March 2018 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 2,361
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of Mexico; Modifications to Greater Amberjack Recreational Fishing Year and Fixed Closed Season
Document Number: 2018-06317
Type: Rule
Date: 2018-03-29
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS issues regulations to implement management measures described in a framework action to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP), as prepared by the Gulf of Mexico Fishery Management Council (Council). This final rule revises the recreational fishing year and modifies the recreational fixed closed season for greater amberjack in the Gulf of Mexico (Gulf) exclusive economic zone (EEZ). The purposes of this final rule and the framework action are to constrain recreational harvest to assist in ending overfishing, and to rebuild the greater amberjack stock in the Gulf, while achieving optimum yield of the stock in the Gulf.
Fisheries Off West Coast States; Pacific Coast Groundfish Fishery Management Plan; Authorization of an Oregon Recreational Fishery for Midwater Groundfish Species
Document Number: 2018-06316
Type: Rule
Date: 2018-03-29
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
This final rule authorizes the use of midwater long-leader gear for recreational fishing in waters seaward of a boundary line approximating the 40 fathoms depth contour off the coast of Oregon. Both charter and private vessels are authorized to use midwater long- leader gear seaward of the 40 fathom seasonal depth closure, while being monitored with the existing Oregon Ocean Recreational Boat Sampling (ORBS) program. The use of midwater long-leader gear is intended to limit bycatch of overfished and rebuilding rockfish species, such as bottom-dwelling yelloweye rockfish, while still allowing for the catch of abundant midwater species such as yellowtail and widow rockfish. The season will occur between April and September, months currently subject to depth restrictions.
North Pacific Fishery Management Council; Public Meeting
Document Number: 2018-06315
Type: Notice
Date: 2018-03-29
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Center of Independent Experts will meet April 16 through April 18, 2018 to review the stock assessments for Bering Sea and Aleutian Island yellowfin sole, northern rock sole, and Alaska plaice.
Fisheries of the Northeastern United States; Summer Flounder, Scup, and Black Sea Bass Fisheries; Scoping Process
Document Number: 2018-06314
Type: Notice
Date: 2018-03-29
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Mid-Atlantic Fishery Management Council has been preparing an amendment to the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan, known as the ``Comprehensive Summer Flounder Amendment,'' to modify aspects of the fishery management plan related to summer flounder commercial and recreational management. To avoid delaying the amendment while waiting for updated recreational information, the Council is now splitting several issues within this original action, including fishery management plan goals and objectives, commercial allocation, commercial moratorium permits, and commercial framework provisions into a separate action that will continue to be developed as an EIS. The Council is taking comments on this modified action, which is now being referred to as the ``Summer Flounder Commercial Issues Amendment.'' Following completion of this ``Commercial Issues'' amendment, the Council may then develop at least one future action relating to recreational fishery issues and commercial/recreational allocation to incorporate updated recreational fishery data when it becomes available later this year. The purpose of this notification is to alert and seek comment from the public about the Council's consideration of splitting this amendment, by delaying some issues to be pursued via later actions.
Importer of Controlled Substances Application: Lannett Company, Inc.
Document Number: 2018-06313
Type: Notice
Date: 2018-03-29
Agency: Drug Enforcement Administration, Department of Justice
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-06312
Type: Notice
Date: 2018-03-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Mid-Atlantic Fishery Management Council (MAFMC); Public Meetings
Document Number: 2018-06311
Type: Notice
Date: 2018-03-29
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Mid-Atlantic Fishery Management Council's (Council) Surfclam and Ocean Quahog Advisory Panel will hold a public meeting.
Notice of Intent To Grant Exclusive Patent License
Document Number: 2018-06310
Type: Notice
Date: 2018-03-29
Agency: National Aeronautics and Space Administration, Agencies and Commissions
NASA hereby gives notice of its intent to grant an exclusive patent license in the United States to practice the invention described and claimed in U.S. Provisional 62/616,479 entitled, ``A Corrected BMI for Improved Assessment of Human Weight-Related Pathology'' to AQ Digital Health, having its principal place of business in Baltimore, MD.
Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-06309
Type: Notice
Date: 2018-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-06307
Type: Notice
Date: 2018-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Government-Owned Inventions; Availability for Licensing and Collaboration; Notification of Q&A Webinar
Document Number: 2018-06306
Type: Notice
Date: 2018-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The invention named in this notice is owned by agencies of the United States Government and is available for licensing in accordance with the U.S. Federal Technology Transfer Act of 1986. Related data for 510(k) submission is available as part of the licensing package. The technology and related data are being licensed to achieve expeditious commercialization of federally funded research and development. A U.S. Provisional patent application has been filed to extend market coverage. CDC also seeks collaboration partners with interest in adapting the test for different equipment, point-of-care, or more rapid processing.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple TTB Information Collection Requests
Document Number: 2018-06305
Type: Notice
Date: 2018-03-29
Agency: Department of the Treasury
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; Comment Request; Fastener Quality Act Insignia Recordal Process
Document Number: 2018-06295
Type: Notice
Date: 2018-03-29
Agency: Department of Commerce, Patent and Trademark Office
Certain Access Control Systems and Components Thereof; Notice of the Commission's Final Determination Finding a Violation of Section 337; Issuance of Limited Exclusion Order and Cease and Desist Orders; Termination of the Investigation
Document Number: 2018-06293
Type: Notice
Date: 2018-03-29
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has found a violation of section 337 in this investigation and has issued a limited exclusion order prohibiting importation of infringing access control systems and components thereof and issued cease and desist orders directed to the following respondents: Techtronic Industries Company Ltd. of Tsuen Wan, Hong Kong (``TTi HK''); Techtronic Industries North America Inc. of Hunt Valley, Maryland (``TTi NA''); One World Technologies, Inc. of Anderson, South Carolina (``One World''); and OWT Industries, Inc. of Pickens, South Carolina (``OWT''). The investigation is terminated.
Bump-Stock-Type Devices
Document Number: 2018-06292
Type: Proposed Rule
Date: 2018-03-29
Agency: Department of Justice, Bureau of Alcohol, Tobacco, Firearms and Explosives
The Department of Justice (Department) proposes to amend the Bureau of Alcohol, Tobacco, Firearms, and Explosives regulations to clarify that ``bump fire'' stocks, slide-fire devices, and devices with certain similar characteristics (bump-stock-type devices) are ``machineguns'' as defined by the National Firearms Act of 1934 (NFA) and the Gun Control Act of 1968 (GCA), because such devices allow a shooter of a semiautomatic firearm to initiate a continuous firing cycle with a single pull of the trigger. Specifically, these devices convert an otherwise semiautomatic firearm into a machinegun by functioning as a self-acting or self-regulating mechanism that harnesses the recoil energy of the semiautomatic firearm in a manner that allows the trigger to reset and continue firing without additional physical manipulation of the trigger by the shooter. Hence, a semiautomatic firearm to which a bump-stock-type device is attached is able to produce automatic fire with a single pull of the trigger. With limited exceptions, primarily as to government agencies, the GCA makes it unlawful for any person to transfer or possess a machinegun unless it was lawfully possessed prior to the effective date of the statute. The bump-stock-type devices covered by this proposed rule were not in existence prior to the GCA's effective date, and therefore would fall within the prohibition on machineguns if this Notice of Proposed Rulemaking (NPRM) is implemented. Consequently, current possessors of these devices would be required to surrender them, destroy them, or otherwise render them permanently inoperable upon the effective date of the final rule.
Request for Information on Regulatory Challenges to Safely Transporting Hazardous Materials by Surface Modes in an Automated Vehicle Environment; Correction
Document Number: 2018-06290
Type: Proposed Rule
Date: 2018-03-29
Agency: Pipeline and Hazardous Materials Safety Administration, Department of Transportation
This request for information notice replaces the version published in the Federal Register on March 22, 2018 (83 FR 12529), to make technical corrections to the prior version. The Pipeline and Hazardous Materials Safety Administration (PHMSA) requests information on matters related to the development and potential use of automated technologies for surface modes (i.e., highway and rail) in hazardous materials transportation. In anticipation of the development, testing, and integration of Automated Driving Systems in surface transportation, PHMSA is issuing this request for information on the factors the Agency should consider to ensure continued safe transportation of hazardous materials without impeding emerging surface transportation technologies.
Importation of Fresh Cherimoya Fruit From Chile Into the United States
Document Number: 2018-06289
Type: Rule
Date: 2018-03-29
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are amending the regulations to allow the importation of fresh cherimoya fruit from Chile into the continental United States in accordance with a systems approach as an alternative to the current required treatment. Commercial consignments of fresh cherimoya fruit are currently authorized entry into all ports of the United States from Chile subject to a mandatory soapy water and wax treatment. The systems approach includes requirements for production site registration, low pest prevalence area certification, post-harvest processing, and inspection at the packinghouse. The fruit will also be required to be imported in commercial consignments and accompanied by a phytosanitary certificate with an additional declaration stating that the consignment was produced in accordance with the regulations. Fresh cherimoya fruit that does not meet the conditions of the systems approach or is imported into locations outside the continental United States will continue to be allowed to be imported into the United States subject to the current soapy water and wax treatment. This will allow for the importation of fresh cherimoya fruit from Chile while continuing to provide protection against the introduction of plant pests into the continental United States.
Importation of Pummelo From Thailand Into the Continental United States
Document Number: 2018-06288
Type: Proposed Rule
Date: 2018-03-29
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
We are proposing to amend the regulations to allow the importation of fresh pummelo fruit from Thailand into the continental United States. As a condition of entry, fresh pummelo fruit from Thailand would be subject to a systems approach that would include irradiation treatment, packinghouse processing requirements, and port of entry inspection. The fruit would also be required to be imported in commercial consignments and be accompanied by a phytosanitary certificate issued by the national plant protection organization of Thailand. This action would allow for the importation of fresh pummelo fruit from Thailand while continuing to provide protection against the introduction of plant pests into the continental United States.
Notice of Realty Action: Classification for Lease and/or Conveyance for Recreation and Public Purposes of Public Lands for a Park in the Northwest Portion of the Las Vegas Valley, Clark County, Nevada
Document Number: 2018-06287
Type: Notice
Date: 2018-03-29
Agency: Department of the Interior, Bureau of Land Management
The Bureau of Land Management (BLM), Las Vegas Field Office, has examined and found suitable for classification for lease and subsequent conveyance under the provisions of the Recreation and Public Purposes (R&PP) Act, as amended, approximately 2.98 acres of public land in the Las Vegas Valley, Clark County, Nevada. The City of Las Vegas proposes to use the land for a community 2.98-acre park that will help meet future expanding recreation needs in the northwestern part of the Las Vegas Valley.
Notice of Proposed Reinstatement of Terminated Oil and Gas Leases; OKNM127909, OKNM127910, OKNM127911, OKNM127912, OKNM127913, OKNM127917, and OKNM127920, Oklahoma
Document Number: 2018-06285
Type: Notice
Date: 2018-03-29
Agency: Department of the Interior, Bureau of Land Management
In accordance with the Mineral Leasing Act of 1920, Red Fork (USA) Investments, Inc., timely filed a petition for reinstatement of competitive oil and gas leases OKNM 127909, OKNM 127910, OKNM 127911, OKNM 127912, OKNM 127913, and OKNM 127920, in Payne County, Oklahoma, and OKNM 127917, in Noble County, Oklahoma. The lessee paid the required rentals accruing from the date of termination. No new leases were issued that affect these lands. The Bureau of Land Management proposes to reinstate these leases.
Proposed Collection; Comment Request
Document Number: 2018-06284
Type: Notice
Date: 2018-03-29
Agency: Department of Defense, Office of the Secretary
In compliance with the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense for Personnel and Readiness announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Oranges and Grapefruit Grown in the Lower Rio Grande Valley in Texas; Decreased Assessment Rate
Document Number: 2018-06282
Type: Rule
Date: 2018-03-29
Agency: Agricultural Marketing Service, Department of Agriculture
This rule implements a recommendation from the Texas Valley Citrus Committee (Committee) to decrease the assessment rate established for the 2017-18 and subsequent fiscal periods for oranges and grapefruit handled under Marketing Order 906. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated. This rule also makes administrative revisions to the subpart headings of the Order.
Automation in the Railroad Industry
Document Number: 2018-06281
Type: Notice
Date: 2018-03-29
Agency: Federal Railroad Administration, Department of Transportation
This request for information notice replaces the version published in the Federal Register on March 22, 2018 (83 FR 12646), to make technical corrections to the prior version. FRA requests information and comment on the future of automation in the railroad industry. FRA is interested in hearing from industry stakeholders, the public, local and State governments, and any other interested parties on the potential benefits, costs, risks, and challenges to implementing automated railroad operations. FRA also seeks comment on how the agency can best support the railroad industry's development and implementation of new and emerging technologies in automation that could lead to safety improvements or increased efficiencies in railroad operations.
Suspension of Community Eligibility
Document Number: 2018-06279
Type: Rule
Date: 2018-03-29
Agency: Federal Emergency Management Agency, Department of Homeland Security
This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https:// www.fema.gov/national-flood-insurance-program-community-statu s-book.
Agency Information Collection Activities: Proposed Collection; Comment Request; National Catastrophic Resource Catalog
Document Number: 2018-06277
Type: Notice
Date: 2018-03-29
Agency: Federal Emergency Management Agency, Department of Homeland Security
The Federal Emergency Management Agency (FEMA), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on a new information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning the identification and cataloging of fire and emergency services personnel and equipment that might be available to support a catastrophic national disaster response.
Millennium Challenge Corporation Advisory Council Notice of Open Meeting
Document Number: 2018-06275
Type: Notice
Date: 2018-03-29
The Millennium Challenge Corporation Advisory Council will hold its spring meeting on April 17 2018. See SUPPLEMENTARY INFORMATION for agenda and other information.
Notice of Public Meeting of the Oregon Advisory Committee to the U.S. Commission on Civil Rights
Document Number: 2018-06273
Type: Notice
Date: 2018-03-29
Agency: Commission on Civil Rights
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Oregon Advisory Committee (Committee) will hold a meeting via web conference on Tuesday, April 17, 2018, from 1:00 p.m.-2:30 p.m. PST for the purpose of hearing public testimony on human trafficking issues in the state.
Notice of Public Meeting of the Oregon Advisory Committee to the U.S. Commission on Civil Rights
Document Number: 2018-06272
Type: Notice
Date: 2018-03-29
Agency: Commission on Civil Rights
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Oregon Advisory Committee (Committee) will hold a meeting via web conference on Tuesday, April 3, 2018, from 1:00 p.m.-2:30 p.m. PST for the purpose of hearing public testimony on human trafficking issues in the state.
Proposed Collection; Comment Request
Document Number: 2018-06271
Type: Notice
Date: 2018-03-29
Agency: Department of Defense, Office of the Secretary
In compliance with the Paperwork Reduction Act of 1995, the Defense Logistics Agency announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Airworthiness Directives; ATR-GIE Avions de Transport Régional Airplanes
Document Number: 2018-06270
Type: Proposed Rule
Date: 2018-03-29
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for all ATR-GIE Avions de Transport R[eacute]gional Model ATR42 and Model ATR72 airplanes. This proposed AD was prompted by reports of cracking in main landing gear (MLG) universal joints (U-joints). This proposed AD would require repetitive detailed inspections of the affected U-joints for cracks, and replacement if necessary. This proposed AD would also provide an optional terminating action for the repetitive inspections. We are proposing this AD to address the unsafe condition on these products.
Modification and Revocation of Multiple Air Traffic Service (ATS) Routes; Northcentral United States
Document Number: 2018-06268
Type: Rule
Date: 2018-03-29
Agency: Federal Aviation Administration, Department of Transportation
This action amends and removes multiple VHF Omnidirectional Range (VOR) Federal airways in northcentral United States as part of the FAA's Next Generation Air Transportation System (NextGen) efforts to safely improve the overall efficiency of the National Airspace System (NAS) and due to the decommissioning of the Tiverton, OH, VOR/ Distance Measuring Equipment (VOR/DME) navigation aid. This action also incorporates NAV CANADA's amendment to one of the airways that crosses into Canada's airspace.
Product Change-Priority Mail Negotiated Service Agreement
Document Number: 2018-06265
Type: Notice
Date: 2018-03-29
Agency: Postal Service, Agencies and Commissions
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Solicitation of Nominations for Appointment to Small Business Regional Regulatory Fairness Boards
Document Number: 2018-06263
Type: Notice
Date: 2018-03-29
Agency: Small Business Administration, Agencies and Commissions
The SBA Office of the National Ombudsman (ONO) is issuing this notice to solicit nominations of qualified owners, operators, and officers of small business concerns to be considered for appointment by the SBA Administrator as a member of a Small Business Regional Regulatory Fairness Board (``RegFair Board''). The RegFair Board members on the ten regional boards serve as advisors to the National Ombudsman on regulatory enforcement and compliance issues of concern to small business owners within their respective regions and surface those issues to the attention of the National Ombudsman. Nominations of qualified candidates are being sought to fill vacancies on the RegFair Boards. RegFair Board members are appointed by, and serve at the pleasure of, the SBA Administrator for terms of no longer than three years. The Administrator may reappoint an individual for additional terms of service. Board members serve without compensation. They will, however, be reimbursed for authorized travel-related expenses at per diem rates established by GSA when asked to perform official duties as a Board member.
Union Pacific Railroad Company-Abandonment Exemption-in Harris County, Tex.
Document Number: 2018-06262
Type: Notice
Date: 2018-03-29
Agency: Surface Transportation Board, Department of Transportation
Southern Nuclear Operating Company, Inc.; Vogtle Electric Generating Plant, Units 3 and 4; Reactor Vessel Head Vent Capacity
Document Number: 2018-06261
Type: Notice
Date: 2018-03-29
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption to allow a departure from elements of the certification information of Tier 1 of the generic AP1000 design control document (DCD) and is issuing License Amendment Nos. 114 and 113 to Combined Licenses (COL), NPF-91 and NPF-92, respectively. The COLs were issued to Southern Nuclear Operating Company, and Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC, MEAG Power SPVJ, LLC, MEAG Power SPVP, LLC, and the City of Dalton, Georgia (collectively referred to as the licensee); for construction and operation of the Vogtle Electric Generating Plant (VEGP) Units 3 and 4, located in Burke County, Georgia. The granting of the exemption allows the changes to Tier 1 information asked for in the amendment. Because the acceptability of the exemption was determined in part by the acceptability of the amendment, the exemption and amendment are being issued concurrently. The exemption revises the plant-specific Tier 1 information and corresponding changes to COL Appendix C, and the amendment changes the associated plant-specific DCD Tier 2 material incorporated into the VEGP Updated Final Safety Analysis Report (UFSAR), to update Reactor Coolant System (RCS) requirements for reactor vessel head vent (RVHV) mass flow rate for the VEGP Units 3 and 4.
Fiscal Year 2018 Generic Drug Regulatory Science Initiatives; Public Workshop; Request for Comments
Document Number: 2018-06260
Type: Notice
Date: 2018-03-29
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 workshop entitled ``FY 2018 Generic Drug Regulatory Science Initiatives.'' The purpose of the public workshop is to provide an overview of the status of regulatory science initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholdersindustry, academia, patient advocates, professional societies, and other interested partiesas it fulfills its commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its fiscal year (FY) 2019 regulatory science initiatives.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2018-06259
Type: Notice
Date: 2018-03-29
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2018-06258
Type: Notice
Date: 2018-03-29
Agency: Department of Health and Human Services, National Institutes of Health
Product-Specific Guidance for Doxycycline Hyclate; Revised Draft Guidance for Industry; Availability
Document Number: 2018-06253
Type: Notice
Date: 2018-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry on generic doxycycline hyclate oral delayed-release tablets, entitled ``Product- Specific Guidance for Doxycycline Hyclate.'' The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for doxycycline hyclate oral delayed-release tablets.
Good Guidance Practices; Technical Amendment
Document Number: 2018-06252
Type: Rule
Date: 2018-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is amending its good guidance practices regulation to inform the public on how to electronically submit a draft of a proposed guidance to the Agency. This technical amendment is nonsubstantive.
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