July 2, 2014 – Federal Register Recent Federal Regulation Documents
Results 101 - 124 of 124
Periodic Reporting
The Commission is noticing a recent Postal Service filing concerning the initiation of a proceeding to consider proposed changes in analytical principles (Proposals Three through Eight). This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Agency Information Collection Activities: Proposed Collection; Comment Request
The U.S. Nuclear Regulatory Commission (NRC) invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is summarized below. We are required to publish this notice in the Federal Register under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). Information pertaining to the requirement to be submitted: 1. The title of the information collection: 10 CFR Part 100 ``Reactor Site Criteria.'' 2. Current OMB approval number: 3150-0093. 3. How often the collection is required: As necessary in order for the NRC to assess the adequacy of proposed seismic design bases and the design bases for other site hazards for nuclear power and test reactors constructed and licensed in accordance with Parts 50 and 52 of Title 10 of the Code of Federal Regulations (10 CFR) and the Atomic Energy Act of 1954, as amended. 4. Who is required or asked to report: Applicants and licensees for nuclear power and test reactors. 5. The number of annual respondents: 2.3 (7 respondents over a 3- year period). 6. The number of hours needed annually to complete the requirement or request: 167,900 hours (73,000 per application x 2.3 applications). 7. Abstract: Part 100, Reactor Site Criteria, establishes approval requirements for proposed sites for the purpose of constructing and operating stationary power and testing reactors pursuant to the provisions of 10 CFR parts 50 or 52. These reactors are required to be sited, designed, constructed, and maintained to withstand geologic hazards, such as faulting, seismic hazards, and the maximum credible earthquake, to protect the health and safety of the public and the environment. Non-seismic siting criteria must also be evaluated. Seismic siting criteria include such factors as population density, the proximity of man-related hazards, and site atmospheric dispersion characteristics. The NRC uses the information required by 10 CFR part 100 to evaluate whether natural phenomena and potential man-made hazards will be appropriately accounted for in the design of nuclear power and test reactors. Submit, by September 2, 2014, comments that address the following questions: 1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility? 2. Is the burden estimate accurate? 3. Is there a way to enhance the quality, utility, and clarity of the information to be collected? 4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology? The public may examine and have copied for a fee publicly-available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. The OMB clearance requests are available at the NRC's Web site: https://www.nrc.gov/public-involve/ doc-comment/omb/. The document will be available on the NRC's home page site for 60 days after the signature date of this notice. Comments submitted in writing or in electronic form will be made available for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. Comments submitted should reference Docket No. NRC-2014-0148. You may submit your comments by any of the following methods: Electronic comments go to https:// www.regulations.gov and search for Docket No. NRC-2014-0148. Mail comments to the Acting NRC Clearance Officer, Brenda Miles (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Questions about the information collection requirements may be directed to the Acting NRC Clearance Officer, Brenda Miles (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7884, or by email to INFOCOLLECTS.Resource@NRC.GOV.
Agency Information Collection Activities: Proposed Collection; Comment Request
The U.S. Nuclear Regulatory Commission (NRC) invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is summarized below. We are required to publish this notice in the Federal Register under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). Information pertaining to the requirement to be submitted: 1. The title of the information collection: 10 CFR Part 36, ``Licenses and Radiation Safety Requirements for Irradiators.'' 2. Current OMB approval number: 3150-0158. 3. How often the collection is required: Annually. 4. Who is required or asked to report: Irradiator licensees licensed by NRC or an Agreement State. 5. The number of annual respondents: 56 (8 NRC licensees and 48 Agreement State licensees). 6. The number of hours needed annually to complete the requirement or request: 34,048 hours (4,864 NRC licensee hours + 29,184 Agreement State licensee hours). 7. Abstract: Part 36 of Title 10 of the Code of Federal Regulations (10 CFR) contains requirements for the issuance of a license authorizing the use of sealed sources containing radioactive materials in irradiators used to irradiate objects or materials for a variety of purposes in research, industry, and other fields. The subparts cover specific requirements for obtaining a license or license exemption, design and performance criteria for irradiators; and radiation safety requirements for operating irradiators, including requirements for operating irradiators, including requirements for operator training, written operating and emergency procedures, personnel monitoring, radiation surveys, inspection, and maintenance. Part 36 also contains the recordkeeping and reporting requirements that are necessary to ensure that the irradiator is being safely operated so that it does not pose any danger to the health and safety of the general public and the irradiator employees. Submit, by September 2, 2014, comments that address the following questions: 1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility? 2. Is the burden estimate accurate? 3. Is there a way to enhance the quality, utility, and clarity of the information to be collected? 4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology? The public may examine and have copied for a fee publicly-available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. The OMB clearance requests are available at the NRC's Web site: https://www.nrc.gov/public-involve/ doc-comment/omb/. The document will be available on the NRC home page site for 60 days after the signature date of this notice. Comments submitted in writing or in electronic form will be made available for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. Comments submitted should reference Docket No. NRC-2014-0134. You may submit your comments by any of the following methods: Electronic comments go to https:// www.regulations.gov and search for Docket No. NRC-2014-0134. Mail comments to the Acting NRC Clearance Officer, Brenda Miles (T-5 F50), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Questions about the information collection requirements may be directed to the Acting NRC Clearance Officer, Brenda Miles (T-5 F50), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by telephone: 301-415-7884, or by email to: INFOCOLLECTS.Resource@NRC.GOV.
Agency Information Collection Activities: Proposed Collection; Comment Request
The U.S. Nuclear Regulatory Commission (NRC) invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is summarized below. We are required to publish this notice in the Federal Register under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). Information pertaining to the requirement to be submitted: 1. The title of the information collection: Voluntary Reporting of Performance Indicators. 2. Current OMB approval number: 3150-0195. 3. How often the collection is required: Quarterly. 4. Who is required or asked to report: Power reactor licensees. 5. The number of annual respondents: 100. 6. The number of hours needed annually to complete the requirement or request: 81,250 hours (80,000 hours of reporting and 1,250 hours of recordkeeping). 7. Abstract: As part of a joint industry-NRC initiative, the NRC receives information submitted voluntarily by power reactor licensees regarding selected performance attributes known as performance indicators (PIs). Performance indicators are objective measures of the performance of licensee systems or programs. The NRC uses PIs information and inspection results in its Reactor Oversight Process to make decisions about plant performance and regulatory response. Licensees transmit PIs electronically to reduce burden on themselves and the NRC. Submit, by September 2, 2014, comments that address the following questions: 1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility? 2. Is the burden estimate accurate? 3. Is there a way to enhance the quality, utility, and clarity of the information to be collected? 4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology? The public may examine and have copied for a fee publicly-available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. The OMB clearance requests are available at the NRC's Web site: https://www.nrc.gov/public-involve/ doc-comment/omb/. The document will be available on the NRC's home page site for 60 days after the signature date of this notice. Comments submitted in writing or in electronic form will be made available for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. Comments submitted should reference Docket No. NRC-2014-0157. You may submit your comments by any of the following methods: Electronic comments go to https:// www.regulations.gov and search for Docket No. NRC-2014-0157. Mail comments to the Acting NRC Clearance Officer, Brenda Miles (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Questions about the information collection requirements may be directed to the Acting NRC Clearance Officer, Brenda Miles (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by telephone: 301-415-7884, or by email to: INFOCOLLECTS.Resource@NRC.GOV.
Agency Information Collection Activities: Proposed Collection; Comment Request
The U.S. Nuclear Regulatory Commission (NRC) invites public comment about our intention to request the OMB's approval for renewal of an existing information collection that is summarized below. We are required to publish this notice in the Federal Register under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). Information pertaining to the requirement to be submitted: 1. The title of the information collection: NRC Form 445, ``Request for Approval of Official Foreign Travel.'' 2. Current OMB approval number: 3150-0193. 3. How often the collection is required: On occasion. 4. Who is required or asked to report: Non-Federal consultants, contractors and NRC's invited travelers (i.e., non-NRC employees). 5. The number of annual respondents: 20. 6. The number of hours needed annually to complete the requirement or request: 40 hours (2 hours per response). 7. Abstract: NRC Form 445, ``Request for Approval of Foreign Travel,'' is supplied by consultants, contractors, and NRC's invited travelers who must travel to foreign countries in the course of conducting business for the NRC. In accordance with 48 CFR part 20, ``NRC Acquisition Regulation,'' contractors traveling to foreign countries are required to complete this form. The information requested includes the name of the Office Director/Regional Administrator or Chairman, as appropriate, the traveler's identifying information, purpose of travel, listing of the trip coordinators, other NRC's travelers and contractors attending the same meeting, and a proposed itinerary. Revisions to NRC's Management Directives 14.1 and 5.13 require each traveler to obtain a briefing on the most recent status of the threat environment prior to travel, and to requisition government issued communication devices such as cell phones and laptops for use while travelling. These and other procedural changes necessitated a redesign of NRC Form 445. Submit, by September 2, 2014, comments that address the following questions: 1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility? 2. Is the burden estimate accurate? 3. Is there a way to enhance the quality, utility, and clarity of the information to be collected? 4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology? The public may examine and have copied for a fee, publicly- available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. The OMB clearance requests are available at the NRC's Web site: https://www.nrc.gov/public-involve/ doc-comment/omb/. The document will be available on the NRC's home page site for 60 days after the signature date of this notice. Comments submitted in writing or in electronic form will be made available for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. Comments submitted should reference Docket No. NRC-2014-0105. You may submit your comments by any of the following methods. Electronic comments go to https:// www.regulations.gov and search for Docket No. NRC-2014-0105. Mail comments to the Acting NRC Clearance Officer, Brenda Miles (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Questions about the information collection requirements may be directed to the Acting NRC Clearance Officer, Brenda Miles (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7884, or by email to INFOCOLLECTS.Resource@NRC.GOV.
Defense Business Board; Notice of Federal Advisory Committee Meeting
The Department of Defense is publishing this notice to announce the following Federal advisory committee meeting of the Defense Business Board. This meeting is open to the public.
Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act, Concerning Outsourcing Facilities; Revised Request for Nominations
The Food and Drug Administration (FDA or Agency) is preparing to develop a list of bulk drug substances (active ingredients) that may be used to compound drug products in accordance with section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) concerning outsourcing facilities. In response to a notice published in the Federal Register of December 4, 2013, interested groups and individuals previously nominated a wide variety of substances for this list. However, many of those nominations were not for bulk drug substances used in compounding as active ingredients, and none included sufficient information to justify inclusion of the nominated substances on the list. To improve the efficiency of the process for developing the list of bulk drug substances that may be used to compound drug products under section 503B of the FD&C Act, FDA is providing more detailed information on what it needs to evaluate a nomination. Because the deadline for nominations has passed, FDA is reopening the nomination process so that interested persons can submit nominations of bulk drug substances and provide adequate support to justify placing the substances on the list. Bulk drug substances that were previously nominated will not be further considered unless they are renominated and adequately supported. Substances that are not adequately supported will not be placed on the list.
Final Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance entitled ``Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act.'' The guidance announces the Agency's intention with regard to enforcement of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to regulate entities that compound drugs, now that the FD&C Act has been amended by the Drug Quality and Security Act (DQSA). The guidance reflects the Agency's current thinking on the issues addressed by the guidance.
Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulations to revise the list of drug products that may not be compounded under the exemptions provided by the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the drug products have been withdrawn or removed from the market after the drug products or components of such drug products were found to be unsafe or not effective. Specifically, the proposed rule would add 25 drug products to this list of drug products and modify the description of one drug product on this list to add an exception. These revisions are necessary because new information has come to the Agency's attention since March 8, 1999, when FDA published the original list as a final rule. FDA is also withdrawing the previous proposed rule regarding additions to this list (see the Federal Register of January 4, 2000).
Draft Guidance for Industry on Current Good Manufacturing Practice-Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Current Good Manufacturing PracticeInterim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act.'' This draft guidance describes FDA's current expectations regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound human drugs and register with FDA as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in accordance with provisions added by the Drug Quality and Security Act (DQSA). FDA is also soliciting public input on specific potential alternative approaches regarding certain CGMP requirements. These potential approaches are explained in detail in the draft guidance.
Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Request for Nominations
The Food and Drug Administration (FDA or Agency) is preparing to develop a list of bulk drug substances (active ingredients) that may be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), although they are neither the subject of a United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. In response to a notice published in the Federal Register of December 4, 2013, interested groups and individuals previously nominated a wide variety of substances for this list. However, many of those nominations either were for a substance that is already the subject of a USP monograph or a component of an FDA-approved drug, were not for bulk drug substances used in compounding as active ingredients, or did not include sufficient information to justify inclusion of the nominated substance on the list. To improve the efficiency of the process for developing the list of bulk drug substances that may be used to compound drug products under section 503A, FDA is providing more detailed information on what it needs to evaluate a nomination. Because the deadline for nominations has passed, FDA is reopening the nomination process so that interested persons can submit nominations of bulk drug substances that are not the subject of a USP or NF monograph or a component of an FDA-approved drug. Interested persons will also have the opportunity to provide adequate support to justify placement of the substances on the list. Bulk drug substances that were previously nominated will not be further considered unless they are renominated and those nominations are adequately supported. Substances that are already eligible for use in compounding or that are not adequately supported will not be placed on the list.
Signal Systems Reporting Requirements
FRA is issuing this final rule as part of a paperwork reduction initiative. The final rule eliminates the regulatory requirement that each railroad carrier file a signal system status report with FRA every five years. FRA believes the report is no longer necessary because FRA receives more updated information regarding railroad signal systems through alternative sources. Separately, FRA is amending the criminal penalty provision in the Signal Systems Reporting Requirements by updating two outdated statutory citations.
New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor's Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April and May 2014. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to remove an obsolete entry for a drug for which approval was withdrawn in 1996.
New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline; Procaine Penicillin; and Sulfamethazine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a three-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for growth promotion indications in swine and to reflect the reformulation of the Type A medicated article as a two-way, fixed-ratio, combination drug product without penicillin.
Withdrawal of Approval of Part of a New Animal Drug Application; Procaine Penicillin
The Food and Drug Administration (FDA) is withdrawing approval of those parts of a new animal drug application (NADA) for a three-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for growth promotion indications in swine. This action is being taken at the sponsor's request because the three-way Type A medicated article is no longer manufactured.
Approval and Promulgation of Air Quality Implementation Plans; Indiana; Indiana PM2.5
The Environmental Protection Agency (EPA) is taking final action to approve portions of submissions from Indiana addressing EPA's requirements for its new source review (NSR) and prevention of significant deterioration (PSD) program with respect to particulate matter smaller than 2.5 micrometers (PM2.5) and ozone precursors. This rulemaking will finalize portions of two proposed rulemaking actions, one published in the Federal Register on August 19, 2013 and another published on November 1, 2013.
Airworthiness Directives; The Boeing Company Airplanes
We propose to supersede Airworthiness Directive (AD) 2013-24- 13, which applies to certain The Boeing Company Model 737-100, -200, - 200C, -300, -400, -500, -600, -700, -700C, -800, and -900 series airplanes. AD 2013-24-13 currently requires replacing the pivot link assembly for certain airplanes, replacing the seat track link assemblies or modifying the existing seat track link assembly for certain airplanes, or modifying the existing seat track link assembly fastener for certain airplanes. AD 2013-24-13 also requires inspecting, changing, or repairing the seat track link assembly for certain other airplanes. Since we issued AD 2013-24-13, a paragraph reference was found to be mis-identified. This proposed AD would correct this paragraph reference. We are proposing this AD to prevent seat detachment in an emergency landing, which could cause injury to occupants of the passenger compartment and affect emergency egress.
Changes to the Inland Navigation Rules
The Coast Guard is amending the inland navigation rules and their annexes to align the regulations with amendments made by the International Maritime Organization to the Convention on the International Regulations for Preventing Collisions at Sea, to which the United States is a signatory, and to incorporate recommendations made by the Navigation Safety Advisory Council. These changes harmonize domestic and international law by reducing and alleviating equipment requirements on vessels, addressing technological advancements, such as wing-in-ground craft, and increasing public awareness of the inland navigation rules. These changes also make references to applicable requirements easier to locate by using the same format in domestic regulations as is used in the international convention.
National Emission Standards for Hazardous Air Pollutants: Off-Site Waste and Recovery Operations
The Environmental Protection Agency (EPA) is proposing amendments to the national emission standards for hazardous air pollutants (NESHAP) for off-site waste and recovery operations (OSWRO) to address the results of the residual risk and technology review (RTR) conducted under the Clean Air Act (CAA). In light of our residual risk and technology review, we are proposing to amend the requirements for leak detection and repair and the requirements for certain tanks. In addition, the EPA is proposing amendments to revise regulatory provisions pertaining to emissions during periods of startup, shutdown and malfunction; add requirements for electronic reporting of performance test results; revise the routine maintenance provisions; clarify provisions pertaining to open-ended valves and lines; add monitoring requirements for pressure relief devices; clarify provisions for some performance test methods and procedures; and make several minor clarifications and corrections.
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