October 30, 2017 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2017-10-30-ReaderAids
Type: Reader Aids
Date: 2017-10-30
Unmanned Aircraft Systems Integration Pilot Program
Document Number: 2017-23746
Type: Administrative Order
Date: 2017-10-30
Agency: Executive Office of the President
Sunshine Act Meetings
Document Number: 2017-23664
Type: Notice
Date: 2017-10-30
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Expanded Collaborative Search Pilot Program
Document Number: 2017-23661
Type: Notice
Date: 2017-10-30
Agency: Department of Commerce, Patent and Trademark Office
The United States Patent and Trademark Office (USPTO) conducted two separate Collaborative Search Pilot Programs (CSPs) during the period of 2015 through 2017. One of these programs was conducted with the Japan Patent Office (JPO) and the other with the Korean Intellectual Patent Office (KIPO). Improvements in patent quality and examination pendency were identified as positive outcomes from these two original CSPs. Building on the success of these two programs, the USPTO is participating in a new, expanded CSP (Expanded CSP) in which applicants may request that multiple partnering Intellectual Property (IP) offices exchange search results for their counterpart applications prior to formulating and issuing their office actions. In Expanded CSP, each designated partner IP office will independently conduct a prior art search for its corresponding counterpart application. The search results will then be exchanged between the designated partner IP office(s) and the USPTO before any IP office issues an office action. By this exchange of search results, the examiners in all designated partner IP offices will have a more comprehensive set of prior art references to consider when making initial patentability determinations. In addition to changing the number of IP offices that may be providing search results to the USPTO, Expanded CSP provides applicants with more flexibility by not requiring that applicants follow the procedures of the First Action Interview Pilot Program (FAI). Expanded CSP will allow the USPTO to study the impact on examination processes resulting from exchanges of search results between the USPTO and multiple partner IP offices prior to formulating and issuing office actions.
Sunshine Act Meetings
Document Number: 2017-23619
Type: Notice
Date: 2017-10-30
Agency: Federal Retirement Thrift Investment Board, Agencies and Commissions
Agency Information Collection Activities; Submission for OMB Review; Comment Request; DOL-Only Performance Accountability, Information, and Reporting System
Document Number: 2017-23569
Type: Notice
Date: 2017-10-30
Agency: Department of Labor, Office of the Secretary
The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) revision titled, ``DOL-Only Performance Accountability, Information, and Reporting System,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-23561
Type: Notice
Date: 2017-10-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Information Collection for Evaluation of Education, Communication, and Training Activities for Mobile Populations. This data collection will enable to evaluate its mobile populations and stakeholders communication, training, and education material's effectiveness.
Removing the Prohibition on the Importation of Jadeite or Rubies Mined or Extracted From Burma, and Articles of Jewelry Containing Jadeite or Rubies Mined or Extracted From Burma
Document Number: 2017-23560
Type: Rule
Date: 2017-10-30
Agency: Department of Homeland Security, U.S. Customs and Border Protection, Department of the Treasury
This document amends the U.S. Customs and Border Protection (CBP) regulations to remove the provision relating to the prohibition on the importation of jadeite or rubies mined or extracted from Burma, and articles of jewelry containing jadeite or rubies mined or extracted from Burma. This reflects the termination of all Burmese sanctions by Executive Order 13742, of October 7, 2016.
Drawbridge Operation Regulation; Nanticoke River, Seaford, DE
Document Number: 2017-23559
Type: Rule
Date: 2017-10-30
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is modifying the operating schedule that governs the SR 13 Bridge across the Nanticoke River, mile 39.6, in Seaford, Delaware (DE). This modification will require the bridge to open on signal every Saturday and Sunday during the winter season, if at least 24 hours notice is given. This action is necessary to balance bridge operations and maintenance with the existing needs of navigation.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2017-23558
Type: Notice
Date: 2017-10-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy
Document Number: 2017-23557
Type: Notice
Date: 2017-10-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
Bulk Manufacturer of Controlled Substances Application: Euticals Inc.
Document Number: 2017-23556
Type: Notice
Date: 2017-10-30
Agency: Drug Enforcement Administration, Department of Justice
Combined Notice of Filings #1
Document Number: 2017-23553
Type: Notice
Date: 2017-10-30
Agency: Department of Energy, Federal Energy Regulatory Commission
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Examinations and Testing of Electrical Equipment, Including Examination, Testing, and Maintenance of High Voltage Longwalls
Document Number: 2017-23552
Type: Notice
Date: 2017-10-30
Agency: Department of Labor, Office of the Secretary
The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, ``Examinations and Testing of Electrical Equipment, Including Examination, Testing, and Maintenance of High Voltage Longwalls,'' 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). Public comments on the ICR are invited.
Proposed Collection of Information; Comment Request
Document Number: 2017-23551
Type: Notice
Date: 2017-10-30
Agency: Department of Labor, Office of Workers' Compensation Programs
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Office of Workers' Compensation Programs (OWCP) is soliciting comments concerning the proposed collection: Application For Self-Insurance Under The Black Lung Benefits Act, 1240-0NEW (CM-2017; CM-2017a; CM-2017b). A copy of the proposed information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.
President's Committee on the International Labor Organization Charter Renewal
Document Number: 2017-23550
Type: Notice
Date: 2017-10-30
Agency: Department of Labor
On September 29, 2017, President Trump continued the President's Committee on the International Labor Organization (ILO) for two years through September 30, 2019. In response, and pursuant to the Federal Advisory Committee Act (FACA), the Secretary of Labor renewed the committee's charter on October 23, 2017. Purpose: The President's Committee on the International Labor Organization was established in 1980 by Executive Order 12216 to monitor and assess the work of the ILO and make recommendations to the President regarding United States policy towards the ILO. The committee is chaired by the Secretary of Labor and the Department of Labor's Bureau of International Labor Affairs is responsible for providing the necessary support for the committee. The committee is composed of seven members: The Secretary of Labor (chair), the Secretary of State, the Secretary of Commerce, the Assistant to the President for National Security Affairs, the Assistant to the President for Economic Policy, and one representative each from organized labor and the business community, designated by the Secretary. The labor and business members are the presidents of the American Federation of Labor and Congress of Industrial Organizations (AFL-CIO) and the United States Council for International Business (USCIB), respectively, as the most representative organizations of U.S. workers and employers engaged in ILO matters.
Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “The Silver Caesars: A Renaissance Mystery” Exhibition
Document Number: 2017-23549
Type: Notice
Date: 2017-10-30
Agency: Department of State
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``The Silver Caesars: A Renaissance Mystery,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The Metropolitan Museum of Art, New York, New York, from on or about December 12, 2017, until on or about March 11, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Sealing of Abandoned Areas Standard
Document Number: 2017-23548
Type: Notice
Date: 2017-10-30
Agency: Department of Labor, Office of the Secretary
The Department of Labor (DOL) is submitting the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) titled, ``Sealing of Abandoned Areas Standard,'' 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). Public comments on the ICR are invited.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Request for Assistance From the Department of Labor, Employee Benefits Security Administration
Document Number: 2017-23547
Type: Notice
Date: 2017-10-30
Agency: Department of Labor, Office of the Secretary
The Department of Labor (DOL) is submitting the Employee Benefits Security Administration (EBSA) sponsored information collection request (ICR) titled, ``Request for Assistance from the Department of Labor, Employee Benefits Security Administration,'' 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). Public comments on the ICR are invited.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Rehabilitation Plan and Award
Document Number: 2017-23546
Type: Notice
Date: 2017-10-30
Agency: Department of Labor, Office of the Secretary
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) revision titled, ``Rehabilitation Plan and Award,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.
The President's National Security Telecommunications Advisory Committee
Document Number: 2017-23544
Type: Notice
Date: 2017-10-30
Agency: Department of Homeland Security
The President's National Security Telecommunications Advisory Committee (NSTAC) will meet via teleconference on Thursday, November 16, 2017. The meeting will be open to the public.
Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest
Document Number: 2017-23543
Type: Notice
Date: 2017-10-30
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Mounting Apparatuses for Holding Portable Electronic Devices and Components Thereof, DN 3268; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.
Certain Shaving Cartridges, Components Thereof and Products Containing Same Institution of Investigation
Document Number: 2017-23542
Type: Notice
Date: 2017-10-30
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on September 25, 2017, under section 337 of the Tariff Act of 1930, as amended, on behalf of The Gillette Company LLC of Boston, Massachusetts. A supplement to the complaint was filed on September 28, 2017. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain shaving cartridges, components thereof and products containing same by reason of infringement of U.S. Patent No. 9,193,077 (``the '077 patent''). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
Certain Amorphous Metal and Products Containing Same; Institution of Investigation
Document Number: 2017-23541
Type: Notice
Date: 2017-10-30
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on September 19, 2017, under section 337 of the Tariff Act of 1930, as amended, on behalf of Metglas, Inc. of Conway, South Carolina and Hitachi Metals, Ltd. of Japan. Supplements were filed on September 20, 2017, and October 6, 2017. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, or in the sale of certain amorphous metal and products containing same by reason of misappropriation of trade secrets, the threat or effect of which is to destroy or substantially injure a domestic industry in the United States. The complainants request that the Commission institute an investigation and, after the investigation, issue a general exclusion order, or in the alternative a limited exclusion order, and cease and desist orders.
Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Plants for Planting; Establishing a Category for Plants for Planting Not Authorized for Importation Pending Pest Risk Analysis
Document Number: 2017-23540
Type: Notice
Date: 2017-10-30
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request revision to and extension of approval of an information collection associated with the category of plants for planting that are not authorized for importation pending pest risk analysis.
Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Tomatoes From France, Morocco, Western Sahara, Chile, and Spain
Document Number: 2017-23539
Type: Notice
Date: 2017-10-30
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the importation of fresh tomatoes from France, Morocco, Western Sahara, Chile, and Spain.
Agency Information Collection Activity Under OMB Review: Claim, Authorization & Invoice for Prosthetic Items & Services
Document Number: 2017-23538
Type: Notice
Date: 2017-10-30
Agency: Department of Veterans Affairs
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Health Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Certain Paper Clips From the People's Republic of China: Continuation of Antidumping Duty Order
Document Number: 2017-23537
Type: Notice
Date: 2017-10-30
Agency: Department of Commerce, International Trade Administration
As a result of the determinations by the Department of Commerce (Department) and the International Trade Commission (ITC) that revocation of the antidumping duty (AD) order on certain paper clips (paper clips) from the People's Republic of China (PRC) would likely lead to a continuation or recurrence of dumping and material injury to an industry in the United States, the Department is publishing a notice of continuation of the AD order.
Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Ocean Perch in the Western Regulatory Area of the Gulf of Alaska
Document Number: 2017-23536
Type: Rule
Date: 2017-10-30
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS is prohibiting directed fishing for Pacific ocean perch in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2017 total allowable catch of Pacific ocean perch in the Western Regulatory Area of the GOA.
Submission for Review: OPM Form 1654-B, Combined Federal Campaign Federal Retiree Pledge Form
Document Number: 2017-23534
Type: Notice
Date: 2017-10-30
Agency: Office of Personnel Management
The Office of Combined Federal Campaign, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on an information collection request (ICR) 3206-NEW, OPM Form 1654-B, the Combined Federal Campaign Retiree Pledge Form. As required by the Paperwork Reduction Act of 1995, as amended by the Clinger-Cohen Act, OPM is soliciting comments for this collection. The information collection was previously published in the Federal Register on August 22, 2017 at 82 FR 39918 allowing for a 60-day public comment period. No comments were received for this information collection. The purpose of this notice is to allow an additional 30 days for public comments.
Appraisal Subcommittee Notice of Meeting
Document Number: 2017-23533
Type: Notice
Date: 2017-10-30
Agency: Federal Financial Institutions Examination Council, Agencies and Commissions
Notice of Public Meeting, BLM Alaska Resource Advisory Council
Document Number: 2017-23532
Type: Notice
Date: 2017-10-30
Agency: Department of the Interior, Bureau of Land Management
In accordance with the Federal Land Policy and Management Act of 1976 as amended and the Federal Advisory Committee Act of 1972, the Bureau of Land Management (BLM) Alaska Resource Advisory Council (RAC) will meet as indicated below.
Motor Vehicle Safety Standards; Electronic Stability Control Systems for Heavy Vehicles
Document Number: 2017-23531
Type: Rule
Date: 2017-10-30
Agency: National Highway Traffic Safety Administration, Department of Transportation
This final rule addresses a petition for reconsideration of the final rule for FMVSS No. 136, Electronic stability control systems for heavy vehicles. The petitioner, Truck and Engine Manufacturers Association (EMA), requested that NHTSA amend the test conditions for the agency's performance test by allowing a larger lane width for long wheelbase truck tractors. After a careful technical review of the petition and the issues raised by the petitioner, the agency has decided to grant the petition because there is sufficient evidence to indicate that a larger lane width is needed for testing of long wheelbase truck tractors.
North Pacific Fishery Management Council; Public Meeting
Document Number: 2017-23530
Type: Notice
Date: 2017-10-30
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The North Pacific Fishery Management Council (Council) Social Science Plan Team will meet telephonically on November 14, 2017.
Notice of OFAC Sanctions Actions
Document Number: 2017-23529
Type: Notice
Date: 2017-10-30
Agency: Department of the Treasury, Office of Foreign Assets Control
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of nine persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
Advisory Committee on Infant Mortality; Notice of Charter Renewal
Document Number: 2017-23528
Type: Notice
Date: 2017-10-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Infant Mortality (ACIM) has been rechartered. The effective date of the renewed ACIM charter is September 30, 2017.
Release of Waybill Data
Document Number: 2017-23527
Type: Notice
Date: 2017-10-30
Agency: Surface Transportation Board, Department of Transportation
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017; Draft Guidance for Industry; Availability
Document Number: 2017-23526
Type: Notice
Date: 2017-10-30
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 ``Assessing User Fees Under the Generic Drug User Fee Amendments of 2017.'' This draft guidance provides stakeholders information regarding the implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures surrounding its application.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Previously Approved Collection: Red Ribbon Week Patch
Document Number: 2017-23524
Type: Notice
Date: 2017-10-30
Agency: Department of Justice
The Department of Justice (DOJ), Drug Enforcement Administration, 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.
Cost-of-Living Increase and Other Determinations for 2018
Document Number: 2017-23522
Type: Notice
Date: 2017-10-30
Agency: Social Security Administration, Agencies and Commissions
Under title II of the Social Security Act (Act), there will be a 2.0 percent cost-of-living increase in Social Security benefits effective December 2017. In addition, the national average wage index for 2016 is $48,664.73. The cost-of-living increase and national average wage index affect other program parameters as described below.
Social Security Disability Program Demonstration Project: Promoting Opportunity Demonstration (POD)
Document Number: 2017-23521
Type: Notice
Date: 2017-10-30
Agency: Social Security Administration, Agencies and Commissions
We are announcing a demonstration project for the Social Security disability program under title II of the Social Security Act (Act). Under this project, we will modify program rules applied to beneficiaries who work and receive title II disability benefits. We are required to conduct the Promoting Opportunity Demonstration (POD), in compliance with section 823 of the Bipartisan Budget Act (BBA) of 2015. In this project, we will test simplified work incentives and use a benefit offset based on earnings as an alternative to rules we currently apply to title II disability beneficiaries who work. Under the benefit offset, we will reduce title II disability benefits by $1 for every $2 that a beneficiary earns above a certain threshold. We will select beneficiaries and offer them the opportunity to volunteer for the project. When we make the selection, we will include beneficiaries who receive title II disability benefits only as well as beneficiaries who receive both title II disability benefits and Supplemental Security Income (SSI) based on disability or blindness under title XVI of the Act. We are modifying rules that apply to the title II program and the Ticket to Work program under title XI. We will continue to apply the usual SSI program rules for participants who receive SSI payments in addition to title II disability benefits.
Product Labeling for Certain Ultrasonic Surgical Aspirator Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-23520
Type: Notice
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Product Labeling for Certain Ultrasonic Surgical Aspirator Devices.'' FDA is providing a specific labeling recommendation in this guidance to promote the safe and effective use of ultrasonic surgical aspirator devices. The labeling recommendation is being made in light of the risk of tissue dissemination and relates to use of these devices in the removal of uterine fibroids.
Standard Development Organizations Whose Susceptibility Test Interpretive Criteria Standards May Be Recognized by the Food and Drug Administration; Request for Information
Document Number: 2017-23519
Type: Notice
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is requesting information to assist in identifying standard development organizations (SDOs) that meet the requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act), of the 21st Century Cures Act (Cures Act), which was signed into law on December 13, 2016.
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements
Document Number: 2017-23518
Type: Notice
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the requirements for electronic submission of postmarketing safety reports for human drug and biological products.
Manufacturers Sharing Patient-Specific Information From Medical Devices With Patients Upon Request; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-23517
Type: Notice
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request.'' FDA developed this guidance to clarify our position regarding manufacturers appropriately and responsibly sharing ``patient-specific information''information unique to an individual patient or unique to that patient's treatment or diagnosis that has been recorded, stored, processed, retrieved, and/or derived from a legally marketed medical devicewith that patient at that patient's request. This guidance provides information and recommendations to industry, health care providers, and FDA staff about the mechanisms and considerations for device manufacturers sharing such information with individual patients when they request it.
Medical Devices; Neurological Devices; Classification of the Non-Electroencephalogram Physiological Signal Based Seizure Monitoring System
Document Number: 2017-23516
Type: Rule
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the non-EEG physiological signal based seizure monitoring system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Alumni Commissioner's Fellowship Program Fellows
Document Number: 2017-23515
Type: Notice
Date: 2017-10-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Survey of Alumni Commissioner's Fellowship Program Fellows.
Victory Media, Inc.; Analysis To Aid Public Comment
Document Number: 2017-23514
Type: Notice
Date: 2017-10-30
Agency: Federal Trade Commission, Agencies and Commissions
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order embodied in the consent agreementthat would settle these allegations.
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