Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types
Document Number: 2018-16189
Type: Notice
Date: 2018-07-30
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.
Medical Device User Fee Rates for Fiscal Year 2019
Document Number: 2018-16178
Type: Notice
Date: 2018-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2019, which apply from October 1, 2018, through September 30, 2019. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2019, you should not submit a Small Business Certification Request. This document provides information on how the fees for FY 2019 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Center for Devices and Radiological Health: Experiential Learning Program
Document Number: 2018-16177
Type: Notice
Date: 2018-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH or Center) is announcing the 2019 Experiential Learning Program (ELP). This training is intended to provide CDRH and other FDA staff with an opportunity to understand laboratory practices, quality system management, patient perspective/ input, and challenges that impact the medical device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities, and others to participate in this formal training program for CDRH and other FDA staff, or to contact CDRH for more information regarding the ELP.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
Document Number: 2018-16161
Type: Notice
Date: 2018-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2018-16156
Type: Notice
Date: 2018-07-30
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.
Prescription Polyethylene Glycol 3350; Denial of a Hearing and Order Withdrawing Approval of Abbreviated New Drug Applications; Temporary Stay of Effective Date
Document Number: 2018-16148
Type: Notice
Date: 2018-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice that the effective date of an April 2, 2018, order denying requests for a hearing and withdrawing approval of abbreviated new drug applications (ANDAs) for certain prescription laxatives with the active ingredient polyethylene glycol 3350 (PEG 3350) is stayed until November 2, 2018.
Submission for OMB Review; Comment Request
Document Number: 2018-15987
Type: Notice
Date: 2018-07-30
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Neurological Disorders and Stroke, Muscular Dystrophy Coordinating Committee Call for Committee Membership Nominations
Document Number: 2018-16112
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations for an individual to serve as a nonfederal public member on the Muscular Dystrophy Coordinating Committee.
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Health Disparities Subcommittee (HDS)
Document Number: 2018-16103
Type: Notice
Date: 2018-07-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Advisory Committee to the Director, Centers for Disease Control and PreventionHealth Disparities Subcommittee (ACD, CDC-HDS). This meeting is open to the public, limited only by the 50 audio phone lines. The public is also welcome to listen to the meeting by teleconference. Please dial (866) 918-8397 and enter code 9346283. There are 50 lines available. The public comment period is from 3:15 p.m.-3:20 p.m.
National Center for Health Statistics (NCHS), ICD-10 Coordination and Maintenance (C&M) Committee Meeting
Document Number: 2018-16102
Type: Notice
Date: 2018-07-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The CDC, National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff, announces the following meeting of the ICD-10 Coordination and Maintenance (C&M) Committee meeting. This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 240 people. We will be broadcasting the meeting live via Webcast at hhtp:// www.cms.gov/live/.
Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC)
Document Number: 2018-16101
Type: Notice
Date: 2018-07-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC).
Notice To Announce Commission of a Surgeon General's Report on Oral Health
Document Number: 2018-16096
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
On behalf of the United States Department of Health and Human Services, the Office of the Surgeon General, the National Institutes of Health, and the National Institute of Dental and Craniofacial Research, the U.S. Public Health Service's Oral Health Coordinating Committee announces the commission of a Surgeon General's Report presenting prominent issues affecting oral health. The report will document progress in oral health in the twenty years since the 2000 Surgeon General's Report on Oral Health, identify existing knowledge gaps, and articulate a vision for the future.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-16091
Type: Notice
Date: 2018-07-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-16090
Type: Notice
Date: 2018-07-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2019
Document Number: 2018-16069
Type: Notice
Date: 2018-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2019 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2018, and will remain in effect through September 30, 2019.
Generic Drug User Fee Rates for Fiscal Year 2019
Document Number: 2018-16067
Type: Notice
Date: 2018-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2019 rates for GDUFA II fees.
Prospective Grant of Exclusive Patent License: Radiotherapy for Metastatic Castration-Resistant Prostate Cancer
Document Number: 2018-16066
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive commercialization patent license to Sinotau Pharmaceutical Group, headquartered in Beijing, China, to practice the inventions embodied in the patent application(s) listed in the Supplementary Information section of this notice.
Prospective Grant of Exclusive Patent License: Radiotherapeutics Against Somatostatin-Receptor Expressing Neuroendocrine Tumors
Document Number: 2018-16065
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Molecular Targeting Technologies, Inc. (MTTI); a Delaware corporation, with its principle place of business in West Chester, Pennsylvania, to practice the inventions embodied in the patent application listed in the SUPPLEMENTARY INFORMATION section of this notice.
National Institute of Neurological Disorders and Stroke Notice of Closed Meetings
Document Number: 2018-16061
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice to Close Meeting
Document Number: 2018-16060
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cancer Immunotherapy
Document Number: 2018-16058
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to Midissia Therapeutics (``Midissia'') located in San Francisco, CA.
Meeting of the President's Council on Sports, Fitness, and Nutrition
Document Number: 2018-16056
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the President's Council on Sports, Fitness, and Nutrition (PCSFN) will hold its annual meeting. The meeting will be open to the public.
Proposed Collection; 60-Day Comment Request; Intramural Continuing Umbrella of Research Experiences (iCURE) Application (National Cancer Institute)
Document Number: 2018-16053
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Submission for OMB Review; 30-Day Comment Request Collection of Customer Service, Demographic, and Smoking/Tobacco Use Information From the National Cancer Institute's Contact Center (CC) Clients (NCI)
Document Number: 2018-16048
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-16046
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-16045
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
ICU Medical, Inc., et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
Document Number: 2018-16037
Type: Notice
Date: 2018-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 31 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Results From Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies; Draft Guidance for Industry; Availability
Document Number: 2018-16036
Type: Notice
Date: 2018-07-27
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 ``Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.'' This document is intended to provide guidance to sponsors on the evidence necessary to demonstrate the effectiveness of new drugs, including biological drugs, or new drug uses intended for slowly progressive, low-prevalence rare diseases that are associated with substrate deposition and are caused by single enzyme defects. This guidance applies only to those low-prevalence rare diseases with a well-characterized pathophysiology and in which changes in substrate deposition can be readily measured in relevant tissue(s).
Determination That Metaxalone Tablets, 640 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2018-16031
Type: Notice
Date: 2018-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that metaxalone tablets, 640 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for metaxalone tablets, 640 mg, if all other legal and regulatory requirements are met.
Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance for Industry; Availability
Document Number: 2018-16030
Type: Notice
Date: 2018-07-27
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 document entitled ``Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance for Industry.'' The draft guidance document notifies blood establishments that collect blood and blood components that we have determined babesiosis to be a relevant transfusion-transmitted infection (RTTI) and provides recommendations for donor screening, donation testing, donor deferral, and product management to reduce the risk of transfusion-transmitted babesiosis (TTB). The recommendations contained in the guidance apply to the collection of blood and blood components, except Source Plasma.
Peripheral Vascular Atherectomy Devices-Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-16029
Type: Notice
Date: 2018-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Peripheral Vascular Atherectomy DevicesPremarket Notification [510(k)] Submissions.'' This draft guidance provides recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device. This draft guidance is not final nor is it in effect at this time.
Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Guidance for Industry; Availability
Document Number: 2018-16027
Type: Notice
Date: 2018-07-27
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 final guidance for industry entitled ``Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.'' FDA does not expect to grant any additional orphan-drug designation to drugs for pediatric subpopulations of common diseases (i.e., diseases or conditions with an overall prevalence of 200,000 or greater). This will help resolve an unintended loophole in the Pediatric Research Equity Act (PREA) orphan exemption process where a sponsor holding a pediatric-subpopulation designation can submit a marketing application for use of its drug in the non-orphan adult population of that disease, get a pediatric- subpopulation designation for the pediatric subset of the disease, and, due to this designation, be exempt from conducting the pediatric studies normally required under PREA when seeking approval of the adult indication.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-16008
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; and Medicaid Promoting Interoperability Program
Document Number: 2018-14985
Type: Proposed Rule
Date: 2018-07-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This major proposed rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute.
Scholarly and Journalistic Activities Deemed Not To Be Research: 2018 Requirements; Draft Guidance; When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 Through January 20, 2019: 2018 Requirements; Draft Guidance Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements; Draft Guidance
Document Number: 2018-15908
Type: Notice
Date: 2018-07-25
Agency: Department of Health and Human Services
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health is announcing the availability of three draft guidance documents titled, ``Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements,'' ``When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements,'' and ``Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements,'' respectively.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-15907
Type: Notice
Date: 2018-07-25
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is jointly owned by an agency of the U.S. Government with Vanderbilt University, University of Alabama and University of Pennsylvania and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; New Data Collection; National Center on Law and Elder Rights (NCLER)
Document Number: 2018-15906
Type: Notice
Date: 2018-07-25
Agency: Department of Health and Human Services
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to ACL's National Center on Law and Elder Rights.
Administration for Community Living; Notice of Federal Review of the Puerto Rico State Council on Developmental Disabilities (SCDD) and the Protection and Advocacy System (P&A)
Document Number: 2018-15905
Type: Notice
Date: 2018-07-25
Agency: Department of Health and Human Services
Representatives of the Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL), will be conducting a federal review of the Puerto Rico State Council on Developmental Disabilities (SCDD) and the Protection and Advocacy System (P&A) on September 17-21, 2018. AIDD is soliciting comments from interested parties on your experiences with the work, program, and strategies employed by P&A and SDCC in meeting the needs of individuals with developmental disabilities and their families in Puerto Rico. You are encouraged to share your experiences by way of any of the following methods: Email: Clare.huerta@acl.hhs.gov. Telephone: 202-795-7301. Mail Comments To: Clare Huerta, Program Specialist, Administration on Intellectual and Developmental Disabilities, Administration for Community Living, 330 C Street SW, 1st Floor, Washington, DC 20201. Comments should be received by September 10, 2018 in order to be included in the final report.
Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments; Draft Guidance for Industry; Availability
Document Number: 2018-15870
Type: Notice
Date: 2018-07-25
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 ``Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments.'' This draft guidance applies to orally administered drug products and provides recommendations to sponsors who will use or recommend use of liquids and/or soft foods as vehicles for drug administration in investigational new drug applications (INDs), new drug applications (NDAs), Biologics License Applications (BLAs), as applicable, and in supplements to these applications.
Facilitating Competition and Innovation in the Biological Products Marketplace; Public Hearing; Request for Comments
Document Number: 2018-15859
Type: Proposed Rule
Date: 2018-07-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing a public hearing on FDA's approach to enhancing competition and innovation in the biological products marketplace, including by facilitating greater availability of biosimilar and interchangeable products.
Submission for OMB Review; Comment Request
Document Number: 2018-15830
Type: Notice
Date: 2018-07-25
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-15825
Type: Notice
Date: 2018-07-25
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Center for Substance Abuse Treatment: Notice of Meeting
Document Number: 2018-15824
Type: Notice
Date: 2018-07-25
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Secretarial Review and Publication of the National Quality Forum 2017 Annual Report to Congress and the Secretary of the Department of Health and Human Services Submitted by the Consensus-Based Entity Regarding Performance Measurement
Document Number: 2018-15763
Type: Notice
Date: 2018-07-25
Agency: Department of Health and Human Services
This notice acknowledges the Secretary of the Department of Health and Human Services' (the Secretary) receipt and review of the National Quality Forum 2017 Annual Report to Congress and the Secretary submitted by the consensus-based entity under contract with the Secretary in accordance with the Social Security Act. The Secretary has reviewed and is publishing the report in the Federal Register together with the Secretary's comments on the report not later than 6 months after receiving the report in accordance with the Act.
Submission for OMB Review; 30-Day Comment Request; DERT Extramural Grantee Data Collection (NIEHS)
Document Number: 2018-15802
Type: Notice
Date: 2018-07-24
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-15782
Type: Notice
Date: 2018-07-24
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 Pharmacy Compounding Advisory Committee (PCAC). The general function of the committee is to provide advice on scientific, technical, and medical issues concerning drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and to make appropriate recommendations to the Agency. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR)
Document Number: 2018-15781
Type: Notice
Date: 2018-07-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR). This meeting is open to the public, limited only by 1,500 web conference lines. Public participants should pre-register for the meeting as described below. The public is welcome to view/listen to the meeting via Adobe Connect. Pre- registration is required by clicking the links below. Web ID: https://adobeconnect.cdc.gov/e3pmwd6fhge/event/ registration.html. Dial in number: 888-790-3293 (100 seats). Participant code: 3762458.
Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment; Public Workshop
Document Number: 2018-15779
Type: Notice
Date: 2018-07-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Regulatory Perspectives on Otic and Vestibular Toxicity: Challenges in Translating Animal Studies to Human Risk Assessment.'' The purpose of the public workshop is to identify the challenges involved in the translation of toxicities from animal studies to clinical trials, to highlight potential endpoints that can be used in both nonclinical and clinical phases of drug development, and to provide a platform for engaging discussions to improve safety assessments for drugs impacting auditory and vestibular functions. This public workshop will bring together regulatory medical and toxicologist reviewers, veterinary and clinical neurologists, and experts in evaluating auditory and vestibular endpoints.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies To Establish Product Withdrawal Periods in Aquatic Species; Draft Guidance for Industry; Availability
Document Number: 2018-15778
Type: Notice
Date: 2018-07-24
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 (GFI) #257 entitled ``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species'' (VICH GL57). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH draft guidance document is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements. This draft guidance document provides recommendations on what should be included in a marker residue depletion study design for aquatic food-producing species.
Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development; Draft Guidance for Industry; Availability
Document Number: 2018-15777
Type: Notice
Date: 2018-07-24
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 ``Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.'' This draft guidance describes FDA's current recommendations regarding how to optimize and standardize dietary management in clinical trials for the development of drugs treating inborn errors of metabolism (IEM) for which dietary management is a key component of patients' metabolic control. Optimizing dietary management in these patients before entry into and during the clinical trial(s) is essential to providing an accurate evaluation of the efficacy of new drug products.