April 15, 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of March 10, 2014 (79 FR 13308). The document withdrew approval of 8 new drug applications (NDAs) and 46 abbreviated new drug applications (ANDAs) for prescription pain medications containing propoxyphene from multiple applicants. The document failed to withdraw approval of NDA 017507, held by Xanodyne Pharmaceuticals, Inc. (Xanodyne). Xanodyne wrote to FDA asking the Agency to withdraw approval of NDA 017507 and waiving its opportunity for a hearing. FDA confirms the withdrawal of approval of NDA 017507.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Data Integrity and Compliance With CGMP.'' The purpose of the draft guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. The draft guidance is in response to an increase in CGMP violations involving data integrity observed in recent CGMP inspections. When finalized, the draft guidance is intended to provide the Agency's current thinking on the creation and handling of data in accordance with CGMP requirements.

The Food and Drug Administration (FDA) is soliciting information regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information gathered from public comments will assist with the design and development of the pilot project(s) that FDA establishes under the DSCSA.

The Federal Communications Commission (FCC), as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act (PRA) of 1995. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and (e) ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.

As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

This notice announces the availability of the Department of the Interior's (Department) draft 2016-2020 Environmental Justice Strategic Plan (Strategic Plan). This draft Strategic Plan builds on the Department's 2012-2017 Environmental Justice Strategic Plan and will guide the Department's actions regarding environmental justice for the upcoming years. Updates to Federal agencies' environmental justice strategic plans are conducted periodically to increase interagency cooperation and participation opportunities for minority, low-income, American Indian and Alaska Native Communities, and Tribal governments.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: David Sharlip, NLM Project Clearance Liaison, Office of Administrative and Management Analysis Services, OAMAS, NLM, NIH, Building 38A, Room B2N12, 8600 Rockville Pike, Bethesda, MD 20894, or call non-toll-free number (301) 496-5441, or Email your request, including your address to: sharlipd@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: NLM People Locator System 0925-0612, Expiration Date: 07/31/2016, EXTENSION, National Library of Medicine (NLM), National Institutes of Health (NIH). Need and Use of Information Collection: This collection of data is intended to assist in the reunification of family members and friends who are separated during a disaster. Experience in operational drills and during real-world disasters such as the January 2010 earthquakes in Haiti demonstrates that family members and loved ones are often separated during disasters and have significant difficulty determining each other's safety, condition, and location. Reunification can not only improve their emotional well-being during the recovery period, but also improve the chances that injured victims will be cared for once they are released from urgent medical care. Family and friends are also a valuable source of medical information that may be important to the care of injured victims (e.g., by providing family or personal medical history, information about allergies). The National Library of Medicine (NLM) aims to assist Federal, State and Local agencies in disaster relief efforts and to serve its mission of supporting national efforts to the response to disasters via the PEOPLE LOCATOR[supreg] system and related mobile app (ReUniteTM) developed as part of the intramural Lost Person Finder (LPF) R&D project. The information collection would support efforts to reunite family and friends who are separated during a disaster. Information about missing (``lost'') people would be collected from family members or loved ones who are searching for them. Information about recovered (``found'') people could be provided by medical personnel, volunteers and other relief workers assisting in the disaster recovery effort. Information collected about missing and recovered persons would vary including any one of the following and possibly all: A photograph, name (if available for a found person), age group (child, adult) and/or range, gender, status (alive and well, injured, deceased, unknown), and location. The information collection would be voluntary. It would be activated only during times of declared emergencies, training and demonstration support activities, and would operate in declared emergencies until relief efforts have ceased in response to a particular disaster. This data collection is authorized pursuant to sections 301, 307, 465 and 478A of the Public Health Service Act [42 U.S.C. 241, 242l, 286 and 286d]. NLM has in its mission the development and coordination of communication technology to improve the delivery of health services. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 7,500.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB), Division of Adolescent Development and Support (DADS), announces the award of a single-source expansion supplement grant of $852,000 to the National Safe Place Network located in Louisville, KY, to support costs associated with the expansion of the scope of approved activities under its award for the Runaway and Homeless Youth Training and Technical Assistance Center (RHYTTAC).

This is a notice to inform the public of the next meetings of the Secretary's Advisory Committee on Animal Health. The meetings are being organized by the Animal and Plant Health Inspection Service to discuss matters of animal health.

The Administration for Children and Families (ACF), Office of Child Support Enforcement (OCSE), Division of Program Innovation, announces the award of a single-source program expansion supplement grant in the amount of $34,568 to the Washington State Department of Social and Health Services in Lacey, WA, to support the development of additional dissemination tools such as reports and web-based trainings on the lessons learned and early findings from the Evaluation of the Behavioral Interventions for Child Support Services of the Behavioral Interventions for Child Support Services (BICS) Demonstration. In FY 2014, OCSE competitively awarded a cooperative agreement to the Washington State Department of Social and Health Services to conduct a 5-year evaluation of OCSE's national demonstration called Behavioral Interventions for Child Support Services (BICS) under Funding Opportunity Announcement (FOA) number HHS-2014-ACF-OCSE-FD- 0822. Under this FOA, a total of $1.7 million of 1115 funds are made available over the five year project period to conduct this evaluation. The Washington State Department of Social and Health Services was the only grantee that received funding under this FOA.

The U.S. Department of State (Department) is issuing this Notice of Intent (NOI) to inform the public that it will prepare an Environmental Impact Statement (EIS), consistent with the National Environmental Policy Act (NEPA) of 1969 (as implemented by the Council on Environmental Quality regulations found at 40 CFR parts 1500-1508), to evaluate potential impacts from the construction, connection, operation, and maintenance of a proposed new 20-inch diameter pipeline and associated infrastructure in North Dakota that would export crude oil from the United States to Canada. The Upland Pipeline EIS will address potential direct, indirect, and cumulative environmental impacts from the proposed action and will evaluate a range of reasonable alternatives, including a no action alternative. The Department also plans to host a public scoping meeting on Tuesday, May 10, 2016 from 4:00-7:00 p.m. at the Farm Festival Building in Tioga, North Dakota to solicit public comments for consideration in establishing the scope of the EIS.

The Office of the Secretary of Defense proposes to alter a system of records, DMDC 04, entitled ``Emergency Evacuation Tracking and Repatriation.'' Repatriation centers will use this information to track and account for individuals evacuated from emergency situations due to military operations, political situations, natural disasters, or other potentially dangerous circumstances. Repatriation centers assist evacuees in securing requested relocation services, and recording and recovering relocation costs.

The Government of the United States received a request from the Government ofMorocco, submitted on March 9, 2016, and updated on April 1, 2016, on behalf of CROSSING to initiate consultations under Article 4.3.3 of the USMFTA. The Government of Morocco is requesting that the United States and Morocco (``the Parties'') consider revising the rules of origin for pants, skirts, jackets, shirts and casual dresses to address availability of supply of certain woven fabrics in the territories of the Parties. The President of the United States may proclaim a modification to the USMFTA rules of origin for textile and apparel products after the United States reaches an agreement with the Government of Morocco on a modification under Article 4.3.6 of the USMFTA to address issues of availability of supply of fibers, yarns, or fabrics in the territories of the Parties. CITA hereby solicits public comments on this request, in particular with regard to whether certain woven fabrics can be supplied by the U.S. domestic industry in commercial quantities in a timely manner.

As authorized under the provisions of the Federal Land Policy and Management Act of 1976, and pursuant to 43 CFR 8364.1, certain public land near Stead, Nevada, will be temporarily closed to all public use to provide for public safety during the 2016 Reno Air Racing Association Pylon Racing Seminar and the Reno National Championship Air Races.

The Environmental Protection Agency (EPA) is notifying the public that the Agency has found that the motor vehicle emissions budgets (MVEBs or ``budgets'') for the years 2014 and 2017 in the San Joaquin Valley Moderate Area Plan, as revised in a December 29, 2014 submittal, for the 2006 24-hour fine particulate (PM2.5) national ambient air quality standards (NAAQS) are adequate for transportation conformity purposes. The Moderate Area Plan was submitted to the EPA on March 4, 2013 by the California Air Resources Board (CARB) as a revision to the California State Implementation Plan (SIP) and includes a demonstration of reasonable further progress for the 2006 PM2.5 NAAQS. CARB submitted a Supplement to the Moderate Area Plan on November 6, 2014 (``2014 Supplement'') and a revision to the budgets on December 29, 2014. We refer to these submittals collectively as the ``2012 PM2.5 Plan'' or ``Plan.'' Upon the effective date of this notice of adequacy, the San Joaquin Valley metropolitan planning organizations (MPO) and the U.S. Department of Transportation (DOT) must use these budgets for future transportation conformity determinations.

We, the U.S. Fish and Wildlife Service (Service), under the Endangered Species Act of 1973, as amended (ESA), announce the availability of the Midwest Wind Energy Multi-Species Habitat Conservation Plan (MSHCP). Planning partners include the State conservation agencies from the States of Michigan, Indiana, Wisconsin, Minnesota, Iowa, Illinois, and Missouri, the American Wind Energy Association (AWEA), who is representing a consortium of wind energy companies called WEBAT (Wind Energy Bat Action Team), and The Conservation Fund. The Plan Area encompasses all lands within the States of Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Ohio, and Wisconsin. The covered species include six federally listed bat and bird species, one bat species that may be listed in the future, and the bald eagle. The activities covered under the MSHCP (``covered activities'') include the construction, operation, maintenance, decommissioning and repowering of wind energy facilities, as well as monitoring activities. Up to 18,004 megawatts (MW) of existing facilities and 33,000 MW of new wind development are proposed to be covered under the MSHCP. In accordance with the National Environmental Policy Act of 1969 (NEPA), as amended, and the Council on Environmental Quality (CEQ) regulations, the Service is also announcing the availability of the MSHCP draft environmental impact statement (DEIS).

This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for use to assist the homeless.