October 2019 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 2,601
Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting
Document Number: 2019-23609
Type: Notice
Date: 2019-10-30
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Mid-Atlantic Fishery Management Council (Council) will hold a webinar-based meeting with the public to provide information on options available to commercial fishing operators for electronically submitting required Vessel Trip Reports (VTRs) in the Greater Atlantic Region. This is in support of the Council's joint action with the New England Fishery Management Council that could require electronic reporting of VTRs by operators holding commercial fishing permits for species managed by either council that require the submission of VTRs.
Airworthiness Directives; Dassault Aviation Airplanes
Document Number: 2019-23580
Type: Proposed Rule
Date: 2019-10-30
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to supersede Airworthiness Directive (AD) 2018-19-26, which applies to all Dassault Aviation Model MYSTERE- FALCON 200 airplanes. AD 2018-19-26 requires revising the maintenance or inspection program, as applicable, to incorporate new or more restrictive maintenance requirements and airworthiness limitations. Since the FAA issued AD 2018-19-26, the FAA determined that new or more restrictive airworthiness limitations are necessary. This proposed AD would require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. The FAA is proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; Airbus SAS Airplanes
Document Number: 2019-23579
Type: Proposed Rule
Date: 2019-10-30
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to adopt a new airworthiness directive (AD) for certain Airbus SAS Model A350-941 airplanes. This proposed AD was prompted by a determination that ram air turbine (RAT) performance may be below the expected (certificated) level when the landing gear is extended. This proposed AD would require installing flight control and guidance system (FCGS) software (SW) X11 Standard (STD), as specified in a European Union Aviation Safety Agency (EASA) AD, which will be incorporated by reference. The FAA is proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; De Havilland Aircraft of Canada Limited (Type Certificate Previously Held by Bombardier, Inc.) Airplanes
Document Number: 2019-23575
Type: Proposed Rule
Date: 2019-10-30
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to adopt a new airworthiness directive (AD) for certain De Havilland Aircraft of Canada Limited Model DHC-8-400 series airplanes. This proposed AD was prompted by reports of wear on fuel couplings, bonding springs, and sleeves as well as fuel tube end ferrules and fuel component end ferrules. This proposed AD would require repetitive inspections of certain parts for discrepancies that meet specified criteria, and replacement as necessary; repetitive inspections of certain parts for damage and wear, and rework of parts; and electrical bonding checks of certain couplings. This proposed AD would also require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. For certain airplanes, this proposed AD would allow a modification that would terminate the repetitive inspections. The FAA is proposing this AD to address the unsafe condition on these products.
Regulated Navigation Area; Saint Simons Sound, GA
Document Number: 2019-23540
Type: Rule
Date: 2019-10-30
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is amending a temporary RNA for navigable waters in Saint Simons Sound, GA. Entry of vessels greater than 500 gross tons into the area is prohibited, unless specifically authorized by the Captain of the Port (COTP) Savannah. The RNA is needed to protect personnel, vessels, and the marine environment from potential hazards created by salvage and pollution response operations taking place near the grounded freight vessel GOLDEN RAY.
Airworthiness Directives; Airbus SAS Airplanes
Document Number: 2019-23530
Type: Proposed Rule
Date: 2019-10-30
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to adopt a new airworthiness directive (AD) for certain Airbus SAS Model A350-941 and -1041 airplanes. This proposed AD was prompted by a report indicating that during inspection of the installation of oxygen containers, certain fasteners of the oxygen containers and adjacent panels in the passenger supply channels (PSCs) were found damaged or unlocked, which could result in insufficient clearance between the oxygen container and adjacent panels. This proposed AD would require a one-time inspection of the oxygen containers and adjacent panels and applicable corrective actions, as specified in a European Union Aviation Safety Agency (EASA) AD, which will be incorporated by reference. The FAA is proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; Bombardier, Inc., Airplanes
Document Number: 2019-23529
Type: Proposed Rule
Date: 2019-10-30
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to supersede Airworthiness Directive (AD) 2003-09-04 R1, which applies to certain Bombardier, Inc., Model CL-600- 2B19 (Regional Jet series 100 & 440) airplanes. AD 2003-09-04 R1 requires revising the airworthiness limitations for certain structural inspections; repair if necessary; and submission of inspection findings to the airplane manufacturer. Since the FAA issued AD 2003-09-04 R1, the agency determined that additional airplanes are affected, that new or more restrictive airworthiness limitations are necessary, and that the compliance time must be revised to include a phase-in time for certain tasks. This proposed AD would revise the applicability to include additional airplanes; revise certain compliance times; and require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. The FAA is proposing this AD to address the unsafe condition on these products.
Montana Regulatory Program
Document Number: 2019-23514
Type: Rule
Date: 2019-10-30
Agency: Department of the Interior, Office of Surface Mining Reclamation and Enforcement
The Office of Surface Mining Reclamation and Enforcement (OSMRE) is approving an amendment to the Montana coal regulatory program (the Montana program or the State program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). The proposed changes to the Montana program are in response to a 2011 state legislative change, which enacted a new State statutory provision under the Montana Strip and Underground Mine Reclamation Act (MSUMRA). The statutory change, directs the State Board to adopt rules governing underground mining that uses in situ coal gasification. Montana proposes to revise its State program to incorporate the addition and proposes changes to the Administrative Rules of Montana (ARM) pertaining to the regulation of in situ coal gasification operations.
Great Lakes Pilotage Rates-2020 Annual Review and Revisions to Methodology
Document Number: 2019-23510
Type: Proposed Rule
Date: 2019-10-30
Agency: Coast Guard, Department of Homeland Security
In accordance with the Great Lakes Pilotage Act of 1960, the Coast Guard is proposing new base pilotage rates for the 2020 shipping season. This proposed rule would adjust the pilotage rates to account for changes in district operating expenses, an increase in the number of pilots, and anticipated inflation. The net result of decreased operating expenses for the associations compared to the previous year, inflation of pilot compensation, and the addition of one working pilot at the beginning of the 2020 shipping season is a 3 percent increase in pilotage rates. In addition, the Coast Guard is not proposing any surcharges for the 2020 shipping season, which would result in a 1 percent net decrease in pilotage costs compared to the 2019 season, when combined with the changes above. The Coast Guard is also proposing to clarify the rules related to the working capital fund.
Revisions to the Office of Hearings and Appeals Procedural Regulations
Document Number: 2019-23509
Type: Rule
Date: 2019-10-30
Agency: Department of Energy
The Office of Hearings and Appeals Procedural Regulations set forth the default procedures for appearance and practice before the Office of Hearings and Appeals (OHA), the quasi-judicial branch of the Department of Energy (DOE). The procedures set forth in this regulation apply to all proceedings before the OHA where a comprehensive procedural scheme is not found in another DOE regulation. Through this rulemaking, the OHA simplified and modernized its procedures.
Energy Labeling Rule
Document Number: 2019-23505
Type: Rule
Date: 2019-10-30
Agency: Federal Trade Commission, Agencies and Commissions
The Commission amends the Energy Labeling Rule (``Rule'') to make the Rule easier to use by reorganizing several sections, amending language to increase clarity, eliminating several obsolete provisions, and making minor corrections.
Determination of Rates and Terms for Digital Performance of Sound Recordings and Making of Ephemeral Copies To Facilitate Those Performances (Web V)
Document Number: 2019-23485
Type: Proposed Rule
Date: 2019-10-30
Agency: Copyright Royalty Board, Library of Congress, Library of Congress, Agencies and Commissions
The Copyright Royalty Judges are publishing for comment proposed regulations governing the rates and terms for the digital performance of sound recordings by noncommercial educational webcasters and for the making of ephemeral recordings necessary for the facilitation of such transmissions for the period commencing January 1, 2021, and ending on December 31, 2025.
Schedules of Controlled Substances: Extension of Temporary Placement of FUB-AMB in Schedule I of the Controlled Substances Act
Document Number: 2019-23372
Type: Rule
Date: 2019-10-30
Agency: Drug Enforcement Administration, Department of Justice
The Acting Administrator of the Drug Enforcement Administration is issuing this temporary scheduling order to extend the temporary schedule I status of a synthetic cannabinoid, methyl 2-(1-(4- fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA), including its optical, positional and geometric isomers, salts, and salts of isomers. The schedule I status of FUB-AMB currently is in effect until November 4, 2019. This temporary order will extend the temporary scheduling of FUB- AMB for one year, or until the permanent scheduling action for this substance is completed, whichever occurs first.
Amendments to Procedures With Respect to Applications Under the Investment Company Act of 1940
Document Number: 2019-23082
Type: Proposed Rule
Date: 2019-10-30
Agency: Securities and Exchange Commission, Agencies and Commissions
The Securities and Exchange Commission (the ``Commission'') is proposing amending rule 0-5 under the Investment Company Act of 1940 (``Act'') to establish an expedited review procedure for applications that are substantially identical to recent precedent as well as a new rule to establish an internal timeframe for review of applications outside of such expedited procedure. In addition, the Commission is proposing amending rule 0-5 under the Act to deem an application outside of expedited review withdrawn when the applicant does not respond in writing to comments within 120 days.
National Emission Standards for Hazardous Air Pollutants: Rubber Tire Manufacturing Residual Risk and Technology Review
Document Number: 2019-21837
Type: Proposed Rule
Date: 2019-10-30
Agency: Environmental Protection Agency
The U.S. Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Rubber Tire Manufacturing source category. The proposal addresses the results of the residual risk and technology review (RTR) conducted as required under the Clean Air Act (CAA). The proposed amendments address the startup, shutdown, and malfunction (SSM) provisions of the rule and amend provisions regarding electronic reporting of certain notifications, performance test results, and semiannual reports.
Appraisals for Higher-Priced Mortgage Loans Exemption Threshold
Document Number: 2019-21559
Type: Rule
Date: 2019-10-30
Agency: Federal Reserve System, Agencies and Commissions, Office of the Comptroller of the Currency, Department of Treasury, Department of the Treasury, Bureau of Consumer Financial Protection
The OCC, the Board, and the Bureau are finalizing amendments to the official interpretations for their regulations that implement section 129H of the Truth in Lending Act (TILA). Section 129H of TILA establishes special appraisal requirements for ``higher-risk mortgages,'' termed ``higher-priced mortgage loans'' or ``HPMLs'' in the agencies' regulations. The OCC, the Board, the Bureau, the Federal Deposit Insurance Corporation (FDIC), the National Credit Union Administration (NCUA), and the Federal Housing Finance Agency (FHFA) (collectively, the Agencies) issued joint final rules implementing these requirements, effective January 18, 2014. The Agencies' rules exempted, among other loan types, transactions of $25,000 or less, and required that this loan amount be adjusted annually based on any annual percentage increase in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). If there is no annual percentage increase in the CPI-W, the OCC, the Board, and the Bureau will not adjust this exemption threshold from the prior year. However, in years following a year in which the exemption threshold was not adjusted, the threshold is calculated by applying the annual percentage increase in the CPI-W to the dollar amount that would have resulted, after rounding, if the decreases and any subsequent increases in the CPI-W had been taken into account. Based on the CPI-W in effect as of June 1, 2019, the exemption threshold will increase from $26,700 to $27,200, effective January 1, 2020.
Truth in Lending (Regulation Z)
Document Number: 2019-21557
Type: Rule
Date: 2019-10-30
Agency: Federal Reserve System, Agencies and Commissions, Bureau of Consumer Financial Protection
The Board and the Bureau are publishing final rules amending the official interpretations and commentary for the agencies' regulations that implement the Truth in Lending Act (TILA). The Dodd- Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) amended TILA by requiring that the dollar threshold for exempt consumer credit transactions be adjusted annually by the annual percentage increase in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). If there is no annual percentage increase in the CPI-W, the Board and the Bureau will not adjust this exemption threshold from the prior year. However, in years following a year in which the exemption threshold was not adjusted, the threshold is calculated by applying the annual percentage change in the CPI-W to the dollar amount that would have resulted, after rounding, if the decreases and any subsequent increases in the CPI-W had been taken into account. Based on the annual percentage increase in the CPI-W as of June 1, 2019, the exemption threshold will increase from $57,200 to $58,300 effective January 1, 2020. Because the Dodd-Frank Act also requires similar adjustments in the Consumer Leasing Act's threshold for exempt consumer leases, the Board and the Bureau are making similar amendments to each of their respective regulations implementing the Consumer Leasing Act elsewhere in this issue of the Federal Register.
Consumer Leasing (Regulation M)
Document Number: 2019-21554
Type: Rule
Date: 2019-10-30
Agency: Federal Reserve System, Agencies and Commissions, Bureau of Consumer Financial Protection
The Board and the Bureau are finalizing amendments to the official interpretations and commentary for the agencies' regulations that implement the Consumer Leasing Act (CLA). The Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) amended the CLA by requiring that the dollar threshold for exempt consumer leases be adjusted annually by the annual percentage increase in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). If there is no annual percentage increase in the CPI-W, the Board and the Bureau will not adjust this exemption threshold from the prior year. However, in years following a year in which the exemption threshold was not adjusted, the threshold is calculated by applying the annual percentage change in the CPI-W to the dollar amount that would have resulted, after rounding, if the decreases and any subsequent increases in the CPI-W had been taken into account. Based on the annual percentage increase in the CPI-W as of June 1, 2019, the exemption threshold will increase from $57,200 to $58,300 effective January 1, 2020. Because the Dodd-Frank Act also requires similar adjustments in the Truth in Lending Act's threshold for exempt consumer credit transactions, the Board and the Bureau are making similar amendments to each of their respective regulations implementing the Truth in Lending Act elsewhere in this issue of the Federal Register.
Publication or Submission of Quotations Without Specified Information
Document Number: 2019-21260
Type: Proposed Rule
Date: 2019-10-30
Agency: Securities and Exchange Commission, Agencies and Commissions
The Securities and Exchange Commission (the ``SEC'' or the ``Commission'') is proposing amendments to 17 CFR 240.15c2-11 (the ``Rule'') under the Securities Exchange Act of 1934 (the ``Exchange Act''). The Rule governs the publication of quotations for securities in a quotation medium other than a national securities exchange, i.e., over-the-counter (``OTC'') securities. The Commission is proposing to provide greater transparency to investors and other market participants by requiring that information about the issuer and the security be current and publicly available; limit certain existing exceptions to the Rule, including the ``piggyback exception,'' to provide greater protections to retail investors; reduce regulatory burdens on broker- dealers for the publication of quotations of certain OTC securities that may be less susceptible to potential fraud and manipulation, such as securities of certain issuers with higher capitalization and securities that were issued in underwritten offerings; and streamline the Rule, remove obsolete provisions without undermining the important investor protections of the Rule, and make technical, non-substantive changes. The Commission is also seeking comment about information repositories.
Reader Aids
Document Number: FR-2019-10-29-ReaderAids
Type: Reader Aids
Date: 2019-10-29
Revisions to Civil Penalty Amounts
Document Number: C1-2019-14101
Type: Rule
Date: 2019-10-29
Agency: Federal Aviation Administration, Department of Transportation, Federal Motor Carrier Safety Administration, Federal Railroad Administration, Maritime Administration, National Highway Traffic Safety Administration, Pipeline and Hazardous Materials Safety Administration, Saint Lawrence Seaway Development Corporation, Office of the Secretary
Sunshine Act Meetings
Document Number: 2019-23719
Type: Notice
Date: 2019-10-29
Agency: Inter-American Foundation, Agencies and Commissions
Airworthiness Directives; Pratt & Whitney Turbofan Engines
Document Number: 2019-23715
Type: Rule
Date: 2019-10-29
Agency: Federal Aviation Administration, Department of Transportation
The FAA is superseding Airworthiness Directive (AD) 2019-19-11 for certain Pratt & Whitney (PW) PW1519G, PW1521G, PW1521GA, PW1524G, PW1525G, PW1521G-3, PW1524G-3, PW1525G-3, PW1919G, PW1921G, PW1922G, PW1923G, and PW1923G-A model turbofan engines. AD 2019-19-11 required initial and repetitive inspections of the low-pressure compressor (LPC) inlet guide vane (IGV) and the LPC rotor 1 (R1) and, depending on the results of the inspections, possible replacement of the LPC. This AD requires the same inspection of the LPC R1 for cracks or damage, removes the inspection of the LPC IGV for proper alignment, and expands the applicability to certain additional PW turbofan engines. This AD also reduces the compliance time for these inspections for certain PW turbofan engines. This AD was prompted by recent findings of cracks in the LPC R1 and an additional in-flight failure of the LPC R1. The FAA is issuing this AD to address the unsafe condition on these products.
Sunshine Act Meetings
Document Number: 2019-23688
Type: Notice
Date: 2019-10-29
Agency: Commodity Futures Trading Commission, Agencies and Commissions
Sunshine Act Meetings
Document Number: 2019-23674
Type: Notice
Date: 2019-10-29
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Trade Adjustment Assistance (TAA) Efforts To Improve Outcomes; Correction
Document Number: 2019-23622
Type: Notice
Date: 2019-10-29
Agency: Employment and Training Administration, Department of Labor
The Department of Labor's (DOL's) Employment and Training Administration (ETA) published a document in the Federal Register of September 25, 2019, soliciting public comments on the Trade Adjustment Assistance (TAA) Efforts to Improve Outcomes Information Collection Request (84 FR 50475). The document contained an incorrect date by which written comments must be received.
Johnson-O'Malley Program; Preliminary Report
Document Number: 2019-23617
Type: Notice
Date: 2019-10-29
Agency: Department of the Interior, Bureau of Indian Affairs
As required by the Johnson-O'Malley (JOM) Act of 1934, as amended by the JOM Supplemental Indian Education Program Modernization Act, the Bureau of Indian Education (BIE) is publishing a Preliminary Report that describes the number of eligible Indian students served or potentially served by each eligible entity, using the most applicable and accurate data from the fiscal year proceeding the fiscal year for which the initial determination is to be made. BIE is also seeking written comments from eligible entities to gain feedback about the preliminary report.
Methylene Chloride (MC); Draft Toxic Substances Control Act (TSCA) Risk Evaluation and TSCA Science Advisory Committee on Chemicals (SACC) Meeting; Notice of Availability, Public Meeting, and Request for Comment
Document Number: 2019-23614
Type: Notice
Date: 2019-10-29
Agency: Environmental Protection Agency
EPA is announcing the availability of and soliciting public comment on the draft Toxic Substances Control Act (TSCA) risk evaluation of Methylene Chloride (MC). The purpose of the risk evaluation process under TSCA is to determine, upon issuance of a final risk evaluation, whether a chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation. EPA is also submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review and is announcing that there will be an in-person public meeting of the TSCA SACC to consider and review the draft risk evaluation. Preceding the in-person meeting, there will be a preparatory virtual public meeting for the panel to consider the scope and clarity of the draft charge questions for the peer review.
Investor Advisory Committee Meeting
Document Number: 2019-23607
Type: Notice
Date: 2019-10-29
Agency: Securities and Exchange Commission, Agencies and Commissions
The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, is providing notice that it will hold a public meeting. The public is invited to submit written statements to the Committee.
Submission for OMB Review; Comment Request
Document Number: 2019-23602
Type: Notice
Date: 2019-10-29
Agency: Securities and Exchange Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2019-23601
Type: Notice
Date: 2019-10-29
Agency: Securities and Exchange Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2019-23600
Type: Notice
Date: 2019-10-29
Agency: Securities and Exchange Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2019-23599
Type: Notice
Date: 2019-10-29
Agency: Securities and Exchange Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2019-23598
Type: Notice
Date: 2019-10-29
Agency: Securities and Exchange Commission, Agencies and Commissions
Proposed Collection; Comment Request
Document Number: 2019-23597
Type: Notice
Date: 2019-10-29
Agency: Securities and Exchange Commission, Agencies and Commissions
Submission for OMB Review; Comment Request
Document Number: 2019-23596
Type: Notice
Date: 2019-10-29
Agency: Securities and Exchange Commission, Agencies and Commissions
Certain Swap Data Repository and Data Reporting Requirements
Document Number: 2019-23595
Type: Proposed Rule
Date: 2019-10-29
Agency: Commodity Futures Trading Commission, Agencies and Commissions
On May 13, 2019, the Commodity Futures Trading Commission (Commission) published in the Federal Register a notice of proposed rulemaking (NPRM) titled Certain Swap Data Repository and Data Reporting Requirements. The comment period for the NPRM was originally scheduled to close on July 29, 2019. The Commission subsequently extended the comment period for 90 days to October 28, 2019. The Commission is further extending the comment period for this NPRM by an additional 90 days to January 27, 2020.
Notice of Public Hearing and Business Meeting; November 13 and December 11, 2019
Document Number: 2019-23592
Type: Notice
Date: 2019-10-29
Agency: Delaware River Basin Commission, Agencies and Commissions
Petition for Waiver of Compliance
Document Number: 2019-23590
Type: Notice
Date: 2019-10-29
Agency: Federal Railroad Administration, Department of Transportation
Arts and Artifacts Indemnity Panel Advisory Committee
Document Number: 2019-23589
Type: Notice
Date: 2019-10-29
Agency: National Foundation on the Arts and the Humanities, Agencies and Commissions, Federal Council on the Arts and the Humanities
Pursuant to the Federal Advisory Committee Act, notice is hereby given that the Federal Council on the Arts and the Humanities will hold a meeting of the Arts and Artifacts International Indemnity Panel.
Southern Natural Gas Company, LLC; Notice of Request Under Blanket Authorization
Document Number: 2019-23587
Type: Notice
Date: 2019-10-29
Agency: Department of Energy, Federal Energy Regulatory Commission
Information Collection Activity; Comment Request
Document Number: 2019-23586
Type: Notice
Date: 2019-10-29
Agency: Department of Agriculture, Rural Utilities Service
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), the United States Department of Agriculture's Rural Utilities Service (RUS), invites comments on this information collection for which the Agency intends to request approval from the Office of Management and Budget (OMB).
Type V Drug Master Files for Center for Drug Evaluation and Research-Led Combination Products Using Device Constituent Parts With Electronics or Software; Draft Guidance for Industry; Availability
Document Number: 2019-23585
Type: Notice
Date: 2019-10-29
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 ``Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software.'' A drug master file (DMF) is a voluntary submission to FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. This draft guidance explains when a Type V DMF may be used to submit information regarding a combination product for which the Center for Drug Evaluation and Research (CDER) has primary jurisdiction (i.e., a CDER-led combination product) and which features a device constituent part with electronics and/or software that is planned to be used as a platform, that is, may be used in multiple CDER-led combination products. The draft guidance also describes the administrative process and outlines the recommended content for these Type V DMF submissions and amendments.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-23584
Type: Notice
Date: 2019-10-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; 2019-20 National Postsecondary Student Aid Study (NPSAS:20)
Document Number: 2019-23582
Type: Notice
Date: 2019-10-29
Agency: Department of Education
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Privacy Act of 1974; System of Records
Document Number: 2019-23581
Type: Notice
Date: 2019-10-29
Agency: Department of Education
In accordance with the Privacy Act of 1974, as amended (Privacy Act), the U.S. Department of Education (Department) modifies the system of records entitled ``Federal Student Aid Application File'' (18-11-01). The Federal Student Aid Application File system of records contains information provided by applicants for title IV of the Higher Education Act of 1965, as amended, (HEA) program assistance, which is collected from the Free Application for Federal Student Aid (FAFSA). Among other purposes described in this notice, the information collected is maintained in order to: Determine an applicant's eligibility for the Federal student financial assistance programs authorized by title IV of the HEA; make a loan, grant, or scholarship; and verify the identity of the applicant.