July 18, 2013 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 107
Pipeline Safety: Reminder of Requirements for Utility LP-Gas and LPG Pipeline Systems
PHMSA is issuing an Advisory Bulletin to remind owners and operators of liquefied petroleum gas (LPG) and utility liquefied petroleum gas (utility LP-Gas) plants that although they must follow the American National Standards Institute/National Fire Protection Association (ANSI/NFPA) standards 58 or 59, they must also follow certain sections and requirements of Part 192.
Notice of Intent To Collect Fees on the John Day River, Oregon
Pursuant to applicable provisions of the Federal Lands Recreation Enhancement Act (REA), the Bureau of Land Management's (BLM) Prineville District Office is proposing to begin collecting fees for day and overnight trips (floats) on the Service Creek (River Mile 157) to Tumwater Falls (River Mile 10) stretch of the John Day River, between Service Creek, Oregon, and the confluence of the John Day River and the Columbia River, Oregon. The John Day River system was designated as a National Wild and Scenic River on October 28, 1988, and as a Special Area in the John Day Basin Resource Management Plan (February 2001).
Notice of Intent To Prepare a Resource Management Plan for the Bering Sea-Western Interior Planning Area, Alaska and Associated Environmental Impact Statement
In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) Anchorage Field Office, Anchorage, Alaska, intends to prepare a Resource Management Plan (RMP) with an associated Environmental Impact Statement (EIS) for the RMP for the Bering Sea-Western Interior (BSWI) Planning Area and by this notice announces the beginning of the scoping process to solicit public comments and identify issues. The RMP will replace the existing 1981 Southwest Planning Area Management Framework Plan and portions of the 1986 Central Yukon RMP Record of Decision.
Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation To Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Enforcement Policy Regarding IND Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies,'' dated July 2013. This guidance informs members of the medical and scientific community and other interested persons that we intend to exercise enforcement discretion regarding the investigational new drug (IND) requirements for the use of fecal microbiota for transplantation (FMT) to treat C. difficile infection not responding to standard therapies. FDA intends to exercise this discretion provided that the treating physician obtains adequate informed consent from the patient or his or her legally authorized representative for the use of FMT products. Informed consent should include, at a minimum, a statement that the use of FMT products to treat C. difficile is investigational and a discussion of its potential risks. This policy does not extend to other uses of FMT. FDA intends to exercise this discretion on an interim basis while we further consider the matter. This guidance has an immediate implementation date because FDA has determined that prior public participation is not feasible or appropriate.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 4040-0004, which expired on March 31, 2013. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 4040-0003, which expired on November 30, 2011. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Electronic Government Office (EGOV), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for reinstatement of a previously-approved information collection assigned OMB control number 4040-0010, which expired on August 31, 2011. The ICR also requests categorizing the form as a common form, meaning HHS will only request approval for its own use of the form rather than aggregating the burden estimate across all Federal Agencies as was done for previous actions on this OMB control number. The SF-424 Project Abstract form and the SF-424 Key Contacts form were previously assigned to OMB control number 4040-0003. EGOV seeks to move these two instruments to the OMB control number 4040-0010. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs
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.
Assessment of the Risk of Human Salmonellosis Associated With the Consumption of Tree Nuts; Request for Comments, Scientific Data and Information
The Food and Drug Administration (FDA or we) is requesting comments and scientific data and information that may help us in performing a quantitative assessment of the risk of human salmonellosis (an infection with bacteria called Salmonella) associated with the consumption of tree nuts. The purpose of the risk assessment will be to quantify the public health risk associated with the consumption of potentially Salmonella contaminated tree nuts and to evaluate the impact of risk-based preventive controls on the risk of human salmonellosis arising from consumption of tree nuts.
Endangered and Threatened Wildlife and Plants; Designation of Critical Habitat for the Northwest Atlantic Ocean Distinct Population Segment of the Loggerhead Sea Turtle (Caretta caretta)
We, the U.S. Fish and Wildlife Service (Service or USFWS), announce the reopening of the comment period on the March 25, 2013, proposed rule to designate specific areas in the terrestrial environment as critical habitat for the Northwest Atlantic Ocean Distinct Population Segment (DPS) of the Loggerhead Sea Turtle (Caretta caretta) under the Endangered Species Act of 1973, as amended (Act). We also announce the availability of a draft economic analysis (DEA) of the proposed designation of critical habitat and an amended required determinations section of the proposal. We also announce that, based on a reevaluation of the applicable Habitat Conservation Plan, we are removing Unit LOGG-T-FL-04 from consideration for exclusion from critical habitat. We are reopening the comment period to allow all interested parties an opportunity to comment simultaneously on the proposed rule, the associated DEA, and the amended required determinations section. Comments previously submitted need not be resubmitted, as they will be fully considered in preparation of the final rule.
Endangered and Threatened Species: Designation of Critical Habitat for the Northwest Atlantic Ocean Loggerhead Sea Turtle Distinct Population Segment (DPS) and Determination Regarding Critical Habitat for the North Pacific Ocean Loggerhead DPS
We, the National Marine Fisheries Service (NMFS), propose critical habitat for the Northwest Atlantic Ocean loggerhead sea turtle Distinct Population Segment (DPS) (Caretta caretta) within the Atlantic Ocean and the Gulf of Mexico. Specific areas proposed for designation include 36 occupied marine areas within the range of the Northwest Atlantic Ocean DPS. These areas contain one or a combination of nearshore reproductive habitat, winter area, breeding areas, and migratory corridors. We are also asking for comment on whether to include as critical habitat in the final rule some areas that contain foraging habitat and two large areas that contain Sargassum habitat. The U.S. Fish and Wildlife Service addressed terrestrial areas (nesting beaches) in a separate document. No marine areas meeting the definition of critical habitat were identified within the jurisdiction of the United States for the North Pacific Ocean DPS, and therefore we are not proposing to designate critical habitat for that DPS. We are soliciting comments from the public on all aspects of the proposal, including information on the economic, national security, and other relevant impacts. We will consider additional information received prior to making a final designation.
Proposed Collection; Comment Request on Information Collection Tools Relating to the Offshore Voluntary Disclosure Program (OVDP)
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning the Offshore Voluntary Disclosure Program (OVDP).
Petitions for Modification of Application of Existing Mandatory Safety Standards
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and 30 CFR part 44 govern the application, processing, and disposition of petitions for modification. This notice is a summary of petitions for modification submitted to the Mine Safety and Health Administration (MSHA) by the parties listed below to modify the application of existing mandatory safety standards codified in Title 30 of the Code of Federal Regulations.
Hazardous Materials: Improving the Safety of Railroad Transportation of Hazardous Materials
FRA and PHMSA invite interested persons to participate in a public meeting addressing the transportation of hazardous materials by rail. FRA and PHMSA are undertaking a comprehensive review of operational factors that affect the safety of the transportation of hazardous materials by rail and are seeking input from stakeholders and interested parties.
Proposed Collection; Comment Request for Revenue Procedure 2004-29
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning statistical sampling in Sec. 274 Context.
Proposed Collection; Comment Request for Regulation Project
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning an existing, qualified severance of a trust for generation-skipping transfer (GST) tax purposes.
Rescission of Supervised Investment Bank Holding Company Rules
The Securities and Exchange Commission (the ``Commission'') is rescinding rules under the Securities Exchange Act of 1934 (the ``Exchange Act'') that established the Commission's program for supervising investment bank holding companies. The Commission is taking this action pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act (the ``Dodd-Frank Act''), which eliminated the applicable section effective July 21, 2011. The Commission also is rescinding certain exemptive provisions in its broker-dealer risk assessment rules and delegation of authority rules that pertain to the supervised investment bank holding company program rules that are being rescinded.
Proposed Collection; Comment Request for Revenue Procedure 2007-48
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning the rotable spare parts safe harbor method.
Amendments to Regulations Governing Ocean Transportation Intermediary Licensing and Financial Responsibility Requirements, and General Duties
The Federal Maritime Commission proposes to amend its rules governing the licensing, financial responsibility requirements and duties of Ocean Transportation Intermediaries. The proposed rule is intended to adapt to changing industry conditions, improve regulatory effectiveness, improve transparency, streamline processes and reduce regulatory burdens. The Commission received requests and for a 60-day extension from the National Customs Brokers and Forwarders Association of America Inc., supported by the Transportation Intermediaries Association and from the Pacific Coast Council of Customs Brokers and Freight Forwarders Association, Inc. The Commission determined to grant a 30-day extension of time.
Non-Vessel-Operating Common Carrier Negotiated Rate Arrangements; Tariff Publication Exemption
The Federal Maritime Commission (Commission) revises its rules to impose registration requirements on foreign-based unlicensed non- vessel-operating common carriers and to extend an exemption from certain provisions and requirements of the Shipping Act of 1984 and the Commission regulations to foreign-based unlicensed non-vessel-operating common carriers that agree to negotiated rate arrangements.
Statement on Regulatory Burden
The Farm Credit Administration (FCA, our, or we) issues this notice in order to consider whether our existing regulations are inefficient or burdensome. We seek public comment on the appropriateness of the requirements we impose on Farm Credit System (System) institutions, including the Federal Agricultural Mortgage Corporation (Farmer Mac). We ask for comments on our regulations that may duplicate other requirements, are ineffective, are not based on law, or impose burdens that are greater than the benefits received.
Scientific Information Request on Vitamin D and Calcium
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public on Vitamin D and Calcium. Scientific information is being solicited to inform the Vitamin D and Calcium: A Systematic Review of Health Outcomes project, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on vitamin D and calcium will improve the quality of this systematic review. AHRQ is conducting this systematic review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). AHRQ is republishing this document due to errors found on our first publication of July 3, 2013 (https://www.gpo.gov/fdsys/pkg/FR-2013-07- 03/pdf/2013-5730.pdf). Please disregard the July 3 publication.
Scientific Information Request on Imaging Tests for the Staging of Colorectal Cancer
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions on imaging tests for the staging of colorectal cancer (e.g., Chest x-ray, computed tomography, multidetector computed tomography (MD-CT), CT colonography, magnetic resonance imaging (MRI), transabdominal ultrasound (TUS), endoscopic ultrasound (EUS), transrectal ultrasound (TRUS), positron emission tomography (PET), positron emission tomography combined with computed tomography (PET/CT fusion), or positron emission tomography combined with magnetic resonance imaging (PET/MRI fusion)) from medical device manufacturers. Scientific information is being solicited to inform our Comparative Effectiveness Review of Imaging Tests for the Staging of Colorectal Cancer, which is currently being conducted by one of the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on these devices will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). AHRQ is republishing this document due to errors found on our first publication of June 27, 2013 (https://www.gpo.gov/fdsys/pkg/FR-2013-06- 27/pdf/2013-15288.pdf). Please disregard the June 27 publication.
Certain Reduced Folate Nutraceutical Products and L-Methylfolate Raw Ingredients Used Therein; Commission Determination Not To Review Initial Determinations Terminating the Investigation as to Certain Respondents and Terminating the Investigation in the Entirety
Notice is hereby given that the U.S. International Trade Commission has determined not to review initial determinations (``IDs'') (Order Nos. 14-15) of the presiding administrative law judge terminating the investigation as to certain respondents on the basis of settlement agreements and withdrawal of the complaint, and terminating the investigation in the entirety. The investigation is hereby terminated.
Certain Sintered Rare Earth Magnets, Methods of Making Same and Products Containing Same; Commission Determination Not to Review an Initial Determination Granting an Unopposed Motion by Complainants; Termination of the Investigation
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (``ALJ'') initial determination (``ID'') (Order No. 130) granting complainants' unopposed motion to terminate the investigation as to remaining respondents Beats Electronics, LLC of Santa Monica, California (``Beat''); Bosch Security Systems, Inc. of Burnsville, Minnesota (``Bosch''); and Callaway Golf Co. of Carlsbad, California (``Callaway'') based upon withdrawal of the complaint, and terminating the investigation in its entirety.
Marine Mammals; File No. 16992
Notice is hereby given that a permit has been issued to Paul Nachtigall, Ph.D., Hawaii Institute of Marine Biology, University of Hawaii, P.O. Box 1106, Kailua, HI 96734 to conduct research on captive cetaceans.
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