Federal Register Vol. 80, No.174,

The Secretary tasked the MFAC with providing recommendations on access to USDA programs and services by minority farmers and ranchers. Please visit our Web site at: http://www.outreach.usda.gov/sdfr/FAC.htm for additional information on the MFAC.

The public is asked to pre-register for the meeting by September 17, 2015. You may pre-register for the public meeting by submitting an email to [email protected] with your name, organization or affiliation, or any comments for the committee's consideration. You may also fax this information to (202) 720-7704. Members of the public who wish to make comments during the committee meeting must register at the check-in table.

The agenda is as follows: Day 1: USDA presentations and public comments; Day 2: Committee discussions, public comments. Day 3: Committee deliberations and public comment. Please visit the Minority Farmers and Ranchers Advisory Committee Web site for the full agenda. All agenda topics and documents will be made available to the public at: http://www.outreach.usda.gov/sdfr/FAC.htm. Copies of the agenda will also be distributed at the meeting.

Meeting Accommodations: USDA is committed to ensuring that everyone is accommodated in our work environment, programs, and events. If you are a person with a disability and request reasonable accommodations to participate in this meeting, please note the request in your registration and you may contact Mrs. Kenya Nicholas in advance of the meeting by or before close of business on September 15, 2015, by phone at (202) 720-6350, fax (202) 720-7704, or email: [email protected].

Under the regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-72, referred to below as the regulations), the Animal and Plant Health Inspection Service (APHIS) prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into or disseminated within the United States.

Section 319.56-4 contains a performance-based process for approving the importation of certain fruits and vegetables that, based on the findings of a pest risk analysis, can be safely imported subject to one or more of the designated phytosanitary measures listed in paragraph (b) of that section.

In accordance with that process, we published a notice1 in the Federal Register on March 12, 2015 (80 FR 12976-12977, Docket No. APHIS-2015-0001), in which we announced the availability, for review and comment, of a pest risk assessment (PRA) that identifies pests of quarantine significance that could follow the pathway of importation of cranberries from Chile into the continental United States. Based on the PRA, a risk management document (RMD) was prepared to identify phytosanitary measures that could be applied to the cranberries to mitigate the pest risk.

We solicited comments on the PRA and RMD for 60 days, ending on May 11, 2015. We received six comments by that date, from an organization of State plant regulatory agencies, importers, the Chilean Government, and private citizens. All comments we received supported the importation of cranberries from Chile into the continental United States.

Therefore, in accordance with § 319.56-4(c)(2)(ii), we are announcing our decision to authorize the importation of cranberries from Chile into the continental United States subject to the following phytosanitary measures:

• The cranberries must be imported as commercial consignments only;

• Each consignment of cranberries must be accompanied by a phytosanitary certificate issued by the national plant protection organization of Chile; and

• Each consignment of cranberries is subject to inspection upon arrival at the port of entry to the United States.

These conditions will be listed in the Fruits and Vegetables Import Requirements database (available at http://www.aphis.usda.gov/favir). In addition to these specific measures, cranberries from Chile will be subject to the general requirements listed in § 319.56-3 that are applicable to the importation of all fruits and vegetables.

The purpose of the meeting is to:

1. Review and discuss outreach efforts to USDA leadership, partners, and other federal agencies, and

2. Develop draft agenda for December meeting.

The teleconference is open to the public. However, the public is strongly encouraged to RSVP prior to the teleconference to ensure all related documents are shared with public meeting participants. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should submit a request in writing 10 days before the planned meeting 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 time requests for oral comments must be sent to Laurie Schoonhoven, 1400 Independence Avenue SW., Mailstop 1123, Washington, DC 20250 or by email to [email protected]. A summary of the meeting will be posted on the Web site listed above within 21 days after the meeting.

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.

On August 11, 2015, the Department of Commerce (the Department) received antidumping duty (AD) Petitions concerning imports of certain hot-rolled steel flat products (hot-rolled steel) from Australia, Brazil, Japan, Korea, the Netherlands, Turkey, and the United Kingdom, filed in proper form on behalf of AK Steel Corporation, ArcelorMittal USA LLC, Nucor Corporation, SSAB Enterprises, LLC, Steel Dynamics, Inc., and United States Steel Corporation (Petitioners).1 The AD Petitions were accompanied by three countervailing duty (CVD) Petitions.2 Petitioners are domestic producers of hot-rolled steel.3

On August 14, 2015, the Department requested additional information and clarification of certain areas of the Petitions.4 Petitioners filed responses to these requests on August 18, 2015, August 20, 2015, and August 26, 2015.5

In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), Petitioners allege that imports of hot-rolled steel from Australia, Brazil, Japan, Korea, the Netherlands, Turkey, and the United Kingdom, are being, or are likely to be, sold in the United States at less-than-fair value within the meaning of section 731 of the Act, and that such imports are materially injuring, or threatening material injury to, an industry in the United States. Also, consistent with section 732(b)(1) of the Act, the Petitions are accompanied by information reasonably available to Petitioners supporting their allegations.

The Department finds that Petitioners filed these Petitions on behalf of the domestic industry because Petitioners are interested parties as defined in section 771(9)(C) of the Act. The Department also finds that Petitioners demonstrated sufficient industry support with respect to the initiation of the AD investigations that Petitioners are requesting.6

Because the Petitions were filed on August 11, 2015, the period of investigations (POI) is, pursuant to 19 CFR 351.204(b)(1), July 1, 2014, through June 30, 2015.

The product covered by these investigations is hot-rolled steel from Australia, Brazil, Japan, Korea, the Netherlands, Turkey, and the United Kingdom. For a full description of the scope of these investigations, see the “Scope of the Investigations,” in Appendix I of this notice.

During our review of the Petitions, the Department issued questions to, and received responses from, Petitioners pertaining to the proposed scope to ensure that the scope language in the Petitions would be an accurate reflection of the products for which the domestic industry is seeking relief.7

As discussed in the preamble to the Department's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage (scope). The Department will consider all comments received from parties and, if necessary, will consult with parties prior to the issuance of the preliminary determination. If scope comments include factual information (see 19 CFR 351.102(b)(21)), all such factual information should be limited to public information. In order to facilitate preparation of its questionnaires, the Department requests all interested parties to submit such comments by 5 p.m. Eastern Daylight Time (EDT) on Monday, September 21, 2015, which is the first business day after 20 calendar days from the signature date of this notice.8 Any rebuttal comments, which may include factual information, must be filed by 5 p.m. EDT on Tuesday, October 1, 2015, which is 10 calendar days after the initial comments.

The Department requests that any factual information the parties consider relevant to the scope of the investigations be submitted during this time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigations may be relevant, the party may contact the Department and request permission to submit the additional information. All such comments must be filed on the records of each of the concurrent AD and CVD investigations.

All submissions to the Department must be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS).9 An electronically filed document must be received successfully in its entirety by the time and date when it is due. Documents excepted from the electronic submission requirements must be filed manually (i.e., in paper form) with Enforcement and Compliance's APO/Dockets Unit, Room 18022, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, and stamped with the date and time of receipt by the applicable deadlines.

The Department will give interested parties an opportunity to provide comments on the appropriate physical characteristics of hot-rolled steel to be reported in response to the Department's AD questionnaires. This information will be used to identify the key physical characteristics of the subject merchandise in order to report the relevant factors and costs of production accurately as well as to develop appropriate product-comparison criteria.

The Department will release a proposed list of physical characteristics and product-comparison criteria, and interested parties will have the opportunity to provide any information or comments that they feel are relevant to the development of an accurate list of physical characteristics. Specifically, they may provide comments as to which characteristics are appropriate to use as: (1) General product characteristics and (2) product-comparison criteria. We note that it is not always appropriate to use all product characteristics as product-comparison criteria. We base product-comparison criteria on meaningful commercial differences among products. In other words, although there may be some physical product characteristics utilized by manufacturers to describe hot-rolled steel, it may be that only a select few product characteristics take into account commercially meaningful physical characteristics. In addition, interested parties may comment on the order in which the physical characteristics should be used in matching products. Generally, the Department attempts to list the most important physical characteristics first and the least important characteristics last.

All comments and submissions to the Department must be filed electronically using ACCESS, as explained above, on the records of the Australia, Brazil, Japan, Korea, the Netherlands, Turkey, and the United Kingdom less-than-fair-value investigations.

Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 732(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, the Department shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”

Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both the Department and the ITC must apply the same statutory definition regarding the domestic like product,10 they do so for different purposes and pursuant to a separate and distinct authority. In addition, the Department's determination is subject to limitations of time and information. Although this may result in different definitions of the like product, such differences do not render the decision of either agency contrary to law.11

Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (i.e., the class or kind of merchandise to be investigated, which normally will be the scope as defined in the Petitions).

With regard to the domestic like product, Petitioners do not offer a definition of the domestic like product distinct from the scope of the investigations. Based on our analysis of the information submitted on the record, we have determined that hot-rolled steel constitutes a single domestic like product and we have analyzed industry support in terms of that domestic like product.12

In determining whether Petitioners have standing under section 732(c)(4)(A) of the Act, we considered the industry support data contained in the Petitions with reference to the domestic like product as defined in the “Scope of the Investigations,” in Appendix I of this notice. Petitioners provided their production volume of the domestic like product in 2014, as well as an estimate of total production of the domestic like product for the entire domestic industry.13 To establish industry support, Petitioners compared their own production to total estimated production of the domestic like product for the entire domestic industry.14

Our review of the data provided in the Petitions, General Issues Supplement, and other information readily available to the Department indicates that Petitioners have established industry support.15 First, the Petitions established support from domestic producers (or workers) accounting for more than 50 percent of the total production of the domestic like product and, as such, the Department is not required to take further action in order to evaluate industry support (e.g., polling).16 Second, the domestic producers (or workers) have met the statutory criteria for industry support under section 732(c)(4)(A)(i) of the Act because the domestic producers (or workers) who support the Petitions account for at least 25 percent of the total production of the domestic like product.17 Finally, the domestic producers (or workers) have met the statutory criteria for industry support under section 732(c)(4)(A)(ii) of the Act because the domestic producers (or workers) who support the Petitions account for more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the Petitions.18 Accordingly, the Department determines that the Petitions were filed on behalf of the domestic industry within the meaning of section 732(b)(1) of the Act.

The Department finds that Petitioners filed the Petitions on behalf of the domestic industry because they are interested parties as defined in section 771(9)(C) of the Act and they have demonstrated sufficient industry support with respect to the AD investigations that they are requesting the Department to initiate.19

Petitioners allege that the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise sold at less than normal value (NV). In addition, Petitioners allege that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.20 Petitioners contend that the industry's injured condition is illustrated by reduced market share; underselling and price suppression or depression; lost sales and revenues; decline in production, shipments, and capacity utilization; and decline in financial performance.21 We have assessed the allegations and supporting evidence regarding material injury, threat of material injury, and causation, and we have determined that these allegations are properly supported by adequate evidence and meet the statutory requirements for initiation.22

The Petitions

On August 11, 2015, the Department of Commerce (Department) received countervailing duty (CVD) petitions concerning imports of certain hot-rolled steel flat products (hot-rolled steel) from Brazil, the Republic of Korea (Korea), and Turkey, filed in proper form on behalf of AK Steel Corporation, ArcelorMittal USA LLC, Nucor Corporation, SSAB Enterprises, LLC, Steel Dynamics, Inc., and United States Steel Corporation, (collectively, Petitioners). The CVD petitions were accompanied by antidumping duty (AD) petitions also concerning imports of hot-rolled steel from Australia, Brazil, Japan, Korea, the Netherlands, Turkey, and the United Kingdom.1 Petitioners are domestic producers of hot-rolled steel.2

On August 14, 2015, the Department requested information and clarification for certain areas of the Petitions.3 Petitioners filed responses to these requests on August 21 and 26, 2015.4 On August 19, 2015, the Department sought additional information with regard to the Brazilian CVD Petition.5 Petitioners filed additional Brazilian CVD responses on August 20 and 25, 2015.6

In accordance with section 702(b)(1) of the Tariff Act of 1930, as amended (the Act), Petitioners allege that the Governments of Brazil (GOB), Korea (GOK), and Turkey (GOT) are providing countervailable subsidies (within the meaning of sections 701 and 771(5) of the Act) to imports of hot-rolled steel from the Brazil, Korea, and Turkey, respectively, and that such imports are materially injuring, or threatening material injury to, an industry in the United States. Also, consistent with section 702(b)(1) of the Act, the Petitions are accompanied by information reasonably available to Petitioners supporting their allegations.

The Department finds that Petitioners filed the Petitions on behalf of the domestic industry because Petitioners are interested parties as defined in section 771(9)(C) of the Act. The Department also finds that Petitioners demonstrated sufficient industry support with respect to the initiation of the CVD investigations that Petitioners are requesting.7

The period of investigations is January 1, 2014, through December 31, 2014.8

The product covered by these investigations is hot-rolled steel from the Brazil, Korea, and Turkey. For a full description of the scope of these investigations, see the “Scope of the Investigations” in Appendix I of this notice.

During our review of the Petitions, the Department discussed with Petitioners the proposed scope to ensure that the scope language in the Petitions would be an accurate reflection of the products for which the domestic industry is seeking relief.9

As discussed in the preamble to the Department's regulations,10 we are setting aside a period for interested parties to raise issues regarding product coverage (scope). The Department will consider all comments received from parties and, if necessary, will consult with parties prior to the issuance of the preliminary determinations. If scope comments include factual information (see 19 CFR 351.102(b)(21)), all such factual information should be limited to public information. In order to facilitate preparation of its questionnaires, the Department requests all interested parties to submit such comments by 5 p.m. Eastern Time (ET) on Monday, September 21, 2015, which is the first business day after 20 calendar days from the signature date of this notice.11 Any rebuttal comments, which may include factual information, must be filed by 5 p.m. ET on Tuesday, October 1, 2015, which is 10 calendar days after the initial comments deadline.

The Department requests that any factual information the parties consider relevant to the scope of the investigations be submitted during this time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigations may be relevant, the party may contact the Department and request permission to submit the additional information. All such comments must be filed on the records of each of the concurrent AD and CVD investigations.

All submissions to the Department must be filed electronically using Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). An electronically-filed document must be received successfully in its entirety by the time and date it is due. Documents excepted from the electronic submission requirements must be filed manually (i.e., in paper form) with Enforcement and Compliance's APO/Dockets Unit, Room 18022, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, and stamped with the date and time of receipt by the applicable deadlines.

Pursuant to section 702(b)(4)(A)(i) of the Act, the Department notified representatives of the GOB, GOK, and GOT of the receipt of the Petitions. Also, in accordance with section 702(b)(4)(A)(ii) of the Act, the Department provided representatives of the GOB, GOK, and GOT the opportunity for consultations with respect to the CVD Petitions. On August 25, 2015, consultations were held with the GOB, on August 27, 2015, consultations were held with the GOK, and on August 28, 2015, consultations were held with the GOT. All invitation letters and memoranda regarding these consultations are on file electronically via ACCESS.

Section 702(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 702(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 702(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, the Department shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”

Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both the Department and the ITC must apply the same statutory definition regarding the domestic like product,12 they do so for different purposes and pursuant to a separate and distinct authority. In addition, the Department's determination is subject to limitations of time and information. Although this may result in different definitions of the like product, such differences do not render the decision of either agency contrary to law.13

Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (i.e., the class or kind of merchandise to be investigated, which normally will be the scope as defined in the Petitions).

With regard to the domestic like product, Petitioners do not offer a definition of the domestic like product distinct from the scope of the investigations. Based on our analysis of the information submitted on the record, we have determined that hot-rolled steel constitutes a single domestic like product and we have analyzed industry support in terms of that domestic like product.14

Background: The Travel Promotion Act of 2009 (TPA) was signed into law by President Obama on March 4, 2010. The TPA established the Corporation for Travel Promotion (the Corporation), as a non-profit corporation charged with the development and execution of a plan to (A) provide useful information to those interested in traveling to the United States; (B) identify and address perceptions regarding U.S. entry policies; (C) maximize economic and diplomatic benefits of travel to the United States through the use of various promotional tools; (D) ensure that international travel benefits all States and the District of Columbia, and (E) identify opportunities to promote tourism to rural and urban areas equally, including areas not traditionally visited by international travelers.

The Corporation is governed by a Board of Directors, consisting of 11 members with knowledge of international travel promotion or marketing, broadly representing various regions of the United States. The TPA directs the Secretary of Commerce (after consultation with the Secretary of Homeland Security and the Secretary of State) to appoint the Board of Directors for the Corporation.

At this time, the Department will be selecting four individuals with the appropriate expertise and experience from specific sectors of the travel and tourism industry to serve on the Board as follows:

(A) 1 shall have appropriate expertise and experience in a city convention and visitors' bureau;

(B) 1 shall have appropriate expertise and experience in the restaurant industry;

(C) 1 shall have appropriate expertise and experience as an official in a State tourism office; and

(D) 1 shall have appropriate expertise and experience as an official in the hotel accommodations sector.

To be eligible for Board membership, individuals must have international travel and tourism marketing experience, be a current or former chief executive officer, chief financial officer, or chief marketing officer or have held an equivalent management position. Additional consideration will be given to individuals who have experience working in U.S. multinational entities with marketing budgets, and who are audit committee financial experts as defined by the Securities and Exchange Commission (in accordance with section 407 of PL 107-204 [15 U.S.C. 7265]). Individuals must be U.S. citizens, and in addition, cannot be federally-registered lobbyists or registered as a foreign agent under the Foreign Agents Registration Act of 1938, as amended.

Those selected for the Board must be able to meet the time and effort commitments of the Board.

Board members serve at the discretion of the Secretary of Commerce (who may remove any member of the Board for good cause). The terms of office of each member of the Board appointed by the Secretary shall be 3 years. Board members can serve a maximum of two consecutive full three-year terms. Board members are not considered Federal government employees by virtue of their service as a member of the Board and will receive no compensation from the Federal government for their participation in Board activities. Members participating in Board meetings and events may be paid actual travel expenses and per diem when away from their usual places of residence by Brand USA.

To be considered for appointment, please provide the following:

1. Name, title, and personal resume of the individual requesting consideration, including address, email address and phone number; and

2. A brief statement of why the person should be considered for appointment to the Board. This statement should also address the individual's relevant international travel and tourism marketing experience and indicate clearly the sector or sectors enumerated above in which the individual has the requisite expertise and experience. Individuals who have the requisite expertise and experience in more than one sector can be appointed for only one of those sectors. Appointments of members to the Board will be made by the Secretary of Commerce.

NOAA established the OEAB under the Federal Advisory Committee Act (FACA) and legislation that gives the agency statutory authority to operate an ocean exploration program and to coordinate a national program of ocean exploration. The OEAB advises NOAA leadership on strategic planning, exploration priorities, competitive ocean exploration grant programs, and other matters as the NOAA Administrator requests.

OEAB members represent government agencies, the private sector, academic institutions, and not-for-profit institutions involved in all facets of ocean exploration—from advanced technology to citizen exploration.

In addition to advising NOAA leadership, NOAA expects the OEAB to help to define and develop a national program of ocean exploration—a network of stakeholders and partnerships advancing national priorities for ocean exploration.

This committee's charter is being renewed pursuant to 10 U.S.C. 2904 and in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(a).

The Board is a non-discretionary Federal advisory committee. Pursuant to 10 U.S.C. 2904(e), the Strategic Environmental Research and Development Program Council (“the Council”) shall refer to the Board, and the Board shall review, each proposed research project including its estimated cost, for research in and development of technologies related to environmental activities in excess of $1,000,000. The Council, pursuant to its responsibilities under 10 U.S.C. 2902(d)(1) and in an effort to enhance the Board's review process, has lowered the dollar threshold for referral by the Council to the Board to any proposed research project in excess of $900,000. The Board shall make any recommendations to the Council that the Board considers appropriate regarding such project or proposal.

The Board may make recommendations to the Council regarding technologies, research, projects, programs, activities, and, if appropriate, funding within the scope of the Strategic Environmental Research and Development Program. In addition, the Board shall assist and advise the Council in identifying the environmental data and analytical assistance activities that should be covered by the policies and procedures prescribed pursuant to 10 U.S.C. 2902(d)(1).

The Board may make recommendations to the Council regarding technologies, research, projects, programs, activities, and, if appropriate, funding within the scope of the Strategic Environmental Research and Development Program. In addition, the Board shall assist and advise the Council in identifying the environmental data and analytical assistance activities that should be covered by the policies and procedures prescribed pursuant to 10 U.S.C. 2902(d)(1).

The Department of Defense (DoD), through the Office of the USD(AT&L) and the Strategic Environmental Research and Development Program, provides support for the Board's performance functions and ensures compliance with the requirements of the FACA, the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended) (“the Sunshine Act”), governing Federal statutes and regulations, and established DoD policies and procedures.

Pursuant to 10 U.S.C. 2904(a), the Secretary of Defense and the Secretary of Energy, in consultation with the Administrator of the Environmental Protection Agency, shall jointly appoint not less than six and not more than 14 members.

Pursuant to 10 U.S.C. 2904(b), the Board membership shall be composed of the following:

a. Permanent members of the Board are the Science Advisor to the President and the Administrator of the National Oceanic and Atmospheric Administration or their respective designees;

b. Non-permanent members of the Board shall be appointed from among persons eminent in the fields of basic sciences, engineering, ocean and environmental sciences, education, research management, international and security affairs, health physics, health sciences, or social sciences, with due regard given to the equitable representation of scientists and engineers who are women or who represent minority groups. One such member of the Board shall be a representative of environmental public interest groups, and one such member shall be a representative of the interests of State governments.

Pursuant to 10 U.S.C. 2904(b)(3), the Secretary of Defense and the Secretary of Energy, in consultation with the Administrator of the Environmental Protection Agency, shall request that:

a. the head of the National Academy of Sciences, in consultation with the head of the National Academy of Engineering and the head of the Institutes of Medicine of the National Academy of Sciences, nominate persons for appointment to the Board;

b. the Council on Environmental Quality nominate for appointment to the Board at least one person who is a representative of environmental public interest groups; and

c. the National Association of Governors nominate for appointment to the Board at least one person who is a representative of the interests of State governments.

The Board, pursuant to 10 U.S.C. 2904(d), shall develop procedures for carrying out its responsibilities. Such procedures shall define a quorum as a majority of the members and shall provide for the annual election of the Board's Chair by the members of the Board.

The Board, pursuant to 10 U.S.C. 2904(d), shall develop procedures for carrying out its responsibilities. Such procedures shall define a quorum as a majority of the members and shall provide for the annual election of the Board's Chair by the members of the Board. Board members appointed by the Secretary of Defense and the Secretary of Energy, who are not full-time or permanent part-time Federal officers or employees, shall be appointed as experts or consultants pursuant to 5 U.S.C. 3109 to serve as special government employee (SGE) members. Board members who are full-time or permanent part-time Federal officers or employees will be appointed pursuant to 41 CFR 102-3.130(a) to serve as regular government employee (RGE) members.

SGE members are appointed to provide advice on the basis of their best judgment without representing any particular point of view and in a manner that is free from conflict of interest. Pursuant to 10 U.S.C. 2904(h), each member of the Board shall be required to file a financial disclosure report under title I of the Ethics in Government Act of 1978 (5 U.S.C. Appendix, as amended).

The members shall be appointed for terms of not less than two and not more than four years, as provided in 10 U.S.C. 2904(b)(4) and approved by the Secretary of Defense. All appointments shall be renewed by the Secretary of Defense on an annual basis. Members shall not serve more than two consecutive terms of service, unless authorized by the Secretary of Defense. With the exception of reimbursement of official Board-related travel and per diem, members of the Board serve without compensation.

DoD, when necessary and consistent with the Board's mission and DoD policies and procedures, may establish subcommittees, task forces, or working groups to support the Board. Establishment of subcommittees will be based upon a written determination, to include terms of reference, by the Secretary of Defense, the Deputy Secretary of Defense, or the USD(AT&L), as the Board's Sponsor.

Such subcommittees shall not work independently of the Board and shall report all of their recommendations and advice solely to the Board for full and open deliberation and discussion. Subcommittees, task forces, or working groups have no authority to make decisions and recommendations, verbally or in writing, on behalf of the Board. No subcommittee or any of its members can update or report, verbally or in writing, on behalf of the Board, directly to the DoD or any Federal officer or employee.

Each subcommittee member, based upon his or her individual professional experience, provides his or her best judgment on the matters before the Board, and he or she does so in a manner that is free from conflict of interest. All subcommittee members will be appointed by the Secretary of Defense or the Deputy Secretary of Defense for a term of service of two-to-four years, with annual renewals, even if the individual in question is already a member of the Board. Subcommittee members will not serve more than two consecutive terms of service, unless authorized by the Secretary of Defense or the Deputy Secretary of Defense.

Subcommittee members who are not full-time or permanent part-time Federal officers or employees will be appointed as experts or consultants pursuant to 5 U.S.C. 3109 to serve as SGE members. Subcommittee members who are full-time or permanent part-time Federal officers or employees will be appointed pursuant to 41 CFR 102-3.130(a) to serve as RGE members. With the exception of reimbursement of official travel and per diem related to the Board or its subcommittees, subcommittee members will serve without compensation.

All subcommittees operate under the provisions of FACA, the Sunshine Act, governing Federal statutes and regulations, and established DoD policies and procedures.

The Board's Designated Federal Officer (DFO) must be a full-time or permanent part-time DoD officer or employee, appointed in accordance with established DoD policies and procedures. The Board's DFO is required to attend at all meetings of the Board and its subcommittees for the entire duration of each and every meeting. However, in the absence of the Board's DFO, a properly approved Alternate DFO, duly appointed to the Board according to established DoD policies and procedures, must attend the entire duration of all meetings of the Board and its subcommittees.

The DFO, or the Alternate DFO, calls all meetings of the Board and its subcommittees; prepares and approves all meeting agendas; and adjourns any meeting when the DFO, or the Alternate DFO, determines adjournment to be in the public interest or required by governing regulations or DoD policies and procedures.

Pursuant to 10 U.S.C. 2904(d), the minimum number of Board meetings is four per year. Pursuant to 41 CFR 102-3.105(j) and 102-3.140, the public or interested organizations may submit written statements to Board membership about the Board's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the Board.

All written statements shall be submitted to the DFO for the Board, and this individual will ensure that the written statements are provided to the membership for their consideration. Contact information for the Board's DFO can be obtained from the GSA's FACA Database—http://www.facadatabase.gov/.

The DFO, pursuant to 41 CFR 102-3.150, will announce planned meetings of the Board. The DFO, at that time, may provide additional guidance on the submission of written statements that are in response to the stated agenda for the planned meeting in question.

Pursuant to subsection (o) of the Privacy Act of 1974, as amended (5 U.S.C. 552a), DoD and VA have concluded an agreement to renew a computer matching program between the agencies. The purpose of this agreement is to verify an individual's continuing eligibility for VA benefits by identifying VA disability benefit recipients who return to active duty and to ensure that benefits are terminated if appropriate. The VA will provide identifying information on disability compensation recipients to DMDC to match against a file of active duty (including full-time National Guard and Reserve) personnel. A copy of the computer matching agreement between VA and DMDC is available upon request to the public. Requests should be submitted to the address in the FOR FURTHER INFORMATION CONTACT section.

Set forth below is the notice of the renewal of the computer matching program required by paragraph 6.c. of the Office of Management and Budget Guidelines on computer matching published in the Federal Register on June 19, 1989 at 54 FR 25818. The matching agreement, as required by 5 U.S.C. 552a(r) of the Privacy Act of 1974, as amended, and an advance copy of this notice was submitted on August 26, 2015, to the House Committee on Government Reform, the Senate Committee on Governmental Affairs, and the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget pursuant to paragraph 4d of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records about Individuals,” dated February 8, 1996 (February 20, 1996; 61 FR 6427).

A. Participating Agencies: Participants in this computer matching program are the Veterans Benefits Administration of the Department of Veterans Affairs (VA) and the Defense Manpower Data Center (DMDC) of the Department of Defense (DoD). The VA is the source agency, i.e., the activity disclosing the records for the purpose of the match. The DMDC is the specific recipient activity or matching agency, i.e., the agency that performs the computer matching.

B. Purpose of the Match: The purpose of this agreement is to verify an individual's continuing eligibility for VA benefits. VA will provide identifying information on disability compensation and pension recipients to DMDC to match against a file of active duty (including full-time National Guard and Reserve) personnel. The purpose is to identify those recipients who have returned to active duty and are ineligible to receive VA compensation and pension so that benefits can be adjusted or terminated, if appropriate in order.

C. Authority for Conducting the Match: The legal authority for conducting the matching program for use in the administration of VA's Compensation and Pension Benefits Program is contained in 38 U.S.C. 5304(c), Prohibition Against Duplication of Benefits, which precludes pension, compensation, or retirement pay on account of any person's own service, for any period for which he or she receives active duty pay. The head of any Federal department or agency shall provide, pursuant to 38 U.S.C. 5106, such information as requested by VA for the purpose of determining eligibility for, or amount of benefits, or verifying other information which respect thereto.

D. Records To Be Matched: The systems of records maintained by the respective agencies under the Privacy Act of 1974, as amended, 5 U.S.C. 552a, from which record will be disclosed for the purpose of this computer matching agreement are as follows:

1. VA will use the system of records identified as “Compensation, Pension, Education and Vocational Rehabilitation and Employment Records—VA” (58VA21/22/28), published at 74 FR 29275 (June 19, 2009), and last amended at 77 FR 42593 (July 19, 2012). Disclosure of data will be pursuant to routine use 39.

2. DoD will use the system of records identified as DMDC 01, entitled, “Defense Manpower Data Center Data Base”, published November 23, 2011, 76 FR 72391. Disclosure of data will be pursuant to routine use 1.(e).

E. Description of Computer Matching Program: VA will provide DMDC with an electronic file that contains specified data elements of individual VA disability compensation and pension recipients. Upon receipt of the electronic file, DMDC will perform a computer match using all nine digits of the SSNs in the VA file against a DMDC computer database. The DMDC database consists of pay records of active duty (including full-time National Guard and Reserve) military members. Matching records, “hits” based on the SSN, will produce the member's name, branch of service, and unit designation, and other pertinent data elements. The hits will be furnished to VA, which is responsible for verifying and determining the data on the electronic reply file are consistent with the source file and for resolving all discrepancies or inconsistencies on an individual basis. VA will also be responsible for making final determinations as to positive identification, eligibility for benefits, and verifying any other information with respect thereto.

The listing will be sorted by VA file number by Regional Office number. VA will then take necessary action to terminate compensation payments of any benefit recipient identified as being on active duty while receiving compensation pay after following the verification of procedures detailed in this agreement.

F. Inclusive Dates of the Matching Program: This computer matching program is subject to public comment and review by Congress and the Office of Management and Budget. If the mandatory 30 day period for comment has expired and no comments are received and if no objections are raised by either Congress or the Office of Management and Budget within 40 days of being notified of the proposed match, the computer matching program becomes effective and the respective agencies may begin the exchange at a mutually agreeable time and thereafter on a quarterly basis. By agreement between VA and DMDC, the matching program will be in effect for 18 months with an option to renew for 12 additional months unless one of the parties to the agreement advises the other by written request to terminate or modify the agreement.

G. Address for Receipt of Public Comments or Inquiries: Chief, Defense Privacy and Civil Liberties Division, Office of the Deputy Chief Management Officer, Office of the Secretary of Defense, 9010 Defense Pentagon, Washington, DC 20301-9010. Telephone (703)571-0070.

Notice is hereby given that the State of New York (NYS or State) has petitioned the United States Environmental Protection Agency, Region 2, pursuant to section 312(f)(3) of Public Law 92-500 as amended by Public Law 95-217 and Public Law 100-4, that adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available for Seneca Lake, Cayuga Lake and the Seneca River.

Adequate facilities are defined as one sewage pumpout station for every 300 to 600 boats pursuant to the Clean Vessel Act: Pumpout Station and Dump Station Technical Guidelines (Federal Register, Vol. 59, No. 47, March 10, 1994).

On April 17, 2015, EPA published notice of its tentative affirmative determination that adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available for Seneca Lake, Cayuga Lake and the Seneca River, and its approval of New York's proposal to ban the discharge of treated and untreated sewage from vessels into those waters under Clean Water Act (“CWA”) § 312(f)(3). (78 FR 59681, September 27, 2013) EPA solicited public comments for 30 days, and the comment period ended on May 17, 2015. EPA received a total of twenty two comments via letter and email. All of the twenty two commenters support EPA's proposed determination. All of the relevant comments received have been considered, as discussed below, and EPA hereby issues a final affirmative determination that adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available within Seneca Lake, Cayuga Lake and the Seneca River.

Comment 1: Several commenters, including boaters, residents, Non-Governmental Organizations (NGOs) and community advocates expressed strong support for the establishment of a vessel waste no discharge zone (“NDZ”) for Seneca Lake, Cayuga Lake, the Seneca River and tributaries thereto. Some commenters pointed out that this action will reduce pathogens and chemicals, improve water quality and further protect drinking water, wildlife habitats and restore the lakes.

EPA Response: The petition was submitted under CWA § 312(f)(3), which allows New York to establish a vessel sewage no discharge zone if the state determines that the protection and enhancement of the quality of some or all of the waters within the state require greater environmental protection and if EPA determines that adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available within those waters. These comments are consistent with New York's determination of need.

Comment 2: One commenter suggested that stricter enforcement regulations for sewage discharge in Seneca Lake, Cayuga Lake and the Seneca River are needed.

EPA Response: We appreciate this comment. EPA's determination in the present action is limited to whether adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available within Seneca Lake, Cayuga Lake and the Seneca River and does not address the adequacy of enforcement of the proposed ban. This comment is noted but is beyond the scope of EPA's determination on this matter.

Comment 3: One commenter supports the proposed NDZ and suggests that EPA and DEC do more to protect water quality from land use changes, pollution discharges and energy development.

EPA Response: We appreciate this comment. As noted above, EPA's determination in the present action is limited to whether adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available within Seneca Lake, Cayuga Lake and the Seneca River and does not address the need for additional efforts to protect water quality. This comment is noted but is beyond the scope of EPA's determination on this matter.

Certification of Need: New York's petition contains a certification by the Commissioner of the New York State Department of Environmental Conservation (NYSDEC) that the protection and enhancement of Seneca Lake, Cayuga Lake, the Seneca River and the navigable tributaries thereto, requires greater environmental protection than the applicable Federal standards provide. The certification states that Seneca Lake and Cayuga Lake are water bodies of unique ecological, economic and public health significance, as well as drinking water sources. Pathogens and chemicals contained in the currently-lawful effluent from discharging marine sanitation devices (MSDs) threaten public health and the environment and contravene the State's ongoing efforts to control point and non-point source pollution from municipal discharges, combined sewer overflows and storm water runoff. The proposed NDZ represents one component of a comprehensive approach to water quality management. Protecting Seneca Lake, Cayuga Lake and the Seneca River warrants this greater level of environmental protection in order to maintain excellent water quality, prevent future degradation and speed the recovery of impaired segments.

Seneca Lake is the largest and deepest of all the Finger Lakes at 4.2 trillion gallons in volume and 291 feet in average depth. The maximum depth of the lake is 618 feet. The Seneca Lake Watershed comprises 14% of the greater Oswego River Watershed. While the water quality of the lake is generally good, the lake is on the NYSDEC Priority Waterbody List as a Water with Minor Impacts. This means that the current uses of the lake are fully supported but some negative water quality impacts have been observed and action must be taken to ensure that the water will continue to support its uses in the future. Pollutants that negatively impact the lake include pathogens and oxygen demand from the Watkins Glen wastewater treatment plant and general lakeside activities as well as sediment from eroding stream banks and steep slopes surrounding the lake. As part of its broader efforts to protect and enhance the water quality of Seneca Lake, New York seeks to eliminate the discharge of pathogens and chemicals from all vessels using the lake.

Cayuga Lake has a maximum depth of 435 feet and a volume of about 2.5 trillion gallons. The Cayuga Lake Watershed comprises 15% of the greater Oswego River Watershed. While the water quality of Cayuga Lake is generally good, the northern to mid-south portions of the lake are on the NYSDEC Priority Waterbody List as Threatened Segments because of the lake's significant value as a drinking water resource. As part of its broader effort to preserve and enhance water quality to maintain the lake's use as drinking waters with minimal required treatment, New York seeks to eliminate the discharge of pathogens and chemicals from all vessels using the lake.

In determining whether adequate facilities exist for the safe and sanitary removal and treatment of sewage from all vessels using a water body, EPA relies on the “Clean Vessel Act: Pumpout Station and Dump Station Technical Guidelines,” (59 FR 11290) published by the U.S. Department of the Interior (DOI), which provides that at least one pumpout station should be provided for every 300 to 600 boats over 16 feet in length. The guidance also provides that approximately 20% of boats between 16 and 26 feet, 50% of boats between 26 and 40 feet and all vessels over 40 feet in length can be assumed to have an installed toilet with some type of MSD. Vessels below 16 feet in length are generally presumed not to have an MSD onboard.

In support of its petition, New York provided information on the vessel population in the proposed NDZ. The population of recreational vessels using Seneca Lake, Cayuga Lake and the Seneca River was estimated based on the New York State Office of Parks, Recreation and Historic Preservation's 2012 Boating Report (OPRHP Report) for the counties of Cayuga, Ontario, Schuyler, Seneca, Steuben, Tompkins and Yates, which surround the lakes. While it is very unlikely that every single vessel registered in these counties will operate in the proposed NDZ simultaneously, the state took a conservative approach and considered all boats registered in these counties as part of the overall recreational vessel population of the proposed NDZ.

According to the OPRHP Report, in the seven counties surrounding the proposed NDZ, there are 16,740 registered boats between 16 and 25 feet long, 1,161 boats between 26 and 40 feet long and 71 boats over 40 feet long. Applying the percentages in the DOI guidance yields an estimate of 3,967 recreational vessels with MSDs that operate in the proposed NDZ.

The population of commercial vessels using Seneca Lake, Cayuga Lake and the Seneca River was estimated based on information provided by the Genesee Finger Lakes Regional Planning Board and the Finger Lakes Institute as well as information obtained from the Internet. According to these sources, the majority of commercial vessels operating in the proposed NDZ are chartered fishing boats. There are at least 18 charter services that operate primarily in Seneca Lake and Cayuga Lake, as well as 11 cruise companies. These companies own anywhere from one to three vessels. A conservative assumption of 40 companies (18 charter companies + 11 cruise companies + 11 unlisted businesses) with three vessels each yields a total of 120 commercial vessels that operate in the proposed NDZ. As an additional conservative assumption, all 120 commercial vessels are assumed to have MSDs. Therefore, there are approximately 4,090 vessels with MSDs operating in the proposed NDZ.

In further support of its petition, New York provided information on the number of pumpout facilities available to the recreational and commercial vessels in the proposed NDZ. The federal Clean Vessel Act of 1992 made grants available to states for construction, replacement and renovation of recreational vessel pumpouts. New York applied for the first federal grant in 1994 and initiated a statewide program known as the Clean Vessel Assistance Program (CVAP), managed and administered by New York State Environmental Facilities Corporation that has helped establish and support 17 pumpout facilities serving Seneca Lake, Cayuga Lake and the Seneca River, of which two are pumpout boats and 15 are dockside pumpouts. EPA independently updated and verified these pumpout information and concluded that two pumpout boats are out of operation and only 14 dockside pumpouts are operational. An additional three pumpout facilities are available to the public but are not funded through CVAP. All these current 17 pumpout (14 CVAP + 3 non-CVAP pumpouts = 17 pumpouts) facilities either discharge to a holding tank, to a municipal wastewater treatment plant or to an on-site septic system.

While some commercial shipping vessels are so large as to require special docking accommodations or mobile pumpouts to access pumpout services, the commercial vessels that operate in the proposed NDZ are all small enough to use the same pumpouts that the recreational vessels use. Therefore, the total number of pumpout facilities available for use by the vessels that operate in the proposed NDZ is 17. A list of pumpout facilities, phone numbers, locations, hours of operation, water depth and fees is provided below:

Based on a total vessel population of 4,090 and 17 currently available pumpout facilities, the ratio of boats to pumpouts is 241:1, which means there are significantly more pumpouts than the recommended range of 300-600:1. In addition, the pumpouts are well distributed between the lakes (7 are in Cayuga Lake and 10 are in Seneca Lake).

Based on the information above, and after considering the relevant public comments, EPA hereby makes a final affirmative determination that adequate facilities for the safe and sanitary removal and treatment of sewage are reasonably available for all vessels that use the waters of Seneca Lake, Cayuga Lake and the Seneca River. Accordingly, pursuant to 33 CFR 1322(f)(3) and 40 CFR 140.4(a), New York may completely prohibit the discharge from all vessels of any sewage, whether treated or not, into such waters.

OMB Control Number: 3060-XXXX.

Title: Sections 96.17; 96.21; 96.23; 96.33; 96.35; 96.39; 96.41; 96.43; 96.45; 96.51; 96.57; 96.59; 96.61; 96.63; 96.67, Commercial Operations in the 3550-3650 MHz Band.

Form Number: N/A.

Type of Review: New information collection.

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

Number of Respondents: 110,782 respondents; 136,432 responses.

Estimated Time per Response: 0 to .5 hours.

Frequency of Response: One-time and on occasion reporting requirements; other reporting requirements—as-needed basis for the equipment safety certifications, and consistently (likely daily) responses automated via the device.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for these collections are contained in 47 U.S.C. 151, 152, 154(i), 154(j), 155(c), 302(a), 303, 304, 307(e), and 316 of the Communications Act of 1934.

Total Annual Burden: 37,977 hours.

Total Annual Cost: $7,318,100.

Privacy Impact Assessment: No impact(s).

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

Needs and Uses: The FCC adopted a Report and Order, FCC 15-47, that establishes rules for commercial use of 150 megahertz in the 3550-3700 MHz (3.5 GHz) band and created a new Citizens Broadband Radio Service, on April 17, 2015, published at 80 FR 36163 (June 23, 2015). The order creates a Spectrum Access System (SAS), an online database that will manage and coordinate frequency use in the band through registration and other technical information. The Commission seeks approval from the Office of Management and Budget (OMB) for the information collection requirements contained in FCC 15-47. The SAS will use the information to assign frequencies, manage interference, and authorize spectrum use. The Commission will use the information to authorize the SAS Administrator(s) and ESC operator(s). The following is a description of the information collection requirements for which the Commission seeks OMB approval:

Section 96.17(d) requires that FSS Earth Station licensees register annually with the SAS to receive interference protection.

Section 96.21(a)(3) requires that existing commercial wireless broadband licensees operating in the band register in order to receive interference protection.

Sections 96.23(b); 96.33(b); 96.39(a)(1) and (c)-(e); 96.43(b); 96.45(d) require that the Citizens Broadband Radio Services Devices (CBSDs), which will operate on the Citizens Broadband Radio Service, must be registered with an SAS before use, provide specified information to the SAS, and adhere to certain operating parameters.

Section 96.35(e) requires that users operating Category B CBSDs must coordinate among each other and resolve interference through technological solutions or other agreements.

Sections 96.39(a) and (b) require that CBSDs report their geographic coordinates to an SAS automatically through the device or by a professional installer.

Sections 96.39(f) and (g) require that CBSDs incorporate sufficient security measures so that they are only able to communicate with the SAS and approved users and devices.

Section 96.41(d)(1) requires that licensees must report the use of an alternative Received Signal Strength Limit (RSSL) to the SAS.

Section 96.51 requires that manufacturers include a statement of compliance with the Commission's Radio Frequency (RF) safety rules with equipment authorization applications. Sections 96.57(a)-(c); 96.59(a); 96.61 require that the SAS be capable of receiving registration and technical information from CBSDs, SASs, and ESCs, as well as employ secure communication protocols.

Section 96.63 requires that SAS Administrator applicants must demonstrate to the Commission that they are qualified to manage an SAS.

Section 96.67 requires that an Environmental Sensing Capability (ESC), used to protect federal radar systems from interference, may only operate after receiving Commission approval and be able to communicate information about the presence of a federal system and maintain security of the detected signals.

These rules which contain information collection requirements are designed to provide for flexible use of this spectrum, while managing three tiers of users in the band, and create a low-cost entry point for a wide array of users. The rules will encourage innovation and investment in mobile broadband use in this spectrum while protecting incumbent users. Without this information, the Commission would not be able to carry out its statutory responsibilities.

The meeting will be held on September 29, 2015, from 1:00 p.m. to 4:00 p.m. in the Commission Meeting Room of the FCC, Room TW-305, 445 12th Street SW., Washington, DC 20554. The Task Force is a Federal Advisory Committee that studies and will report findings and recommendations on PSAP structure and architecture to determine whether additional consolidation of PSAP infrastructure and architecture improvements would promote greater efficiency of operations, safety of life, and cost containment, while retaining needed integration with local first responder dispatch and support. On December 2, 2014, pursuant to the FACA, the Commission established the Task Force charter for a period of two years, through December 2, 2016. At this meeting, the Task Force will vote on the recommendations and report of Working Group 3, “Optimal Approach to Next-Generation 911 Resource Allocation for PSAPs.”

Members of the general public may attend the meeting. The FCC will attempt to accommodate as many attendees as possible; however, admittance will be limited to seating availability. The Commission will provide audio and/or video coverage of the meeting over the Internet from the FCC's Web page at http://www.fcc.gov/live.

Open captioning will be provided for this event. Other reasonable accommodations for people with disabilities are available upon request. Requests for such accommodations should be submitted via email to [email protected] or by calling the Consumer & Governmental Affairs at (202) 418-0432 (TTY). Such requests should include a detailed description of the accommodation requested. In addition, please include a way the FCC may contact you if it needs more information. Please allow at least five days' advance notice; last minute requests will be accepted, but may be impossible to fill.

Intended Recipients: Rise Health, The Health Collaborative, and My Health.

Purpose of Award: The Centers for Medicare & Medicaid Services (CMS) is authorized to test innovative payment and service delivery models to reduce program expenditures under Medicare, Medicaid, and the Children's Health Insurance Program (CHIP) while preserving or enhancing the quality of care furnished to individuals under such programs. In October 2012, CMS launched the Comprehensive Primary Care (CPC) initiative as a multi-payer demonstration to test a model that fosters collaboration between public and private health insurance companies (“payers”) to strengthen primary care. The program includes 479 participating primary care practices and 38 participating payers across 7 regional areas within the United States. The CMS Innovation Center executed a Memorandum of Understanding (MOU) with each participating payer within the 7 regional areas covered by the program. One of the stated goals in the MOU is improving the flow of cost and utilization data to CPC primary care practices. The test model will aggregate multi-payer data for each primary care practice rather than practices receiving the data individually from each payer.

This single-source cooperative agreement award will allow the inclusion of Medicare data into the CPC multi-payer data model. The awardees will combine Medicare Fee-for-Service (FFS) data with utilization data from participating payers resulting in the creation of uniform and actionable reports to support physicians care coordination and quality improvement efforts.

Amount of the Award: There will be three (3) single-source, cooperative agreements awarded in the initial amount of $200,000-$450,000 per award for the first budget period. An award for a non-competing continuation at $200,000-$450,000 may be awarded for a period of 12 months.

Justification for Single Source Award: Commercial payers within the 7 regions have agreed to work together to improve data-sharing to the CPC practices. Each of the awardees currently maintain contracts with all of the CPC payers for data-sharing and have worked with the payers and practices to develop business requirements for the CPC multi-payer claims database system. If CMS were to award another source, the vendor would not be aggregating Medicare claims data with claims data from the regional payers, as each of the payers have selected the three entities of this award to perform this function. Doing so would undermine the CPC practices' ability to improve care and lower costs through care coordination and quality improvement and is counter to CMS's MOU with the payers. In conclusion, the only entities capable of providing the data aggregation services described are the three entities identified for the single-source awards.

Project Period: The anticipated period of performance for each cooperative agreement is 12 months from date of award with one continuation period of up to 12 months.

Provisions of the Notice: Title: Testing a Model of Data Aggregation under the Comprehensive Primary Care (CPC) Initiative.

CFDA Number: 93.646.

Estimated Award Date: September 12, 2015.

CMS has solicited proposal from Rise Health, The Health Collaborative, and My Health to include Medicare data into the multi-payer data model of the CPC initiative.

CMS requested the following to be submitted with each application:

Applications will be reviewed using the following evaluation criteria:

1. Proposed Approach—describe the development and implementation strategy for collecting and aggregating Medicare data with payer data from across the specified regions, including an anticipated timeline and activities associated with building the infrastructure needed to implement the project.

2. Organizational Capacity and Management Plan—demonstrates sufficient infrastructure and capacity to plan and implement the cooperative agreement activities and associated funding.

3. Evaluation and Reporting—overview of plans for quarterly reporting to CMS on the progress of the data aggregation activities funded under this cooperative agreement.

4. Budget and Budget Narrative—provide a detailed cost breakdown with explanations and justifications for the proposed cooperative agreement activities.

The ACL's Pension Counseling & Information Program consists of six regional pension counseling projects, covering 29 states. The state of Illinois, with 6.4 million workers and a pension participation rate of 42%, is one of the largest states without an ACL-funded pension counseling project. The Pension Action Center at UMass Boston, which conducts ACL's New England Pension Assistance Project, is currently providing pension counseling services to residents of Illinois with funding from the Retirement Research Foundation. Additional funds are needed to leverage the foundation's funding, in order to ensure that the current provision of services to Illinois residents will be continued. This supplementary funding would be provided for the approved period.

In 2012, n4a and NASUAD were awarded grants from ACL to build the business capacity of state and community-based aging and disability organizations for managed long-term services and supports (MLTSS). This one-year of grant funding, through continuation grant, will continue to support n4a and NASUAD in their efforts to:

• Identify and track emerging trends, best practices, barriers, lessons learned and progress in the aging and disability networks' integration into MLTSS and delivery system reform;

• increase state and community-based aging and disability organizations' capacity, readiness and involvement in the provision of MLTSS through the provision of broad-based and targeted technical assistance, education and training; and

• develop products that complement and enhance the first two areas of focus.

This program is authorized under the Older Americans Act of 1965, as amended in 2006, Public Law 109-365.

I. Background

FDA is announcing the availability of a document entitled “Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis); Guidance for Industry.” The guidance document provides HCT/P Establishments with updated recommendations concerning donor testing for evidence of T. pallidum infection. HCT/P Establishments must, as required under § 1271.80(a) and (c) (21 CFR 1271.80(a) and (c)), test a donor specimen for evidence of infection due to T. pallidum using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies under 21 CFR 1271.90. The guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in § 1271.80(c). FDA will no longer exercise enforcement discretion that permits the use of diagnostic syphilis tests or pre-amendments devices for use as an HCT/P donor screening test because the wide availability of FDA-licensed, approved, or cleared test systems with an indication for use in donor screening no longer supports such enforcement discretion. FDA recommends that HCT/P Establishments implement the recommendations in the guidance as soon as feasible, but not later than 6 months after issuance of this guidance.

In the Federal Register of November 5, 2013 (78 FR 66366), FDA announced the availability of the draft guidance of the same title, dated October 2013. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. FDA did not make changes to the recommendations in the draft guidance. FDA made editorial changes to improve clarity. The guidance announced in this notice finalizes the draft guidance dated October 2013.

In the Federal Register of February 28, 2007 (72 FR 9007), FDA announced the availability of the guidance entitled “Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),” dated February 2007. FDA issued a revised version of this guidance under the same title, dated August 2007 (hereafter referred to as the 2007 Donor Eligibility guidance). The guidance announced in this notice supersedes the recommendations on compliance with the requirements for testing HCT/P donors for T. pallidum that are contained in the 2007 Donor Eligibility guidance.

The guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis); Guidance for Industry.” 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.

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 guidance at either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

In FR Doc. 2015-18969, appearing on page 45998, in the Federal Register of Monday August 3, 2015, the following corrections are made:

On page 45998, in the second full paragraph of the third column, the registration link, https://www.SignUp4.net/public/ap.aspx?EID=SIXT10E, is corrected to read http://www.cvent.com/events/6th-annual-coalition-against-major-diseases-food-and-drug-administration-scientific-workshop-public-/invitation-ed6c207cbf09447185a891e4bf62ad7a.aspx?i=70715ca1-f255-46b2-a370-3fe3881bbab2.

On page 45998, in the third full paragraph of the third column, the registration deadline, October 14, 2015, is corrected to read October 13, 2015.

On page 45998, in the third full paragraph of the third column, the link for the FDA Meeting information page, http://www.fda.gov/Drugs/NewsEvents/ucm410863.htm, is corrected to read http://www.fda.gov/Drugs/NewsEvents/ucm457486.htm.

I. Background

IVDs, including laboratory-developed tests that utilize NGS technology to reveal information about an individual's genome, are rapidly becoming a major driver of modern healthcare. As part of the White House's Precision Medicine Initiative, FDA is exploring a novel approach for NGS test regulation that includes leveraging well-curated databases of genetic variation to provide evidence about the clinical relevance of test results. To open this discussion, FDA drafted a discussion paper and held an open public workshop titled “Optimizing FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” in February 2015 to discuss and receive feedback from the community on possible regulatory approaches to NGS-based diagnostic tests. (Workshop material, including the discussion paper, can be accessed at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm427296.htm.) The workshop announced in this document seeks to build on the feedback FDA received at the public workshop in February 2015. The Agency is therefore requesting public input on strategies for the regulatory use of databases for NGS tests that produce results on variation in the human genome.

This public workshop will consist of brief presentations that will frame the goals of the workshop and interactive discussions of key topics with several panel sessions. Following the presentations and panel discussions, there will be a moderated discussion where participants will be asked to provide their individual perspectives. The workshop discussion will focus on the development, operation (including curation), and use of databases of genetic variants.

In advance of the meeting, FDA plans to post a discussion paper outlining FDA's most current thinking about the possible uses of databases of genetic variants for NGS test regulation and a summary of the issues FDA believes need consideration at the workshop at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) FDA will place the discussion paper on file in the public docket (docket number found in brackets in the heading of this document) and will post it at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. The deadline for submitting comments on this document for presentation at the public workshop is October 26, 2015, although comments related to this document can be submitted until November 25, 2015. A detailed agenda will be posted on this Web site in advance of the workshop.

I. Background

In vitro diagnostic devices, including laboratory-developed tests, that utilize NGS technology to generate information on an individual's genome are rapidly transforming healthcare. As part of the White House's Precision Medicine Initiative, FDA envisions implementing a novel framework for NGS test regulation that includes developing sufficiently flexible assay performance standards that can accommodate innovation, including test modifications, while assuring NGS test safety and effectiveness. To start this discussion, FDA drafted a discussion paper and held an open public workshop titled “Optimizing FDA's Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” in February 2015 to discuss and receive feedback from the community on possible regulatory approaches to NGS-based diagnostic tests. Workshop material including the discussion paper can be accessed at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm427296.htm. The workshop announced in this document seeks to build on the feedback FDA received at the public workshop in February 2015, with a goal to assess standard needs, propose performance standard content, and help in the development of the standards necessary for this effort. The Agency is therefore requesting public input on the proposed standards-based regulatory strategy for NGS tests that produce results on variation in the human genome.

This public workshop will consist of brief presentations to provide information to frame the goals of the workshop and interactive discussions via several panel sessions. Following the presentations, there will be a moderated discussion where participants and additional panelists will be asked to provide their individual perspectives. The workshop discussion will focus on standards-based regulatory strategies to assure the analytical validity of NGS tests that produce results on variation in the human genome.

The presentations and discussions will focus on several topics, including an example of a possible performance standard (methods) focusing on a single intended use; a general framework and architecture for standard needs, including currently existing guidelines and standards to be developed; and possible different approaches.

In advance of the meeting, FDA plans to post a white paper outlining FDA's most current thinking for a standards-based approach to analytical performance evaluation of NGS diagnostic tests and a summary of the issues FDA believes need consideration at the workshop at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) FDA will place the discussion paper on file in the public docket (docket number found in brackets in the heading of this document) and will post it at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. The deadline for submitting comments on this document for presentation at the public workshop is October 26, 2015, although comments related to this document can be submitted until November 25, 2015. A detailed agenda will be posted on this Web site in advance of the workshop.

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg base/vial, is the subject of NDA 12-122 held by Eli Lilly, and initially approved onNovember 14, 1960. GLUCAGON is indicated for treatment of severe hypoglycemia and as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel, and colon.

Under NDA 12-122, GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg base/vial, was produced from animal sources. On September 11, 1998, FDA approved Eli Lilly's NDA 20-928 for GLUCAGON (glucagon rDNA origin), 1mg/vial. Subsequently, Eli Lilly discontinued sales of animal-sourced GLUCAGON in 2002. In 2005, FDA moved animal-sourced GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg base/vial, to the “Discontinued Drug Product List” section of the Orange Book.

Walter G. Jump, on behalf of Cornerstone Regulatory, submitted a citizen petition dated August 7, 2007 (Docket No. FDA-2007-P-0248), under 21 CFR 10.30, requesting that the Agency determine whether animal-sourced GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg base/vial, was withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition, reviewing Agency records, and based on the information we have at this time, FDA has determined under § 314.161 that GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg base/vial, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg base/vial, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal from sale of GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg base/vial. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that the product was not withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg base/vial, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg base/vial, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. However, it is the Agency's view that it would be challenging for a prospective applicant to provide adequate data to meet the statutory requirements for an ANDA that relies on NDA 12-122 for GLUCAGON (glucagon hydrochloride) for injection in the absence of comparative data with the animal-sourced glucagon approved in NDA 12-122.

FDA is announcing the availability of a guidance for industry entitled “Nonclinical Evaluation of Endocrine-Related Drug Toxicity.” This guidance focuses on nonclinical testing designed to assess the potential for a drug to cause endocrine effects that are unintentional and adverse. The standard comprehensive test battery is generally sufficient to identify endocrine-related toxicity. Depending on the outcome of a standard battery of nonclinical tests, additional nonclinical studies may be warranted to more fully characterize the endocrine-related toxicity potential of a drug.

This guidance finalizes the draft guidance entitled “Endocrine Disruption Potential of Drugs: Nonclinical Evaluation” issued on September 20, 2013 (78 FR 57859). Revisions to the draft guidance address public comments and try to give more clarity regarding when additional studies could be appropriate.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on nonclinical evaluation of endocrine-related drug toxicity. 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 refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively.

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.

I. Background

FDA is announcing the availability of a revised draft guidance for industry and review staff entitled “Formal Dispute Resolution: Appeals Above the Division Level.” In the course of the review of applications for user fee products, a wide variety of scientific and/or medical issues are discussed that are critical to a sponsor's drug product development program. Sometimes, a sponsor may disagree with the Agency on a matter, and a dispute arises. Because these disputes often involve complex scientific and/or medical matters, it is critical that there be procedures in place to help ensure open, prompt discussion of such disputes. The procedures and policies described in this guidance are intended to promote rapid resolution of scientific and/or medical disputes between sponsors and CDER or CBER.

This draft guidance revises the draft guidance of the same name issued March 13, 2013 (78 FR 15955). Based on the docket comments for the draft guidance as well as on its own initiative, FDA made the following changes. The scope of the guidance was expanded to include formal dispute resolution requests for human drug applications covered under the Biosimilar User Fee Act of 2012. Additionally, certain areas were revised to provide more clarity, such as when a matter is and is not appropriate for a formal dispute resolution request, and information to include in the supporting background information. Also, this guidance clarifies that CDER and CBER intend to manage formal requests for appeals of scientific and/or medical disputes related to an application for a user fee product under any of the available regulatory mechanisms (i.e., 21 CFR 10.75, 312.48(c), 314.103(c)), through the formal dispute resolution process.

This revised draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on formal dispute resolution requests for appeals above the division level. 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 revised draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in this draft guidance have been approved under OMB control number 0910-0430. This draft guidance is a revision of an earlier version of the guidance. The revised version contains no additional information collections; therefore, it continues to be covered under OMB control number 0910-0430.

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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

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

Sponsors are required to monitor studies evaluating new drugs, biologics, and devices (21 CFR 312.50 and 312.56 for drugs and biologics and 21 CFR 812.40 and 812.46 for devices). Various individuals and groups play different roles in clinical trial monitoring. One such group is a data monitoring committee (DMC), appointed by a sponsor to evaluate the accumulating outcome data in some trials. A clinical trial DMC is a group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials. The DMC advises the sponsor regarding the continuing safety of current trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial.

The guidance document referenced in this document is intended to assist sponsors of clinical trials in determining when a DMC is needed for monitoring a study, and how such committees should operate. The guidance addresses the roles, responsibilities, and operating procedures of DMCs, describes certain reporting and recordkeeping responsibilities, including the following: (1) Sponsor reporting to FDA on DMC recommendations related to safety; (2) standard operating procedures (SOPs) for DMCs; (3) DMC meeting records; (4) sponsor notification to the DMC regarding waivers; and (5) DMC reports based on meeting minutes to the sponsor.

The requirement of the sponsor to report DMC recommendations related to serious adverse events in an expedited manner in clinical trials of new drugs (21 CFR 312.32(c)) would not apply when the DMC recommendation is related to an excess of events not classifiable as serious. Nevertheless, the Agency recommends in the guidance that sponsors inform FDA about all recommendations related to the safety of the investigational product whether or not the adverse event in question meets the definition of “serious.”

In the guidance, FDA recommends that sponsors establish procedures to do the following things:

• Assess potential conflicts of interest of proposed DMC members;

• Ensure that those with serious conflicts of interest are not included in the DMC;

• Provide disclosure to all DMC members of any potential conflicts that are not thought to impede objectivity and, thus, would not preclude service on the DMC;

• Identify and disclose any concurrent service of any DMC member on other DMCs of the same, related, or competing products;

• Ensure separation, and designate a different statistician to advise on the management of the trial, if the primary trial statistician takes on the responsibility for interim analysis and reporting to the DMC; and

• Minimize the risks of bias that are associated with an arrangement under which the primary trial statistician takes on the responsibility for interim analysis and reporting to the DMC, if it appears infeasible or highly impractical for any other statistician to take over responsibilities related to trial management.

The Agency recommends in the guidance that the DMC or the group preparing the interim reports to the DMC maintain all meeting records. This information should be submitted to FDA with the clinical study report (21 CFR 314.50(d)(5)(ii)).

The sponsor must report to FDA certain serious and unexpected adverse events in drugs and biologics trials (§ 312.32) and unanticipated adverse device effects in the case of device trials (21 CFR 812.150(b)(1)). The Agency recommends in the guidance that sponsors notify DMCs about any waivers granted by FDA for expedited reporting of certain serious events.

The Agency recommends in the guidance that DMCs should issue a written report to the sponsor based on the DMC meeting minutes. Reports to the sponsor should include only those data generally available to the sponsor. The sponsor may convey the relevant information in this report to other interested parties, such as study investigators. Meeting minutes or other information that include discussion of confidential data would not be provided to the sponsor.

Description of Respondents: The submission and data collection recommendations described in this document affect sponsors of clinical trials and DMCs.

Burden Estimate: Table 1 provides the burden estimate of the annual reporting burden for the information to be submitted in accordance with the guidance. Table 2 provides the burden estimate of the annual recordkeeping burden for the information to be maintained in accordance with the guidance. Table 3 provides the burden estimate of the annual third-party disclosure burden for the information to be submitted in accordance with the guidance.

Reporting, Recordkeeping, and Third-Party Disclosure Burdens: Based on information from FDA review divisions, FDA estimates there are approximately 740 clinical trials with DMCs regulated by the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health. FDA estimates that the average length of a clinical trial is 2 years, resulting in an annual estimate of 370 clinical trials. Because FDA has no information on which to project a change in the use of DMCs, FDA estimates that the number of clinical trials with DMCs will not change significantly. For purposes of this information collection, FDA estimates that each sponsor is responsible for approximately 10 trials, resulting in an estimated 37 sponsors that are affected by the guidance annually.

Based on information provided to FDA by sponsors that have typically used DMCs for the kinds of studies for which this guidance recommends them, FDA estimates that the majority of sponsors have already prepared SOPs for DMCs, and only a minimum amount of time is necessary to revise or update them for use for other clinical studies. FDA receives very few requests for waivers regarding expedited reporting of certain serious events; therefore, FDA has estimated one respondent per year to account for the rare instance a request may be made. Based on FDA's experience with clinical trials using DMCs, FDA estimates that the sponsor on average would issue two interim reports per clinical trial to the DMC. FDA estimates that the DMCs would hold two meetings per year per clinical trial resulting in the issuance of two DMC reports of meeting minutes to the sponsor. One set of both of the meeting records should be maintained per clinical trial.

The “Average Burden per Response” and “Average Burden per Recordkeeping” are based on FDA's experience with comparable recordkeeping and reporting provisions applicable to FDA regulated industry. The “Average Burden per Response” includes the time the respondent would spend reviewing, gathering, and preparing the information to be submitted to the DMC, FDA, or the sponsor. The “Average Burden per Recordkeeping” includes the time to record, gather, and maintain the information.

The information collection provisions in the guidance for 21 CFR 312.30, 312.32, 312.38, 312.55, and 312.56 have been approved under OMB control number 0910-0014; § 314.50 has been approved under OMB control number 0910-0001; and 21 CFR 812.35 and 812.150 have been approved under OMB control number 0910-0078.

In the Federal Register of March 27, 2015 (80 FR 16402), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

PACHA was established by Executive Order 12963, dated June 14, 1995, as amended by Executive Order 13009, dated June 14, 1996. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective prevention and care of HIV disease and AIDS. The functions of the Council are solely advisory in nature.

The Council consists of not more than 25 members. Council members are selected from prominent community leaders with particular expertise in, or knowledge of, matters concerning HIV and AIDS, public health, global health, philanthropy, marketing or business, as well as other national leaders held in high esteem from other sectors of society. Council members are appointed by the Secretary or designee, in consultation with the White House Office on National AIDS Policy. Pursuant to advance written agreement, Council members shall receive no stipend for the advisory service they render as members of PACHA. However, as authorized by law and in accordance with federal travel regulations, PACHA members may receive per diem and reimbursement for travel expenses incurred in relation to performing duties for the Council.

This announcement is to solicit nominations of qualified candidates to fill current vacancies on the PACHA.

Nominations: In accordance with the PACHA charter, persons nominated for appointment as members of the PACHA should be among prominent community leaders and authorities with particular expertise in, or knowledge of, matters concerning HIV and AIDS, public health, global health, philanthropy, marketing or business, as well as other national leaders held in high esteem from other sectors of society. The following information should be included in the package of material submitted for each individual being nominated for consideration of appointment:

• Name, return address, daytime telephone number, and affiliation(s) of the individual being nominated, the basis for the individual's nomination, and a statement bearing an original signature of the nominated individual that, if appointed, he or she is willing to serve as a member of the Council;

• Name, return address, and daytime telephone number at which the nominator may be contacted. Nomina­tions from organizations must identify a principal contact person; and a

• Copy of a current resume or curriculum vitae for the nominated individual.

Individuals can nominate themselves for consideration of appointment to the Council. All nominations must include the required information. Incomplete nominations will not be processed for consideration. The letter from the nominator and certification of the nominated individual must bear original signatures; reproduced copies of these signatures are not acceptable.

The Department is legally required to ensure that the membership of HHS federal advisory committees is fairly balanced in terms of points of view represented and the functions to be performed by the advisory committee. Every effort is made to ensure that the views of women, all ethnic and racial groups, and people with disabilities are represented on HHS federal advisory committees and, therefore, the Department encourages nominations of qualified candidates from these groups. The Department also encourages geographic diversity in the composition of the Council. Appointment to the Council shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status. The Standards of Ethical Conduct for Employees of the Executive Branch are applicable to individuals who are appointed as members of the Council. Individuals being considered for appointment as public voting members will be required to complete and submit a report of their financial holdings. An ethics review must be conducted to ensure that individuals appointed as members of PACHA are not involved in any activity that may pose a potential conflict of interest for the official duties that are to be performed.

On September 18, 2014, the President issued Executive Order 13676 on Combating Antibiotic-Resistant Bacteria (https://www.whitehouse.gov/the-press-office/2014/09/18/executive-order-combating-antibiotic-resistant-bacteria) and the Antimicrobial Resistance Challenge was called for in the accompanying White House Fact Sheet https://www.whitehouse.gov/the-press-office/2014/09/18/fact-sheet-obama-administration-takes-actions-combat-antibiotic-resistan). The development and use of rapid, point-of-care, and innovative diagnostic tests for identification and characterization of resistant bacteria was a goal identified in the National Strategy for Combating Antibiotic-Resistant Bacteria released in September 2014 (https://www.whitehouse.gov/sites/default/files/docs/carb_national_strategy.pdf) and addressed in the National Action Plan for Combating Antibiotic-Resistant Bacteria released in March 2015 (https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf).

In conformance to the above documents, the NIH and BARDA are sponsoring a prize competition, and the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are contributing technical and regulatory expertise to develop the award evaluation process.

The aim of the prize competition is to incentivize the development of one or more in vitro diagnostic tests that would be of significant clinical and public health utility to combat the development and spread of antibiotic resistant bacteria. For example, such a diagnostic test could be used by health care providers to identify bacterial infections in patients to help guide their decisions about the necessity of prescribing antibiotics, and if so, which antibiotics may be effective—thus promoting antibiotic stewardship. Another important diagnostic use could be to facilitate clinical trials for new antibacterial products by allowing for the enrichment of patient populations with specific infections, thus advancing the development of new antibacterial agents. The prize-winning diagnostic(s) must exhibit a set of predefined technical criteria and performance characteristics based on the intended use(s).

When exercising prize authority under the America COMPETES Act (http://www.thefederalregister.org/fdsys/pkg/PLAW-111publ358/html/PLAW-111publ358.htm), agencies are to “consult widely both within and outside the federal Government” when developing prize competitions. As such, HHS is seeking input from the medical, public health, and scientific communities; the pharmaceutical and medical diagnostic sectors; patients and other advocacy groups; and the public at-large in order to receive broad input on the type(s) of diagnostic(s) that may be developed in an appropriate time frame to be of significant utility in combating the development and spread of antibiotic resistant bacteria.

HHS has previously issued a Request for Information (RFI) to obtain comments on several topics as they pertain to a rapid, point-of-care diagnostic test(s) that could be developed in an appropriate time frame to be of significant clinical and public health utility in combating the development and spread of antibiotic resistant bacteria. A prioritized list of 18 bacteria of highest concern can be found in Table 3 of the National Action Plan (https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf). Input received from the RFI and during the public consultation will be used by HHS to develop the technical criteria and performance characteristics of the diagnostic(s) for which the prize(s) will be offered. The design of the Challenge will take into account previous guidance obtained in the aforementioned National Strategy and National Action Plan to combat antibiotic resistant bacteria.

The agenda of the public consultation meeting will be devoted to presentations and discussions on the objectives and criteria for the antimicrobial diagnostic challenge competition. Presentations will focus on the need for rapid diagnostics to address antimicrobial resistance; development and use of rapid diagnostics for drug resistant microorganisms; pathogen/resistance markers identification versus phenotypic susceptibility; antibiotic stewardship in the clinical setting; and regulatory perspectives on rapid diagnostic development.

Any interested person may submit written comments to be considered during the public consultation to the discussion board for this Challenge accessible on https://www.challenge.gov. This statement should include your name, address, telephone number and when applicable, the business or professional affiliation. Written comments can be submitted from October 1, 2015 at 8:30 a.m. EDT to October 6, 2015 at 5:00 p.m. EDT.

This web-based discussion board also provides an open forum for discussion of this prize competition. The online community is open to the public and will allow for a broad and interactive discussion of the topics covered by this public consultation. This platform will allow users to submit ideas about a desired diagnostic test and to comment on the ideas that have been submitted by others.

Background The National Customs Automation Program

The National Customs Automation Program (NCAP) was established in Subtitle B of Title VI—Customs Modernization, in the North American Free Trade Agreement Implementation Act (Pub. L. 103-182, 107 Stat. 2057, Dec. 8, 1993) (Customs Modernization Act) (19 U.S.C. 1411-14). Through NCAP, the initial thrust of customs modernization was on trade compliance and the development of the Automated Commercial Environment (ACE), the planned successor to the Automated Commercial System (ACS). ACE is an automated and electronic system for commercial trade processing which is intended to streamline business processes, facilitate growth in trade, ensure cargo security, and foster participation in global commerce, while ensuring compliance with U.S. laws and regulations and reducing costs for CBP and all of its communities of interest. The ability to meet these objectives depends on successfully modernizing CBP's business functions and the information technology that supports those functions. CBP's modernization efforts are accomplished through phased releases of ACE component functionality designed to replace a specific legacy ACS or paper function, or to create a new function. Each release begins with a test and ends with mandatory use of the new ACE feature, thus retiring the legacy ACS or paper function as applicable. Each release builds on previous releases and sets the foundation for subsequent releases.

The Customs Modernization Act provides the Commissioner of CBP with the authority to conduct limited test programs or procedures designed to evaluate planned components of the NCAP. The test described in this notice is authorized pursuant to the Customs Modernization Act and section 101.9(b) of title 19 of the Code of Federal Regulations (19 CFR 101.9(b)) which provides for the testing of NCAP programs or procedures. As provided in 19 CFR 101.9(b), for purposes of conducting an NCAP test, the Commissioner of CBP may impose requirements different from those specified in the CBP regulations.

This test is also in furtherance of the International Trade Data System (ITDS) key initiatives, set forth in section 405 of the Security and Accountability for Every Port Act of 2006 (Pub. L. 109-347, 120 Stat. 1884, Oct. 13, 2006) (SAFE Port Act) (19 U.S.C. 1411(d)) and Executive Order 13659 of February 19, 2014, Streamlining the Export/Import Process for America's Businesses. The purpose of ITDS, as stated in section 405 of the SAFE Port Act, is to eliminate redundant information requirements, efficiently regulate the flow of commerce, and effectively enforce laws and regulations relating to international trade, by establishing a single portal system, operated by CBP, for the collection and distribution of standard electronic import and export data required by all participating Federal agencies. CBP is developing ACE as the “single window” for the trade community to comply with the ITDS requirement established by the SAFE Port Act.

Executive Order 13659 requires that by December 2016, ACE, as the ITDS single window, have the operational capabilities to serve as the primary means of receiving from users the standard set of data and other relevant documentation (exclusive of applications for permits, licenses, or certifications) required for the release of imported cargo and clearance of cargo for export, and to transition from paper-based requirements and procedures to faster and more cost-effective electronic submissions to, and communications with, U.S. government agencies.

Under existing regulations, rail carriers are not required to submit a paper or electronic manifest for cargo exported from the United States by rail. However, as discussed below, under 19 CFR 192.14, the U.S. Principal Party in Interest (USPPI) is required to submit certain advance information to CBP for export cargo leaving the United States by rail.1

Section 343(a) of the Trade Act of 2002, as amended (Trade Act) (19 U.S.C. 2071 note), required CBP to promulgate regulations providing for the mandatory transmission of electronic cargo information by way of a CBP-approved electronic data interchange (EDI) system before the cargo is brought into or departs the United States by any mode of commercial transportation (sea, air, rail, or truck). The required cargo information is that which is reasonably necessary to enable high-risk shipments to be identified for purposes of ensuring cargo safety and security and preventing smuggling pursuant to the laws enforced and administered by CBP. Section 192.14 of title 19 of the Code of Federal Regulations (19 CFR 192.14) implements the requirements of the Trade Act with regard to cargo departing the United States.

Under 19 CFR 192.14, the USPPI must file any required Electronic Export Information (EEI) for the cargo on the train in the Automated Export System (AES). The USPPI or its authorized agent must transmit and verify system acceptance of this EEI, generally no later than 2 hours prior to the arrival of the train at the border. The rail carrier may not load cargo without first receiving from the USPPI or its authorized agent either the related EEI filing citation, covering all cargo for which the EEI is required, or exemption legends, covering cargo for which EEI need not be filed. While the rail carrier is not required to submit a rail cargo export manifest to CBP, the outbound rail carrier must annotate the carrier's outward manifest, waybill, or other export documentation with the applicable AES proof of filing, post departure, downtime, exclusion or exemption citations, conforming to the approved data formats found in the Bureau of the Census Foreign Trade Regulations (FTR) (See 15 CFR part 30).

The ACE Export Manifest for Rail Cargo Test will test the feasibility of requiring rail carriers to file export manifest data. In addition, the ACE Export Manifest for Rail Cargo Test will test the functionality regarding the filing of export manifest data for rail cargo electronically to ACE in furtherance of the ITDS initiatives described above. CBP has re-engineered AES to move it to an ACE system platform. The re-engineering and incorporation of AES into ACE will result in the creation of a single automated export processing platform for certain export manifest, commodity, licensing, export control, and export targeting transactions. This will reduce costs for CBP, partner government agencies, and the trade community, and improve facilitation of export shipments through the supply chain.

The ACE Export Manifest for Rail Cargo Test will also test the feasibility of requiring the rail carrier to submit manifest information electronically in ACE generally within a specified time before the cargo is loaded on the train. As described in the paragraph below, in the test, participants will submit export manifest data electronically to ACE at least 2 hours prior to loading of the cargo or, for empty rail cars, upon assembly of the train. This timeframe will also enable CBP to link the EEI submitted by the USPPI with the export manifest information. This capability will better enable CBP to assess risk and effectively target and inspect shipments prior to the loading of cargo to ensure compliance with all U.S. export laws.

Participants in the ACE Export Manifest for Rail Cargo Test agree to provide export manifest data electronically at least 2 hours prior to loading of the cargo onto the train in preparation for departure from the United States or, for empty rail cars, upon assembly of the train. The ACE Export Manifest data submission will be used to target high-risk rail cargo. CBP expects that test participants will have access to the manifest data early in the planning stages of an export rail cargo transaction and will be able to comply with these timeframes. CBP anticipates that these timeframes will provide CBP adequate time to perform proper risk assessment and identification of shipments to be inspected early enough in the supply chain to enhance security while minimizing disruption to the flow of goods. Although CBP will aim to identify shipments for inspection prior to loading, inspections could potentially happen at any time before the train departs the United States.

Any rail cargo identified as potentially high-risk will receive a hold until required additional information related to the shipment is submitted to clarify non-descriptive, inaccurate, or insufficient information, a physical inspection is performed, or some other appropriate action is taken, as specified by CBP. Once the cargo is cleared for loading, a release message will be generated and transmitted to the filer.

The ACE Export Manifest for Rail Cargo Test data elements are mandatory unless otherwise indicated. Data elements that are indicated as “conditional” must be transmitted to CBP only if the particular information pertains to the shipment or cargo. The ACE Export Manifest for Rail Cargo data elements are to be submitted at the lowest bill level. The data elements for all shipments, including empty rail cars, consist of:

Recovery of endangered or threatened animals and plants to the point where they are again secure, self-sustaining members of their ecosystems is a primary goal of our endangered species program and the Endangered Species Act of 1973, as amended (Act; 16 U.S.C. 1531 et seq.). Recovery means improvement of the status of listed species to the point at which listing is no longer needed under any criteria specified in section 4(a)(1) of the Act. To help guide the recovery effort, we prepare recovery plans for most listed species. Recovery plans describe actions considered necessary for conservation of the species, establish criteria for downlisting or delisting, and estimate time and cost for implementing recovery measures. The Act requires the development of recovery plans for listed species, unless such a plan would not promote the conservation of a particular species.

The Service listed the Mississippi gopher frog (Rana capito sevosa) under the Act, as an endangered distinct vertebrate population segment (DPS) of the gopher frog (Rana capito) on December 4, 2001 (66 FR 62993). On June 12, 2012, we published a final rule (77 FR 35118) designating critical habitat for this listed entity, changing its status to “species,” and changing its name to dusky gopher frog (Rana sevosa) based on taxonomic changes and the acceptance of these changes by the herpetological scientific community. The frog's current distribution is restricted to the State of Mississippi. At the time of listing, only one population of the species was known. Subsequently, two other naturally occurring populations were discovered. One additional dusky gopher frog population has been established in Mississippi as a result of translocation experiments. Presently, we estimate that a minimum of 135 individual adult frogs survive in the wild, the vast majority of which occur in the original population known at the time of listing.

Principal threats to the dusky gopher frog include degradation and destruction of breeding and nonbreeding habitat, habitat fragmentation, and alteration of hydrological patterns due to urbanization and climate change. Additional threats include the restricted range of the dusky gopher frog, its small number of populations, and disease. All these factors act to increase the vulnerability of the species to a single catastrophic event and to the deleterious effects of genetic inbreeding.

Section 4(f) of the Act requires us to provide public notice and an opportunity for public review and comment prior to final approval of recovery plans. We and other Federal agencies will take these comments into account in the course of implementing approved recovery plans.

The Technical/Agency Draft Recovery Plan for the Dusky Gopher Frog was developed by the Dusky Gopher Frog Recovery Team and our Mississippi Field Office. This draft plan was published on September 10, 2014, and made available for public comment through November 10, 2014 (79 FR 53728).

We received public comments on our draft recovery plan and incorporated them into the final plan, as appropriate. We also considered the information we received from peer reviewers in our preparation and approval of this final recovery plan.

The Service's recovery objectives are to work to reduce threats so that the dusky gopher frog may be downlisted to threatened status. Defining reasonable delisting criteria is not possible at this time, given the current low number of populations and individuals, lack of information about the species' biology, and magnitude of threats. Therefore, this recovery plan only establishes downlisting criteria for the dusky gopher frog.

Downlisting of the dusky gopher frog will be considered when:

1. Six viable metapopulations* are documented within blocks of recovery focus areas (described in Section II of the recovery plan) and are widely distributed across the range of the species. The six metapopulations would include a minimum of 12 breeding ponds and would be distributed as follows:

a. One metapopulation in Block #1 (Louisiana: Portions of St. Tammany, Tangipahoa, and Washington Parishes, west to the Tangipahoa River);

b. Two metapopulations each in Block #2 (South-Central Mississippi: North of State Hwy. 26, between the Pearl and Pascagoula Rivers; Forrest County and portions of Lamar, Pearl River, Perry, and Stone Counties) and Block #3 (South Mississippi: South of Hwy. 26, between the Pearl and Pascagoula Rivers; Hancock and Harrison Counties, and portions of Jackson, George, Pearl River, and Stone Counties); and

c. One metapopulation in either Block #4 (Eastern Mississippi: East of Pascagoula/Leaf Rivers; portions of George, Greene, Jackson, and Wayne Counties) or Block #5 (Alabama: West of the Mobile River Delta; Mobile and Washington Counties, small portion of Choctaw County).

2. Long-term monitoring (at least 10 years) of each metapopulation is able to document population viability (viability standard to be defined through a recovery task). The 10-year timeframe will allow monitoring of recruitment events and other population attributes in a species that has been characterized by highly variable reproductive and survival rates. In each of at least two annual breeding events within a 3-year period, a total of 30 egg masses per metapopulation must be documented and recruitment must be verified.

3. Breeding and adjacent upland habitats within the six metapopulations are protected long term through management agreements, public ownership, or other means, in sufficient quantity and quality (to be determined by recovery task) to support growing populations.

4. Studies of the dusky gopher frog's biological and ecological requirements are completed, and any required recovery measures discovered during these studies are developed and implemented.

* Information defining what constitutes a viable metapopulation can be found in the Service's final recovery plan.

The authority for this action is section 4(f) of the Endangered Species Act, 16 U.S.C. 1533 (f).

I. Abstract

The Doug D. Nebert NSDI Champion of the Year Award honors a respected colleague, technical visionary, and recognized national leader in the establishment of spatial data infrastructures that significantly enhance the understanding of our physical and cultural world. The award is sponsored by the Federal Geographic Data Committee (FGDC) and its purpose is to recognize an individual or a team representing Federal, State, Tribal, regional, and (or) local government, academia, or non-profit and professional organization that has developed an outstanding, innovative, and operational tool, application, or service capability used by multiple organizations that furthers the vision of the National Spatial Data Infrastructure (NSDI).

National nominations are accepted from the public and private sector individuals, teams, organizations, and professional societies. Nomination packages include three sections: (A) Cover Sheet, (B) Summary Statement, and (C) Supplemental Materials. The cover sheet includes professional contact information. The Summary Statement is limited to two pages and describes the nominee's achievements in the development of an outstanding, innovative, and operational tool, application, or service capability that directly supports the spatial data infrastructures. Nominations may include up to 10 pages of supplemental information such as resume, publications list, and/or letters of endorsement. The award consists of a citation and plaque, which are presented to the recipient at an appropriate public forum by the FGDC Chair. The name of the recipient is also inscribed on a permanent plaque, which are displayed by the FGDC.

OMB Control Number: 1028—NEW.

Title: Doug D. Nebert NSDI Champion of the Year Award.

Type of Request: New information collection.

Affected Public: Personnel from Federal, State, Local, and Tribal governments; Private Sector; Academia; and Non-profit organizations.

Respondent's Obligation: None. Participation is voluntary.

Frequency of Collection: This is an annual offer.

Estimated Annual Number of Respondents: 10.

Estimated Total Number of Annual Responses: 10.

Estimated Time per Response: 10 hours.

Estimated Annual Burden Hours: 100 hours.

Estimated Reporting and Recordkeeping “Non-Hour Cost” Burden: None.

Public Disclosure Statement: The PRA (44 U.S.C. 3501, et seq.) provides that an agency may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number and current expiration date.

We are soliciting comments as to: (a) Whether the proposed collection of information is necessary for the agency to perform its duties, including whether the information is useful; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, usefulness, and clarity of the information to be collected; and (d) how to minimize the burden on the respondents, including the use of automated collection techniques or other forms of information technology.

Please note that the comments submitted in response to this notice are a matter of public record. Before including your personal mailing address, phone number, email address, or other personally identifiable information in your comment, you should be aware that your entire comment, including your personally identifiable information, may be made publicly available at any time. While you can ask us in your comment to withhold your personally identifiable information from public view, we cannot guarantee that we will be able to do so.

Pursuant to the Act of August 15, 1953, Public Law 83-277, 67 Stat. 586, 18 U.S.C. 1161, as interpreted by the Supreme Court in Rice v. Rehner, 463 U.S. 713 (1983), the Secretary of the Interior shall certify and publish in the Federal Register notice of adopted liquor ordinances for the purpose of regulating liquor transactions in Indian country. The Pueblo of Santa Ana Tribal Council of the Pueblo of Santa Ana adopted the amendments to the Pueblo's Title 10—Licensing & Regulation, Chapter 1—Liquor Code (Chapter), Section 126, by Resolution No. 2015-R-09 on June 11, 2015. This Federal Register notice amends and supersedes the Pueblo of Santa Ana Liquor Ordinance, enacted by the Pueblo of Santa Ana Tribal Council, which was last published on April 7, 2006 (71 FR 17903).

This notice is published in accordance with the authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs. I certify that the Pueblo of Santa Ana Council of the Pueblo of Santa Ana duly adopted this amendment to the Pueblo's Title 10—Licensing & Regulation, Chapter 1—Liquor Code (Chapter) by Resolution No. 2015-R-09 on June 11, 2015.

Section 126 Pueblo of Santa Ana Liquor Code shall read as follows:

Section 101: FINDINGS.

The Tribal Council finds as follows:

A. The introduction, possession and sale of alcoholic beverages on the Santa Ana Indian Reservation has, for a long time, been clearly recognized as a matter of special concern to the Pueblo and its members and to the United States; and

B. Under federal law and New Mexico state law, and as a matter of inherent Tribal sovereignty, the question of when and to what extent alcoholic beverages may be introduced into and sold or consumed within the Santa Ana Indian Reservation is to be decided by the governing body of the Tribe; and

C. It is desirable that the Tribal Council legislate comprehensively on the subject of the sale and possession of alcoholic beverages within the Santa Ana Indian Reservation, both to establish a consistent and reasonable Tribal policy on this important subject, as well as to facilitate economic development projects within the Santa Ana Indian Reservation that may involve outlets for the sale and consumption of alcoholic beverages; and

D. It is the policy of the Tribal Council that the introduction, sale and consumption of alcoholic beverages within the Santa Ana Indian Reservation be carefully regulated so as to protect the public health, safety and welfare, and that licensees be made fully accountable for violations of conditions of their licenses and the consequences thereof.

Section 102: DEFINITIONS.

As used in this Chapter, the following words shall have the following meanings:

A. “Council” means the Tribal Council of the Pueblo of Santa Ana.

B. “Development Area” means those lands within the Santa Ana Indian Reservation and that are situated west of the Rio Grande and south of the Rio Jemez, but not including any lands within the boundaries of the Santa Ana Pueblo Grant as confirmed by Congress by the Act of February 9, 1869, c. 26, 15 Stat. 438 (provided however, that if such term is more specifically defined in a planning or zoning statute or ordinance adopted by the Tribal Council, or in any regulations issued under the authority of any such duly adopted planning or zoning statute or ordinance, such definition shall supersede and control the definition of such term set forth herein).

C. “Governor” means the Governor of the Pueblo of Santa Ana.

D. “Licensed Premises” means the location within the Santa Ana Indian Reservation at which a licensee is permitted to sell and allow the consumption of alcoholic beverages, and may, if requested by the applicant and approved by the Governor, include any related or associated facilities under the control of the licensee, or within which the licensee is otherwise authorized to conduct business (but subject to any conditions or limitations as to sales within such area that may be imposed by the Governor in issuance of the license).

E. “Licensee” means a person or entity that has been issued a license to sell alcoholic beverages on the licensed premises under the provision of this Liquor Code.

F. “Liquor” or “Alcoholic Beverage” includes the four varieties of liquor commonly referred to as alcohol, spirits, wine and beer, and all fermented, spirituous, vinous or malt liquors or combinations thereof, mixed liquor, any part of which is fermented, spirituous, vinous, or malt liquor, or any otherwise intoxicating liquid, including every liquid or solid or semi-solid or other substance, patented or not, containing alcohol, spirits, wine or beer and intended for oral consumption.

G. “Liquor Code” means the Santa Ana Pueblo Liquor Code, this Chapter.

H. “Person” means any natural person, partnership, corporation, joint venture, association, or other legal entity.

I. “Pueblo” or “Tribe” means the Pueblo of Santa Ana.

J. “Sale” or “sell” means any exchange, barter, or other transfer of goods from one person to another for commercial purposes, whether with or without consideration.

K. “Santa Ana Indian Reservation” means all lands within the exterior boundaries of the Santa Ana Indian Reservation, all lands within the exterior boundaries of the El Ranchito Grant and the Santa Ana Pueblo Grant, and all other lands owned by the Pueblo subject to federal law restrictions on alienation or held by the United States for the use and benefit of the Pueblo.

L. “Special Event” means a bona fide special occasion such as a fair, fiesta, show, tournament, contest, meeting, picnic or similar event within the Development Area, sponsored by an established business or organization, lasting no more than three days. A special event may be open to the public or to a designated group, and it may be a one-time event or periodic, provided, however, that such events held more than four times a year by the same business or organization may not be deemed special events for purposes of this Liquor Code, in the discretion of the Governor.

M. “Server” means an individual who sells, serves or dispenses alcoholic beverages for consumption on or off licensed premises, including persons who manage, direct or control the sale or service of alcohol.

Section 103: SOVEREIGN IMMUNITY PRESERVED.

Nothing in the Liquor Code shall be construed as a waiver or limitation of the sovereign immunity of the Pueblo.

Section 104: INITIAL COMPLIANCE.

No person shall be disqualified from being issued a license under the provisions of this Liquor Code, or shall be found to have violated any provision of this Chapter, solely because such person, having been duly authorized to engage in the sale of alcoholic beverages within the Santa Ana Indian Reservation under the law as it existed prior to enactment of this Liquor Code, continues to engage in such business without a license issued under the provisions of this Liquor Code after the effective date hereof, so long as such person, within 90 days after such effective date (or within 30 days after receiving written notice from the Pueblo of the enactment of the Liquor Code, whichever is later) submits an application for such license in compliance with the provisions of this Liquor Code, and a license is thereafter issued in due course; provided, however, that upon the issuance of a license under the provisions of this Liquor Code to any person or entity, or upon the rejection of an application for such license by any person or entity, no license issued by the State of New Mexico or issued under the provisions of any prior law of the Pueblo that is held by such person or entity, or that purports to authorize the possession, sale or consumption of alcoholic beverages on premises covered by a license issued (or a license application rejected) under the provisions of this Liquor Code, shall have any further validity or effect within the Santa Ana Indian Reservation.

Section 105: SEVERABILITY.

In the event any provision of this Liquor Code is held invalid or unenforceable by any court of competent jurisdiction, the remainder of the Code shall continue in full force and effect, notwithstanding the invalidity or unenforceability of such provision, to the fullest extent practicable.

Section 121: PROHIBITION.

The sale, introduction for sale, purchase, or other dealing in alcoholic beverages, except as is specifically authorized by the Liquor Code, is prohibited within the Santa Ana Indian Reservation.

Section 122: POSSESSION FOR PERSONAL USE.

Possession of alcoholic beverages for personal use shall be lawful within the Santa Ana Indian Reservation only if such alcoholic beverages were lawfully purchased from an establishment duly licensed to sell such beverages, whether on or off the Santa Ana Indian Reservation, and are possessed by a person or persons 21 years of age or older. Such possession is otherwise prohibited.

Section 123: TRANSPORTATION THROUGH RESERVATION NOT AFFECTED.

Nothing herein shall pertain to the otherwise lawful transportation of alcoholic beverages through the Santa Ana Indian Reservation by persons remaining upon public highways (or other areas paved for motor vehicles) and where such beverages are not delivered, sold at retail or offered for sale at retail to anyone within the Santa Ana Indian Reservation.

Section 124: REQUIREMENT OF PUEBLO LICENSE.

No person shall sell any alcoholic beverage within the Santa Ana Indian Reservation at retail, or offer any such beverage for sale at retail, unless such person holds a license issued by the Pueblo under the provisions of this Chapter.

Section 125: ALL SALES FOR PERSONAL USE.

No person licensed to sell alcoholic beverages within the Santa Ana Indian Reservation shall sell any such beverage for resale, but all such sales shall be for the personal use of the purchaser. Nothing herein shall prohibit a duly licensed wholesale dealer in alcoholic beverages from selling and delivering such beverages to properly licensed retailers within the Santa Ana Indian Reservation, so long as such sales and deliveries are otherwise in conformity with the laws of the State of New Mexico and this Liquor Code.

Section 126: PACKAGE SALES AND SALES OF LIQUOR BY THE DRINK PERMITTED.

Sales of alcoholic beverages on the Santa Ana Indian Reservation may be in package form or for consumption on the premises, or both, so long as the seller is properly licensed by the Pueblo to make sales of that type. No seller of alcoholic beverages shall permit any person to bring onto premises where liquor by the drink is authorized to be sold any alcoholic beverages purchased elsewhere, unless such person is otherwise licensed to possess or distribute such beverages on such premises, except that a restaurant holding a premises license may allow a customer who is ordering a meal, and who is legally entitled to consume alcoholic beverages, to bring onto the premises one or more bottles of wine that were legally acquired from a New Mexico licensed retailer or wholesaler (but not to exceed one bottle per person at the table), for consumption with such customer's meal, provided that any such bottle is opened by an employee of the restaurant who is legally entitled to serve alcoholic beverages, and the restaurant may charge a corkage fee for each such bottle opened.

Section 127: NO SALES TO MINORS.

No alcoholic beverages may be sold within the Santa Ana Indian Reservation to persons under the age of 21 years.

Section 128: HOURS AND DAYS OF SALE.

Alcoholic beverages may be sold, offered for sale or consumed on licensed premises within the Santa Ana Indian Reservation at such hours as are established by the Licensee, but provided that in no event shall any such sales or consumption occur between the hours of 2:00 a.m. and 7:00 a.m. on any day.

Section 129: [Repealed.]

Section 130: OTHER PROHIBITIONS ON SALES.

The Tribal Council may, by duly enacted resolution, establish other days on which or times at which sales or consumption of alcoholic beverages are not permitted within the Santa Ana Indian Reservation. The Council shall give notice of any such enactment promptly to all licensees within the Santa Ana Indian Reservation. In addition, the Governor of the Pueblo may, in the event of a bona fide emergency, and by written order, prohibit the sale of any alcoholic beverages within the Santa Ana Indian Reservation for a period of time not to exceed 48 hours. The Governor shall give prompt notice of such emergency order to all licensees within the Santa Ana Indian Reservation. No such emergency order may extend beyond 48 hours, unless during that time the Tribal Council meets and determines that the emergency requires a further extension of such order.

Section 131: LOCATION OF SALES, CONSUMPTION.

No person licensed to sell alcoholic beverages within the Santa Ana Indian Reservation shall make such sales except at the licensed premises specifically designated in such license. No person holding a premises license shall permit consumption of alcoholic beverages purchased from such licensee to occur off of the licensed premises; except that nothing herein shall prohibit a premises licensee from permitting a customer who has purchased a bottle of wine with a meal, but only partially consumed the contents of such bottle, from taking the partially consumed bottle off of the premises, after such bottle has been recorked by the licensee and placed in a sealed bag, to which a receipt for the purchase of the bottle has been affixed.

Section 132: SALES TO BE MADE BY ADULTS.

A. No person shall be employed as a server at a licensed premises unless within 30 days after such person's employment such person has obtained alcohol server training equivalent to that required under the laws of the State of New Mexico.

B. No person shall be employed to sell, serve or accept payment for any sale of alcoholic beverages, or to oversee or direct or have any other involvement in any such sale, within the Santa Ana Indian Reservation, who is less than 21 years of age, except that a premises licensee that operates a restaurant or other facility that is held out to the public as a place where meals are prepared and served may employ persons 19 years of age or older to sell or serve alcoholic beverages to persons who are also ordering food, provided that no person under the age of 21 shall be employed as a bartender by any licensee within the Santa Ana Indian Reservation.

Section 133: ALL SALES CASH.

No licensee shall make any sale of any alcoholic beverages within the Santa Ana Indian Reservation without receiving payment therefor by cash, check, credit card, cash equivalent (such as gaming chips) or voucher issued by the licensee and specifically intended to be redeemable for alcoholic beverages, at or about the time the sale is made; provided, that nothing herein shall preclude a licensee from receiving a delivery of alcoholic beverages from a duly authorized wholesaler where arrangements have been made to pay for such delivery at a different time; and provided further that nothing herein shall preclude a licensee from allowing a customer to purchase more than one alcoholic beverage in sequence, and to pay for all such purchases at the conclusion thereof, so long as payment is made in full before the customer has left the licensed premises; and provided further that nothing herein shall prevent a licensee from distributing alcoholic beverages to customers without charge, so long as such distribution is not otherwise in violation of any provision of this Liquor Code.

Section 151: REQUIREMENT OF LICENSE.

Any person who sells, offers for sale, stores or possesses for commercial purposes, or maintains premises for the consumption of alcoholic beverages within the Santa Ana Indian Reservation, must be duly licensed under the provisions of this Liquor Code.

Section 152: CLASSES OF LICENSES.

The following types or classes of licenses for the sale or distribution of alcoholic beverages within the Santa Ana Indian Reservation shall be permitted:

A. Package license, which shall authorize the licensee to store, possess, sell and offer for sale alcoholic beverages in unopened containers, or in containers that may only be opened by employees of the licensee, for consumption only off the licensed premises.

B. Premises license, which shall authorize the licensee to store, possess and sell alcoholic beverages for consumption on the licensed premises, and to permit such consumption on the licensed premises, provided that such license when held by an inn or hotel shall also permit the licensee to stock any individual guest room with alcoholic beverages contained in a compartment available to the registered guest to whom such room is rented and who is 21 years of age or older; and provided further that a premises licensee may allow a patron who has purchased a bottle of wine with a meal, but who has not consumed all of the contents of such bottle, to leave the premises with the partially filled bottle, after the bottle has been recorked and placed in a sealed bag by the licensee, with a receipt showing the customer's payment for the bottle attached to the bag.

C. Special event license, which shall authorize the licensee to possess, distribute, sell and offer for sale alcoholic beverages for consumption only on the licensed premises, and to permit such consumption, but only for a bona fide special event, and only during the period or periods specified in such license, which period or periods shall be limited to the periods during which the special event is occurring and from beginning to end shall not exceed 72 hours.

Section 153: QUALIFICATIONS FOR LICENSE.

A. No person shall be entitled to be issued a license under the provisions of this Liquor Code who has previously been the subject of any proceeding resulting in the revocation or the denial of a renewal of any license for the sale of alcoholic beverages issued by the Pueblo or by any state or other jurisdiction, or who has been convicted of any felony in any jurisdiction involving theft, corruption, dishonesty or embezzlement, or who has not at the time the application for license is submitted attained the age of 21 years, or who is otherwise determined by the Pueblo to be unfit to be licensed to sell alcoholic beverages, or whose spouse is a person not qualified to hold a license under the provisions of this section.

B. No partnership or corporation shall be entitled to be issued a license under the provisions of this Liquor Code if any individual occupying any management or supervisory position within such corporation or partnership, or who sits on the management committee or board of directors or trustees thereof, or who holds or controls a financial interest of ten percent or more in such partnership or corporation, is a person who would not be entitled to be issued a license under the provisions of this section.

C. No person shall be entitled to be issued a package or premises license hereunder unless such person has, by virtue of an approved lease or other valid interest in lands within the Santa Ana Indian Reservation, lawful entitlement to engage in a business within the Development Area with which such license would be compatible, and can demonstrate that such person is otherwise capable of complying with all of the requirements imposed on licensees by this Liquor Code.

D. No application for a package or premises license shall be issued for any licensed premises outside of the Development Area.

E. Notwithstanding anything in this section to the contrary, the Pueblo and its agencies, programs and enterprises shall be entitled to be issued licenses hereunder in appropriate circumstances, provided that all other provisions of this Liquor Code are complied with.

Section 154: PACKAGE AND PREMISES LICENSE APPLICATION; PROCEDURE; FEES.

A. Every person seeking a package or premises license under the provisions of this Liquor Code (other than the Pueblo or any of its agencies, programs or enterprises) shall submit to the Pueblo's Tribal Administrator, or such other person as the Governor may designate to handle such matters (hereinafter referred to as “Liquor License Administrator”) a written application, under oath, in the form prescribed by and containing the information required by this section.

B. If the applicant is a natural person, the application shall contain, at a minimum, all of the following information:

1. The full legal name of the applicant, plus any other names under which the applicant has been known or done business during the previous 20 years, and the applicant's date and place of birth, as shown by a certified copy of the applicant's birth certificate.

2. The applicant's current legal residence address and business address, if any, and every residence address that the applicant has maintained during the previous ten years, with the dates during which each such address was current.

3. The trade name, business address and description of every business in which the applicant has engaged or had any interest (other than stock ownership or partnership interest amounting to less than five percent of total capital) during the previous ten years, and the dates during which the applicant engaged in or held an interest in any such business.

4. A listing of every other jurisdiction in which the applicant has ever applied for a license to sell or distribute alcoholic beverages, the date on which each such application was filed, the name of the regulatory agency with which the application was filed, the action taken on each such application, and if any such license was issued, the dates during which it remained in effect, and as to each such license a statement whether any action was ever taken by the regulatory body to suspend or revoke such license, with full dates and details of any such incident.

5. A listing of every crime with which the applicant has ever been charged, other than routine traffic offenses (but including any charge of driving while intoxicated or the like), giving as to each the date on which the charge was made, the location, the jurisdiction, the court in which the matter was heard, and the outcome or ultimate disposition thereof.

6. The name and address of every person or entity holding any security interest in any of the assets of the business to be conducted by the applicant, or in any of the proceeds of such business.

7. A detailed plat of the business premises within the Development Area, including the floor plans of any structure and the details of any exterior areas intended to be part of the licensed premises, together with evidence of the applicant's right to conduct business on such premises.

8. A detailed description of the business conducted or intended to be conducted on the licensed premises, and including (but not limited to) hours of operation and number of employees.

9. The type(s) of license(s) requested.

C. If the applicant is a corporation, the corporation, each officer of the corporation and every person holding 10% or more of the outstanding stock in the corporation shall submit an application complying with the provisions of paragraph B of this section, and in addition, the applicant shall also submit the following:

1. A certified copy of its Articles of Incorporation and Bylaws.

2. The names and addresses of all officers and directors and those stockholders owning 5% or more of the voting stock of the corporation and the amount of stock held by each such stockholder.

3. The name of the resident agent of the corporation who would be authorized to accept service of process, including orders and notices issued by the Pueblo, and who will have principal supervisory responsibility for the business to be conducted on the licensed premises.

4. Such additional information regarding the corporation as the Liquor License Administrator may require to assure a full disclosure of the corporation's structure and financial responsibility.

D. If the applicant is a partnership, the partnership, the managing partner and every partner having an interest amounting to 10% or more of the total equity interest in the partnership shall submit applicants complying with the provisions of paragraph B of this section, and in addition, the applicant shall submit the following:

1. A certified copy of the Partnership Agreement.

2. The names and addresses of all general partners and of all limited partners contributing 10% or more of the total value of contributions made to the limited partnership or who are entitled to 10% or more of any distributions of the limited partnership.

3. The name and address of the partner, or other agent of the partnership, authorized to accept service of process, including orders and notices issued by the Pueblo, and who will have principal supervisory responsibility for the business to be conducted in the licensed premises.

4. Such additional information regarding the partnership as the Liquor License Administrator may require to assure a full disclosure of the partnership's structure and financial responsibility.

E. Every applicant who is a natural person, and every person required by paragraphs C or D of this section to comply with the provisions of paragraph B, shall also submit with the application a complete set of fingerprints, taken under the supervision of and certified to by an officer of an authorized law enforcement agency located within the State of New Mexico.

F. Every applicant for either a package license or a premises license shall submit with the completed license application a non-refundable license processing fee, in the amount set forth below:

G. Upon receiving a completed license application together with the required fee, the Liquor License Administrator shall cause a background investigation to be performed of the applicant, to determine whether the applicant is qualified to be licensed under the provisions of this Liquor Code. Upon the written recommendation of the Liquor License Administrator (if requested by the applicant), the Governor may, in his discretion, issue a preliminary license to the applicant effective for a period of no more than 90 days, but which shall be renewable for one additional period of 90 days in the event the background investigation cannot be completed within the first 90-day period; provided, however, that in no event shall the issuance of a preliminary license, or the renewal of such license for an additional 90-day period, entitle the applicant to favorable consideration with respect to the application for a package or premises license.

H. The Pueblo or any of its agencies, programs or enterprises may apply for a package or premises license by submitting an application to the Liquor License Administrator identifying the applicant, describing in detail the purpose of the license, including a detailed description of the proposed licensed premises, and including the appropriate fee as set forth in Paragraph F of this section.

Section 155: ISSUANCE OF LICENSE.

A. The Liquor License Administrator shall, after reviewing all of the information submitted by the applicant or revealed by the background investigation, submit a report to the Governor recommending either approval or denial of the application for the license, and stating the reasons for such recommendation.

B. Upon review of the recommendation of the Liquor License Administrator, if the Governor finds that the applicant satisfies the requirements of Section 153 of this chapter, the Governor shall issue the license, authorizing the applicant to engage in sales of alcoholic beverages within the Santa Ana Indian Reservation as permitted by the class of license applied for, and specifying in detail the licensed premises where such sales are permitted (which shall be within the Development Area), but subject also to all the terms and conditions of this Liquor Code, and to such other appropriate conditions, not inconsistent with the provisions of this Liquor Code, as the Governor may deem reasonable and necessary under the circumstances.

C. In the event the Governor concludes, on the basis of the Liquor License Administrator's report, that the applicant does not satisfy the requirements of Section 153 of this chapter, the Governor shall issue a notice denying the application, and explaining the basis for such denial.

D. Any applicant whose application is denied shall have the right to appeal such denial, by filing a Notice of Appeal with the Office of the Governor and with the Santa Ana Tribal Court, within 30 days of the date of receipt of the Notice of Denial. Upon receiving a copy of a Notice of Appeal, the Governor's office shall prepare a copy of the entire file pertaining to the application and shall transmit it to the Tribal Court, with a copy to the applicant. The Pueblo, represented by the Pueblo's attorney, shall appear in the action in the Tribal Court. The proceedings in the Tribal Court shall be based upon the record that was before the Liquor License Administrator and the Governor, except that the applicant may, upon a showing of good cause, be permitted to submit additional evidence to rebut or explain information relied on by the Governor for his denial of the application that was not obtained from the applicant. The Tribal Court shall affirm the Governor's decision unless it finds that the Governor acted arbitrarily or capriciously or otherwise abused his discretion in making his determination.

E. Any party that is aggrieved by the decision of the Tribal Court may petition the Tribal Council to review the Tribal Court decision, in writing, within 30 days after issuance of the Tribal Court decision. The petition shall set forth the specific grounds on which the petitioner claims the Tribal Court erred in its decision, and why its decision should be reviewed, and shall be served on the Governor and all parties. The prevailing party may submit a response to the petition within 15 days of service of the petition. The Governor shall place the petition on the agenda of the next Tribal Council meeting after service of the response (or the expiration of the 15-day period, if no response is filed), and the Tribal Council shall, at such meeting, decide whether to hear the petition. In the event the Tribal Council decides to hear the petition, the Governor shall notify all parties of that decision, and of the date on which the Tribal Council shall consider the matter. The Governor shall provide each Tribal Council member with a copy of the Tribal Court decision, the petition for Tribal Council review and the response, if any, and the complete record before the Tribal Court shall be available for inspection by any Tribal Council member. The Tribal Council shall hear each party's representative present its arguments, and shall decide by majority vote whether a license should be issued to the applicant. The Tribal Council's decision shall be final and nonreviewable.

Section 156: TERM; RENEWAL; FEE.

A. Each package or premises license issued hereunder shall have a term of one (1) year from the date of issuance, provided that such license shall be renewable for additional periods of one year each by any licensee who has complied fully with the terms and provisions of the license and of this Liquor Code during the term of the license, and who remains fully qualified to be licensed under the provisions of Section 153 of this Chapter, upon payment to the Pueblo of a license renewal fee in the amount of the initial application fee, and submission of an application for renewal on a form specified by the Liquor License Administrator, no less than thirty (30) days prior to the expiration date of the license. The renewal form shall require the applicant to note any changes in the information submitted with the original license application. The failure to submit a timely renewal application, with the required fee, may subject the licensee to a late charge of $500.00. If the renewal application is not submitted prior to expiration of the license, the Liquor License Administrator may treat the license as having expired, and may require the licensee to file a new application in compliance with Section 154 of this chapter.

B. Upon receipt of an application for renewal of a license, and a recommendation of the Liquor License Administrator, the Governor shall determine whether the licensee has conducted its operations in compliance with the provisions of this Code, and is otherwise qualified to be licensed. In the event the Governor receives information indicating that the licensee has not complied with the provisions of this Code or is otherwise not qualified to be licensed hereunder, the Governor shall deny the application for renewal, giving the licensee written notice thereof with a statement of the reasons for such denial.

C. A licensee may appeal a denial of an application for renewal of its license, by filing a Notice of Appeal with the Office of the Governor and with the Santa Ana Tribal Court, within 30 days of receipt of the Notice of Denial of the application for renewal. Upon receiving the Notice of Appeal, the Governor's office shall prepare a complete copy of the entire file pertaining to the application and shall transmit it to the Tribal Court, with a copy to the applicant. The Pueblo, represented by the Pueblo's attorney, shall appear in the action in the Tribal Court. The proceedings in the Tribal Court shall be based upon the information submitted to the Governor by the licensee and any other information obtained by the Governor in the course of processing the application, except that the licensee shall be permitted to submit additional evidence to rebut or explain information relied on by the Governor for his denial of the application that was not obtained from the licensee. The licensee may apply to the Tribal Court for an order maintaining the license in effect during the pendency of the appeal, but in the absence of such order, the license shall expire at the end of its term. The Tribal Court shall affirm the Governor's decision unless it finds that the Governor acted arbitrarily or capriciously or otherwise abused his discretion in making his determination.

D. Any party that is aggrieved by the decision of the Tribal Court may petition the Tribal Council to review the Tribal Court decision, in writing, within 30 days after issuance of the Tribal Court decision. The petition shall set forth the specific grounds on which the petitioner claims the Tribal Court erred in its decision, and why its decision should be reviewed, and shall be served on the Governor and all parties. The prevailing party may submit a response to the petition within 15 days of service of the petition. The Governor shall place the petition on the agenda of the next Tribal Council meeting after service of the response (or the expiration of the 15-day period, if no response is filed), and the Tribal Council shall, at such meeting, decide whether to hear the petition. In the event the Tribal Council decides to hear the petition, the Governor shall notify all parties of that decision, and of the date on which the Tribal Council shall consider the matter. The Governor shall provide each Tribal Council member with a copy of the Tribal Court decision, the petition for Tribal Council review and the response, if any, and the complete record before the Tribal Court shall be available for inspection by any Tribal Council member. The Tribal Council shall hear each party's representative present its arguments, and shall decide by majority vote whether the license should be renewed. The Tribal Council's decision shall be final and nonreviewable.

Section 157: CONDITIONS OF LICENSE.

No licensee shall have any property interest in any license issued under the provisions of this Liquor Code, and every such license shall be deemed to confer a privilege, revocable by the Pueblo in accordance with the provisions of this Chapter. The continued validity of every package and premises license issued hereunder shall be dependent upon the following conditions:

A. Every representation made by the licensee and any of its officers, directors, shareholders, partners or other persons required to submit information in support of the application, shall have been true at the time such information was submitted, and shall continue to be true, except to the extent the licensee advises the Liquor License Administrator in writing of any change in any such information, and notwithstanding any such change, the licensee shall continue to be qualified to be licensed under the provisions of this Liquor Code.

B. The licensee shall at all times conduct its business on the Santa Ana Indian Reservation in full compliance with the provisions of this Liquor Code and with the other laws of the Pueblo.

C. The licensee shall maintain in force, public liability insurance covering the licensed premises, insuring the licensee and the Pueblo against any claims, losses or liability whatsoever for any acts or omissions of the licensee or of any business invitee on the licensed premises resulting in injury, loss or damage to any other party, with coverage limits of at least $1 million per injured person, and the Liquor License Administrator shall at all times have written evidence of the continued existence of such policy of insurance.

D. The licensee shall continue to have authority to engage in business within the Development Area, and shall have paid all required rentals, assessments, taxes, or other payments due the Pueblo.

E. The business conducted on the licensed premises shall be conducted by the licensee or its employees directly, and shall not be conducted by any lessee, sublessee, assignee or other transferee, nor shall any license or any interest therein be sold, assigned, leased or otherwise transferred to any other person.

F. All alcoholic beverages sold on the licensed premises shall have been obtained from a New Mexico licensed wholesaler.

G. The licensee shall submit to the jurisdiction of the Tribal Court of the Pueblo with respect to any action brought by the Pueblo or any of its agencies or officials to enforce the provisions of this Liquor Code, or with respect to any action arising out of the licensee's sale or service of alcoholic beverages on the licensed premises.

Section 158: SANCTIONS FOR VIOLATION OF LICENSE.

A. Upon determining that any person licensed by the Pueblo to sell alcoholic beverages under the provisions of this chapter is for any reason no longer qualified to hold such license under the provisions of Section 153 hereof, or has violated any of the conditions set forth in Section 157, the Governor shall immediately serve written notice upon such licensee directing that he show cause within ten (10) calendar days why his license should not be suspended or revoked, or a fine imposed. The notice shall specify the precise grounds relied upon and the action proposed.

B. If the licensee fails to respond to such notice within ten (10) calendar days of service of such notice, the Governor shall issue an order suspending the license for such period as the Governor deems appropriate, or revoking the license, effective immediately, or imposing a fine, in such amount as the Governor deems reasonable. If the licensee, within the 10-day period, files with the Office of the Governor a written response and request for a hearing before the Santa Ana Tribal Court, such hearing shall be set no later than thirty (30) calendar days after receipt of such request.

C. At the hearing, the licensee, who may be represented by counsel, shall present evidence and argument directed at the issue of whether or not the asserted grounds for the proposed action are in fact true, and whether such grounds justify such action. The Pueblo may present such other evidence as it deems appropriate.

D. The court after considering all of the evidence and arguments shall issue a written decision either upholding the proposed action of the Governor, modifying such action by imposing some lesser penalty, or ruling in favor of the licensee, and such decision shall be final and conclusive.

Section 159: SPECIAL EVENT LICENSE.

A. Any person authorized to conduct business within the Development Area, or any established organization (including any agency, department or enterprise of the Pueblo) that includes any member of the Pueblo and that has authority to conduct any activities within the Santa Ana Indian Reservation, that is not a licensee hereunder and that has not had an application for a license rejected, may apply to the Liquor License Administrator for a special event license, which shall entitle the applicant to distribute alcoholic beverages, whether or not for consideration, in connection with a bona fide special event to be held by the applicant within the Development Area. Any such application must be filed in writing, in a form prescribed by the Liquor License Administrator, no later than ten (10) calendar days prior to the event, and must be accompanied by a fee in an amount set by the Liquor License Administrator from time to time, and must contain at least the following information:

1. The exact days and times during which the event will occur (provided, that in no event shall any license be in effect for a period exceeding 72 hours, from the beginning of the first day of the event until the end of the last day);

2. The precise location within the Development Area where the event will occur, and where alcoholic beverages will be distributed;

3. The nature and purpose of the event, and the identity or categories of persons who are invited to participate;

4. The nature of any food and beverages to be distributed, and the manner in which such distribution shall occur;

5. Details of all provisions made by the applicant for sanitation, security and other measures to protect the health and welfare of participants at the event;

6. Certification that the event will be covered by a policy of public liability insurance as described in Section 157(C) of this Liquor Code, that includes the Pueblo as a co-insured, or that the applicant will indemnify the Pueblo and hold it harmless from any claims, demands, liability or expense as a result of the act or omission of any person in connection with the special event, in which latter case the Liquor License Administrator or Governor may require a bond to assure compliance with such indemnification provision.

7. Any other information required by the Liquor License Administrator relative to the event.

B. The Liquor License Administrator, or the Governor, shall act to approve or reject the application no later than three days following submission of the application with the required fee. If the application is approved, the Liquor License Administrator or the Governor shall issue the license, which shall specify the hours during which and the premises within which sales, distribution and consumption of alcoholic beverages may occur. If any application is rejected, the rejection shall indicate the grounds therefor, and the applicant shall be entitled to file a new application correcting any deficiencies or problems found in the original application that warranted the rejection.

C. Alcoholic beverages may be sold or distributed pursuant to a special event license only at the location and during the hours specified in such license, in connection with the special event, only to participants in such special event, and only for consumption on the premises described in the license. Such sales or distribution must comply with any conditions imposed by the license, and with all other applicable provisions of this Liquor Code. All such alcoholic beverages must have been obtained from a New Mexico licensed wholesaler or retailer.

Section 160: DISPLAY OF LICENSE.

Every person licensed by the Pueblo to sell alcoholic beverages within the Santa Ana Indian Reservation shall prominently display the license on the licensed premises during hours of operation.

Section 181: PURCHASE FROM OR SALE TO UNAUTHORIZED PERSONS.

Within the Santa Ana Indian Reservation, no person shall purchase any alcoholic beverage at retail except from a person licensed by the Pueblo under the provisions of this title; no person except a person licensed by the Pueblo under the provisions of this title shall sell any alcoholic beverage at retail; nor shall any person sell any alcoholic beverage for resale to any person other than a person properly licensed by the Pueblo under the provisions of this title.

Section 182: SALE TO MINORS.

A. No person shall sell or serve any alcoholic beverage to any person under the age of 21 years.

B. It shall be a defense to an alleged violation of this Section that the purchaser presented to the seller or server an apparently valid identification document showing the purchaser's age to be 21 years or older, provided that the seller or server, as the case may be, had no actual or constructive knowledge of the falsity of the identification document, and relied in good faith on its apparent validity.

Section 183: PURCHASE BY MINOR.

No person under the age of 21 years shall purchase, attempt to purchase or possess any alcoholic beverage.

Section 184: SALE TO PERSON UNDER THE INFLUENCE OF ALCOHOL.

No person shall sell any alcoholic beverage to a person who the seller has reason to believe is intoxicated or who the seller has reason to believe intends to provide such alcoholic beverage to an intoxicated person.

Section 185: PURCHASE BY PERSON UNDER THE INFLUENCE OF ALCOHOL.

No intoxicated person shall purchase any alcoholic beverage.

Section 186: DRINKING IN PUBLIC PLACES.

No person shall consume any alcoholic beverage in any public place within the Santa Ana Indian Reservation except on premises licensed by the Pueblo for the sale of alcoholic beverages by the drink.

Section 187: BRINGING LIQUOR ONTO LICENSED PREMISES.

No person shall bring any alcoholic beverage for personal consumption onto any premises within the Santa Ana Indian Reservation where liquor is authorized to be sold by the drink, unless such beverage was purchased on such premises, or unless the possession or distribution of such beverages on such premises is otherwise permitted under the provisions of this Liquor Code.

Section 188: OPEN CONTAINERS PROHIBITED.

No person shall have an open container of any alcoholic beverage in a public place, other than on premises licensed for the sale of alcoholic beverages by the drink, or in any automobile, whether moving or standing still. This Section shall not apply to empty containers such as aluminum cans or glass bottles collected for recycling.

Section 189: USE OF FALSE OR ALTERED IDENTIFICATION.

No person shall purchase or attempt to purchase any alcoholic beverage by the use of any false or altered identification document that falsely purports to show the individual to be 21 years of age or older.

Section 190: PENALTIES.

A. Any person convicted of committing any violation of this Chapter shall be subject to punishment of up to one (1) year imprisonment or a fine not to exceed Five Thousand Dollars ($5,000.00), or to both such imprisonment and fine.

B. Any person not a member of the Pueblo, upon committing any violation of any provision of this Chapter, may be subject to a civil action for trespass, and upon having been determined by the court to have committed the alleged violation, shall be found to have trespassed upon the lands of the Pueblo, and shall be assessed such damages as the court deems appropriate in the circumstances.

C. Any person suspected of having violated any provision of this Chapter shall, in addition to any other penalty imposed hereunder, be required to surrender any alcoholic beverages in such person's possession to the officer making the arrest or issuing the complaint.

Section 191: JURISDICTION.

Any and all actions, whether civil or criminal, arising from or pertaining to alleged violations of this title or any duty imposed hereby, or seeking any relief against the Pueblo or any officer or employee of the Pueblo with respect to any matter addressed by this Liquor Code, shall be brought in the Tribal Court of the Pueblo, which court shall have exclusive jurisdiction thereof. No waiver of this provision shall be implied by any court, and no such waiver shall be valid unless expressly set forth in a written resolution of the Tribal Council.

The supplemental plat of sections 23 and 24 in Township 5 South, Range 78 West, Sixth Principal Meridian, Colorado, was accepted on August 19, 2015, and filed on August 21, 2015.

The Bureau of Land Management and the United States Forest Service will manage the lands to protect the cultural, recreational, and biological resources within and along the Wild and Scenic Trinity River, including a $46 million Federal investment restoration of the natural functionality of the river, wetland, and riparian areas, fisheries habitat, and recreation improvements.

By virtue of the authority vested in the Secretary of the Interior by Section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714, it is ordered as follows:

1. Subject to valid existing rights, the following described lands are hereby withdrawn from location and entry under the United States mining laws, but not from leasing under the mineral or geothermal leasing laws or disposal under the Mineral Materials Act of 1947, in order to protect the cultural, recreational, and biological resources within and along the Trinity Wild and Scenic River:

The areas described in (a) aggregate 3,123 acres, more or less, in Trinity County.

The areas described in (b) aggregate 541 acres, more or less, in Trinity County.

The total areas described in (a) and (b) aggregate 3,664 acres in Trinity County.

2. The withdrawal made by this order does not alter the applicability of the public land laws other than under the mining laws.

3. This withdrawal will expire 20 years from the effective date of this order, unless, as a result of a review conducted before the expiration date pursuant to Section 204(f) of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714(f), the Secretary determines that the withdrawal shall be extended.