to further locate, document, and monitor these significant cultural resources. Establishing a national marine sanctuary in eastern Lake Ontario could also expand education and outreach to interpret sanctuary resources for the public, as well as promote the responsible use of sanctuary resources. Furthermore, a sanctuary has the potential to increase tourism and economic opportunities in local coastal communities.

The process for designating the Lake Ontario area as a national marine sanctuary includes the following stages:

1. Public Scoping Process— Information collection and characterization, including the consideration of public comments received during scoping;

2. Preparation of documents— Preparation and release of draft designation documents, including: A draft environmental impact statement (DEIS), prepared pursuant to the National Environmental Policy Act (NEPA), that identifies boundary alternatives; a draft management plan (DMP); and a notice of proposed rulemaking (NPRM) to define proposed sanctuary regulations. Draft documents would be used to initiate consultations with federal, state, or local agencies, tribes and other interested parties, as appropriate;

3. Public review and comment on the DEIS, DMP, and NPRM;

4. Preparation and release of a final environmental impact statement, final management plan, including a response to public comments, with a final rule and regulations, if appropriate.

5. The designation and regulations shall take effect after the end of a review period of forty-five days of a continuous session of Congress. During this same period, the Governor of the state in whose waters the sanctuary is partially or entirely located has the opportunity to concurrently review the designation.

With this notice, NOAA is initiating a public scoping process to gather information from individuals, organizations, and government agencies on the designation of the Great Lake Ontario area as a national marine sanctuary based on the community-based nomination of January 2017, especially:

(a) The spatial extent of the proposed sanctuary;

(b) the location, nature, and value of the resources that would be protected by a sanctuary;

(c) the management plan framework most appropriate to the resources in the area;

(d) the potential socioeconomic, cultural, and biological impacts of designation;

(e) threats to underwater cultural resources within the proposed sanctuary; and

(f) potential names for the new sanctuary.

This notice confirms that NOAA will fulfill its responsibility under section 106 of the National Historic Preservation Act (NHPA) through the ongoing NEPA process, pursuant to 36 CFR 800.8(a) including the use of NEPA documents and public and stakeholder meetings to meet the section 106 requirements. The NHPA specifically applies to any agency undertaking that may affect historic properties. Pursuant to 36 CFR 800.16(1)(1), historic properties includes: “any prehistoric or historic district, site, building, structure or object included in, or eligible for inclusion in, the National Register of Historic Places maintained by the Secretary of the Interior. The term includes artifacts, records, and remains that are related to and located within such properties. The term includes properties of traditional religious and cultural importance to an Indian tribe or Native Hawaiian organization and that meet the National Register criteria.”

In fulfilling its responsibility under the NHPA and NEPA, NOAA intends to identify consulting parties; identify historic properties and assess the effects of the undertaking on such properties; initiate formal consultation with the State Historic Preservation Officer, the Advisory Council of Historic Preservation, federally-recognized tribes, and other consulting parties; involve the public in accordance with NOAA's NEPA procedures, and develop in consultation with identified consulting parties alternatives and proposed measures that might avoid, minimize or mitigate any adverse effects on historic properties and describe them in any environmental assessment or draft environmental impact statement.

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

Title of Collection: National Center for College Students with Disabilities (NCCSD) Database of Disability Services and Activities in Higher Education.

OMB Control Number: 1840-NEW.

Type of Review: A new information collection.

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

Total Estimated Number of Annual Responses: 4,583.

Total Estimated Number of Annual Burden Hours: 13,749.

Abstract: The National Center for College Students with Disabilities (NCCSD) at the Association on Higher Education and Disability (AHEAD) is authorized by Congress in the Higher Education Opportunity Act of 2008 (§ 777.4) and was established in 2016. The NCCSD College Disability Resource Database is designed to address a gap in information about services and accessibility for college students with disabilities, who make up 11% of the undergraduate population. Existing general information about colleges is available in the Department of Education's online College Navigator and College Affordability and Transparency Center, but the only information about students with disabilities in these databases is the percentage of students registered with campus disability services offices. At this time, there are no national or federal surveys or databases that provide systematic collection of information about campus-level disability-related services, access, and activities at colleges and universities in the United States. The NCCSD survey will ask all U.S. campuses to provide basic information about disability services, accessibility of campus, and disability-related activities that may affect inclusion and the campus climate. The data will be available to the public in an accessible and searchable database, to help prospective college students and their families make informed decisions during the college search process. Because the database will be public, researchers and policymakers will also be able to utilize the data to gather information about disability and higher education in systematic ways.

Title 40 CFR 123.62(b)(3) states that the EPA will approve or disapprove program revisions on the requirements of this part. Furthermore, title 40 CFR 123.62(b)(4) indicates that a program revision shall become effective upon the approval of the EPA. These revisions are effective on March 27, 2019.

This action is directed to the public in general. This action may be of interest to persons who are interested in risk evaluations of existing chemical substances under the Toxic Substances Control Act (TSCA) in general, and PV29 in particular. Since other persons may also be interested in this, the Agency has not attempted to describe all that may be interested in this action.

EPA is announcing the availability of updated systematic review supplemental file with data evaluation scoring sheets which are available in Docket ID No. EPA-HQ-OPPT-2018-0604 at http://www.regulations.gov. EPA is seeking public comment on the draft risk evaluation for PV29 in light of the additional materials being made publicly available. These materials have been considered in the risk evaluation process of PV29 and all comments received in response to this solicitation will be provided to the TSCA SACC for consideration during their peer review.

Do not submit CBI information to EPA through regulations.gov or via email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov, or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: The New Source Performance Standards (NSPS) for Surface Coating of Plastic Parts for Business Machines (40 CFR part 60 subpart TTT) were proposed on January 8, 1986, promulgated on January 29, 1988, and amended on October 17, 2000. These regulations apply to new facilities that perform industrial surface coating operations on plastic parts for use in the manufacture of business machines: Each spray booth that applies prime coats, color coats, texture coats or touch-up coats. New facilities include those that commenced construction, modification, or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR part 60, subpart TTT.

In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS.

Form Numbers: None.

Respondents/affected entities: Facilities that perform industrial surface coating on plastic parts for business machines.

Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart TTT).

Estimated number of respondents: 10 (total).

Frequency of response: Initially, quarterly and semiannually.

Total estimated burden: 992 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $113,000 (per year), which includes $0 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is no change in the labor hours in this ICR compared to the previous ICR. This is due to two considerations: (1) The regulations have not changed over the past three years and are not anticipated to change over the next three years; and (2) the growth rate for the industry is very low, negative or non-existent, so there is no significant change in the overall burden.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov, or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: The New Source Performance Standards (NSPS) for Secondary Lead Smelters (40 CFR part 60, subpart L) apply to existing facilities and new secondary lead smelting facilities: Any pot furnace of more than 250 kg (550 lb) charging capacity, blast (cupola) furnaces, and reverberatory furnaces. The affected facilities include any facility producing lead from a lead bearing scrap material by smelting to the metallic form. Blast furnace means any furnace used to recover metal from slag. Reverberatory furnaces include furnaces of various types, e.g., stationary, rotating, rocking and tilting. New facilities include those that commenced construction, modification, or reconstruction after the date of proposal. This information is being collected to assure compliance with 40 CFR part 60, subpart L.

In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS.

Form Numbers: None.

Respondents/affected entities: Secondary lead smelting facilities.

Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart L).

Estimated number of respondents: 12 (total).

Frequency of response: Initially.

Total estimated burden: 32 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $3,620 (per year), which includes $0 annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: The adjustment decrease in burden from the most recently-approved ICR is due to a decrease in the number of sources. There is a decrease in the number of estimated sources from 14 to 12 due to consolidation within the sector. The reduced number of estimated sources also led to a decrease in the number of responses.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov, or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: The New Source Performance Standards (NSPS) for Synthetic Fiber Production Facilities (40 CFR part 60, subpart HHH) were proposed on November 23, 1982, promulgated on April 5, 1984, and amended on October 17, 2000. These regulations apply to both existing and new synthetic fiber production plants with a solvent-spun, synthetic fiber process that produce more than 500 megagrams (Mgs) of fiber per year that commenced construction or reconstruction after the date of proposal. The provisions of this subpart do not apply to any facility that uses the reaction spinning process to produce spandex fiber, or the viscose process to produce rayon fiber, or to facilities that commence modification, but not reconstruction, after the date of proposal. This information is being collected to assure compliance with 40 CFR part 60, subpart HHH.

In general, all NSPS standards require initial notifications, performance tests, and periodic reports by the owners/operators of the affected facilities. They are also required to maintain records of the occurrence and duration of any startup, shutdown, or malfunction in the operation of an affected facility, or any period during which the monitoring system is inoperative. These notifications, reports, and records are essential in determining compliance, and are required of all affected facilities subject to NSPS.

Form Numbers: None.

Respondents/affected entities: Synthetic fiber production plants with a solvent-spun, synthetic fiber process that produce more than 500 megagrams (Mgs) of fiber per year.

Respondent's obligation to respond: Mandatory (40 CFR part 60, subpart HHH).

Estimated number of respondents: 22 (total).

Frequency of response: Initially, semiannually, and quarterly.

Total estimated burden: 1,880 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $380,000 (per year), which includes $165,000 in annualized capital/startup and/or operation & maintenance costs.

Changes in the Estimates: There is no change in burden for this ICR compared to the previous ICR. This situation is due to two considerations: (1) The regulations have not changed over the past three years and are not anticipated to change over the next three years; and (2) the growth rate for the industry is very low, negative or non-existent, so there is no significant change in the overall burden.

On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.

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

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

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

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

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

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

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

Report title: Senior Credit Officer Opinion Survey on Dealer Financing Terms.

Agency form number: FR 2034.

OMB control number: 7100-0325.

Frequency: Quarterly.

Respondents: U.S. financial institutions and U.S. branches and agencies of foreign banks.

Estimated number of respondents: 25.

Estimated average hours per response: 5.

Estimated annual burden hours: 500.

General description of report: This survey collects qualitative and limited quantitative information from senior credit officers at responding financial institutions on (1) stringency of credit terms, (2) credit availability and demand across the entire range of securities financing and over-the-counter derivatives transactions, and (3) the evolution of market conditions and conventions applicable to such activities. Given the Board's interest in financial stability, the information this survey collects is critical to the monitoring of credit markets and capital market activity. Information from the survey is also considered by the Federal Open Market Committee (FOMC) as it sets monetary policy. Aggregate survey results are made available to the public on the Board's website. 1 In addition, selected aggregate survey results may be discussed in Governors' speeches and may be published in Federal Reserve Bulletin articles and in the semi-annual Monetary Policy Report to the Congress.

Legal authorization and confidentiality: The FR 2034 is authorized pursuant to sections 2A and 12A of the Federal Reserve Act (“FRA”). Section 2A of the FRA requires that the Board and the FOMC maintain long-run growth of the monetary and credit aggregates commensurate with the economy's long run potential to increase production, so as to promote effectively the goals of maximum employment, stable prices, and moderate long-term interest rates (12 U.S.C. 225a). Under section 12A of the FRA, the FOMC is required to implement regulations relating to the open market operations conducted by Federal Reserve Banks. Those transactions must be governed with a view to accommodating commerce and business and with regard to their bearing upon the general credit situation of the country (12 U.S.C. 263). The Board and the FOMC use the information obtained from the FR 2034 to help fulfill these obligations. The FR 2034 is voluntary. Information collected on the FR 2034 is granted confidential treatment under exemption (b)(4) of the Freedom of Information Act, 5 U.S.C. 552(b)(4), which protects from disclosure “trade secrets and commercial or financial information obtained from a person and privileged or confidential.”

On June 15, 1984, OMB delegated to the Board authority under the PRA to approve and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.

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

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

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

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

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

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

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

Report title: Semiannual Report of Derivatives Activity.

Agency form number: FR 2436.

OMB control number: 7100-0286.

Frequency: Semiannually.

Respondents: U.S. dealers of over-the-counter (OTC) derivatives.

Estimated number of respondents: 8.

Estimated average hours per response: 236.

Estimated annual burden hours: 3,776.

General description of report: The Semiannual Report of Derivatives Activity collects derivatives market statistics from the eight largest U.S. dealers of OTC derivatives. Data are collected on the notional amounts and gross fair values of the volumes outstanding of broad categories of foreign exchange, interest rate, equity, commodity-linked, and credit default swap OTC derivatives contracts across a range of underlying currencies, interest rates, and equity markets.

This collection of information complements the triennial Central Bank Survey of Foreign Exchange and Derivatives Market Activity (FR 3036; OMB No. 7100-0285). The FR 2436 collects similar data on the outstanding volume of derivatives, but not on derivatives turnover. The Board conducts both surveys in coordination with other central banks. The aggregated U.S. data is compiled and forwarded to the Bank for International Settlements (BIS), which publishes global market statistics that are aggregates of national data.

Legal authorization and confidentiality: This report is authorized under sections 2A and 12A of the Federal Reserve Act (FRA). Section 2A of the FRA requires the Federal Reserve Board and the Federal Open Market Committee (FOMC) to maintain long run growth of the monetary and credit aggregates commensurate with the economy's long run potential to increase production, so as to promote effectively the goals of maximum employment, stable prices, and moderate long-term interest rates (12 U.S.C. 225a). Section 12A of the FRA requires the FOMC to implement regulations relating to the open market operations conducted by Federal Reserve Banks with a view to accommodating commerce and business and with regard to their bearing upon the general credit situation of the country (12 U.S.C. 263). Because the Federal Reserve System uses the information obtained from the FR 2436 to fulfill these obligations, these statutory provisions provide the legal authorization for the collection of information on the FR 2436.

The FR 2436 is voluntary. Because the release of this information would cause substantial harm to the competitive position of the entity from whom the information was obtained, the information collected on the FR 2436 may be granted confidential treatment under exemption (b)(4) of the Freedom of Information Act (5 U.S.C. 552(b)(4)), which protects from disclosure “trade secrets and commercial or financial information obtained from a person and privileged or confidential.”

Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis of Agreement Containing Consent Orders to Aid Public Comment describes the terms of the consent agreement and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page for April 10, 2019, on the World Wide Web, at https://www.ftc.gov/news-events/commission-actions.

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before May 17, 2019. Write “Tronox/Cristal USA; File No. 1710085” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the https://www.regulations.gov website.

Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online through the https://www.regulations.gov website.

If you prefer to file your comment on paper, write “Tronox/Cristal USA; File No. 1710085” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex D), Washington, DC 20580; or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

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

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

Visit the FTC website at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding, as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before May 17, 2019. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

The Federal Trade Commission (“Commission”) has accepted, subject to final approval, an Agreement Containing Consent Orders (“Consent Agreement”) with Tronox Limited (“Tronox”), National Industrialization Company (“TASNEE”), National Titanium Dioxide Company Limited (“Cristal”), and Cristal USA Inc. The purpose of the Consent Agreement is to remedy the anticompetitive effects that would result from Tronox's proposed acquisition of Cristal's titanium dioxide (“TiO2”) business.

On February 21, 2017, Tronox announced that it had entered into a definitive agreement to acquire all of Cristal's TiO2 business for $1.67 billion and a 24 percent stake in the combined entity (“Acquisition”). The proposed Acquisition would combine two of the three largest producers of TiO2 manufactured through the chloride process (“chloride TiO2”) in the United States and Canada (“North America”). On December 5, 2017, the Commission issued an administrative Complaint challenging the proposed Acquisition and authorized staff to seek, if necessary, a preliminary injunction in federal district court. The Commission's Complaint alleged that the proposed Acquisition, if consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the FTC Act, as amended, 15 U.S.C. 45, by substantially lessening competition in the market for the sale of chloride TiO2 to North American customers (“North American chloride TiO2 market”). After extensive pre-trial discovery, the administrative trial before the Administrative Law Judge (“ALJ”) began on May 18, 2018 and was conducted over sixteen hearing days until June 22, 2018.

In July 2018, because Tronox could have closed the transaction before the ALJ could issue a decision, however, the Commission filed a federal complaint in the U.S. District Court for the District of Columbia to seek a preliminary injunction. After a three-day hearing at the federal district court, Judge Trevor N. McFadden ruled for the Commission and issued an opinion and order granting the motion for a preliminary injunction on September 12, 2018. In his opinion, Judge McFadden found that the Commission established a strong presumption of anticompetitive effects in the market for chloride TiO2 in North America and that the parties' rebuttal evidence did not overcome the presumption. After the completion of the federal court action, the ALJ issued an Initial Decision on December 7, 2018. Like the decision in the federal court, the ALJ found that the Acquisition may substantially lessen competition in the relevant market in violation of Section 7 of the Clayton Act and Section 5 of the FTC Act. The parties thereafter engaged with Commission staff in settlement discussions to resolve the Commission's concerns relating to lost competition in the North American chloride TiO2 market.

To remedy the anticompetitive effects that would result from the proposed Acquisition in the North American chloride TiO2 market, the proposed Decision and Order (“Order”) contained in the Consent Agreement requires Tronox to divest Cristal's North American TiO2 business to INEOS Enterprises (“Ineos”) no later than 30 days from the close of the Acquisition. The divestiture package includes all of Cristal's North American TiO2 production assets, including two chloride TiO2 manufacturing plants located in Ashtabula, Ohio, a research, development, and administrative support facility near Baltimore, Maryland, necessary intellectual property associated with the manufacture and sale of chloride TiO2 in and from North America, an option to acquire rights to use the licensed intellectual property to produce chloride TiO2 products at a new manufacturing facility outside North America, customer contracts in North America with respect to chloride TiO2, the ability to hire all Cristal personnel necessary to operate the business, and access to various transitional services. In short, the Consent Agreement provides Ineos with everything it needs to compete effectively in the North American chloride TiO2 market, along with the ability to produce globally in the future if the business opportunity arises.

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

Tronox, a publicly traded company headquartered in Stamford, Connecticut, is one of the top three manufacturers of chloride TiO2 in North America. Tronox operates one TiO2 pigment manufacturing plant in Hamilton, Mississippi, and two other plants in Botlek, the Netherlands, and Kwinana, Australia. Tronox's three plants produce chloride TiO2 exclusively.

Cristal, headquartered in Jeddah, Saudi Arabia, is a corporation majority-owned by National Industrialization Company (“TASNEE”), a limited company, headquartered in Riyadh, Saudi Arabia. Cristal's primary U.S. subsidiary is Cristal USA Inc., a corporation with its executive offices and principal place of business located in Glen Burnie, Maryland. Cristal, through various subsidiaries, owns and operates chloride TiO2 manufacturing plants in Ashtabula, Ohio, the United Kingdom, Australia, and Saudi Arabia. Cristal also produces sulfate TiO2 at plants in Brazil, China, and France. All of Cristal's TiO2 production in North America is chloride TiO2.

The relevant product market in which to assess the competitive effects of the proposed Acquisition is chloride TiO2. TiO2 is a white pigment used to provide opacity, whiteness, and brightness to a vast array of products, including paint, industrial coatings, plastics, paper, and other products. Chloride TiO2 has distinct, superior characteristics that cannot be provided by any other type of TiO2, including sulfate TiO2. Most North American customers would not substitute sulfate TiO2 for chloride TiO2 in response to a small but significant increase in price.

The relevant geographic market is North America, defined as the United States and Canada. The North American market has competitive dynamics, including pricing and demand characteristics, that differ from other geographic regions and limit the ability of North American customers to engage in arbitrage across different geographic regions. Import duties, shipping and handling costs, and other logistical challenges would render such efforts uneconomical and impractical.

The market for chloride TiO2 in North America is characterized by a limited number of suppliers. Tronox and Cristal are two of the three largest producers of chloride TiO2 in North America and together with The Chemours Company, the top three TiO2 companies control the vast majority of chloride TiO2 sales to North American customers and more than 80 percent of overall North American chloride TiO2 manufacturing capacity.

The proposed Acquisition would cause the already concentrated North American chloride TiO2 market to become even more concentrated, increasing the Herfindahl-Hirschman Index (“HHI”) by more than 700, resulting in a post-Acquisition HHI exceeding 3,000. This increase in concentration far exceeds the thresholds set out in the Horizontal Merger Guidelines for raising a presumption that the Acquisition would create or enhance market power.

As both the federal and administrative courts have already determined, absent a divestiture, the proposed Acquisition is likely to cause competitive harm in the North American chloride TiO2 market. As stated in the Decision, for the sole purpose of settling this matter, Tronox and Cristal do not dispute that the likely effect of the proposed Acquisition, if consummated without a divestiture, may be substantially to lessen competition in the North American chloride TiO2 market. Tronox and Cristal are two of the three largest producers of chloride TiO2 in North America. The proposed Acquisition would have anticompetitive effects in two ways: (1) Increasing the likelihood of anticompetitive coordination among the North American chloride TiO2 companies; and (2) increasing Tronox's incentive and ability to unilaterally curtail production of chloride TiO2 in North America, which would lead to higher prices for chloride TiO2 in North America.

Entry into the North American chloride TiO2 market is neither likely nor timely to deter or counteract any anticompetitive effects of the proposed Acquisition. The chloride TiO2 market is characterized by substantial barriers to entry. Market participants confirmed that building a new TiO2 plant would take multiple years and a large capital investment. Moreover, chloride plants rely on closely held proprietary technology. Expansion or repositioning by the remaining firms that would defeat anticompetitive effects is also unlikely in the already mature North American chloride TiO2 market.

The proposed Consent Agreement restores the competition that would have been lost from the proposed Acquisition by requiring Tronox to divest Cristal's North American TiO2 business to Ineos, a multinational corporation comprised of chemical manufacturing businesses. The proposed divestiture package provides everything needed for Ineos to compete effectively in the North American chloride TiO2 market.

Under the Order, Tronox is required to divest Cristal's North American TiO2 business to Ineos no later than 30 days from the close of the Acquisition. The divestiture package consists of the following: Two chloride TiO2 manufacturing plants and all related facilities in Ashtabula, Ohio; other physical assets in North America, such as a research and development, and administrative support facility near Baltimore (“Baltimore Administration and Technical Center” or “BATC”) and research and development equipment located at BATC; the ability to hire the relevant Cristal personnel located in North America, including all employees at the Ashtabula complex and almost all of the support personnel located at BATC; transfer or license of all intellectual property right necessary to manufacture chloride TiO2 products at Ashtabula; an option, exercisable by Ineos during a ten-year period after closing, to acquire rights to use the licensed intellectual property to produce chloride TiO2 products at a new manufacturing facility outside North America; and customer contracts related to Cristal's chloride TiO2 sales in North America. The Order also provides that, during a discrete period, the Commission has a limited ability to modify the lists of excluded assets and retained employees if needed for Ineos to run the business effectively.

The Order requires that, at the request of Ineos, Tronox must provide transition assistance for a period of at least two years, and imposes other terms designed to ensure the viability of the divested business. The Commission also requires the parties to maintain all of the assets in the ordinary course of business pending divestiture to Ineos, and is issuing a separate Order to Maintain Assets at the time it accepts the Consent Agreement for public comment.

A Monitor will oversee Tronox's compliance with the obligations set forth in the Order, the Order to Maintain Assets, and the divestiture agreements. If Tronox does not fully comply with the divestiture requirements of the Order, the Commission may appoint a Divestiture Trustee to divest Cristal's North American TiO2 business and perform Tronox's other obligations consistent with the Order.

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

A. Solicitation of Public Comment

Written comments and suggestions from the public should address one or more of the following four points:

(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) 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;

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

(4) 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.

The FAR clause 16.203, Fixed-price contracts with economic price adjustment, and associated clauses at 52.216-2, 52.216-3, and 52.216-4, provide for upward and downward revision of the stated contract price upon occurrence of specified contingencies. In order for the contracting officer to be aware of price changes, the firm must provide pertinent information to the Government. The information is used to determine the proper amount of price adjustments required under the contract.

Respondents: 3,550.

Responses per Respondent: 214.

Annual Responses: 759,700.

Hours per Response: 1.5.

Total Burden Hours: 1,139,550.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW, Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0068, Economic Price Adjustment, in all correspondence.

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

In the Federal Register of July 20, 2006 (71 FR 41221), FDA announced the availability of a document entitled “Manufactured Food Regulatory Program Standards.” These program standards are the framework that States should use to design and manage their manufactured food programs. There are 43 State programs enrolled, which receive an average of $230,000 (maximum of $300,000) each year for a period of 5 years from the year they first enroll, provided there is significant conformance with and/or maintenance of the 10 standards.

In the first year of implementing the program standards, the State program conducts a baseline self-assessment to determine if it meets the elements of each standard. FDA suggests that the State program use the worksheets and forms contained in the draft program standards; however, it can use alternate forms that are equivalent. The State program maintains the documents and verifies records required for each standard. The information contained in the documents must be current and fit for use. If the State program fails to meet all program elements and documentation requirements of a standard, it develops a strategic plan which includes the following: (1) The individual element of documentation requirement of the standard that was not met, (2) improvements needed to meet the program element or documentation requirement of the standard, and (3) projected completion dates for each task.

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

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

This information collection supports Agency regulations, associated guidance, and Form FDA 3926 concerning individual patient expanded access. Individual patient expanded access allows an individual patient who has a serious or immediately life-threatening disease or condition and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition, the use of an investigational new drug (IND) outside of a clinical investigation, or the use of an approved drug where availability is limited by a risk evaluation and mitigation strategy. When applicable criteria in § 312.305(a) (21 CFR 312.305(a)) (which apply to all types of expanded access) and the criteria in § 312.310(a) (21 CFR 312.310(a)) (which apply specifically to individual patient expanded access, including for emergency use) are met, FDA may permit expanded access.

Section 312.305(b) sets forth the submission requirements for all types of expanded access requests. To assist respondents with requirements in § 312.305, we developed Form FDA 3926 (Individual Patient Expanded Access Investigational New Drug Application) and the guidance document entitled, “Individual Patient Expanded Access Applications: Form FDA 3926,” which are available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm and https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm432717.pdf, respectively.

The physician may satisfy some of the submission requirements by referring to information in an existing IND, ordinarily the one held by the investigational drug's manufacturer, if the physician obtains permission from that IND holder. If permission is obtained, the physician should then provide to FDA a letter of authorization (LOA) from the existing IND holder that permits FDA to reference that IND.

One of the requirements under § 312.305(b)(2) is that a “cover sheet” must be included “meeting the requirements of § 312.23(a).” This provision applies to several types of submissions under part 312 (21 CFR part 312), ranging from commercial INDs under § 312.23 that involve large groups of patients enrolled in clinical trials to requests from physicians to use an investigational drug for an individual patient. Sponsors currently use Form FDA 1571 for all types of IND submissions to meet the requirements in § 312.23(a).

Concerned that physicians requesting expanded access for an individual patient may encounter difficulty in completing Form FDA 1571 and the associated documents because the form is not tailored to requests for individual patient expanded access, we developed Form FDA 3926 to comply with the IND submission requirements in §§ 312.23, 312.305(b), and 312.310(b). Form FDA 3926 provides a streamlined means to request expanded access and is available for licensed physicians. FDA considers a completed Form FDA 3926 with the box in Field 10 checked and the form signed by the physician to be a request in accordance with § 312.10 for a waiver of any additional requirements in part 312 for an IND submission, including additional information currently provided in Form FDA 1571 and Form FDA 1572 (Statement of Investigator, which provides the identity and qualifications of the investigator conducting the clinical investigation).

Under § 312.310(d), in an emergency situation that requires the patient to be treated before a written submission can be made, the request to use the investigational drug for individual patient expanded access may be made by telephone (or other rapid means of communication) to the appropriate FDA review division. Authorization of the emergency use may be given by an FDA official over the telephone, provided the physician explains how the expanded access use will meet the requirements of §§ 312.305 and 312.310 and agrees to submit an expanded access application within 15 working days of FDA's initial authorization of the expanded access use (§ 312.310(d)). The physician may choose to use Form FDA 3926 for the expanded access application.

As explained in the instructions for Form FDA 3926 and discussed in the guidance document, the following information is submitted to FDA:

• Initials for the patient and date of submission.

• Type of submission (initial or followup submission).

• Clinical information, including indication, brief clinical history of the patient (age, gender, weight, allergies, diagnosis, prior therapy, response to prior therapy), and the reason for requesting the proposed treatment, including an explanation of why the patient lacks other therapeutic options.

• Treatment information, including the investigational drug's name and the name of the entity supplying the drug (generally the manufacturer), the applicable FDA review division (if known), and the treatment plan. This should include the planned dose, route and schedule of administration, planned duration of treatment, monitoring procedures, and planned modifications to the treatment plan in the event of toxicity.

• LOA, generally obtained from the entity that is the sponsor of the IND ( e.g., commercial sponsor/drug manufacturer) being referenced, if applicable.

• Physician's qualification statement. An appropriate statement includes medical school attended, year of graduation, medical specialty, State medical license number, current employment, and job title. Alternatively, the relevant portion of the physician's curriculum vitae may be attached.

• Physician's contact information, including name, physical address, email address, telephone number, facsimile number, and physician's IND number, if previously issued by FDA.

• Contents of submission (for followup/additional submissions), including the type of submission being made. FDA accepts Form FDA 3926 for certain followup/additional submissions, which include the following: Initial written IND safety report (§ 312.32(c)); followup to a written IND safety report (§ 312.32(d)); annual report (§ 312.33); summary of expanded access use (treatment completed) (§ 312.310(c)(2)); change in treatment plan (§ 312.30); general correspondence or response to FDA request for information (§ 312.41); and response to clinical hold (§ 312.42(e)).

• Request for authorization to use Form FDA 3926 for individual patient expanded access application.

• Signature of the physician certifying that treatment will not begin until 30 days after FDA receives the completed application and all required material unless the submitting physician receives earlier notification from FDA that the treatment may proceed. The physician agrees not to begin or continue clinical investigations covered by the IND if those studies are placed on clinical hold. The physician also certifies that informed consent will be obtained in compliance with Federal requirements (including FDA's regulations in 21 CFR part 50) and that an institutional review board (IRB) that complies with all Federal requirements (including FDA's regulations in 21 CFR part 56) will be responsible for initial and continuing review and approval of the expanded access use. The physician also acknowledges that in the case of an emergency request, treatment may begin without prior IRB approval, provided the IRB is notified of the emergency treatment within 5 working days of treatment. The physician agrees to conduct the investigation in accordance with all other applicable regulatory requirements.

In the Federal Register of November 7, 2018 (83 FR 55723), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

Based on a review of the information collection, we are retaining the currently approved burden estimate. The estimates for “number of respondents,” “number of responses per respondent,” and “total annual responses” were obtained from reports and data management systems from the Center for Drug Evaluation and Research (CDER) and from other sources familiar with the number of submissions received for individual patient expanded access use under part 312. The estimates for “average burden per response” were based on information CDER provided and personnel of the U.S. Department of Health and Human Services familiar with preparing and reviewing expanded access submissions by practicing physicians.

Based on data from the Document Archiving, Reporting, and Regulatory Tracking System for the number of submissions to FDA using FDA Form 3926 during fiscal years 2015, 2016, and 2017, we estimate that approximately 790 licensed physicians would use FDA Form 3926 to submit 1.46 requests per physician (respondent) for individual patient expanded access, for a total of 1,153 responses annually. Based on these estimates, FDA calculates the total annual responses to be 2,394 (1,153 requests for individual patient expanded access and 1,241 followup submissions) by 790 physicians for an average of 3.03 responses per respondent. FDA estimates the average burden per response to be 45 minutes (0.75 hour). Based on this estimate, FDA calculates the total burden to be 1,795 hours.

I. Background

Study data standards describe a standard way to exchange clinical and nonclinical research data between computer systems. These standards provide a consistent general framework for organizing study data, including templates for datasets, standard names for variables, and standard ways of doing calculations with common variables. Establishing common study data standards provides new opportunities to transform the vast, diverse, and continually increasing amount of clinical study data into useful information to speed the delivery of new therapies to patients. Having standard, uniform study data enables FDA scientists to combine data from multiple studies to explore many new research questions and gain new insights. Data standards also help FDA receive, process, review, and archive submissions more efficiently and effectively by preventing submission reviewers from having to navigate a high volume of less-structured data, which allows reviewers more time to focus on the scientific review.

The Center for Drug Evaluation and Research (CDER) established the Data Standards Program in 2010. The program has led CDER's efforts to standardize data and has helped FDA meet its commitments in the Prescription Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017 (PDUFA V). Accomplishments to date include the following: (1) Publication of a final guidance entitled “Providing Regulatory Submissions in Electronic Format—eCTD Specifications”; developing a repeatable test process to ensure data standards meet FDA needs; (2) working with FDA's Center for Biologics Evaluation and Research to compile a prioritized list of disease and therapeutic areas for which additional data standardization is needed; and (3) working with partners to develop a series of use cases for clinical study data related to Human Immunodeficiency Virus therapies, vaccines, and comparative clinical endpoint bioequivalence studies.

Standards models that span the data lifecycle from data collection ( e.g., Clinical Data Acquisition Standards Harmonization (CDASH)) to tabulated representation ( e.g., Standard for the Exchange of Nonclinical Data (SEND) and Study Data Tabulation Model (SDTM)) are foundational for analysis data standards ( e.g., Analysis Data Model (ADaM)). FDA is conducting this public workshop to support the PDUFA VI goals to advance the development and application of analysis data standards.

During the public workshop, speakers and participants will address a range of issues related to the development and implementation of analysis data standards. Items for discussion will include stakeholder experience implementing analysis data standards in electronic submissions. Input will be sought on the key challenges and opportunities to: (1) Improve the efficiency, predictability, and quality of data submissions; (2) support data traceability; and (3) support optimal implementation of analysis data standards. Input will also be sought on approaches to reduce the variability of formats used to submit study data, improve the integration of data across studies, and enable the use of data from sources other than traditional clinical trials.

Registration: To register for the public workshop, visit the following website: https://healthpolicy.duke.edu/events/analysis-data-standards-workshop. 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 workshop must register online by June 10, 2019, midnight Eastern Time. There will be no onsite registration. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Duke-Margolis will post on its website if registration closes before the day of the public workshop.

If you need special accommodations due to a disability, please contact Sarah Supsiri at the Duke-Margolis Center for Health Policy, 202-791-9561, sarah.supsiri@duke.edu, no later than June 5, 2019.

Streaming Webcast of the Public Workshop: This public workshop will also be webcast. Webcast participants will be able to submit questions and comments via the webcast portal. Following the workshop, archived video footage will be available on the Duke-Margolis website at https://healthpolicy.duke.edu/events/analysis-data-standards-workshop. Organizations are requested to register all participants, but to view using one connection per location whenever possible. Webcast participants will be sent technical system requirements in advance of the event. Before joining the streaming webcast of the public workshop, we recommend that you review these technical system requirements. 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 will not be available.

Workshop Materials: All event materials will be provided to registered attendees via email before the workshop and will also be publicly available on the Duke-Margolis website at https://healthpolicy.duke.edu/events/analysis-data-standards-workshop.

Comments

The information collection notice was previously published in the Federal Register on November 23, 2018, at 83 FR 60885, allowing for a 60-day public comment period. USCIS did receive 5 comments in connection with the 60-day notice.

You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2008-0012 in the search box. Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) 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;

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

(4) 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.

(1) Type of Information Collection Request: Extension, Without Change, of a Currently Approved Collection.

(2) Title of the Form/Collection: Application for Waiver of the Foreign Residence Requirement of Section 212(e) of the Immigration and Nationality Act.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: I-612; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. This information collection is necessary and may be submitted only by an alien who believes that compliance with foreign residence requirements would impose exceptional hardship on his or her spouse or child who is a citizen of the United States, or a lawful permanent resident; or that returning to the country of his or her nationality or last permanent residence would subject him or her to persecution on account of race, religion, or political opinion. Certain aliens admitted to the United States as exchange visitors are subject to the foreign residence requirements of section 212(e) of the Immigration and Nationality Act (the Act). Section 212(e) of the Act also provides for a waiver of the foreign residence requirements in certain instances.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection I-612 is 7,200 and the estimated hour burden per response is .333 hours.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 2,398 hours.

(7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $882,000.

I. This Notice

Section 8071 of the ”Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the ”SUPPORT for Patients and Communities Act” (Pub. L. 115-271, approved October 24, 2018) (the Act), the Secretary of HUD must establish a funding formula within 60 days of enactment to allocate whatever funds are appropriated “for assistance to States to provide individuals in recovery from a substance use disorder stable, temporary housing for a period of not more than 2 years or until the individual secures permanent housing, whichever is earlier”. The purpose of this notice is to establish this formula.

The Act has specific criteria that the Secretary must use to establish the formula. Those criteria first limit the number of eligible states  1 to receive funding to just those “States with an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate, according to the Centers for Disease Control and Prevention”. The national age adjusted overdose mortality rate in 2016 was 19.8 per 100,000 persons. There were 25 states, including the District of Columbia, above the national rate.

Among the eligible states, the Act requires that the formula to be needs based, with states having greater need getting more funding. The Act specifies that need be determined using the following criteria:

• The highest average rates of unemployment based on data provided by the Bureau of Labor Statistics for calendar years 2013 through 2017; with this factor weighted at 15 percent. To calculate this factor, HUD uses the Bureau of Labor Statistics Local Area Unemployment Statistics (LAUS) Annual Average Series data downloaded from https://www.bls.gov/lau/rdscnp16.htm on November 28, 2018.

• The lowest average labor force participation rates based on data provided by the Bureau of Labor Statistics for calendar years 2013 through 2017; with this factor weighted at 15%. For purposes of creating a variable that results in a larger number equaling the problem, HUD has calculated the highest average NON-participation in the labor force rate. This is calculated as the non-institutionalized population over age 16 less those employed and looking for work (unemployed). To calculate this factor, HUD uses the Bureau of Labor Statistics Local Area Unemployment Statistics (LAUS) Annual Average Series data downloaded from https://www.bls.gov/lau/rdscnp16.htm on November 28, 2018.

• The highest age-adjusted rates of drug overdose deaths based on data from the Centers for Disease Control and Prevention; with this factor weighted at 70 percent. The 2016 rates were downloaded from https://www.cdc.gov/drugoverdose/data/statedeaths.html on November 21, 2018.

The statute is specific that the data for the first two factors of the formula be from 2013 through 2017. The statute does not specify the currency of the data to be used for determining the eligible states as well as the third factor, overdose deaths. For this Notice, and for any funds that are appropriated in FY 2019 for allocation by this formula, HUD will use the 2016 overdose death rates that were available within 60 days of the law passing. If funds are appropriated in any year after FY 2019, HUD will redetermine eligible states and recalculate the formula using the most current data on drug overdose deaths available within 60 days of when funds are appropriated.

For the eligible states, including the District of Columbia, HUD is establishing the formula based on rates of problems rather than on shares of the count of problems. The specific formula is represented by the following equation, where the weight specifies what percent of the funds will be allocated on that specific variable:

At this time, no funds have been appropriated for this program. If funds are appropriated in FY 2019, the funds would be allocated based on the percentages shown in Table 1. Table 1 shows the percent allocated, in order of highest percent allocated to lowest among the 25 states and the District of Columbia that have an age-adjusted rate of drug overdose deaths that is above the national overdose mortality rate. For example, this allocation would provide 6.47 percent of whatever is allocated to West Virginia and 5.01 percent to the District of Columbia, the two states with the greatest need as measured by percent of problems described above.

This notice involves the establishment of a formula allocation and does not constitute a development decision affecting the physical condition of specific project areas or building sites. Accordingly, under 40 CFR 1508.4 of the regulations of the Council on Environmental Quality and 24 CFR 50.19(c)(6) of HUD's regulations, this notice is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).

Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any policy document that has federalism implications if the document either imposes substantial direct compliance costs on state and local governments and is not required by statute, or the document preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the executive order. This notice establishes a formula as required under the SUPPORT for Patients and Communities Act, for allocating funds to states, subject to appropriations. This notice also details the technical methods used in making said formula. As a result, this notice is not subject to review under the order.

The 2017 Tax Cuts and Jobs Act (Pub. L. 115-97) created new tax incentives for investments made in Opportunity Zones to spur economic development and job creation by encouraging long-term investment in low-income communities nationwide. Opportunity Zones are designated census tracts that provide incentives for long-term private sector investment in economically distressed communities. State executives nominated census tracts of communities most in need of private investment to the U.S. Department of the Treasury, which then certified the tracts as Opportunity Zones. The Opportunity Zone designation encourages investment in these certified census tracts by granting investors extensive Federal tax advantages for using their capital gains to finance new projects and enterprises (or substantially improve existing projects and enterprises) located within Opportunity Zones.

Executive Order 13853 created the White House Opportunity and Revitalization Council with the HUD Secretary (or the Secretary's designee) as the Chair. This Executive Order directs the Council to:

(a) Assess the actions each Federal agency can take under existing authorities to prioritize or focus Federal investments and programs on urban and economically distressed communities, including qualified opportunity zones;

(b) Assess the actions each agency can take under existing authorities to minimize all regulatory and administrative costs and burdens that discourage public and private investment in urban and economically distressed communities, including qualified opportunity zones;

(c) Regularly consult with officials from State, local, and tribal governments and individuals from the private sector to solicit feedback on how best to stimulate the economic development of urban and economically distressed areas, including qualified opportunity zones;

(d) Coordinate Federal interagency efforts to help ensure that private and public stakeholders—such as investors; business owners; institutions of higher education (including Historically Black Colleges and Universities, as defined by 50 U.S.C. 3224(g)(2), and tribally controlled colleges and universities, as defined by 25 U.S.C. 1801(a)(4)); K-12 education providers; early care and education providers; human services agencies; State, local, and tribal leaders; public housing agencies; non-profit organizations; and economic development organizations—can successfully develop strategies for economic growth and revitalization;

(e) Recommend policies that would:

(i) Reduce and streamline regulatory and administrative burdens, including burdens on applicants applying for multiple Federal assistance awards;

(ii) Help community-based applicants, including recipients of investments from qualified opportunity funds, identify and apply for relevant Federal resources; and

(iii) Make it easier for recipients to receive and manage multiple types of public and private investments, including by aligning certain program requirements;

(f) Evaluate the following:

(i) Whether and how agencies can prioritize support for urban and economically distressed areas, including qualified opportunity zones, in their grants, financing, and other assistance;

(ii) Appropriate methods for Federal cooperation with and support for States, localities, and tribes that are innovatively and strategically facilitating economic growth and inclusion in urban and economically distressed communities, including qualified opportunity zones, consistent with preserving State, local, and tribal control;

(iii) Whether and how to develop an integrated web-based tool through which entrepreneurs, investors, and other stakeholders can see the full range of applicable Federal financing programs and incentives available to projects located in urban and economically distressed areas, including qualified opportunity zones;

(iv) Whether and how to consider urban and economically distressed areas, including qualified opportunity zones, as possible locations for Federal buildings, through consultation with the General Services Administration;

(v) Whether and how Federal technical assistance, planning, financing tools, and implementation strategies can be coordinated across agencies to assist communities in addressing economic problems, engaging in comprehensive planning, and advancing regional collaboration; and

(vi) What data, metrics, and methodologies can be used to measure the effectiveness of public and private investments in urban and economically distressed communities, including qualified opportunity zones.

There are more than 8,700 Census tracts designated by a Governor or other chief administrative official as Opportunity Zones across all 50 States, the District of Columbia, and five U.S. territories. The following are relevant data and characteristics of the Opportunity Zones and those who reside within Opportunity Zones:

• Nearly 35 million Americans live in communities designated as Opportunity Zones.

• On average, the median family income in an Opportunity Zone is 37 percent below the State median.

• More than one-in-five of all Opportunity Zones have a poverty rate over 40 percent, compared to just over one-in-eight “low-income communities” (LICs) and one-in-20 Census tracts nationwide.

• 71 percent of Opportunity Zones meet the U.S. Treasury Department's definition of “severely distressed.”  1

• Life expectancy is on average three years shorter for Opportunity Zone residents than it is nationally.

• Approximately 22 percent of Opportunity Zone adult residents have not attained a high school diploma, compared to 13 percent nationally.

Below is a snapshot of HUD's programs and initiatives within Opportunity Zones. 2 These statistics are being provided in order to facilitate the public's thought process—as well as generate ideas and answers to the questions asked later in this request for information—regarding HUD's existing program presence within Opportunity Zones. Most numbers are rounded to the nearest thousand. Where percentages of the total are given, those percentages exclude data for which location is unreliable or misleading.

○ 2,394,000 persons living in HUD-assisted housing within Opportunity Zones, representing about 27 percent of residents of HUD-assisted housing.

○ 14 proposed EnVision Center sites inside or within 1 mile of an Opportunity Zone.

○ 371,000 public housing units within Opportunity Zones, representing about 38 percent of the total.

○ 738,000 persons living in public housing within Opportunity Zones, representing about 39 percent of the total.

○ 2,254 public housing developments within Opportunity Zones, or about 33 percent of the national total.

○ 465,000 housing choice voucher (HCV) units within Opportunity Zones, 22 percent of the total.

○ 992,000 persons with HCVs, or 21 percent of the national total, living within Opportunity Zones.

○ 62,000 project-based voucher (PBV) units within Opportunity Zones, which is 32 percent of the total.

○ 116,000 persons living in PBV units within Opportunity Zones, representing 32 percent of the total.

○ 65 Choice Neighborhood Grants—with a total of approximately $571,643,000 in grant funding—from 2010-2016 within Opportunity Zones. 3 These are 68 percent of all Choice Neighborhood Grants and 86 percent of national Choice Neighborhood Grant spending. 46 of these grants were Planning Grants, and the other 19 were Implementation Grants.

○ 337,000 project-based rental assistance (PBRA) units within Opportunity Zones, or 27 percent of the national total.

○ 548,000 persons living in PBRA units within Opportunity Zones, or 27 percent of the total.

○ 2,400 Multi-Family (MF) housing properties with Federal Housing Administration (FHA) mortgage insurance within Opportunity Zones, representing 21 percent of multifamily housing properties with FHA mortgage insurance.

○ $14,755,260,000 in unpaid principal balance for MF properties with FHA mortgage insurance within Opportunity Zones, for 17 percent of the national total.

○ 617,000 FHA-insured Single-Family properties within Opportunity Zones, or 8 percent of the total.

○ $75,353,474,000 in unpaid principal balance for Single-Family properties with FHA mortgage insurance within Opportunity Zones, or 6 percent of all Single-Family unpaid principal balance.

○ 536 healthcare facilities with FHA mortgage insurance in Opportunity Zones, representing 12 percent of all such facilities.

○ $4,017,448,000 in unpaid principal balance for healthcare facilities with FHA insurance in Opportunity Zones, representing 12 percent of the total unpaid principal balance on FHA-insured mortgages on healthcare facilities.

○ Almost one-third of Rental Assistance Demonstration (RAD) Component 1 conversions fall within Opportunity Zones.

○ Over 1,200 cities, urban counties, States, Puerto Rico, and U.S. Territories received over $3,000,000,000 in Community Development Block Grant (CDBG) funding each year between fiscal years 2014 and 2019. Since all communities can potentially receive CDBG funding, either directly from HUD or through their respective State government, funds could be used to assist activities and projects in Opportunity Zones nationwide.

○ There are 600 outstanding Section 108 guaranteed loans with an outstanding loan balance of $1,250,000,000 for community and economic development projects nationwide. Under the Section 108 Loan Guarantee Program, CBDG grantees nationwide have approximately $14 billion in available borrowing capacity that could potentially be deployed in Opportunity Zones.

○ Approximately $84,000,000,000 in Community Development Block Grant—Disaster Recovery (CDBG-DR) funds has been awarded since 2001 to help cities, counties, and States recover from Presidentially-declared disasters. Nearly half of this amount has been awarded in response to disasters occurring between 2015 and 2017. Since CDBG-DR assistance may fund a broad range of recovery activities, these funds could be used in eligible disaster-impacted Opportunity Zones.

○ 256,000 HOME Investment Partnerships Program (HOME) housing projects completed—with a total of approximately $2,853,095,000 in grant funds expended—from 1996-2018 within Opportunity Zones.

○ There are 186 Opportunity Zones within HUD's 14 Urban Promise Zones.

○ An approximate numerical breakdown of Opportunity Zones throughout HUD's 10 regions:

HUD has determined that it should undertake a substantive review of existing policies, practices, planned actions, regulations and guidance regarding HUD-administered programs to identify actions HUD can take to encourage beneficial investment in urban and economically distressed communities, including Opportunity Zones, while continuing to fulfill its mission to create strong, sustainable, inclusive communities and quality affordable homes for all. In conducting this review, HUD believes that it would benefit from the information and perspectives of State, local and tribal officials, experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole. HUD is, therefore, requesting information to guide and enhance this review.

To assist in HUD's approach to Opportunity Zones, HUD invites ideas and information on the following questions:

(1) How should HUD use its existing authorities to maximize the beneficial impact of public and private investments in urban and economically distressed communities, including Opportunity Zones? For example:

a. What actions can HUD take under existing authorities to prioritize or focus Federal investments and programs on urban and economically distressed communities, including Opportunity Zones?

b. What actions can HUD take under existing authorities to minimize all of the regulatory and administrative costs and burdens that discourage public and private investment in urban and economically distressed communities, including Opportunity Zones?

c. What tools can HUD provide to make local communities, investors and other stakeholders more aware of the full range of applicable Federal financing programs and incentives available to projects located in urban and economically distressed areas, including Opportunity Zones?

d. What polices could HUD implement that would help community-based applicants, including recipients of investments from Qualified Opportunity Funds, identify and apply for relevant Federal resources?

e. What policies could HUD implement that would make it easier for recipients to receive and manage multiple types of public and private investments, including by aligning certain program requirements?

(2) HUD is considering creating an information portal on Opportunity Zones. What types of information should HUD include in such a tool? How can it be made accessible to and most usable by HUD's various stakeholders and customers? If the portal includes information on Federal financing programs and incentives beyond those offered by HUD, what types of information would be most useful to include?

(3) In what ways could HUD structure preference points for Opportunity Zones and incorporate policy objectives in the rating factors for applications in discretionary grant competitions to increase the incentive to invest in Opportunity Zones? In addition, how should HUD prioritize support for urban and economically distressed areas, including Opportunity Zones, in its grants, financing, and other assistance?

(4) What types of technical assistance should be offered through HUD?

(5) What role can HUD play in helping to ensure that existing residents, businesses, and community organizations in Opportunity Zones benefit from the influx of investment and remain the focus of their community's growth moving forward?

(6) How can HUD properly evaluate the impact of Opportunity Zones on communities?

(7) How should HUD interact with other stakeholders to maximize the success of the Opportunity Zone incentive? For example:

a. How should HUD interact with officials from State, local, and tribal governments, institutions, local and regional agencies, businesses, and individuals from the private sector to most effectively encourage beneficial investment in urban and economically distressed areas?

b. How should HUD participate in Federal interagency efforts to help ensure that private and public stakeholders can successfully develop strategies for economic growth and revitalization in urban and economically distressed areas? Stakeholders might include investors; business owners; institutions of higher education (including Historically Black Colleges and Universities, as defined by 50 U.S.C. 3224(g)(2), and tribally controlled colleges and universities, as defined by 25 U.S.C. 1801(a)(4)); K-12 education providers; early care and education providers; human services agencies; State, local, and tribal leaders; public housing agencies; non-profit organizations; and economic development organizations.

c. How should Federal technical assistance, planning, financing tools, and implementation strategies be coordinated across agencies to assist communities in addressing economic problems, engaging in comprehensive planning, and advancing regional collaboration?

(8) How might Qualified Opportunity Fund investments support the goal of ending homelessness?

(9) Are there other aspects of Opportunity Zones that should be considered and are not addressed in this request for information?

I. Background

Division G, Title II of the Consolidated Appropriations Act, 2019 requires that the HUD Secretary, for the calendar year 2019 funding cycle, provide renewal funding for each public housing agency (PHA) based on validated voucher management system (VMS) leasing and cost data for the prior calendar year and by applying an inflation factor as established by the Secretary, by notice published in the Federal Register . This notice announces the availability of the FY 2019 inflation factors and describes the methodology for calculating them. Tables in PDF and Microsoft Excel formats showing Renewal Funding Inflation Factors (RFIFs) by HUD Fair Market Rent Area are available electronically from the HUD data information page at: https://www.huduser.gov/portal/datasets/rfif/rfif.html.

RFIFs are used to adjust the allocation of HCV program funds to PHAs for local changes in rents, utility costs, and tenant incomes. To calculate the RFIFs, HUD first forecasts a national inflation factor, which is the annual change in the national average Per Unit Cost (PUC). HUD then calculates individual area inflation factors, which are based on the annual changes in the two-bedroom Fair Market Rent (FMR) for each area. Finally, HUD adjusts the individual area inflation factors to be consistent with the national inflation factor.

HUD's forecast of the national average PUC is based on forecasts of gross rent and tenant income. Each forecast is produced using historical and forecasted macroeconomic data as independent variables, where the forecasts are consistent with the Economic Assumptions of the Administration's FY 2019 Budget. The forecast of gross rent is itself based on forecasts of the Consumer Price Index (CPI) Rent of Primary Residence Index and the CPI Fuels and Utilities Index. Forecasted values of these series are applied to the FY 2019 national average two-bedroom FMR to produce a CY 2019 value. A “notional” PUC is calculated as the difference between gross rent value and 30 percent of tenant income (the standard for tenant rent contribution in the voucher program). The change between the forecasted CY 2019 notional PUC and the CY 2018 notional PUC is the expected national change in PUC, or 4.00 percent. HUD uses a notional PUC as opposed to the actual PUC to project costs that are consistent with PHAs leasing the same number and quality of units. For more information on HUD's forecast methodology, see 82 FR 26710.

In cases where the FY 2019 FMR is not based on an ad hoc rent survey, the inflation factor for an individual geographic area is based on the annualized change in the area's FMR between FY 2018 and FY 2019. These changes in FMRs are then scaled such that the voucher-weighted average of all individual area inflation factors is equal to the national inflation factor, i.e., the expected annual change in national PUC from CY 2018 to CY 2019, and such that no area has a factor less than one. For PHAs operating in multiple FMR areas, HUD calculates a voucher-weighted average inflation factor based on the count of vouchers in each FMR area administered by the PHA as captured in HUD administrative data as of December 31, 2018.

In 2018, HUD sought comment on potential alternatives to calculate renewal funding inflation factors for areas with an FMR that is based on an ad hoc rent survey (see FR-6099-N-01). In recent years, the use of surveys has resulted in large inflation factors in the first year an ad hoc survey is used in the FMR calculation, followed by much smaller inflation factors even as the underlying survey remains in effect. Commenters generally stressed the importance of including ad hoc surveys in the inflation factor calculation to ensure agencies that face higher per unit costs also receive higher funding. Therefore, HUD is continuing to use its existing methodology of incorporating ad hoc surveys in the calculation of inflation factors. HUD will also track and evaluate the impacts of very large increases in inflation factors.

HUD subsequently applies the calculated individual area inflation factors to eligible renewal funding for each PHA based on VMS leasing and cost data for the prior calendar year.

As explained above, inflation factors based on area FMR changes are produced for all FMR areas and applied to eligible renewal funding for each PHA. The tables showing the RFIFs, available electronically from the HUD data information page, list the inflation factors for each FMR area on a state-by-state basis. The inflation factors use the same OMB metropolitan area definitions, as revised by HUD, that are used in the FY 2019 FMRs. PHAs should refer to the Area Definitions Table on the following web page to make certain that they are referencing the correct inflation factors: http://www.huduser.org/portal/datasets/rfif/FY2019/FY2019_RFIF_FMR_AREA_REPORT.pdf. The Area Definitions Table lists areas in alphabetical order by state, and the counties associated with each area. In the six New England states, the listings are for counties or parts of counties as defined by towns or cities. HUD is also releasing the data in Microsoft Excel format to assist users who may wish to use these data in other calculations. The Excel file is available at https://www.huduser.gov/portal/datasets/rfif/rfif.html. Note that, as described earlier, the actual renewal funding inflation factor applied to agency funding will be the voucher-weighted average of the FMR area factors when the PHA operates in multiple areas.

This notice involves a statutorily required establishment of a rate or cost determination which 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 U.S. Fish and Wildlife Service, invite the public to comment on applications for permits under section 10(a)(1)(A) of the Endangered Species Act, as amended (ESA; 16 U.S.C. 1531 et seq. ). The requested permits would allow the applicants to conduct activities intended to promote recovery of species that are listed as endangered under the ESA.

With some exceptions, the ESA prohibits activities that constitute take of listed species unless a Federal permit is issued that allows such activity. The ESA's definition of “take” includes such activities as pursuing, harassing, trapping, capturing, or collecting in addition to hunting, shooting, harming, wounding, or killing.

A recovery permit issued by us under section 10(a)(1)(A) of the ESA authorizes the permittee to conduct activities with endangered or threatened species for scientific purposes that promote recovery or for enhancement of propagation or survival of the species. These activities often include such prohibited actions as capture and collection. Our regulations implementing section 10(a)(1)(A) for these permits are found in the Code of Federal Regulations (CFR) at 50 CFR 17.22 for endangered wildlife species, 50 CFR 17.32 for threatened wildlife species, 50 CFR 17.62 for endangered plant species, and 50 CFR 17.72 for threatened plant species.

Proposed activities in the following permit requests are for the recovery and enhancement of propagation or survival of the species in the wild. The ESA requires that we invite public comment before issuing this permit. Accordingly, we invite local, State, Tribal, and Federal agencies and the public to submit written data, views, or arguments with respect to this application. The comments and recommendations that will be most useful and likely to influence agency decisions are those supported by quantitative information or studies.

Written comments we receive become part of the administrative record associated with this action. 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 request in your comment that we withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.

If we decide to issue a permit to the applicants listed in this notice, we will publish a notice in the Federal Register.

We publish this notice under section 10(c) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq. ).

The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of ICON Health & Fitness, Inc. on April 11, 2019. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain cardio-strength training magnetic-resistance cable exercise machines and components thereof. The complaint names as respondents: Nautilus, Inc. of Vancouver, WA; and ZheJiang Lixuan Health Technology Co., Ltd. a/k/a Zhejiang Arcanapower Health Technology Co., Ltd. a/k/a Arcana Power Co., Ltd. of China. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders, and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).

Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.

In particular, the Commission is interested in comments that:

(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;

(ii) Identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;

(iii) Identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;

(iv) Indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and

(v) Explain how the requested remedial orders would impact United States consumers.

Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the Federal Register . There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation. Any written submissions on other issues should be filed no later than by close of business nine calendar days after the date of publication of this notice in the Federal Register . Complainant may file a reply to any written submission no later than the date on which complainant's reply would be due under § 210.8(c)(2) of the Commission's Rules of Practice and Procedure (19 CFR 210.8(c)(2)).

Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3380”) in a prominent place on the cover page and/or the first page. ( See Handbook for Electronic Filing Procedures, Electronic Filing Procedures  1 ). Persons with questions regarding filing should contact the Secretary (202-205-2000).

Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel  2 , solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS. 3

This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).

The Commission instituted this investigation on October 12, 2018, based on a complaint filed by Fisher & Paykel Healthcare Limited of Auckland, New Zealand (“F&P”). 83 FR 51705 (Oct. 12, 2018). The complaint alleged violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 in the importation, sale for importation, and the sale within the United States after importation of certain obstructive sleep apnea treatment mask systems and components thereof by reason of the infringement of certain claims of U.S. Patent Nos. 9,333,315; 9,517,317; 9,539,405; 9,907,925; and 9,974,914. The notice of investigation named as respondents ResMed Corp. and ResMed Inc., both of San Diego, California; and ResMed Limited of Bella Vista, Australia (collectively, “ResMed”). The Office of Unfair Import Investigations did not participate in this investigation.

On February 22, 2019, the parties jointly moved to terminate the investigation based upon settlement.

On March 18, 2019, the presiding ALJ granted the motion as the subject ID (Order No. 10). The ID finds that the motion complies with Commission Rule 210.21, see 19 CFR 210.21(a)-(b), and that the settlement agreement will not adversely affect the public interest, 19 CFR 210.50(b)(2). ID at 1-2.

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 has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Current Lighting Solutions, LLC, General Electric Co., and Consumer Lighting (U.S.), LLC d/b/a GE Lighting on April 11, 2019. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain LED packages containing PFS phosphor and products containing same. The complaint names as respondents: Cree, Inc. of Durham, NC; Cree Hong Kong Ltd. of Hong Kong; and Cree Huizhou Solid State Lighting Co. Ltd. of China. The complainant requests that the Commission issue a limited exclusion order, cease and desist orders, and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).

Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.

In particular, the Commission is interested in comments that:

(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;

(ii) Identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;

(iii) Identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;

(iv) Indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and

(v) Explain how the requested remedial orders would impact United States consumers.

Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the Federal Register . There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation. Any written submissions on other issues should be filed no later than by close of business nine calendar days after the date of publication of this notice in the Federal Register . Complainant may file a reply to any written submission no later than the date on which complainant's reply would be due under § 210.8(c)(2) of the Commission's Rules of Practice and Procedure (19 CFR 210.8(c)(2)).

Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3379”) in a prominent place on the cover page and/or the first page. ( See Handbook for Electronic Filing Procedures, Electronic Filing Procedures  1 ). Persons with questions regarding filing should contact the Secretary (202-205-2000).

Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel  2 , solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.  3

This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

Overview of this information collection:

(1) Type of Information Collection: Extension, without change, of a currently approved collection.

(2) The Title of the Form/Collection: Voluntary Magazine Questionnaire for Agencies/Entities Who Store Explosive Materials.

(3) The agency form number, if any, and the applicable component of the Department sponsoring the collection:

Form number: None.

Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.

(4) Affected public who will be asked or required to respond, as well as a brief abstract:

Primary: State, Local, or Tribal Government.

Other: None.

Abstract: This information collection is used to identify the number and locations of public explosives storage facilities (magazines), which will enable ATF to respond properly to local emergencies such as natural disasters.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 1,000 respondents will respond to this information collection, and it will take each respondent approximately 30 minutes to complete their responses.

(6) An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 500 hours, which is equal to 1,000 (# of respondents) * 1 (# of responses per respondent) * .5 (30 minutes).

If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 3E.405A, Washington, DC 20530.

Final Determination of Royalty Distribution I. Introduction

The Copyright Royalty Judges (Judges) initiated the captioned proceedings to determine proper distribution of royalties deposited with the Library of Congress for retransmission of broadcast signals by cable and satellite during the years 2004-2009 and 1999-2009, respectively. 1 See 78 FR 50113 (Aug. 16, 2013) (cable retransmissions); and 78 FR 50114 (Aug. 16, 2013) (satellite retransmissions). In the Program Suppliers category, controversies exist between MPAA-represented Program Suppliers (MPAA) and Worldwide Subsidy Group LLC d/b/a Independent Producers Group (IPG). In the Devotional category, controversies exist between the Settling Devotional Claimants (SDC)  2 and IPG. The Judges determine the funds shall be distributed as follows:

After accounting for administrative fees, the Copyright Office Licensing Division shall distribute remaining funds, together with interest accrued on each fund balance, in such a way as to effect these distribution percentages as if they had been determined on the day following each royalty deposit and continuing until the date of each partial distribution.

The Judges make this determination for the following reasons.

The Judges initiated this Phase II proceeding  3 on August 16, 2013, and held a preliminary hearing to resolve disputes over the validity and categorization of claims on December 8-16, 2014. The Judges issued an order resolving claims disputes on March 13, 2015. See Memorandum Opinion and Ruling on Validity and Categorization of Claims (Mar. 13, 2015) ( Claims Ruling ). 4 The Judges held a hearing from April 13-17, 2015, in which they received evidence and expert testimony concerning the proper distribution of royalties in the categories at issue in this proceeding. In accordance with 37 CFR 351.12, at the conclusion of the hearing and after closing arguments of counsel, the Chief Judge announced the end of presentation of evidence and closed the record, apart from allowing an exception for parties to file corrected and redacted exhibits in accordance with the Judges' rulings during the hearing and after the hearing based on filed and pending evidentiary motions. See 4/17/15 Tr. at 285.

After considering the entire record in the proceeding, the Judges found that no party had “presented a methodology and data that, together, are sufficient to support a final distribution in the contested categories.” Order Reopening Record and Scheduling Further Proceedings, at 1 (May 4, 2016) ( Order Reopening Record ). The Judges set aside the participants' evidence, reopened the record, and directed the parties to present additional evidence and expert opinion. 5 Id. at 2. The Judges permitted the participants to reintroduce any previously-introduced evidence and to designate prior testimony in accordance with 37 CFR 351.4(b)(2). Id. at 8.

The participants filed Written Direct Statements (WDSs) in the reopened proceeding on August 22, 2016. Shortly thereafter, the SDC filed a notice consenting to distribution of satellite royalties in the Devotional category in accordance with IPG's proposed royalty shares. See Notice of Consent to 1999-2009 Satellite Shares Proposed By Independent Producers Group and Motion for Entry of Distribution Order (Aug. 26, 2016) (Notice and Motion). IPG responded by opposing the Notice and Motion and filing an Amended WDS (AWDS) in which its economic expert, Dr. Charles Cowan, revised his written report and changed his proposed royalty shares. In response to motions by the SDC and MPAA, the Judges struck IPG's AWDS for failing to comply with the Judges' procedural rules. See Order Granting MPAA and SDC Motions to Strike IPG Amended Written Direct Statement and Denying SDC Motion for Entry of Distribution Order (Oct. 7, 2016) ( Oct. 7 Order ). 6 Specifically, the Judges determined that IPG could not file its AWDS as of right, had failed to file a motion requesting leave to file an AWDS, and failed to explain how its AWDS differed from its WDS. See id. at 3-4. IPG subsequently sought leave to file an AWDS, renewing the arguments it had made in opposition to the SDC's and MPAA's motions to strike. The SDC and MPAA opposed IPG's motion. The Judges accepted IPG's AWDS and granted the SDC and MPAA an additional opportunity to conduct discovery related to the AWDS. See Order on IPG Motion for Leave to File Amended Written Direct Statement (Jan. 10, 2017) ( Jan. 10 Order ). 7

The SDC and MPAA filed Written Rebuttal Statements (WRSs) on December 15, 2017, in accordance with the Judges' procedural schedule. IPG elected not to file a WRS, filing a “notice” instead. IPG had initiated a collateral attack on the Judges' interlocutory Claims Ruling in U.S. District Court on December 8, 2017, and was seeking a temporary restraining order to stay this proceeding. 8 In addition, IPG had filed a motion on December 11, 2017, with the Judges seeking a stay of their proceeding. Neither of those motions had been resolved as of the due date for WRSs. 9 IPG thus did not submit or seek admission of any rebuttal testimony in the reopened proceeding.

Shortly before the scheduled rehearing in the reopened proceeding, MPAA and the SDC filed a joint Motion in Limine and Motion for Summary Disposition seeking to exclude all exhibits proposed by IPG and to conclude the proceeding summarily. See Order Granting in Part Joint Motion in Limine and Denying Joint Motion for Summary Judgment, at 1 (Apr. 6, 2018) ( Order on Motion in Limine ). The moving parties sought to exclude the written direct testimony  10 of Dr. Cowan, IPG's expert (and sole) witness, because he would not be available to testify in person, and would not, therefore, be subject to cross-examination by opposing counsel. 11 The moving parties sought to exclude the remaining IPG exhibits, which consisted entirely of designated prior testimony of witnesses in past distribution proceedings, because IPG failed to comply with the Judges' procedural rule governing submission of designated prior testimony. 12 Id. at 2. The Judges excluded Dr. Cowan's written testimony and all of IPG's proffered exhibits, except to the extent that IPG might use the testimony and exhibits in cross-examining MPAA's and the SDC's witnesses. Id. at 2-3, 5; 4/9/18 Tr. 146-47 (Barnett, C.J.).

The Judges construed the moving parties' request for summary disposition as a request to conduct a paper proceeding in accordance with 17 U.S.C. 803(b)(5)(B). The Judges denied the request, concluding that, in light of the failure of proofs by all parties that necessitated the reopened proceeding, it would be appropriate for the Judges to take live testimony, and allow IPG to cross-examine witnesses, in order to determine whether the moving parties' respective second attempts at constructing distribution methodologies were adequate. Order on Motion in Limine, at 4.

The Judges held a hearing in the reopened proceeding on April 9-10, 2018, and heard closing arguments on May 24, 2018. The record now before the Judges consists of the oral testimony of the witnesses presented by MPAA and the SDC at that hearing, together with all exhibits admitted at the hearing (including any properly designated testimony from the earlier hearing or prior proceedings). IPG did not present any witnesses, and, pursuant to the Order on Motion in Limine, the Judges admitted no IPG exhibits.

The Judges issued an Initial Determination on January 22, 2019. No participant filed a timely petition for rehearing. Consequently, this Final Determination is identical in substance to the Initial Determination.

The Copyright Act does not contain a statutory standard for apportioning cable and satellite royalty funds among claimants. The Judges and their predecessors, however, have long held that royalties should be awarded in accordance with the relative marketplace value of the programming. See Distribution of the 2000, 2001, 2002 and 2003 Cable Royalty Funds: Final Distribution Order, 78 FR 64984, 64986 (Oct. 30, 2013) ( 2000-03 Cable Determination ). 13 Pursuant to 17 U.S.C. 803(a)(1), the Judges act “in accordance with” these prior decisions. The Judges look to “hypothetical, simulated, or analogous markets” to assess relative marketplace value, since there is no actual, unregulated marketplace for retransmission of broadcast signals by cable and satellite. 2000-03 Cable Determination, 78 FR at 64986.

Under applicable precedent, the Judges are not required to identify a methodology that would allow them to distribute cable and satellite royalties with “mathematical precision.” Id. (citing National Ass'n of Broadcasters v. Librarian of Congress, 146 F.3d 907, 929 (D.C. Cir. 1998)). The Judges' distribution determinations must instead lie within a “zone of reasonableness.” See National Ass'n of Broadcasters, 146 F.3d at 929; see also Asociacion de Compositores y Editores de Musica Latino Americana v. Copyright Royalty Tribunal, 854 F.2d 10, 12 (2d Cir. 1988) (recognizing “zone of reasonableness” standard in Phase II royalty distribution proceedings); Christian Broadcasting Network, Inc. v. Copyright Royalty Tribunal, 720 F.2d 1295, 1304 (D.C. Cir. 1983).

IPG vigorously attacked the use of viewership evidence for determining relative market value of programming. Since both MPAA and the SDC utilize methodologies based on viewership evidence, the Judges consider these arguments together, before considering the methodologies individually.

Expert witnesses for MPAA and the SDC testified that relative viewership is an appropriate metric for determining relative marketplace value in this proceeding. See Written Direct Testimony of Erkan Erdem, Trial Ex. 7000, at 8-9, 12 (Erdem WDT); Written Direct Testimony of Jeffrey S. Gray, Trial Ex. 8002, ¶¶ 17-18 (Gray WDT); and Written Direct Testimony of John S. Sanders, Trial Ex. 7001, at 21 (Sanders WDT). MPAA and the SDC both argue that the Judges have previously relied on viewership evidence to apportion royalties among copyright owners in Phase II distribution proceedings. See SDC PFF ¶ 24 (citing 2000-03 Cable Determination and Distribution of 1998 and 1999 Cable Royalty Funds, 80 FR 13423 (Mar. 13, 2015) ( 1998-99 Phase II Cable Determination )); MPAA PCOL ¶ 15 (citing 2000-03 Cable Determination ).

IPG, on the other hand, argues that the Judges are barred by precedent from determining relative marketplace value based on viewership evidence. See, e.g., IPG PFF ¶ 132. IPG bases its argument on the rejection of viewing evidence by a Copyright Arbitration Royalty Panel (CARP) in the 1998-99 Phase I cable royalty distribution proceeding, and the Librarian of Congress' statement in his opinion adopting the panel decision that “[t]he Nielsen study was not useful because it measured the wrong thing.” Final Order, Docket No. 2001-8 CARP CD 98-99, 69 FR 3606, 3613 (Jan. 26, 2004) ( 1998-99 Librarian Order ). IPG has made the same argument in past Phase II proceedings. See, e.g., IPG PFF, Docket No. 2008-1 CRB CD 98-99 (Phase II), at 32 (Sept. 23, 2014); and IPG PFF in connection with Program Suppliers Category, Docket No. 2008-2 CRB CD 2000-2003 (Phase II), at 32 (June 14, 2013). The Judges have rejected IPG's argument on each occasion, see, e.g., Distribution of 1998 and 1999 Cable Royalty Funds, 80 FR 13423, 13433 (Mar. 13, 2015) ( 1998-99 Phase II Cable Determination ); 2000-03 Cable Determination, 78 FR at 64995, and do so again in this proceeding.

The Copyright Act requires the Judges to act “on the basis of prior determinations and interpretations of the Copyright Royalty Tribunal, Librarian of Congress, the Register of Copyrights, copyright arbitration royalty panels . . ., and the Copyright Royalty Judges . . . .” 17 U.S.C. 803(a)(1). As the Judges have recently had occasion to confirm, the 1998-99 Librarian Order and the CARP report that it adopted are in the nature of “ `precedent' that the Judges must consider . . . .” Initial Determination of Royalty Allocation, Docket No. 14-CRB-0010-CD (2010-13), at 96 (Oct. 18, 2018) ( 2010-13 Cable Allocation Determination ) (footnote omitted). 14 However, the Judges conclude, consistent with 1998-99 Phase II Cable Determination and the 2000-03 Cable Determination, that those prior decisions in no way preclude the Judges from accepting a distribution methodology founded on Nielsen viewing data.

The Judges have ruled in more recent proceedings that measurements of viewership are relevant to determining relative market value. See 2010-13 Cable Allocation Determination at 97; 1998-99 Phase II Cable Determination, 80 FR at 13433; and 2000-03 Cable Determination, 78 FR at 64995. “[V]iewership can be a reasonable and directly measurable metric for calculating relative market value in cable distribution proceedings. Indeed . . . viewership is the initial and predominant heuristic that a hypothetical CSO would consider in determining whether to acquire a bundle of programs for distant retransmission . . ..” 2000-03 Cable Determination, 78 FR at 64995. Put another way, a CSO's demand for programming derives from consumers' desire to view the programming.

2010-13 Cable Allocation Determination, at 97 (footnote omitted); see also Erdem WDT at 8-9; 4/9/18 Tr. 90-91, 94 (Erdem).

The cases that IPG cites stand for the proposition that the Judges decline to apportion royalties among program categories solely based on viewership studies. As the Judges clarified recently, they do so, not because those studies “measure[] the wrong thing,” but because, standing alone, they are “inadequate” measures of relative value when comparing heterogeneous program categories. 2010-13 Cable Allocation Determination, at 118. In the 2010-13 proceeding, the parties presented evidence that “cable operators will pay substantially more for certain types of programming than for other programming with equal or higher viewership.” Id. Evidence of viewership alone fails adequately to “explain the premium that certain types of programming can demand in the marketplace.” Id. Consequently, the Judges have looked to other evidence, such as CSO surveys and fee-based regression analyses, to inform their allocation of funds among categories.

As the D.C. Circuit has acknowledged, however, “different considerations apply in Phase I and Phase II proceedings.” Indep. Producers Grp. v. Librarian of Congress, 792 F.3d 132, 142 (D.C. Cir. 2015) ( IPG v. Librarian ); see also Distribution of 1993, 1994, 1995, 1996 and 1997 Cable Royalty Funds, 66 FR 66433, 66453 (Dec. 6, 2001) (allocation methodology used in Phase I proceeding “does not translate well to a Phase II proceeding dealing with one program category”) ( 93-97 Librarian Order ). In a Phase II (or distribution phase) proceeding, the Judges must apportion royalties among relatively homogenous programs within a program category. The “premium” that some categories of programming can demand, irrespective of their levels of viewership, does not enter into the picture when all of the programs are in the same category. Thus, in distribution phase proceedings, the Judges have determined and continue to determine relative marketplace value based on evidence of viewership.

That is not to say that viewership evidence alone is an optimal means of determining relative market value. The Judges have acknowledged that viewership evidence may be “subject to marginal adjustments needed to maximize subscribership.” 2000-03 Cable Determination, 78 FR at 64995. Nevertheless, the Judges have found viewership evidence to be an acceptable alternative in the absence of evidence “by which to establish the relative marketplace values of . . . programs in the optimal theoretical manner.” 1998-99 Phase II Cable Determination, 80 FR at 13432. The Judges may, however, make appropriate adjustments to proposed allocations based on viewership evidence, provided those adjustments are supported by other record evidence.

In short, the authorities on which IPG relies—the 1998-99 Librarian Order and the CARP report that it adopted—are not on point. The Judges will follow the precedents from Phase II distribution cases and consider viewership evidence in apportioning royalties among programs within programming categories.

MPAA's proposed apportionment of royalties in the Program Suppliers category is in proportion to the respective number of hours that cable and satellite subscribers viewed MPAA-represented and IPG-represented programs on a distant basis. See Gray WDT at 4. Generally, MPAA added the hours of distant viewing of MPAA-represented programs and divided by the total number of distant viewing hours for both MPAA- and IPG-represented programs to determine the MPAA share. See id. ¶ 49.

MPAA's expert, Dr. Gray, derived levels of distant viewing from three types of Nielsen data: Local ratings viewing data  15 collected from meters recording from 2000 to 2009; distant viewing data from viewer diaries recorded from 2000 to 2003; and distant viewing household metered data from 2008 to 2009. See id. ¶¶ 29-31. Because of cost considerations in obtaining the Nielsen and Gracenote data for all stations distantly retransmitted by CSOs and satellite carriers in every royalty year, for most of the royalty years, Dr. Gray selected a sample of stations retransmitted by CSOs and satellite carriers based on a stratified random sampling methodology. 16 See id. ¶ 26. Dr. Gray used data from Gracenote, Inc. 17 and program logs from the Canadian Radio-television and Telecommunications Commission (CRTC) to identify compensable MPAA and IPG programming carried on the sample stations. See id. ¶¶ 32, 35.

MPAA did not supply Dr. Gray with Nielsen custom analyses 18 of distant viewing for all of the years covered in this proceeding. See Gray WDT ¶ 28 (“both due to cost and time, among other constraints, custom analyses of certain types of Nielsen data were not available for all royalty years”). Because he did not have distant household viewing data for every year, Dr. Gray devised a methodology to predict levels of distant viewing using the data that MPAA made available to him. He “establish[ed] a mathematical relationship between local ratings and distant viewing levels for the years the data are available” and “extrapolate[d] that mathematical relationship using a regression analysis to estimate distant viewing for all compensable programs each year . . ..” Gray WDT ¶ 36; see also id. ¶ 47 (regression calculates “mathematical relationship between distant viewing and (1) local ratings for the program, (2) the total number of distant subscribers of that station, (3) the time of day the program aired by quarter hour, (4) the type of program aired, (5) the station affiliation the program aired on, and (6) the aggregate total fees paid by CSOs or satellite carriers in [sic] year the program aired”). Dr. Gray then replaced the actual viewing data with the values for distant viewership his regression model predicted, to compute viewership (and thus royalty) shares. See id. ¶ 49.

IPG argued that the Judges should reject MPAA's methodology because Dr. Gray relied on an “unreasonably small amount of data”  19 in computing royalty shares. IPG PCL ¶ 134; s ee id. ¶¶ 19-22. Specifically, IPG argued that Dr. Gray failed to supplement his original methodology with enough additional data to overcome the Judges' earlier objection  20 that his proposed royalty shares were supported by insufficient data. See IPG PFF ¶¶ 20-22. IPG stated that “[i]n response to the Order Reopening Record, the only change to Gray's analysis was the addition of Nielsen 2008-2009 National People Meter distant viewing data. No data was added for calendar years 2004-2007.” Id. ¶ 20 (citations omitted). IPG asserted, “MPAA could have performed a National People Meter distant viewing analysis for each of the years 2000-2009, but contended that it was `difficult' but not `impossible' given the three-month timeframe afforded by the Judges . . ..” Id. ¶ 21 (citations omitted).

MPAA responded that IPG mischaracterized the record. MPAA noted that in addition to incorporating an additional two years' metered distant viewing data (for both cable and satellite) into his analysis, Dr. Gray “also modified his regression specification to address the Judges' concerns set forth in their May 4, 2016 Order.” MPAA Reply PFF ¶ 6 (citing 4/10/18 Tr. 393-94 (Gray)). By adding the additional two years of data to his cable analysis, Dr. Gray increased the number of distant viewing observations used in his regression analysis from 1.68 million to 3.86 million (the increase for satellite was “a similar order of magnitude”). See 4/10/18 Tr. 395-96 (Gray). As to the availability of additional distant viewing data for 2004-2007, Dr. Gray testified that it was “nearly impossible to attain.” Id. at 396 (Gray).

In the Order Reopening Record, the Judges stated that they could not rely upon MPAA's viewership-based methodology without either “contemporaneous data (whether local ratings and distant viewership data, as Dr. Gray utilized, or other data and analysis that might underlie a modified methodology); or (2) competent evidence that persuades the Judges that such data are not needed to produce reliable results . . ..” Order Reopening Record at 4.

Dr. Gray modified his methodology in response to the Order Reopening Record. Most notably, he added two years of contemporaneous distant viewing data, increasing the number of distant viewing observations by approximately 130%. Dr. Gray testified that the addition of the contemporaneous distant viewing data resulted in little change to his regression-based viewing estimates:

4/10/18 Tr. 399 (Gray). Dr. Gray testified further that these results “comported with” his expectation that the additional data would not change his estimates significantly: “[E]ven based upon the 2000-2003 analysis, that . . . estimated a relationship between distant viewing and a host of factors, local ratings being one of them . . . that mathematical relationship I did not expect to change much over time, particularly to the advantage or disadvantage to one party.” Id. at 399-400. Dr. Gray also testified that, in his opinion, based on the foregoing analysis, the absence of distant viewing data for 2004-2007 did not render his analysis unreliable. Id. at 397.

The Judges find that Dr. Gray's analysis, and the reasonable proximity of his current results to his previous results ( i.e., those without the benefit of the 2008-09 distant viewing data), constitute competent evidence that persuades the Judges that further contemporaneous distant viewing data are not needed to produce reliable estimates of distant viewing shares. The Judges reject IPG's contention that Dr. Gray relied on an inadequate amount of data. 21

IPG criticized Dr. Gray's analysis for relying on a “sliver of data,” then “supplant[ing]” those data with regression-based predictions of distant viewing. See IPG PFF ¶¶ 25-37.

As discussed in the preceding section, the Judges reject IPG's contention that Dr. Gray relied on an inadequate amount of data. As to Dr. Gray's use of regression-based predictions of distant viewing, IPG has presented no evidence or expert analysis that even suggests that this approach is improper or unreliable. Moreover, the Judges have relied on a similar approach that Dr. Gray presented on MPAA's behalf in an earlier Phase II distribution proceeding. See 2000-03 Cable Determination, 78 FR at 64994-98, 65002-03. IPG has provided the Judges with no basis for rejecting that approach in the instant proceeding.

In the course of IPG's discussion of Dr. Gray's “supplanting” of distant viewing observations with regression-based predictions, IPG also pointed out that Dr. Gray used imputed values for local ratings whenever the Nielsen data did not include ratings measurements. See IPG PFF ¶¶ 26-28. IPG noted that, during the period covered by this proceeding, Nielsen produced meter-based local ratings only in the “56 largest U.S. markets.” Id. ¶ 27. IPG stated, “Gray only had local ratings data from 56 markets, and conspicuously failed to clarify what number of the 122 sampled cable retransmitted stations were covered by such markets.” However, IPG presented no analysis that would explain whether—much less how and why—these observations are problematic or diminish the reliability of Dr. Gray's methodology. The Judges, therefore, give no weight to IPG's observations concerning Dr. Gray's imputation of local ratings in certain markets.

IPG argued that Dr. Gray, in his live testimony, admitted that the MPAA methodology failed to measure relative market value. IPG PFF at 18. According to IPG, “[Dr.] Gray actually constructed his methodology on the incorrect assumption that the willing seller is the copyright owner and the willing buyer is the broadcast station, i.e., not a CSO/SSO.” Id. ¶ 39. IPG noted that the Judges have previously found that, in determining the relative market value of programming, the seller in the hypothetical market is the copyright owner and the buyer is the Cable System Operator (CSO) or Satellite System Operator (SSO). Id. ¶ 42 (citing Distribution of 1998 and 1999 Cable Royalty Funds, 69 FR 3606, 3613 (Jan. 26, 2004) ( 1998-1999 Phase I Determination )).

In his live testimony, Dr. Gray sought to elaborate on the nature of the hypothetical market for retransmission of television programming absent the compulsory licenses in sections 111 and 119. 22 Dr. Gray described a hypothetical market in which broadcast stations would, in essence, act as middlemen between copyright owners on one hand and cable and satellite operators on the other. In Dr. Gray's opinion as an economist, broadcast stations in an unregulated market would “pay for the right to transmit [programming] in its local market and then pay a surcharge for the right to retransmit to a cable system or satellite system.” 4/10/18 Tr. 456 (Gray). The broadcast station will then “seek to recoup its surcharge in its transactions with the cable system and the satellite system.” Id. at 457.

IPG contended that, because of Dr. Gray's views concerning the role of broadcasters in the hypothetical market, he concluded, “[V]iewership ratings are significant because they are what a broadcaster considers significant.” IPG PFF ¶ 41. That is not what Dr. Gray actually said in his testimony. Dr. Gray testified that in an unregulated market cable and satellite systems would be “negotiating to retransmit the bundled signal, and they will do that in proportion to how much it is going to be valued by the subscriber, as evidenced by distant viewing.” 4/10/Tr. 457 (Gray). In essence, Dr. Gray was repeating the argument that underlies the use of viewership evidence to determine relative market value, which the Judges discussed, supra, 23 The Judges are not persuaded by IPG's further attempt to discredit viewership evidence.

IPG argued that “Dr. Gray disregard[ed] the premise of the `Program Suppliers' program categorization, and his own stated premise, by injecting impermissible factors into his analysis that have a `significant' effect on the regression analysis and his predicted distant viewership.” IPG PFF at 21. Noting that Dr. Gray described the Program Suppliers category as “relatively homogenous,” IPG contended that Dr. Gray's use of explanatory variables for, e.g., Tribune Media program type and station affiliation were inconsistent with that description and, thus, improper. Id. ¶¶ 48-53. IPG did not present any evidence or expert analysis to support that contention, and the Judges therefore reject it.

IPG argued that the levels of “zero viewing”  24 in the Nielsen data that Dr. Gray relied on render his analysis unreliable. See IPG PFF ¶¶ 54-67; see also id. ¶¶ 29-31. IPG relies on the 93-97 Librarian Order to argue that the Judges are precluded from relying on Nielsen's viewing measurements.

IPG stated that MPAA's expert witness, Dr. Gray, “acknowledged that for Nielsen distant diary data, only sixteen weeks of sweeps data was utilized, with approximately 80% average zero viewing.” IPG PFF ¶ 60. IPG then argued that “[m]athematically . . . this constitutes 94% zero viewing (16 weeks × .8 plus 36 weeks × 0.0 [ sic ]  25 /52 = 94% zero viewing).” Id. IPG compares this purported zero viewing percentage unfavorably with levels of zero viewing that the Librarian found unacceptable in the 93-97 Librarian Order. See id. ¶ 56.

IPG's assertions regarding the levels of zero viewing in the data underlying the respective methodologies are without evidentiary basis. IPG's reliance on Dr. Gray's testimony is entirely misplaced: Dr. Gray did not “acknowledge” IPG's estimate of 80% average zero viewing for the sweeps periods. More importantly, Dr. Gray testified that it is improper to impute zero values to periods not covered by the Nielsen data, as IPG's counsel attempted to do. See 4/10/19 Tr. 428-31 (Gray).

IPG failed to demonstrate the existence of a high incidence of zero viewing. The Judges, therefore, need not reach the question whether MPAA has “demonstrate[d] “the causes for the large amounts of zero viewing and explain[ed] in detail the effect of the zero viewing on the reliability of the results” of its methodology. 93-97 Librarian Order, 66 FR at 66450. 26

IPG argued that Dr. Gray included the time of day, broken down into six dayparts, as part of his methodology for determining relative market value. Id. ¶ 70. IPG contends that the use of dayparts was one reason the Judges rejected IPG's proposed methodology in the Order Reopening Record, and should reject MPAA's methodology for the same reason. See id.

Dr. Gray used local ratings as an input in his regression analysis. In cases in which local ratings were unavailable because programs were broadcast outside Nielsen metered markets, he used imputed values. See supra, section IV.B.2; Gray WDT ¶ 48 n.41. The imputed values were “the average local ratings of retransmitted programs of the same type broadcasting during the same time of day.” Id. Dr. Gray defined six time- of-day categories, and computed average ratings for the various Tribune program types ( e.g., “Game Show,” “Movie,” or “Network Series”). Id. “For example, a Network Series program broadcasting at 9 p.m. with no local ratings information is given the average local rating of all Network Series programs broadcasting between 8 p.m. and 11 p.m.” Id. Dr. Gray used the imputed ratings values, together with Nielsen metered ratings and other data points in his regression analysis to predict the distant viewing values that he aggregated and used in computing relative market value.

By contrast, in the methodology the Judges rejected in the Order Reopening Record, IPG used the time of day that a program was broadcast as one of a number of “indicia of economic value,” along with program length, fees paid, and number of subscribers. See Written Direct Testimony of Dr. Laura Robinson, ¶ 10 (Robinson WDT). Dr. Robinson's use of time of day was different from Dr. Gray's use of time of day. The Judge's ruling in the Order Reopening Record is not directly on point, and IPG has presented no evidence or expert analysis that would lead the Judges to conclude that the Judges should apply their earlier criticism to cover the present circumstances.

IPG asserted that, by using both Nielsen meter data and diary data in his methodology, Dr. Gray violated “a clear edict . . . that doing so invalidated the purported results of any analysis relying thereon.” IPG PFF ¶ 76. To support its assertion, IPG quotes a statement from a 1992 CRT decision: “Mr. Lindstrom stated that it was invalid to mix metered viewing with diary viewing. We accept Mr. Lindstrom's statement.”  27 1989 Cable Royalty Distribution Proceeding, 57 FR 15286, 15300 (Apr. 27, 1992); see also id. at 15291 (referring to the same testimony by Mr. Lindstrom).

Mr. Lindstrom's testimony in the 1989 Cable Royalty Distribution Proceeding is not part of the record of this proceeding. There is no evidence before the Judges that could give context and meaning to the CRT's laconic summary of Mr. Lindstrom's statement. The Judges note, however, that the CRT's earlier mention of this same testimony was less categorical, merely stating, “mixing meter data with diary data could invalidly alter the percentage viewing shares . . ..” Id. at 15291 (emphasis added).

Mr. Lindstrom did testify, however, in the instant proceeding. Mr. Lindstrom testified on direct examination about the decision to use meter data for 2008-09 to supplement Dr. Gray's earlier analysis. See 4/10/18 Tr. 300-03 (Lindstrom). Mr. Lindstrom raised the issue of mixing data collection methodologies in the course of this discussion, noting his concern regarding the mixing of diary and meter data to measure distant viewing for the same time frame — i.e., 2008-09. See id. at 302. In neither his direct nor his cross-examination testimony did Mr. Lindstrom criticize Dr. Gray's use of diary and meter data in his regression. Accordingly, IPG's counsel had the opportunity to explore the “mixed data” issue when cross-examining Dr. Gray. See 37 CFR 351.10(b) (cross-examination permitted on “matters raised on direct examination”). Nonetheless, IPG's counsel did not conduct cross-examination on this issue.

Further, the CRT did not—and the Judges do not—issue “edicts,” clear or otherwise. Even if it did, the CRT's brief statement in the 1989 Cable Royalty Distribution Proceeding would not qualify as one. The statement is an evidentiary finding, based on testimony regarding a specific study. Neither the testimony, nor the study is in evidence. The testimony in this proceeding supports neither IPG's categorical statement concerning mixing of diary and meter data, nor IPG's application of that statement to Dr. Gray's study. The Judges reject IPG's criticism of Dr. Gray's use of distant viewing data in this proceeding. 28

The Judges find and conclude that MPAA's distribution methodology is adequate on its face. IPG has presented no evidence or expert analysis that could serve as a basis for rejecting MPAA's methodology or adjusting MPAA's proposed royalty shares to account for any alleged methodological shortcomings. The Judges award royalty shares in the Program Suppliers category as proposed by MPAA and detailed in Table 1.

Dr. Erkan Erdem, the SDC's economic expert, devised a methodology that estimates relative marketplace value by using Nielsen local ratings, scaled by numbers of distant subscribers, as a proxy for distant cable and satellite viewership. See Erdem WDT at 13. Broadly speaking, Dr. Erdem multiplied the ratings reported in Nielsen's Report on Devotional Programming (RODP)  29 by the numbers of distant subscribers to cable and satellite systems that carry the programs reported in the RODP to obtain what he described as a “reasonable proxy” for distant viewership. See id. at 13, 15. He then summed the resulting distant viewership estimates for each of IPG's and the SDC's programs, and allocated the royalty shares proportionally. See id. at 15. In this respect, the SDC's current methodology does not differ from the methodology the SDC presented prior to the Order Reopening Record.

Dr. Erdem sought to validate his reliance on local ratings in his methodology by conducting three regression analyses “to establish that there is a positive, statistically significant correlation between local and distant ratings . . ..” Erdem WDT at 18. His initial analysis (prior to the Order Reopening Record ) relied only on February 1999 data to establish this correlation. See id. In his testimony in the reopened proceeding, Dr. Erdem used distant viewing data for all four sweeps periods in 1999 through 2003. He continued to find a positive and statistically significant correlation in all three regression analyses. See id. at 19. Dr. Erdem's analysis also showed that “after controlling for local ratings, distant ratings appear to be consistent and stable over 1999-2003.” Id. at 20.

During each of the years covered by this proceeding, Nielsen produced RODPs for each of four quarterly “sweeps” periods. When he initially computed royalty shares, Dr. Erdem only had RODPs for one month in each year from 1999 through 2003. 30 See Order Reopening Record at 5. The SDC obtained copies of page R-7 (the summary page) from an additional eight RODPs (May, July, and November 1999; May and July 2000; November 2001; July 2002; and May 2003) (the Supplemental Nielsen RODPs). Erdem WDT at 17. Dr. Erdem “exclude[d] the Supplemental Nielsen RODPs from [his] baseline royalty share calculations,” but used them in four analyses to demonstrate the validity and reliability of those baseline calculations. Id.

First, Dr. Erdem “analyzed the consistency of ratings for claimed programs over all Nielsen sweep months over 2004-2009” ( i.e., the years for which he had complete sets of RODPs) by calculating how often a claimed program that is rated in February is also rated in the remaining three sweeps months. Id. at 20. He found that “if a program was rated in February, it was also rated in all three remaining sweep months for approximately 91 percent of the time implying that it is highly likely that a program is rated for the rest of the year if it is rated in February.” Id. Dr. Erdem conducted the same analysis including 1999 (using the Supplemental Nielsen RODPs for the remaining sweep periods for that year) and he obtained “almost identical” results (91.84% including 1999 versus 90.70% excluding 1999). Id. at 20, 31 Ex. 4.

Second, Dr. Erdem “calculated the change in the ratings between February and every other sweep month for each claimed program” in 2004-2009. Id. at 21 (footnote omitted). He found that ratings for any given program were “highly stable within a year,” rarely differing by more than 0.1 percentage points. Id. When Dr. Erdem included 1999 in this analysis, he found “the change was at most 0.1 percentage points for 96.4 percent of the time (calculated over 278 comparisons).” Id.

Third, Dr. Erdem “checked the impact of using only February ratings data on [his] royalty estimates even for years when [he had] access to four reports,” reasoning that “[i]f the impact is small, then this is further evidence that February is representative of the whole year.” Id. He found that the largest changes in the SDC's computed royalty shares were 2.8 percentage points for cable and 0.3 percentage points for satellite. Id.

Finally, Dr. Erdem computed royalty shares for 1999-2003 using all of the Supplemental Nielsen RODPs. He found “the impact of using a more comprehensive data has almost no impact (when rounded to 1 decimal point) on the royalty shares.” 31 Id.

IPG acknowledged that the SDC obtained additional data that Dr. Erdem used to bolster the analysis that he presented before the Judges reopened the record. See IPG PFF ¶ 83. IPG argued, however, that Dr. Erdem was not sufficiently familiar with one portion of the additional data: distant household viewing hours (HHVH) data for 2000-2003 that Nielsen prepared for MPAA and that the SDC received through discovery. Id. ¶ 85. IPG supported this conclusion only with the fact that Dr. Erdem received the data in discovery, instead of developing, designing or commissioning it himself. Id.

IPG's criticism is unsupported by expert analysis or record evidence. Therefore, the Judges reject it.

IPG noted that the SDC methodology measures distant viewership using national average ratings set forth on the R-7 summary page of RODPs. IPG asserted, “there is no way to determine if a higher rating was derived from a station with de minimus [ sic ] distant subscribers or extraordinarily high distant subscribers.” IPG PFF ¶¶ 89-90. IPG contended that the RODPs include local ratings on a station-by-station basis but that Dr. Erdem failed to use that information in the SDC methodology. Id. ¶ 90.

In this proceeding, the Judges must determine royalty shares on an annualized basis. The two methodologies presented by MPAA and the SDC demonstrate that there are different ways of measuring those shares. MPAA starts with disaggregated viewership measurements and aggregates them up to royalty shares. The SDC begins with data that Nielsen has already aggregated and averaged on an annualized basis. IPG, in spite of its criticism of the MPAA methodology, appears to criticize the SDC for not using the same general approach.

In the absence of any expert analysis supporting IPG's assertion, the Judges find no credible support in the record to indicate that Dr. Erdem's choice of a starting place is deficient. Dr. Erdem reasonably explained and justified his methodological choices as part of his expert testimony. Therefore, the Judges accept Dr. Erdem's testimony as authoritative. Criticism by IPG's counsel is not a substitute for expert rebuttal testimony. The Judges reject this criticism of the SDC's methodology because it is unsupported by expert analysis or record evidence.

IPG argued that Dr. Erdem based his conclusion that there is a positive and statistically significant correlation between local ratings and distant viewership on a quantum of data that the Judges previously found to be insufficient in the Order Reopening Record. See IPG PFF ¶ 93. Specifically, IPG faulted Dr. Erdem for using only 1999-2003 distant HHVH data to establish the existence of a correlation between local ratings and distant viewing. Id. ¶¶ 83-84, 93. 32 IPG noted that the Judges rejected MPAA's original methodology in this proceeding because Dr. Gray relied on distant viewership data from 2000-2003 to establish a mathematical relationship between local ratings and distant viewing that he used to predict levels of distant viewing for the entire period covered by the proceeding. See id. ¶  93; Order Reopening Record at 3.

The Judges did find the original methodologies and data that the parties presented in this proceeding to be substantively insufficient. The Judges required the parties to present additional data “or competent persuasive evidence that such data are not needed to produce reliable results . . ..” Id. at 5; see id. at 4. MPAA and the SDC have done both. Specifically, both MPAA and the SDC have now presented a quantum of persuasive evidence and analysis demonstrating a positive correlation between local ratings and distant viewing that is consistent over time. See Erdem WDT at 19-20; 4/9/18 Tr. 63-65 (Erdem); cf. Gray WDT ¶¶ 13-14 (additional two years of contemporary distant viewing data produced results “consistent with” earlier results without those data). That consistency provides the Judges with adequate assurance regarding the reliability of the viewing data in the record to support a consistent positive correlation between local ratings and distant viewing data over the years at issue in this proceeding, particularly when computing the royalty shares directly from local ratings data as in Dr. Erdem's methodology. The Judges, therefore, reject IPG's argument that Dr. Erdem used insufficient distant viewing data.

IPG stated, “[f]or the first time, in his oral testimony [Dr.] Erdem revealed that his asserted local ratings/distant viewership correlation is not between broadcasts for which he has both local ratings data and distant viewership data, but annual averages of broadcasts for programs.” IPG PFF ¶ 97. 33 IPG then argued that Dr. Erdem's analysis does not support a conclusion that there is a positive correlation between local ratings and distant viewing, because there is no way of knowing whether the local ratings and distant viewing measurements relate to the same broadcasts. See id. ¶¶ 98-99.

I. Abstract

The NASA Business Opportunities Expo is an annual event sponsored by the NASA KSC Prime Contractor Board, U.S. Air Force 45th Space Wing and Canaveral Port Authority. Attendees include: Small businesses who want to meet and network with NASA and KSC Prime Contractors; large contractors seeking teaming opportunities with Small Businesses; and construction companies interested in learning more about NASA contract opportunities.

Exhibitors include businesses offering a variety of products and services, representatives from each NASA center, the Patrick Air Force Base 45th Space Wing, prime contractors and other government agencies.

Attendee Information collected is name, Company, address, email, telephone. Exhibitors are asked to provide the same information, plus company information that is published in the event program: Commercial and Government Entity (CAGE) Code, Primary North American Industry Classification System (NAICS) Code, Business Categories, Core company capabilities and Past or current work/contracts with NASA.

Title: NASA Business Opportunities Expo.

OMB Number: 2700-xxxx.

Type of Review: New.

Affected Public: Individuals.

Average Expected Annual Number of Activities: 1.

Average Number of Respondents per Activity: 2300.

Annual Responses: 2300: Attendee 2100, Exhibitor 200.

Frequency of Responses: 1 per year.

Average Minutes per Response: Attendee-1, Exhibitor-5.

Burden Hours: 51.7.

Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collected has practical utility; (2) the accuracy of NASA's estimate of the burden (including hours and cost) of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including automated collection techniques or the use of other forms of information technology.

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

Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App.), notice is hereby given of the following meeting:

This meeting will discuss applications for the Institutes for Advanced Topics in the Digital Humanities, submitted to the Office of Digital Humanities. Because this meeting will include review of personal and/or proprietary financial and commercial information given in confidence to the agency by grant applicants, the meeting will be closed to the public pursuant to sections 552b(c)(4) and 552b(c)(6) of Title 5, U.S.C., as amended. I have made this determination pursuant to the authority granted me by the Chairman's Delegation of Authority to Close Advisory Committee Meetings dated April 15, 2016.

As required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection (OMB No. 3206-0034). The Office of Management and Budget is particularly interested in comments that:

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

2. 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;

3. Enhance the quality, utility, and clarity of the information to be collected; and

4. 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 submissions of responses.

Form RI 30-2 is used annually to determine if disability retirees under age 60 have earned income which will result in the termination of their annuity benefits under title 5, U.S.C. Sections 8337 and 8455. It also specifies the conditions to be met and the documentation required for a person to request reinstatement.

Agency: Retirement Services, Office of Personnel Management.

Title: Annuitant's Report of Earned Income.

OMB Number: 3206-0034.

Frequency: On occasion.

Affected Public: Individuals or Households.

Number of Respondents: 21,000.

Estimated Time per Respondent: 35 minutes.

Total Burden Hours: 12,250.