July 30, 2014 – Federal Register Recent Federal Regulation Documents

Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A; Guidance for Industry and Food and Drug Administration Staff
Document Number: 2014-17901
Type: Notice
Date: 2014-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.'' This document provides CDRH's interpretation of key provisions of section 517A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which were added by the FDA Safety and Innovation Act (FDASIA), as these provisions pertain to requests for documentation of rationales for significant decisions and requests for supervisory review of regulatory decisions and actions taken by CDRH.
Product Change-Priority Mail Negotiated Service Agreement
Document Number: 2014-17899
Type: Notice
Date: 2014-07-30
Agency: Postal Service, Agencies and Commissions
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-17898
Type: Notice
Date: 2014-07-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Product Change-Priority Mail Negotiated Service Agreement
Document Number: 2014-17897
Type: Notice
Date: 2014-07-30
Agency: Postal Service, Agencies and Commissions
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Negotiated Service Agreement
Document Number: 2014-17896
Type: Notice
Date: 2014-07-30
Agency: Postal Service, Agencies and Commissions
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Negotiated Service Agreement
Document Number: 2014-17895
Type: Notice
Date: 2014-07-30
Agency: Postal Service, Agencies and Commissions
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Product Change-Priority Mail Negotiated Service Agreement
Document Number: 2014-17894
Type: Notice
Date: 2014-07-30
Agency: Postal Service, Agencies and Commissions
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Franklyn Seabrooks, M.D.; Decision and Order
Document Number: 2014-17893
Type: Notice
Date: 2014-07-30
Agency: Drug Enforcement Administration, Department of Justice
Robert V. Cattani, M.D.; Decision and Order
Document Number: 2014-17892
Type: Notice
Date: 2014-07-30
Agency: Drug Enforcement Administration, Department of Justice
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; FDA Safety Communication Readership Survey
Document Number: 2014-17891
Type: Notice
Date: 2014-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``FDA Safety Communication Readership Survey'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).
Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting
Document Number: 2014-17890
Type: Notice
Date: 2014-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
Findings of Research Misconduct
Document Number: 2014-17889
Type: Notice
Date: 2014-07-30
Agency: Department of Health and Human Services
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Zhihua Zou, Ph.D., Harvard Medical School and Fred Hutchinson Cancer Research Center: Based on the reports of investigations conducted by Harvard Medical School (HMS) and Fred Hutchinson Cancer Research Center (FHCRC) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Zhihua Zou, former Postdoctoral Fellow, Department of Neurobiology, HMS, and former Staff Scientist, Division of Basic Sciences, FHCRC, engaged in research misconduct in research supported by National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH), grants R01 DC001622 and R01 DC004842. ORI found that Respondent engaged in research misconduct by falsifying data that were included in two (2) publications:
Proposed Information Collection; Comment Request; Alaska Pacific Halibut Fisheries: Charter Permits
Document Number: 2014-17888
Type: Notice
Date: 2014-07-30
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Department of Commerce, 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.
Proposed Information Collection; Comment Request; Alaska Rockfish Program: Permits and Reports
Document Number: 2014-17887
Type: Notice
Date: 2014-07-30
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Department of Commerce, 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.
Steben Alternative Investment Funds and Steben & Company, Inc.; Notice of Application
Document Number: 2014-17883
Type: Notice
Date: 2014-07-30
Agency: Securities and Exchange Commission, Agencies and Commissions
In the Matter of Entergy Nuclear Operations
Document Number: 2014-17873
Type: Notice
Date: 2014-07-30
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is issuing a confirmatory order to Entergy Nuclear Operations, Inc., confirming agreements reached in an Alternative Dispute Resolution session held on May 15, 2014. As part of the agreement, Entergy will take actions to verify security staff and management training credentials, strengthen its safety culture, present the issue at industry meetings, set standards for security senior management and perform an independent effectiveness review. Entergy is also required to notify the NRC periodically of the status of its efforts.
Comprehensive Review of Licensing and Operating Rules for Satellite Services
Document Number: 2014-17869
Type: Rule
Date: 2014-07-30
Agency: Federal Communications Commission, Agencies and Commissions
The Federal Communications Commission published a document in the Federal Register at 79 FR 8308, February 12, 2014, revising Commission rules. That document inadvertently included a reference to 2 GHz Mobile-Satellite Service in Sec. 25.285(a)(2). This document corrects the final regulation by revising that provision.
Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request
Document Number: 2014-17868
Type: Notice
Date: 2014-07-30
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the following proposal for the collection of information under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The NRC published a Federal Register notice with a 60-day comment period on this information collection on April 29, 2014. 1. Type of submission, new, revision, or extension: Extension. 2. The title of the information collection: Grant and Cooperative Agreement Provisions. 3. Current OMB approval number: 3150-0107. 4. The form number if applicable: Not applicable. 5. How often the collection is required: Technical performance reports are required every 6 months; other information is submitted on occasion, as needed. 6. Who will be required or asked to report: Grant and Cooperative Agreement Recipients. 7. An estimate of the number of annual responses: 668 (450 responses plus 218 recordkeepers). 8. The estimated number of annual respondents: 218. 9. An estimate of the total number of hours needed annually to complete the requirement or request: 5,081 (4,742 reporting hours plus 339 recordkeeping hours). 10. Abstract: The Acquisition Management Division is responsible for awarding grants and cooperative agreements (financial assistance) for the NRC. Acquisition Management Division collects information from assistance recipients in accordance with grant and cooperative agreement provisions in order to administer NRC's financial assistance program. The information collected under the provisions ensures that the Government's rights are protected, the agency adheres to public laws, the work proceeds on schedule, and that disputes between the Government and the recipient are settled. The public may examine and have copied for a fee publicly-available documents, including the final 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 and questions should be directed to the OMB reviewer listed below by August 29, 2014. Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-17867
Type: Notice
Date: 2014-07-30
Agency: Nuclear Regulatory Commission, Agencies and Commissions
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: Generic Communications Program. 2. Current OMB approval number: 3150-XXXX. 3. How often the collection is required: On occasion. 4. Who is required or asked to report: Nuclear power reactor licensees, non-power reactors and materials applicants and licensees. 5. The number of annual respondents: 500. 6. The number of hours needed annually to complete the requirement or request: 156,000. 7. Abstract: The NRC is requesting approval of a generic clearance to collect information concerning possible non-routine generic problems which would require prompt action from NRC to preclude potential threats to public health and safety. Submit, by September 29, 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-2014-0174. 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-2014-0174. Mail comments to the Acting NRC Clearance Officer, Kristen Benney (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, Kristen Benney (T-5 F50), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by telephone at 301-415-6355, or by email to INFOCOLLECTS.Resource@NRC.GOV.
Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request
Document Number: 2014-17866
Type: Notice
Date: 2014-07-30
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the following proposal for the collection of information under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The NRC published a Federal Register notice with a 60-day comment period on this information collection on May 7, 2014. 1. Type of submission, new, revision, or extension: Extension. 2. The title of the information collection: 10 CFR Part 61, Licensing Requirements for Land Disposal of Radioactive Waste. 3. Current OMB approval number: 3150-0135. 4. The form number if applicable: Not applicable. 5. How often the collection is required: Applications for licenses are submitted as needed. Other reports are submitted annually and as other events require. 6. Who will be required or asked to report: Applicants for and holders of an NRC license (to include Agreement State licensees) for land disposal of low-level radioactive waste; and all generators, collectors, and processors of low-level waste intended for disposal at a low-level waste facility. 7. An estimate of the number of annual responses: 16 (12 reporting responses + 4 recordkeepers). 8. The estimated number of annual respondents: 4. 9. An estimate of the total number of hours needed annually to complete the requirement or request: 5,372 hours (56 hours reporting + 5,316 hours recordkeeping). 10. Abstract: Part 61 of Title 10 of the Code of Federal Regulations (10 CFR), establishes the procedures, criteria, and license terms and conditions for the land disposal of low-level radioactive waste. The reporting and recordkeeping requirements are mandatory and, in the case of application submittals, are required to obtain a benefit. The information collected in the applications, reports, and records is evaluated by the NRC to ensure that the licensee's or applicant's disposal facility, equipment, organization, training, experience, procedures, and plans provide an adequate level of protection of public health and safety, common defense and security, and the environment. The public may examine and have copied for a fee publicly-available documents, including the final 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 and questions should be directed to the OMB reviewer listed below by August 29, 2014. Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date. Danielle Y. Jones, Desk Officer, Office of Information and Regulatory Affairs (3150-0135), NEOB-10202, Office of Management and Budget, Washington, DC 20503. Comments can also be emailed to Danielle_Y_Jones@omb.eop.gov or submitted by telephone at 202-395-1741. The Acting NRC Clearance Officer is Kristen Benney, telephone: 301- 415-6355.
Pipeline Safety: Request for Revision of a Previously Approved Information Collection-National Pipeline Mapping System Program (OMB Control No. 2137-0596).
Document Number: 2014-17865
Type: Notice
Date: 2014-07-30
Agency: Pipeline and Hazardous Materials Safety Administration, Department of Transportation
In accordance with the Paperwork Reduction Act of 1995, PHMSA invites public comments on our intent to request the Office of Management and Budget's approval to revise and renew an information collection currently under OMB Control Number 2137-0596 titled: ``National Pipeline Mapping System Program.'' The collection currently requires operators to submit geospatial data, attributes, metadata, public contact information and a transmittal letter to the National Pipeline Mapping System (NPMS) program. The proposed revisions will require operators to submit additional information to the NPMS.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Nondiscrimination Compliance Information Reporting Under the Workforce Investment Act of 1998
Document Number: 2014-17862
Type: Notice
Date: 2014-07-30
Agency: Department of Labor, Office of the Secretary
On July 31, 2014, the Department of Labor (DOL) will submit the Office of the Assistant Secretary for Administration and Management (OASAM) sponsored information collection request (ICR) revision titled, ``Nondiscrimination Compliance Information Reporting Under the Workforce Investment Act of 1998,'' 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.). Public comments on the ICR are invited.
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2014-17861
Type: Notice
Date: 2014-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Meeting
Document Number: 2014-17860
Type: Notice
Date: 2014-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2014-17859
Type: Notice
Date: 2014-07-30
Agency: Department of Health and Human Services
Regulatory Capital Rules: Advanced Approaches Risk-Based Capital Rule, Revisions to the Definition of Eligible Guarantee
Document Number: 2014-17858
Type: Rule
Date: 2014-07-30
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions, Federal Reserve System, Department of Treasury, Office of the Comptroller of the Currency
The Office of the Comptroller of the Currency (OCC), the Board of Governors of the Federal Reserve System (Board), and the Federal Deposit Insurance Corporation (FDIC) (collectively, the agencies) are adopting a final rule that revises the definition of eligible guarantee in the agencies' advanced approaches risk-based capital rule, adopted in the agencies' July 2013 regulatory capital rule (2013 capital rule). The final rule removes the requirement that an eligible guarantee be made by an eligible guarantor for purposes of calculating the risk- weighted assets of an exposure (other than a securitization exposure) under the advanced approaches risk-based capital rule as incorporated into the 2013 capital rule (advanced approaches). The change to the definition of eligible guarantee applies to all banks, savings associations, bank holding companies, and savings and loan holding companies that are subject to the advanced approaches.
New Postal Product
Document Number: 2014-17857
Type: Notice
Date: 2014-07-30
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission is noticing a recent Postal Service filing concerning an addition of Priority Mail Contract 88 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
New Postal Product
Document Number: 2014-17855
Type: Notice
Date: 2014-07-30
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission is noticing a recent Postal Service filing concerning an addition of Priority Mail Contract 86 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
New Postal Product
Document Number: 2014-17853
Type: Notice
Date: 2014-07-30
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission is noticing a recent Postal Service filing concerning an addition of Priority Mail Contract 87 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
New Postal Product
Document Number: 2014-17850
Type: Notice
Date: 2014-07-30
Agency: Postal Regulatory Commission, Agencies and Commissions
The Commission is noticing a recent Postal Service filing concerning an addition of Priority Mail Contract 85 to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Agency Information Collection Activities; Comment Request; DC School Choice Incentive Program
Document Number: 2014-17848
Type: Notice
Date: 2014-07-30
Agency: Department of Education
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing an extension of an existing information collection.
Importation of Fresh Blueberries From Morocco Into the Continental United States
Document Number: 2014-17843
Type: Rule
Date: 2014-07-30
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are amending the regulations concerning the importation of fruits and vegetables to allow the importation of fresh blueberries from Morocco into the continental United States. As a condition of entry, the blueberries must be produced under a systems approach employing a combination of mitigation measures for two quarantine pests, Ceratitis capitata and Monilinia fructigena, and must be inspected prior to exportation from Morocco and found free of these pests. The blueberries may be imported in commercial consignments only and must be treated with one of two approved postharvest treatments to mitigate C. capitata. The blueberries will have to be accompanied by a phytosanitary certificate with an additional declaration stating that the conditions for importation have been met. This action will allow the importation of blueberries from Morocco while continuing to protect against the introduction of plant pests into the United States.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2014-17840
Type: Notice
Date: 2014-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Meeting
Document Number: 2014-17839
Type: Notice
Date: 2014-07-30
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2014-17838
Type: Notice
Date: 2014-07-30
Agency: Department of Health and Human Services, National Institutes of Health
Classified National Security Information
Document Number: 2014-17836
Type: Rule
Date: 2014-07-30
Agency: Federal Emergency Management Agency, Department of Homeland Security, Office of the Secretary
The Department of Homeland Security (DHS) is revising its procedures for managing classified national security information. DHS is updating its regulations to incorporate new and revised procedures pursuant to Executive Order 13526, ``Classified National Security Information.'' Further, DHS is delegating to the Chief Security Officer of DHS the responsibility of serving as the ``Senior Agency Official'' pursuant to Executive Order 13526. The Chief Security Officer acted in this capacity under the predecessor Executive Order as well. Finally, DHS is also removing outdated regulations dealing with classified national security information at 44 CFR part 8.
Combined Notice of Filings #1
Document Number: 2014-17830
Type: Notice
Date: 2014-07-30
Agency: Department of Energy, Federal Energy Regulatory Commission
Sam D. Hamilton Noxubee National Wildlife Refuge, Mississippi; Draft Comprehensive Conservation Plan and Environmental Assessment
Document Number: 2014-17788
Type: Notice
Date: 2014-07-30
Agency: Fish and Wildlife Service, Department of the Interior
We, the Fish and Wildlife Service (Service), announce the availability of a draft comprehensive conservation plan and environmental assessment (Draft CCP/EA) for Sam D. Hamilton Noxubee National Wildlife Refuge in Oktibbeha, Winston, and Noxubee Counties, Mississippi, for public review and comment. In this Draft CCP/EA, we describe the alternative we propose to use to manage this refuge for the 15 years following approval of the final CCP.
Lifesaving Equipment: Production Testing and Harmonization With International Standards
Document Number: 2014-17653
Type: Rule
Date: 2014-07-30
Agency: Coast Guard, Department of Homeland Security
This rule finalizes the amendments to Coast Guard regulations for certain lifesaving equipment, including launching appliances (winches and davits), release mechanisms, survival craft (lifeboats, inflatable liferafts, and inflatable buoyant apparatus), rescue boats, and automatic disengaging devices, which were published as an interim rule and amended by a second interim rule. Additionally, it finalizes the amendments to the requirements for Coast Guard-approved release mechanisms proposed in a supplementary notice of proposed rulemaking (SNPRM). This final rule harmonizes the Coast Guard's design, construction, and performance standards for this lifesaving equipment with international standards, while providing for the use of qualified independent laboratories, instead of Coast Guard inspectors, during the approval process and for production inspections of certain types of lifesaving equipment.
Revision of Delegations of Authority
Document Number: 2014-17352
Type: Rule
Date: 2014-07-30
Agency: Department of Agriculture, Rural Utilities Service, Office of the Secretary
This document revises the delegations of authority from the Secretary of Agriculture and general officers of the Department of Agriculture (USDA) to reflect changes and additions to the delegations required by the Agricultural Act of 2014, Public Law 113-79. Other additions, deletions, and changes are made as summarized below.
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