September 19, 2019 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2019-09-19-ReaderAids
Type: Reader Aids
Date: 2019-09-19
Sunshine Act Meeting
Document Number: 2019-20453
Type: Notice
Date: 2019-09-19
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
Sunshine Act Meeting
Document Number: 2019-20427
Type: Notice
Date: 2019-09-19
Agency: Consumer Product Safety Commission, Agencies and Commissions
Sunshine Act Meeting
Document Number: 2019-20426
Type: Notice
Date: 2019-09-19
Agency: Consumer Product Safety Commission, Agencies and Commissions
Sunshine Act Meeting
Document Number: 2019-20421
Type: Notice
Date: 2019-09-19
Agency: National Credit Union Administration, Agencies and Commissions
Children's Health Protection Advisory Committee (CHPAC); Charter Renewal
Document Number: 2019-20344
Type: Notice
Date: 2019-09-19
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is publishing this notice to announce that it is re-establishing the Children's Health Protection Advisory Committee (CHPAC).
Presidential Declaration of a Major Disaster for Public Assistance Only for the State of Arkansas
Document Number: 2019-20331
Type: Notice
Date: 2019-09-19
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 Arkansas (FEMA- 4460-DR), dated 09/13/2019. Incident: Severe Storms, Straight-line Winds, Tornadoes, and Flooding. Incident Period: 06/23/2019 through 06/24/2019.
Special Local Regulations; Ironman Triathlon, Augusta, GA
Document Number: 2019-20330
Type: Rule
Date: 2019-09-19
Agency: Coast Guard, Department of Homeland Security
The Coast Guard will enforce special local regulations for the Ironman Triathlon in Augusta, Georgia on September 29, 2019, to provide for the safety of life on navigable waterways during this event. Our regulation for marine events within the Seventh Coast Guard District identifies the regulated area for this event in Augusta, GA. During the enforcement periods, the operator of any vessel in the regulated area must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.
Science and Technology Reinvention Laboratory (STRL) Personnel Demonstration Project in the Technical Center of the U.S. Army Space and Missile Defense Command (USASMDC)
Document Number: 2019-20329
Type: Notice
Date: 2019-09-19
Agency: Department of Defense, Office of the Secretary
This Federal Register Notice (FRN) serves as notice of the proposed adoption of an existing STRL Personnel Management Demonstration Project by the Technical Center, U.S. Army Space and Missile Defense Command (USASMDC). The Technical Center proposes to adopt, with some modifications, the STRL Personnel Demonstration Project implemented at the U.S. Army Combat Capabilities Development Command (CCDC) Aviation and Missile Center (AvMC) (previously designated as the Aviation and Missile Research, Development, and Engineering Center).
Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h
Document Number: 2019-20328
Type: Notice
Date: 2019-09-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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 collection of information relating to general licensing provisions for biologics license applications (BLAs), changes to an approved application, labeling, revocation and suspension, postmarketing studies status reports, and Form FDA 356h.
Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of Zika Virus
Document Number: 2019-20327
Type: Notice
Date: 2019-09-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Luminex Corp., for the xMAP MultiFLEX Zika RNA Assay. FDA revoked this Authorization on July 3, 2019, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by Luminex Corp. by a letter dated June 18, 2019. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.
Membership in the National Parks Overflights Advisory Group
Document Number: 2019-20326
Type: Notice
Date: 2019-09-19
Agency: Federal Aviation Administration, Department of Transportation
By Federal Register notice on June 3, 2019 the Federal Aviation Administration (FAA) and the National Park Service (NPS) invited interested persons to apply to fill one existing and two upcoming vacancies on the National Parks Overflights Advisory Group (NPOAG). This notice informs the public of the selections made for the vacancies representing air tour operator and environmental concerns. No selection was made for the existing opening representing Native American tribal concerns so this notice also invites persons interested in that opening to apply. Persons previously submitting applications for the Native American tribal representative opening will need to resubmit their application.
Water Quality Trading Under The National Pollutant Discharge Elimination System Program
Document Number: 2019-20324
Type: Notice
Date: 2019-09-19
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is requesting comment on policy approaches for addressing ``baseline'' issues in watersheds with EPA-approved Total Maximum Daily Loads (TMDLs) where policy makers would like to pursue water quality trading as a regulatory option for National Pollutant Discharge Elimination System (NPDES) permit compliance. These policy approaches may also be of interest to stakeholders pursuing market-based water quality improvement programs outside of the NPDES permit program.
Safer Technologies Program for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2019-20322
Type: Notice
Date: 2019-09-19
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 draft guidance entitled ``Safer Technologies Program for Medical Devices.'' This draft guidance describes a new, voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program. Devices and device-led combination products are eligible for this program if they are subject to review under a premarket approval application (PMA), De Novo classification request (``De Novo request''), or premarket notification (510(k)). Consistent with the Agency's statutory mission to protect and promote public health, FDA believes that this ``Safer Technologies Program'' or ``STeP'' will help patients have more timely access to these medical devices and device-led combination products by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance. This draft guidance is not final nor is it in effect at this time.
Proposed Collection; Comment Request for Form 1099-DIV
Document Number: 2019-20317
Type: Notice
Date: 2019-09-19
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Internal Revenue Service, 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 information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning Form 1099-DIV, Dividends and Distributions.
Citizen Petitions and Petitions for Stay of Action Subject to the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Document Number: 2019-20312
Type: Notice
Date: 2019-09-19
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 final guidance for industry entitled ``Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.'' Among other things, this guidance provides FDA's current thinking on what constitutes a 505(q) petition and describes some of the considerations that FDA will take into account in determining whether a petition is submitted with the primary purpose of delaying the approval of an application. This guidance finalizes the draft guidance for industry entitled ``Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act'' issued in October 2018.
Board for International Food and Agricultural Development; Notice of Meeting
Document Number: 2019-20311
Type: Notice
Date: 2019-09-19
Agency: Agency for International Development, Agencies and Commissions
Submission for OMB Review: Assessing Models of Coordinated Services for Low-Income Children and Their Families (AMCS) (New Collection)
Document Number: 2019-20307
Type: Notice
Date: 2019-09-19
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new study, Assessing Models of Coordinated Services for Low-Income Children and Their Families (AMCS).
Meeting of the Civil Nuclear Trade Advisory Committee
Document Number: 2019-20305
Type: Notice
Date: 2019-09-19
Agency: Department of Commerce, International Trade Administration
This notice sets forth the schedule and proposed agenda for a meeting of the Civil Nuclear Trade Advisory Committee (CINTAC).
U.S. Department of Commerce Trade Finance Advisory Council; Meeting
Document Number: 2019-20304
Type: Notice
Date: 2019-09-19
Agency: Department of Commerce, International Trade Administration
The U.S. Department of Commerce Trade Finance Advisory Council (TFAC or Council) will hold a meeting on Thursday, October 3, 2019 at the Milken Institute, in Santa Monica, CA. The meeting is open to the public with registration instructions provided below.
Supplemental Evidence and Data Request on Therapies for Clinically Localized Prostate Cancer
Document Number: 2019-20303
Type: Notice
Date: 2019-09-19
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Therapies for Clinically Localized Prostate Cancer, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Judges Panel of the Malcolm Baldrige National Quality Award
Document Number: 2019-20301
Type: Notice
Date: 2019-09-19
Agency: Department of Commerce, National Institute of Standards and Technology
The Judges Panel of the Malcolm Baldrige National Quality Award (Judges Panel) will meet in closed session Monday, November 4, 2019 through Friday, November 8, 2019, from 8:30 a.m. until 5:30 p.m. Eastern Time each day. The purpose of this meeting is to review recommendations from site visits and recommend 2019 Malcolm Baldrige National Quality Award (Award) recipients. The meeting is closed to the public in order to protect the proprietary data to be examined and discussed at the meeting.
Georgia; Emergency and Related Determinations
Document Number: 2019-20300
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of an emergency for the State of Georgia (FEMA-3422-EM), dated September 1, 2019, and related determinations.
South Carolina; Emergency and Related Determinations
Document Number: 2019-20299
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of an emergency for the State of South Carolina (FEMA-3421-EM), dated September 1, 2019, and related determinations.
Seminole Tribe of Florida; Emergency and Related Determinations
Document Number: 2019-20298
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of an emergency for the Seminole Tribe of Florida (FEMA-3420-EM), dated August 31, 2019, and related determinations.
Florida; Emergency and Related Determinations
Document Number: 2019-20297
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of an emergency for the State of Florida (FEMA-3419-EM), dated August 30, 2019, and related determinations.
Virgin Islands; Emergency and Related Determinations
Document Number: 2019-20296
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of an emergency for the territory of the U.S. Virgin Islands (FEMA-3418-EM), dated August 28, 2019, and related determinations.
Puerto Rico; Emergency and Related Determinations
Document Number: 2019-20294
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of an emergency for the Commonwealth of Puerto Rico (FEMA-3417-EM), dated August 27, 2019, and related determinations.
Florida; Amendment No. 18 to Notice of a Major Disaster Declaration
Document Number: 2019-20293
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of a major disaster for the State of Florida (FEMA-4337-DR), dated September 10, 2017, and related determinations.
Agency Information Collection Activities; Comment Request; Mandatory Civil Rights Data Collection
Document Number: 2019-20292
Type: Notice
Date: 2019-09-19
Agency: Department of Education
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
South Carolina; Amendment No. 1 to Notice of an Emergency Declaration
Document Number: 2019-20290
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of an emergency declaration for the State of South Carolina (FEMA-3421-EM), dated September 1, 2019, and related determinations.
Seminole Tribe of Florida; Amendment No. 1 to Notice of an Emergency Declaration
Document Number: 2019-20289
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of an emergency declaration for the Seminole Tribe of Florida (FEMA-3420-EM), dated August 31, 2019, and related determinations.
Florida; Amendment No. 1 to Notice of an Emergency Declaration
Document Number: 2019-20288
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of an emergency declaration for the State of Florida (FEMA-3419-EM), dated August 30, 2019, and related determinations.
Puerto Rico; Amendment No. 1 to Notice of an Emergency Declaration
Document Number: 2019-20287
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of an emergency declaration for the Commonwealth of Puerto Rico (FEMA-3417-EM), dated August 27, 2019, and related determinations.
California; Amendment No. 1 to Notice of an Emergency Declaration
Document Number: 2019-20286
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of an emergency declaration for the State of California (FEMA-3415-EM), dated July 8, 2019, and related determinations.
California; Amendment No. 1 to Notice of an Emergency Declaration
Document Number: 2019-20285
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This notice amends the notice of an emergency declaration for the State of California (FEMA-3398-EM), dated July 28, 2018, and related determinations.
Wisconsin; Major Disaster and Related Determinations
Document Number: 2019-20284
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of a major disaster for the State of Wisconsin (FEMA-4459-DR), dated August 27, 2019, and related determinations.
Louisiana; Major Disaster and Related Determinations
Document Number: 2019-20283
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of a major disaster for the State of Louisiana (FEMA-4458-DR), dated August 27, 2019, and related determinations.
Muscogee (Creek) Nation; Major Disaster and Related Determinations
Document Number: 2019-20281
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of a major disaster for the Muscogee (Creek) Nation (FEMA-4456-DR), dated August 7, 2019, and related determinations.
West Virginia; Major Disaster and Related Determinations
Document Number: 2019-20278
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of a major disaster for the State of West Virginia (FEMA-4455-DR), dated August 2, 2019, and related determinations.
New Hampshire; Major Disaster and Related Determinations
Document Number: 2019-20275
Type: Notice
Date: 2019-09-19
Agency: Federal Emergency Management Agency, Department of Homeland Security
This is a notice of the Presidential declaration of a major disaster for the State of New Hampshire (FEMA-4457-DR), dated August 15, 2019, and related determinations.
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