Federal Register Vol. 80, No.129,

The purpose of the meeting is:

1. Establish meeting schedule for 2015 and 2016;

2. Vote for the election of the chairperson; and

3. Identify potential field trip dates to review completed projects.

The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by July 29, 2015, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Attention: Louis Haynes, RAC Coordinator, Ashley NF Supervisor's Office, 355 North Vernal Avenue, Vernal, Utah 84078; by email to [email protected], or via facsimile to 435-781-5142.

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

The purpose of the meeting is:

1. Outline meeting objectives,

2. Agenda review,

3. Discussion of administrative needs, and

4. Review projects submitted for Title II funding.

The meeting is open to the public. This is the second of two meetings of the RAC to determine which projects will be considered for funding. This first meeting was an initial sort of projects with possible approval of projects; the second meeting allows for additional public input and presentations needed for project clarification. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Richard Newton, RAC Designated Federal Officer, Emmett Ranger District, 1805 Highway 16 #5, Emmett, ID; by email to [email protected], or via facsimile to 208-374-5623.

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

The purpose of the meeting is:

1. Outline meeting objectives,

2. Selection of a new Chairman,

3. Discussion of administrative needs, and

4. Review projects submitted for Title II funding.

The meeting is open to the public. This is the first of two meetings of the RAC to determine which projects will be considered for funding. This first meeting will function as an initial sort of projects with possible approval of projects; the second meeting will allow for additional public input and presentations needed for project clarification. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Richard Newton, RAC Designated Federal Officer, Emmett Ranger District, 1805 Highway 16 #5, Emmett, ID; by email to [email protected], or via facsimile to 208-374-5623.

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

Background

On April 9, 2015, the Department published the Preliminary Results. The POR is July 1, 2013 through June 30, 2014. We invited interested parties to comment on the Preliminary Results. We received no comments.

The Department conducted this administrative review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act).

The merchandise subject to the order is solid urea, a high-nitrogen content fertilizer which is produced by reacting ammonia with carbon dioxide. The product is currently classified under the Harmonized Tariff Schedules of the United States (HTSUS) item number 3102.10.00.00. Previously, such merchandise was classified under item number 480.3000 of the Tariff Schedules of the United States. Although the HTSUS subheading is provided for convenience and customs purposes, the written description of the merchandise subject to the order is dispositive.

The Department made no changes to its calculations announced in the Preliminary Results.

For the final results of this review, we determine that a weighted-average dumping margin of 0.00 percent exists for MCC EuroChem for the POR.

In accordance with 19 CFR 351.212 and the Final Modification, 2 the Department will instruct U.S. Customs and Border Protection (CBP) to liquidate all appropriate entries for MCC EuroChem without regard to antidumping duties.

For entries of subject merchandise during the POR produced by MCC EuroChem for which it did not know its merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.3

The merchandise covered by the order includes tapered roller bearings. The subject merchandise is currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 8482.20.00, 8482.91.00.50, 8482.99.15, 8482.99.45, 8483.20.40, 8483.20.80, 8483.30.80, 8483.90.20, 8483.90.30, 8483.90.80, 8708.70.6060, 8708.99.2300, 8708.99.4850, 8708.99.6890, 8708.99.8115, and 8708.99.8180. The HTSUS subheadings are provided for convenience and customs purposes only; the written description of the scope of the order is dispositive.2

The Department is conducting this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act). As noted above, there are two mandatory respondents in this administrative review: CPZ/SGBC and Yantai CMC. For CPZ/SGBC, we calculated constructed export prices in accordance with section 772 of the Act. Because the PRC is a non-market economy (NME) within the meaning of section 771(18) of the Act, normal value has been calculated in accordance with section 773(c) of the Act.

For Yantai CMC, we preliminarily find that this respondent is ineligible for a separate rate because it has failed to demonstrate an absence of de facto government control in this administrative review. Therefore, we did not calculate a separate margin for Yantai CMC.

For a full description of the methodology underlying our conclusions, see the Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov and in the Central Records Unit, room B0824 of the main Department of Commerce building. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at http://enforcement.trade.gov/frn/index.html. The signed Preliminary Decision Memorandum and the electronic version of the Preliminary Decision Memorandum are identical in content. A list of the topics discussed in the Preliminary Decision Memorandum is attached as the Appendix to this notice.

The statute and the Department's regulations do not address the establishment of the rate applied to individual respondents not selected for individual examination when the Department limits its examination in an administrative review pursuant to section 777A(c)(2) of the Act. Generally, the Department looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance when calculating the rate for separate-rate respondents that are not examined individually in an administrative review. Section 735(c)(5)(A) of the Act notes a preference that we are not to calculate an all-others rate using rates for individually-examined respondents which are zero, de minimis, or based entirely on facts available. Section 735(c)(5)(B) of the Act provides that, where all rates are zero, de minimis, or based entirely on facts available, the Department may use “any reasonable method” for assigning a rate to non-examined respondents.

For these preliminary results, we calculated a margin of zero percent for CPZ/SGBC. Therefore, we preliminarily determine that the application of the rate from the previous administrative review to the non-examined separate-rate companies is consistent with precedent 3 and the most appropriate method to determine the separate rate in the instant review. Pursuant to this method, we are preliminarily assigning the margin of 0.65 percent, the most recent margin calculated for the non-examined separate-rate respondents,4 to the non-examined separate-rate respondents in the instant review.

Because Yantai CMC did not demonstrate that it was entitled to a separate rate, the Department preliminarily finds Yantai CMC to be part of the PRC-wide entity.5 The rate previously established for the PRC-wide entity is 92.84 percent.

The Department preliminarily determines that the following weighted-average dumping margins exist for the period June 1, 2013, through May 31, 2014:

The Department will disclose calculations performed for these preliminary results to the parties within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b). Interested parties may submit case briefs no later than 30 days after the date of publication of these preliminary results of review.6 Rebuttals to case briefs may be filed no later than five days after case briefs are filed and all rebuttal briefs must be limited to comments raised in the case briefs. Parties who submit comments are requested to submit with the argument: (1) A statement of the issue; (2) a brief summary of the argument; and (3) a table of authorities.7

Any interested party may request a hearing within 30 days of publication of this notice.8 Hearing requests should contain the following information: (1) The party's name, address, and telephone number; (2) the number of participants; and (3) a list of the issues to be discussed. Oral presentations will be limited to issues raised in the briefs.9 If a request for a hearing is made, parties will be notified of the time and date for the hearing to be held at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230.10

All submissions, with limited exceptions, must be filed electronically using ACCESS. An electronically filed document must be received successfully in its entirety by 5 p.m. Eastern Time (ET) on the due date. Documents excepted from the electronic submission requirements must be filed manually (i.e., in paper form) with the APO/Dockets Unit in Room 18022 and stamped with the date and time of receipt by 5 p.m. ET on the due date.

Unless otherwise extended, the Department intends to issue the final results of this administrative review, which will include the results of its analysis of all issues raised in the case briefs, within 120 days of publication of these preliminary results, pursuant to section 751(a)(3)(A) of the Act.

Upon issuance of the final results, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.11 The Department intends to issue assessment instructions to CBP 15 days after the publication of the final results of this review. For each individually-examined respondent in this review (i.e., CPZ/SGBC) which has a weighted-average dumping margin which is not zero or de minimis (i.e., less than 0.5 percent), we will calculate importer-specific assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those sales, in accordance with 19 CFR 351.212(b)(1).12 Where either the respondent's weighted-average dumping margin is zero or de minimis, or an importer-specific ad valorem dumping margin is zero or de minimis, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

For the respondents which were not selected for individual examination in this administrative review and which qualified for a separate rate, the assessment rate will be equal to the dumping margin assigned to the non-examined separate-rate companies in the 2012-2013 administrative review of TRBs from the PRC.13

For the final results, if we continue to treat Yantai CMC as part of the PRC-wide entity, we will instruct CBP to apply an ad valorem assessment rate of 92.84 percent to all entries of subject merchandise during the POR which were exported by Yantai CMC.

For entries that were not reported in the U.S. sales databases submitted by companies individually examined during this review, the Department will instruct CBP to liquidate such entries at the PRC-wide rate. In addition, if the Department determines that an exporter under review had no shipments of the subject merchandise, any suspended entries that entered under that exporter's case number (i.e., at that exporter's rate) will be liquidated at the PRC-wide rate.14

The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For the exporters listed above which have a separate rate, the cash deposit rate will be the rate established in the final results of this review (except, if the rate is zero or de minimis, then a cash deposit rate of zero will be established for that company); (2) for previously investigated or reviewed PRC and non-PRC exporters not listed above that have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recently completed segment of this proceeding; (3) for all PRC exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be the rate for the PRC-wide entity, 92.84 percent; and (4) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporter(s) that supplied that non-PRC exporter. These deposit requirements, when imposed, shall remain in effect until further notice.

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

We are issuing and publishing these preliminary results of review in accordance with sections 751(a)(l) and 777(i)(l) of the Act, and 19 CFR 351.221(b)(4).

Background

Based on a request from Qingshui, the Department initiated a CCR on Qingshui to determine whether it is the successor-in-interest to Cangshan Qingshui, for purposes of determining antidumping duties due as a result of the Order. The Department preliminarily determined that Qingshui is the successor-in-interest to Cangshan Qingshui and is entitled to its cash deposit rate with respect to entries of merchandise subject to the AD order on fresh garlic from the PRC.3 The Department provided interested parties 30 days from the date of publication of the preliminary results to submit comments or request a public hearing in accordance with 19 CFR 351.309(c)(1)(ii). No parties submitted comments or requests for a public hearing.

The products covered by the order are all grades of garlic, whole or separated into constituent cloves, whether or not peeled, fresh, chilled, frozen, water or other neutral substance, but not prepared or preserved by the addition of other ingredients or heat processing. The differences between grades are based on color, size, sheathing, and level of decay. The scope of the order does not include the following: (a) Garlic that has been mechanically harvested and that is primarily, but not exclusively, destined for non-fresh use; or (b) garlic that has been specially prepared and cultivated prior to planting and then harvested and otherwise prepared for use as seed. The subject merchandise is used principally as a food product and for seasoning. The subject garlic is currently classifiable under subheadings: 0703.20.0000, 0703.20.0010, 0703.20.0015, 0703.20.0020, 0703.20.0090, 0710.80.7060, 0710.80.9750, 0711.90.6000, 0711.90.6500, 2005.90.9500, 2005.90.9700, 2005.99.9700, and of the Harmonized Tariff Schedule of the United States (HTSUS).

Although the HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope of the order is dispositive. In order to be excluded from the order, garlic entered under the HTSUS subheadings listed above that is (1) mechanically harvested and primarily, but not exclusively, destined for non-fresh use or (2) specially prepared and cultivated prior to planting and then harvested and otherwise prepared for use as seed must be accompanied by declarations to U.S. Customs and Border Protection to that effect.

Because no party submitted comments opposing the Department's Preliminary Results, and the record contains no other information or evidence that calls into question the Preliminary Results, the Department determines that Qingshui is the successor-in-interest to Cangshan Qingshui.

As a result of this determination, the Department finds that Qingshui is entitled to the cash deposit rate previously assigned to Cangshan Qingshui as determined in the new shipper review of Cangshan Qingshui.4 Consequently, the Department will instruct U.S. Customs and Border Protection to collect estimated antidumping duties for all shipments of subject merchandise produced and/or exported by Qingshui, and entered, or withdrawn from warehouse, for consumption on or after the publication date of this notice in the Federal Register at $3.06 per kilogram, which is the current antidumping duty cash deposit rate for Cangshan Qingshui.5 This cash deposit requirement shall remain in effect until further notice.

This notice serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.306. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.

We are issuing and publishing these final results in accordance with sections 751(b)(1) and 777(i) of the Act, and 19 CFR 351.216.

The National Institute of Standards and Technology (NIST) is one of our Nation's oldest Federal laboratories (for more information, visit www.nist.gov). As a bureau in the Department of Commerce, the NIST mission is to promote U.S. innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve our quality of life. From early electrical measurement research to today's quantum information science, NIST has long been, and continues to be, a center for high-impact research meeting the needs of academia, industry, and government. The NIST laboratories conduct world-class research, often in close collaboration with industry, which advances the nation's technology infrastructure and helps U.S. companies continually improve products and services.

NIST publishes this notice to seek comments on the NIST Plan for Providing Public Access to the Results of Federally Funded Research (NIST Public Access Plan), posted at www.nist.gov/data. The NIST Public Access Plan documents NIST's plan to implement new responsibilities and procedures to manage the public access of scientific data and publications. Comments received on the NIST Public Access Plan will inform NIST as it revises its directives that implement the Plan.

NIST is taking steps to make its scientific data and publications more readily available and accessible by the public, as directed in several recent White House memoranda, Office of Management and Budget Memoranda M-10-06, Open Government Directive, and M-13-13, Open Data Policy—Managing Information as an Asset; and the February 22, 2013, Office of Science and Technology Policy Memorandum, Increasing Access to the Results of Federally Funded Scientific Research.

The NIST Public Access Plan applies to the results of research funded wholly or in part by NIST, presented in peer-reviewed scholarly publications and as research data. Research data means the recorded factual material commonly accepted in the scientific community as necessary to validate research findings, but not any of the following: preliminary analyses,1 drafts of scientific papers, plans for future research, peer reviews, or communications with colleagues. This “recorded” material excludes physical objects (e.g., laboratory samples). Research data does not include: Trade secrets, commercial information, materials necessary to be held confidential by a researcher until they are published, or similar information which is protected under law; and personnel and medical information and similar information the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, such as information that could be used to identify a particular person in a research study.2

Putting new plans in place to manage public access to NIST data and publications stands to significantly benefit the public and NIST by ensuring that the integrity of NIST data and publications is maintained throughout their life cycles, and by increasing the visibility of NIST measurements, standards, technology, and research activities. Stakeholder consultation is a critical step in the development of NIST's plan for managing public access to research results.

In May 2013, NIST co-sponsored two public comment meetings at the National Academy of Sciences on providing public access to federally supported R&D data and publications.3 The stakeholder input gathered at these public meetings and information from ongoing dialogue with other Federal agencies were considered in the development of the NIST Public Access Plan. NIST invites respondents to comment on the following questions that pertain to the implementation of its public access policy:

• What are the best practices (from academia, industry, and other stakeholder communities) in managing public access of data?

• What are the biggest challenges to implementing a public access policy, and how can these challenges be addressed?

• What criteria could the NIST laboratories use in prioritizing the public release of datasets?

• How can NIST improve its plan to provide greater public access to NIST data?

All comments must be received in accordance with the DATES section of the notice above.

The committee plans to address elements of 2016-2018 Atlantic herring fishery specifications, including the specification of management uncertainty, the stockwide Atlantic herring annual catch limit (ACL), domestic annual harvesting (DAH), domestic annual processing (DAP), U.S. at-sea processing (USAP), Border Transfer (BT), fixed gear set-aside (FGSA), and Research Set-Aside (RSA). They also plan to develop options (as appropriate) for 2016-2018 Atlantic herring sub-ACLs (by management area) and gear/area catch caps for river herring and shad (RH/S). The committee will develop recommendations for seasonal sub-ACLs in any management areas. Additionally, they will discuss and develop options (as appropriate) to modify management measures related to Atlantic herring RSAs. Other business will be discussed as necessary.

Although non-emergency issues not contained in this agenda may come before these groups for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.

All appointments are made pursuant to Section 4314 of Chapter 43 of Title 5 of the United States Code.

The following individuals are appointed as members of the Committee Performance Review Board responsible for making recommendations to the appointing and awarding authorities on performance appraisal ratings and performance awards for Senior Executive Service employees:

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

Title: “Process for Review of Swaps for Mandatory Clearing,” (OMB Control No. 3038-0097).

Abstract: The Commodity Exchange Act and Commission regulations require a derivatives clearing organization (“DCO”) that wishes to accept a swap for clearing to be eligible to clear the swap and to submit the swap to the Commission for a determination as to whether the swap is required to be cleared. Commission Regulation 39.5 sets forth the process for these submissions. The Commission uses the information in this collection to determine whether a DCO that wishes to accept a swap for clearing is eligible to clear the swap and whether the swap should be required to be cleared.

Burden Statement: The respondent burden for this collection is estimated to average 40 hours per response.

Respondents/Affected Entities: Derivatives clearing organizations.

Estimated Number of Respondents: 14.

Estimated Total Annual Burden on Respondents: 560 hours.

Frequency of Collection: On occasion.

Due to difficulties beyond the control of the Designated Federal Officer, the Department of Defense was unable to finalize the meeting announcement for the scheduled meeting of the Threat Reduction Advisory Committee on July 15-16, 2015, to ensure compliance with 41 CFR 102-3.150(a). Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.

Purpose of Meeting: This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (FACA) (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150. The TRAC will obtain, review and evaluate classified information related to the Committee's mission to advise on technology security, Combating Weapons of Mass Destruction (C-WMD), counter terrorism and counter proliferation.

Agenda: All discussions for the two-day meeting will be classified. On Wednesday, July 15, the Chair will open the meeting with remarks that outline the topics that will be covered in the two-day meeting. Following the opening remarks, the TRAC will receive a brief on the Office of Net Assessment and China. Following that brief, a representative from the Joint Atomic Energy Intelligence Committee will brief the TRAC on Russian Weapons Technology. The TRAC will then receive an overview brief on the National Nuclear Security Agency. Following the briefing, the TRAC will receive an overview brief that focuses on Department of Homeland Security Science and Technology. The first day will conclude with a TRAC-only session to discuss the information presented and how it relates to previous and current TRAC studies. The TRAC will continue to meet on July 16, 2015. The Chair will open the day with brief comments that summarize the previous day and outline the current day. Following his comments, the Director of the Defense Threat Reduction Agency & U.S. Strategic Center for Combatting Weapons of Mass Destruction & Standing Joint Force Headquarters—Elimination, will provide an overview of the organization to the TRAC. Following that, the TRAC will discuss the findings and recommendations from the Nuclear Strategic Stability focused information gathering group. Following that, the TRAC will discuss two new taskings: one that will focus on emerging issues for the Defense Threat Reduction Agency & U.S. Strategic Center for Combatting Weapons of Mass Destruction & Standing Joint Force Headquarters—Elimination, and the other will focus on North Korea. Following that, the Chair will lead a discussion on a new tasking, which will focus entirely on Russia and China. The Chair will conclude the meeting by providing an outline for the way forward and expectations for the next plenary that will take place in the fall.

Meeting Accessibility: Pursuant to 5 U.S.C. 552b, and 41 CFR 102-3.155, the Department of Defense has determined that the meeting shall be closed to the public. The Under Secretary of Defense for Acquisition, Technology, and Logistics, in consultation with the Department of Defense FACA Attorney, has determined in writing that the public interest requires all sessions of this meeting be closed to the public because the discussions will be concerned with classified information and matters covered by 5 U.S.C. 552b(c)(1). Such classified matters are inextricably intertwined with the unclassified material and cannot reasonably be segregated into separate discussions without disclosing secret material.

Committee's Designated Federal Officer or Point of Contact: Mr. William Hostyn, DoD, Defense Threat Reduction Agency/J/2/5/8R-ACP, 8725 John J. Kingman Road, MS 6201, Fort Belvoir, VA 22060-6201. Email: [email protected]. Phone: (703) 767-4453. Fax: (703) 767-4206.

Written Statements: Pursuant to section 10(a)(3) of FACA and 41 CFR 102-3.105(j) and 102-3.140, the public or interested organizations may submit written statements to the membership of the Committee at any time or in response to the stated agenda of a planned meeting. Written statements should be submitted to the Committee's Designated Federal Officer. The Designated Federal Officer's contact information is listed in the section immediately above or it can be obtained from the General Services Administration's FACA Database—http://www.facadatabase.gov/committee/committee.aspx?cid=1663&aid=41.

Written statements that do not pertain to a scheduled meeting of the Committee may be submitted at any time. However, if individual comments pertain to a specific topic being discussed at a planned meeting, then these statements must be submitted no later than five business days prior to the meeting in question. The Designated Federal Officer will review all submitted written statements and provide copies to all TRAC members.

On February 10, 2015, we published in the Federal Register (80 FR 7379) a proposed waiver of 34 CFR 75.261(a) and (c)(2) and extension of the project period (proposed waiver and extension) in order to—

(1) Enable the Secretary to provide additional funds to the current NHCTEP grantees with FY 2015 funds and possibly FY 2016 funds for project periods through FY 2016 and possibly through FY 2017; and

(2) Request comments on the proposed waiver and extension.

There are no substantive differences between the proposed waiver and extension and the final waiver and extension.

Public Comment: In response to our invitation in the proposed waiver and extension, we received six comments. Generally, we do not address comments that raise concerns not related to the proposed waiver and extension.

An analysis of the comments received in response to the proposed waiver and extension follows.

Comment: Almost all commenters supported the proposed waiver and extension of the NHCTEP project period. The commenters provided various reasons for their support of the waiver and extension, including the great need for funding beyond the two-year project period.

One commenter, who supported the proposed waiver and extension, stated that an abrupt suspension in the NHCTEP grantees' training services, as well as outreach, recruitment, academic, and retention efforts, would be detrimental to students who would then have to rely on welfare services instead of vocational training opportunities.

Another commenter stated that the continuity of funding would be a tremendous stabilizing benefit to the program and students. The commenter further stated that NHCTEP grantees have placed students in well-paying jobs with opportunities for advancement and the continuity of support would be more effective in maintaining their high-quality services. The commenter expressed the view that the extension would also help maximize their recruitment efforts, as well as positively affect the direct participation and completion of the Native Hawaiian students enrolled in NHCTEP-funded projects.

Two commenters indicated that the continuation of an existing NHCTEP grantee's program and its consortium of sub-grantees would allow them to continue to provide valued career and technical education (CTE) services to Native Hawaiian students, including special needs students. Also, the commenters stated that continuation grant awards would allow the consortium to continue providing specialized CTE training that would maximize both the participation and completion of Native Hawaiian students.

Finally, a commenter stated that the proposed waiver and extension would allow NHCTEP-funded projects more time to prepare Native Hawaiian high school students for postsecondary training or the workforce.

Discussion: We appreciate the support of the commenters and agree that extending the current NHCTEP grant period will allow current NHCTEP grantees to continue to work toward accomplishing the goals and objectives stated in their 2013 NHCTEP grant applications, including providing specialized CTE training to Native Hawaiian students. We agree that it is important that there not be a lapse in programming provided by NHCTEP grantees to CTE students.

Changes: None.

Comment: One commenter asked why the Department used the notice and comment procedures of the Administrative Procedure Act (APA) for this proposed waiver and extension. The commenter characterized the waiver and extension as a general statement of policy that would not fall within the APA's notice and comment rulemaking requirements, and inquired as to why the Department treated the waiver and extension differently. The commenter also cited the APA's exception of interpretive rules and statements of policy from the requirement for rules to have an effective date no fewer than 30 days after their date of publication.

Discussion: The APA defines a “rule” as “an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy” and requires agencies to follow notice and comment procedures when formulating, amending, or repealing rules. 5 U.S.C. 551, 553. As the commenter notes, the APA provides some exceptions to this requirement. For instance, absent another statute to the contrary, the APA exempts “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice” from its notice and comment rulemaking requirements. 5 U.S.C. 553(b)(A). In addition, the APA exempts “matter[s] relating to . . . loans, grants, benefits, or contracts” from notice and comment rulemaking. 5 U.S.C. 553(a)(2).

However, the General Education Provisions Act limits applicability of the APA's grants exemption to regulations (1) governing the first grant program under a new or substantially revised program authority, or (2) where the Secretary finds that use of notice and comment rulemaking would cause “extreme hardship to the intended beneficiaries of the program affected by such regulations.” 20 U.S.C. 1232(d). Neither of those two exceptions was applicable. As a result, the Department followed its standard practice of utilizing notice and comment rulemaking procedures for rules governing its grant programs.

The commenter is correct that the proposed waiver and extension could arguably be construed as an interpretive rule, which would not require use of the APA's notice and comment procedures. See 5 U.S.C. 553(b)(A). However, it is the Department's general practice to err on the side of providing the public with more openness, accessibility and transparency into its actions whenever practicable. This is especially true where, as here, no party is likely to be adversely affected by the Department's decision to seek notice and comment.

Changes: None.

NHCTEP, authorized by section 116 of the Carl D. Perkins Career and Technical Education Act of 2006 (the Perkins Act), supports grants to community-based organizations primarily serving and representing Native Hawaiians. Under this program, grantees carry out projects that provide organized educational activities offering a sequence of courses that—

(a) Provides individuals with coherent and rigorous content aligned with challenging academic standards and relevant technical knowledge and skills needed to prepare for further education and careers in current or emerging professions;

(b) Provides technical skill proficiency, an industry-recognized credential, a certificate, or an associate degree; and

(c) Includes competency-based applied learning that contributes to the academic knowledge, higher-order reasoning and problem-solving skills, work attitudes, general employability skills, technical and occupation-specific skills, and knowledge of all aspects of an industry, including entrepreneurship, of an individual. Projects may include prerequisite courses (other than remedial courses) that meet the definitional requirements of section 3(5)(A) of the Perkins Act (20 U.S.C. 2302(5)(A)).

On June 14, 2013, we published in the Federal Register (78 FR 35877) a notice inviting applications for NHCTEP grants (2013 NIA). Although the Secretary invited applications with a proposed project period of five years in previous NHCTEP competitions, in 2013, in anticipation of congressional reauthorization of the Perkins Act, the Department invited applications with proposed project periods of two years. The project periods for the NHCTEP projects funded under the 2013 NIA are scheduled to end in FY 2015. Because there is the potential for changes in the Perkins Act for NHCTEP beyond 2015, we do not believe it is in the public interest to hold a new NHCTEP competition in FY 2015 for projects that may then operate for just one year, or to announce a competition under which eligible entities would be expected to proceed through the application preparation and submission process while lacking critical information about the future of the program. Further, we do not think that it is in the public interest to have a lapse in the services currently provided by the NHCTEP grantees.

For these reasons, the Secretary waives the requirements of 34 CFR 75.261(a) and (c)(2) that generally prohibit project period extensions involving the obligation of additional Federal funds and extends the NHCTEP project period for up to 24 months. The waiver and extension will allow the current NHCTEP grantees to request and receive Federal funding annually for project periods through FY 2016 and possibly through FY 2017. We will fund the extended project period by using funds appropriated for FY 2015 or FY 2016, depending on whether the grants are extended for one or two years.

Any activities carried out during the period of a NHCTEP continuation award will have to be consistent with, or a logical extension of, the scope, goals, and objectives of the grantee's application as approved in the FY 2013 NHCTEP competition. The requirements applicable to continuation awards for this competition set forth in the 2013 NIA and the requirements in 34 CFR 75.253 will apply to any continuation awards sought by the current NHCTEP grantees. We will base our decisions regarding continuation awards on the program narratives, budgets, budget narratives, and program performance reports submitted by the current grantees, and the requirements in 34 CFR 75.253.

The waiver and extension will not exempt the current NHCTEP grantees from the appropriation account closing provisions of 31 U.S.C. 1552(a), nor will they extend the availability of funds previously awarded to current NHCTEP grantees. As a result of 31 U.S.C. 1552(a), appropriations available for a limited period may be used for payment of valid obligations for only five years after the expiration of their period of availability for Federal obligation. After that time, the unexpended balance of those funds is canceled and returned to the U.S. Department of the Treasury and is unavailable for restoration for any purpose (31 U.S.C. 1552(b)).

The Secretary certifies that the final waiver and extension and the activities required to support additional years of funding will not have a significant economic impact on a substantial number of small entities. The small entities that will be affected by this waiver and extension are the seven currently funded NHCTEP grantees and any potential applicants.

The Secretary further certifies that the final waiver and extension will not have a significant economic impact on these entities because the extension of an existing project imposes minimal compliance costs, and the activities required to support the additional years of funding will not impose additional regulatory burdens or require unnecessary Federal supervision.

This waiver and extension does not contain any information collection requirements.

NHCTEP is not subject to Executive Order 12372 and the regulations in 34 CFR part 79.

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the 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 this 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.

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: William D. Ford Federal Direct Loan Program: Internship/Residency and Loan Debt Burden Forbearance Forms.

OMB Control Number: 1845-0018.

Type of Review: A revision of an existing information collection.

Respondents/Affected Public: Individuals or Households.

Total Estimated Number of Annual Responses: 27,042.

Total Estimated Number of Annual Burden Hours: 6,393.

Abstract: These forms serve as the means by which borrowers in the William D. Ford Federal Direct Loan (Direct Loan), Federal Family Education Loan (FFEL) and the Federal Perkins Loan (Perkins Loan) Programs may request forbearance of repayment on their loans if they meet certain conditions. The U.S. Department of Education and other loan holders uses the information collected on these forms to determine whether a borrower meets the eligibility requirements for the specific type of forbearance.

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: William D. Ford Federal Direct Loan Program Deferment Request Forms.

OMB Control Number: 1845-0011.

Type of Review: A revision of an existing information collection.

Respondents/Affected Public: Individuals or Households.

Total Estimated Number of Annual Responses: 3,345,642.

Total Estimated Number of Annual Burden Hours: 535,303.

Abstract: These forms serve as the means by which borrowers in the William D. Ford Federal Direct Loan (Direct Loan), Federal Family Education Loan (FFEL) and the Federal Perkins Loan (Perkins Loan) Programs may request deferment of repayment on their loans if they meet certain statutory and regulatory criteria. The U.S. Department of Education and other loan holders uses the information collected on these forms to determine whether a borrower meets the eligibility requirements for the specific deferment type being submitted.

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

Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

Abstract: The Clean Water Act section 305(b) reports contain information on the water quality standards attainment status of assessed waters, and, when waters are impaired, the pollutants and potential sources affecting water quality. This information helps track State progress in addressing water pollution. Section 303(d) of the Clean Water Act requires States to identify and rank waters that cannot meet water quality standards (WQS) following the implementation of technology-based controls. Under section 303(d), States are also required to establish total maximum daily loads (TMDLs) for listed waters not meeting standards as a result of pollutant discharges. In developing the section 303(d) lists, States are required to consider various sources of water quality related data and information, including the section 305(b) State water quality reports. Section 106(e) requires that states annually update monitoring data and use it in their section 305(b) report. Section 314(a) requires states to report on the condition of their publicly-owned lakes within the section 305(b) report.

EPA's Assessment and Watershed Protection Division (AWPD) works with its Regional counterparts to review and approve or disapprove State section 303(d) lists and TMDLs from 56 respondents (the 50 States, the District of Columbia, and the five Territories). Section 303(d) specifically requires States to develop lists and TMDLs “from time to time,” and EPA to review and approve or disapprove the lists and the TMDLs. EPA also collects State 305(b) reports from 59 respondents (the 50 States, the District of Columbia, five Territories, and 3 River Basin Commissions).

Tribes are not required to submit section 305(b) reports. However, to meet the needs of Tribes at all levels of development, EPA has prepared guidance that presents the basic steps a Tribe should take to collect the water quality information it needs to make effective decisions about its program, its goals, and its future directions. Tribal water quality monitoring and reporting activities are covered under the Section 106 Tribal Grants Program and not included in the burden estimates for this ICR.

During the period covered by this ICR renewal, respondents will: Complete their 2016 section 305(b) reports and 2016 section 303(d) lists; complete their 2018 section 305(b) reports and 2018 section 303(d) lists; transmit annual electronic updates of ambient monitoring data via the Water Quality Exchange; and continue to develop TMDLs according to their established schedules. EPA will prepare biennial updates on assessed and impaired waters for Congress and the public for the 2016 reporting cycle and for the 2018 cycle, and EPA will review 303(d) list and TMDL submissions from respondents.

The burdens of specific activities that States undertake as part of their section 305(b) and 303(d) programs are derived from a project among EPA, States and other interested stakeholders to develop a tool for estimating the States' resource needs for State water quality management programs. This project has developed the State Water Quality Management Workload Model (SWQMWM), which estimates and sums the workload involved in more than one hundred activities or tasks comprising a State water quality management program. Over twenty States contributed information about their activities that became the basis for the model. According to the SWQMWM, to meet section 305(b) and 303(d) reporting requirements the States will conduct: Watershed monitoring and characterization; modeling and analysis; development of a TMDL document for public review; public outreach; formal public participation; tracking; planning; legal support; etc. In general, respondents have conducted each of these reporting and record keeping activities for past section 305(b) and 303(d) reporting cycles and thus have staff and procedures in place to continue their section 305(b) and 303(d) reporting programs. The burden associated with these tasks is estimated in this ICR to include the total number of TMDLs that may be submitted during the period covered by this ICR.

Form Numbers: None.

Respondents/affected entities: Entities potentially affected by this action are States, Territories and Tribes with Clean Water Act (CWA) responsibilities.

Respondent's obligation to respond: Mandatory: Integrated Water Quality Inventory Reports (Clean Water Act sections 305(b), 303(d), 314(a), and 106(e)).

Estimated number of respondents: 59 (total).

Frequency of response: Biennial.

Total estimated burden: 3,740,017 (per year) hours. Burden is defined at 5 CFR 1320.03(b)

Total estimated cost: $203,728,300 (per year), includes $0 annualized capital or operation & maintenance costs.

Changes in Estimates: There is no change of hours in the total estimated respondent burden compared with the ICR currently approved by OMB, published on August 31, 2012. EPA is currently designing the Water Quality Framework, which is a new way of integrating EPA's data and information systems to more effectively support reporting and tracking water quality protection and restoration actions. The Framework will streamline water quality assessment and reporting by reducing transactions associated with paper copy reviews and increasing electronic data exchange. The Framework is in line with EPA's E-Enterprise Initiative, which seeks to assess and reformulate EPA's business process to reduce burden through the improved use of technology. EPA expects that the reporting burden will decrease and will revise the ICR burden after the new information system is implemented for the 2018 reporting cycle.

Members of the public wishing to gain access to the teleconference, make brief oral comments, or provide a written statement to the NEEAC must contact Javier Araujo, Designated Federal Officer, at [email protected] or 202-564-2642 by 10 business days prior to each regularly scheduled meeting.

Meeting Access: For information on access or services for individuals with disabilities or to request accommodations, please contact Javier Araujo at [email protected] or 202-564-2642, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request.

Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for June 29, 2015), on the World Wide Web at: http://www.ftc.gov/os/actions.shtm.

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before July 29, 2015. Write “JS Autoworld, Inc.—Consent Agreement; File No. 152-3069” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site.

Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which . . . is privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).1 Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest.

Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/planetnissanconsent by following the instructions on the web-based form. If this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that Web site.

If you file your comment on paper, write “JS Autoworld, Inc.—Consent Agreement; File No. 152-3069” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before July 29, 2015. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.htm.

The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing consent order from JS Autoworld, Inc., also doing business as Planet Nissan. The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement's proposed order.

The respondent is a motor vehicle dealer. According to the FTC's complaint, the respondent has misrepresented in certain advertisements: (1) vehicle purchase prices; (2) that advertised monthly payment amounts were for vehicle purchases, not leases; and (3) that consumers can pay $0 at signing to obtain vehicles shown in the advertisements for the advertised monthly amount. The complaint alleges therefore that the representations are false or misleading in violation of Section 5 of the FTC Act.

In addition, the complaint alleges that the respondent violated the Consumer Leasing Act (“CLA”) and Regulation M for failing to disclose or to disclose clearly and conspicuously certain costs and terms when advertising vehicles for lease.

The FTC's complaint also alleges that the respondent violated the Truth in Lending Act (“TILA”) and Regulation Z by failing to disclose or to disclose clearly and conspicuously certain costs and terms when advertising credit.

The proposed consent order contains provisions designed to prevent respondent from engaging in similar acts or practices in the future. Part I.A of the order prohibits respondent from misrepresenting the cost of: (1) purchasing a vehicle with financing, including but not necessarily limited to, the amount or percentage of the downpayment, the number of payments or period of repayment, the amount of any payment, the annual percentage rate or any other finance rate, and the repayment obligation over the full term of the loan, including any balloon payment; or (2) leasing a vehicle, including but not necessarily limited to, the total amount due at lease inception, the downpayment, amount down, acquisition fee, capitalized cost reduction, any other amount required to be paid at lease inception, and the amounts of all monthly or other periodic payments. Part I.B prohibits the respondent from misrepresenting any other material fact about the price, sale, financing, or leasing of any vehicle.

Part II of the proposed order addresses the CLA allegations. Part II.A prohibits respondent from stating the amount of any payment or that any or no initial payment is required at lease inception without disclosing clearly and conspicuously: (1) that the transaction advertised is a lease; (2) the total amount due at lease signing or delivery; (3) whether or not a security deposit is required; (4) the number, amounts, and timing of scheduled payments; and (5) that an extra charge may be imposed at the end of the lease term. Part II.B prohibits the respondent from violating any provision of the CLA or Regulation M.

Part III of the proposed order addresses the TILA allegations. Part III.A requires the respondent to make all of the disclosures required by TILA and Regulation Z when any of its advertisements state relevant triggering terms. Part III.B requires that if any finance charge is advertised, the rate be stated as an “annual percentage rate” using that term or the abbreviation “APR.” In addition, Part III.C prohibits the respondent from failing to comply in any respect with TILA and Regulation Z.

Part IV of the proposed order requires respondent to keep copies of relevant advertisements and materials substantiating claims made in the advertisements. Part V requires the respondent provide copies of the order to certain of its personnel. Part VI requires notification to the Commission regarding changes in corporate structure that might affect compliance obligations under the order. Part VII requires respondent to file compliance reports with the Commission. Finally, Part VIII is a provision “sunsetting” the order after twenty (20) years, with certain exceptions.

The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the complaint or proposed order, or to modify the proposed order's terms in any way.

Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for June 29, 2015), on the World Wide Web at: http://www.ftc.gov/os/actions.shtm.

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before July 29, 2015. Write “TC Dealership, L.P.—Consent Agreement; File No. 152-3096” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site.

Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which . . . is privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).1 Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest.

Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/planethyundaiconsent by following the instructions on the web-based form. If this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that Web site.

If you file your comment on paper, write “TC Dealership, L.P.—Consent Agreement; File No. 152-3096” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before July 29, 2015. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.htm.

The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing consent order from TC Dealership, L.P., also doing business as Planet Hyundai. The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement's proposed order.

The respondent is a motor vehicle dealer. According to the FTC's complaint, the respondent has misrepresented in certain advertisements: (1) Vehicle purchase prices; (2) that advertised monthly payment amounts were for vehicle purchases, not leases; and (3) that consumers can pay $0 at signing to obtain vehicles shown in the advertisements for the advertised monthly amount. The complaint alleges therefore that the representations are false or misleading in violation of Section 5 of the FTC Act.

In addition, the complaint alleges that the respondent violated the Consumer Leasing Act (“CLA”) and Regulation M for failing to disclose or to disclose clearly and conspicuously certain costs and terms when advertising vehicles for lease.

The FTC's complaint also alleges that the respondent violated the Truth in Lending Act (“TILA”) and Regulation Z by failing to disclose or to disclose clearly and conspicuously certain costs and terms when advertising credit.

The proposed consent order contains provisions designed to prevent respondent from engaging in similar acts or practices in the future. Part I.A of the order prohibits respondent from misrepresenting the cost of: (1) Purchasing a vehicle with financing, including but not necessarily limited to, the amount or percentage of the downpayment, the number of payments or period of repayment, the amount of any payment, the annual percentage rate or any other finance rate, and the repayment obligation over the full term of the loan, including any balloon payment; or (2) leasing a vehicle, including but not necessarily limited to, the total amount due at lease inception, the downpayment, amount down, acquisition fee, capitalized cost reduction, any other amount required to be paid at lease inception, and the amounts of all monthly or other periodic payments. Part I.B prohibits the respondent from misrepresenting any other material fact about the price, sale, financing, or leasing of any vehicle.

Part II of the proposed order addresses the CLA allegations. Part II.A prohibits respondent from stating the amount of any payment or that any or no initial payment is required at lease inception without disclosing clearly and conspicuously: (1) That the transaction advertised is a lease; (2) the total amount due at lease signing or delivery; (3) whether or not a security deposit is required; (4) the number, amounts, and timing of scheduled payments; and (5) that an extra charge may be imposed at the end of the lease term. Part II.B prohibits the respondent from violating any provision of the CLA or Regulation M.

Part III of the proposed order addresses the TILA allegations. Part III.A requires the respondent to make all of the disclosures required by TILA and Regulation Z when any of its advertisements state relevant triggering terms. Part III.B requires that if any finance charge is advertised, the rate be stated as an “annual percentage rate” using that term or the abbreviation “APR.” In addition, Part III.C prohibits the respondent from failing to comply in any respect with TILA and Regulation Z.

Part IV of the proposed order requires respondent to keep copies of relevant advertisements and materials substantiating claims made in the advertisements. Part V requires the respondent provide copies of the order to certain of its personnel. Part VI requires notification to the Commission regarding changes in corporate structure that might affect compliance obligations under the order. Part VII requires respondent to file compliance reports with the Commission. Finally, Part VIII is a provision “sunsetting” the order after twenty (20) years, with certain exceptions.

The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the complaint or proposed order, or to modify the proposed order's terms in any way.

The time of delivery or performance is an essential contract element and must be clearly stated in solicitations and contracts. The contracting officer may set forth a required delivery schedule or may allow an offeror to propose an alternate delivery schedule, for other than those for construction and architect-engineering, by inserting in solicitations and contracts a clause substantially the same as either FAR 52.211-8, Time of Delivery, or FAR 52.211-9, Desired and Required Time of Delivery. These clauses allow the contractor to fill in their proposed delivery schedule. The information is needed to assure supplies or services are obtained in a timely manner.

Respondents: 3,440.

Responses per Respondent: 5.

Annual Responses: 17,200.

Hours per Response: .167.

Total Burden Hours: 2,872.

Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulation (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0043, Delivery Schedules, in all correspondence.

In accordance with FAR 16.4, incentive contracts are normally used when a firm fixed-price contract is not appropriate and the required supplies or services can be acquired at lower costs, and sometimes with improved delivery or technical performance, by relating the amount of profit or fee payable under the contract to the contractor's performance.

The information required periodically from the contractor, such as cost of work already performed, estimated costs of further performance necessary to complete all work, total contract price for supplies or services accepted by the Government for which final prices have been established, and estimated costs allocable to supplies or services accepted by the Government and for which final prices have not been established, is needed to negotiate the final prices of incentive-related items and services. Contractors are required to submit the information in accordance with several incentive fee FAR clauses: FAR 52.216-16, Incentive Price Revision—Firm Target; FAR 52.216-17, Incentive Price Revision—Successive Targets; and FAR 52.216-10, Incentive Fee.

The contracting officer evaluates the information received to determine the contractor's performance in meeting the incentive target and the appropriate price revision, if any, for the items or services.

Respondents: 1,000.

Responses per Respondent: 2.

Annual Responses: 2,000.

Hours per Response: 1.5.

Total Burden Hours: 3,000.

Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulation (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0067, Incentive Contracts, in all correspondence.

Contents

This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

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

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Solicitation for Applications for Medicare Prescription Drug Plan 2017 Contracts; Use: The information will be collected under the solicitation of proposals from prescription drug plans, Medicare Advantage (MA) plans that offer integrated prescription drug and health care coverage (MA-PD) plans, Cost Plan, PACE, and Employer Group Waiver Plan applicants. The information will be used by CMS to: ensure that applicants meet CMS requirements and to support the determination of contract awards. Participation in the Part D program is voluntary. Only organizations that are interested in participating in the program will respond to the solicitation. The MA-PDs that voluntarily participate in the Part C program must submit a Part D application and successful bid. Form Number: CMS-10137 (OMB Control Number: 0938-0936); Frequency: Yearly; Affected Public: Private sector (Business or other For-profits and Not-for-profit institutions); Number of Respondents: 254; Total Annual Responses: 230; Total Annual Hours: 2,109. (For policy questions regarding this collection contact Arianne Spaccarelli at 410-786-5715).

2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Part C—Medicare Advantage and 1876 Cost Plan Expansion Application; Use: The information will be collected under the solicitation of Part C applications from Medicare Advantage, Employer Group Waiver Plan, and Cost Plan applicants and will be used by CMS to ensure that applicants meet CMS requirements, and to support the determination of contract awards. Participation is voluntary whereby only organizations that are interested in participating in the program will respond to the solicitation. Medicare Advantage (MA) organizations that offer integrated prescription drug and health care products (MA-PD plans) that voluntarily participate in the Part C program must submit a Part D application and successful bid. Form Number: CMS-10237 (OMB Control Number: 0938-0935); Frequency: Yearly; Affected Public: Private sector (Business or other For-profits and Not-for-profit institutions); Number of Respondents: 566; Total Annual Responses: 566; Total Annual Hours: 21,926. (For policy questions regarding this collection contact Wanda Pigatt-Canty at 410-786-6177).

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Qualification of Biomarker—Plasma Fibrinogen in Studies Examining Exacerbations and/or All-Cause Mortality for Chronic Obstructive Pulmonary Disease.” This draft guidance provides qualification recommendations for the use of plasma fibrinogen, measured at baseline, as a prognostic biomarker to enrich clinical trial populations of COPD subjects at high risk for exacerbations and/or all-cause mortality for inclusion in interventional clinical trials. This biomarker should be considered with other subject demographic and clinical characteristics, including a prior history of COPD exacerbations, as an enrichment factor in these trials.

Specifically, this draft guidance provides the COU for which this biomarker is qualified through the CDER Biomarker Qualification Program. Qualification of this biomarker for this specific COU represents the conclusion that analytically valid measurements of the biomarker can be relied on to have a specific use and interpretable meaning. This biomarker can be used by drug developers for the qualified COU in submission of IND applications, NDAs, and BLAs without the relevant CDER review group reconsidering and reconfirming the suitability of the biomarker. “Qualification” means that the use of this biomarker in the specific COU is not limited to a single, specific drug development program. Making the qualification recommendations widely known and available for use by drug developers will contribute to drug innovation, thus supporting public health.

As stated previously, in the Federal Register of January 7, 2014 (79 FR 831), FDA announced the availability of a final guidance for industry entitled “Qualification Process for Drug Development Tools” that described the process that would be used to qualify DDTs and to make new DDT qualification recommendations available on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. The current draft guidance is an attachment to that final guidance.

CDER has initiated this formal qualification process to work with developers of these biomarker DDTs to guide them as they refine and evaluate DDTs for use in the regulatory context. Once qualified, DDTs will be publicly available for use in any drug development program for the qualified COU. As described in the January 2014 guidance, biomarker DDTs should be developed and reviewed using this process. For more information on FDA's DDTs Qualification Programs, refer to the following Web site: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugDevelopmentToolsQualificationProgram/default.htm.

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 Agency's current thinking on the use of plasma fibrinogen as an enrichment biomarker in interventional clinical trials of COPD patients. 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 guidance contains an information collection that is 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 information collection has been approved under the OMB control numbers 0910-0001 and 0910-0014. The information requested in this guidance is currently submitted to FDA to support medical product effectiveness (see 21 CFR 312.30, 21 CFR 314.50(d)(5), and 21 CFR 314.126(b)(6)).

Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

FDA is revoking the biologics license (U.S. License No. 0916) issued to CHEMBIOMED, 9515 107th St., Rm. 401, Edmonton AB T5K 2C3, Canada, for the manufacture of Anti-A (Murine Monoclonal), Anti-B (Murine Monoclonal), Anti-Lea (Murine Monoclonal) and Anti-Leb (Murine Monoclonal). Proceedings to revoke U.S. License No. 0916 were initiated under § 601.5(b) (21 CFR 601.5(b)) because FDA determined through various means that a meaningful inspection of CHEMBIOMED could not be conducted because the manufacturer was no longer in operation.

In a phone conversation that occurred on July 7, 1992, a former CHEMBIOMED employee informed FDA that CHEMBIOMED was no longer in business, had ceased the manufacture of licensed products, and had also ceased shipments of licensed products to the United States.

In a letter dated June 16, 1995, FDA requested from the Authorized Official (Responsible Head) of CHEMBIOMED a status update for the production of all of the products for which CHEMBIOMED held a U.S. license. This letter requested that the firm notify FDA in writing of the firm's status and also informed the Authorized Official that in the absence of a response to this letter that FDA would take action to revoke CHEMBIOMED's U.S. license. FDA did not receive a response to its letter dated June 16, 1995.

In a certified, return-receipt letter dated October 18, 1995, FDA requested that the Authorized Official of CHEMBIOMED inform FDA whether or not the firm intended to pursue a product license application supplement request dated May 6, 1987. In the October 18, 1995 letter, FDA also informed the Authorized Official that the product license application supplement request had been placed in the FDA inactive files. FDA did not receive a response to its certified, return-receipt letter dated October 18, 1995.

In a letter to CHEMBIOMED dated December 19, 2012, FDA provided notice of FDA's intent to revoke U.S. License No. 0916, and announced its intent to offer an opportunity for a hearing. FDA indicated that FDA registrations for CHEMBIOMED facilities have not been updated since May 12, 1994. The letter also advised the Authorized Official that, under § 601.5(b)(1)(i) and (ii) of FDA's regulations, proceedings for license revocation may be instituted when FDA finds that authorized FDA employees have been unable to gain access to an establishment for the purpose of carrying out an inspection, or when the manufacturing of a product has been discontinued to an extent that a meaningful inspection cannot be made at the establishment. The December 19, 2012 letter to CHEMBIOMED, sent via United Parcel Service, was returned as undeliverable.

In addition, Health Canada advised FDA that CHEMBIOMED was no longer in operation, according to the Industry Canada Web site: www.ic.gc.ca. CHEMBIOMED (Corporation No. 0228176 and Business No. 100938521RC0001 under the governing legislation of the Canada Business Corporations Act) was issued a Certificate of Incorporation on August 15, 1977, and later was issued a Certificate of Dissolution on March 17, 1999.

Under § 12.21(b) (21 CFR 12.21(b)), FDA published in the Federal Register of January 14, 2015 (80 FR 1917), a notice of opportunity for a hearing (NOOH) on a proposal to revoke the biologics license (U.S. License No. 0916) issued to CHEMBIOMED for the manufacture of Anti-A (Murine Monoclonal), Anti-B (Murine Monoclonal), Anti-Lea (Murine Monoclonal) and Anti-Leb (Murine Monoclonal). In the NOOH, FDA explained that the proposed license revocation was based on information that the firm was no longer in operation and the manufacture of its licensed products has been discontinued. FDA also noted in the NOOH that the documentation in support of the license revocation had been placed on file with the Division of Dockets Management under the docket number found in brackets in the heading of the notice.

The NOOH provided the firm 30 days to submit an electronic or written request for a hearing and 60 days to submit any data and information justifying a hearing. The NOOH provided other interested persons with 60 days to submit electronic or written comments on the proposed revocation. The firm did not respond within the 30-day time period with an electronic or written request for a hearing, and under § 12.21(b), the 30-day time period prescribed in the NOOH may not be extended. No comments from other interested persons were received within the 60-day time period.

Accordingly under 21 CFR 12.38, section 351 of the Public Health Service Act (42 U.S.C. 262), and under the authority delegated to the Commissioner of Food and Drugs and redelegated to the Director and Deputy Director of the Center for Biologics Evaluation and Research (FDA Staff Manual Guide 1410.203), the biologics license (U.S. License No. 0916) issued to CHEMBIOMED, LTD. for the manufacture of Anti-A (Murine Monoclonal), Anti-B (Murine Monoclonal), Anti-Lea (Murine Monoclonal) and Anti-Leb (Murine Monoclonal) is revoked, effective July 7, 2015.

I. Background

On August 26, 2010, Chung Po Liu pleaded guilty to the felony crime of entering honey, a food, into the commerce of the United States by means of a false statement, in violation of 18 U.S.C. 542 and 2. Liu admitted that he had caused his customs broker to declare Thailand to be the country of origin of one honey shipment, although the majority of the honey originated in China, and to declare the Philippines to be the country of origin of a second honey shipment, although the honey originated in China. Liu admitted that, in each instance, he had documents in his possession establishing that the honey originated in China, that the declaration of country of origin was false, and that he was without reasonable cause to believe it was true. Liu also admitted that the United States began requiring the deposit of estimated anti-dumping duties of between 183 percent and 221 percent on all non-exempt honey of Chinese origin beginning in 2001. Liu did not deposit estimated anti-dumping duties for either of these two shipments of imported honey. Liu also pleaded guilty to the misdemeanor crime of introducing adulterated food into interstate commerce in violation of sections 301(a), 303(a)(1), and 402(a)(2)(C)(i) of the FD&C Act (21 U.S.C. 331(a), 333(a)(1), and 342(a)(2)(C)(i)). Liu admitted that he had introduced honey that contained the unsafe food additive ciprofloxacin, an antibiotic, into interstate commerce. On December 20, 2010, the U.S. District Court for the Western District of Washington entered a criminal judgment against Liu under his guilty plea.

Section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 335a(b)(1)(C)) authorizes FDA to debar a person from importing articles of food or offering food for importation into the United States based on a finding, under section 306(b)(3) of the FD&C Act, that the person was convicted of a felony for conduct relating to the importation of food into the United States. By letter dated April 25, 2011, in accordance with section 306(i) of the FD&C Act and 21 CFR 10.50(c)(20) and 12.21(b), FDA, Office of Regulatory Affairs (ORA) notified Liu that the Agency proposed to debar him for 5 years from importing any articles of food or offering such articles for importation into the United States and offered an opportunity to request a hearing on the proposed order of debarment to resolve disputed issues of material fact. ORA advised Liu that a request for a hearing may not rest upon mere allegations or denials, but must present specific facts showing that there is a genuine and substantial issue of fact that requires a hearing.

In a letter dated May 24, 2011, Liu requested a hearing on his proposed debarment. On June 11, 2011, Liu submitted materials in support of his hearing request. In these materials, which were submitted in accordance with 21 CFR 12.22, Liu acknowledges his felony conviction. However, he urges FDA not to exercise its authority to debar him based on that conviction. In the alternative, he argues that any debarment should be limited to the 1-year period of supervised release that the court ordered him to serve after his release from custody after serving his sentence of incarceration of 1 year and 1 day.

Under the authority delegated to him by the Commissioner of Food and Drugs, the Director of the Office of Scientific Integrity (the Director) has considered Liu's submission. FDA will grant a hearing only if the material submitted shows that there is a genuine and substantial issue of fact for resolution at the hearing. Hearings will not be granted on issues of policy or law, on mere allegations, denials, or general descriptions of positions and contentions, or on data and information insufficient to justify the factual determination urged (see 21 CFR 12.24(b)). Based on this review, the Director has concluded that Liu has failed to raise a genuine and substantial issue of fact for resolution at a hearing and that a hearing is not justified. Accordingly, Liu's request for a hearing is denied, and FDA is issuing this notice to explain the basis for this decision (see 21 CFR 12.24(a) and 12.28).

Liu raises two primary arguments in support of his hearing request. Liu first contends generally that debarment is “unwarranted in law and without justification by the facts in the case.” He also urges that FDA should not debar him due to his advanced age and ill health, or, alternatively, that FDA should debar him for a time period of less than 5 years, the debarment period proposed in the Notice of Opportunity for Hearing.

Liu notes that, under section 306(b), the decision whether to debar him is committed to FDA's discretion, and that FDA is authorized to debar him “as a result of conviction of certain crimes” (June 21 submission at 1). Indeed, section 306(b)(3) of the FD&C Act states that a person is subject to debarment if the person has been convicted of a felony for conduct relating to the importation into the United States of any food. Liu does not dispute that he was convicted of a felony crime in violation of 18 U.S.C. 542 and 2, or that his conviction was based on conduct relating to the importation of honey, a food. In the plea agreement Liu signed, which he does not now refute, he admitted that: (1) He entered or introduced, or attempted to enter or introduce, into the commerce of the United States, imported merchandise; (2) he did so by means of any fraudulent or false invoice, declaration, affidavit, letter, paper, or by means of any false statement, written or verbal; and (3) he was without reasonable cause to believe the truth of such statement or procured the making of any such false statement as to any matter material thereto without reasonable cause to believe the truth of such statement (Plea Agreement at 2). He further admitted that this conduct related to the importation of honey, a food (see, for example, Plea Agreement at 11-12, June 21 submission at 2-3). Accordingly, Liu is subject to debarment under section 306(b)(3) on the basis of that felony conviction.

Since Liu's felony conviction for conduct relating to the importation into the United States of honey establishes a predicate from which FDA may choose to exercise its authority to debar him, Liu's June 21 submission in support of his request for a hearing attempts to raise factual issues concerning the application of the factors in section 306(c)(3) that FDA is required to consider in determining the appropriateness and the period of debarment. These are the applicable criteria: (1) The nature and seriousness of any offense involved; (2) the nature and extent of management participation in any offense involved, whether corporate policies and practices encouraged the offense, including whether inadequate institutional controls contributed to the offense; (3) the nature and extent of voluntary steps to mitigate the impact on the public of any offense involved, including . . . full cooperation with any investigations (including the extent of disclosure to appropriate authorities of all wrongdoing) . . . and any other actions taken to substantially limit potential or actual adverse effects on the public health; (4) whether the extent to which changes in ownership, management, or operations have corrected the causes of any offense involved and provide reasonable assurances that the offense will not occur in the future; and (5) prior convictions under the FD&C Act or under other Acts involving matters within the jurisdiction of FDA.

Significantly, the health and age of an individual subject to debarment are not included as factors relevant to FDA's exercise of the Agency's debarment authority. Although a defendant may sometimes argue that poor health and advanced age should be considered in mitigation of punishment, debarment under 21 U.S.C. 335a is not a punitive sanction. Instead it is remedial in purpose. (See DiCola v. FDA, 77 F.3d 504, 507 (D.C. Cir. 1996) (permanent debarment of convicted individual is not punishment, but instead is a remedy to protect the integrity of the drug industry and public confidence in that industry); Bae v. Shalala, 44 F.3d 489, 493 (7th Cir. 1995) (purpose of statute establishing debarment authority was to restore consumer confidence in generic drugs by eradicating widespread corruption in generic drug approval process).) In determining whether to debar Liu, as well as the length of a term of debarment, FDA acts to protect the public health and not to punish Liu. Because we are acting for this remedial, not punitive, purpose, Liu's arguments concerning his health and age are not relevant to this proceeding.

I address each of the relevant factors in turn.

Liu emphasizes that he was not convicted of the charge for which he was originally indicted, conspiracy to violate 18 U.S.C. 545 by conspiring to enter goods into the United States through false statement, and to smuggle goods. He urges that conviction under the original charge would have required proof that he acted “knowingly and intentionally” (June 21 submission at 3). He devotes much of his submission to his argument that he did not act “knowingly and intentionally.” According to Liu's June 21 submission, Liu's accomplices, Yong Xiang Yan, the owner of Changge Jixiang Bee Products, Ltd. of Henan China, and Boa Zhong Zhang, a vice-president and part owner of Changge, established a scheme to transship and import into the United States Chinese honey, using Indigo Distribution Corp. in the Philippines. He disclaims knowledge of the nature and extent of their operations (June 21 submission at 4).

However, these allegations are not relevant. Liu's conviction was not for violating, or conspiring to violate, 18 U.S.C. 545. The offense that must be considered is his felony violation of 18 U.S.C. 542 and 2, which was based on Liu's causing the false declarations to be made even though he was without reasonable cause to believe the truth of such statements. Even in his June 21 submission, Liu expressly acknowledges that he had documents in his possession indicating that, as described in the Plea Agreement and as charged in the superseding information to which he pleaded guilty, two shipments of honey he imported actually originated in China (June 21 submission at 3). He leaves unchallenged the factual basis for his conviction: That, without reasonable cause to believe the truth of the statements, he caused his customs broker to falsely state that the shipments originated in Thailand (December 20, 2006, shipment) and the Philippines (February 14, 2007, shipment). Although he dismisses these as a “few emails . . . among many hundreds of documents relating to the importation of honey found in Mr. Liu's house” (June 21 submission at 3), he fully admits that these communications were in his possession. Liu has raised no factual issue for resolution at a hearing concerning whether he acted without reasonable cause to believe the truth of the statements concerning where the honey was produced.

We further note that the statement of facts, which Liu admitted in his plea agreement, provides additional information concerning his actions which demonstrate the financial motive behind this offense. Had Liu instructed his customs broker to declare the country of origin as China, he and his companies would have been responsible for anti-dumping duties in the amount of 221 percent of the value of the honey (Plea Agreement at 11-12). Liu's misrepresentation was thus both material and meaningful in the imports process, and it could not have been lost on Liu how important the country of origin was in the context of the anti-dumping duties for Chinese honey.

Finally, I note that Liu's conviction did not rest on a single false statement. Instead, he pleaded guilty to a superseding information that included false statements with respect to two separate entries of imported Chinese honey, 2 months apart. His conviction did not rest on a single isolated incident, but on a repeated violation.

Therefore, it is undisputed that Liu was responsible for multiple material false statements that resulted in the avoidance of significant duties for the importation of two shipments of honey with a total declared value of $186,912. As such, I agree with ORA's evaluation of this consideration and find that the nature and seriousness of Liu's felony offense weighs strongly in favor of debarment.

Next, I consider whether Liu's response raised specific facts showing that there is a genuine and substantial issue of fact that requires a hearing concerning the nature and extent of management participation in the offense, including whether corporate policies and practices encouraged the offense, and whether inadequate institutional controls contributed to the offense.

In the Notice of Opportunity for a Hearing, ORA stated, “As the owner of the importing companies, you were responsible for the accuracy of declarations made to United States customs officials. You were without reasonable cause to believe the truth of these declarations regarding the origins of the honey. Further, you directly profited from the domestic sale of the imported honey.”

Liu has not challenged these statements, and all of the descriptions of Liu's actions in the June 21 submission show him to act alone, as the individual responsible for importing these two shipments of honey. I agree with ORA that, based upon these facts, the nature and extent of Liu's management participation in the offense weighs in favor of debarment.

Next, I consider whether Liu has raised specific facts showing that there is a genuine and substantial issue of fact that requires a hearing concerning the nature and extent of voluntary steps to mitigate the impact of his offense on the public, including full cooperation with any investigations (including the extent of disclosure to appropriate authorities of all wrongdoing) and any other actions taken to substantially limit potential or actual adverse effects on the public health.

In the Notice of Opportunity for a Hearing, ORA stated, “You took no steps to mitigate the impact on the public of your actions.” Liu has not challenged this statement. As such, I agree with ORA that the nature and extent of Liu's voluntary steps to mitigate the impact to the public weighs in favor of debarment.

In the Notice of Opportunity for Hearing, ORA determined that this factor was not applicable for consideration. Liu has not challenged that determination.

In the Notice of Opportunity for Hearing, ORA acknowledged that the Agency was unaware of any prior convictions involving matters within the jurisdiction of FDA. The lack of previous violations of the FD&C Act or related statutes by Liu weighs against debarment.

The Director of the Office of Scientific Integrity, under section 306(b)(3)(A) of the FD&C Act and under authority delegated to him, finds that Liu has been convicted of a felony for conduct relating to the importation of food into the United States. Accordingly, FDA may debar Liu from importing articles of food or offering such articles for import into the United States for a period of not more than 5 years.

I have considered the arguments raised by Liu regarding the relevant factors listed in section 306(c)(3) of the FD&C Act and have determined that Liu has raised no genuine and substantial issues of fact that require resolution at an evidentiary hearing. I have considered the factors in section 306(c)(3) of the FD&C Act. The nature and seriousness of Liu's offense, Liu's management participation in the offense, and the lack of any voluntary steps to mitigate the impact of the offense weigh in favor of debarring. Although Liu appears to have no prior criminal convictions involving matters within the jurisdiction of FDA, that consideration does not counterbalance to a sufficient degree the remaining considerations to warrant decreasing the period of debarment. Of particular note is the nature and seriousness of the offense, in light of the volume of honey that was imported, the amount of duties that were avoided, and the fact that false statements were made with regard to two shipments of honey. I agree with ORA's proposed period of debarment and find that a debarment of 5 years is appropriate.

As a result of the foregoing findings, Liu is debarred for a period of 5 years from importing articles of food or offering such articles for import into the United States, effective (see DATES). Under section 301(cc) of the FD&C Act, the importing or offering for import into the United States of an article of food by, with the assistance of, or at the direction of Liu is a prohibited act.

Any application by Liu for termination of debarment under section 306(d) of the FD&C Act should be identified with Docket No. FDA-2011-N-0169 and sent to the Division of Dockets Management Branch (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j). Publicly available submissions may be seen in the Division of Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain documents in the Docket at http://www.regulations.gov.

Status: This advisory council meeting will be open to the public.

Purpose: The purpose of the 131st National Advisory Council on Nurse Education and Practice (NACNEP) meeting is to provide advice and recommendations on policy and program development related to the role of nursing in Interprofessional Education (IPE) and Practice. The purpose is to discuss existing IPE models in an academic setting and the intersect between education and practice as it relates to Health Care delivery reform. The goal of the meeting is to solicit recommendations for IPE in an academic setting and the intersect important to IPE and practice. Strengths, challenges, achievable solutions, and replicable models required and/or available to move from discussion to action will be identified. Additionally, the meeting will discuss topics for future work of the council. This meeting will conclude with a formulation of recommendations and form the basis for NACNEP's mandated Thirteenth Annual Report to the Secretary of the U.S. Department of Health and Human Services and Congress.

Agenda: A final agenda will be posted on the NACNEP Web site 3 days prior to the meeting. Agenda items are subject to change as priorities dictate.

Further information regarding NACNEP including the roster of members, reports to Congress, and minutes from previous meetings is available at the NACNEP Web site. Members of the public and interested parties may request to participate in the meeting by contacting Staff Assistant, Jeanne Brown. Access to the meeting will be granted on a first come, first-served basis and space is limited. Public participants may submit written statements in advance of the scheduled meeting. If you would like to provide oral public comment during the meeting you will need to register with Erin Fowler, Designated Federal Official (DFO). Public comment will be limited to 3 minutes per speaker and is tentatively scheduled for after lunch on the first day of the meeting. Statements and comments can be addressed to Erin Fowler. Please send by email to: [email protected].

Please be advised that committee members are given copies of all written statements submitted by the public prior to the meeting. Any further public participation will be at the discretion of the Chair, with approval of the DFO in attendance. Registration through the designated contact for the public comment session is required. Any member of the public who wishes to have printed materials distributed to the Advisory Group should submit materials to the point of contact no later than 12:00 p.m. EST on July 13, 2015.

Status: The meeting will be open to the public.

Purpose: Pursuant to Public Law 109-129, 42 U.S.C. 274k (section 379 of the Public Health Service Act, as amended), the ACBSCT advises the Secretary of the Department of Health and Human Services and the Administrator, Health Resources and Services Administration, on matters related to the activities of the C.W. Bill Young Cell Transplantation Program (Program) and the National Cord Blood Inventory Program.

Agenda: The Council will hear a report from the ACBSCT Work Group on Advancing Hematopoietic Stem Cell Transplantation for Hemoglobinopathies. The Council also will hear presentations and discussions on topics including: past recommendations made to the Secretary, cord blood bank economics, status of Food and Drug Administration licensure of cord blood banks, and potential impact of haploidentical transplants. Agenda items are subject to changes as priorities indicate.

After Council discussions, members of the public will have an opportunity to provide comment. Because of the Council's full agenda and timeframe in which to cover the agenda topics, public comment may be limited. All public comments will be included in the record of the ACBSCT meeting. Meeting summary notes will be posted on HRSA's Program Web site at http://bloodcell.transplant.hrsa.gov/ABOUT/Advisory_Council/index.html.

The draft meeting agenda will be posted on https://www.blsmeetings.net/acbsct. Those participating at this meeting should pre-register by visiting https://www.blsmeetings.net/acbsct. The deadline to pre-register for this meeting is Thursday, September 10, 2015. Registration will be confirmed on site. For all logistical questions and concerns, please contact Anita Allen, Seamon Corporation, at (301) 658-3442 or send an email to [email protected].

Participants can also join this meeting via teleconference by:

1. (Audio Portion) Calling the Conference Phone Number (800-988-0202) and providing the Participant Passcode (9115853); and

2. (Visual Portion) Connecting to the ACBSCT Adobe Connect Pro Meeting using the following URL and entering as GUEST: https://hrsa.connectsolutions.com/acbsct_webinar/ (copy and paste the link into your browser if it does not work directly, and enter as a guest).

Participants should call and connect 15 minutes prior to the meeting for logistics to be set up. If you have never attended an Adobe Connect meeting, please test your connection using the following URL: https://hrsa.connectsolutions.com/common/help/en/support/meeting_test.htm. In order to obtain a quick overview, go to the following URL: http://www.adobe.com/go/connectpro_overview. Call (301) 443-0437 or send an email to [email protected] if you are having trouble connecting to the meeting site.

Public Comment: It is preferred that persons interested in providing an oral presentation email a written request, along with a copy of their presentation, to Patricia Stroup, MBA, MPA, Executive Secretary, Healthcare Systems Bureau, Health Resources and Services Administration, at [email protected]. Requests should contain the name, address, telephone number, email address, and any business or professional affiliation of the person desiring to make an oral presentation. Groups having similar interests are requested to combine their comments and present them through a single representative.

The allocation of time may be adjusted to accommodate the level of expressed interest. Persons who do not file an advance request for a presentation, but desire to make an oral statement, may request it during the public comment period. Public participation and ability to comment will be limited as time permits.

The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10 et seq., provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of Health and Human Services, who is named as the respondent in each proceeding. The Secretary has delegated this responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation.

A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.

Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that within 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the Federal Register. Set forth below is a list of petitions received by HRSA on May 1, 2015, through May 31, 2015. This list provides the name of petitioner, city and state of vaccination (if unknown then city and state of person or attorney filing claim), and case number. In cases where the Court has redacted the name of a petitioner and/or the case number, the list reflects such redaction.

In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described in Section 2112(b)(2) of the PHS Act in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading “For Further Information Contact”), with a copy to HRSA addressed to Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, 5600 Fishers Lane, Room 11C-26, Rockville, MD 20857. The Court's caption (Petitioner's Name v. Secretary of Health and Human Services) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program.