Federal Register Vol. 81, No.95,

Title: 7 CFR part 226, Child and Adult Care Food Program.

OMB Number: 0584-0055.

Expiration Date: September 30, 2016.

Type of Request: Revision of a currently approved collection.

Abstract: Section 17 of the Richard B. Russell National School Lunch Act (NSLA), as amended, (42 U.S.C. 1766), authorizes the CACFP to provide cash reimbursement and commodity assistance, on a per meal basis, for food service to children in nonresidential child care centers and family day care homes, and to eligible adults in nonresidential adult day care centers. The U.S. Department of Agriculture, through the Food and Nutrition Service, has established application, monitoring, and reporting requirements to manage the CACFP effectively. The purpose of this submission to OMB is to obtain approval to continue the discussed information collection. States and service institutions participating in the CACFP will submit to FNS account and record information reflecting their efforts to comply with statutory and regulatory Program requirements. Examples of data collected and reported with this collection include, but are not limited to: applications and supporting documents; records of enrollment; records supporting the free and reduced price eligibility determinations; daily records indicating numbers of program participants in attendance and the number of meals served by type and category; and receipts, invoices and other records of CACFP costs and documentation of non-profit operation of food service.

This is a revision of a currently approved collection. It revises reporting burden as a result of increases in the number of sponsoring organizations and facilities, and an increase in the number of enrolled participants, who are required to submit information. It also adds a new requirement for written documentation when requesting substitutions for fluid milk or food components for participants with special non-disability, dietary needs. This requirement is added by the regulation Child and Adult Care Food Program: Meal Pattern Revisions Related to the Healthy, Hunger-Free Kids Act of 2010, published April 25, 2016 to 7 CFR 226.20 (g) Exceptions and variations in reimbursable meals.

This revision removes two reporting requirements that had been duplicated in the current burden estimate (i.e. counted twice), and one typed error in the number of day care home sponsors, which reduce the burden. Current OMB inventory for this collection consists of 2,234,840 hours. As a result of program changes and adjustments, program burden was increased slightly by 236,715 hours since last renewal. The average burden per response and the annual burden hours for reporting and recordkeeping are explained below and summarized in the charts which follow.

Affected Public: 56 State agencies, 21,052 Institutions, 180,740 facilities (includes 113,847, family day care homes and 66,893 sponsored center facilities) and 4,055,172 households.

Estimated Number of Respondents: 4,257,020.

Estimated Number of Responses per Respondent: 1.824365.

Estimated Total Annual Responses: 7,766,360.

Estimate Time per Response: 0.318238 hrs.

Estimated Total Annual Burden: 2,471,555 hrs.

Current OMB Inventory for Part 226: 2,234,840 hrs.

Difference (change in burden with this renewal): 236,715 hrs.

Refer to the table below for estimated total annual burden.

The Council recently took action to provide more flexibility in managing the harvest of red snapper by the various components of the Gulf reef fish recreational sector. In 2014, the Council established separate private angling and Federal charter vessel/headboat (for-hire) components of the red snapper recreational sector. There has been a decrease over time in the proportion of red snapper harvested by anglers fishing from Federal for-hire vessels and differences in regulatory environments faced by Federal for-hire operators and private anglers. These factors contributed to the Council's decision to restructure the red snapper recreational sector to increase flexibility for each component.

The purpose of Amendment 41 is to develop a management approach for federally permitted Gulf reef fish charter vessels that reduces management uncertainty, provides flexibility and improves economic conditions for the owners and operators of Federal charter vessels, and increases opportunities for anglers who fish from Federal charter vessels to harvest red snapper.

NMFS, in collaboration with the Council, will develop a DEIS for Amendment 41 to describe and analyze alternatives to address the management needs described above, including the “no action” alternative. In accordance with the regulations issued by the Council on Environmental Quality (CEQ) for implementing the National Environmental Policy Act (NEPA; 40 CFR parts 1500-1508), NMFS, in collaboration with the Council, has identified preliminary environmental issues as a means to initiate discussion for scoping purposes only. These preliminary issues may not represent the full range of issues that eventually will be evaluated in the DEIS. A copy of the Amendment 41 draft options paper is available at: http://sero.nmfs.noaa.gov/sustainable_fisheries/gulf_fisheries/reef_fish/index.html.

Comments on the scope of the DEIS may be submitted in writing to NMFS (see ADDRESSES) during the 30-day scoping period. After the scoping period and throughout the development of Amendment 41, the Council will accept written comments on the action, and oral comments may be made during the public testimony portion of any Council meeting. The upcoming Council meetings will be in Clearwater Beach, Florida on June 20-24, 2016, and New Orleans, Louisiana on August 15-19, 2016.

After the DEIS associated with Amendment 41 is completed, it will be filed with the Environmental Protection Agency (EPA). After filing, the EPA will publish a notice of availability of the DEIS for public comment in the Federal Register. Consistent with the CEQ regulations, the DEIS will have a 45-day public comment period.

The Council and NMFS will consider public comments received on the DEIS in developing the final environmental impact statement (FEIS) and before adopting final management measures for the amendment. NMFS will submit the consolidated final amendment and supporting FEIS to the Secretary of Commerce (Secretary) for review as required by the Magnuson-Stevens Fishery Conservation and Management Act.

NMFS will announce, through a notification in the Federal Register, the availability of the final amendment for public review during the Department of Commerce Secretarial review period and will consider all public comments. During Secretarial review, NMFS will also file the FEIS with the EPA, and the EPA will publish a notice of availability for the FEIS in the Federal Register. This public comment period is expected to be concurrent with the Secretarial review period and will end prior to final agency action to approve, disapprove, or partially approve the Amendment 41.

NMFS will announce, through a document published in the Federal Register, all public comment periods on the final amendment, its proposed implementing regulations, and the availability of its associated FEIS. NMFS will consider all public comments received during the Secretarial review period, whether they are on the final amendment, the proposed regulations, or the FEIS, prior to final agency action.

Background: The WTSA, which occurs every four years, sets the overall strategic direction and activities for upcoming ITU Telecommunication Standardization Sector (ITU-T) work; defines the general policy for the ITU-T; approves, modifies or rejects ITU-T Standards (known as “recommendations”); and establishes the structure for the ITU-T study groups, approves their expected work program for the next four-year period, and appoints their Chairmen and Vice-Chairmen. The next WTSA conference will be held from October 25 to November 3, 2016, in Yasmine Hammamet, Tunisia. Participants historically include ministers, ambassadors, government delegates, regional and international organizations, and representatives from academia, civil society, and the private sector.

The U.S. Department of State initiated U.S. preparations for WTSA-2016 in January 2016, which are focused on developing formal U.S. priorities for WTSA-2016.1

NTIA, as the principal adviser to the President on telecommunications and information policy, seeks input from stakeholders and other interested parties to develop its recommendations to the U.S. Department of State and to inform any NTIA delegates who will attend the WTSA. NTIA's participation in the U.S. WTSA-2016 preparatory process is intended to ensure that U.S. proposals and positions support the nation's telecommunications, converged communications infrastructure, information and technology policies to promote economic growth and digital innovation, and do not duplicate the standards development processes of other bodies.

Discussion: There are numerous standards organizations and fora around the globe focused on various aspects of telecommunication and information policies. No single organization can cover all ground, nor should it try or claim to do so.

The purpose of this Notice and Request for Public Comment is to seek input from stakeholders and other interested parties to share their perspectives as to whether and how the work of the ITU-T results in standards that meet their needs. We are interested in particular on input related to ITU-T restructuring and work methods and rules of procedure.

NTIA requests comment on the questions below. NTIA also welcomes input and comments on any specific issues being advanced by other countries, private sector organizations, and stakeholders for WTSA-2016.

(1) Are there overarching objectives and priorities that the U.S. delegation should adopt for WTSA-2016 and the ITU-T? What is the best way for the U.S. delegation to advance and ultimately achieve these objectives and priorities?

(2) In an environment with a wide range of industry led, multistakeholder standards development organization (SDOs) leading the development of telecommunications and information standards, does an intergovernmental organization, such as the ITU, provide any unique value? How does ITU involvement in global standards development influence, or affect U.S. industry interests in engaging in and promoting the international digital economy?

(3) What do you believe is the percentage of participation of relevant organizations or companies in the ITU-T study groups? What is the value of this participation in the ITU-T study groups? Does this participation meeting the needs of relevant organizations or companies?

(4) Is there a wide implementation of the ITU-T recommendations in the United States or elsewhere by relevant organizations or companies? Why or why not? Can you provide examples of these implementations, if any?

(5) The WTSA-12 Action Plan (see https://www.ntia.doc.gov/files/ntia/WTSA16/WTSA-12-Action-Plan.pdf) identified issues that will be discussed during WTSA-2016. Which of these issues are the most important to focus on in the upcoming WTSA-2016? What positions should be taken with respect to these issues?

(6) Are the ITU-T work methods and/or rules of procedure effective? Why or why not? What, if any, modifications to ITU-T Resolutions and Recommendations (see https://www.ntia.doc.gov/page/wtsa-12-resolutions-and-opinions) or to the ITU-T working methods or rules of procedure would you recommend to improve efficiency and effectiveness? Are there structural changes to the ITU-T that could make the organization more relevant?

(7) What are the most important international standardization public policy issues and topics? And why? In what areas or subjects do you believe the ITU-T has a particular role or expertise?

(8) Assuming the ITU-T study group structure remains as it is today, in which study groups and activities should NTIA prioritize its participation and why?

(9) How could cooperation and collaboration between ITU-T and other SDOs be strengthened? How could cooperation and collaboration among the three ITU sectors be strengthened?

(10) The ITU and its membership have identified a standardization gap between developed and developing countries and a need to bridge that gap to ensure greater participation by all countries in the work of the ITU-T. What is the best way to address this gap? Would ITU programs on this topic be better placed within the ITU-D or the ITU-T? What other steps can be taken to bridge this gap?

NTIA invites comment on the questions set forth in this Notice and Request for Public Comment as well as input on any other issues relevant to NTIA's participation in the ITU-T that will assist NTIA in its consultations with the U.S. Department of State and other U.S. government agencies in preparation for WTSA-2016.

Background: The CAFTA-DR Agreement provides a list in Annex 3.25 for fabrics, yarns, and fibers that the Parties to the CAFTA-DR Agreement have determined are not available in commercial quantities in a timely manner in the territory of any Party. The CAFTA-DR Agreement provides that this list may be modified pursuant to Article 3.25.4 and 3.25.5, when the President of the United States determines that a fabric, yarn, or fiber is not available in commercial quantities in a timely manner in the territory of any Party. See Annex 3.25 of the CAFTA-DR Agreement; see also section 203(o)(4)(C) of the CAFTA-DR Implementation Act.

The CAFTA-DR Implementation Act requires the President to establish procedures governing the submission of a request and providing opportunity for interested entities to submit comments and supporting evidence before a commercial availability determination is made. In Presidential Proclamations 7987 and 7996, the President delegated to CITA the authority under section 203(o)(4) of CAFTA-DR Implementation Act for modifying the Annex 3.25 list. Pursuant to this authority, on September 15, 2008, CITA published modified procedures it would follow in considering requests to modify the Annex 3.25 list of products determined to be not commercially available in the territory of any Party to CAFTA-DR (Modifications to Procedures for Considering Requests Under the Commercial Availability Provision of the Dominican Republic-Central America-United States Free Trade Agreement, 73 FR 53200) (“CITA's procedures”).

On April 12, 2016, the Chairman of CITA received a request for a Commercial Availability determination (“Request”) from Grunfeld, Desiderio, Lebowitz, Silverman, & Klestadt, LLC, on behalf of Tang Textiles & Apparel, for certain warp stretch woven rayon blend fabrics. On April 14, 2016, in, in accordance with CITA's procedures, CITA notified interested parties of the Request, which was posted on the dedicated Web site for CAFTA-DR Commercial Availability proceedings. In its notification, CITA advised that any Response with an Offer to Supply (“Response”) must be submitted by April 26, 2016, and any Rebuttal Comments to a Response must be submitted by May 2, 2016, in accordance with sections 6 and 7 of CITA's procedures. No interested entity submitted a Response to the Request advising CITA of its objection to the Request and its ability to supply the subject product.

In accordance with section 203(o)(4)(C) of the CAFTA-DR Implementation Act, and section 8(c)(2) of CITA's procedures, as no interested entity submitted a Response objecting to the Request and providing an offer to supply the subject product, CITA has determined to add the specified fabric to the list in Annex 3.25 of the CAFTA-DR Agreement.

The subject product has been added to the list in Annex 3.25 of the CAFTA-DR Agreement in unrestricted quantities. A revised list has been posted on the dedicated Web site for CAFTA-DR Commercial Availability proceedings.

I. Background

Section 1013(b)(1) of the Consumer Financial Protection Act, 12 U.S.C. 5493(b)(1) establishes the Office of Research (OR) and assigns to it the responsibility of researching, analyzing, and reporting on topics relating to the Bureau's mission, including developments in markets for consumer financial products and services, consumer awareness, and consumer behavior.

The Academic Research Council is a consultative body comprised of scholars that help the Office of Research perform these responsibilities. Section 3 of the ARC Charter states: “The Council will provide the Office of Research advice and feedback on research methodologies, framing research questions, data collection, and analytic strategies. Additionally, the Council will provide both backward- and forward-looking feedback on the Office of Research's research work and will offer input into its research strategic planning process and research agenda.”

The Academic Research Council will discuss methodology and direction for consumer finance research at the Bureau.

Persons who need a reasonable accommodation to participate should contact [email protected], 202-435-9EEO, 1-855-233-0362, or 202-435-9742 (TTY) prior to the meeting or event to request assistance. The request must identify the date, time, location, and title of the meeting or event, the nature of the assistance requested, and contact information for the requester. CFPB will strive to provide but cannot guarantee that accommodation will be provided for late requests.

Individuals who wish to attend the Academic Research Council meeting must RSVP to [email protected] by noon, May 18, 2016. Members of the public must RSVP by the due date and must include “ARC” in the subject line of the RSVP.

The Council's agenda will be made available to the public on May 10, 2016, via www.consumerfinance.gov. Individuals should express in their RSVP if they require a paper copy of the agenda.

Title; Associated Form; and OMB Number: Improving Caregiver Outcomes through Structured Support Via Military Caregiver Peer Forums; OMB Control Number 0704-XXXX.

Needs and Uses: The information collection requirement is necessary to assess how participants are using the Military Caregiver PEER (Personalized Experiences, Engagement and Resources) Forums, how participating in the PEER Forums benefits them, and the role that PEER Forums play in the landscape of social support services available to caregivers. Military Caregiver PEER Forums are located on military bases across the country where caregivers can convene, converse among their peers, share resources and best practices, and provide support for the challenges they face. The results will be used to determine how the PEER Forums are currently improving and might better continue to improve caregiver well-being by reducing caregiver burden and addressing caregiver isolation. DoD will use the information gathered by this project to assess the implementation of PEER Forums and implement improvements, if needed. A complementary objective is to use the information gathered by this project to provide DoD with a framework for ongoing monitoring and evaluation of PEER Forums.

Affected Public: Business or other for profit; Not-for-profit institutions.

Annual Burden Hours: 95.

Number of Respondents: 95.

Responses per Respondent: 1.

Annual Responses: 95.

Average Burden per Response: 60 minutes.

Frequency: One-time.

Respondents are: Administrators who oversee the PEER forums, Recovery Care Coordinators who refer caregivers to the PEER forums, Military and Family Life Counselors who run the PEER forums, and caregivers who have been referred to participate in the PEER forums.

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: Impact Aid Program Application for Section 7002 Assistance.

OMB Control Number: 1810-0036.

Type of Review: An extension of an existing information collection.

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

Total Estimated Number of Annual Responses: 250.

Total Estimated Number of Annual Burden Hours: 375.

Abstract: The U.S. Department of Education is requesting an extension for the Application for Assistance under section 7002 of title VII of the Elementary and Secondary Education Act (ESEA). This application is for a grant program otherwise known as Impact Aid Payments for Federal Property. Local Educational Agencies (LEAs) that have lost taxable property due to Federal activities request financial assistance by completing an annual application. Please note that this formula grant program was previously authorized under title VIII of the ESEA (as amended), but will move to title VII under the Every Student Succeeds Act, which reauthorized the ESEA, effective for FY 2017. Regulations for section 7002 of the Impact Aid Program are found at 34 CFR 222, subpart B.

The Department contacts local educational agencies that we determine to be newly eligible for SRSA funding, informs them of their eligibility, and instructs them to apply for funding. Due to unanticipated delays in the eligibility determination process, eligible applicants were not able to submit their applications for FY 2016 awards under the SRSA program by the close of the initial application period. Therefore, we are reopening the application period until May 31, 2016, 4:30:00 p.m., Washington, DC time. All other requirements and conditions stated in the notice inviting applications remain the same.

Applicants that did not meet the initial May 2 deadline must submit applications by May 31 to be considered for FY 2016 funding. Applicants that already submitted timely applications that meet all of the requirements of the notice inviting applications do not have to resubmit their applications.

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: Survey on the Use of Funds Under Title II, Part A (SEA Uses of Funds).

OMB Control Number: 1810-0711.

Type of Review: An extension of an existing information collection.

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

Total Estimated Number of Annual Responses: 52.

Total Estimated Number of Annual Burden Hours: 260.

Abstract: This SEA survey helps the Department of Education understand how SEAs use their allocated Title II, Part A funds. In addition, many States have adopted new college- and career-ready standards and assessments and new educator evaluation systems; this survey provides insight into whether states are using title II, part A funds to support these goals. The survey also allows the Department to assess whether SEAs are using title II, part A funds to carry out their approved plans for equitable access to excellent educators.

Corrections

On May 10, 2016, we published in the Federal Register (81 FR 28837) a notice inviting applications for new awards for FY 2016 for the CSP Grants for Replication and Expansion of High-Quality Charter Schools program. On page 28837 of that notice, in the third column, under DATES, and on page 28842, in the first column, under 3. Submission Dates and Times, we change the Date of Pre-Application Webinar from “June 16, 2016,” to “May 24, 2016.” The time and duration of the webinar remain the same.

Also, on page 28837, in the third column, under DATES, we correct the Deadline for Transmittal of Applications from “June 20, 2016,” to “June 24, 2016.” The Deadline for Transmittal of Applications listed in the first column on page 28842 is correct and remains unchanged.

All other requirements and conditions stated in the notice inviting applications, including the deadline for intergovernmental review, remain the same.

Accessible Format: Individuals with disabilities can obtain this document and a copy of the application package in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT.

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

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

Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

Public Participation: The meeting is open to the public. The EM SSAB, Hanford, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Kristen Holmes at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Kristen Holmes at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

Minutes: Minutes will be available by writing or calling Kristen Holmes's office at the address or phone number listed above. Minutes will also be available at the following Web site: http://www.hanford.gov/page.cfm/hab.

Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

Purpose of the Environmental Monitoring and Remediation Committee (EM&R): The EM&R Committee provides a citizens' perspective to NNMCAB on current and future environmental remediation activities resulting from historical Los Alamos National Laboratory (LANL) operations and, in particular, issues pertaining to groundwater, surface water and work required under the New Mexico Environment Department Order on Consent. The EM&R Committee will keep abreast of DOE-EM and site programs and plans. The committee will work with the NNMCAB to provide assistance in determining priorities and the best use of limited funds and time. Formal recommendations will be proposed when needed and, after consideration and approval by the full NNMCAB, may be sent to DOE-EM for action.

Purpose of the Waste Management (WM) Committee: The WM Committee reviews policies, practices and procedures, existing and proposed, so as to provide recommendations, advice, suggestions and opinions to the NNMCAB regarding waste management operations at the Los Alamos site.

Tentative Agenda:

Public Participation: The NNMCAB's Committees welcome the attendance of the public at their combined committee meeting and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Menice Santistevan at least seven days in advance of the meeting at the telephone number listed above. Written statements may be filed with the Committees either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Menice Santistevan at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

Minutes: Minutes will be available by writing or calling Menice Santistevan at the address or phone number listed above. Minutes and other Board documents are on the Internet at: http://energy.gov/em/nnmcab/northern-new-mexico-citizens-advisory-board.

Exports of electricity from the United States to a foreign country are regulated by the Department of Energy (DOE) pursuant to sections 301(b) and 402(f) of the Department of Energy Organization Act (42 U.S.C. 7151(b), 7172(f)) and require authorization under section 202(e) of the Federal Power Act (16 U.S.C. 824a(e)).

On March 21, 2016, DOE received an application from the Applicant for authority to transmit electric energy from the United States to Mexico as a power marketer solely over the TDM Gen-Tie, an authorized international electric transmission facility issued in Presidential Permit PP-235-2 and for a period not to extend beyond the date of termination of the associated Presidential Permit PP-235-2.

In its application, the Applicant states that it does own or control an electric generation or transmission facility at the point where the 230kV generation tie-line crosses the U.S. Mexico border, and does not have a franchised service area. The Applicant's request is limited to the delivery of intermittent and de minimis start-up and station power to the TDM Facility over the TDM-Gen-Tie. The electric energy that the Applicant proposes to export to Mexico would be surplus energy purchased from third parties such as electric utilities and Federal power marketing agencies pursuant to voluntary agreements. The existing international transmission facility to be utilized by the Applicant have previously been authorized by Presidential permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.

Procedural Matters: Any person desiring to be heard in this proceeding should file a comment or protest to the application at the address provided above. Protests should be filed in accordance with Rule 211 of the Federal Energy Regulatory Commission's (FERC) Rules of Practice and Procedures (18 CFR 385.211). Any person desiring to become a party to these proceedings should file a motion to intervene at the above address in accordance with FERC Rule 214 (18 CFR 385.214). Five copies of such comments, protests, or motions to intervene should be sent to the address provided above on or before the date listed above.

Comments and other filings concerning the Applicant's application to export electric energy to Mexico should be clearly marked with OE Docket No. EA-418. An additional copy is to be provided to both Daniel A. King, Sempra U.S. Gas & Power, LLC, 488 8th Ave., HQ12S1, San Diego, CA 92101 and Jose A. Lau, Sempra International, LLC, 488 8th Ave., HQ13N1, San Diego, CA 92101.

A final decision will be made on this application after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after a determination is made by DOE that the proposed action will not have an adverse impact on the sufficiency of supply or reliability of the U.S. electric power supply system.

Copies of this application will be made available, upon request, for public inspection and copying at the address provided above, by accessing the program Web site at http://energy.gov/node/11845, or by emailing Angela Troy at [email protected].

Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

Public Participation: The EM SSAB, Oak Ridge, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Melyssa P. Noe at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to the agenda item should contact Melyssa P. Noe at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

Minutes: Minutes will be available by writing or calling Melyssa P. Noe at the address and phone number listed above. Minutes will also be available at the following Web site: http://energy.gov/orem/services/community-engagement/oak-ridge-site-specific-advisory-board.

Background: The SAB was established pursuant to the Environmental Research, Development, and Demonstration Authorization Act (ERDDAA), codified at 42 U.S.C. 4365, to provide independent scientific and technical advice to the Administrator on the technical basis for Agency positions and regulations. The SAB is a federal advisory committee chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2. The SAB will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies. Pursuant to FACA and EPA policy, notice is hereby given that the SAB Environmental Economics Advisory Committee will hold two public teleconferences to discuss its draft report on the EPA's methodology for updating its mortality risk valuation estimates for policy analysis. The committee will provide advice to the Administrator through the chartered SAB.

The EPA's Office of Policy requested advice on proposed improvements to the Agency's methodology for estimating benefits associated with reduced risk of mortality. This methodology takes into account the amounts that individuals are willing to pay for reductions in mortality risk. The resulting values are combined into an estimate known as the value of statistical life (VSL) which is used in regulatory benefit-cost analysis. The EPA also requested that the SAB review options for accounting for changes in the VSL over time as real income grows, known as income elasticity of willingness to pay. The EPA submitted the following documents to the SAB for review: (1) Valuing Mortality Risk for Policy: A Meta-analytic Approach, a white paper prepared by the EPA Office of Policy to describe the Agency's interpretation and application of SAB recommendations received in July 2011 regarding updates to the EPA's estimates of mortality risk valuation; (2) The Effect of Income on the Value of Mortality and Morbidity Risk Reductions, a report prepared for the EPA's Office of Air and Radiation on options for updating the Agency's recommended estimate for the income elasticity of the value of statistical life; and (3) Recommended Income Elasticity and Income Growth Estimates: Technical Memorandum, an EPA memorandum providing supplementary information to the report. The SAB Environmental Economics Advisory Committee met on March 7-8, 2016, to receive agency briefings, hear public comments, and deliberate on responses to the EPA charge questions (81 FR 4296-4297). The purpose of the teleconferences described in this notice is to discuss the committee's draft report with responses to the charge questions. The two committee teleconferences will be conducted as one complete meeting beginning on June 16, 2016 and continuing on June 17, 2016, if needed to complete agenda items. Additional information about this SAB advisory activity can be found at the following URL: http://yosemite.epa.gov/sab/sabproduct.nsf/fedrgstr_activites/Valuing%20fatal%20risk%20for%20policy?OpenDocument.

Technical Contacts: Any technical questions concerning the EPA documents reviewed by the SAB should be directed to Dr. Nathalie Simon in the EPA's National Center for Environmental Economics, by telephone at (202) 566-2347 or by email at [email protected].

Availability of Meeting Materials: Prior to the meeting, the teleconference agenda, draft committee report, and other materials will be available on the SAB Web site at http://www.epa.gov/sab.

Procedures for Providing Public Input: Public comment for consideration by EPA's federal advisory committees and panels has a different purpose from public comment provided to EPA program offices. Therefore, the process for submitting comments to a federal advisory committee is different from the process used to submit comments to an EPA program office. Federal advisory committees and panels, including scientific advisory committees, provide independent advice to the EPA. Interested members of the public may submit relevant information on the topic of this advisory activity, and/or the group conducting the activity, for the SAB to consider during the advisory process. Input from the public to the SAB will have the most impact if it provides specific scientific or technical information or analysis for SAB committees and panels to consider or if it relates to the clarity or accuracy of the technical information. Members of the public wishing to provide comment should contact the DFO directly. Oral Statements: In general, individuals or groups requesting an oral presentation at the teleconference will be limited to three minutes. Interested parties wishing to provide comments should contact Dr. Armitage, DFO, in writing (preferably via email) at the contact information noted above by June 9, 2016, to be placed on the list of public speakers for the meeting. Written Statements: Written statements will be accepted throughout the advisory process; however, for timely consideration by committee members, statements should be supplied to the DFO (preferably via email) at the contact information noted above by June 9, 2016. It is the SAB Staff Office general policy to post written comments on the Web page for advisory meetings. Submitters are requested to provide an unsigned version of each document because the SAB Staff Office does not publish documents with signatures on its Web sites. Members of the public should be aware that their personal contact information, if included in any written comments, may be posted to the SAB Web site. Copyrighted material will not be posted without explicit permission of the copyright holder.

Accessibility: For information on access or services for individuals with disabilities, please contact Dr. Armitage at the contact information provided above. To request accommodation of a disability, please contact Dr. Armitage preferably at least ten days prior to the meeting to give EPA as much time as possible to process your request.

OMB Control Number: 3060-1096.

Title: Prepaid Calling Card Service Provider Certification, WC Docket No. 05-68.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents and Responses: 121 respondents; 1,452 responses.

Estimated Time per Response: 2.5 hours-20 hours.

Frequency of Response: Quarterly reporting requirement, third party disclosure requirement and recordkeeping requirement.

Obligation to Respond: Mandatory. Statutory authority for this information collection is contained in 47 U.S.C. 151, 152, 154(i), 201, 202 and 254 of the Communications Act of 1934, as amended.

Total Annual Burden: 12,100 hours.

Total Annual Cost: No cost.

Privacy Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: The Commission does not anticipate providing confidentiality of the information submitted by prepaid calling card providers. Particularly, the prepaid calling card providers must send reports to their transport providers. Additionally, the quarterly certifications sent to the Commission will be made public through the Commission's Electronic Comment Filing System (ECFS) process. These certifications will be filed in the Commission's docket associated with this proceeding. If the respondents submit information they believe to be confidential, they may request confidential treatment of such information under 47 CFR 0.459 of the Commission's rules.

Needs and Uses: The Commission will submit this expiring information collection after this comment period in order to obtain the full three-year clearance from the Office of Management and Budget (OMB).

The Commission is requesting approval for an extension (no change in the reporting, recordkeeping and/or third-party disclosure requirements). Prepaid calling card service providers must report quarterly the percentage of interstate, intrastate and international access charges to carriers from which they purchase transport services. Prepaid calling card providers must also file certifications with the Commission quarterly that include the above information and a statement that they are contributing to the federal Universal Service Fund based on all interstate and international revenue, except for revenue from the sale of prepaid calling cards by, to, or pursuant to contract with the Department of Defense (DoD) or a DoD entity.

OMB Control Number: 3060-0798.

Title: FCC Application for Radio Service Authorization; Wireless Telecommunications Bureau; Public Safety and Homeland Security Bureau.

Form Number: FCC Form 601.

Type of Review: Revision of a currently approved collection.

Respondents: Individuals and households; Business or other for-profit entities; Not-for-profit institutions; and State, local or tribal government.

Number of Respondents and Responses: 253,320 respondents and 253,320 responses.

Estimated Time per Response: 0.5-1.25 hours.

Frequency of Response: Recordkeeping requirement, third party disclosure requirement, on occasion reporting requirement and periodic reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in 47 U.S.C. 151, 152, 154, 154(i), 155(c), 157, 201, 202, 208, 214, 301, 302a, 303, 307, 308, 309, 310, 311, 314, 316, 319, 324, 331, 332, 333, 336, 534, 535 and 554.

Total Annual Burden: 222,055 hours.

Total Annual Cost: $71,306,250.

Privacy Impact Assessment: Yes.

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

Needs and Uses: FCC Form 601 is a consolidated, multi-part application form that is used for market-based and site-based licensing for wireless telecommunications services, including public safety licenses, which are filed through the Commission's Universal Licensing System (ULS). FCC Form 601 is composed of a main form that contains administrative information and a series of schedules used for filing technical and other information. This form is used to apply for a new license, to amend or withdraw a pending application, to modify or renew an existing license, cancel a license, request a duplicate license, submit required notifications, request an extension of time to satisfy construction requirements, or request an administrative update to an existing license (such as mailing address change), request a Special Temporary Authority or Developmental License. Respondents are encouraged to submit FCC Form 601 electronically and are required to do so when submitting FCC Form 601 to apply for an authorization for which the applicant was the winning bidder in a spectrum auction.

The data collected on FCC Form 601 includes the FCC Registration Number (FRN), which serves as a “common link” for all filings an entity has with the FCC. The Debt Collection Improvement Act of 1996 requires entities filing with the Commission use an FRN.

On July 20, 2015, the Commission released the part 1 R&O in which it updated many of its part 1 competitive bidding rules (See Updating Part 1 Competitive Bidding Rules; Expanding the Economic and Innovation Opportunities of Spectrum Through Incentive Auctions; Petition of DIRECTV Group, Inc. and EchoStar LLC for Expedited Rulemaking to Amend Section 1.2105(a)(2)(xi) and 1.2106(a) of the Commission's Rules and/or for Interim Conditional Waiver; Implementation of the Commercial Spectrum Enhancement Act and Modernization of the Commission's Competitive Bidding Rules and Procedures, Report and Order, Order on Reconsideration of the First Report and Order, Third Order on Reconsideration of the Second Report and Order, and Third Report and Order, FCC 15-80, 30 FCC Rcd 7493 (2015), modified by Erratum, 30 FCC Rcd 8518 (2015) (Part 1 R&O)). Of relevance to the information collection at issue here, the Commission: (1) Implemented a new general prohibition on the filing of auction applications by entities controlled by the same individual or set of individuals (but with a limited exception for qualifying rural wireless partnerships); (2) modified the eligibility requirements for small business benefits, and updated the standardized schedule of small business sizes, including the gross revenues thresholds used to determine eligibility; (3) established a new bidding credit for eligible rural service providers; (4) adopted targeted attribution rules to prevent the unjust enrichment of ineligible entities; and (5) adopted rules prohibiting joint bidding arrangements with limited exceptions. The updated Part 1 rules apply to applicants seeking licenses and permits.

Additionally, on June 2, 2014 the Commission released the Mobile Spectrum Holdings R&O, in which the Commission updated its spectrum screen and established rules for its upcoming auctions of low-band spectrum. Of relevance to the information collection at issue here, the Commission stated that it could reserve spectrum in order to ensure against excessive concentration in holdings of below-1-GHz spectrum (In the Matter of Policies Regarding Mobile Spectrum Holdings, Expanding the Economic and Innovation Opportunities of Spectrum Through Incentive Auctions, FCC 14-63, Report and Order, 29 FCC Rcd 6133, 90) 135 (2014) (Mobile Spectrum Holdings R&O). See also Application Procedures for Broadcast Incentive Auction Scheduled to Begin on March 29, 2016; Technical Formulas for Competitive Bidding, Public Notice, 30 FCC Rcd 11034, Appendix 3 (WTB 2015); Wireless Telecommunications Bureau Releases Updated List of Reserve-Eligible Nationwide Service Providers in each PEA for the Broadcast Incentive Auction, Public Notice, AU No. 14-252 (WTB 2016).

The Commission seeks approval for revisions to its previously approved collection of information under OMB Control Number 3060-0798 to permit the collection of the additional information for Commission licenses and permits, pursuant to the rules and information collection requirements adopted by the Commission in the Part 1 R&O and the Mobile Spectrum Holdings R&O. As part of the collection, the Commission is seeking approval for the information collection and recordkeeping requirements associated with 47 CFR 1.2210(j), 1.2112(b)(2)(iii), 1.2112(b)(2)(v), 1.2112(b)(2)(vii), and 1.2112(b)(2)(viii). Also, in certain circumstances, the Commission requires the applicant to provide copies of their agreements and/or submit exhibits.

In addition, the Commission seeks approval for various other, non-substantive editorial/consistency edits and updates to FCC Form 601 that correct inconsistent capitalization of words and other typographical errors, and better align the text on the form with the text in the Commission rules both generally and in connection with recent non-substantive, organizational amendments to the Commission's rules. The Commission therefore seeks approval for a revision to its currently approved information collection on FCC Form 601 to revise FCC Form 601 accordingly.

OMB Control Number: 3060-0207.

Title: Part 11—Emergency Alert System (EAS), Order, FCC 16-32.

Form Number: N/A.

Type of Review: Revision of a currently approved collection.

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

Number of Respondents and Responses: 63,080 respondents; 3,596,546 responses.

Estimated Time per Response: 1 hour (EAS Participants); 20 hours (SECCs).

Frequency of Response: One-time reporting requirement and recordkeeping requirement.

Obligation to Respond: Obligatory for all entities required to participate in EAS. Statutory authority for this collection of information is contained in 47 U.S.C. 154(i) and 606 of the Communications Act of 1934, as amended.

Total Annual Burden: 110,476 hours.

Total Annual Cost: No cost.

Privacy Impact Assessment: No Impact(s).

Nature and Extent of Confidentiality: There is no need for confidentiality.

Needs and Uses: Part 11 contains rules and regulations addressing the nation's Emergency Alert System (EAS). The EAS provides the President with the capability to provide immediate communications and information to the general public at the national, state and local area level during periods of national emergency. The EAS also provides state and local governments and the National Weather Service with the capability to provide immediate communications and information to the general public concerning emergency situations posing a threat to life and property. State and local use of the EAS is required to be described in State EAS Plans that are administered by State Emergency Communications Committees (SECC) and submitted to the FCC for approval.

In the Third Report and Order in EB Docket No. 04-296, FCC 11-12, the Commission adopted rules establishing a regulatory structure for a national test of the EAS. In order for the Commission to determine the extent to which the test, and by extension the EAS, was successful, the FCC adopted rules requiring EAS Participants, within forty five (45) days of the date of the first national EAS test, to record and submit to the Commission the following test-related diagnostic information for each alert received from each message source monitored at the time of the national test:

• Whether they received the alert message during the designated test;

• whether they retransmitted the alert;

• if they were not able to receive and/or transmit the alert, their `best effort' diagnostic analysis regarding the cause(s) for such failure;

• a description of their station identification and level of designation (PEP, LP-1, etc.);

• the date/time of receipt of the EAN message by all stations; the date/time of PEP station acknowledgement of receipt of the EAN message to FOC;

• the date/time of initiation of actual broadcast of the Presidential message;

• the date/time of receipt of the EAT message by all stations;

• who they were monitoring at the time of the test, and the make and

• model number of the EAS equipment that they utilized.

The Third Report and Order indicates that the national tests of EAS, and related information collections will likely be carried out on an annual basis. On March 10, 2010, OMB approved the collection as indicated by the related Notice of Office of Management and Budget Action notification.

The FCC is submitting this information collection to the Office of Management and Budget (OMB) as a revision of the previously approved information collection that established the mandatory Electronic Test Reporting System (ETRS) that EAS Participants must utilize to file identifying and test result data as part of their participation in nationwide EAS testing. Specifically, the Order adopted in EB Docket No. 04-296, FCC 16-32, amends the State EAS Plan filing requirements set forth at Section 11.21 of the Commission's rules to require EAS Participants (i.e., the broadcasters, cable systems, and other service providers subject to the FCC's EAS rules) to provide the following information to their respective SECC, who in turn will include such information in the State EAS Plan submitted to the Commission for approval:

• A description of any actions taken by the EAS Participant (acting individually, in conjunction with other EAS Participants in the geographic area, and/or in consultation with state and local emergency authorities), to make EAS alert content available in languages other than English to its non-English speaking audience(s);

• A description of any future actions planned by the EAS Participant, in consultation with state and local emergency authorities, to provide EAS alert content in languages other than English to its non-English speaking audience(s), along with an explanation for the EAS Participant's decision to plan or not plan such actions; and

• Any other relevant information that the EAS Participant may wish to provide.

In addition, in the event that there is a material change to any of the information that EAS Participants are required to furnish their respective SECCs, EAS Participants must, within 60 days of the occurrence of such material change, submit aa letter to their respective SECCs, copying the Commission's Public Safety and Homeland Security Bureau (Bureau) that describe such change. The SECCs are required to incorporate the information in such letters as amendments to the State EAS Plans on file with the Bureau.

This information will be used by FCC staff to gauge the effectiveness of the EAS's capacity to disseminate in-language EAS emergency alert content to persons who communicate in a language other than English or may have a limited understanding of the English language; to determine whether private and local efforts to disseminate EAS multilingual content might be incorporated into the overall national EAS structure; and to confirm that private and local EAS multilingual operations are consistent with national plans, FCC regulations, and EAS operation.

The Commission expects that the costs to EAS Participants to comply with these reporting requirements will be minimal, and largely limited to internal administrative charges associated with drafting a brief statement, and submitting that statement, and any other relevant information that the EAS Participant may wish to provide to their SECC for inclusion into the State EAS Plan for the state in which the EAS Participant operates. The Commission further expects that the vast majority of EAS Participants are not engaged in multilingual EAS activities and therefore will need to submit nothing more than a very brief statement to their SECC explaining their decision to plan or not plan future actions to provide EAS alert content in languages other than English to their non-English speaking audience(s). For the presumably small percentage of EAS Participants that actually are engaged in multilingual EAS activities, the filing will merely require that they supply a summary of actions they already have taken in this regard. Accordingly, the FCC estimates that complying with the reporting requirement will take EAS Participants, on average, approximately one hour. The FCC estimates that compiling the EAS Participant summaries of multilingual EAS activities and incorporating such information into the State EAS Plan will take SECCs, on average, approximately 20 hours.

The following information collection contained in part 11 may be impacted by these rule amendments: Section 11.21 requires that state and local EAS plans be reviewed and approved by the Chief, Public Safety and Homeland Security, prior to implementation to ensure that they are consistent with national plans, FCC regulations, and EAS operation.

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Use of Electronic Health Record Data in Clinical Investigations.” The draft guidance is intended to assist sponsors, clinical investigators, contract research organizations, IRBs, and other interested parties on the use of EHR data in FDA-regulated clinical investigations. In particular, the draft guidance provides recommendations on the following: (1) Deciding whether and how to use EHRs as a source of data in clinical investigations; (2) using EHRs that are interoperable with electronic systems supporting clinical investigations; (3) ensuring the quality and the integrity of EHR data that are collected and used as electronic source data in clinical investigations; and (4) ensuring that the use of EHR data collected and used as electronic source data in clinical investigations meet FDA's inspection, recordkeeping, and record retention requirements. In an effort to modernize and streamline clinical investigations, the goals of the draft guidance are to facilitate use of EHR data in clinical investigations and to promote the interoperability of EHRs and electronic systems supporting the clinical investigation.

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

This draft guidance refers to collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The draft guidance pertains to sponsors, clinical investigators, contract research organizations, IRBs, and other interested parties who use EHR systems as electronic source data in FDA-regulated clinical investigations and who send certain information to FDA or others or who keep certain records and make them available to FDA inspectors. The collections of information discussed in the draft guidance are contained in our investigational new drug regulations in part 312 (21 CFR part 312), approved under OMB control number 0910-0014, including §§ 312.58(a) and 312.62(b); investigational device exemption regulations in § 812.140 (21 CFR 812.140) approved under OMB control number 0910-0078; and electronic records; electronic signatures regulations in 21 CFR part 11, approved under OMB control number 0910-0303. The use of EHR systems as a source of data, as described in the draft guidance, would not result in any new costs, including capital costs or operating and maintenance costs, because sponsors and others already have and are experienced with using computer-based equipment and software necessary to be consistent with the draft guidance.

Persons with access to the Internet may obtain the draft guidance at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or http://www.regulations.gov.

Technology description follows.

Title of invention: Method for Purifying Antibodies.

Description of Technology: This technology is a method for purifying a biologic composition, comprising diafiltering the biologic composition into a composition comprising phosphate buffered saline (PBS) to obtain a purified composition. The method is particularly useful for removing one or more impurities from the biologic composition, such as bis(2-hydroxyethyl)amino-tris(hydroxymethyl)methane (Bis-tris).The technology is directed to large scale manufacturing of Chimeric 14.18 (Ch14.18) monoclonal antibodies. Ch14.18 is an anti-GD2 monoclonal antibody and has been described in Gillies et al., Journal of Immunological Methods 125:191-202 (1989).

Potential Commercial Applications:

• Large scale manufacturing of chimeric monoclonal antibodies

Value Proposition:

• Cost effective means of removing impurities to produce GMP grade chimeric antibodies for regulatory approval.

Development Stage: Clinical Phase II, FDA/EMA approved Chemistry, Manufacturing and Controls (CMC) large scale manufacturing to produce GMP grade chimeric antibodies.

Inventor(s): David A. Meh (United Therapeutics Corporation), Timothy Atolagbe (United Therapeutics Corporation), G. Mark Farquharson (United Therapeutics Corporation), Samir Shaban (National Cancer Institute), Mary Koleck (National Cancer Institute), George Mitra (National Cancer Institute).

Intellectual Property:

HHS Ref. No. E-291-2014/0-US-01, corresponding to US Provisional Patent App. No. 62/028,994, filed July 25, 2014, entitled “Method for Purifying Antibodies using PBS”

HHS Ref. No. E-291-2014/0-US-02, corresponding to US Patent App. No. 14/809,211, filed July 25, 2015, entitled “Method for Purifying Antibodies using PBS”

HHS Ref. No. E-291-2014/0-PCT-03, corresponding to International Patent App. No. PCT/US2015/042241, filed July 27, 2015, entitled “Method for Purifying Antibodies”

Publications:

1. FDA published document: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125516Orig1s000TOC.cfm

2. US Food and Drug Administration. FDA approves first therapy for high-risk neuroblastoma.http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm437460.htm

3. WO2016015048 METHOD FOR PURIFYING ANTIBODIES https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2016015048

Contact Information: Requests for copies of the patent application or inquiries about licensing, research collaborations, and co-development opportunities should be sent to John D. Hewes, Ph.D., email: [email protected].

Technology description follows.

Title of invention: Improved Pepper Spray for Repellency and Incapacitation.

Description of Technology: Non-lethal means of temporarily incapacitating a person are greatly needed for law enforcement and for personal protection. A common approach is to use pepper spray. Although current pepper sprays are effective, they cause pain for excessively long periods, and could be life threatening for people who suffer from asthma and have hypersensitive airways. This technology describes a composition for use in an aerosol or spray, that when administered, causes a painful stimulation and incapacitates a person for only a brief period. This technology may improve safety over currently available pepper sprays.

Potential Commercial Applications:

• Law enforcement (policing, riot control, crowd control)

• Incapacitating agent for use in hostage situations

• Personal self-defense

Value Proposition:

• Incapacitating pepper spray with reduced toxicity and enhanced safety.

• May reduce potential agency liability in case of an adverse response of an individual who was sprayed (due to reduced toxicity may not be as life threatening to those suffering from asthma or have hypersensitive airways as standard pepper sprays).

• Mixture can be incorporated into a spray, aerosol, or other dispersions.

Development Stage: Basic (Target ID).

Inventor(s): Peter M. Blumberg (NCI), Larry V. Pearce (NCI).

Intellectual Property:

HHS Reference No. E-048-2010/0.

U.S. Provisional Application 61/340,063 (HHS Reference No. E-048-2010/0-US-01) filed March 12, 2010 entitled, “Improved Pepper Spray for Repellency and Incapacitation of People and Animals”.

PCT Application PCT/US2011/028132 (HHS Reference No. E-048-2010/0-PCT-02) filed March 11, 2011 entitled, “Agonist/Antagonist Compositions and Methods of Use”.

Canada: Application 2,792, 878 (HHS Reference No. E-048-2010/0-CA-03) filed March 11, 2011 entitled, “Agonist/Antagonist Compositions and Methods of Use” (Pending).

U.S. Patent Application 13/634,447 (HHS Reference No. E-048-2010/0-US-04) filed September 12, 2012 entitled, “Agonist/Antagonist Compositions and Methods of Use”.

U.S. Patent Application 15/010,830 (HHS Reference No. E-048-2010/0-US-05) filed January 29, 2016 entitled, “Agonist/Antagonist Compositions and Methods of Use” (Pending).

Collaboration Opportunity: Researchers at the NCI seek licensing for use as a non-lethal incapacitation agent.

Contact Information: Requests for copies of the patent application or inquiries about licensing, research collaborations, and co-development opportunities should be sent to John D. Hewes, Ph.D., email: [email protected].

HUD announces its intention to sell in ADPLS certain unsubsidized non-performing mortgage loans (Mortgage Loans) secured by single family properties located throughout the United States. A listing of the Mortgage Loans is included in the due diligence materials made available to qualified bidders. The Mortgage Loans will be sold without FHA insurance and with servicing released. HUD will offer qualified bidders an opportunity to bid competitively on the Mortgage Loans.

The BIP describes in detail the procedure for bidding in ADPLS. The BIP also includes a standardized non-negotiable Conveyance, Assignment and Assumption Agreement (CAA Agreement). Qualified bidders will be required to submit a deposit with their bid. Deposits are calculated based upon each qualified bidder's aggregate bid price.

HUD will evaluate the bids submitted and determine the successful bid, in terms of the best value to HUD, in its sole and absolute discretion. If a qualified bidder is successful, the qualified bidder's deposit will be non-refundable and will be applied toward the purchase price. Deposits will be returned to unsuccessful bidders. For ADPLS, settlements are expected to take place on or about June 27, 2016, and July 29th, 2016.

This notice provides some of the basic terms of sale. The CAA Agreement, which is included in the BIP, provides comprehensive contractual terms and conditions. To ensure a competitive bidding process, the terms of the bidding process and the CAA Agreement are not subject to negotiation.

The BIP describes how qualified bidders may access the due diligence materials remotely via a high-speed Internet connection.

HUD reserves the right to remove Mortgage Loans from ADPLS at any time prior to the Award Date. HUD also reserves the right to reject any and all bids, in whole or in part, and include any Mortgage Loans in a later sale. Deliveries of Mortgage Loans will occur in at least two settlements and the number of Mortgage Loans delivered will vary depending upon the number of Mortgage Loans the Participating Servicers have submitted for the payment of an FHA insurance claim. The Participating Servicers will not be able to submit claims on loans that are not included in the Mortgage Loan Portfolio set forth in the BIP.

There can be no assurance that any Participating Servicer will deliver a minimum number of Mortgage Loans to HUD or that a minimum number of Mortgage Loans will be delivered to the Purchaser.

The ADPLS Mortgage Loans are assigned to HUD pursuant to section 204(a)(1)(A) of the National Housing Act as amended under Title VI of the Departments of Veterans Affairs and Housing and Urban Development and Independent Agencies Appropriations Act, 1999. The sale of the Mortgage Loans is pursuant to section 204(g) of the National Housing Act.

HUD selected an open competitive whole-loan sale as the method to sell the Mortgage Loans for this specific sale transaction. For ADPLS, HUD has determined that this method of sale optimizes HUD's return on the sale of these Mortgage Loans, affords the greatest opportunity for all qualified bidders to bid on the Mortgage Loans, and provides the quickest and most efficient vehicle for HUD to dispose of the Mortgage Loans.

In order to bid in ADPLS as a qualified bidder, a prospective bidder must complete, execute and submit both a Confidentiality Agreement and a Qualification Statement acceptable to HUD. In the Qualification Statement, the prospective bidder must provide certain representations and warranties regarding (i) a prospective bidder, (ii) a prospective bidder's board of directors, (iii) a prospective bidder's direct parent, (iii) a prospective bidder's subsidiaries, and (iv) any related entity with which the prospective bidder shares a common officer, director, subcontractor or sub-contractor who has access to Confidential Information as defined in the Confidentiality Agreement or is involved in the formation of a bid transaction (“Related Entities”), and (v) a prospective bidder's repurchase lenders. The prospective bidder is ineligible to bid on any of the Mortgage Loans included in ADPLS if the prospective bidder, its Related Entities or its repurchase lenders, is any of the following, unless other exceptions apply as provided for the in Qualification Statement.

1. An individual or entity that is currently debarred, suspended, or excluded from doing business with HUD pursuant to the Governmentwide Suspension and Debarment regulations at Title 2 of the Code of Federal Regulations, Parts 180 and 2424;

2. An individual or entity that is currently suspended, debarred or otherwise restricted by any department or agency of the federal government or of a state government from doing business with such department or agency;

3. An individual or entity that is currently debarred, suspended, or excluded from doing mortgage related business, including having a business license suspended, surrendered or revoked, by any federal, state or local government agency, division or department;

4. An entity that has had its right to act as a Government National Mortgage Association (“Ginnie Mae”) issuer terminated and its interest in mortgages backing Ginnie Mae mortgage-backed securities extinguished by Ginnie Mae;

5. An individual or entity that is in violation of its neighborhood stabilizing outcome obligations or post-sale reporting requirements under a Conveyance, Assignment and Assumption Agreement executed for a past sale;

6. An employee of HUD's Office of Housing, a member of such employee's household, or an entity owned or controlled by any such employee or member of such an employee's household with household to be inclusive of the employee's father, mother, stepfather, stepmother, brother, sister, stepbrother, stepsister, son, daughter, stepson, stepdaughter, grandparent, grandson, granddaughter, father-in-law, mother-in-law, brother-in-law, sister-in-law, son-in-law, daughter-in-law, first cousin, the spouse of any of the foregoing, and the employee's spouse;

7. A contractor, subcontractor and/or consultant or advisor (including any agent, employee, partner, director, or principal of any of the foregoing) who performed services for or on behalf of HUD in connection with the sale;

8. An individual or entity that knowingly acquired or will acquire prior to the sale date material non-public information, other than that information which is made available to Bidder by HUD pursuant to the terms of this Qualification Statement, about Mortgage Loans offered in the sale;

9. An individual or entity that knowingly uses the services, directly or indirectly, of any person or entity ineligible under 1 through 11 to assist in preparing any of its bids on the Mortgage Loans;

10. An individual or entity which knowingly employs or uses the services of an employee of HUD's Office of Housing (other than in such employee's official capacity); or

11. A Participating Servicer that contributed Mortgage Loans to a pool on which the Bidder is placing a bid.

The Qualification Statement has additional representations and warranties which the prospective bidder must make, including but not limited to the representation and warranty that the prospective bidder or its Related Entities are not and will not knowingly use the services, directly or indirectly, of any person or entity that is, any of the following (and to the extent that any such individual or entity would prevent Bidder from making the following representations, such individual or entity has been removed from participation in all activities related to this sale and has no ability to influence or control individuals involved in formation of a bid for this sale):

(1) An entity or individual is ineligible to bid on any included Mortgage Loan or on the pool containing such Mortgage Loan because it is an entity or individual that:

(a) Serviced or held any Mortgage Loan at any time during the two-year period prior to the bid, or

(b) Is any principal of any entity or individual described in the preceding sentence;

(c) Any employee or subcontractor of such entity or individual during that two-year period; or

(d) Any entity or individual that employs or uses the services of any other entity or individual described in this paragraph in preparing its bid on such Mortgage Loan.

HUD reserves the right, in its sole and absolute discretion, to disclose information regarding ADPLS, including, but not limited to, the identity of any successful qualified bidder and its bid price or bid percentage for any pool of loans or individual loan, upon the closing of the sale of all the Mortgage Loans. Even if HUD elects not to publicly disclose any information relating to ADPLS, HUD will disclose any information that HUD is obligated to disclose pursuant to the Freedom of Information Act and all regulations promulgated thereunder.

This notice applies to ADPLS and does not establish HUD's policy for the sale of other mortgage loans.

The 15-member Council advises the Secretary of the Interior, through the BLM, on a variety of planning and management issues associated with public land management in Nevada. Topics for discussion at the meeting will include, but are not limited to:

• June 2 & 3—landscape vegetative management, rangeland health assessments, Fire Invasive Assessment Tool (FIAT), sage grouse, drought, and fire restoration. Managers' reports of district office activities will be distributed at each meeting.

• August 11 & 12—Sage Grouse, Wild Horse & Burro, Land Health projects, Managers' report of district office activities will be distributed at each meeting.

The Council may raise other topics at the meetings.

Final agendas will be posted on-line at the BLM Sierra Front-Northwestern Great Basin RAC Web site at http://www.blm.gov/nv/st/en/res/resource_advisory.html and will be published in local and regional media sources at least 14 days before each meeting.

Individuals who need special assistance such as sign language interpretation or other reasonable accommodations, or who wish to receive a copy of each agenda, may contact Lisa Ross no later than 10 days prior to each meeting.

The Commission instituted this investigation on March 30, 2015, based on a complaint filed by BASF Corporation of Florham Park, New Jersey and UChicago Argonne LLC of Lemont, Illinois (collectively, “Complainants”). 80 FR 16696 (Mar. 30, 2015). The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended (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 lithium metal oxide cathode materials, lithium-ion batteries for power tool products containing same, and power tool products with lithium-ion batteries containing same by reason of infringement of one or more of claims 1-4, 7, 13, and 14 of U.S. Patent No. 6,677,082 (“the '082 patent”) and claims 1-4, 8, 9, and 17 of U.S. Patent No. 6,680,143 (“the '143 patent”). Id. The notice of investigation named the following respondents: Umicore N.V. of Brussels, Belgium; Umicore USA Inc. of Raleigh, North Carolina (collectively, “Umicore”); Makita Corporation of Anjo, Japan; Makita Corporation of America of Buford, Georgia; and Makita U.S.A. Inc. of La Mirada, California (collectively, “Makita”). Id. The Office of Unfair Import Investigations is a party to the investigation.

On November 5, 2015, the ALJ granted a joint motion by Complainants and Makita to terminate the investigation as to Makita based upon settlement. See Order No. 32 (Nov. 5, 2015). The Commission determined not to review. See Notice (Nov. 23, 2015).

On December 1, 2015, the ALJ granted an unopposed motion by Complainants to terminate the investigation as to claim 8 of the '082 patent. See Order No. 35 (Dec. 1, 2015). The Commission determined not to review Order No. 35. See Notice (Dec. 22, 2015).

On February 29, 2016, the ALJ issued his final ID, finding a violation of section 337 by Umicore in connection with claims 1-4, 7, 13, and 14 of the '082 patent and claims 1-4, 8, 9, and 17 of the '143 patent. Specifically, the ID found that the Commission has subject matter jurisdiction, in rem jurisdiction over the accused products, and in personam jurisdiction over Umicore. ID at 10-11. The ID found that Complainants satisfied the importation requirement of section 337 (19 U.S.C. 1337(a)(1)(B)). Id. at 9-10. The ID found that the accused products directly infringe asserted claims 1-4, 7, 13, and 14 of the '082 patent; and asserted claims 1-4, 8, 9, and 17 of the '143 patent, and that Umicore contributorily infringes those claims. See ID at 65-71, 83-85. The ID, however, found that Complainants failed to show that Umicore induces infringement of the asserted claims. Id. at 79-83. The ID further found that Umicore failed to establish that the asserted claims of the '082 or '143 patents are invalid for lack of enablement or incorrect inventorship. ID at 118-20. The ID also found that Umicore's laches defense fails as a matter of law (ID at 122-124) and also fails on the merits (ID at 124-126). Finally, the ID found that Complainants established the existence of a domestic industry that practices the asserted patents under 19 U.S.C. 1337(a)(2). See ID at 18, 24.

On March 14, 2016, Umicore filed a petition for review of the ID. Also on March 14, 2016, the Commission investigative attorney (“IA”) petitioned for review of the ID's finding that a laches defense fails as a matter of law in section 337 investigations. Further on March 14, 2016, Complainants filed a contingent petition for review of the ID. That same day, Umicore filed a motion under Commission Rules 210.15(a)(2) and 210.38(a) (19 CFR 210.15(a)(2) and 210.38(a)), for the Commission to reopen the record in this investigation to admit a paper published on October 29, 2015, and a press release issued that day (collectively, “documents”). On March 22, 2016, the parties filed responses to the petitions for review. On March 24, 2016, Complainants and the IA filed oppositions to Umicore's motion to reopen the record. On April 5, 2016, Umicore moved for leave to file a reply. The Commission has determined to grant Umicore's motion for leave to file a reply.

On April 8, 2016, 3M Corporation (“3M”) filed a motion to intervene under Commission Rule 210.19. 3M requests that the Commission grant it “with full participation rights in this Investigation in order to protect its significant interests in the accused materials.”

Having examined the record of this investigation, including the final ID, the petitions for review, and the responses thereto, the Commission has determined to review the final ID in part. Specifically, the Commission has determined to review (1) the ID's contributory and induced infringement findings; (2) the ID's domestic industry findings under 19 U.S.C. 1337(a)(3)(C); and (3) the ID's findings on laches.

The Commission has determined to deny Umicore's motion to reopen the record to admit the documents. The Commission notes that the documents that Umicore seeks to introduce into evidence were available as of October 29, 2015, the last day of the hearing before the ALJ. Thus, Umicore could not have presented them prior to the hearing. Nothing, however, prevented Umicore from filing a timely motion under Commission Rule 210.42(g) requesting the ALJ to reopen the record and consider the documents prior to issuance of the final ID. The Commission notes that the final ID did not issue until February 29, 2016, four months after the documents were published. Yet, Umicore made no attempt to request the ALJ to consider the documents in the final ID. Thus, the Commission has determined to deny Umicore's motion to reopen the record at this late stage.

The Commission has determined to deny 3M's motion to intervene. The Commission notes that 3M filed a public interest statement on April 8, 2016, making substantially the same arguments it makes in its motion to intervene. The Commission will consider 3M's comments in considering remedy, bonding and the public interest this investigation if a violation of section 337 is found.

The parties are requested to brief their positions on the issues under review with reference to the applicable law and the evidentiary record. In connection with its review, the Commission is interested in responses to the following questions:

Pursuant to Commission rule 210.45 (19 CFR 210.45), Umicore's request for a Commission hearing has been granted. A notice providing the scope and details of the hearing will be forthcoming.

In connection with the final disposition of this investigation, the Commission may (1) issue an order that could result in the exclusion of the subject articles from entry into the United States, and/or (2) issue one or more cease and desist orders that could result in the respondent being required to cease and desist from engaging in unfair acts in the importation and sale of such articles. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so. For background, see Certain Devices for Connecting Computers via Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843 (December 1994) (Commission Opinion).

If the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors the Commission will consider include the effect that an exclusion order and/or cease and desist orders would have on (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.

If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve or disapprove the Commission's action. See Presidential Memorandum of July 21, 2005. 70 FR 43251 (July 26, 2005). During this period, the subject articles would be entitled to enter the United States under bond, in an amount determined by the Commission and prescribed by the Secretary of the Treasury. The Commission is therefore interested in receiving submissions concerning the amount of the bond that should be imposed if a remedy is ordered.

Written Submissions: The parties to the investigation are requested to file written submissions on the issues identified in this notice. Parties to the investigation, interested government agencies, and any other interested parties are encouraged to file written submissions on the issues of remedy, the public interest, and bonding. Such submissions should address the recommended determination by the ALJ on remedy and bonding. Complainants and the IA are requested to submit proposed remedial orders for the Commission's consideration. Complainants are also requested to state the date that the patents expire and the HTSUS numbers under which the accused products are imported. Complainants are further requested to supply the names of known importers of the Umicore products at issue in this investigation. The written submissions and proposed remedial orders must be filed no later than close of business on May 23, 2016. Reply submissions must be filed no later than the close of business on June 2, 2016. Opening submissions are limited to 50 pages. Reply submissions are limited to 25 pages. Such submissions should address the ALJ's recommended determinations on remedy and bonding. No further submissions on any of these issues will be permitted unless otherwise ordered by the Commission.

Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit eight true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the investigation number (“Inv. No. 337-TA-951”) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, http://www.usitc.gov/secretary/fed_reg_notices/rules/handbook_on_electronic_filing.pdf). 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. A redacted non-confidential version of the document must also be filed simultaneously with any confidential filing. All non-confidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.

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 Occupational Safety and Health Administration is providing notice that Nemko-CCL, Inc. (CCL), is applying for expansion of its current recognition as an NRTL. CCL requests the addition of two (2) recognized testing and certification sites, and twenty-two (22) additional test standards to its NRTL scope of recognition. Additionally, CCL is applying to relocate its headquarters to Ottawa, Canada, after its existing headquarters in Salt Lake City, Utah was destroyed in a fire.

OSHA recognition of an NRTL signifies that the organization meets the requirements specified in title 29, Code of Federal Regulations, section 1910.7 (29 CFR 1910.7). Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within its scope of recognition and is not a delegation or grant of government authority. Recognition enables employers to use products approved by the NRTL to meet OSHA standards that require product testing and certification.

The Agency processes applications by an NRTL for initial recognition and for an expansion or renewal of this recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the Agency publish two notices in the Federal Register in processing an application. In the first notice, OSHA announces the application and provides its preliminary finding. In the second notice, the Agency provides its final decision on the application. These notices set forth the NRTL's scope of recognition or modifications of that scope. OSHA maintains an informational Web page for each NRTL, including CCL, which details the NRTL's scope of recognition. These pages are available from the OSHA Web site at http://www.osha.gov/dts/otpca/nrtl/index.html.

Each NRTL's scope of recognition includes: (1) The type of products the NRTL may test, with each type specified by its applicable test standard; and (2) the recognized site(s) that has/have the technical capability to perform the product testing and product-certification activities for test standards within the NRTL's scope.

CCL currently has one facility (site) recognized by OSHA for product testing and certification, with its headquarters located at: Nemko-CCL 1940 West Alexander Street, Salt Lake City, Utah 84119-2039. A complete list of CCL sites recognized by OSHA is available at https://www.osha.gov/dts/otpca/nrtl/ccl.html.

CCL submitted two applications, one dated January 28, 2015 (OSHA-2013-0016-008), and a second dated January 26, 2016 (OSHA-2013-0016-009), to expand its recognition to include the addition of two recognized testing and certification sites located at: Nemko North America, Inc., 2210 Faraday Avenue, Suite 150, Carlsbad, California 92008; and Nemko Canada, Inc., 303 River Road, Ottawa, Ontario, Canada K1V 1H2. OSHA staff performed an on-site review of CCL's testing facilities on November 17-18, 2015, at CCL Ottawa, and on January 11-12, 2016, at CCL California. During these assessments, the assessors found some nonconformances with the requirements of 29 CFR 1910.7. CCL addressed these issues sufficiently, and OSHA staff preliminarily determined that OSHA should grant the applications.

CCL's first application also requested the addition of twenty-two test standards to its scope of recognition. OSHA staff performed a detailed analysis of the application packet, reviewed other pertinent information, and conducted the on-site reviews described above in relation to this application.

Table 1 below lists the appropriate test standards found in CCL's application for expansion for testing and certification of products under the NRTL Program.

On October 28, 2015, CCL provided notice to OSHA that their company headquarters located at 1940 West Alexander Road, Salt Lake City, Utah 84119-2039 had been completely destroyed in a fire that occurred on October 25, 2015. CCL temporarily moved their testing operations to their Ottawa and California locations while searching for a location to re-establish their headquarters. OSHA advised CCL that their inability to perform testing at their recognized site could lead to revocation from the NRTL Program, but proceeded to conduct the November 2015 and January 2016 on-site assessments of the Ottawa and California proposed sites because these assessments were scheduled before the fire occurred. In January of 2016, CCL advised OSHA that they wanted to move their headquarters to the Ottawa, Canada site and had secured a new location for their Salt Lake City, Utah site, which would now serve as an administrative site with no test capabilities. OSHA performed an electronic assessment of this new administrative site located at Nemko-CCL, Inc. 2964 West 4700 South, Suite 200, Salt Lake City, Utah 84129, on February 17, 2016.

CCL submitted acceptable applications for expansion of its scope of recognition, and relocation of its company headquarters. OSHA's review of the application files and its detailed on-site and electronic assessments indicate that CCL can meet the requirements prescribed by 29 CFR 1910.7 for expanding its recognition to include the addition of these two sites and twenty-two test standards for NRTL testing and certification and the new headquarters site. This preliminary finding does not constitute an interim or temporary approval of CCL's applications.

OSHA welcomes public comment as to whether CCL meets the requirements of 29 CFR 1910.7 for expansion of its recognition as an NRTL. Comments should consist of pertinent written documents and exhibits. Commenters needing more time to comment must submit a request in writing, stating the reasons for the request. Commenters must submit the written request for an extension by the due date for comments. OSHA will limit any extension to 10 days unless the requester justifies a longer period. OSHA may deny a request for an extension if it is not adequately justified. To obtain or review copies of the exhibits identified in this notice, as well as comments submitted to the docket, contact the Docket Office, Room N-2625, Occupational Safety and Health Administration, U.S. Department of Labor, at the above address. These materials also are available online at http://www.regulations.gov under Docket No. OSHA-2013-0016.

OSHA staff will review all comments to the docket submitted in a timely manner and, after addressing the issues raised by these comments, will recommend to the Assistant Secretary for Occupational Safety and Health whether to grant CCL's applications for expansion of its scope of recognition. The Assistant Secretary will make the final decision on granting the applications. In making this decision, the Assistant Secretary may undertake other proceedings prescribed in Appendix A to 29 CFR 1910.7.

OSHA will publish a public notice of this final decision in the Federal Register.

David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, 200 Constitution Avenue NW., Washington, DC 20210, authorized the preparation of this notice. Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.

On April 3, 2016, Broadcast Music, Inc. (BMI), the American Society of Composers, Authors and Publishers (ASCAP), SESAC, Inc. (SESAC) (together the Performing Rights Organizations or PROs) and The Harry Fox Agency LLC (with the PROs, the Settling Claimants) filed with the Copyright Royalty Judges (Judges) a Motion for Partial Distribution of the Musical Works Fund . . . (Motion). In the Motion, the Settling Claimants asserted that they have reached a confidential settlement among themselves concerning the distribution shares of the 2012 and 2013 DART Musical Works Fund royalties.

The Settling Claimants contend that they are, or they represent, “the vast majority” of claimants entitled to the Musical Works Fund royalties at issue in this proceeding. As support for their request, the Settling Claimants assert that, since 1997, non-settling music writer or publisher claimants have established claims to and have received less than 0.1% of the Musical Works Fund, if any. The Settling Claimants request a partial distribution of 95% of the subject royalty funds pursuant to Section 801(b)(3)(C) of the Copyright Act (Act).

Under section 801(b)(3)(C) of the Act, before ruling on a partial distribution motion the Judges must publish a notice in the Federal Register to ascertain whether any claimant entitled to receive a share of the subject royalty fees has a reasonable objection to the proposed distribution. Consequently, this Notice seeks comments from interested claimants on whether any reasonable objection exists that would preclude distribution of 95% of the 2012 and 2013 DART Musical Works Fund royalties to the Settling Claimants. Any party wishing to advise the judges of the existence and extent of an objection must do so, in writing, by the end of the comment period. The judges will not consider any objections with respect to the partial distribution motion that come to their attention after the close of that period.

Interested claimants must submit comments to only one of the following addresses. Unless responding by email, claimants must submit an original, five paper copies, and an electronic version on a CD.

Email: [email protected]; or

U.S. mail: Copyright Royalty Board, P.O. Box 70977, Washington, DC 20024-0977; or

Overnight service (only USPS Express Mail is acceptable): Copyright Royalty Board, P.O. Box 70977, Washington, DC 20024-0977; or

Commercial courier: Address package to: Copyright Royalty Board, Library of Congress, James Madison Memorial Building, LM-403, 101 Independence Avenue SE., Washington, DC 20559-6000. Deliver to: Congressional Courier Acceptance Site, 2nd Street NE., and D Street NE., Washington, DC; or

Hand delivery: Library of Congress, James Madison Memorial Building, LM-401, 101 Independence Avenue SE., Washington, DC 20559-6000.

Each year, Federal agencies create billions of records on paper, film, magnetic tape, and other media. To control this accumulation, agency records managers prepare schedules proposing retention periods for records and submit these schedules for NARA's approval. These schedules provide for timely transfer into the National Archives of historically valuable records and authorize disposal of all other records after the agency no longer needs them to conduct its business. Some schedules are comprehensive and cover all the records of an agency or one of its major subdivisions. Most schedules, however, cover records of only one office or program or a few series of records. Many of these update previously approved schedules, and some include records proposed as permanent.

The schedules listed in this notice are media-neutral unless otherwise specified. An item in a schedule is media-neutral when an agency may apply the disposition instructions to records regardless of the medium in which it has created or maintains the records. Items included in schedules submitted to NARA on or after December 17, 2007, are media-neutral unless the item is specifically limited to a specific medium. (See 36 CFR 1225.12(e).)

Agencies may not destroy Federal records without the approval of the Archivist of the United States. The Archivist grants this approval only after thorough consideration of the records' administrative use by the agency of origin, the rights of the Government and of private people directly affected by the Government's activities, and whether or not the records have historical or other value.

In addition to identifying the Federal agencies and any subdivisions requesting disposition authority, lists the organizational unit(s) accumulating the records or lists that the schedule has agency-wide applicability (in the case of schedules that cover records that may be accumulated throughout an agency); provides the control number assigned to each schedule, the total number of schedule items, and the number of temporary items (the records proposed for destruction); and includes a brief description of the temporary records. The records schedule itself contains a full description of the records at the file unit level as well as their disposition. If NARA staff has prepared an appraisal memorandum for the schedule, it also includes information about the records. You may request additional information about the disposition process at the addresses above.

1. Department of Agriculture, Farm Service Agency (DAA-0161-2016-0001, 4 items, 4 temporary items). Records related to loans administered by the Commodity Credit Corporation.

2. Department of Agriculture, Food and Nutrition Service (DAA-0462-2016-0001, 1 item, 1 temporary item). Master files of an electronic information system used to collect and track data relating to the Supplemental Nutritional Assistance Program.

3. Department of the Army, Agency-wide (DAA-AU-2016-0007, 1 item, 1 temporary item). Records relating to requests for waivers for applicants who do not meet established standards for enlistment in the Army.

4. Department of the Army, Agency wide (DAA-AU-2016-0018, 1 item, 1 temporary item). Records of economic data gathered during water management projects.

5. Department of Defense, Defense Finance and Accounting Service (DAA-0507-2016-0001, 1 item, 1 temporary item). Revision of item for foreign military sales case files to add collection and disbursement vouchers.

6. Department of Defense, Defense Threat Reduction Agency (DAA-0374-2014-0016, 1 item, 1 temporary item). Records relating to policies and procedures for verifying location of weapons systems.

7. Department of Defense, Defense Threat Reduction Agency (DAA-0374-2014-0030, 1 item, 1 temporary item). Records relating to the development of strategic plans including balanced scorecard and program review documentation.

8. Department of Homeland Security, Immigration and Customs Enforcement (DAA-0567-2015-0014, 6 items, 6 temporary items). Records related to removal travel operations including copies of international deportation agreements, guidance briefings, detainee custody review case files, and transportation logistics materials.

9. Department of Homeland Security, United States Citizenship and Immigration Services (DAA-0566-2016-0012, 3 items, 3 temporary items). Undeliverable and returned outgoing mail, to include submitted documentation and notices.

10. Department of Justice, Bureau of Alcohol, Tobacco, Firearms, and Explosives (DAA-0436-2016-0001, 2 items, 2 temporary items). Master files of an electronic information system used to collect and manage information gathered in the investigation of reported incidents of internal misconduct.

11. Department of Labor, Office of Congressional and Intergovernmental Affairs (DAA-0174-2013-0003, 9 items, 8 temporary items). Records related to congressional and intergovernmental affairs including correspondence and casework files, notification and announcement files, work files, appointment files, subject files, general correspondence, and related materials. Proposed for permanent retention are memorandum files.

12. Department of the Treasury, Internal Revenue Service (DAA-0058-2016-0007, 1 item, 1 temporary item). Master files of an electronic information system used for fraud detection.

13. Department of the Treasury, Internal Revenue Service (DAA-0058-2016-0009, 1 item, 1 temporary item). Master files of an electronic information system used for transaction processing and data validation.

14. Department of the Treasury, Internal Revenue Service (DAA-0058-2016-0010, 1 item, 1 temporary item). Master files of an electronic information system used to detect fraudulent tax return filings.

15. Department of the Treasury, Internal Revenue Service (DAA-0058-2016-0011, 1 item, 1 temporary item). Records of a Web site used to support a taxpayer rights conference.

16. Court Services and Offenders Supervision Agency for the District of Columbia, Agency-wide (DAA-0562-2014-0002, 4 items, 1 temporary item). Internal administrative directives. Proposed for permanent retention are records of high-level officials, mission-related policies and procedures, and annual reports and strategic plans.

17. Court Services and Offenders Supervision Agency for the District of Columbia, Agency-wide (DAA-0562-2016-0001, 2 items, 2 temporary items). Records documenting court-ordered expunction.

18. Environmental Protection Agency, Office of Water (DAA-0412-2016-0001, 1 item, 1 temporary item). Electronic data obtained from injection well activity reports and managed by the Underground Injection Control Program Summary System.

Background

The committee advises NARA on the full range of programs, policies, and plans for the Center for Legislative Archives in the Office of Legislative Archives, Presidential Libraries, and Museum Services (LPM).

I. Obtaining Information and Submitting Comments A. Obtaining Information

Please refer to Docket ID NRC-2016-0098 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2016-0098.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected]. The draft RIS, “Disposition of Information Related to the Time Period that Safety-Related Structures, Systems, or Components are Installed,” is available in ADAMS under Accession No. ML16111B121.

• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

Please include Docket ID NRC-2016-0098 in your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at http://www.regulations.gov as well as entering the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

The NRC staff has developed draft RIS 2016-xx, “Disposition of Information Related to the Time Period that Safety-Related Structures, Systems, or Components are Installed,” to clarify NRC requirements and programs that provide quality assurance and ensure the operability of safety-related SSCs. When a licensee either becomes aware that a safety-related SSC has been installed for longer that the amount of time described in the licensing basis, or becomes aware of credible information that challenges the presumption that a safety-related SSC can continue to perform its safety function(s), the licensee must assess the information consistent with their licensing basis and applicable NRC requirements. These instances must be addressed in accordance with a licensee's NRC-approved quality assurance program, operability/functionality determination process, and corrective action program.

The NRC issues RISs to communicate with stakeholders on a broad range of matters. This may include clarification of existing requirements and regulations.

The NRC is requesting public comment on the draft RIS. The NRC plans to hold a public meeting to discuss this draft RIS. All comments that are to receive consideration in the final RIS must still be submitted electronically or in writing as indicated in the ADDRESSES section of this document. Additional details regarding the meeting will be posted at least 10 days prior to the public meeting on the NRC's Public Meeting Schedule Web site at http://www.nrc.gov/public-involve/public-meetings/index.cfm. The NRC staff will make a final determination regarding issuance of the RIS after it considers any public comments received in response to this request.

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

1. Each Trust is organized as a Delaware statutory trust and is registered under the Act as an open-end management investment company. The Corporation is a Maryland corporation and is registered as an open-end management investment company. Each Trust and the Corporation has issued one or more series, each of which has its own investment objective and its own investment policies.1 TCWIMC is a California corporation and MWAM is a California limited liability company, and each of TCWIMC and MWAM is registered as an investment adviser under the Investment Advisers Act of 1940 (“Advisers Act”). Both are wholly-owned subsidiaries (direct or indirect) of the TCW Group, Inc., which, in turn, is owned indirectly by two investment funds that are controlled by The Carlyle Group, L.P. In the future, the Advisers may advise Funds that are money market funds that comply with rule 2a-7 under the Act (collectively, the “Money Market Funds”).2

2. The Funds may lend cash to banks or other entities by entering into repurchase agreements or purchasing short-term instruments. The Funds may also need to borrow money for temporary purposes. In order to meet an unexpected volume of redemptions or to cover unanticipated cash shortfalls, the Metropolitan West Funds have contracted for a revolving credit facility with the Bank of New York Mellon Corporation, and other lenders that may be added in the future to the lending syndicate (“Bank Borrowing”). The TCW Alternative Funds and TCW Funds, Inc. may in the future join this credit facility or enter into other arrangements with other bank lenders (each also a “Bank Borrowing”). The amount of borrowing under each of these lines of credit is limited to the amount specified by fundamental investment restrictions, the terms specified in the agreements, and/or other policies of the applicable Fund and section 18 of the Act.

3. If Funds that experience a cash shortfall were to draw down on their Bank Borrowing, they would pay interest at a rate that is likely to be higher than the rate that could be earned by non-borrowing Funds on investments in repurchase agreements and other short-term money market instruments of the same maturity as the Bank Borrowing (“Short-Term Instruments”). Applicants assert the difference between the higher rate paid on Bank Borrowing and what the bank pays to borrow under repurchase agreements or other arrangements represents the bank's profit for serving as the middleperson between a borrower and lender and is not attributable to any material difference in the credit quality or risk of such transactions.

4. The Funds seek to enter into master interfund lending agreements with each other (the “InterFund Program”) that would permit each Fund whose policies permit it to do so to lend money directly to and borrow money directly from other Funds for temporary purposes through the InterFund Program (an “Interfund Loan”). The Money Market Funds will not participate as borrowers. Applicants state that the requested will relief enable the Funds to access an available source of money and reduce costs incurred by the Funds that need to obtain loans for temporary purposes and permit those Funds that have cash available: (i) To earn a return on the money that they might not otherwise be able to invest; or (ii) to earn a higher rate of interest on investment of their short-term balances. Although the proposed InterFund Program would reduce the Funds' need to borrow from banks or through custodian drafts, the Funds would be free to establish and/or continue committed lines of credit or other borrowing arrangements with banks.

5. Applicants anticipate that the proposed InterFund Program would provide a borrowing Fund with significant savings at times when the cash position of the Fund is insufficient to meet temporary cash requirements. This situation could arise when shareholder redemptions exceed anticipated cash volumes and certain Funds have insufficient cash on hand to satisfy such redemptions. When the Funds liquidate portfolio securities to meet redemption requests, they often do not receive payment in settlement for up to three days (or longer for certain foreign transactions). However, redemption requests normally are effected on the day following the trade date. The proposed InterFund Program would provide a source of immediate, short-term liquidity pending settlement of the sale of portfolio securities.

6. Applicants also anticipate that a Fund could use the InterFund Program when a sale of securities “fails” due to circumstances beyond the Fund's control, such as a delay in the delivery of cash to the Fund's custodian or improper delivery instructions by the broker effecting the transaction. “Sales fails” may present a cash shortfall if the Fund has undertaken to purchase a security using the proceeds from securities sold. Alternatively, the Fund could: (i) “Fail” on its intended purchase due to lack of funds from the previous sale, resulting in additional cost to the Fund; or (ii) sell a security on a same-day settlement basis, earning a lower return on the investment. Use of the InterFund Program under these circumstances would enable the Fund to have access to immediate short-term liquidity.

7. While Bank Borrowing and/or custodian overdrafts generally could supply Funds with needed cash to cover unanticipated redemptions and sales fails, under the proposed InterFund Program, a borrowing Fund would pay lower interest rates than those that would be payable under short-term loans offered by banks or custodian overdrafts. In addition, Funds making short-term cash loans directly to other Funds would earn interest at a rate higher than they otherwise could obtain from investing their cash in Short-Term Instruments. Thus, applicants assert that the proposed InterFund Program would benefit both borrowing and lending Funds.

8. The interest rate to be charged to the Funds on any Interfund Loan (the “Interfund Loan Rate”) would be the average of the “Repo Rate” and the “Bank Loan Rate,” both as defined below. The Repo Rate would be the highest current overnight repurchase agreement rate available to a lending Fund. The Bank Loan Rate for any day would be calculated by the InterFund Program Team, as defined below, on each day an Interfund Loan is made according to a formula established by each Fund's board of trustees (the “Board”) intended to approximate the lowest interest rate at which a bank short-term loan would be available to the Fund. The formula would be based upon a publicly available rate (e.g., Federal funds rate and/or LIBOR) plus an additional spread of basis points and would vary with this rate so as to reflect changing bank loan rates. The initial formula and any subsequent modifications to the formula would be subject to the approval of each Fund's Board. In addition, the Board of each Fund would periodically review the continuing appropriateness of reliance on the formula used to determine the Bank Loan Rate, as well as the relationship between the Bank Loan Rate and current bank loan rates that would be available to the Fund.

9. Certain members of the Advisers' administration personnel (other than investment advisory personnel) (the “InterFund Program Team”) would administer the InterFund Program. No portfolio manager of any Fund will serve as a member of the InterFund Program Team. Under the proposed InterFund Program, the portfolio managers for each participating Fund could provide standing instructions to participate daily as a borrower or lender. The InterFund Program Team on each business day would collect data on the uninvested cash and borrowing requirements of all participating Funds. Once the InterFund Program Team has determined the aggregate amount of cash available for loans and borrowing demand, the InterFund Program Team will allocate loans among borrowing Funds without any further communication from the portfolio managers of the Funds. Applicants anticipate that there typically will be far more available uninvested cash each day than borrowing demand. Therefore, after the InterFund Program Team has allocated cash for Interfund Loans, the InterFund Program Team will invest any remaining cash in accordance with the standing instructions of the relevant portfolio manager or such remaining amounts will be invested directly by the portfolio managers of the Funds.

10. The InterFund Program Team would allocate borrowing demand and cash available for lending among the Funds on what the InterFund Program Team believes to be an equitable basis, subject to certain administrative procedures applicable to all Funds, such as the time of filing requests to participate, minimum loan lot sizes, and the need to minimize the number of transactions and associated administrative costs. To reduce transaction costs, each Interfund Loan normally would be allocated in a manner intended to minimize the number of participants necessary to complete the loan transaction. The method of allocation and related administrative procedures would be approved by the Board of each of the Funds, including a majority of the Board members who are not “interested persons,” as defined in section 2(a)(19) of the Act (“Independent Board Members”), to ensure that both borrowing and lending Funds participate on an equitable basis.

11. The InterFund Program Team, on behalf of the Advisers. would: (a) Monitor the Interfund Loan Rate and the other terms and conditions of the Interfund Loans; (b) limit the borrowings and loans entered into by each Fund to ensure that they comply with the Fund's investment policies and limitations; (c) implement and follow procedures designed to ensure equitable treatment of each Fund; and (d) make quarterly reports to the Board of each Fund concerning any transactions by the applicable Fund under the InterFund Program and the Interfund Loan Rate.

12. The Advisers, through the InterFund Program Team, would administer the InterFund Program as disinterested fiduciaries as part of their duties under the investment management and administrative agreements with each Fund and would receive no additional fee as compensation for its services in connection with the administration of the InterFund Program.

13. No Fund may participate in the InterFund Program unless: (a) The Fund has obtained shareholder approval for its participation, if such approval is required by law; (b) the Fund has fully disclosed all material information concerning the InterFund Program in its registration statement on Form N-1A; and (c) the Fund's participation in the InterFund Program is consistent with its investment objectives, limitations and organizational documents.

14. As part of the Board's review of the continuing appropriateness of a Fund's participation in the proposed credit facility as required by condition 14, the Board of the Fund, including a majority of the Independent Board Members, also will review the process in place to appropriately assess: (i) If the Fund participates as a lender, any effect its participation may have on the Fund's liquidity risk; and (ii) if the Fund participates as a borrower, whether the Fund's portfolio liquidity is sufficient to satisfy its obligations under the facility along with its other liquidity needs.

15. In connection with the InterFund Program, applicants request an order under section 6(c) of the Act exempting them from the provisions of sections 18(f) and 21(b) of the Act; under section 12(d)(1)(J) of the Act exempting them from section 12(d)(1) of the Act; under sections 6(c) and 17(b) of the Act exempting them from sections 17(a)(1), 17(a)(2), and 17(a)(3) of the Act; and under section 17(d) of the Act and rule 17d-1 under the Act to permit certain joint arrangements and transactions.

1. Section 17(a)(3) of the Act generally prohibits any affiliated person of a registered investment company, or affiliated person of an affiliated person, from borrowing money or other property from the registered investment company. Section 21(b) of the Act generally prohibits any registered management company from lending money or other property to any person, directly or indirectly, if that person controls or is under common control with that company. Section 2(a)(3)(C) of the Act defines an “affiliated person” of another person, in part, to be any person directly or indirectly controlling, controlled by, or under common control with, such other person. Section 2(a)(9) of the Act defines “control” as the “power to exercise a controlling influence over the management or policies of a company,” but excludes circumstances in which “such power is solely the result of an official position with such company.” Applicants state that the Funds may be under common control by virtue of having common investment advisers and/or by having common trustees, directors, managers and/or officers.

2. Section 6(c) of the Act provides that an exemptive order may be granted where an exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Section 17(b) of the Act authorizes the Commission to exempt a proposed transaction from section 17(a) provided that the terms of the transaction, including the consideration to be paid or received, are fair and reasonable and do not involve overreaching on the part of any person concerned, and the transaction is consistent with the policy of the investment company as recited in its registration statement and with the general purposes of the Act. Applicants believe that the proposed arrangements satisfy these standards for the reasons discussed below.

3. Applicants assert that sections 17(a)(3) and 21(b) of the Act were intended to prevent a party with strong potential adverse interests to, and some influence over the investment decisions of, a registered investment company from causing or inducing the investment company to engage in lending transactions that unfairly inure to the benefit of such party and that are detrimental to the best interests of the investment company and its shareholders. Applicants assert that the proposed transactions do not raise these concerns because: (a) The Advisers, through the InterFund Program Team members, would administer the InterFund Program as disinterested fiduciaries as part of their duties under the investment management and administrative agreements with each Fund; (b) all Interfund Loans would consist only of uninvested cash reserves that the Fund otherwise would invest in short-term repurchase agreements or other short-term investments; (c) the Interfund Loans would not involve a greater risk than such other investments; (d) the lending Fund would receive interest at a rate higher than it could otherwise obtain through such other investments; and (e) the borrowing Fund would pay interest at a rate lower than otherwise available to it under its bank loan agreements or through custodian overdrafts and avoid the commitment fees associated with lines of credit. Moreover, applicants assert that the other terms and conditions that applicants propose also would effectively preclude the possibility of any Fund obtaining an undue advantage over any other Fund.

4. Section 17(a)(1) of the Act generally prohibits an affiliated person of a registered investment company, or any affiliated person of such a person, from selling securities or other property to the investment company. Section 17(a)(2) of the Act generally prohibits an affiliated person of a registered investment company, or any affiliated person of such a person, from purchasing securities or other property from the investment company. Section 12(d)(1) of the Act generally prohibits a registered investment company from purchasing or otherwise acquiring any security issued by any other investment company except in accordance with the limitations set forth in that section.

5. Applicants state that the obligation of a borrowing Fund to repay an Interfund Loan could be deemed to constitute a security for the purposes of sections 17(a)(1) and 12(d)(1). Applicants also state that any pledge of securities to secure an Interfund Loan by the borrowing Fund to the lending Fund could constitute a purchase of securities for purposes of section 17(a)(2) of the Act. Section 12(d)(1)(J) of the Act provides that the Commission may exempt persons or transactions from any provision of section 12(d)(1) if and to the extent that such exemption is consistent with the public interest and the protection of investors. Applicants contend that the standards under sections 6(c), 17(b), and 12(d)(1)(J) are satisfied for all the reasons set forth above in support of their request for relief from sections 17(a)(3) and 21(b) and for the reasons discussed below. Applicants state that the requested relief from section 17(a)(2) of the Act meets the standards of section 6(c) and 17(b) because any collateral pledged to secure an Interfund Loan would be subject to the same conditions imposed by any other lender to a Fund that imposes conditions on the quality of or access to collateral for a borrowing (if the lender is another Fund) or the same or better conditions (in any other circumstance).

6. Applicants state that section 12(d)(1) was intended to prevent the pyramiding of investment companies in order to avoid imposing on investors additional and duplicative costs and fees attendant upon multiple layers of investment companies. Applicants submit that the proposed InterFund Program does not involve these abuses. Applicants note that there will be no duplicative costs or fees to the Funds or their shareholders, and that each Adviser will receive no additional compensation for its services in administering the InterFund Program. Applicants also note that the purpose of the proposed InterFund Program is to provide economic benefits for all the participating Funds and their shareholders. Section 18(f)(1) of the Act prohibits open-end investment companies from issuing any senior security except that a company is permitted to borrow from any bank, provided, that immediately after the borrowing, there is asset coverage of at least 300 per centum for all borrowings of the company. Under section 18(g) of the Act, the term “senior security” generally includes any bond, debenture, note or similar obligation or instrument constituting a security and evidencing indebtedness. Applicants request exemptive relief under section 6(c) from section 18(f)(1) to the limited extent necessary to implement the InterFund Program (because the lending Funds are not banks).

7. Applicants believe that granting relief under section 6(c) is appropriate because the Funds would remain subject to the requirement of section 18(f)(1) that all borrowings of a Fund, including combined Interfund Loans and bank borrowings, have at least 300% asset coverage. Based on the conditions and safeguards described in the application, applicants also submit that to allow the Funds to borrow from other Funds pursuant to the proposed InterFund Program is consistent with the purposes and policies of section 18(f)(1).

8. Section 17(d) of the Act and rule 17d-1 under the Act generally prohibit an affiliated person of a registered investment company, or any affiliated person of such a person, when acting as principal, from effecting any joint transaction in which the investment company participates, unless, upon application, the transaction has been approved by the Commission. Rule 17d-1(b) under the Act provides that in passing upon an application filed under the rule, the Commission will consider whether the participation of the registered investment company in a joint enterprise, joint arrangement or profit sharing plan on the basis proposed is consistent with the provisions, policies and purposes of the Act and the extent to which such participation is on a basis different from or less advantageous than that of the other participants.

9. Applicants assert that the purpose of section 17(d) is to avoid overreaching by and an unfair advantage to insiders. Applicants assert that the InterFund Program is consistent with the provisions, policies and purposes of the Act in that it offers both reduced borrowing costs and enhanced returns on loaned funds to all participating Funds and their shareholders. Applicants note that each Fund would have an equal opportunity to borrow and lend on equal terms consistent with its investment policies and fundamental investment limitations. Applicants assert that each Fund's participation in the proposed InterFund Program would be on terms that are no different from or less advantageous than that of other participating Funds.

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

1. The Interfund Loan Rate will be the average of the Repo Rate and the Bank Loan Rate.

2. On each business day, when an interfund loan is to be made, the InterFund Program Team will compare the Bank Loan Rate with the Repo Rate and will make cash available for Interfund Loans only if the Interfund Loan Rate is: (a) More favorable to the lending Fund than the Repo Rate; and (b) more favorable to the borrowing Fund than the Bank Loan Rate.

3. If a Fund has outstanding Bank Borrowings, any Interfund Loan to the Fund will: (a) Be at an interest rate equal to or lower than the interest rate of any outstanding bank loan; (b) be secured at least on an equal priority basis with at least an equivalent percentage of collateral to loan value as any outstanding bank loan that requires collateral; (c) have a maturity no longer than any outstanding bank loan (and in any event not over seven days); and (d) provide that, if an event of default occurs under any agreement evidencing an outstanding bank loan to the Fund, that event of default by the Fund, will automatically (without need for action or notice by the lending Fund) constitute an immediate event of default under the interfund lending agreement which both (i) entitles the lending Fund to call the Interfund Loan immediately and exercise all rights with respect to any collateral and (ii) causes the call to be made if the lending bank exercises its right to call its loan under its agreement with the borrowing Fund.

4. A Fund may borrow on an unsecured basis through the InterFund Program only if the relevant borrowing Fund's outstanding borrowings from all sources immediately after the interfund borrowing total 10% or less of its total assets, provided that if the borrowing Fund has a secured loan outstanding from any other lender, including but not limited to another Fund, the lending Fund's Interfund Loan will be secured on at least an equal priority basis with at least an equivalent percentage of collateral to loan value as any outstanding loan that requires collateral. If a borrowing Fund's total outstanding borrowings immediately after an Interfund Loan would be greater than 10% of its total assets, the Fund may borrow through the InterFund Program only on a secured basis. A Fund may not borrow through the InterFund Program or from any other source if its total outstanding borrowings immediately after the borrowing would be more than 331/3% of its total assets or any lower threshold provided for by a Fund's fundamental restriction or non-fundamental policy.

5. Before any Fund that has outstanding interfund borrowings may, through additional borrowings, cause its outstanding borrowings from all sources to exceed 10% of its total assets, it must first secure each outstanding Interfund Loan to a Fund by the pledge of segregated collateral with a market value at least equal to 102% of the outstanding principal value of the loan. If the total outstanding borrowings of a Fund with outstanding Interfund Loans exceed 10% of its total assets for any other reason (such as a decline in net asset value or because of shareholder redemptions), the Fund will within one business day thereafter either: (a) Repay all its outstanding Interfund Loans to other Funds; (b) reduce its outstanding indebtedness to other Funds to 10% or less of its total assets; or (c) secure each outstanding Interfund Loan to other Funds by the pledge of segregated collateral with a market value at least equal to 102% of the outstanding principal value of the loan until the Fund's total outstanding borrowings cease to exceed 10% of its total assets, at which time the collateral called for by this condition 5 shall no longer be required. Until each Interfund Loan that is outstanding at any time that a Fund's total outstanding borrowings exceed 10% of its total assets is repaid or the Fund's total outstanding borrowings cease to exceed 10% of its total assets, the Fund will mark the value of the collateral to market each day and will pledge such additional collateral as is necessary to maintain the market value of the collateral that secures each outstanding Interfund Loan to Funds at least equal to 102% of the outstanding principal value of the Interfund Loans.

6. No Fund may lend to another Fund through the InterFund Program if the loan would cause the lending Fund's aggregate outstanding loans through the InterFund Program to exceed 15% of its current net assets at the time of the loan.

7. A Fund's Interfund Loans to any one Fund shall not exceed 5% of the lending Fund's net assets.

8. The duration of Interfund Loans will be limited to the time required to receive payment for securities sold, but in no event more than seven days. Loans effected within seven days of each other will be treated as separate loan transactions for purposes of this condition.

9. A Fund's borrowings through the InterFund Program, as measured on the day when the most recent loan was made, will not exceed the greater of 125% of the Fund's total net cash redemptions for the preceding seven calendar days or 102% of a Fund's sales fails for the preceding seven calendar days.

10. Each Interfund Loan may be called on one business day's notice by a lending Fund and may be repaid on any day by a borrowing Fund.

11. A Fund's participation in the InterFund Program must be consistent with its investment restrictions, policies, limitations and organizational documents.

12. The InterFund Program Team will calculate total Fund borrowing and lending demand through the InterFund Program, and allocate Interfund Loans on an equitable basis among the Funds, without the intervention of any portfolio manager. The InterFund Program Team will not solicit cash for the InterFund Program from any Fund or prospectively publish or disseminate loan demand data to portfolio managers. The InterFund Program Team will invest all amounts remaining after satisfaction of borrowing demand in accordance with the standing instructions of the relevant portfolio manager or such remaining amounts will be invested directly by the portfolio managers of the Funds.

13. The InterFund Program Team will monitor the Interfund Loan Rate charged and the other terms and conditions of the Interfund Loans and will make a quarterly report to the Boards concerning the participation of the Funds in the InterFund Program and the terms and other conditions of any extensions of credit under the InterFund Program.

14. Each Board, including a majority of its Independent Board Members, will:

(a) Review, no less frequently than quarterly, the participation of each Fund it oversees in the InterFund Program during the preceding quarter for compliance with the conditions of any order permitting such participation;

(b) establish the Bank Loan Rate formula used to determine the interest rate on Interfund Loans;

(c) review, no less frequently than annually, the continuing appropriateness of the Bank Loan Rate formula; and

(d) review, no less frequently than annually, the continuing appropriateness of the participation in the InterFund Program by each Fund it oversees.

15. Each Fund will maintain and preserve for a period of not less than six years from the end of the fiscal year in which any transaction by it under the InterFund Program occurred, the first two years in an easily accessible place, written records of all such transactions setting forth a description of the terms of the transaction, including the amount, the maturity and the Interfund Loan Rate, the rate of interest available at the time each Interfund Loan is made on overnight repurchase agreements and Bank Borrowings, and such other information presented to the Boards of the Funds in connection with the review required by conditions 13 and 14.

16. In the event an Interfund Loan is not paid according to its terms and the default is not cured within two business days from its maturity or from the time the lending Fund makes a demand for payment under the provisions of the interfund lending agreement, the Adviser to the lending Fund promptly will refer the loan for arbitration to an independent arbitrator selected by the Board of any Fund involved in the loan who will serve as arbitrator of disputes concerning Interfund Loans.3 The arbitrator will resolve any problem promptly, and the arbitrator's decision will be binding on both Funds. The arbitrator will submit, at least annually, a written report to the Board of each Fund setting forth a description of the nature of any dispute and the actions taken by the Funds to resolve the dispute.

17. The Advisers will prepare and submit to the Board for review an initial report describing the operations of the InterFund Program and the procedures to be implemented to ensure that all Funds are treated fairly. After the commencement of the InterFund Program, the Advisers will report on the operations of the InterFund Program at each Board's quarterly meetings. Each Fund's chief compliance officer, as defined in rule 38a-1(a)(4) under the Act, shall prepare an annual report for its Board each year that the Fund participates in the InterFund Program, that evaluates the Fund's compliance with the terms and conditions of the application and the procedures established to achieve such compliance. Each Fund's chief compliance officer will also annually file a certification pursuant to Item 77Q3 of Form N-SAR as such form may be revised, amended or superseded from time to time, for each year that the Fund participates in the InterFund Program, that certifies that the Fund and its Adviser have implemented procedures reasonably designed to achieve compliance with the terms and conditions of the order. In particular, such certification will address procedures designed to achieve the following objectives:

(a) That the Interfund Loan Rate will be higher than the Repo Rate but lower than the Bank Loan Rate;

(b) compliance with the collateral requirements as set forth in the application;

(c) compliance with the percentage limitations on interfund borrowing and lending;

(d) allocation of interfund borrowing and lending demand in an equitable manner and in accordance with procedures established by the Board; and

(e) that the Interfund Loan Rate does not exceed the interest rate on any third party borrowings of a borrowing Fund at the time of the Interfund Loan.

Additionally, each Fund's independent registered public accountants, in connection with their audit examination of the Fund, will review the operation of the InterFund Program for compliance with the conditions of the application and their review will form the basis, in part, of the auditor's report on internal accounting controls in Form N-SAR.

18. No Fund will participate in the InterFund Program, upon receipt of requisite regulatory approval, unless it has fully disclosed in its registration statement on Form N-1A (or any successor form adopted by the Commission) all material facts about its intended participation.