February 2018 – Federal Register Recent Federal Regulation Documents

Results 251 - 300 of 2,127
Information Collection Requirement; Defense Federal Acquisition Regulation Supplement; Requests for Equitable Adjustment
Document Number: 2018-03856
Type: Notice
Date: 2018-02-26
Agency: Defense Acquisition Regulations System, Department of Defense
In compliance with the Paperwork Reduction Act of 1995, DoD announces the proposed extension of a public information collection requirement and seeks public comment on the provisions thereof. DoD invites comments on: Whether the proposed collection of information is necessary for the proper performance of the functions of DoD, including whether the information will have practical utility; the accuracy of the 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 the use of automated collection techniques or other forms of information technology. The Office of Management and Budget (OMB) has approved this information collection requirement for use through September 30, 2018. DoD proposes that OMB extend its approval for three additional years.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-03855
Type: Notice
Date: 2018-02-26
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed changes to the currently approved information collection project: ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component.'' This proposed information collection was previously published in the Federal Register on December 22, 2017 and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-03854
Type: Notice
Date: 2018-02-26
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.''
Request for Nominations
Document Number: 2018-03853
Type: Notice
Date: 2018-02-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations of four qualified candidates to be considered for appointment as members of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (Committee). The Committee consists of 18 public members, including two co-chairs. The Committee membership maintains a balance of diverse experiences and expertise. Those requesting consideration require expertise in areas such as: Public health; epidemiology; laboratory practice; immunology; infectious diseases; behavioral health and science including, but not limited to opioid use and related expertise; health education; healthcare delivery; state health programs; clinical care; preventive health; medical education; health services and clinical research; and healthcare financing. In addition, people living with HIV and affected populations as well as individuals employed by state and local health and education agencies, HIV/viral hepatitis/STD community-based organizations, and the ethics or religious community are encouraged to submit nomination packages for consideration. Current federal employees will not be considered.
Availability of Draft Integrated Feasibility Report and Environmental Impact Statement for the Gulf Intracoastal Waterway: Brazos River Floodgates and Colorado River Locks Systems Feasibility Study, Brazos and Matagorda Counties, TX
Document Number: 2018-03852
Type: Notice
Date: 2018-02-26
Agency: Department of Defense, Department of the Army, Corps of Engineers
Pursuant to the National Environmental Policy Act (NEPA), the U.S. Army Corps of Engineers, Galveston District (USACE) announces the release of the Draft Integrated Feasibility Report and Environmental Impact Statement (DIFR-EIS) for the Recommended Plan of the Gulf Intracoastal Waterway (GIWW): Brazos River Floodgates (BRFG) and Colorado River Locks (CRL) Systems Feasibility Study, Brazos and Matagorda Counties, TX. The DIFR-EIS documents the existing condition of environmental resources in and around areas considered for development, and potential impacts on those resources as a result of implementing the alternatives.
Policy and Procedural Guidance for Processing Requests To Alter U.S. Army Corps of Engineers Civil Works Projects Pursuant to Section 408
Document Number: 2018-03851
Type: Notice
Date: 2018-02-26
Agency: Department of Defense, Department of the Army, Corps of Engineers
On February 5, 2018, the U.S. Army Corps of Engineers (USACE) published a notice announcing the availability of a draft Engineer Circular (EC), which is an agency policy document, for a 30-day comment period. This draft EC provides the proposed policies and procedures related to how USACE will process certain requests by others to alter a USACE civil works project pursuant to Section 14 of the Rivers and Harbors Act of 1899, as amended (more commonly referred to as Section 408). This notice announces the extension of the comment period by an additional 30 days. The extension of the comment period is a result of requests by entities to allow more time to submit their comments. The draft EC is available for review on the USACE Section 408 website (https://www.usace.army.mil/Missions/Civil-Works/Section408/) and at https://www.regulations.gov reference docket number COE-2018-0003.
Submission for OMB Review; Comment Request
Document Number: 2018-03850
Type: Notice
Date: 2018-02-26
Agency: Defense Acquisition Regulations System, Department of Defense
The Defense Acquisition Regulations System has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2018-03849
Type: Notice
Date: 2018-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed
Document Number: 2018-03848
Type: Notice
Date: 2018-02-26
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations
Document Number: 2018-03847
Type: Notice
Date: 2018-02-26
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.
Alternative Method for Calculating Off-Cycle Credits Under the Light-Duty Vehicle Greenhouse Gas Emissions Program: Applications From General Motors and Toyota Motor North America
Document Number: 2018-03846
Type: Notice
Date: 2018-02-26
Agency: Environmental Protection Agency
EPA is requesting comment on applications General Motors (GM), and Toyota Motor North America (Toyota) for off-cycle carbon dioxide (CO2) credits under EPA's light-duty vehicle greenhouse gas emissions standards. ``Off-cycle'' emission reductions can be achieved by employing technologies that result in real-world benefits, but where that benefit is not adequately captured on the test procedures used by manufacturers to demonstrate compliance with emission standards. EPA's light-duty vehicle greenhouse gas program acknowledges these benefits by giving automobile manufacturers several options for generating ``off-cycle'' carbon dioxide (CO2) credits. Under the regulations, a manufacturer may apply for CO2 credits for off-cycle technologies that result in off-cycle benefits. In these cases, a manufacturer must provide EPA with a proposed methodology for determining the real-world off-cycle benefit. These two manufacturers have submitted applications that describe methodologies for determining off-cycle credits. The off-cycle technologies vary by manufacturer and include thermal control technologies such as high efficiency alternators, an efficient air conditioning compressor, and active climate control seats. Pursuant to applicable regulations, EPA is making descriptions of each manufacturer's off-cycle credit calculation methodologies available for public comment.
Agency Information Collection Activities; Proposed Collection; Comment Request; Revisions to the RCRA Definition of Solid Waste
Document Number: 2018-03845
Type: Notice
Date: 2018-02-26
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is planning to submit the information collection request (ICR), Revisions to the RCRA Definition of Solid Waste (EPA ICR No. 2310.04, OMB Control No. 2050- 0202) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through April 30, 2018. 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.
National Environmental Justice Advisory Council; Notification of Request for Nominations to the National Environmental Justice Advisory Council
Document Number: 2018-03844
Type: Notice
Date: 2018-02-26
Agency: Environmental Protection Agency
The U.S. Environmental Protection Agency (EPA) invites nominations from a diverse range of qualified candidates to be considered for appointment to its National Environmental Justice Advisory Council (NEJAC). The NEJAC was chartered to provide advice regarding broad, cross-cutting issues related to environmental justice. This notice solicits nominations to fill approximately four (4) new vacancies for terms through September, 2019. To maintain the representation outlined by the charter, nominees will be selected to represent: academia (2 vacancies); business and industry (1 vacancy); and state and local government (1 vacancy). Vacancies are anticipated to be filled by September 2018. Sources in addition to this Federal Register Notice will be utilized in the solicitation of nominees.
Modification of Significant New Use of a Certain Chemical Substance; Extension of Comment Period
Document Number: 2018-03843
Type: Proposed Rule
Date: 2018-02-26
Agency: Environmental Protection Agency
EPA issued a proposed rule in the Federal Register of February 8, 2018, proposing to amend the significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for oxazolidine, 3,3'-methylenebis[5-methyl-, which was the subject of a premanufacture notice (PMN) and a significant new use notice (SNUN). This document extends the comment period for 17 days and provides notice that EPA has added two documents to the docket.
Consumer Advisory Board Subcommittee Meetings
Document Number: 2018-03842
Type: Notice
Date: 2018-02-26
Agency: Bureau of Consumer Financial Protection
This notice sets forth the announcement of two public subcommittee meetings of the Consumer Advisory Board (CAB or Board) of the Bureau of Consumer Financial Protection (CFPB or Bureau). The notice also describes the functions of the Board its subcommittees.
Crystalline Silicon Photovoltaic Cells and Modules From China; Notice of Commission Determinations To Conduct Full Five-Year Reviews
Document Number: 2018-03841
Type: Notice
Date: 2018-02-26
Agency: International Trade Commission, Agencies and Commissions
The Commission hereby gives notice that it will proceed with full reviews pursuant to the Tariff Act of 1930 to determine whether revocation of the antidumping and countervailing duty orders on crystalline silicon photovoltaic cells and modules from China would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. A schedule for the reviews will be established and announced at a later date.
Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting
Document Number: 2018-03838
Type: Notice
Date: 2018-02-26
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Working Group of the Northeast Trawl Advisory Panel (NTAP) of the Mid-Atlantic Fishery Management Council will hold a meeting.
Gulf of Mexico Fishery Management Council; Public Meeting
Document Number: 2018-03837
Type: Notice
Date: 2018-02-26
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Gulf of Mexico Fishery Management Council will hold a meeting of its Law Enforcement Technical Committee (LETC), in conjunction with the Gulf States Marine Fisheries Commission's Law Enforcement Committee (LEC).
New England Fishery Management Council; Public Meeting
Document Number: 2018-03836
Type: Notice
Date: 2018-02-26
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The New England Fishery Management Council (Council) is scheduling a four-day public meeting to undertake an independent review to assess past Council performance and solicit suggestions for improvement. Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Multiple IRS Information Collection Requests
Document Number: 2018-03834
Type: Notice
Date: 2018-02-26
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.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Claim Against the United States for the Proceeds of a Government Check
Document Number: 2018-03833
Type: Notice
Date: 2018-02-26
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.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Generic Clearance for Voluntary Surveys To Implement E.O. 12862
Document Number: 2018-03832
Type: Notice
Date: 2018-02-26
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.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Small Business Lending Fund (SBLF) Supplemental Reports
Document Number: 2018-03831
Type: Notice
Date: 2018-02-26
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.
World War One Centennial Commission; Notification of Upcoming Public Advisory Meeting
Document Number: 2018-03830
Type: Notice
Date: 2018-02-26
Agency: General Services Administration, Agencies and Commissions
Notice of this meeting is being provided according to the requirements of the Federal Advisory Committee Act. This notice provides the schedule and agenda for the March 20, 2018 meeting of the World War One Centennial Commission (the Commission). The meeting is open to the public.
Advisory Committee on Arlington National Cemetery; Solicitation for New Members
Document Number: 2018-03829
Type: Notice
Date: 2018-02-26
Agency: Department of Defense, Department of the Army
The Advisory Committee on Arlington National Cemetery is an independent Federal advisory committee chartered to provide the Secretary of Defense, through the Secretary of the Army, independent advice and recommendations on Arlington National Cemetery, including, but not limited to cemetery administration, the erection of memorials at the cemetery, and master planning for the cemetery. The Secretary of the Army may act on the Committee's advice and recommendations. The Committee is comprised of no more than nine (9) members. Subject to the approval of the Secretary of Defense, the Secretary of the Army appoints no more than seven (7) of these members. The purpose of this notice is to solicit resumes from a wide range of highly qualified individuals desiring appointment to the Committee. Appointment as a members of the Committee and its sub-committees may be made for terms of service ranging from one to four years. All nominees by the Secretary of the Army for Secretary of Defense for approval must be preeminent authorities in their respective fields of interest or expertise. This notice solicits submissions of resumes from interested and highly qualified individuals to fill Committee membership vacancies that may occur through September 30, 2018.
Fisheries of the Northeastern United States; Scup Fishery; Framework Adjustment 10
Document Number: 2018-03828
Type: Proposed Rule
Date: 2018-02-26
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS proposes modifications to the commercial scup quota periods, as recommended by the Mid-Atlantic Fishery Management Council. The proposed change would move the month of October from the Summer Period to the Winter II Period. This rule is intended to increase fishing opportunities by allowing for more scup to be landed by extending the Winter II Period when possession limits are higher.
Submission for OMB Review; Comment Request
Document Number: 2018-03826
Type: Notice
Date: 2018-02-26
Agency: Department of Agriculture
Agency Information Collection Activities: Information Collection Renewal; Comment Request; Bank Appeals Follow-Up Questionnaire
Document Number: 2018-03825
Type: Notice
Date: 2018-02-26
Agency: Office of the Comptroller of the Currency, Department of Treasury, Department of the Treasury
The OCC, 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 a continuing information collection as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. Currently, the OCC is soliciting comment concerning the renewal of an existing collection titled ``Bank Appeals Follow-Up Questionnaire.''
Final Finding of No Significant Impact for the Proposed Rehabilitation or Replacement of Buildings at the Gulfport Job Corps Center, 3300 20th Street, Gulfport, Mississippi 39501
Document Number: 2018-03823
Type: Notice
Date: 2018-02-26
Agency: Employment and Training Administration, Department of Labor
The Department of Labor (DOL or Department), ETA, Office of Job Corps, is issuing a Final Finding of No Significant Impact (FONSI) regarding the proposed rehabilitation or replacement of buildings at the Gulfport Job Corps Center (JCC) in Gulfport, Mississippi.
Boyce Hydro Power, LLC; Order Proposing Revocation of License
Document Number: 2018-03821
Type: Notice
Date: 2018-02-26
Agency: Department of Energy, Federal Energy Regulatory Commission
Public Citizen, Inc. v. PJM Interconnection LLC; Notice of Complaint
Document Number: 2018-03820
Type: Notice
Date: 2018-02-26
Agency: Department of Energy, Federal Energy Regulatory Commission
Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Information Collection; Claims Filed Under the Radiation Exposure Compensation Act
Document Number: 2018-03818
Type: Notice
Date: 2018-02-26
Agency: Department of Justice
The Department of Justice (DOJ), Civil Division, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies.
Accreditation and Approval of Inspectorate America Corporation (Martinez, CA), as a Commercial Gauger and Laboratory
Document Number: 2018-03816
Type: Notice
Date: 2018-02-26
Agency: Department of Homeland Security, U.S. Customs and Border Protection
Notice is hereby given, pursuant to CBP regulations, that Inspectorate America Corporation (Martinez, CA), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of January 25, 2017.
Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company
Document Number: 2018-03815
Type: Notice
Date: 2018-02-26
Agency: Federal Reserve System, Agencies and Commissions
Accreditation and Approval of Inspectorate America Corporation (Lutcher, LA), as a Commercial Gauger and Laboratory
Document Number: 2018-03814
Type: Notice
Date: 2018-02-26
Agency: Department of Homeland Security, U.S. Customs and Border Protection
Notice is hereby given, pursuant to CBP regulations, that Inspectorate America Corporation (Lutcher, LA), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of April 4, 2017.
Agency Information Collection Activities; Proposed Collection Comments Requested; Extension With Change of Currently Approved Collection: 2017-19 Survey of Sexual Victimization (SSV)
Document Number: 2018-03813
Type: Notice
Date: 2018-02-26
Agency: Department of Justice
The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Advisory Commission on Childhood Vaccines
Document Number: 2018-03812
Type: Notice
Date: 2018-02-26
Agency: Department of Health and Human Services, Health Resources and Service Administration
In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the Advisory Commission on Childhood Vaccines (ACCV). This meeting will be open to the public. Information about the ACCV and the agenda for this meeting can be obtained by accessing the following website: https://www.hrsa.gov/ advisorycommittees/childhoodvaccines/.
Accreditation and Approval of Coastal Gulf and International (Luling, LA), as a Commercial Gauger and Laboratory
Document Number: 2018-03811
Type: Notice
Date: 2018-02-26
Agency: Department of Homeland Security, U.S. Customs and Border Protection
Notice is hereby given, pursuant to CBP regulations, that Coastal Gulf and International (Luling, LA), has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of July 19, 2017.
Proposed Information Collection; Comment Request; Public Employment and Payroll Forms
Document Number: 2018-03810
Type: Notice
Date: 2018-02-26
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.
Q11 Development and Manufacture of Drug Substances-Questions and Answers (Chemical Entities and Biotechnological/Biological Entities); International Council for Harmonisation; Guidance for Industry; Availability
Document Number: 2018-03809
Type: Notice
Date: 2018-02-26
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 guidance entitled ``Q11 Development and Manufacture of Drug SubstancesQuestions and Answers (Chemical Entities and Biotechnological/Biological Entities).'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance consists of questions and answers that were developed to clarify the principles for selecting starting materials described in the ICH guidance ``Q11 Development and Manufacture of Drug Substances'', published November 20, 2012. The guidance is intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials. The questions and answers focus on chemical entity drug substances, and provide recommendations on the information that should be provided in marketing authorization applications and/or master files to justify the starting materials.
Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-03808
Type: Notice
Date: 2018-02-26
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 Psychopharmacologic Drugs Advisory Committee. The general function of the committee 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.
National Register of Historic Places; Notification of Pending Nominations and Related Actions
Document Number: 2018-03807
Type: Notice
Date: 2018-02-26
Agency: Department of the Interior, National Park Service
The National Park Service is soliciting comments on the significance of properties nominated before February 3, 2018, for listing or related actions in the National Register of Historic Places.
Agency Information Collection Activities; Proposed eCollection; eComments Requested
Document Number: 2018-03806
Type: Notice
Date: 2018-02-26
Agency: Department of Justice
Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Training Division's Curriculum Management Section (CMS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published allowing for a 60 day comment period.
Center for Drug Evaluation and Research and You: Keys to Effective Engagement; Public Workshop
Document Number: 2018-03805
Type: Notice
Date: 2018-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is announcing the following public workshop entitled ``CDER and You: Keys to Effective Engagement.'' The purpose of the public workshop is to build upon previous efforts to help advocates understand how they can engage with FDA to enhance drug development and safety. This marks the third annual CDER public workshop for patient advocacy groups.
Promoting the Use of Complex Innovative Designs in Clinical Trials; Public Meeting; Request for Comments
Document Number: 2018-03804
Type: Notice
Date: 2018-02-26
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 ``Promoting the Use of Complex Innovative Designs in Clinical Trials.'' The topic to be discussed is the use of complex innovative designs (CID) in clinical trials of drugs and biological products to inform regulatory decision making. This meeting will inform development of a guidance document as required by the 21st Century Cures Act (Cures Act) and is being conducted to meet the performance goal of convening a public workshop on CID included in the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA). This meeting will also inform the development of a CID pilot program. FDA is seeking comments on the use of CID to inform regulatory decision making and is also seeking input on the CID pilot program.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-03803
Type: Notice
Date: 2018-02-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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