January 8, 2020 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2020-01-08-ReaderAids
Type: Reader Aids
Date: 2020-01-08
Sunshine Act Meetings
Document Number: 2020-00168
Type: Notice
Date: 2020-01-08
Agency: Securities and Exchange Commission, Agencies and Commissions
Notice of Agreements Filed
Document Number: 2020-00114
Type: Notice
Date: 2020-01-08
Agency: Federal Maritime Commission, Agencies and Commissions
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2020-00113
Type: Notice
Date: 2020-01-08
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2020-00112
Type: Notice
Date: 2020-01-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2020-00111
Type: Notice
Date: 2020-01-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00110
Type: Notice
Date: 2020-01-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00109
Type: Notice
Date: 2020-01-08
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Proposed Filing of Plats of Survey; Montana
Document Number: 2020-00108
Type: Notice
Date: 2020-01-08
Agency: Department of the Interior, Bureau of Land Management
The plats of survey for the lands described in this notice are scheduled to be officially filed 30 calendar days after the date of this publication in the BLM Montana State Office, Billings, Montana. The surveys, which were executed at the request of the Bureau of Land Management, Butte Field Office, Butte Montana, are necessary for the management of these lands.
Proposed Information Collection Activity; Data Collection for the Next Generation of Enhanced Employment Strategies Project (New Collection)
Document Number: 2020-00107
Type: Notice
Date: 2020-01-08
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Planning, Research, and Evaluation (OPRE) within the Administration for Children and Families (ACF) is proposing data collection activities conducted for the Next Generation of Enhanced Employment Strategies (NextGen) Project. The objective of this project is to identify and rigorously evaluate innovative interventions designed to promote employment and economic security among low-income individuals with complex challenges to employment. The project will include an experimental impact study, descriptive study, and cost study.
Supplemental Evidence and Data Request on Treatments for Acute Pain: A Systematic Review
Document Number: 2020-00104
Type: Notice
Date: 2020-01-08
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 Treatments for Acute Pain: A Systematic Review, 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.
Certain Collated Steel Staples From the People's Republic of China: Preliminary Affirmative Determination of Sales at Less Than Fair Value, Preliminary Affirmative Determination of Critical Circumstances, Postponement of Final Determination and Extension of Provisional Measures
Document Number: 2020-00103
Type: Notice
Date: 2020-01-08
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) preliminarily determines that certain collated steel staples (collated staples) from the People's Republic of China (China) are being, or are likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is October 1, 2018 through March 31, 2019.
Notice of Availability of Final Supplement Analysis of the Complex Transformation Supplemental Programmatic Environmental Impact Statement
Document Number: 2020-00102
Type: Notice
Date: 2020-01-08
Agency: Department of Energy, National Nuclear Security Administration
The National Nuclear Security Administration (NNSA), a semi- autonomous agency within the United States (U.S.) Department of Energy (DOE), announces the availability of a Final Supplement Analysis (SA) of the Complex Transformation Supplemental Programmatic Environmental Impact Statement (SPEIS) (DOE/EIS-0236-SA-02). NNSA prepared the Final SA to determine whether, prior to implementing a Modified Distributed Center of Excellence (DCE) Alternative for plutonium operations to enable producing plutonium pits at a rate of no fewer than 80 pits per year by 2030, the existing Complex Transformation SPEIS should be supplemented, a new environmental impact statement be prepared, or that no further National Environmental Policy Act (NEPA) analysis is required. NNSA published the Draft Supplement Analysis of the Complex Transformation Supplemental Programmatic Environmental Impact Statement on June 28, 2019, and announced a 45-day comment period. After considering all comments received, NNSA prepared the Final SA and concluded that no further NEPA documentation at a programmatic level is required.
North Pacific Fishery Management Council; Public Meeting
Document Number: 2020-00099
Type: Notice
Date: 2020-01-08
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The North Pacific Fishery Management Council (Council) and its advisory committees will meet January 27, 2020 to February 2, 2020.
New England Fishery Management Council; Public Meeting
Document Number: 2020-00096
Type: Notice
Date: 2020-01-08
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The New England Fishery Management Council (Council) is scheduling a public meeting of its Groundfish Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: 2020-00095
Type: Notice
Date: 2020-01-08
Agency: Federal Reserve System, Agencies and Commissions
Quartz Surface Products From India and Turkey; Scheduling of the Final Phase of Countervailing Duty and Antidumping Duty Investigations
Document Number: 2020-00094
Type: Notice
Date: 2020-01-08
Agency: International Trade Commission, Agencies and Commissions
The Commission hereby gives notice of the scheduling of the final phase of antidumping and countervailing duty investigation Nos. 701-TA-624-625 and 731-TA-1450-1451 (Final) pursuant to the Tariff Act of 1930 (``the Act'') to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of quartz surface products from India and Turkey, provided for in subheading 6810.99.00 of the Harmonized Tariff Schedule of the United States, preliminarily determined by the Department of Commerce (``Commerce'') to be subsidized and sold at less-than-fair-value.
Granting of Requests for Early Termination of the Waiting Period Under the Premerger Notification Rules
Document Number: 2020-00093
Type: Notice
Date: 2020-01-08
Agency: Federal Trade Commission, Agencies and Commissions
Union Pacific Railroad Company-Temporary Trackage Rights Exemption-BNSF Railway Company
Document Number: 2020-00092
Type: Notice
Date: 2020-01-08
Agency: Surface Transportation Board, Department of Transportation
Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry; Extension of Comment Period
Document Number: 2020-00091
Type: Notice
Date: 2020-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice entitled ``Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry'' that appeared in the Federal Register of October 25, 2019. The Agency is taking this action to allow interested persons additional time to submit comments.
Civil Monetary Penalties-2020 Adjustment
Document Number: 2020-00089
Type: Rule
Date: 2020-01-08
Agency: Surface Transportation Board, Department of Transportation
The Surface Transportation Board (Board) is issuing a final rule to implement the annual inflationary adjustment to its civil monetary penalties, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.
Combined Notice of Filings #1
Document Number: 2020-00088
Type: Notice
Date: 2020-01-08
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #2
Document Number: 2020-00086
Type: Notice
Date: 2020-01-08
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings
Document Number: 2020-00085
Type: Notice
Date: 2020-01-08
Agency: Department of Energy, Federal Energy Regulatory Commission
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Oil Pollution Prevention; Spill Prevention, Control, and Countermeasure (SPCC) Plans (Renewal)
Document Number: 2020-00079
Type: Notice
Date: 2020-01-08
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Spill Prevention, Control, and Countermeasure (SPCC) Plans (EPA ICR Number 0328.18, OMB Control Number 2050-0021) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through May 31, 2020. Public comments were previously requested via the Federal Register on September 11, 2019, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Tips and Complaints Regarding Environmental Violations (Renewal)
Document Number: 2020-00078
Type: Notice
Date: 2020-01-08
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Tips and Complaints Regarding Environmental Violations (EPA ICR Number 2219.03, OMB Control Number 2020-0032) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through January 21, 2020. Public comments were previously requested via the Federal Register on August 22, 2019 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Sewage Sludge Treatment Plants (Renewal)
Document Number: 2020-00077
Type: Notice
Date: 2020-01-08
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), NSPS for Sewage Sludge Treatment Plants (EPA ICR Number 1063.14, OMB Control Number 2060-0035), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through March 31, 2020. Public comments were previously requested, via the Federal Register, on May 6, 2019 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may neither conduct nor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications
Document Number: 2020-00076
Type: Notice
Date: 2020-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19 New Drug Applications
Document Number: 2020-00075
Type: Notice
Date: 2020-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 19 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration (All Food and Drug Administration-Regulated Products)
Document Number: 2020-00074
Type: Notice
Date: 2020-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 for the generic collection for focus groups as used by FDA (all FDA-regulated products).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Feed Regulatory Program Standards
Document Number: 2020-00073
Type: Notice
Date: 2020-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Alaco, Inc., et al.; Proposal To Withdraw Approval of Seven New Animal Drug Applications; Opportunity for a Hearing
Document Number: 2020-00072
Type: Notice
Date: 2020-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Veterinary Medicine (CVM) is proposing to withdraw approval of seven new animal drug applications (NADAs) and is announcing an opportunity for the NADA holders to request a hearing on this proposal. The basis for the proposal is that the NADA holders have repeatedly failed to file required annual reports for those NADAs.
Modernizing the Food and Drug Administration's Data Strategy; Public Meeting; Request for Comments
Document Number: 2020-00071
Type: Notice
Date: 2020-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Modernizing FDA's Data Strategy.'' The purpose of the public meeting and the request for comments is to discuss possible Agency level approaches to modernizing FDA's data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics.
Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff; Extension of Comment Period
Document Number: 2020-00070
Type: Notice
Date: 2020-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice entitled ``Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff; Availability'' that appeared in the Federal Register of November 25, 2019. The Agency is taking this action to allow interested persons additional time to submit comments before finalization of the guidance.
Proposed Information Collection; Comment Request; Voluntary Self-Disclosure of Antiboycott Violations
Document Number: 2020-00069
Type: Notice
Date: 2020-01-08
Agency: Department of Commerce, Bureau of Industry and Security
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Proposed Information Collection; Comment Request; Voluntary Self-Disclosure of Violations of the Export Administration Regulations
Document Number: 2020-00068
Type: Notice
Date: 2020-01-08
Agency: Department of Commerce, Bureau of Industry and Security
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2020-00067
Type: Notice
Date: 2020-01-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2020-00066
Type: Notice
Date: 2020-01-08
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Comment Request; Job Corps Application Data
Document Number: 2020-00064
Type: Notice
Date: 2020-01-08
Agency: Employment and Training Administration, Department of Labor
The Department of Labor (DOL), Employment Training Administration (ETA) is soliciting comments concerning a proposed extension for the authority to conduct the information collection request (ICR) titled ``Job Corps Application Data.'' This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).
Revocation of Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection of and/or Diagnosis of Zika or Ebola Virus
Document Number: 2020-00063
Type: Notice
Date: 2020-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the revocation of three Emergency Use Authorizations (EUAs) (the Authorizations) issued to OraSure Technologies, Inc. (OraSure) for the OraQuick Ebola Rapid Antigen Test used with whole blood specimens; OraSure for the OraQuick Ebola Rapid Antigen Test used with cadaveric oral fluid swab specimens; and DiaSorin Inc. (DiaSorin) for the LIAISON XL Zika Capture IgM II assay. FDA revoked both of OraSure's Authorizations on October 10, 2019, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in consideration of a De Novo classification request granted to OraSure for the OraQuick Ebola Rapid Antigen Test on October 10, 2019. FDA revoked DiaSorin's Authorization on October 28, 2019, under the FD&C Act, in consideration of the premarket clearance of DiaSorin's LIAISON XL Zika Capture IgM II assay, which FDA determined to be substantially equivalent to a legally marketed class II predicate device on October 28, 2019. The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.
Agency Information Collection Activities: Submission for OMB Review; Comment Request (OMB No. 3064-0029; -0030; -0070; -0104; -0204)
Document Number: 2020-00058
Type: Notice
Date: 2020-01-08
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
The FDIC, as part of its obligations under the Paperwork Reduction Act of 1995, invites the general public and other Federal agencies to take this opportunity to comment on the renewal of the existing information collections described below. On October 29, 2019, the FDIC requested comment for 60 days on a proposal to renew these information collections. No comments were received. The FDIC hereby gives notice of its plan to submit to OMB a request to approve the renewal of these information collections, and again invites comment on their renewal.
Agency Information Collection Activity: (Complaint of Employment Discrimination; Information for Pre-Complaint Processing)
Document Number: 2020-00055
Type: Notice
Date: 2020-01-08
Agency: Department of Veterans Affairs
The Office of Resolution Management (ORM), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to the notice.
Arizona Public Service Company; Palo Verde Nuclear Generating Station, Units 1, 2, and 3; Extend Implementation Times
Document Number: 2020-00054
Type: Notice
Date: 2020-01-08
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is considering issuance of amendments to Renewed Facility Operating License Nos. NPF- 41, NPF-51, and NPF-74, issued to Arizona Public Service Company (the licensee), for operation of the Palo Verde Nuclear Generating Station, Units 1, 2, and 3 (Palo Verde). The proposed amendments would extend the implementation time from February 23, 2020, to August 31, 2020, for the NRC-approved license amendments issued May 29, 2019, associated with risk-informed completion times in accordance with Nuclear Energy Institute (NEI) Topical Report NEI 06-09, Revision 0-A, ``Risk-Informed Technical Specification Initiative 4b, Risk-Managed Technical Specifications (RMTS) Guidelines.'' The licensee is requesting this extension due to unforeseen circumstances.
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