Privacy Act; Implementation
Department of the Navy is updating the Navy Privacy Act Program by adding the (k)(2) exemption to accurately describe the basis for exempting the records in the system of records notice N05800-2, Professional Responsibility Files. This direct final rule makes non-substantive changes to the Department of the Navy's Program rules. This will improve the efficiency and effectiveness of DoD's program by ensuring the integrity of the security and investigative material compiled for law enforcement purposes by the Department of the Navy and the Department of Defense. This rule is being published as a direct final rule as the Department of Defense does not expect to receive any adverse comments, and so a proposed rule is unnecessary.
Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical Laboratory Improvement Amendments of 1988 Waiver Applications
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on collections of information associated with Clinical Laboratory Improvement Amendments of 1988 waiver applications.
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Food and Drug Administration Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the use of the FDA Electronic Submission Gateway (ESG) and the Safety Reporting Portal (the SRP) to collect adverse event reports and other safety information for FDA-regulated products.
Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Endangered and Threatened Wildlife and Plants; Draft Recovery Plan for Four Subspecies of Island Fox
We, the U.S. Fish and Wildlife Service, announce the availability of our Draft Recovery Plan for Four Subspecies of Island Fox (Urocyon littoralis) under the Endangered Species Act of 1973, as amended (Act). Each of the four subspecies, San Miguel Island fox (Urocyon littoralis littoralis), Santa Rosa Island fox (U. l. santarosae), Santa Cruz Island fox (U. l. santacruzae), and Santa Catalina Island fox (U. l. catalinae), is endemic to the Channel Island off southern California for which it is named. We request review and comment on our plan from local, State, and Federal agencies, and the public. We will also accept any new information on the species' status throughout its range.
Meeting of the Community Preventive Services Task Force (Task Force)
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is independent and nonfederal. Its members are nationally known leaders in public health practice, policy, and research, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to assess the effectiveness of community, environmental, population, and healthcare system interventions in public health and health promotion. During this meeting, the Task Force will consider the findings of systematic reviews and issue recommendations and findings to help inform decision making about policy, practice, and research in a wide range of U.S. settings. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).
Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public Webcast
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the notice of a public webcast concerning compliance with the Federal Select Agent Program. The purpose of this notice is to notify all interested parties, including individuals and entities possessing, using, or transferring biological agents and toxins listed in 7 CFR 331.3, 9 CFR 121.3 and 121.4, or 42 CFR 73.3 and 73.4, of the webcast. The webcast is organized by the U.S. Department of Agriculture's Animal and Plant Health Inspection Service (USDA/APHIS), the Department of Health and Human Services Centers for Disease Control and Prevention (HHS/CDC), and the Department of Justice's Federal Bureau of Investigation (FBI). Issues to be discussed include changes to the select agent regulations; occupational health, information and physical security; personnel suitability; Bioterrorism Security Risk Assessment Form (FD-961 form); and changes to the Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins (APHIS/CDC Form 1).
Privacy Act of 1974; System of Records
The Department of the Navy is amending two systems of records notices in its existing inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.
New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Lincomycin and Spectinomycin Soluble Powder; Sulfadimethoxine Oral Solution and Soluble Powder; Tiamulin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three abbreviated new animal drug applications (ANADAs) from Teva Animal Health, Inc., to Phibro Animal Health Corp. FDA is also amending the regulations to reflect a change of sponsor's address for Phibro Animal Health Corp. and for Eka Chemicals, Inc.
Safety Zone; Water Main Crossing; Choctawhatchee Bay; Santa Rosa Beach, FL
The Coast Guard is establishing a temporary safety zone for a portion of the Gulf Intracoastal Waterway in Choctawhatchee Bay, Santa Rosa Beach, FL. This action is necessary for the protection of persons and vessels, on navigable waters, during the construction of a subaqueous water main. Entry into or transiting in this zone will be prohibited to all vessels, mariners, and persons unless specifically authorized by the Captain of the Port Mobile or a designated representative.
Notice of Submission for OMB Review; Office of Special Education and Rehabilitative Services; Grantee Reporting Form-Rehabilitation Services Administration (RSA) Annual Payback Report
The Annual Payback Report collects data on the status of ``current'' and ``exited'' RSA scholars who are/were the recipients of scholarships. The information collected will provide performance data relevant to the rehabilitation fields and degrees pursued by RSA scholars, as well as the fund owed and the rehabilitation work completed by them.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Authorization for Release of Medical Information for Black Lung Benefits
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) revision titled, ``Authorization for Release of Medical Information for Black Lung Benefits,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).
Agency Information Collection Activities; Submission for OMB Review; Comment Request; YouthBuild Impact Evaluation, Youth Follow-Up Surveys
The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) proposal titled, ``YouthBuild Impact Evaluation, Youth Follow-Up Surveys,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).
Labor-Management Relations Information Collection Requests
The Federal Mediation and Conciliation Service (FMCS) hereby announces the submission of the following public information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The information collection request is the Notice to Mediation Agencies (Agency Form F-7), OMB control number 3076-0004. No comments were received pursuant to FMCS's prior 60-day notice in the Federal Register on June 26, 2012. However, we would like to make a correction to that notice. The collection is actually being submitted to OMB as a reinstatement with change of a previously approved collection. The changes include modest streamlining and improvements for clarity. OMB is interested in comments on specific aspects of the collection. The OMB is particularly interested in comments that: (1) 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; (2) Evaluates the accuracy of the agency's estimates of the burden of the proposed collection information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collections of information on those who are to respond, including the use of appropriate automated, electronic collection technologies or other forms of information technology. Burden: FMCS receives approximately 21,000 responses to the form Notice to Mediation Agencies (OMB No. 3076-004). Affected Entities: Private sector employers and labor unions involved in interstate commerce that file notices for mediation services to the FMCS and state, local and territorial agencies.