September 21, 2016 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 116
Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System
The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument 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 magnetic surgical instrument system's 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.
Reporting of Computational Modeling Studies in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Reporting of Computational Modeling Studies in Medical Device Submissions.'' The purpose of this guidance document is to provide recommendations to industry on the formatting, organization, and content of reports of computational modeling and simulation (CM&S) studies that are used as valid scientific evidence to support medical device submissions, and to assist FDA staff in the review of computational modeling and simulation studies by improving the consistency and predictability of the review of CM&S and facilitating full interpretation and complete review of those studies.
Rio Grande National Forest; Colorado; Revision of the Land Management Plan for the Rio Grande National Forest; Correction
The USDA Forest Service published a notice of intent to prepare an environmental impact statement in the Federal Register of September 12, 2016. The document contains confusing language regarding establishing standing for participation in the agency's admininstrative review process.
Fiscal Year 2017 Draft Work Plan
The Denali Commission (Commission) is an independent federal agency based on an innovative federal-state partnership designed to provide critical utilities, infrastructure and support for economic development and training in Alaska by delivering federal services in the most cost-effective manner possible. The Commission was created in 1998 with passage of the October 21, 1998 Denali Commission Act (Act) (Title III of Pub. L. 105-277, 42 U.S.C. 3121). The Act requires that the Commission develop proposed work plans for future spending and that the annual Work Plan be published in the Federal Register, providing an opportunity for a 30-day period of public review and written comment. This Federal Register notice serves to announce the 30-day opportunity for public comment on the Denali Commission Draft Work Plan for Federal Fiscal Year 2017 (FY 2017).
Notice of Public Meeting, North Slope Science Initiative-Science Technical Advisory Panel
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act, the U.S. Department of the Interior, North Slope Science Initiative (NSSI)Science Technical Advisory Panel (STAP) will meet as indicated below.
Environmental Impact Statement: Suffolk County, New York
The FHWA is issuing this notice to advise the public that the Record of Decision (ROD) and the Final Environmental Impact Statement (FEIS) for the proposed Interstate 495 (Long Island Expressway) Rest Area Upgrade Project between Exits 51 & 52 (eastbound) in the Town of Huntington, Suffolk County, New York (NYSDOT Project Identification Number: 0229.14) are being rescinded.
Submission for OMB Review; Comment Request-Follow-Up Activities for Product-Related Injuries
Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Consumer Product Safety Commission (Commission or CPSC) announces that it has submitted to the Office of Management and Budget (OMB) a request for extension of approval of a collection of information from persons who have been involved in or have witnessed incidents associated with consumer products.
Proposed Collection; Comment Request
In compliance with the Paperwork Reduction Act of 1995, the United States Military Entrance Processing Command (USMEPCOM), 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: 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; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and 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.
Fisheries of the Exclusive Economic Zone Off Alaska; Exchange of Flatfish in the Bering Sea and Aleutian Islands Management Area
NMFS is exchanging unused flathead sole and rock sole Community Development Quota (CDQ) for yellowfin sole CDQ acceptable biological catch (ABC) reserves in the Bering Sea and Aleutian Islands management area. This action is necessary to allow the 2016 total allowable catch of yellowfin sole in the Bering Sea and Aleutian Islands management area to be harvested.
Charter Amendment of Department of Defense Federal Advisory Committees
The Department of Defense (DoD) is publishing this notice to announce it is amending the charter for the Air University Board of Visitors.
36(b)(1) Arms Sales Notification
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Food and Drug Administration's Application of Statutory Factors in Determining When a Risk Evaluation and Mitigation Strategy Is Necessary; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``FDA's Application of Statutory Factors in Determining When a REMS Is Necessary.'' This draft guidance is intended to clarify how FDA applies the factors set forth in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) in determining whether a risk evaluation and mitigation strategy (REMS) is necessary to ensure that the benefits of a drug outweigh its risks. This guidance is one of several being developed to fulfill performance goals that FDA agreed to satisfy in the context of the fifth reauthorization of the prescription drug user fee program (the Prescription Drug User Fee Act V).
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Labor Standards for Federal Service Contracts
The Department of Labor (DOL) is submitting the Wage and Hour Division (WHD) sponsored information collection request (ICR) titled, ``Labor Standards for Federal Service Contracts,'' to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq. Public comments on the ICR are invited.
Filing Dates for the Kentucky Special Election in the 1st Congressional District
Kentucky has scheduled a special general election on November 8, 2016, to fill the U.S. House of Representatives seat in the 1st Congressional District vacated by Representative Ed Whitfield. Committees required to file reports in connection with the Special General Election on November 8, 2016, shall file a 12-day Pre-General Report, and a 30-day Post-General Report.
Deposit of Biological Materials
The United States Patent and Trademark Office (USPTO), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the renewal of a continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
Submission for OMB Review; Comment Request, Pro Bono Survey; Correction
The United States Patent and Trademark Office published a document in the Federal Register on August 22, 2016, concerning requests for comments on a Pro Bono Survey. The Pro Bono Survey is used by the Pro Bono Advisory Council (PBAC) and the USPTO to provide information to the USPTO regarding the current status and effectiveness of each region's pro bono hub. The document contained an incorrect cost burden based on the estimate of the hourly burden rate. The hourly rate estimate should use the Bureau of Labor Statistics hourly wage for lawyers instead of the American Intellectual Property Law Association hourly wage for intellectual property lawyers.
Product Change-First-Class Package Service Negotiated Service Agreement
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-First-Class Package Service Negotiated Service Agreement
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
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-Parcel Select Negotiated Service Agreement
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.
Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Alaska
This notice announces EPA's approval of the State of Alaska's request to revise/modify its EPA Administered Permit Programs: The National Pollutant Discharge Elimination System EPA-authorized program to allow electronic reporting.
Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Oregon
This notice announces EPA's approval of the State of Oregon's request to revise/modify certain of its EPA-authorized programs to allow electronic reporting.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Gasoline Distribution Facilities (Renewal)
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), ``NESHAP for Gasoline Distribution Facilities (40 CFR part 63, subpart R) (Renewal)'' (EPA ICR No. 1659.09, OMB Control No. 2060-0325), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through September 30, 2016. Public comments were requested previously via the Federal Register (80 FR 32116) on June 5, 2015 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Review and Approval of Projects
This document contains proposed rules that would amend the regulations of the Susquehanna River Basin Commission (Commission) to clarify application requirements and standards for review of projects, amend the rules dealing with the mitigation of consumptive uses, add a subpart to provide for registration of grandfathered projects, and revise requirements dealing with hearings and enforcement actions. These rules are designed to enhance the Commission's existing authorities to manage the water resources of the basin and add regulatory clarity.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Automobile and Light-Duty Truck Surface Coating (Renewal)
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), ``NESHAP for Automobile and Light-duty Truck Surface Coating (40 CFR part 63, subpart IIII) (Renewal)'' (EPA ICR No. 2045.06, OMB Control No. 2060-0550), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through September 30, 2016. Public comments were previously-requested via the Federal Register (80 FR 32116) on June 5, 2015 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NESHAP for Stationary Combustion Turbines (Renewal)
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), ``NESHAP for Stationary Combustion Turbines (40 CFR part 63, subpart YYYY) (Renewal)'' (EPA ICR No. 1967.06, OMB Control No. 2060-0540), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through September 30, 2016. Public comments were previously requested via the Federal Register (80 FR 32116) on June 5, 2015, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Registration of Fuels and Fuel Additives-Health-Effects Research Requirements for Manufacturers (Renewal)
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), ``Registration of Fuels and Fuel AdditivesHealth-Effects Research Requirements for Manufacturers (Renewal)'' (EPA ICR No. 1696.09, OMB Control No. 2060-0297) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through September 30, 2016. Public comments were previously requested via the Federal Register (81 FR 22080) on April 14, 2016 during a 60- day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An Agency may not conduct or sponsor and a person is not required to respond to a collection for information unless it displays a currently valid OMB control number.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; National Oil and Hazardous Substances Pollution Contingency Plan Regulation (Renewal)
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), ``National Oil and Hazardous Substances Pollution Contingency Plan Regulation, subpart J (40 CFR 300.900) (Renewal)'' (EPA ICR No. 1664.11, OMB Control No. 2050-0141) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through September 30, 2016. Public comments were previously requested via the Federal Register (81 FR 16174) on March 25, 2016 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Armenpharm, Ltd.; Suspension of Approval of an Abbreviated New Drug Application for Chloramphenicol Capsules, 250 Milligrams; Determination That CHLOROMYCETIN (Chloramphenicol) Capsules, 50 Milligrams and 100 Milligrams, and Three Other Products Were Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) is suspending approval of abbreviated new drug application (ANDA) 060851 for chloramphenicol capsules, 250 milligrams (mg), held by Armenpharm, Ltd. (Armenpharm), 49 South Ridge Rd., P.O. Box D1400, Pomona, NY 10970. FDA has also determined that CHLOROMYCETIN (chloramphenicol) Capsules, 50 mg and 100 mg; AMPHICOL (chloramphenicol) Capsules, 100 mg; and CHLOROMYCETIN PALMITATE (chloramphenicol palmitate) Oral Suspension, 150 mg/5 milliliters (mL), were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve ANDAs for chloramphenicol capsules, 50 mg and 100 mg, or chloramphenicol palmitate oral suspension, 150 mg/5 mL.
36(b)(1) Arms Sales Notification
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Advisory Committee on Supply Chain Competitiveness: Notice of Public Meetings
This notice sets forth the schedule and proposed topics of discussion for public meetings of the Advisory Committee on Supply Chain Competitiveness (Committee).
Indian Gaming; Approval of a Tribal-State Class III Gaming Compact in the State of South Dakota
The Flandreau Santee Sioux Tribe of South Dakota and State of South Dakota entered into a compact replacing and superseding an existing Tribal-State compact governing Class III gaming; this notice announces approval of the compact.
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