2017 – Federal Register Recent Federal Regulation Documents

Results 51 - 100 of 27,453
Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability
Document Number: 2017-28140
Type: Notice
Date: 2017-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological products (hereafter referred to as products). The previous guidance for industry ``Formal Meetings Between the FDA and Sponsors or Applicants'' published May 19, 2009, and the draft guidance for industry ``Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products'' published March 11, 2015, have been withdrawn.
Best Practices for Communication Between Investigational New Drug Application Sponsors and the Food and Drug Administration; Guidance for Industry and Review Staff; Availability
Document Number: 2017-28139
Type: Notice
Date: 2017-12-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry and review staff entitled ``Best Practices for Communication Between IND Sponsors and FDA During Drug Development.'' Timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development facilitate earlier availability of safe and effective drugs to the American public. This guidance describes FDA's philosophy regarding timely interactive communication with IND sponsors as a core activity; describes the scope of appropriate interactions between FDA review teams and IND sponsors; outlines the types of advice appropriate for sponsors to seek from FDA in pursuing their drug development programs; describes the general expectations for the timing of FDA responses to IND sponsor inquiries; describes best practices and communication methods to facilitate interactions between FDA review teams and IND sponsors during drug development; and includes expectations on appropriate methods and frequency of such communications. This guidance does not apply to communications or inquiries from industry trade organizations, consumer or patient advocacy organizations, other government agencies, or other stakeholders not pursuing a development program under an IND. This guidance finalizes the draft guidance issued on December 9, 2015.
Agency Information Collection Activities: Proposed Collection Renewals; Comment Request
Document Number: 2017-28138
Type: Notice
Date: 2017-12-29
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
The FDIC, 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 the renewal of the existing information collections, as required by the Paperwork Reduction Act of 1995 (PRA). Currently, the FDIC is soliciting comment on renewal of the information collections described below.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-28137
Type: Notice
Date: 2017-12-29
Agency: National Archives and Records Administration, Agencies and Commissions
We are proposing a new generic information collection request (generic ICR) entitled Generic Clearance for NARA Public and Education Program Registration. This notice announces that we plan to submit this generic ICR plan to OMB for approval under the Paperwork Reduction Act and solicits comments on specific aspects of the collection plan. We will use this to collect information from individuals registering for an education or other program at NARA.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-28136
Type: Notice
Date: 2017-12-29
Agency: National Archives and Records Administration, Agencies and Commissions
NARA proposes to request an extension from the Office of Management and Budget (OMB) of a currently approved information collection used when veterans or other authorized individuals request information from or copies of documents in military service records. We invite you to comment on this proposed information collection.
Certain Access Control Systems and Components Thereof Notice of Commission Determination To Review in Part a Final Initial Determination; Schedule for Filing Written Submissions; Extension of Target Date
Document Number: 2017-28135
Type: Notice
Date: 2017-12-29
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has determined to review in part the final initial determination (``ID'') issued by the presiding administrative law judge (``ALJ'') on October 23, 2017, finding a violation of section 337 of the Tariff Act of 1930, as amended, as to claims 1-4, 7-12, 15, and 16 of U.S. Patent No. 7,161,319 (``the '319 patent'') and no violation of section 337 as to claim 34 of U.S. Patent No. 7,339,336 (``the '336 patent''). The Commission has also determined to extend the target date to March 2, 2018.
Amendment of the Land Management Plan for Santa Fe National Forest
Document Number: 2017-28134
Type: Notice
Date: 2017-12-29
Agency: Department of Agriculture, Forest Service
The Santa Fe National Forest, located in New Mexico, prepared a significant, programmatic forest plan amendment to allow geothermal leasing to accompany its Final Environmental Impact Statement (FEIS) and a Draft Record of Decision (ROD) for Geothermal Leasing. This notice is to inform the public that a 60-day period is being initiated where individuals or entities with specific concerns on the Santa Fe's Forest Plan Amendment for Geothermal Leasing may file an objection for a Forest Service review prior to the approval of the Record of Decision for Geothermal Leasing.
Underground Injection Control Program; Hazardous Waste Injection Restrictions; Petition for Exemption Reissuance-Class I Hazardous Waste Injection; TM Deer Park Services (TMDPS) Limited Partnership, Deer Park, Texas
Document Number: 2017-28133
Type: Notice
Date: 2017-12-29
Agency: Environmental Protection Agency
Notice is hereby given that a reissuance of an exemption to the Land Disposal Restrictions, under the 1984 Hazardous and Solid Waste Amendments to the Resource Conservation and Recovery Act, has been granted to TMDPS for two Class I hazardous waste injection wells located at their Deer Park, Texas facility. The company has adequately demonstrated to the satisfaction of the EPA by the petition reissuance application and supporting documentation that, to a reasonable degree of certainty, there will be no migration of hazardous constituents from the injection zone for as long as the waste remains hazardous. This final decision allows the underground injection by TMDPS of the specific restricted hazardous wastes identified in this exemption reissuance, into Class I hazardous waste injection wells WDW-169 and WDW-249 until December 31, 2030, unless the EPA moves to terminate this exemption or other petition condition limitations are reached. Additional conditions included in this final decision may be reviewed by contacting the EPA Region 6 Ground Water/UIC Section. A public notice was issued October 11, 2017, and the public comment period closed on November 27, 2017, and no comments were received. This decision constitutes final Agency action and there is no Administrative appeal. This decision may be reviewed/appealed in compliance with the Administrative Procedure Act.
Qualifications of Drivers; Applications for Exemptions; Hearing
Document Number: 2017-28128
Type: Notice
Date: 2017-12-29
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
The FMCSA announces its response to public comments regarding the granting of exemptions from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs). Since February 2013, FMCSA has granted a number of exemptions and published numerous Federal Register notices requesting public comment on additional exemption applications. This notice responds to the substantive comments we received and announces our intention to continue granting additional exemptions.
Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillators
Document Number: 2017-28127
Type: Notice
Date: 2017-12-29
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces receipt of applications from six individuals for an exemption from the prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against operation of a commercial motor vehicle (CMV) by persons with a current clinical diagnosis of myocardial infarction, angina pectoris, coronary insufficiency, thrombosis, or any other cardiovascular disease of a variety known to be accompanied by syncope, dyspnea, collapse, or congestive heart failure. If granted, the exemptions would enable these individuals with implantable cardioverter defibrillators (ICDs) to operate CMVs in interstate commerce.
Adoption of Recommendations
Document Number: 2017-28124
Type: Notice
Date: 2017-12-29
Agency: Administrative Conference of the United States
The Administrative Conference of the United States adopted five recommendations at its Sixty-Eighth Plenary Session. The appended recommendations address Plain Language in Regulatory Drafting; Marketable Permits; Agency Guidance Through Policy Statements; Learning from Regulatory Experience; and Regulatory Waivers and Exemptions.
Information Collection Request; Submission for OMB Review
Document Number: 2017-28120
Type: Notice
Date: 2017-12-29
Agency: Peace Corps, Agencies and Commissions
The Peace Corps will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval. The purpose of this notice is to allow 30 days for public comment in the Federal Register preceding submission to OMB. We are conducting this process in accordance with the Paperwork Reduction Act of 1995.
Information Collection Request; Submission for OMB Review
Document Number: 2017-28119
Type: Notice
Date: 2017-12-29
Agency: Peace Corps, Agencies and Commissions
The Peace Corps will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval. The purpose of this notice is to allow 30 days for public comment in the Federal Register preceding submission to OMB. We are conducting this process in accordance with the Paperwork Reduction Act of 1995.
Information Collection Request; Submission for OMB Review
Document Number: 2017-28118
Type: Notice
Date: 2017-12-29
Agency: Peace Corps, Agencies and Commissions
The Peace Corps will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval. The purpose of this notice is to allow 30 days for public comment in the Federal Register preceding submission to OMB. We are conducting this process in accordance with the Paperwork Reduction Act of 1995.
Information Collection Request; Submission for OMB Review
Document Number: 2017-28117
Type: Notice
Date: 2017-12-29
Agency: Peace Corps, Agencies and Commissions
The Peace Corps will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval. The purpose of this notice is to allow 30 days for public comment in the Federal Register preceding submission to OMB. We are conducting this process in accordance with the Paperwork Reduction Act of 1995.
Environmental Impact Statements; Notice of Availability
Document Number: 2017-28116
Type: Notice
Date: 2017-12-29
Agency: Environmental Protection Agency
Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I
Document Number: 2017-28114
Type: Proposed Rule
Date: 2017-12-29
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is publishing this notice of intent to issue an order temporarily scheduling fentanyl-related substances that are not currently listed in any schedule of the Controlled Substances Act (CSA). The temporary order will place these substances in schedule I. This action is based on a finding by the Administrator that the placement of these synthetic opioids in schedule I is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose regulatory requirements under the CSA on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of these synthetic opioids, as well as administrative, civil, and criminal remedies with respect to persons who fail to comply with such requirements or otherwise violate the CSA with respect to these substances.
Order Renewing Order Temporarily Denying Export Privileges
Document Number: 2017-28113
Type: Notice
Date: 2017-12-29
Agency: Department of Commerce, Bureau of Industry and Security
Product Change-Priority Mail Express and Priority Mail Negotiated Service Agreement
Document Number: 2017-28109
Type: Notice
Date: 2017-12-29
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.
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2017-28107
Type: Notice
Date: 2017-12-29
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Submission to OMB for Review and Approval; Comment Request; Information Collection Request for the National Study of Nutrient Removal and Secondary Technologies: Publicly Owned Treatment Works (POTW) Screener Questionnaire
Document Number: 2017-28104
Type: Notice
Date: 2017-12-29
Agency: Environmental Protection Agency
In compliance with the Paperwork Reduction Act (PRA), this document announces that an Information Collection Request (ICR) for a voluntary surveyInformation Collection Request for the National Study of Nutrient Removal and Secondary Technologies: Publicly Owned Treatment Works (POTW) Screener Questionnaire, EPA ICR No. 2553.01, OMB Control No. 2040 NEWhas been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request for a new collection. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost. 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.
Proposed Amendment of Class E Airspace: Muscatine, IA
Document Number: 2017-28048
Type: Proposed Rule
Date: 2017-12-29
Agency: Federal Aviation Administration, Department of Transportation
This action proposes to amend Class E airspace designated as a surface area and amend Class E airspace extending upward from 700 feet above the surface at Muscatine Municipal Airport, Muscatine, IA. The FAA is proposing this action due to the decommissioning of the Port City VHF omnidirectional range (VOR) facility, which provided navigation guidance for the instrument procedures to this airport. The VOR has been decommissioned as part of the VOR Minimum Operational Network (MON) Program.
TRICARE; Reimbursement of Long Term Care Hospitals and Inpatient Rehabilitation Facilities
Document Number: 2017-28022
Type: Rule
Date: 2017-12-29
Agency: Department of Defense, Office of the Secretary
This final rule establishes reimbursement rates for Long Term Care Hospitals (LTCHs) and Inpatient Rehabilitation Facilities (IRFs) in accordance with the statutory requirement that TRICARE inpatient care ``payments shall be determined to the extent practicable in accordance with the same reimbursement rules as apply to payments to providers of services of the same type under Medicare.'' This final rule adopts Medicare's reimbursement methodologies for inpatient services provided by LTCHs and IRFs. Each reimbursement methodology will be phased in over a 3-year period. This final rule also removes the definitions for ``hospital, long-term (tuberculosis, chronic care, or rehabilitation)'' and ``long-term hospital care,'' and creates separate definitions for ``Long Term Care Hospital'' and ``Inpatient Rehabilitation Facility'' adopting Centers for Medicare & Medicaid Services (CMS) classification criteria. This final rule also includes authority for a year-end, discretionary General Temporary Military Contingency Payment Adjustment (GTMCPA) for inpatient services in TRICARE network IRFs when deemed essential to meet military contingency requirements.
Exemptions from Certain Prohibited Transaction Restrictions
Document Number: 2017-27977
Type: Notice
Date: 2017-12-29
Agency: Employee Benefits Security Administration, Department of Labor
This document contains exemptions issued by the Department of Labor (the Department) from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code). This notice includes the following: 2017-03, JPMorgan Chase & Co., D- 11906; 2017-04, Deutsche Investment Management Americas Inc. (DIMA) and Certain Current and Future Asset Management Affiliates of Deutsche Bank AG, D-11908; 2017-05, Citigroup Inc., D-11909; 2017-06, Barclays Capital Inc., D-11910; 2017-07, UBS Assets Management (Americas) Inc.; UBS Realty Investors LLC; UBS Hedge Fund Solutions LLC; UBS O'Connor LLC; and Certain Future Affiliates in UBS's Asset Management and Wealth Management Americas Divisions, D-11907.
Notice of Request for Extension or Renewal of a Currently Approved Information Collection
Document Number: 2017-27448
Type: Notice
Date: 2017-12-29
Agency: Department of Agriculture
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the Office of the Assistant Secretary for Civil Rights (OASCR) to request a renewal of a currently approved information collection. OASCR will use the information collected to collect the race, ethnicity, and gender (REG) of all program applicants and participants by county and State.
Oil and Gas and Sulphur Operations on the Outer Continental Shelf-Oil and Gas Production Safety Systems-Revisions
Document Number: 2017-27309
Type: Proposed Rule
Date: 2017-12-29
Agency: Department of the Interior
The Bureau of Safety and Environmental Enforcement (BSEE) proposes to amend the regulations regarding oil and natural gas production to reduce certain unnecessary regulatory burdens imposed under the existing regulations, while correcting errors and clarifying current requirements. Accordingly, after thoroughly reexamining the current regulations, and based on experiences from the implementation process, and BSEE policy, BSEE proposes to amend, revise, or remove current regulatory provisions that create unnecessary burdens on stakeholders while maintaining or advancing the level of safety and environmental protection.
Radio Broadcasting Services; Gaylord, Michigan
Document Number: 2017-27115
Type: Proposed Rule
Date: 2017-12-29
Agency: Federal Communications Commission, Agencies and Commissions
The Audio Division dismisses the petition for rulemaking filed by N Content Marketing, LLC (Petitioner), proposing to amend the FM Table of Allotments, by allotting Channel 246C2 at Gaylord, Michigan. Petitioner did not file comments expressing a continuing interest in the proposed Gaylord allotment. It is the Commission's policy to refrain from making an allotment to a community absent an expression of interest. Roy E. Henderson and Great Northern Broadcasting, Inc., jointly (Joint Counterpropsal), as well as Smile FM, separately, submitted counterproposals. The Joint Counterproposal is dismissed and Smile FM is given the opportunity to file its counterproposal as a petition for rulemaking within 60 days for consideration in a new proceeding. We will not allot Channel 246C2 at Gaylord, Michigan.
Reader Aids
Document Number: FR-2017-12-28-ReaderAids
Type: Reader Aids
Date: 2017-12-28
Buy America Waiver Notification
Document Number: 2017-28150
Type: Notice
Date: 2017-12-28
Agency: Federal Highway Administration, Department of Transportation
This notice provides information regarding FHWA's finding that a Buy America waiver is appropriate for iron and steel components of Georgia Ports Authority (GPA)-procured Rail Mounted Gantry (RMG) cranes that will increase intermodal capacity at the Garden City Terminal in Garden City, Georgia. These iron and steel components are not manufactured (from melting to coating) in the United States in sufficient and reasonably available quantities and of a satisfactory quality. This notice follows FHWA's November 20, 2017, notice finding that a Buy America waiver is appropriate for 33 specific iron and steel components of the GPA Project by adding new items to the list of waived products.
Availability of Final Evaluation Findings of State Coastal Programs and National Estuarine Research Reserves
Document Number: 2017-28111
Type: Notice
Date: 2017-12-28
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given of the availability of final evaluation findings of state coastal programs and national estuarine research reserves. The NOAA Office for Coastal Management has completed review of the Coastal Zone Management Program evaluations for the states of New York, New Hampshire, Washington, and Maine. The states were found to be implementing and enforcing their federally approved Coastal Zone Management Programs, addressing the national coastal management objectives identified in CZMA Section 303(2)(A)-(K), and adhering to the programmatic terms of their financial assistance awards. The NOAA Office for Coastal Management has completed review of the National Estuarine Research Reserve evaluations for South Slough, Jacques Cousteau, Wells, and Narragansett Bay. The reserves were found to be adhering to programmatic requirements of the National Estuarine Research Reserve System. Copies of these final evaluation findings may be downloaded at http://coast.noaa.gov/czm/evaluations/ evaluation_findings/index.html or by submitting a written request to the person identified under FOR FURTHER INFORMATION CONTACT.
Evaluation of National Estuarine Research Reserve
Document Number: 2017-28110
Type: Notice
Date: 2017-12-28
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The National Oceanic and Atmospheric Administration (NOAA), Office for Coastal Management will hold a public meeting to solicit comments for the performance evaluation of the Padilla Bay National Estuarine Research Reserve.
Marine Protected Areas Federal Advisory Committee; Public Meeting
Document Number: 2017-28108
Type: Notice
Date: 2017-12-28
Agency: Department of Commerce, National Oceanic and Atmospheric Administration (noaa)
Notice is hereby given of a meeting of the Marine Protected Areas Federal Advisory Committee (Committee) in San Francisco, California.
Presidential Declaration of a Major Disaster for Public Assistance Only for the State of New Mexico
Document Number: 2017-28099
Type: Notice
Date: 2017-12-28
Agency: Small Business Administration, Agencies and Commissions
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of New Mexico (FEMA- 4352-DR), dated 12/20/2017. Incident: Severe Storms and Flooding. Incident Period: 10/04/2017 through 10/06/2017.
Notice of Agreement Filed
Document Number: 2017-28097
Type: Notice
Date: 2017-12-28
Agency: Federal Maritime Commission, Agencies and Commissions
Notice of Commission Staff Attendance
Document Number: 2017-28096
Type: Notice
Date: 2017-12-28
Agency: Department of Energy, Federal Energy Regulatory Commission
Laurito, James P.; Notice of Filing
Document Number: 2017-28091
Type: Notice
Date: 2017-12-28
Agency: Department of Energy, Federal Energy Regulatory Commission
Southwest Power Pool, Inc.; Notice of Institution of Section 206 Proceeding and Refund Effective Date
Document Number: 2017-28090
Type: Notice
Date: 2017-12-28
Agency: Department of Energy, Federal Energy Regulatory Commission
Notice of Institution of Section 206 Proceeding and Refund Effective Date; PJM Interconnection, LLC
Document Number: 2017-28089
Type: Notice
Date: 2017-12-28
Agency: Department of Energy, Federal Energy Regulatory Commission