October 2019 – Federal Register Recent Federal Regulation Documents

Results 451 - 500 of 2,601
National Environmental Policy Act; Mars 2020 Mission
Document Number: 2019-23363
Type: Notice
Date: 2019-10-25
Agency: National Aeronautics and Space Administration, Agencies and Commissions
Pursuant to the National Environmental Policy Act of 1969 (NEPA), as amended, the Council on Environmental Quality Regulations for Implementing the Procedural Provisions of NEPA, and NASA's procedures for implementing NEPA, NASA announces the availability of the Draft supplement to the Final Environmental Impact Statement for the Mars 2020 Mission (Supplemental EIS) for public review and comment. The Draft Supplemental EIS provides updated information related to the potential environmental impacts associated with the proposed Mars 2020 mission.
Pesticide Product Registration; Receipt of Applications for New Active Ingredients (September 2019)
Document Number: 2019-23361
Type: Notice
Date: 2019-10-25
Agency: Environmental Protection Agency
EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.
National Register of Historic Places; Notification of Pending Nominations and Related Actions
Document Number: 2019-23354
Type: Notice
Date: 2019-10-25
Agency: Department of the Interior, National Park Service
The National Park Service is soliciting comments on the significance of properties nominated before October 5, 2019, for listing or related actions in the National Register of Historic Places.
Pesticide Product Registration; Receipt of Applications for New Uses (September 2019)
Document Number: 2019-23353
Type: Notice
Date: 2019-10-25
Agency: Environmental Protection Agency
EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; 2019 Commercial Accountability Measure and Closure for South Atlantic Gray Triggerfish; July Through December Season
Document Number: 2019-23352
Type: Rule
Date: 2019-10-25
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS implements accountability measures for commercial gray triggerfish in the exclusive economic zone (EEZ) of the South Atlantic. NMFS projects commercial landings for gray triggerfish will reach the commercial annual catch limit (ACL)(commercial quota) for the July through December season by October 27, 2019. Therefore, NMFS is closing the commercial sector for gray triggerfish in the South Atlantic EEZ on October 27, 2019. This closure is necessary to protect the gray triggerfish resource.
Notice of Antarctic Meteorite Collection, Documentation, and Curation Plan Received Under the Antarctic Conservation Act of 1978
Document Number: 2019-23350
Type: Notice
Date: 2019-10-25
Agency: National Science Foundation, Agencies and Commissions
On March 31, 2003, the National Science Foundation (NSF) issued a final rule that authorized the collection of meteorites in Antarctica for scientific purposes only. In addition, the regulations provide requirements for appropriate collection, handling, documentation, and curation of Antarctic meteorites to preserve their scientific value. These regulations implement the Antarctic Conservation Act of 1978, as amended by the Antarctic Science, Tourism and Conservation Act of 1996, and Article 7 of the Protocol on Environmental Protection to the Antarctic Treaty. The NSF is required to publish notice of the availability of Meteorite Collection, Documentation, and Curation Plans received under the Antarctic Conservation Act of 1978. This is the required notice.
Manufactured Housing Consensus Committee (MHCC): Notice Inviting Nominations of Individuals To Serve on the Committee
Document Number: 2019-23349
Type: Notice
Date: 2019-10-25
Agency: Department of Housing and Urban Development
The Department of Housing and Urban Development invites the public to nominate individuals for appointment, with the approval of the Secretary, to the Manufactured Housing Consensus Committee (MHCC), a federal advisory committee established by the National Manufactured Housing Construction and Safety Standards Act of 1974, as amended by the Manufactured Housing Improvement Act of 2000. The Department will make appointments from nominations submitted in response to this Notice. Also, individuals that applied last year do not need to re- apply; pursuant to this notice those applications are on file and may be considered for future appointments.
Schedules of Controlled Substances: Placement of Cyclopropyl Fentanyl, Methoxyacetyl fentanyl, ortho-Fluorofentanyl, and para-Fluorobutyryl Fentanyl in Schedule I
Document Number: 2019-23348
Type: Rule
Date: 2019-10-25
Agency: Drug Enforcement Administration, Department of Justice
With the issuance of this final order, the Acting Administrator of the Drug Enforcement Administration maintains the placement of the substances cyclopropyl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide), methoxyacetyl fentanyl (2-methoxy-N-(1-phenethylpiperidin-4-yl)-N- phenylacetamide), ortho-fluorofentanyl (N-(2-fluorophenyl)-N-(1- phenethylpiperidin-4-yl)propionamide), and para-fluorobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide), including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, in schedule I of the Controlled Substances Act. This scheduling action discharges the United States' obligations under the Single Convention on Narcotic Drugs (1961). This action continues to impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research or conduct instructional activities with, or possess), or propose to handle, cyclopropyl fentanyl, methoxyacetyl fentanyl, ortho- fluorofentanyl, and para-fluorobutyryl fentanyl.
Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of North Carolina
Document Number: 2019-23347
Type: Notice
Date: 2019-10-25
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of North Carolina (FEMA-4465-DR), dated 10/04/2019. Incident: Hurricane Dorian. Incident Period: 09/01/2019 through 09/09/2019.
Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of Wisconsin
Document Number: 2019-23346
Type: Notice
Date: 2019-10-25
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Wisconsin (FEMA-4459-DR), dated 08/27/2019. Incident: Severe Storms, Tornadoes, Straight-line Winds, and Flooding. Incident Period: 07/18/2019 through 07/20/2019.
Presidential Declaration Amendment of a Major Disaster for Public Assistance Only for the State of Louisiana
Document Number: 2019-23345
Type: Notice
Date: 2019-10-25
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Louisiana (FEMA-4462-DR), dated 09/19/2019. Incident: Flooding. Incident Period: 05/10/2019 through 07/24/2019.
Notice of Request for Revision to and Extension of Approval of an Information Collection; Introduction of Organisms and Products Altered or Produced Through Genetic Engineering
Document Number: 2019-23344
Type: Notice
Date: 2019-10-25
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the introduction of organisms and products altered or produced through genetic engineering.
Concurrence With OIE Risk Designations for Bovine Spongiform Encephalopathy
Document Number: 2019-23343
Type: Notice
Date: 2019-10-25
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are advising the public of our preliminary concurrence with the World Organization for Animal Health's (OIE) bovine spongiform encephalopathy (BSE) risk designations for Ecuador and Serbia. The OIE recognizes Ecuador as being of controlled risk for BSE and Serbia as being of negligible risk for BSE. We are taking this action based on our review of information supporting the OIE's risk designations for these regions.
Stainless Steel Flanges From the People's Republic of China: Rescission of Countervailing Duty Administrative Review; 2019
Document Number: 2019-23342
Type: Notice
Date: 2019-10-25
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) is rescinding the administrative review of the countervailing duty (CVD) order on stainless steel flanges from the People's Republic of China (China) for the period January 23, 2018, through December 31, 2018.
Fresh Tomatoes From Mexico: Final Determination of Sales at Less Than Fair Value
Document Number: 2019-23341
Type: Notice
Date: 2019-10-25
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) determines that fresh tomatoes from Mexico are being, or are likely to be, sold in the United States at less than fair value (LTFV). The final estimated weighted- average dumping margins are listed below in the ``Final Determination'' section of this notice.
Certain Large Diameter Carbon and Alloy Seamless Standard, Line, and Pressure Pipe (Over 41/2
Document Number: 2019-23340
Type: Notice
Date: 2019-10-25
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) is rescinding the administrative review of the antidumping duty (AD) order on certain large diameter carbon and alloy seamless standard, line, and pressure pipe (over 4\1/2\ inches) from Japan for the period of review (POR) June 1, 2018 through May 31, 2019, based on the timely withdrawal of the request for review.
Certain Small Diameter Carbon and Alloy Seamless Standard, Line, and Pressure Pipe (Under 41/2
Document Number: 2019-23339
Type: Notice
Date: 2019-10-25
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) is rescinding the administrative review of the antidumping duty (AD) order on certain small diameter carbon and alloy seamless standard, line, and pressure pipe (under 4\1/2\ inches) from Japan for the period of review (POR) June 1, 2018 through May 31, 2019, based on the timely withdrawal of the request for review.
Vertical Metal File Cabinets From the People's Republic of China: Final Affirmative Countervailing Duty Determination
Document Number: 2019-23338
Type: Notice
Date: 2019-10-25
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) determines that countervailable subsidies are being provided to producers and exporters of vertical metal file cabinets (file cabinets) from the People's Republic of China (China).
Vertical Metal File Cabinets From the People's Republic of China: Final Determination of Sales at Less Than Fair Value
Document Number: 2019-23337
Type: Notice
Date: 2019-10-25
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) determines that vertical metal file cabinets (file cabinets) 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).
High Pressure Steel Cylinders From the People's Republic of China: Rescission of Countervailing Duty Administrative Review: 2018
Document Number: 2019-23336
Type: Notice
Date: 2019-10-25
Agency: Department of Commerce, International Trade Administration
The Department of Commerce (Commerce) is rescinding the administrative review of the countervailing duty (CVD) order on certain high pressure steel cylinders (steel cylinders) from the People's Republic of China (China) for the period of review (POR) January 1, 2018 through December 31, 2018, based on the timely withdrawal of the requests for review.
Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry
Document Number: 2019-23335
Type: Notice
Date: 2019-10-25
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 revised draft guidance for FDA staff and industry entitled ``Drug Products Labeled as Homeopathic.'' The revised draft guidance, like the original version, describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the United States without the required FDA approval that potentially pose higher risk to public health. In response to comments received, we have revised the draft guidance and are reissuing it in draft form to enable the public to review and comment before it is finalized.
Compliance Policy Guide Sec. 400.400 Conditions Under Which Homeopathic Drugs May Be Marketed; Withdrawal of Guidance
Document Number: 2019-23334
Type: Notice
Date: 2019-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of Compliance Policy Guide Sec. 400.400 (CPG 400.400) entitled ``Conditions Under Which Homeopathic Drugs May be Marketed,'' which was issued in 1988.
Information Collection Being Reviewed by the Federal Communications Commission
Document Number: 2019-23333
Type: Notice
Date: 2019-10-25
Agency: Federal Communications Commission, Agencies and Commissions
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 FCC 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.
Information Collections Being Submitted for Review and Approval to Office of Management and Budget
Document Number: 2019-23332
Type: Notice
Date: 2019-10-25
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, 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. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it might ``further reduce the information collection burden for 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 Office of Management and Budget (OMB) 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 OMB control number.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
Document Number: 2019-23331
Type: Notice
Date: 2019-10-25
Agency: Federal Communications Commission, Agencies and Commissions
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 FCC 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.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
Document Number: 2019-23330
Type: Notice
Date: 2019-10-25
Agency: Federal Communications Commission, Agencies and Commissions
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 FCC 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.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
Document Number: 2019-23329
Type: Notice
Date: 2019-10-25
Agency: Federal Communications Commission, Agencies and Commissions
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 FCC 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.
Information Collection Being Reviewed by the Federal Communications Commission
Document Number: 2019-23328
Type: Notice
Date: 2019-10-25
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. 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 FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) 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 OMB control number.
Proposed Information Collection; Comment Request; Monthly Retail Surveys
Document Number: 2019-23327
Type: Notice
Date: 2019-10-25
Agency: Census Bureau, Department of Commerce
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.
Notice of Orders Issued Under Section 3 of the Natural Gas Act During September 2019
Document Number: 2019-23326
Type: Notice
Date: 2019-10-25
Agency: Department of Energy
The Office of Fossil Energy (FE) of the Department of Energy gives notice that during September 2019, it issued orders granting authority to import and export natural gas, to import and export liquefied natural gas (LNG), to import and export compressed natural gas (CNG), and vacating authorization. These orders are summarized in the attached appendix and may be found on the FE website at https:// www.energy.gov/fe/listing-doefe-authorizationsorders-issued-2 019. They are also available for inspection and copying in the U.S. Department of Energy (FE-34), Division of Natural Gas Regulation, Office of Regulation, Analysis, and Engagement, Office of Fossil Energy, Docket Room 3E-033, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585, (202) 586-9478. The Docket Room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.
Kingdom Energy Products; Hillside Clean Energy LLC; Notice of Transfer of Exemption
Document Number: 2019-23324
Type: Notice
Date: 2019-10-25
Agency: Department of Energy, Federal Energy Regulatory Commission
30-Day Notice of Proposed Information Collection: Application for a U.S. Passport: Corrections, Name Change Within 1 Year of Passport Issuance, and Limited Passport Holders
Document Number: 2019-23322
Type: Notice
Date: 2019-10-25
Agency: Department of State
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Proposed Agency Information Collection Activities; Comment Request
Document Number: 2019-23321
Type: Notice
Date: 2019-10-25
Agency: Federal Reserve System, Agencies and Commissions
The Board of Governors of the Federal Reserve System (Board) invites comment on a proposal to extend for three years, with revision, the Intermittent Survey of Businesses (FR 1374; OMB No. 7100-0302).
Marine Mammals; File No. 23169
Document Number: 2019-23320
Type: Notice
Date: 2019-10-25
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that Red Rock Films, 625 Sligo Avenue, Silver Spring, MD 20910 (Responsible Party: Brian Armstrong), has applied in due form for a permit to conduct commercial or educational photography on marine mammals.
Notice of Meeting
Document Number: 2019-23319
Type: Notice
Date: 2019-10-25
Agency: Commission of Fine Arts, Agencies and Commissions
Endangered and Threatened Wildlife and Plants; Draft Amendment to the Recovery Plan for the Rough Popcornflower
Document Number: 2019-23317
Type: Notice
Date: 2019-10-25
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service (Service), announce the availability of a draft amendment updating the recovery criteria in the Recovery Plan for the Rough Popcornflower (Plagiobothrys hirtus). Rough popcornflower, listed as endangered under the Endangered Species Act (ESA), is an annual herb in the borage family (Boraginaceae), endemic to wet swales and meadows in Douglas County, Oregon. We are updating recovery criteria to better assist in determining when the species has recovered to the point that it may be reclassified as threatened, or that the protections afforded by the ESA are no longer necessary and the species may be removed from the ESA's protections. We request review of this draft recovery plan amendment and invite comments from local, State, Tribal, and Federal agencies, nongovernmental organizations, and the public.
Program-Specific Guidance About Medical Use Licenses
Document Number: 2019-23316
Type: Notice
Date: 2019-10-25
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) has issued Revision 3 to NUREG-1556, Volume 9, ``Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses.'' NUREG-1556 Volume 9 has been revised to include information on updated regulatory requirements, safety culture, security of radioactive materials, protection of sensitive information, and changes in regulatory policies and practices consistent with current regulations. This volume is intended for use by applicants, licensees, and the NRC staff.
In the Matter of Dead Ringer, LLC
Document Number: 2019-23315
Type: Notice
Date: 2019-10-25
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is issuing an Order to Dead Ringer, LLC, imposing a civil penalty of $43,500. On August 8, 2019, the NRC issued a Notice of Violation and Proposed Imposition of Civil Penalty$43,500 to Dead Ringer, LLC, for failing to comply with regulatory requirements regarding the import, possession, and distribution of gun sights containing radioactive material.
Safety Oversight and Certification Advisory Committee; Meeting
Document Number: 2019-23314
Type: Notice
Date: 2019-10-25
Agency: Federal Aviation Administration, Department of Transportation
This notice announces a meeting of the SOCAC.
Environmental Impact Statements; Notice of Availability
Document Number: 2019-23313
Type: Notice
Date: 2019-10-25
Agency: Environmental Protection Agency
Postmarketing Studies and Clinical Trials-Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
Document Number: 2019-23312
Type: Notice
Date: 2019-10-25
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 ``Postmarketing Studies and Clinical TrialsImplementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance revises the guidance for industry of the same name issued April 1, 2011. The draft guidance is being revised to describe the multiple factors that FDA considers, before requiring a postmarketing study or clinical trial for the purposes described in the Federal Food, Drug, and Cosmetic Act (FD&C Act), when determining the sufficiency of the reports under the FD&C Act and the active postmarket risk identification and analysis (ARIA) system available under the FD&C Act to meet these purposes. The draft guidance is also being revised to reflect certain provisions enacted under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act as they relate to postmarketing studies and clinical trials.
Defense Advanced Research Projects Agency, Privacy Act of 1974
Document Number: 2019-23311
Type: Rule
Date: 2019-10-25
Agency: Department of Defense, Office of the Secretary
This final rule removes DoD's regulation concerning the Defense Advanced Research Projects Agency (DARPA) Privacy Program. On April 11, 2019, the DoD published a revised DoD-level Privacy Program rule, which contains the necessary information for an agency-wide Privacy Program regulation under the Privacy Act and now serves as the single Privacy Program rule for the Department. That revised Privacy Program rule also includes all DoD component exemption rules. Therefore, this regulation is now unnecessary and may be removed from the CFR.
Allergan Pharmaceuticals International, LTD; Withdrawal of Approval of a New Drug Application for LO MINASTRIN FE
Document Number: 2019-23309
Type: Notice
Date: 2019-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for LO MINASTRIN FE (ethinyl estradiol tablets, 0.01 milligrams (mg); ethinyl estradiol and norethindrone acetate tablets, 0.01 mg/1mg; and ferrous fumarate tablets, 75 mg), held by Allergan Pharmaceuticals International, LTD, c/o Allergan Sales, LLC, 5 Giralda Farms, Madison, NJ 07940 (Allergan). Allergan notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
Document Number: 2019-23308
Type: Notice
Date: 2019-10-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing its intent to exempt a list of class II devices from premarket notification requirements, subject to certain limitations. The Agency has determined that, based on established factors, these devices no longer require premarket notification to provide reasonable assurance of safety and effectiveness. FDA is publishing this notice to obtain comments regarding the proposed exemptions, in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).