Elaine Kohrman, Forest Supervisor, Cibola National Forest and National Grasslands, 2113 Osuna Rd. NE., Albuquerque, NM 87113.

The Cibola National Forest is preparing an EIS to revise the existing Forest Plan. The EIS process is meant to inform the Forest Supervisor so she can decide which alternative best maintains and restores National Forest System terrestrial and aquatic resources while providing ecosystem services and multiple uses, as required by the National Forest Management Act and the Multiple Use Sustained Yield Act.

The revised Forest Plan will describe the strategic intent of managing the Forest for the next 10 to 15 years and will address the identified needs for change to the existing land management plans. The revised Forest Plan will provide management direction in the form of desired conditions, objectives, standards, guidelines, and suitability of lands. It will identify delineation of new management areas and geographic areas across the Forest; identify the timber sale program quantity; make recommendations to Congress for Wilderness designation; and list rivers and streams eligible for inclusion in the National Wild and Scenic Rivers System. The revised Forest Plan will also provide a description of the plan area's distinctive roles and contributions within the broader landscape, identify watersheds that are a priority for maintenance or restoration, include a monitoring program, and contain information reflecting expected possible actions over the life of the plan.

The revised Forest Plan will provide strategic direction and a framework for decision making during the life of the plan, but it will not make site-specific project decisions and will not dictate day-to-day administrative activities needed to carry on the Forest Service's internal operations. The authorization of project-level activities will be based on the guidance/direction contained in the revised plan, but will occur through subsequent project specific decision-making, including NEPA analysis.

The revised Forest Plan will provide broad, strategic guidance designed to supplement, not replace, overarching laws and regulations. Though strategic guidance will be provided, no decisions will be made regarding the management of individual roads or trails, such as those that might be associated with a Travel Management plan under 36 CFR part 212 . Some issues, although important, are beyond the authority or control of a Forest Plan and will not be addressed during revision. For example, no decision regarding locatable mineral availability will be made, though standards will be brought forward or developed that would mitigate impacts should an availability decision be necessary in the future.

According to the National Forest Management Act, forest plans are to be revised on a 10 to 15 year cycle. The purpose and need for revising the current Forest Plan is (1) the Forest Plan is over 29 years old and 14 years beyond the intended plan period in NFMA, (2) to address changes in economic, social, and ecological conditions, new policies and priorities, and new information based on monitoring and scientific research, and (3) to address the preliminary needs for change to the existing plan, which are summarized below. Extensive public and employee involvement, along with a science-based assessment of the conditions and trends of the Forest's ecological, social, and economic resources, have helped to identify theses preliminary needs for change to the existing Forest Plan.

The Proposed Action is to revise the Forest Plan to address these identified needs for change to the existing Forest Plan. Alternatives to the Proposed Action will be developed to address the significant issues that will be identified through scoping.

What follows is a summary of the preliminary needs for change. A more fully developed description of the preliminary needs for change, is available for review on the plan revision Web site at: http://www.fs.usda.gov/detail/cibola/landmanagement/planning/?cid=fsbdev3_065627.

There is a need to address, either by plan direction or other plan content, how all resource management should be prioritized given varying levels of funding.

There is a need to redraw the management area configuration used in the 1985 Plan. There is a need to update plan component language for the resources, goods, and services provided by the Cibola, and to remove plan components that are redundant with existing law, regulation, or policy.

There is a need to better recognize and potentially enhance the role of the Cibola National Forest in supporting local economies through both commodity production and services-such as recreation and tourism.

There is a need to include plan direction addressing potential climate change effects and invasive species on the Cibola and to include a plan monitoring program.

There is a need to provide direction for an integrated resource approach to the use of planned fire and to address fuel accumulations in the Wildland Urban Interface (WUI).

There is a need to provide direction for achieving sustainability and resiliency for and minimizing risks to vegetation community composition and structure and for restoring natural disturbance cycles where appropriate.

There is a need to provide direction to promote the achievement and maintenance of satisfactory soil condition.

There is a need to provide updated management direction for the protection, maintenance, and restoration of riparian vegetation and channel morphology in the plan area and for restoration of priority watersheds.

There is a need to provide direction on the sustainable management of groundwater, springs, wetlands, riparian areas, and perennial waters and their interconnections.

There is a need to update plan direction on providing a sustainable water supply for multiple uses (wildlife, livestock, recreation, and mining) and public water supplies.

There is a need to provide direction pertinent to riparian management zones around all lakes, perennial and intermittent streams, and open water wetlands.

There is a need to update direction addressing air quality and forest management.

There is a need to develop plan direction to contribute to the recovery and conservation of federally recognized species, maintain viable populations of species of conservation concern, and maintain common and abundant species within the plan area.

There is a need to provide direction addressing habitat(s) for plant and animal species important to tribes and other traditional communities.

There is a need to provide direction for managing aquatic passage and terrestrial habitat connectivity.

There is a need to update direction on the stabilization and preservation of historic properties and address the role of management of historic properties in economic development.

There is a need to update management direction for American Indian and non-Indian traditional cultural properties and sacred sites.

There is a need to provide direction addressing management of historic and contemporary cultural uses by federally recognized Indian tribes and traditional communities not considered under tribal relations.

There is a need to address, at either the management or geographic area scale, the inventory and management of historic properties and other cultural resources and uses.

There is a need to provide direction that addresses the alignment of management of historic properties and landscapes, sacred sites, contemporary uses, and tribal cultural needs with other resource management objectives (particularly but not limited to ecosystem restoration). There is a need to provide direction on the identification and documentation of historic properties at risk of damage or destruction from catastrophic wildland fire.

There is a need to update direction addressing immitigable adverse effects to historic properties.

There is a need to update direction addressing consistency of activities with legally mandated trust responsibilities to tribes.

There is a need to update direction regarding sacred sites, sacred places, natural and cultural resources important to tribes, and requests for reburial of human remains and cultural items.

There is a need to update plan direction regarding administration of temporary closure orders to ensure privacy for tribes engaged in cultural and ceremonial activities.

There is a need to update direction on design, location, installation, maintenance, and abandonment of towers, facilities, and alternative infrastructure within communication and energy generation sites, giving due consideration to the value and importance of high places (mountaintops and ridges) that may be sacred sites or important cultural landscapes to tribes.

There is a need to provide plan direction for restoration treatments for those geographic areas and vegetation types that are most outside of the natural range of variability while considering capability of local infrastructure, contractors, and markets.

There is a need to provide direction for management and removal of miscellaneous forest products for commercial, noncommercial, tribal and/or land grant use.

There is a need to provide direction to the livestock grazing program that incorporates adaptive management toward ecosystem-based desired conditions.

There is a need to integrate sustainable recreation management with that of other Forest resources and to provide guidance for managing a sustainable trails program while addressing use conflicts.

There is a need to provide management direction on the Continental Divide National Scenic Trail.

There is a need to provide guidance for managing recreation activities that occur in areas sensitive to resource degradation or at risk due to high visitation.

There is a need to update direction on managing recreational aviation activities, caves, and recreational activities associated with wildlife, fish, and cultural/historic sites.

There is a need to update plan direction and guidance for implementing the Recreation Opportunity Spectrum classification system and incorporating scenic integrity objectives for managing scenic resources.

There is a need to update direction for managing designated Inventoried Roadless Areas, eligible Wild and Scenic Rivers, designated Research Natural Areas, and for managing designated wilderness.

There is a need to provide direction on management of areas that may be recommended for wilderness, during the interim period while Congress is considering designation.

There is a need to provide direction for areas that may be recommended for various other designations.

There is a need to update direction on the management of infrastructure and for road maintenance in watersheds identified as being impaired or at-risk.

There is a need to update direction for obtaining legal access that addresses public, private landowner, tribal, land grant, and management needs and for progressing toward a contiguity of the land base and a reduction of small unmanageable tracts.

There is a need to provide updated direction regarding management of recreational mining, mineral exploration and extraction, and the use of common minerals.

There is a need to update plan direction for managing existing or proposed transmission corridors and renewable energy generation.

There is a need to provide direction addressing safety concerns pertinent to maintenance activities associated with existing energy and communication corridors.

The Cibola NF initiated public engagement activities in October 2012 and held 29 public meetings and collaborative work sessions through July 2014 to explain the plan revision process and to solicit comments, opinions, data, and ideas from members of the public, governmental entities, tribes, land grants, and non-governmental organizations. Six of these meetings introduced and explained the Cibola's Forest Plan revision effort and called for input and data pertinent to the assessment of conditions, trends, and risks to sustainability. Ten meetings were held to explain the draft assessment report subsequent to its release in April 2014 and to solicit comments, and 13 collaborative work sessions followed, focusing on the needs for change to the 1985 Cibola Forest Plan, based on findings from the assessment and comments received. Attendance at the 29 meetings numbered approximately 600, and nearly 1,800 comment letters or forms were received either at the meetings or by email, postal mail, Web-form, or a Web-based interactive mapping tool. Comments received were displayed on Web-based public reading rooms. Public input on both the assessment report and initial needs-for-change statements was used to update both documents. Information to the public was provided by a dedicated Forest Plan revision Web page and through mailings, flyers, news releases, Twitter, and radio and television interviews. Any comments related to the Cibola's assessment report that are received following the publication of this Notice may be considered in the affected environment sections of the draft and final environmental impact statements.

Written comments received in response to this notice will be analyzed to complete the identification of the needs for change to the existing plan, further develop the proposed action (initial development of the proposed revised plan), and identify potential significant issues. Significant issues will, in turn, form the basis for developing alternatives to the proposed action. Comments on the preliminary needs for change and proposed action will be most valuable if received by April 3, 2015, and should clearly articulate the reviewer's opinions and concerns. Development of the proposed revised plan and associated EIS will occur with opportunities for public engagement throughout the revision process.

Comments received in response to this notice, including the names and addresses of those who comment, will be part of the public record. Comments submitted anonymously will be accepted and considered in the NEPA process; however, anonymous comments will not provide the Agency with the ability to provide the respondent with subsequent environmental documents. See the below Objection process material, particularly the requirements for filing an objection, for how anonymous comments are handled during the objection process. Refer to the Forest's Web site http://www.fs.usda.gov/detail/cibola/landmanagement/planning/?cid=fsbdev3_065627 for information on when public meetings will be scheduled for refining the proposed action and identifying possible alternatives to the proposed action.

Preparation of the revised Forest Plan for the Cibola National Forest began with the assessment of the conditions and trends of the Forest's ecological, social, and economic resources, initiated under the planning procedures contained in the 2012 Forest Service planning rule (36 CFR 219 (2012)).

No permits or licenses are needed for the development or revision of a forest plan.

The decision to approve the revised Forest Plan for the Cibola National Forest Mountain Ranger Districts will be subject to the objection process identified in 36 CFR part 219 Subpart B (219.50 to 219.62). According to 36 CFR 219.53(a), those who may file an objection are individuals and entities who have submitted substantive formal comments related to plan revision during the opportunities provided for public comment during the planning process.

The Needs for Change documentation, the Assessment Report including specialist reports, summaries of the public meetings and public meeting materials, and public comments are posted on the Forest's Web site at: http://www.fs.usda.gov/detail/cibola/landmanagement/planning/?cid=fsbdev3_065627.

As necessary or appropriate, the material available on this site will be further adjusted as part of the planning process using the provisions of the 2012 planning rule.

Section 5(f) of the Export Administration Act of 1979, as amended (EAA), authorizes the Secretary of Commerce to conduct foreign availability assessments to examine and evaluate the effectiveness of U.S. export controls on certain items that are controlled for national security reasons under the Export Administration Regulations (EAR) (15 CFR parts 730-774). The Bureau of Industry and Security (BIS) has been delegated from the Secretary of Commerce the responsibility for conducting these assessments and issuing a final foreign availability determination. Part 768 of the EAR sets forth the procedures related to foreign availability assessments.

On July 16, 2014, BIS received a foreign availability submission from the Semiconductor Equipment and Materials International (SEMI) industry association, a group of companies that does business all over the world and that serve the manufacturing supply chain for the micro- and nano-electronics industries. SEMI's July 16, 2014 submission asserts the foreign availability of anisotropic plasma dry etching equipment in China. This type of semiconductor etching equipment is controlled for national security reasons under Export Control Classification Number (ECCN) 3B001.c on the Commerce Control List (CCL). It is used in the process for producing dual-use semiconductor devices such as flash memories, microwave monolithic integrated circuits, transistors, and analog-to-digital-converters. These devices are used in civil and military applications such as radars, point-to-point radio communications, microprocessors, cellular infrastructure, and satellite communications. The national security control BIS has applied to anisotropic plasma dry etching equipment implements the Wassenaar Arrangement's Dual-Use List 3.B.1.c control. SEMI's submission asserts that anisotropic plasma dry etch equipment of comparable quality to that subject to control under ECCN 3B001.c is available-in-fact from China in sufficient quantities to render the U.S. export control of the equipment ineffective.

After reviewing SEMI's submission, on September 8, 2014, BIS published in the Federal Register a Notice of Foreign Availability Assessment: Anisotropic Plasma Dry Etching Equipment (79 FR 53166), which formally initiated a foreign availability assessment. To carry out the assessment, BIS conducted interagency meetings with stakeholders, obtained input from the exporting community, and visited, in China, a producer of anisotropic plasma dry etching equipment meeting the 3B001.c control parameters, and a foundry using a Chinese-produced anisotropic plasma dry etching tool. As a result of BIS's analysis of the data collected through the assessment, BIS recommended that I determine that the etching equipment of ECCN 3B001.c capability is available-in-fact to China, from a non-U.S. (Chinese) source, in sufficient quantity, and of comparable quality so that continuation of the existing national security export control would be ineffective in achieving its purpose.

After reviewing the assessment and recommendation, I determined that anisotropic plasma dry etching equipment controlled for national security reasons under ECCN 3B001.c on the CCL is foreign available to China. Consequently, BIS has submitted a proposal to the Department of State to remove the Wassenaar Arrangement's Dual-Use List 3.B.1.c control.

The purpose of the meeting is to create a fishery performance report by the Council's Golden Tilefish Advisory Panel (AP). The intent of this report is to facilitate a venue for structured input from the Advisory Panel members for the Golden Tilefish specifications process, including recommendations by the Council and its Scientific and Statistical Committee (SSC).

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

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.

The committee will discuss comments on Omnibus Essential Fish Habitat Amendment 2. Written public comments were submitted between October 10, 2014 and January 8, 2015 and in-person comments were provided at twelve public hearings held during November, December, and January. They will also begin the process of developing final preferred alternative recommendations for the full Council. They will discuss other business as necessary.

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

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

The items of discussion on the agenda are as follows:

For meeting materials see folder “Ecosystem Scientific and Statistical Committee meeting—2015-02” on Gulf Council file server. To access the file server, the URL is https://public.gulfcouncil.org:5001/webman/index.cgi, or go to the Council's Web site and click on the FTP link in the lower left of the Council Web site( http://www.gulfcouncil.org ). The username and password are both “gulfguest”. The Agenda is subject to change.

The meeting will be Webcast over the Internet. A link to the Webcast will be available on the Council's Web site, http://www.gulfcouncil.org.

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

The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Council Office (see ADDRESSES ), at least 5 working days prior to the meeting.

This meeting is being held under the provision of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b as amended), and 41 CFR 102-3.150.

Purpose of the Meeting: The purpose of the meeting is for the Board to review DoD actuarial methods and assumptions to be used in the valuations of the Education Benefits Fund, the Military Retirement Fund, and the Voluntary Separation Incentive Fund, in accordance with the provisions of Section 183, Section 2006, Chapter 74 (10 U.S.C. 1464 et. seq. ), and 10 U.S.C. 1175.

1. Briefing on Investment Experience.

2. September 30, 2014, Valuation Proposed Economic Assumptions *.

3. September 30, 2014, Valuation Proposed Methods and Assumptions—Reserve Programs *.

4. September 30, 2014, Valuation Proposed Methods and Assumptions—Active Duty Programs *.

5. Developments in Education Benefits.

1. Briefing on Investment Experience.

2. September 30, 2014, Valuation of the Military Retirement Fund *.

3. Proposed Methods and Assumptions for September 30, 2015 Valuation of the Military Retirement Fund *.

4. Proposed Methods and Assumptions for September 30, 2014, Voluntary Separation Incentive (VSI) Fund Valuation *.

5. Recent and Proposed Legislation.

* Board approval required.

Public's Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is on a first come basis. The Mark Center is an annex of the Pentagon. Those without a valid DoD Common Access Card must contact Kathleen Ludwig at 571-372-1993 no later than June 16, 2015. Failure to make the necessary arrangements will result in building access being denied. It is strongly recommended that attendees plan to arrive at the Mark Center at least 30 minutes prior to the start of the meeting.

Pursuant to 41 CFR 102-3.105(j) and 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written comments to the Board about its mission and topics pertaining to this public meeting.

Committee's Designated Federal Officer or Point of Contact: Persons desiring to attend the DoD Board of Actuaries meeting or make an oral presentation or submit a written statement for consideration at the meeting must notify Kathleen Ludwig at 571- 372-1993, or Kathleen.A.Ludwig.civ@mail.mil, by June 16, 2015.

The existing Rate Schedule BCP-F8, Rate Order No. WAPA-150 was approved by the Federal Energy Regulatory Commission (FERC) for the period beginning October 1, 2010, and ending September 30, 2015. 1 The existing rate schedule consists of a Base Charge and Rates for electric service. The base charge and rates provide adequate revenue to pay all annual costs, including interest expense, and repay investment within the allowable period. The base charge and rates are calculated annually to ensure repayment of the project within the cost recovery criteria set forth in DOE Order RA 6120.2.

Western proposes to extend the existing electric service rate-setting formula through September 30, 2020, under Rate Order No. WAPA-171, and seek approval of the annual calculation for the FY 2016 Proposed Base Charge and Rates. Under Rate Schedule BCP-F9, Rate Order No. WAPA-171, the Proposed Base Charge and Rates for BCP electric service are expected to increase as a result of projected replacements costs and visitor center costs. The following table lists the Proposed Base Charge and Rates, however, these amounts will change based on actual data published in the FY 2014 financial statements, which are not yet available.

Since the proposed rates constitute a major adjustment as defined by 10 CFR part 903, Western will hold both a public information forum and a public comment forum. Western will review all timely public comments and make amendments or adjustment to the proposal, as appropriate, consistent with 10 CFR 903.23(a) and 10 CFR part 904.

Western is establishing the electric service Base Charge and Rates for BCP under the Department of Energy Organization Act (42 U.S.C. 7152); the Reclamation Act of 1902 (ch. 1093, 32 Stat. 388), as amended and supplemented by subsequent laws, particularly section 9(c) of the Reclamation Project Act of 1939 (43 U.S.C. 485h(c)); and other acts that specifically apply to the projects involved.

By Delegation Order No. 00-037.00A, effective October 25, 2013, the Secretary of Energy delegated: (1) The authority to develop power and transmission rates to the Administrator of Western; (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy; and (3) the authority to confirm, approve, and place into effect on a final basis, to remand, or to disapprove such rates to the FERC. Existing Department of Energy (DOE) procedures for public participation in power rate adjustments (10 CFR part 903) were published on September 18, 1985.

Access to Western facilities is controlled. If you are a U.S. citizen, please be sure to bring an official form of picture identification (that meets the requirement of the Real ID Act), such as a driver's license, U.S. passport, U.S. Government ID, or U.S. Military ID, which you will be asked to show prior to signing in at Western.

If you are a foreign national and plan to attend, please contact Mr. Jack Murray, Rates Manager, (602) 605-2442, email jmurray@wapa.gov, immediately to obtain the necessary form for admittance at Western. To allow time for background checks this form must be completed at least 30 days in advance for visitors from non-sensitive countries; and 45 days in advance for visitors from sensitive countries. Failure to complete this approval process may result in denial of visit.

All brochures, studies, comments, letters, memorandums, and other documents that Western initiated or used to develop the proposed base charge and rates are available for inspection and copying at the Desert Southwest Customer Service Regional Office, located at 615 South 43rd Avenue, Phoenix, Arizona. Many of these documents and supporting information are also available on Western's Web site at: http://www.wapa.gov/dsw/pwrmkt/BCP/RateAdjust.htm.

In compliance with the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321-4347 et seq. ); Council on Environmental Quality Regulations (40 CFR parts 1500-1508); and DOE NEPA Regulations (10 CFR part 1021), Western is in the process of determining whether an environmental assessment or an environmental impact statement should be prepared or if this action can be categorically excluded from those requirements.

Western has an exemption from centralized regulatory review under Executive Order 12866; accordingly, no clearance of this notice by the Office of Management and Budget is required.

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

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

Abstract: The EPA uses contractors to perform services throughout the nation with regard to environmental emergencies involving the release, or threatened release, of oil, radioactive materials, or hazardous chemicals that may potentially affect communities and the surrounding environment. The Agency may request contractors responding to any of these types of incidents to conduct background checks and apply Government-established suitability criteria in Title 5 CFR Administrative Personnel 731.104 Appointments Subject to Investigation, 732.201 Sensitivity Level Designations and Investigative Requirements, and 736.102 Notice to Investigative Sources when determining whether employees are acceptable to perform on given sites or on specific projects. In addition to emergency response contractors, EPA may require background checks for contractor personnel working in sensitive sites or sensitive projects. The background checks and application of the Government's suitability criteria must be completed prior to contract employee performance. The contractor shall maintain records associated with all background checks. Background checks cover citizenship or valid visa status, criminal convictions, weapons offenses, felony convictions, and parties prohibited from receiving federal contracts.

Form numbers: None.

Respondents/affected entities: Private Contractors.

Respondent's obligation to respond: Required to obtain a benefit per Title 5 CFR Administrative Personnel 731.104 Appointments Subject to Investigation, 732.201 Sensitivity Level Designations and Investigative Requirements, and 736.102 Notice to Investigative Sources.

Estimated number of respondents: 1,000.

Frequency of response: Annual.

Total estimated burden: 1,000 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $186,730 (per year), includes $0 annualized capital or operation & maintenance (O&M) costs.

Changes in Estimates: There is no change in the hours in the total estimated respondent burden compared with the ICR currently approved by OMB.

Great care has been taken to assure that this new appointee not only has the highest degree of expertise and commitment, but also brings to the Board diverse points of view relating to environmental education. This appointment is a four-year term which may be renewed once for an additional four years pending successful re-election by the NEEF nominating committee.

This appointee will join the current Board members which include:

• Decker Anstrom (NEEF Chairman) Former U.S. Ambassador, Retired Chairman, The Weather Channel Companies

• Trish Silber (NEEF Vice Chair) President, Aliniad Consulting Partners, Inc.

• Diane Wood (NEEF Secretary) President, National Environmental Education Foundation

• Carlos Alcazar, Founder and Chairman, Culture ONE World

• Megan Reilly Cayten, Co-Founder and Chief Executive Officer, Catrinka, LLC

• Philippe Cousteau, Co-Founder and CEO, EarthEcho International

• David M. Kiser, Vice President, Environment, Health, Safety and Sustainability, International Paper

• Wonya Lucas, President, Lucas Strategic Consulting

• Shannon Schuyler, Principal, Corporate Responsibility Leader, PricewaterhouseCoopers (PwC)

• Jacqueline M. Thomas, Vice President of Corporate Responsibility, Toyota Motor Sales USA Inc.

Section 10(a) of the National Environmental Education Act of 1990 mandates a National Environmental Education Foundation. The Foundation is established in order to extend the contribution of environmental education and training to meeting critical environmental protection needs, both in this country and internationally; to facilitate the cooperation, coordination, and contribution of public and private resources to create an environmentally advanced educational system; and to foster an open and effective partnership among Federal, State, and local government, business, industry, academic institutions, community based environmental groups, and international organizations.

The Foundation is a charitable and nonprofit corporation whose income is exempt from tax, and donations to which are tax deductible to the same extent as those organizations listed pursuant to section 501(c) of the Internal Revenue Code of 1986. The Foundation is not an agency or establishment of the United States. The purposes of the Foundation are—

(A) Subject to the limitation contained in the final sentence of subsection (d) herein, to encourage, accept, leverage, and administer private gifts for the benefit of, or in connection with, the environmental education and training activities and services of the United States Environmental Protection Agency;

(B) to conduct such other environmental education activities as will further the development of an environmentally conscious and responsible public, a well-trained and environmentally literate workforce, and an environmentally advanced educational system;

(C) to participate with foreign entities and individuals in the conduct and coordination of activities that will further opportunities for environmental education and training to address environmental issues and problems involving the United States and Canada or Mexico.

The Foundation develops, supports, and/or operates programs and projects to educate and train educational and environmental professionals, and to assist them in the development and delivery of environmental education and training programs and studies.

The Foundation has a governing Board of Directors (hereafter referred to in this section as `the Board'), which consists of 13 directors, each of whom shall be knowledgeable or experienced in the environment, education and/or training. The Board oversees the activities of the Foundation and assures that the activities of the Foundation are consistent with the environmental and education goals and policies of the Environmental Protection Agency and with the intents and purposes of the Act. The membership of the Board, to the extent practicable, represents diverse points of view relating to environmental education and training. Members of the Board are appointed by the Administrator of the Environmental Protection Agency.

Within 90 days of the date of the enactment of the National Environmental Education Act, and as appropriate thereafter, the Administrator will publish in the Federal Register an announcement of appointments of Directors of the Board. Such appointments become final and effective 90 days after publication in the Federal Register . The directors are appointed for terms of 4 years. The Administrator shall appoint an individual to serve as a director in the event of a vacancy on the Board within 60 days of said vacancy in the manner in which the original appointment was made. No individual may serve more than 2 consecutive terms as a director.

Dr. Perea-Henze, M.D., M.P.H. is currently managing director of HORUS Advisors as a strategy advisor in healthcare, global affairs and government relations.

He worked in the private sector, as senior executive at Merck & Co., Inc. and Pfizer Inc. Among his many responsibilities at these companies he assisted in shaping corporate responsibility, philanthropy and external affairs participating in committees at the Institute of Medicine, World Medical Association, The Clinton Global Initiative and the Gates Foundation.

In the public sector, he served as assistant secretary for policy and planning at the U.S. Department of Veterans Affairs where he had direct oversight for a $9 billion portfolio of priority programs. Before joining the VA in 2010, he was an advisor to the Obama Presidential Transition Team. He was deputy assistant secretary for management and budget at the U.S. Department of Commerce from 1999 to 2001.

He has a medical degree from the University of Chihuahua in Mexico and a master's degree in public health from Yale University. We believe he will be a great addition to the NEEF board and we respectfully submit his name for appointment to the NEEF Board of Directors.

Additional Considerations: Great care has been taken to assure that this new appointee not only has the highest degree of expertise and commitment, but also brings to the Board diverse points of view relating to environmental education. This appointment is a four-year term which may be renewed once for an additional four years pending successful re-election by the NEEF nominating committee.

This appointee will join the current Board members which include:

• Decker Anstrom (NEEF Chairman) Former U.S. Ambassador, Retired Chairman, The Weather Channel Companies

• Trish Silber (NEEF Vice Chair) President, Aliniad Consulting Partners, Inc.

• Diane Wood (NEEF Secretary) President, National Environmental Education Foundation

• Carlos Alcazar, Founder and Chairman, Culture ONE World

• Megan Reilly Cayten, Co-Founder and Chief Executive Officer, Catrinka, LLC

• Philippe Cousteau, Co-Founder and CEO, EarthEcho International

• David M. Kiser, Vice President, Environment, Health, Safety and Sustainability, International Paper

• Wonya Lucas, President, Lucas Strategic Consulting

• Shannon Schuyler, Principal, Corporate Responsibility Leader, PricewaterhouseCoopers (PwC)

• Jacqueline M. Thomas, Vice President of Corporate Responsibility, Toyota Motor Sales USA Inc.

Background: Section 10(a) of the National Environmental Education Act of 1990 mandates a National Environmental Education Foundation. The Foundation is established in order to extend the contribution of environmental education and training to meeting critical environmental protection needs, both in this country and internationally; to facilitate the cooperation, coordination, and contribution of public and private resources to create an environmentally advanced educational system; and to foster an open and effective partnership among Federal, State, and local government, business, industry, academic institutions, community-based environmental groups, and international organizations.

The Foundation is a charitable and nonprofit corporation whose income is exempt from tax, and donations to which are tax deductible to the same extent as those organizations listed pursuant to section 501(c) of the Internal Revenue Code of 1986. The Foundation is not an agency or establishment of the United States. The purposes of the Foundation are—

(A) subject to the limitation contained in the final sentence of subsection (d) herein, to encourage, accept, leverage, and administer private gifts for the benefit of, or in connection with, the environmental education and training activities and services of the United States Environmental Protection Agency;

(B) to conduct such other environmental education activities as will further the development of an environmentally conscious and responsible public, a well-trained and environmentally literate workforce, and an environmentally advanced educational system;

(C) to participate with foreign entities and individuals in the conduct and coordination of activities that will further opportunities for environmental education and training to address environmental issues and problems involving the United States and Canada or Mexico.

The Foundation develops, supports, and/or operates programs and projects to educate and train educational and environmental professionals, and to assist them in the development and delivery of environmental education and training programs and studies.

The Foundation has a governing Board of Directors (hereafter referred to in this section as `the Board'), which consists of 13 directors, each of whom shall be knowledgeable or experienced in the environment, education and/or training. The Board oversees the activities of the Foundation and assures that the activities of the Foundation are consistent with the environmental and education goals and policies of the Environmental Protection Agency and with the intents and purposes of the Act. The membership of the Board, to the extent practicable, represents diverse points of view relating to environmental education and training. Members of the Board are appointed by the Administrator of the Environmental Protection Agency.

Within 90 days of the date of the enactment of the National Environmental Education Act, and as appropriate thereafter, the Administrator will publish in the Federal Register an announcement of appointments of Directors of the Board. Such appointments become final and effective 90 days after publication in the Federal Register . The directors are appointed for terms of 4 years. The Administrator shall appoint an individual to serve as a director in the event of a vacancy on the Board within 60 days of said vacancy in the manner in which the original appointment was made. No individual may serve more than 2 consecutive terms as a director.

Dr. Basile is currently a Professor in the School of Sustainability at Arizona State University (ASU), a Senior Sustainability Scientist in ASU's Global Institute of Sustainability and Affiliate Professor in the School of Public Affairs. He is also the Swedish Knowledge Foundation's Distinguished International Guest Professor of Sustainability-Driven Innovation. Dr. Basile's work has reframed sustainability as a “decision space” and focuses on how to plan, lead and act strategically for emerging sustainability opportunities and challenges. Dr. Basile has been the Executive Director of the ASU Decision Theater, a unique systems exploration and application center. He has also served as a faculty affiliate and advisor to the Sustainability Consortium, a group of over 80 global businesses, universities and NGOs developing science-based standards for sustainable products. At ASU, Dr. Basile's activities include developing novel insights, strategic methods and tools that create solutions for sustainability including novel educational programs in sustainability and leadership in both the United States and the European Union and at both the undergraduate and graduate levels.

Dr. Basile holds a B.S. in Physics from University of California, Irvine and a Ph.D. in Biophysics from University of California, Berkeley. His publications include a three‐volume edited set The Business of Sustainability (Praeger Press, 2011).

OMB Control Number: 3060-0508.

Title: Parts 1 and 22 Reporting and Recordkeeping Requirements.

Form Number: Not applicable.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit entities, Individuals or households, and State, Local or Tribal Governments.

Number of Respondents and Responses: 15,713 respondents; 15,713 responses.

Estimated Time per Response: 15 minutes-10 hours.

Frequency of Response: Recordkeeping requirement; On occasion, quarterly, and semi-annual reporting requirements.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in 47 U.S.C. 154, 222, 303, 309 and 332.

Total Annual Burden: 4,894 hours.

Annual Cost Burden: $19,445,250.

Privacy Act Impact Assessment: Yes.

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information. The information to be collected will be made available for public inspection. Applicants may request materials or information submitted to the Commission be given confidential treatment under 47 CFR 0.459 of the Commission's rules.

Needs and Uses: Part 22 contains the technical and legal requirements for radio stations operating in the Public Mobile Services. The information collected is used to determine on a case-by-case basis, whether or not to grant licenses authorizing construction and operation of wireless telecommunications facilities to common carriers. Further, this information is used to develop statistics about the demand for various wireless licenses and/or the licensing process itself, and occasionally for rule enforcement purposes.

This revised information collection reflects changes in rules applicable to Part 22 800 MHz Cellular Radiotelephone (“Cellular”) Service licensees and applicants, as adopted by the Commission in a Report and Order (“R&O”) on November 7, 2014 (WT Docket No. 12-40; RM No. 11510; FCC 14-181). By the R&O, the Commission eliminates or streamlines certain Cellular Service filing requirements, thereby reducing the information collection burdens for Cellular Service respondents.

OMB Control No.: 3060-0800.

Title: FCC Application for Assignments of Authorization and Transfers of Control: Wireless Telecommunications Bureau and/or Public Safety and Homeland Security Bureau.

Form No.: FCC Form 603.

Type of Review: Revision of a currently approved collection.

Respondents: Individuals or households; business or other for-profit entities; not-for-profit institutions; State, local or Tribal Government.

Number of Respondents and Responses: 2,447 respondents; 2,447 responses.

Estimated Time per Response: 0.5-1.75 hours.

Frequency of Response: Recordkeeping requirement; occasion reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in 47 U.S.C. 4(i), 154(i), 303(r) and 309(j).

Total Annual Burden: 2,759 hours.

Total Annual Cost: $366,975.

Nature and Extent of Confidentiality: In general there is no need for confidentiality. On a case by case basis, the Commission may be required to withhold from disclosure certain information about the location, character, or ownership of a historic property, including traditional religious sites.

Privacy Act Impact Assessment: Yes.

Needs and Uses: FCC Form 603 is a multi-purpose form used to apply for approval of assignment or transfer of control of licenses in the wireless services. The data collected on this form is used by the FCC to determine whether the public interest would be served by approval of the requested assignment or transfer. This form is also used to notify the Commission of consummated assignments and transfers of wireless and/or public safety licenses that have previously been consented to by the Commission or for which notification but not prior consent is required. This form is used by applicants/licensees in the Public Mobile Services, Personal Communications Services, General Wireless Communications Services, Private Land Mobile Radio Services, Broadcast Auxiliary Services, Broadband Radio Services, Educational Radio Services, Fixed Microwave Services, Maritime Services (excluding ships), and Aviation Services (excluding aircraft).

The purpose of this form is to obtain information sufficient to identify the parties to the proposed assignment or transfer, establish the parties' basic eligibility and qualifications, classify the filing, and determine the nature of the proposed service. Various technical schedules are required along with the main form applicable to Auctioned Services, Partitioning and Disaggregation, Undefined Geographical Area Partitioning, Notification of Consummation or Request for Extension of Time for Consummation.

This revised information collection reflects changes in rules applicable to Part 22 800 MHz Cellular Radiotelephone (“Cellular”) Service licensees and applicants, as adopted by the Commission in a Report and Order (“R&O”) on November 7, 2014 (WT Docket No. 12-40; RM No. 11510; FCC 14-181). In addition to other rule revisions that do not affect this information collection, the Commission adopted a revised rule Section 22.948(a) to require the electronic submission of maps (in GIS format and PDF) when the Cellular applicant submits Form 603 to apply for Partitioning and Disaggregation. This requirement very slightly increases the total annual burden hours for this information collection. FCC Form 603 itself is not being revised.

OMB Control No.: 3060-1058.

Title: FCC Application or Notification for Spectrum Leasing Arrangement: Wireless Telecommunications Bureau and/or Public Safety and Homeland Security Bureau.

Form No.: FCC Form 608.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit entities; not-for-profit institutions; State, Local or Tribal Government.

Number of Respondents and Responses: 991 respondents; 991 responses.

Estimated Time per Response: 1 hour.

Frequency of Response: Recordkeeping requirement and on occasion reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in 47 U.S.C. 151, 154(i), 154(j), 155, 158, 161, 301, 303(r), 308, 309, 310, 332 and 503.

Total Annual Burden: 996 hours.

Annual Cost Burden: $1,282,075.

Nature and Extent of Confidentiality: In general there is no need for confidentiality. On a case by case basis, the Commission may be required to withhold from disclosure certain information about the location, character, or ownership of a historic property, including traditional religious sites.

Privacy Act Impact Assessment: Not applicable.

Needs and Uses: FCC Form 608 is a multipurpose form. It is used to provide notification or request approval for any spectrum leasing arrangement (“Lease”) entered into between an existing licensee in certain wireless services and a spectrum lessee. This form also is required to notify or request approval for any spectrum subleasing arrangement (“Sublease”). The data collected on the form is used by the FCC to determine whether the public interest would be served by the Lease or Sublease. The form is also used to provide notification for any Private Commons Arrangement entered into between a licensee, lessee, or sublessee and a class of third-party users (as defined in Section 1.9080 of the Commission's Rules).

This revised information collection reflects changes in rules applicable to Part 22 800 MHz Cellular Radiotelephone (“Cellular”) Service licensees and applicants, as adopted by the Commission in a Report and Order (“R&O”) on November 7, 2014 (WT Docket No. 12-40; RM No. 11510; FCC 14-181). In addition to other rule revisions that do not affect this information collection, the Commission adopted a revised rule Section 22.948(d) to require the electronic submission of maps (in GIS format and PDF) when the Cellular Service applicant submits Form 608.

The requirement very slightly increases the total annual burden hours for this information collection. FCC Form 608 itself is not being revised.

OMB Control No.: 3060-xxxx.

Title: Certification of TV Broadcast Licensee Technical Information in Advance of Incentive Auction.

Form No.: Form 2100, Schedule 381, Pre-Auction Technical Certification Form.

Type of Review: New information collection.

Respondents: Business or other for profit entities; not for profit institutions.

Number of Respondents and Responses: 2,170 respondents and 2,170 responses.

Estimated Time per Response: 2 hours.

Frequency of Response: One-time reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in Public Law 112-96, §§ 6402 (codified at 47 U.S.C. 309(j)(8)(G)), 6403 (codified at 47 U.S.C. 1452), 126 Stat. 156 (2012) (Spectrum Act).

Total Annual Burden: 2,170 hours.

Annual Cost Burden: $542,500.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: Some assurances of confidentiality are being provided to the respondents. Parties filing Form 2100, Schedule 381 may seek confidential treatment of information they provide pursuant to the Commission's existing confidentiality rules (See 47 CFR 0.459).

Needs and Uses: The information gathered in this collection will be used to support the Federal Communications Commission's efforts to hold an incentive auction, as required by the Middle Class Tax Relief and Job Creation Act of 2012 (Spectrum Act) (Pub. L. 112-96, §§ 6402 (codified at 47 U.S.C. 309(j)(8)(G)), 6403 (codified at 47 U.S.C. 1452), 126 Stat. 156 (2012)). In the Incentive Auction Order, the Commission directed the Media Bureau to develop a form to be submitted prior to the incentive auction by each full power and Class A broadcast licensee to certify that it has reviewed the technical data on file with the Commission related to its current license authorization and confirm that the technical data is correct with respect to actual operations FCC Form 2100, Schedule 381, Pre-Auction Technical Certification Form. See Expanding the Economic and Innovation Opportunities of Spectrum Through Incentive Auctions, Report and Order, GN Docket 12-268, Report and Order, 29 FCC Rcd 6567, 6820 (2014) (“Incentive Auction Order”). This data collection will also collect from licensees basic data regarding equipment currently in use at each licensed facility to facilitate the channel reassignment process following the completion of the incentive auction. Licensees will submit FCC Form 2100, Schedule 381 one time, at a deadline to be announced by the Media Bureau in advance of the incentive auction.

OMB Control Number: 3060-0346.

Title: Section 78.27, License Conditions.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

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

Frequency of Response: Annual reporting requirement; on occasion reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 Section 154(i) of the Communications Act of 1934, as amended.

Number of Respondents and Responses: 16 respondents; 16 responses.

Estimated Time per Response: 10 mins. (0.166 hrs.).

Total Annual Burden: 3 hours.

Total Annual Cost: None.

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

Nature and Extent of Confidentiality: There is no need for confidentiality and respondents are not being asked to submit confidential information to the Commission.

Needs and Uses: 47 CFR 78.27(b)(1) requires the licensee of a Cable Television Relay Service (CARS) station to notify the Commission in writing when the station commences operation. Such notification shall be submitted on or before the last day of the authorized one year construction period; otherwise, the station license shall be automatically forfeited. 47 CFR 78.27(b)(2) requires CARS licensees needing additional time to complete construction of the station and commence operation shall request an extension of time 30 days before the expiration of the one year construction period. Exceptions to the 30-day advance filing requirement may be granted where unanticipated delays occur.

OMB Control Number: 3060-0120.

Type of Review: Extension of a currently approved collection.

Title: Broadcast EEO Program Model Report, FCC Form 396-A.

Form Number: FCC Form 396-A.

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

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

Estimated Time per Response: 1 hour.

Frequency of Response: On occasion reporting requirement.

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

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

Total Annual Burden: 5,000 hours.

Total Annual Cost: None.

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

Needs and Uses: The Broadcast Equal Employment Opportunity (EEO) Model Program Report, FCC Form 396-A, is filed in conjunction with applicants seeking authority to construct a new broadcast station, to obtain assignment of construction permit or license and/or seeking authority to acquire control of an entity holding construction permit or license. This program is designed to assist the applicant in establishing an effective EEO program for its station.

As required by the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4) and (e)(11), this document sets forth notice of the proposed new system of records maintained by the FCC. This notice is a summary of the more detailed information about the proposed new system of records, which may be obtained or viewed pursuant to the contact and location information given above in the ADDRESSES section. The purpose for establishing this new system of records, FCC/CGB-4, “ITRS-URD,” is to cover the PII of individuals in the ITRS-URD Program's database(s) who are eligible to register to subscribe to/participate in the ITRS-URD Program's services. The ITRS-URD Program, which is administered under contract with the FCC, is a database registration system that provides a necessary interface for multiple services, including, but not limited to ITRS, individuals who are deaf, deaf-blind, hard of hearing, and/or have speech disabilities and who are eligible under the ADA. These various Telecommunications Relay Services allow people with hearing or speech disabilities (or who are deaf-blind) to place and receive calls.

This notice meets the requirement documenting the proposed new system of records that is to be added to the systems of records that the FCC maintains, and provides the public, OMB, and Congress with an opportunity to comment.

Title: Administrative Activities.

OMB Control Number: 3084-0047.

Type of Review: Extension of a currently approved collection.

Abstract: The currently approved information collection consists of: (a) Applications to the Commission, including applications and notices contained in the Commission's Rules of Practice (primarily Parts I, II, and IV); (b) the FTC's consumer complaint systems; and (c) the FTC's program evaluation activities.

On November 14, 2014, the Commission sought comment on the information collection requirements pertaining to the Commission's administrative activities. 79 FR 68245. No comments were received. As required by OMB regulations, 5 CFR part 1320, the FTC is providing this second opportunity for public comment.

Estimated Annual Hours Burden: 222,851 hours (150 + 222,622 + 64 + 15).

(a) Applications to the Commission, including applications and notices supported pursuant to the Commission's Rules of Practice: 150 hours.

Most applications to the Commission generally fall within the “law enforcement” exception to the PRA and are mostly found in Part III (Rules of Practice for Adjudicative Proceedings) of the Commission's Rules of Practice. See 16 CFR 3.1-3.83. Nonetheless, there are various applications and notices to the Commission contained in other rules (generally in Parts I, II, and IV of the Commission's Rule of Practice). For example, staff estimates that the FTC annually receives approximately 15 requests for clearance submitted by former FTC employees in order to participate in certain matters and screening affidavits submitted by partners or legal or business associates of former employees pursuant to Rule 4.1, 16 CFR 4.1. There are also procedures set out in Rule 4.11(e) for agency review of outside requests for Commission employee testimony, through compulsory process or otherwise, and requests for material pursuant to compulsory process in cases or matters to which the agency is not a party. Rule 4.11(e) requires that a person who seeks such testimony or material submit a statement in support of the request. Staff estimates that agency personnel receive approximately 10 requests per year. Other types of applications and notices are either infrequent or difficult to quantify. Nonetheless, in order to cover any potential “collection of information” for which separate clearance has not been sought, staff conservatively projects the FTC will receive 75 applications or notices per year. Staff estimates each respondent will incur, on average, approximately 2 hours of burden to submit an application or notice, resulting in a cumulative annual total of 150 burden hours (75 applications or notices × 2 burden hours).

Using the burden hours estimated above, staff estimates that the total annual labor cost, based on an estimated average of $115/hour for executives' and attorneys' wages, would be approximately $17,250 (150 hours × $115). 1 There are no capital, start-up, operation, maintenance, or other similar costs to respondents.

(b) Complaint Systems: 222,622 annual hours.

Consumers can submit complaints about fraud and other practices to the FTC's Consumer Response Center by telephone or through an online complaint form at the FTC's Web site. Telephone complaints and inquiries to the FTC are answered both by FTC staff and contractors. These telephone counselors ask for the same information that consumers would enter on the applicable forms available on the FTC's Web site. The FTC also hosts a second online complaint form called econsumer.gov. This form accepts cross-border complaints from consumers through the econsumer.gov Web site and transmits them into the Consumer Sentinel Network. For telephone inquiries and complaints, the FTC staff estimates that it takes 5.9 minutes per call to gather information, and an estimated 5.3 minutes for consumers to enter a complaint online. The burden estimate conservatively assumes that the entire phone call is devoted to collecting information from consumers, although frequently telephone counselors devote a portion of the call to providing requested information to consumers.

As of 2014, the FTC now supports web chat for its online complaint process. Web chat allows consumers to communicate in real time using an easily accessible web interface to obtain technical support for the online complaint process. This feature will enable the FTC to retain consumer complaints from consumers who might otherwise abandon the process. Staff estimates that it will take an average of 5 minutes per chat session to obtain the necessary technical support.

To receive complaints from consumers of possible violations of the rules governing the National Do Not Call Registry, 16 CFR 310.4(b), the FTC maintains both an online form and a toll free hotline with automated voice response system. Consumer complainants must provide the phone number that was called, whether the call was prerecorded, and the date and time of the call. They may also provide either the name or telephone number of the company about which they are complaining, their name and address so they can be contacted for additional information, as well as for a brief comment regarding their complaint. In addition, complainants have the option of answering three yes-or-no questions to help law enforcement investigating complaints. The FTC staff estimates that the time required of consumer complainants to the National Do Not Call Registry is 3 minutes for phone complaints and 2 minutes for online complaints.

To handle complaints about identity theft, the FTC must obtain more detailed information than is required of other complainants. Identity theft complaints generally require more information (such as a description of actions complainants have taken with credit bureaus, companies, and law enforcement, and the identification of multiple suspects) than general consumer complaints and fraud complaints. FTC staff estimates that the online identity theft complaint form takes consumers up to 8.5 minutes to complete.

For consumers who call the CRC with an identity theft complaint, staff estimates that it will take 6.4 minutes per call to obtain complaint information. A substantial portion of identity theft-related calls typically consists of counseling consumers on other steps they should consider taking to obtain relief. The time needed for counseling is excluded from the estimate.

Consumer customer satisfaction surveys give the agency information about the overall effectiveness and timeliness of the FTC call center and online complaint process. An entity called Customer Feedback Insights contacts subsets of consumers throughout the year with several preapproved questions to elicit information from consumers about the overall effectiveness of the phone complaint process. Current estimates are that each respondent will require 4.4 minutes to answer the questions during the phone survey and about 2.7 minutes for the online survey (approximately 20-30 seconds per question).

In addition, the FTC currently uses ForeSee, Inc. for online customer satisfaction surveys on www.ftccomplaintassistant.gov. It randomly selects consumers to take part in a brief survey to provide feedback about the Web site. Estimates relating to ForeSee surveys are included under “Misc. and fraud-related consumer complaints (Web chat)” in the table below.

The FTC also plans to send an electronic survey to all United States-located Consumer Sentinel Network users to identify areas where the system is satisfactory and where it can improve. Staff estimates the survey to not take more than 5 minutes to complete.

What follows are staff's estimates of burden for these various collections of information, including the surveys. The figures for the online forms and consumer hotlines are an average of annualized volume for the respective programs including both current and projected volumes over the three-year clearance period sought and the number of respondents for each activity has been rounded to the nearest thousand.

The cost per respondent should be negligible. Participation is voluntary and will not require any labor expenditures by respondents. There are no capital, start-up, operation, maintenance, or other similar costs to the respondents.

(c) Program Evaluations: 79 hours.

Review of Divestiture Orders —64 hours.

The Commission issues, on average, approximately 10-15 orders in merger cases per year that require divestitures. As a result of a 1999 study authorized by the Office of Management and Budget (OMB) and conducted by the staffs of the Bureau of Competition (BC) and the Bureau of Economics, as well as more recent experience, BC monitors these required divestitures by interviewing representatives of the Commission-approved buyers of the divested assets within the first year after the divestiture is completed.

BC staff interviews representatives of the buyers to ask whether all assets required to be divested were, in fact, divested; whether the buyer has used the divested assets to enter the market of concern to the Commission and, if so, the extent to which the buyer is participating in the market; whether the divestiture met the buyer's expectations; and whether the buyer believes the divestiture has been successful. In a few cases, BC staff may also interview monitor trustees, if appropriate. In all these interviews, staff seeks to learn about pricing and other basic facts regarding competition in the markets of concern to the FTC.

Participation by the buyers is voluntary. Each responding company designates the company representative most likely to have the necessary information; typically, a company executive and an attorney represent the company. Each interview takes less than one hour to complete. BC staff further estimates that it takes each participant no more than one hour to prepare for the interview. Staff conservatively estimates that, for each interview of the responding company, two individuals (a company executive and an attorney) will devote two hours (one hour preparing and one hour participating) each to responding to questions for a total of four hours. Interviews of monitor trustees typically involve only the monitor trustee and take approximately one hour to complete with no more than one hour to prepare for the interview. Assuming that staff evaluates approximately 15 divestitures per year during the three-year clearance period, the total hours burden for the responding companies will be approximately 60 hours per year (15 divestiture reviews × 4 hours for preparing and participating). Staff may include approximately 2 monitor trustee interviews a year, which would add at most 4 hours (2 interviews × 2 hours for preparing and participating.).

Using the burden hours estimated above, staff estimates that the total annual labor cost, based on a conservative estimated average of $135/hour for executives' and attorneys' wages, would be approximately $8,640 (64 hours × $135). 3 There are no capital, start-up, operation, maintenance, or other similar costs to respondents.

Review of Advocacy Program —15 hours.

The FTC's advocacy program draws on the Commission's expertise in competition and consumer protection matters to encourage state and federal legislators, agencies and regulatory officials, courts and private entities to consider the effects of their decisions on competition and consumer welfare. The Commission and staff send approximately 20 letters to such decision makers annually regarding the likely effects of various bills, regulations, and other policies.

In the past, the Office of Policy Planning (“OPP”) has evaluated the effectiveness of these advocacy comments by surveying comment recipients and other relevant decision makers. OPP intends to continue this evaluation by sending an electronic, or where necessary, a paper questionnaire to relevant parties within a year after sending an advocacy.

Most survey questions ask the respondent to agree or disagree with a statement concerning the advocacy comment that they received. Specifically, these questions ask about the consideration, content, influence, and public effect of our comments. The questionnaire also provides respondents with an opportunity to provide additional remarks regarding the comments they received, advocacy comments in general, and the outcome of the matter. These survey results are also included in the FTC's internal performance management indicators, and are used to guide the FTC's selection and prioritization of future advocacy opportunities.

OPP staff estimates that, on average, respondents will take 30 minutes or less to complete the questionnaire. OPP staff estimates that 15 minutes of administrative time will be necessary to prepare a survey for return via mail or email. Accordingly, staff estimates that each respondent will incur 45 minutes of burden, resulting in a cumulative total of 15 burden hours per year (45 minutes of burden per respondent × 20 respondents per year). OPP staff does not intend to conduct any follow-up activities that would involve the respondents' participation.

OPP staff estimates a conservative hourly labor cost of $100 for the time of the survey participants (primarily state representatives and senators) and an hourly labor cost of $20 for administrative support time. Thus, staff estimates a total labor cost of $55 for each response (30 minutes of burden at $100 per hour plus 15 minutes of burden at $20 per hour). Assuming 20 respondents will complete the questionnaire on an annual basis, staff estimates the total annual labor costs will be approximately $1,100 ($55 per response × 20 respondents). There are no capital, start-up, operation, maintenance, or other similar costs to respondents.

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before March 11, 2015. Write “Administrative Activities: FTC File No. P911409” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site.

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

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

Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comment online, or to send it to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/adminactivitiespra2, by following the instructions on the web-based form. If this Notice appears at http://www.regulations.gov, you also may file a comment through that Web site.

If you file your comment on paper, write “Administrative Activities: FTC File No. P911409” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.

The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before March 11, 2015. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.shtm.

Comments on the information collection requirements subject to review under the PRA should also be submitted to OMB. If sent by U.S. mail, address comments to: Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission, New Executive Office Building, Docket Library, Room 10102, 725 17th Street NW., Washington, DC 20503. Comments sent to OMB by U.S. postal mail, however, are subject to delays due to heightened security precautions. Thus, comments instead should be sent by facsimile to (202) 395-5167.

Certain Federal contracts provide for progress payments to be made to the contractor during performance of the contract. Pursuant to FAR clause 52.232-16 “Progress Payments,” contractors are required to request progress payments on Standard Form 1443, “Contractor's Request for Progress Payment,” or an agency approved electronic equivalent. Additionally, contractors may be required to submit reports, certificates, financial statements, and other pertinent information, reasonably requested by the Contracting Officer. The contractual requirement for submission of reports, certificates, financial statements and other pertinent information is necessary for protection of the Government against financial loss through the making of progress payments.

Respondents: 25,161.

Responses per Respondent: 32.

Annual Responses: 805,152.

Hours per Response: .42.

Total Burden Hours: 338,164.

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

Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVCB), 1275 First Street NE., Washington, DC 20417, telephone (202) 501-4755. Please cite OMB Control No. 9000-0010, Progress Payments, in all correspondence.

The Superfund Amendments and Reauthorization Act of 1986 (SARA) (42 U.S.C. 9601 et seq. ) amended the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund) (42 U.S.C. 9601 et seq. ) by establishing certain requirements for ATSDR and the U.S. Environmental Protection Agency (EPA) with regard to hazardous substances that are most commonly found at facilities on the CERCLA National Priorities List (NPL). Among these statutory requirements is a mandate for the Administrator of ATSDR to prepare toxicological profiles for each substance included on the priority list of hazardous substances (also called the Substance Priority List). This list identifies 275 hazardous substances that ATSDR (in cooperation with EPA) has determined pose the most significant potential threat to human health. The availability of the revised list of the 275 priority substances was announced in the Federal Register on May 28, 2014 (79 FR 30613) and is available at www.atsdr.cdc.gov/spl. In addition, ATSDR has the authority to prepare toxicological profiles for substances not found at sites on the National Priorities List, in an effort to “. . . establish and maintain inventory of literature, research, and studies on the health effects of toxic substances” under CERCLA Section 104(i)(1)(B), to respond to requests for consultation under section 104(i)(4), and as otherwise necessary to support the site-specific response actions conducted by ATSDR.

Notice of the availability of these toxicological profiles in draft form for public review and comment was published in the Federal Register on November 22, 2010 (75 FR 71132), with notice of a 90-day public comment period, starting from the actual release date. Following the close of the comment period, chemical-specific comments were addressed, and, where appropriate, changes were incorporated into the profile. This material is available for public inspection at ATSDR.

This notice announces the availability of the Toxicological Profiles for Toxaphene and Trichlorobenzenes prepared by ATSDR. The Toxicological Profiles for these substances will be made available to the public on or about October 17, 2015 at the ATSDR Web site: www.atsdr.cdc.gov/toxprofiles/index.asp.

These final profiles are also available through the U.S. Department of Commerce, National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, Virginia 22161, telephone 1-800-553-6847 for a fee as determined by NTIS.

Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help assure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives.

Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of DHS that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of the Department of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces of attack with a biological, chemical, radiological, or nuclear agent or agents; (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or (4) the identification of a material threat by the Secretary of DHS under section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect national security or the health and security of U.S. citizens living abroad.

Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the reasons for the action. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use. Products appropriate for emergency use may include products and uses that are not approved, cleared, or licensed under sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k), and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the CDC (to the extent feasible and appropriate given the applicable circumstances), FDA  1 concludes: (1) That an agent referred to in a declaration of emergency or threat can cause a serious or life-threatening disease or condition; (2) that, based on the totality of scientific evidence available to FDA, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) The product may be effective in diagnosing, treating, or preventing (i) such disease or condition; or (ii) a serious or life-threatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under section 564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; and (4) that such other criteria as may be prescribed by regulation are satisfied.

No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act. Because the statute is self-executing, regulations or guidance are not required for FDA to implement the EUA authority.

On September 22, 2006, then-Secretary of DHS, Michael Chertoff, determined that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. 2 On August 5, 2014, under section 564(b)(1) of the FD&C Act, and on the basis of such determination, the Secretary of HHS declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus, subject to the terms of any authorization issued under section 564 of the FD&C Act. Notice of the declaration of the Secretary was published in the Federal Register on August 12, 2014 (79 FR 47141). On October 22, 2014, BioFire Defense submitted complete EUA requests for both the BioFire FilmArray NGDS BT-E Assay and for the BioFire FilmArray Biothreat-E test, and on October 25, 2014, FDA issued, an EUA for the BioFire FilmArray NGDS BT-E Assay and an EUA for the BioFire FilmArray Biothreat-E test, subject to the terms of these authorizations. On October 29, 2014, altona submitted a complete EUA request for the RealStar® Ebolavirus RT-PCR Kit 1.0, and on November 10, 2014, FDA issued, an EUA for the RealStar® Ebolavirus RT-PCR Kit 1.0, subject to the terms of this authorization. On November 26, 2014, in response to a request from altona on November 18, 2014, FDA amended and reissued in its entirety the EUA to allow, in addition to altona, distributors that are authorized by altona to distribute the RealStar® Ebolavirus RT-PCR Kit 1.0 with certain conditions applicable to such authorized distributor(s), and to allow the use of the assay under the EUA at certain non-U.S. laboratories, with certain conditions. The EUA, as amended and reissued on November 26, 2014, which includes an explanation for its reissuance, is reprinted in this document. Because the November 26, 2014, Authorization for altona's Ebola assay replaces in its entirety the EUA issued on November 10, 2014, the original Authorization issued on November 10, 2014, is not reprinted in this document.

An electronic version of this document and the full text of the Authorizations are available on the Internet at http://www.regulations.gov.

Having concluded that the criteria for issuance of the Authorizations under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of certain in vitro diagnostic devices. The Authorization for the BioFire FilmArray NGDS BT-E Assay issued on October 25, 2014, in its entirety (not including the authorized versions of the fact sheets and other written materials) follows and provides an explanation of the reasons for its issuance, as required by section 564(h)(1) of the FD&C Act:

The Authorization for the BioFire FilmArray Biothreat-E test issued October 25, 2014, in its entirety (not including the authorized versions of the fact sheets and other written materials) follows and provides an explanation of the reasons for its issuance, as required by section 564(h)(1) of the FD&C Act:

The Authorization for the RealStar® Ebolavirus RT-PCR Kit 1.0, originally issued on November 10, 2014, as amended and reissued in its entirety on November 26, 2014, (not including the authorized versions of the fact sheets and other written materials) follows and provides an explanation of the reasons for its issuance, as required by section 564(h)(1) of the FD&C Act, and its amendment:

In a notice published in the Federal Register of August 25, 2010 (75 FR 52427), we announced the availability of a guidance entitled “Guidance for Industry: Questions and Answers Regarding the Effect of Section 4205 of the Patient Protection and Affordable Care Act of 2010 on State and Local Menu and Vending Machine Labeling Laws.” The guidance stated that we were issuing the guidance to: (1) Ensure that industry and State and local governments understand the immediate effects of the law, and (2) clarify the effect of section 4205 of the Patient Protection and Affordable Care Act of 2010 on State and local menu and vending machine labeling laws.

We are withdrawing this guidance because we recently issued two final rules entitled “Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments” and “Food Labeling; Calorie Labeling of Articles of Food in Vending Machines” (see 79 FR 71156 (December 1, 2014) and 79 FR 71259 (December 1, 2014), respectively). The preambles for these final rules discuss issues relating to Federalism and to federal preemption of State and local laws and reflect our latest thinking on those issues. Consequently, the guidance no longer reflects our current thinking insofar as the law's effect on State and local menu and vending machine labeling laws is concerned.

FDA recognizes that the progression to digital health offers potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with various types of health information technology, including other types of medical devices. The foundation for such intercommunication is hardware and software that functions to transfer, store, convert formats, or display medical device data without modifying the data or controlling the functions or parameters of any connected medical device. 1 In the Federal Register of February 15, 2011 (76 FR 8637), FDA issued a final rule defining MDDS devices, medical image storage devices, and medical image communications devices, reclassifying them from class III (high risk) to class I (low risk). Class I devices are subject to general controls under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Since issuance of the February 2011 final rule, FDA has gained additional experience with these types of technologies and has determined that these devices pose a low risk to the public. Therefore, in the documents that are the subject of this notice, FDA provides guidance on the compliance policy for MDDS devices, medical image storage devices, and medical image communication devices and makes conforming changes to the guidance document “Mobile Medical Applications.” FDA issued a notice of availability of the draft guidances on June 25, 2014 (79 FR 36072).

The guidance document, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices,” states that FDA does not intend to enforce compliance with the regulatory requirements that apply to MDDS devices, medical image storage devices, and medical image communications devices. Blood Establishment Computer Software (BECS) and accessories to BECS are not MDDS devices. Therefore, this guidance does not address the regulation of those devices, which FDA intends to address in another forum. If you have questions about BECS or BECS accessories, please contact the Office of Communication Outreach and Development, CBER at 800-835-4709, 240-402-7800, or email ocod@fda.hhs.gov.

The September 25, 2013, version of the guidance entitled “Mobile Medical Applications” has been updated to be consistent with the policy stated in the guidance document “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices.” The updated version of “Mobile Medical Applications” also incorporates additional examples from FDA's mobile medical applications' Web site (see http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ucm255978.htm ).

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on medical device data systems, medical image storage devices, and medical image communications devices as well as mobile medical applications. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

Persons interested in obtaining a copy of the guidances may do so by downloading an electronic copy from the Internet. A search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov or from CBER at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to download an electronic copy of “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices” or “Mobile Medical Applications” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1400001 to identify the guidance “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices” or document number 1741 to identify the guidance “Mobile Medical Applications.”

The guidance documents “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices” and “Mobile Medical Applications” refer to previously approved information collections found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Review Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 801 and 809 are approved under OMB control number 0910-0485; the collections of information in 21 CFR part 803 are approved under OMB control numbers 0910-0437 and 0910-0291; the collections of information in 21 CFR part 806 are approved under OMB control number 0910-0359; the collections of information in 21 CFR part 807 subparts B and C are approved under OMB control number 0910-0625; the collections of information in 21 CFR part 807 subpart E are approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812 are approved under OMB control number 0910-0078; the collections of information in 21 CFR part 814 subparts A through E are approved under OMB control number 0910-0231; the collections of information in 21 CFR part 820 are approved under OMB control number 0910-0073; and the collections of information regarding section 513(g) of the FD&C Act (21 U.S.C. 360c(g)) are approved under OMB control number 0910-0705.

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.

FDA is announcing the availability of a revised draft guidance for industry entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs.” This revised draft guidance updates prior FDA policy and describes the Agency's current thinking regarding the brief summary requirement for consumer-directed print prescription drug advertisements. Specifically, the revised draft guidance includes recommendations for developing a consumer brief summary and notes that, so long as firms include appropriate information in a print advertisement as outlined in the revised draft guidance, FDA does not intend to object for a failure to include certain other information.

Additionally, this revised draft guidance provides new recommendations regarding the adequate directions for use requirement for consumer-directed print promotional labeling for prescription drug products. Although the requirement in 21 CFR 201.100(d) for firms to provide adequate information for use is generally fulfilled by providing the full FDA-approved package insert (PI), this revised draft guidance provides that, in exercising its enforcement discretion, FDA does not intend to object for failure to include the full PI with consumer-directed print promotional labeling pieces if firms include the appropriate information as outlined in the revised draft guidance, i.e., the same information in the consumer brief summary. This recommendation is designed to standardize the information consumers receive in print prescription drug product advertisements and promotional labeling and to make information more understandable to consumers.

FDA issued a draft guidance in the Federal Register of February 10, 2004 (69 FR 6308), entitled “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements.” FDA requested comments on whether the draft guidance provided sufficient guidance on the content of the consumer brief summary and also requested research results on potential formats for the consumer brief summary. Comments, suggestions, and research were submitted to Docket No. 2004D-0042 and were carefully analyzed and considered before developing this revised draft guidance.

This revised draft guidance incorporates information from recent social science research, clarifies the risk information that should be included in the consumer brief summary, and recommends several formatting options for this information. The revised draft guidance also recommends the use of consumer-friendly language and visual techniques to improve accessibility for consumers. Additionally, this revised draft guidance recommends that firms not disseminate the full PI to fulfill the requirements in § 201.100(d) for consumer-directed print promotional labeling for prescription drugs. Rather, the revised draft guidance recommends that firms provide the same content and format created for the consumer brief summary. FDA is issuing this revised guidance as a draft to allow for public comment on the recommendations.

This revised draft guidance is being issued consistent with FDA's good guidance practices regulations (21 CFR 10.115). The revised draft guidance, when finalized, will represent FDA's current thinking on the brief summary and adequate directions for use requirements. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document. This revised draft guidance also refers to previously approved collection of information found in FDA regulations.

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

Title: Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs.

Description of Respondents: Respondents to this collection of information are manufacturers, packers, and distributors (firms) of prescription human drug products, including biological products.

Burden Estimate: The revised draft guidance pertains to the brief summary requirement for prescription drug advertising and the requirement that adequate directions for use be included with promotional labeling for human prescription drugs when print materials are directed toward consumers.

The revised draft guidance, in part, explains FDA's current policy position that FDA does not intend to object for failure to include the entire PI to fulfill the requirements of § 201.100(d) for promotional labeling pieces directed toward consumers, if firms instead provide information on the most serious and the most common risks associated with the product, while omitting less important information. Specifically, FDA recommends that any Boxed Warning, all Contraindications, certain information regarding Warnings and Precautions ( i.e., the most clinically significant information from the Warnings and Precautions section of the PI, information that would affect a decision to prescribe or take a drug, monitoring or laboratory tests that may be needed, special precautions not set forth in other parts of the PI, and measures that can be taken to prevent or mitigate harm), and the most frequently occurring Adverse Reactions should be included.

Furthermore, FDA recommends that information should include the indication for the use being promoted. Information regarding patient directives (such as “discuss with your health care provider any pre-existing conditions” or “tell your health care provider if you are taking any medications”) should also be included. Other types of information may be included if relevant to the drug or specific indication referred to in the promotional material(s). A statement should be included that more comprehensive information can be obtained from various sources, including the firm.

Thus, the revised draft guidance recommends that firms disclose certain information to others in place of the PI to fulfill the requirements in § 201.100(d). This “third-party disclosure” constitutes a “collection of information” under the PRA.

FDA estimates that approximately 400 firms disseminate 24,000 consumer-directed print promotional labeling pieces annually. FDA estimates that it will take firms approximately 10 hours to compile and draft the information needed to provide the information recommended in the revised draft guidance.

The Coast Guard requires marine employers to establish random drug testing programs for covered crewmembers on inspected and uninspected vessels in accordance with 46 CFR 16.230. Every marine employer is required by 46 CFR 16.500 to collect and maintain a record of drug testing program data for each calendar year, and submit this data by 15 March of the following year to the Coast Guard in an annual MIS report.

Each year, the Coast Guard will publish a notice reporting the results of random drug testing for the previous calendar year's MIS data and the minimum annual percentage rate for random drug testing for the next calendar year. The purpose of setting a minimum random drug testing rate is to assist the Coast Guard in analyzing its current approach for deterring and detecting illegal drug abuse in the maritime industry.

The Coast Guard announces that the minimum random drug testing rate for calendar year 2015 is 25 percent. The Coast Guard may increase this rate if MIS data indicates a qualitative deficiency of reported data or the positive random testing rate is greater than 1.0 percent in accordance with 46 CFR part 16.230(f)(2). MIS data for 2014 indicates that the positive rate is less than one percent industry-wide (0.78 percent).

For 2015, the minimum random drug testing rate will continue at 25 percent of covered employees for the period of January 1, 2015 through December 31, 2015 in accordance with 46 CFR 16.230(e).

The Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5174) authorizes the President to provide temporary housing units to include mobile homes and other readily fabricated dwellings to eligible applicants who require temporary housing as a result of a major disaster. Title 44 CFR 206.117 provides the requirements for disaster-related housing needs of individuals and households who are eligible for temporary housing assistance. The information collected provides the facts necessary to determine the feasibility of the proposed site for placement of temporary housing units and so that FEMA can have access to place the temporary housing unit as well as retrieve it at the end of the use.

Title: Manufactured Housing Operations Forms.

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

OMB Number: 1660-0030.

FEMA Forms: FEMA Form 010-0-09, Request for the Site Inspection; FEMA Form 010-0-10, Landowner's Authorization Ingress-Egress Agreement; FEMA Form 009-0-138, Manufactured Housing Unit Inspection Report; FEMA Form 009-0-136, Unit Installation Work Order; FEMA Form 009-0-130, Maintenance Work Order.

Abstract: FEMA's temporary housing assistance provides temporary housing to eligible survivors of federally declared disasters. This information is required to determine whether the infrastructure of the site supports the installation of a temporary housing unit. This collection also obtains permission to place the unit on the property. The property owner certifies that they will not have a lien placed against the unit for their own debts, thus ensuring they will maintain the property so that FEMA can remove the unit when required.

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

Number of Respondents: 25,000.

Number of Responses: 25,000.

Estimated Total Annual Burden Hours: 4,250 hours.

Estimated Cost: The estimated annual cost to respondents for the hour burden is $134,657.00. There are no annual costs to respondents' operations and maintenance costs for technical services. There is no annual start-up or capital costs. The cost to the Federal Government is $2,076,300.

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

The Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C 5174, authorizes the President to provide temporary housing units to include manufactured homes and other readily fabricated dwellings to eligible applicants who require temporary housing as a result of a major disaster. Requirements for disaster-related housing needs of individuals and households who are eligible for temporary housing assistance may be found at Title 44 CFR 206.117. The information collected provides the information necessary to determine the feasibility of the site for placement of temporary housing units. The information will also provide FEMA with access to place the temporary housing unit as well as retrieve it at the end of the use.

Title: Direct Housing Program Forms.

Type of Information Collection: New information collection.

OMB Number: 1660—NEW.

FEMA Forms: FEMA Form 009-0-137, Unit Pad Requirements—Information Checklist; FEMA Form 009-0-131, Sales Calculation Worksheet; FEMA Form 009-0-129, Ready for Occupancy; FEMA Form 009-0-134, Recertification Worksheet; FEMA Form 009-0-135, Temporary Housing Agreement.

Abstract: The Robert T. Stafford Disaster Relief and Emergency Assistance Act authorizes the President to provide temporary housing units to eligible applicants who require temporary housing as a result of a major disaster. 42 U.S.C. 5174. The information collected provides the information necessary to determine the feasibility of the site for placement of temporary housing and so that FEMA can have access to place temporary housing units as well as retrieve it at the end of the use.

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

Number of Respondents: 25,000.

Number of Responses: 25,000.

Estimated Total Annual Burden Hours: 4,165 hours.

Estimated Cost: The estimated annual cost to respondents for the hour burden is $157,753.54. There are no annual costs to respondents' operations and maintenance costs for technical services. There is no annual start-up or capital costs. The cost to the Federal Government is $2,864,760.00.

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

The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.

Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.

The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq. , and with 44 CFR part 65.

The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.

The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at www.msc.fema.gov for comparison.

The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.

Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below.

The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.

The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.

The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at www.msc.fema.gov for comparison.

The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Mitigation has resolved any appeals resulting from this notification.

The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65.

For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.

The new or modified flood hazard information is the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program (NFIP).

This new or modified flood hazard information, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.

This new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings, and for the contents in those buildings. The changes in flood hazard determinations are in accordance with 44 CFR 65.4.

Interested lessees and owners of real property are encouraged to review the final flood hazard information available at the address cited below for each community or online through the FEMA Map Service Center at www.msc.fema.gov.