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

Results 151 - 200 of 27,499
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-21590
Type: Notice
Date: 2018-10-04
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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-21587
Type: Notice
Date: 2018-10-04
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-21576
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute of Dental & Craniofacial Research: Notice of Closed Meeting
Document Number: 2018-21575
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-21574
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-21573
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-21572
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-21571
Type: Notice
Date: 2018-10-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed revision of information collection project titled Formative and Summative Evaluation of Scaling the National Diabetes Prevention Program (National DPP) in Underserved Areas. This revision is to allow CDC to continue collecting the information needed to assess the effectiveness of its program, ``Scaling the National DPP in Underserved Areas'', and to collect more targeted information on CDC grantees' success in reaching both general and priority populations in underserved areas.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-21570
Type: Notice
Date: 2018-10-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Laboratory Response Network to maintain an integrated national and international network of laboratories that can respond to suspected acts of biological, chemical, or radiological terrorism and other public health emergencies.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2018-21569
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2018-21568
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2018-21567
Type: Notice
Date: 2018-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
Document Number: 2018-21532
Type: Notice
Date: 2018-10-03
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 ``Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance revises the guidance for industry entitled ``Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act'' issued in November 2014. This draft guidance updates the November 2014 guidance to account for recent regulatory changes and describes a change in FDA's current thinking on what constitutes a 505(q) petition. In addition, FDA is revising this guidance to describe some of the considerations FDA will take into account in determining whether a petition is submitted with the primary purpose of delaying the approval of an application.
Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use; Guidance for Industry; Availability
Document Number: 2018-21531
Type: Notice
Date: 2018-10-03
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 ``Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use.'' This guidance finalizes the draft guidance issued October 22, 2015, which provides recommendations on the selection of appropriate package type terms and selection of appropriate discard statements for injectable medical products for human use, packaged in multiple-dose, single-dose, and single-patient-use containers.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2018-21520
Type: Notice
Date: 2018-10-03
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs; Guidance for Industry; Availability
Document Number: 2018-21519
Type: Notice
Date: 2018-10-03
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 ``Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.'' This guidance addresses FDA's current thinking about the relevant age groups to study and how early in drug development applicants should incorporate pediatric patients for development of systemic drugs for atopic dermatitis (AD). This guidance finalizes the draft guidance of the same name issued on April 9, 2018.
Privacy Act of 1974; Matching Program
Document Number: 2018-21506
Type: Notice
Date: 2018-10-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a new matching program between CMS and the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), ``Verification of Eligibility for Minimum Essential Coverage Under the Patient Protection and Affordable Care Act Through a Veterans Health Administration Plan.''
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-21505
Type: Notice
Date: 2018-10-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2018-21504
Type: Notice
Date: 2018-10-03
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-21503
Type: Notice
Date: 2018-10-03
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-21501
Type: Notice
Date: 2018-10-03
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims; Correction
Document Number: 2018-21500
Type: Rule
Date: 2018-10-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors in the final rule that appeared in the August 17, 2018 issue of the Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims''.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF) Final Rule for FY 2019, SNF Value-Based Purchasing Program, and SNF Quality Reporting Program; Correction
Document Number: 2018-21499
Type: Rule
Date: 2018-10-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors in the final rule that appeared in the August 8, 2018 Federal Register (83 FR 39162) entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF) Final Rule for FY 2019, SNF Value- Based Purchasing Program, and SNF Quality Reporting Program.''
Proposed Revised Vaccine Information Materials for Meningococcal ACWY and DTaP (Diphtheria, Tetanus, Pertussis) Vaccines
Document Number: 2018-21491
Type: Notice
Date: 2018-10-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Under the National Childhood Vaccine Injury Act (NCVIA), the Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) develops vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. HHS/CDC seeks written comment on the proposed updated vaccine information statements for meningococcal ACWY and DTaP (diphtheria, tetanus, acellular pertussis) vaccines.
Announcement of Intent To Issue an OPDIV-Initiated Supplement to BCFS Health and Human Services Under the Standing Funding Opportunity Announcement Number HHS-2017-ACF-ORR-ZU-1132, Residential (Shelter) Services for Unaccompanied Children
Document Number: 2018-21454
Type: Notice
Date: 2018-10-03
Agency: Department of Health and Human Services, Administration for Children and Families
Administration for Children and Families, Office of Refugee Resettlement, announces the intent to issue an OPDIV-Initiated Supplement to BCFS Health and Human Services, San Antonio, TX, in the amount of up to $6,500,000. ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions of Unaccompanied Children at the U.S. Southern Border. Planning for increased shelter capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter for Unaccompanied Alien Children referred to its care by the Department of Homeland Security (DHS). To ensure sufficient capacity to provide shelter to unaccompanied children referred to HHS, BCFS proposed to the continuation of services to ORR with 222 variance licensed beds.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2018-21403
Type: Notice
Date: 2018-10-02
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2018-21402
Type: Notice
Date: 2018-10-02
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Food Additives Permitted in Feed and Drinking Water of Animals; 25-Hydroxyvitamin D3
Document Number: 2018-21396
Type: Rule
Date: 2018-10-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of 25- hydroxyvitamin D3 as a source of vitamin D3 activity for layer and breeder chickens and turkeys. This action is in response to two food additive petitions filed by DSM Nutritional Products.
Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use)
Document Number: 2018-21395
Type: Proposed Rule
Date: 2018-10-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that Kemin Industries, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of chromium propionate as a source of supplemental chromium in horse feed.
National Cancer Institute; Notice of Charter Renewal
Document Number: 2018-21372
Type: Notice
Date: 2018-10-02
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2018-21371
Type: Notice
Date: 2018-10-02
Agency: Department of Health and Human Services, National Institutes of Health
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2018-21345
Type: Notice
Date: 2018-10-02
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at http:// www.samhsa.gov/workplace.
Medicare Program: Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures
Document Number: 2018-21223
Type: Proposed Rule
Date: 2018-10-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would revise the regulations setting forth the appeals process that Medicare beneficiaries, providers, and suppliers must follow in order to appeal adverse determinations regarding claims for benefits under Medicare Part A and Part B or determinations for prescription drug coverage under Part D. These changes would help streamline the appeals process and reduce administrative burden on providers, suppliers, beneficiaries, and appeal adjudicators. These revisions, which include technical corrections, would also help to ensure the regulations are clearly arranged and written to give stakeholders a better understanding of the appeals process.
Adaptive Designs for Clinical Trials of Drugs and Biologics; Draft Guidance for Industry; Availability
Document Number: 2018-21314
Type: Notice
Date: 2018-10-01
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 ``Adaptive Designs for Clinical Trials of Drugs and Biologics.'' This document provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic. The guidance describes the basic principles for designing, conducting, and reporting the results from an adaptive clinical trial. The draft guidance will replace the 2010 draft guidance for industry entitled ``Adaptive Design Clinical Trials for Drugs and Biologics.''
Master Protocols: Efficient Clinical Trial Design Strategies To Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry; Availability
Document Number: 2018-21313
Type: Notice
Date: 2018-10-01
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 ``Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.'' This guidance provides advice to sponsors of drugs and biologics for cancer treatment regarding the design and conduct of clinical trials, other than first- in-human (FIH) trials, intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers. In contrast to traditional trial designs, where a single drug is tested in a single disease population in one clinical trial, master protocols use a single infrastructure, trial design, and protocol to simultaneously evaluate multiple drugs and/or disease populations in multiple substudies, allowing for efficient and accelerated drug development.
Self-Contained Breathing Apparatus Compressed Breathing Gas Containers; Request for Information
Document Number: 2018-21256
Type: Notice
Date: 2018-10-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In October 2017, the Department of Transportation (DOT) issued a special permit to the Digital Wave Corporation, allowing the company to extend the service life of certain carbon-fiber reinforced aluminum- lined cylinders. Some stakeholders, including respirator and cylinder manufacturers, have expressed concern to the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention, about the safety of cylinders extended beyond the manufacturers' stated service life. NIOSH is seeking information about the potential effect of the special permit, as it may relate to the safety of self-contained breathing apparatus respirators approved by NIOSH for use in U.S. workplaces.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-21253
Type: Notice
Date: 2018-10-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-21252
Type: Notice
Date: 2018-10-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications; Draft Guidance for Industry; Availability
Document Number: 2018-21243
Type: Notice
Date: 2018-10-01
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 ``Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to an IND, NDA, BLA, or ANDA.'' The draft guidance provides recommendations to industry and FDA staff regarding the content and submission procedures for use-related risk analyses, human factors validation study protocols and reports, threshold analyses, and comparative use human factors study protocols and reports.
Supplemental Evidence and Data Request on Antipsychotics for the Prevention and Treatment of Delirium: A Systematic Review
Document Number: 2018-21242
Type: Notice
Date: 2018-10-01
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Antipsychotics for the Prevention and Treatment of Delirium: A Systematic Review, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Submission for OMB Review; Comment Request
Document Number: 2018-21226
Type: Notice
Date: 2018-10-01
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Distribution Reports and Recordkeeping
Document Number: 2018-21208
Type: Notice
Date: 2018-10-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of our reporting and recordkeeping requirements for antimicrobial animal drug sales and distribution.
Agency Information Collection Activities; Proposed Collection; Comment Request; Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records
Document Number: 2018-21207
Type: Notice
Date: 2018-10-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the guidance entitled ``Guidance for Industry: Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-20995
Type: Notice
Date: 2018-10-01
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.
John D. McCoy; Denial of Hearing; Final Debarment Order
Document Number: 2018-21211
Type: Notice
Date: 2018-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is denying a request for a hearing submitted by John D. McCoy (McCoy) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring McCoy for 4 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that McCoy was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the conduct underlying the conviction undermines the process for the regulation of drugs. In determining the appropriateness and period of McCoy's debarment, FDA has considered the relevant factors listed in the FD&C Act. McCoy has failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
Richard M. Fleming; Denial of Hearing; Final Debarment Order
Document Number: 2018-21210
Type: Notice
Date: 2018-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is denying a request for a hearing submitted by Richard M. Fleming (Fleming) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Fleming for 10 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Fleming was convicted of two felonies under Federal law that involved fraud. Additionally, Fleming has demonstrated a pattern of conduct sufficient to find that there is reason to believe that he may violate requirements under the FD&C Act relating to drug products. In determining the appropriateness and period of Fleming's debarment, FDA considered the relevant factors listed in the FD&C Act. Fleming failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2018-21209
Type: Notice
Date: 2018-09-28
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.
Use of the Names of Dairy Foods in the Labeling of Plant-Based Products
Document Number: 2018-21200
Type: Notice
Date: 2018-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) invites comments on the labeling of plant-based products with names that include the names of dairy foods such as ``milk,'' ``cultured milk,'' ``yogurt,'' and ``cheese.'' We are interested in learning how consumers use these plant-based products and how they understand terms such as, for example, ``milk'' or ``yogurt'' when included in the names of plant- based products. We also are interested in learning whether consumers are aware of and understand differences between the basic nature, characteristics, ingredients, and nutritional content of plant-based products and their dairy counterparts. We are taking this action to inform our development of an approach to the labeling of plant-based products that consumers may substitute for dairy foods.
GlaxoSmithKline, LLC, et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications
Document Number: 2018-21199
Type: Notice
Date: 2018-09-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 24 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.