May 2014 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 2,689
Independent Assessment of the Process for the Review of Device Submissions; Final Comprehensive Findings and Recommendations and First Implementation Plan
The Food and Drug Administration (FDA) is announcing Booz Allen Hamilton's final comprehensive findings and recommendations submitted as part of their independent assessment of the process for the review of medical device submissions. The assessment is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years (FYs) 2013-2017. The assessment is described in section V, Independent Assessment of Review Process Management, of the commitment letter entitled ``MDUFA Performance Goals and Procedures'' (MDUFA III Commitment Letter). The assessment is being conducted in two phases. The final comprehensive findings and recommendations are the last of a series of deliverables, as outlined in the contract statement of work, to be published as part of Phase 1 of the assessment.
Agency Information Collection Activities; Comment Request; Annual Progress Reporting Form for the American Indian Vocational Rehabilitation Services (AIVRS) Program
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Impact Aid Discretionary Construction Grant Program (1894-0001)
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing a revision of an existing information collection.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Protection and Advocacy of Individual Rights (PAIR)
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.
Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries
NMFS is adjusting the Atlantic bluefin tuna (BFT) General category daily retention limit from the default limit of one large medium or giant BFT to four large medium or giant BFT for June 1 through August 31, 2014. This action is based on consideration of the regulatory determination criteria regarding inseason adjustments, and applies to Atlantic tunas General category (commercial) permitted vessels and Highly Migratory Species (HMS) Charter/Headboat category permitted vessels when fishing commercially for BFT.
Proposed Collection; Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Department of the Air Force, Director of Bases, Ranges, and Airspace, Directorate of Operations, Deputy Chief of Staff, Operations, Plans and Requirements, announces a proposed reinstatement of a public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Proposed Collection; Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense (Personnel and Readiness) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Proposed Collection; Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense (Personnel and Readiness) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Proposed Collection; Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense (Personnel and Readiness) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the propsed collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Proposed Collection; Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense (Personnel and Readiness) (Military Personnel Policy), announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Proposed Collection; Comment Request
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Navy Recruiting Command announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Drawbridge Operation Regulation; Berwick Bay-Atchafalaya River, Morgan City, LA
The Commander, Eighth Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the Morgan City Railroad Bridge across Berwick BayAtchafalaya River, mile 17.5 and the Gulf Intracoastal Waterway (Morgan City-Port Allen Alternate Route, mile 0.3) in Morgan City, St. Mary's Parish, Louisiana. This deviation provides for the bridge to remain closed to navigation for four consecutive hours with an opening to pass vessels in the middle for the purpose of conducting scheduled maintenance to the drawbridge.
Drawbridge Operation Regulation; Willamette River, Portland, OR
The Coast Guard has issued a temporary deviation from the operating schedule that governs the upper deck of the Steel Bridge across the Willamette River, mile 12.1, at Portland, OR. This deviation is necessary to accommodate the safe and efficient movement of light rail and roadway traffic associated with the Starlight Parade in Portland, Oregon. This deviation allows the upper deck of the Steel Bridge to remain in the closed position to facilitate efficient movement of event patrons.
Safety Zone, Atlantic Ocean; Virginia Beach, VA
The Coast Guard is establishing a temporary safety zone on the navigable waters of the Atlantic Ocean in Virginia Beach, VA. This safety zone will restrict vessel movement in the specified area during the Patriotic Festival III. This action is necessary to provide for the safety of life and property on the surrounding navigable waters during the air show.
Safety Zones; Marine Events in Captain of the Port Long Island Zone
The Coast Guard proposes to establish four temporary safety zones for three fireworks events and one swim event within the Captain of the Port Long Island Sound Zone. This action is necessary to provide for the safety of life on navigable waters during these events. The safety zones will facilitate public notification of these events and provide protective measures for the maritime public and event participants from the hazards associated with these events. Entering into, transiting through, remaining, anchoring or mooring within these regulated areas would be prohibited unless authorized by the Captain of the Port Sector Long Island Sound.
Drawbridge Operation Regulation; Willamette River, Portland, OR
The Coast Guard has issued a temporary deviation from the operating schedule that governs the upper deck of the Steel Bridge across the Willamette River, mile 12.1, at Portland, OR. This deviation is necessary to accommodate the safe and efficient movement of light rail and roadway traffic associated with the Rose Parade in Portland, Oregon. This deviation allows the upper deck of the Steel Bridge to remain in the closed position to facilitate efficient movement of event patrons.
Safety Zone, Fifth Coast Guard District Fireworks Display Cape Fear River; Wilmington, NC
The Coast Guard is temporarily changing the enforcement location of a safety zone for one specific recurring fireworks display in the Fifth Coast Guard District. This regulation applies to only one recurring fireworks event, held adjacent to the Cape Fear River, Wilmington, North Carolina. The fireworks display formerly originated from a location on land but this year will originate from a barge. The safety zone is necessary to provide for the safety of life on navigable waters during the event. This action is intended to restrict vessel traffic in a portion of the Cape Fear River, Wilmington, North Carolina, during the event.
Drawbridge Operation Regulation; Bush River, Perryman, MD
The Coast Guard is modifying the operating schedule that governs the Amtrak Bridge, at mile 6.8 over Bush River, at Perryman, MD. The rule updates the language of the regulation to reflect the intent of the original schedule and change the interim rule as final.
Drawbridge Operation Regulation; Raccoon Creek, Bridgeport, NJ
The Coast Guard is reopening the comment period to solicit additional comments concerning its notice of proposed rulemaking to change the regulation governing the U.S. Route 130 lift bridge across Raccoon Creek at mile 1.8 at Bridgeport, New Jersey. This notice corrects a misstatement in the notice of proposed rulemaking regarding the bridge data and responds to the initial comments received.
Proposed Information Collection; Comment Request; Annual Wholesale Trade Survey
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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
Meeting of the Chronic Fatigue Syndrome Advisory Committee
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.
Submission for OMB Review; 30-Day Comment Request: Generic Clearance to Support the Safe to Sleep Campaign at the Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on December 30, 2013, pages 79472-79473 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Child Health and Human Development, National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Order Limiting Scheduled Operations at John F. Kennedy International Airport
This action grants with conditions a limited waiver of the slot usage requirement for operating authorizations (slots) at John F. Kennedy International Airport (JFK) due to construction at the airport during the winter 2014/2015 and summer 2015 scheduling seasons. This waiver applies only to JFK slots for the period from March 1, 2015, through October 24, 2015.
Proposed Rules on Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Public Meeting
The Food and Drug Administration (FDA or we) is announcing a public meeting to discuss two proposed rules aimed at updating nutrition information and serving size requirements on the nutrition facts labels to provide consumers with information that could be used to maintain healthy dietary practices. The purpose of the public meeting is to inform the public of the provisions of the proposed rules and the rulemaking process (including how to submit comments, data, and other information to both dockets) as well as solicit oral stakeholder and public comments on the proposed rules and to respond to questions about the proposed rules.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Agency Information Collection; Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Generic Clearance for Questionnaire and Data Collection Testing, Evaluation, and Research for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.
Identity Theft Red Flags (Regulation V)
The Board of Governors of the Federal Reserve System is amending its rule on identity theft ``red flags'' (``Red Flags rule''), which implements section 615(e) of the Fair Credit Reporting Act (FCRA). The Red Flag Program Clarification Act of 2010 (the Clarification Act) added a definition of ``creditor'' in FCRA section 615(e) that is specific to section 615(e). Accordingly, the final rule amends the definition of ``creditor'' in the Red Flags rule to reflect the definition of that term as added by the Clarification Act. The final rule also updates a cross-reference in the Red Flags rule to reflect a statutory change in rulemaking authority.
Privacy of Consumer Information (Regulation P)
The Board of Governors of the Federal Reserve System (Board) is repealing its Regulation P, 12 CFR part 216, which was issued to implement the privacy provisions of the Gramm-Leach-Bliley Act (GLB Act). Title X of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) transferred rulemaking authority for a number of consumer financial protection laws from the Board, and six other Federal agencies, to the Bureau of Consumer Financial Protection (Bureau), including rulemaking authority for the provisions in Subtitle A of Title V of the GLB Act that were implemented in the Board's Regulation P. In December 2011, the Bureau published an interim final rule establishing its own Regulation P to implement these provisions of the GLB Act. The Bureau's Regulation P covers those entities previously subject to the Board's Regulation P. Accordingly, the Board is repealing its Regulation P.
Truth in Savings (Regulation DD)
The Board of Governors of the Federal Reserve System (Board) is repealing its Regulation DD, 12 CFR part 230, which was issued to implement the Truth in Saving Act (TISA). Title X of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) transferred rulemaking authority for a number of consumer financial protection laws, including TISA, from the Board to the Bureau of Consumer Financial Protection (Bureau). In December 2011, the Bureau published an interim final rule establishing its own Regulation DD to implement TISA (Bureau Interim Final Rule). The Bureau Interim Final Rule substantially duplicates the Board's Regulation DD. Under section 1029 of the Dodd-Frank Act, the Board retains authority to issue rules for certain motor vehicle dealers that offer consumer financial services and are not subject to the Bureau's regulatory authority. The Board is not aware of any entities that are motor vehicle dealers engaging in activities subject to TISA that would be subject to the Board's rulemaking authority under section 1029 of the Dodd-Frank Act. Accordingly, the Board is repealing its Regulation DD.
Facilitating the Provision of Spectrum-Based Services to Rural Areas and Promoting Opportunities for Rural Telephone Companies To Provide Spectrum-Based Services
In this document, the Commission announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection requirements associated with Facilitating the Provision of Spectrum-Based Services to Rural Areas and Promoting Opportunities for Rural Telephone Companies To Provide Spectrum-Based Services, FCC 04-166. With this document the Commission is announcing OMB approval and the effective date of the revised requirements.
Agency Information Collection Activities; Proposed eCollection eComments Requested; New Collection: Salt Lake City Police Department HOST Project Stakeholder Survey
The Department of Justice (DOJ), Office of Community Oriented Policing Services (COPS), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the Federal Register Volume 79, Number 57, page 16376, on March 25, 2014, allowing for a 60 day comment period.
Determination That SODIUM PERTECHNETATE TC-99M (Technetium Tc-99m Sodium Pertechnetate) Injection, Oral, 2 to 100 Millicuries per Milliliter and 10 to 60 Millicuries per Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that SODIUM PERTECHNETATE TC-99M (technetium Tc-99m sodium pertechnetate) Injection, Oral, 2 to 100 millicuries per milliliter (mCi/mL) and 10 to 60 mCi/mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for technetium Tc-99m sodium pertechnetate, injection, oral, 2 to 100 mCi/mL and 10 to 60 mCi/mL, if all other legal and regulatory requirements are met.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZACTRAN
The Food and Drug Administration (FDA) has determined the regulatory review period for ZACTRAN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; XARELTO
The Food and Drug Administration (FDA) has determined the regulatory review period for XARELTO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Best Practices in Developing Proprietary Names for Drugs.'' The draft guidance focuses on the safety aspects in the development and selection of proposed proprietary names for all prescription and nonprescription human drug products and biological products. The draft guidance describes naming design practices to help avoid medication errors and provides a qualitative systematic framework for evaluating proprietary names before submitting them for FDA review. FDA is issuing this draft guidance to help drug and biologic product sponsors develop proprietary names that do not cause or contribute to medication errors or otherwise contribute to the misbranding of the drug.
Federal Acknowledgment of American Indian Tribes
This proposed rule would revise regulations governing the process and criteria by which the Secretary acknowledges an Indian tribe. The revisions seek to make the process and criteria more transparent, promote consistent implementation, and increase timeliness and efficiency, while maintaining the integrity of the process. The current process has been criticized as ``broken'' or in need of reform. Specifically, the process has been criticized as too slow (a petition can take decades to be decided), expensive, burdensome, inefficient, intrusive, less than transparent and unpredictable. The proposed rule would reform the process by, among other things, institutionalizing a phased review that allows for faster decisions; reducing the documentary burden; allowing for a hearing on the proposed finding to promote transparency and process integrity; establishing the Assistant Secretary's final determination as final for the Department to promote efficiency; and establishing objective standards, where appropriate, to ensure transparency and predictability. This publication also announces the dates and locations for tribal consultation sessions and public meetings on this proposed rule.
Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Decommissioning of Stage II Vapor Recovery Systems
The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the State of New Hampshire Department of Environmental Services. This revision includes regulatory amendments that require the decommissioning of Stage II vapor recovery systems at gasoline dispensing facilities by December 22, 2015, and a demonstration that such removal is consistent with the Clean Air Act and EPA guidance. The intended effect of this action is to approve New Hampshire's revised vapor recovery regulation. This action is being taken in accordance with the Clean Air Act.
Medical Devices; Gastroenterology-Urology Devices; Classification of Pancreatic Drainage Stent and Delivery System
The Food and Drug Administration (FDA) is classifying the pancreatic drainage stent and delivery system into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the pancreatic drainage stent and delivery system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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