December 30, 2019 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 184
Prospective Grant of an Exclusive Patent License: The Development of Autologous Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-1) T Cell Receptor (TCR) for the Treatment of KK-LC-1 Expressing Human Cancer
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to T-Cure Biosciences, Inc. (T-Cure), located in Sherman Oaks, California.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https:// www.samhsa.gov/workplace/resources/drug-testing/certified-lab -list.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; CNCS External Reviewer Application; Proposed Information Collection; Comment Request
The Corporation for National and Community Service (CNCS) has submitted a public information collection request (ICR) entitled CNCS External Reviewer Application for review and approval in accordance with the Paperwork Reduction Act.
Federal Advisory Committee National Emergency Medical Services Advisory Council; Notice of Meeting
NHTSA announces a meeting of the National Emergency Medical Services Advisory Council (NEMSAC) to be held at DOT Headquarters in Washington, DC. This notice announces the date, time, and location of the meeting, which will be open to the public, as well as provide opportunities for public input to the NEMSAC. The purpose of NEMSAC, a nationally recognized council of emergency medical services representatives and consumers, is to advise and consult with DOT and the Federal Interagency Committee on Emergency Medical Services (FICEMS) on matters relating to emergency medical services (EMS).
Cheeses and Related Cheese Products; Proposal To Permit the Use of Ultrafiltered Milk; Reopening the Comment Period
The Food and Drug Administration (FDA or we) is reopening the comment period for the proposed rule published in the Federal Register of October 19, 2005, entitled ``Cheeses and Related Cheese Products; Proposal to Permit the Use of Ultrafiltered Milk.'' The proposed rule would amend our regulations to provide for the use of fluid ultrafiltered (UF) milk in the manufacture of standardized cheeses and related cheese products. We are reopening the comment period to receive new information and further comment on current industry practices regarding the use of fluid UF milk and fluid UF nonfat milk in the manufacture of standardized cheeses and related cheese products, and the declaration of fluid UF milk and fluid UF nonfat milk when used as ingredients in standardized cheeses and related cheese products.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple Treasury Information Collection Requests
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability; Correction
This document corrects the Notice of Availability from the Food and Drug Administration (FDA, Agency, or we) announcing the availability of a draft guidance for industry entitled ``Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act,'' which published in the Federal Register on Monday, December 23, 2019. This draft guidance describes procedures to obtain a National Drug Code (NDC) for an FDA-approved prescription drug that is imported into the United States in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), which would provide an additional avenue through which drugs could be sold at a lower cost in the U.S. market. This draft guidance is intended to address certain challenges in the private market faced by manufacturers seeking to sell their drugs at lower costs. The Notice was published with two omissions. This document corrects those omissions by republishing the Notice in its entirety to include the omitted language.
Notice of Receipt of Petition for Decision That Nonconforming Model Years 2017 Through 2019 Mercedes Benz Maybach S600 Pullman Passenger Cars Are Eligible for Importation
This document announces the National Highway Traffic Safety Administration (NHTSA) receipt of a petition for a decision that model year (MY) 2017-2019 Mercedes Benz Maybach S600 Pullman passenger cars (PCs) that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.-certified version of the 2017-2019 Mercedes Benz Maybach S600 PCs) and are capable of being readily altered to conform to the standards.
Notice of Receipt of Petition for Decision That Nonconforming Model Year 2015 Porsche 918 Passenger Cars Are Eligible for Importation
This document announces the National Highway Traffic Safety Administration (NHTSA) receipt of a petition for a decision that model year (MY) 2015 Porsche 918 passenger cars (PCs) that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), are eligible for importation into the United States because they are substantially similar to vehicles that were originally manufactured for sale in the United States and that were certified by their manufacturer as complying with the safety standards (the U.S.-certified version of the 2015 Porsche 918 PCs) and are capable of being readily altered to conform to the standards.
Notice of Receipt of Petition for Decision That Nonconforming Model Year 2018-2019 Swift Sprite Alpine 4 Single Axle Camper Trailers Are Eligible for Importation
This document announces the National Highway Traffic Safety Administration (NHTSA) receipt of a petition for a decision that model year (MY) 2018-2019 Swift Sprite Alpine 4 single axle camper trailers that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards (FMVSS), are eligible for importation into the United States because they are capable of being readily altered to conform to the standards.
Deepwater Port License Application: Texas COLT LLC
The Maritime Administration (MARAD) and the U.S. Coast Guard (USCG) announce the cancellation of all actions related to the processing of a license application for the proposed Texas COLT LLC deepwater port. The action announced here includes cancellation of all activities related to the preparation of an Environmental Impact Statement that was announced on Friday, March 8, 2019, in Federal Register Volume 84 Number 46 (Notice of Intent; Notice of Public Meeting; Request for Comments). The action is taken in response to the applicant's decision to withdraw the application.
Advanced Methods To Target and Eliminate Unlawful Robocalls, Call Authentication Trust Anchor
In this document, the Consumer and Governmental Affairs Bureau (Bureau), in consultation with the Wireline Competition Bureau (WCB) and Public Safety and Homeland Security Bureau (PSHSB), solicits input for the first staff report on call blocking, as directed by the Federal Communications Commission (FCC or Commission). The Bureau seeks data and other information on the availability and effectiveness of call- blocking tools offered to consumers, the impact of FCC actions on illegal calls, the impact of call blocking on 911 services and public safety, and any other information that may inform the Commission's analysis of the state of deployment of advanced methods and tools to eliminate illegal and unwanted calls.
Agency Information Collection Activities; Comment Request; 2016/20 Baccalaureate and Beyond (B&B:16/20) Full-Scale Study
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Technical Resource for Incident Prevention (TRIPwire) User Registration and Questionnaire
DHS CISA ISD will submit the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. CISA previously published this ICR for a 60-day public comment period. No comments were received by CISA. The purpose of this notice is to allow an additional 30 days for public comments.
Fisheries of the Exclusive Economic Zone Off Alaska; Chinook Salmon Prohibited Species Catch Limits in the Gulf of Alaska
NMFS is reapportioning the projected unused amount, 3,342 Chinook salmon prohibited species catch limit, from the vessels participating in directed fishing for pollock in the Central Regulatory area of the Gulf of Alaska (GOA) to vessels participating in directed fishing for pollock in the Western Regulatory area of the GOA. This action is consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the Gulf of Alaska.
Information Collection Being Submitted to the Office of Management and Budget for Emergency Review and Approval
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The Commission may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Submission for OMB Review; 30-Day Comment Request Post-Award Reporting Requirements Including Research Performance Progress Report Collection (OD/OPERA)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Submission for OMB Review; 30-Day Comment Request PHS Applications and Pre-Award Reporting Requirements (OD/OPERA)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Proposed Agency Information Collection Activities; Comment Request
Under the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, FRA seeks approval of the Information Collection Request (ICR) abstracted below. Before submitting this ICR to the Office of Management and Budget (OMB) for approval, FRA is soliciting public comment on specific aspects of the activities identified in the ICR.
Commission Information Collection Activities (FERC-923); Comment Request; Extension
In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the requirements and burden of the information collection described below.
Agency Information Collection Activities; Proposed Collection; Comment Request; Consumer Product Risk Reduction Valuation Study: Cognitive Interviews & Focus Groups
The Consumer Product Safety Commission (CPSC) is announcing an opportunity for public comment on a new proposed collection of information by the agency. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register for each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed collection to conduct cognitive interviews and focus groups that will assess consumer comprehension of risk associated with consumer products.
Senior Executive Service Performance Review Board
This notice announces the membership of the Chemical Safety and Hazard Investigation Review Board (CSB) Senior Executive Service (SES) Performance Review Board (PRB).
Draft Environmental Assessment and Draft Habitat Conservation Plan; Receipt of an Application for an Incidental Take Permit, Blue Creek Wind Farm, Van Wert and Paulding Counties, Ohio
We, the U.S. Fish and Wildlife Service, have received an application from Blue Creek Wind Farm, LLC (applicant), for an incidental take permit (ITP) under the Endangered Species Act of 1973, as amended, for its Blue Creek Wind Farm project. If approved, the ITP would authorize the incidental take of the Indiana bat and the northern long-eared bat. The applicant has prepared a draft habitat conservation plan (HCP), which is available for public review. We also announce the availability of a draft environmental assessment, which has been prepared in accordance with the requirements of the National Environmental Policy Act. We request public comment on the application and associated documents.
Comment Request; Multiple Internal Revenue Service Information Collection Requests
The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.
Submission for OMB Review; Provision of Child Support Services in IV-D Cases Under the Hague Child Support Convention; Federally-Approved Forms (OMB #0970-0488)
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) is requesting a three-year extension of the Hague Child Support Forms (OMB #0970-0488, expiration 4/30/2020). There are no changes requested to the form.
Submission for OMB Review; Coparenting and Healthy Relationship and Marriage Education for Dads (New Collection)
The Administration for Children and Families (ACF), Office of Planning, Research, and Evaluation (OPRE) proposes to collect information as part of the Coparenting and Healthy Relationship and Marriage Education for Dads (CHaRMED) study. The purpose of the CHaRMED study is to better understand the services that fatherhood programs provide in the areas of Healthy Marriage and Relationship Education (HMRE) and coparenting to learn what strategies hold promise for promoting active engagement in these services.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; State Health Insurance Assistance Program (SHIP) Data Performance Reports and Information Collection Tools
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This is a revision request for the Office of Management and Budget (OMB) approval for the modification and use of the Data Performance Reports and Information Collection tools for the State Health Insurance Assistance Program (SHIP) under OMB 0985-0040 that expires March 31, 2020.
Agency Information Collection Activities; Proposed Collection; Comment Request; SHIP-SMP Survey of Group Outreach and Education Events, Formerly the “Senior Medicare Program National Beneficiary Survey”, OMB #0985-0056
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 Proposed Revision and solicits comments on the information collection requirements related to the ``National SHIP-SMP Beneficiary Survey of Group Outreach and Education Events''.
Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Construction of the Port of Alaska's Petroleum and Cement Terminal, Anchorage, Alaska
NMFS has received a request from the Port of Alaska (POA) for authorization to take marine mammals incidental to pile driving associated with the construction of a new Petroleum and Cement Terminal (PCT) in Knik Arm, Alaska. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue two successive incidental harassment authorizations (IHAs) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on possible one-year renewals that could be issued under certain circumstances and if all requirements are met, as described in Request for Public Comments at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorizations and agency responses will be summarized in the final notice of our decision.
Agency Information Collection Activities; Proposed Collection; Comment Request; SHIP-SMP Survey of One-on-One Assistance, Formerly the “National Beneficiary Survey of State Health Insurance Assistance Program (SHIP)”, OMB #0985-0057
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 Proposed Revision and solicits comments on the information collection requirements related to the ``SHIP-SMP Survey of One-on-One Assistance''.
Privacy Act of 1974: System of Records
In accordance with the Privacy Act of 1974, the Department of Transportation proposes to rescind a system of records under the Privacy Act of 1974 entitled DOT/FMCSA 006 SAFETYNET. This system of records facilitates authorized sharing of Department of Transportation Federal Motor Carrier Administration records of companies and drivers of commercial motor vehicles and shipping and freight-forwarding companies registered with FMCSA collected and maintained in the Motor Carrier Information Management System (MCMIS).
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification
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 information collection associated with medical device premarket notification (510(k)).
Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978
The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of permit applications received.
Proposed Agency Information Collection Activities; Comment Request
Under the Paperwork Reduction Act of 1995 (PRA) and its implementing regulations, FRA is informing the public that FRA proposes to make three minor revisions to the Quarterly Positive Train Control (PTC) Progress Report Form (Form FRA F 6180.165) and Annual PTC Progress Report Form (Form FRA F 6180.166), which the Office of Management and Budget (OMB) previously approved on September 24, 2018, under its regular processing procedures. In addition, FRA is now proposing to require host railroads operating FRA-certified PTC systems to submit a Statutory Notification of PTC System Failures (Form FRA F 6180.177) to fulfill the temporary reporting requirement under the Positive Train Control Enforcement and Implementation Act of 2015 (PTCEI Act), and FRA is proposing an alternative reporting frequency and reporting location, as the statutory mandate authorizes FRA to establish. Before submitting this revised information collection request (ICR) to OMB for regular clearance and approval, FRA is soliciting public comment on specific aspects of the proposed ICR described below.
Funding Availability: Homeless Providers Grant and Per Diem Program
The Department of Veterans Affairs (VA) is announcing the availability of per diem funds to eligible entities to provide transitional housing beds or service centers for Veterans who are homeless or at risk for becoming homeless under VA's Homeless Providers GPD Program models. VA expects to fund approximately 11,500 beds and approximately 20 service center applications with this Notice of Funding Availability (NOFA) for applicants who will offer one (1) or a combination of the transitional housing bed models (i.e., Bridge Housing, Low Demand, Hospital-to-Housing, Clinical Treatment and Service-Intensive Transitional Housing) and for applicants who will offer service centers. Funding is based on a variety of factors including the quantity and quality of applications as well as the availability of funding.
Polyester Staple Fiber From Korea; Rescission of Antidumping Duty Administrative Review; 2018-2019
The Department of Commerce (Commerce) is rescinding the administrative review of the antidumping duty (AD) order on polyester staple fiber from Korea for the period of review (POR) May 1, 2018 through April 30, 2019, based on the timely withdrawal of the requests for review.
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