Department of Health and Human Services March 2018 – Federal Register Recent Federal Regulation Documents

Medicare Program; Membership and Meeting Announcement for the Advisory Panel on Clinical Diagnostic Laboratory Tests
Document Number: 2018-06556
Type: Notice
Date: 2018-03-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the appointment of three new members to the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) and the next public meeting for the Panel, which is scheduled on Monday, July 16, 2018 and Tuesday, July 17, 2018. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on issues related to clinical diagnostic laboratory tests.
Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items; Update to the Master List of Items Frequently Subject to Unnecessary Utilization
Document Number: 2018-06552
Type: Rule
Date: 2018-03-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces the deletion of four Healthcare Common Procedure Coding System (HCPCS) codes from the Master List of Items Frequently Subject to Unnecessary Utilization that could be potentially subject to Prior Authorization as a condition of payment.
Medicare Program; Public Meeting on June 25, 2018 Regarding New and Reconsidered Clinical Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee Schedule for Calendar Year 2019
Document Number: 2018-06551
Type: Notice
Date: 2018-03-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a public meeting to receive comments and recommendations (including accompanying data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HCPCS) codes being considered for Medicare payment under the clinical laboratory fee schedule (CLFS) for calendar year (CY) 2019. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests. The Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (Advisory Panel on CDLTs) will participate in this Annual Laboratory Public Meeting by gathering information and asking questions to presenters, and will hold its next public meeting on July 16 and 17, 2018. The public meeting for the Advisory Panel on CDLTs will focus on discussion of and recommendations for test codes presented during the June 25, 2018 Annual Laboratory Public Meeting. The Panel meeting also will address other CY 2019 CLFS issues that are designated in the Panel's charter and specified on the meeting agenda may also be discussed.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2018-06522
Type: Notice
Date: 2018-03-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Request for Public Comment: 60 Day Proposed Information Collection: Indian Health Service Purchased/Referred Care Proof of Residency
Document Number: 2018-06521
Type: Notice
Date: 2018-03-30
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act (PRA) of 1995, which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917- XXXX, titled, Purchased/Referred Care (PRC) Proof of Residency. The purpose of this notice is to allow 60 days for public comment to be submitted directly to OMB. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001).
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-06487
Type: Notice
Date: 2018-03-30
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 ``Assessment of a Preventive Service Program in the Context of a Zika Virus Outbreak in Puerto Rico''. Data collected will be used to assess implementation of a patient-centered prevention program and associated outcomes.
Submission for OMB Review; Comment Request
Document Number: 2018-06446
Type: Notice
Date: 2018-03-30
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Health Care Services Outreach Program Performance Improvement and Measurement Systems Measures, OMB No. 0915-0009-Revision
Document Number: 2018-06442
Type: Notice
Date: 2018-03-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. This proposed information collection was previously published in the Federal Register on November 27, 2017, and allowed 60- days for public comment. No public comments were received.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Radiation Exposure Screening and Education Program, OMB No. 0906-0012-Revision
Document Number: 2018-06432
Type: Notice
Date: 2018-03-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. A 60-day Federal Register Notice was published on January 9, 2018. There were no comments. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Rural Health Network Development Program, OMB No. 0906-0010-Revision
Document Number: 2018-06431
Type: Notice
Date: 2018-03-30
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
National Institute on Minority Health and Health Disparities; Notice of Meeting
Document Number: 2018-06401
Type: Notice
Date: 2018-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-06400
Type: Notice
Date: 2018-03-30
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-06392
Type: Notice
Date: 2018-03-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-06391
Type: Notice
Date: 2018-03-30
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
Document Number: 2018-06358
Type: Rule
Date: 2018-03-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name and address, and to make technical amendments to improve the accuracy of the regulations.
New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
Document Number: 2018-06357
Type: Rule
Date: 2018-03-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.
Government-Owned Invention; Availability for Licensing
Document Number: 2018-06364
Type: Notice
Date: 2018-03-29
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-06312
Type: Notice
Date: 2018-03-29
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-06309
Type: Notice
Date: 2018-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-06307
Type: Notice
Date: 2018-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Government-Owned Inventions; Availability for Licensing and Collaboration; Notification of Q&A Webinar
Document Number: 2018-06306
Type: Notice
Date: 2018-03-29
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The invention named in this notice is owned by agencies of the United States Government and is available for licensing in accordance with the U.S. Federal Technology Transfer Act of 1986. Related data for 510(k) submission is available as part of the licensing package. The technology and related data are being licensed to achieve expeditious commercialization of federally funded research and development. A U.S. Provisional patent application has been filed to extend market coverage. CDC also seeks collaboration partners with interest in adapting the test for different equipment, point-of-care, or more rapid processing.
Fiscal Year 2018 Generic Drug Regulatory Science Initiatives; Public Workshop; Request for Comments
Document Number: 2018-06260
Type: Notice
Date: 2018-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``FY 2018 Generic Drug Regulatory Science Initiatives.'' The purpose of the public workshop is to provide an overview of the status of regulatory science initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholdersindustry, academia, patient advocates, professional societies, and other interested partiesas it fulfills its commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its fiscal year (FY) 2019 regulatory science initiatives.
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2018-06259
Type: Notice
Date: 2018-03-29
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Meeting
Document Number: 2018-06258
Type: Notice
Date: 2018-03-29
Agency: Department of Health and Human Services, National Institutes of Health
Product-Specific Guidance for Doxycycline Hyclate; Revised Draft Guidance for Industry; Availability
Document Number: 2018-06253
Type: Notice
Date: 2018-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry on generic doxycycline hyclate oral delayed-release tablets, entitled ``Product- Specific Guidance for Doxycycline Hyclate.'' The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for doxycycline hyclate oral delayed-release tablets.
Good Guidance Practices; Technical Amendment
Document Number: 2018-06252
Type: Rule
Date: 2018-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is amending its good guidance practices regulation to inform the public on how to electronically submit a draft of a proposed guidance to the Agency. This technical amendment is nonsubstantive.
Medical Gas Regulation; Public Workshop; Request for Comments
Document Number: 2018-06251
Type: Proposed Rule
Date: 2018-03-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing an additional public workshop on medical gas regulation entitled ``Medical Gas Regulation: Workshop III.'' FDA has previously held two public workshops entitled ``Medical Gas Regulation: Workshop I'' and ``Medical Gas Regulation: Workshop II.'' The topic to be discussed is potential areas of Federal drug regulation that should be revised with respect to medical gases.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-06221
Type: Notice
Date: 2018-03-28
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: 2018-06184
Type: Notice
Date: 2018-03-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Compounded Drug Products That Are Essentially Copies of an Approved Drug Product Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Document Number: 2018-06169
Type: Notice
Date: 2018-03-28
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.
Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-06168
Type: Notice
Date: 2018-03-28
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 Gastrointestinal Drugs Advisory Committee and the Pediatric Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Cigarettes, Smokeless Tobacco, and Covered Tobacco Products; Change of Office Name and Address; Technical Amendment
Document Number: 2018-06164
Type: Rule
Date: 2018-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is amending its Cigarettes, Smokeless Tobacco, and Covered Tobacco Products regulations to reflect a change of office name and mailing address for the Center for Tobacco Products' (CTP's) Office of Compliance and Enforcement. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient
Document Number: 2018-06155
Type: Notice
Date: 2018-03-28
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 (PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
Document Number: 2018-06154
Type: Notice
Date: 2018-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) 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; Proposed Collection; Comment Request; National Agriculture and Food Defense Strategy Survey
Document Number: 2018-06135
Type: Notice
Date: 2018-03-28
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements for a voluntary survey for the U.S. Department of Health and Human Services (HHS), the U.S. Department of Agriculture (USDA), and the U.S. Department of Homeland Security (DHS), which will inform the FDA Food Safety Modernization Act (FSMA), National Agriculture and Food Defense Strategy (NAFDS) Report to Congress that is required by April 2019. The proposed survey will be used to determine what food defense activities, if any, State Agencies have completed to date.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2018-06117
Type: Notice
Date: 2018-03-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Meetings
Document Number: 2018-06116
Type: Notice
Date: 2018-03-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-06115
Type: Notice
Date: 2018-03-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-06114
Type: Notice
Date: 2018-03-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-06113
Type: Notice
Date: 2018-03-27
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-06082
Type: Notice
Date: 2018-03-27
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: 2018-06081
Type: Notice
Date: 2018-03-27
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: Submission to OMB for Review and Approval; Public Comment Request; NURSE Corps Scholarship Program; Information Collection Request Title: Nurse Corps Scholarship Program, OMB No. 0915-0301-Revision
Document Number: 2018-06077
Type: Notice
Date: 2018-03-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Consultation Procedures: Foods Derived From New Plant Varieties
Document Number: 2018-06069
Type: Notice
Date: 2018-03-27
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 (PRA).
Revision of Organization; Technical Amendment
Document Number: 2018-06065
Type: Rule
Date: 2018-03-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is amending its regulations to reflect organizational change for the Office of Regulatory Policy, Center for Drug Evaluation and Research (CDER), Office of Medical Products and Tobacco. FDA is taking this action to ensure accuracy and clarity in the Agency's regulations.
Orthopaedic Sensing, Measuring, and Advanced Reporting Technology Devices; Public Workshop; Request for Comments; Amendment of Notice
Document Number: 2018-06064
Type: Notice
Date: 2018-03-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing an amendment to the notice of public workshop entitled ``Orthopaedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Devices.'' That workshop was announced in the Federal Register of February 13, 2018. The amendment is being made to reflect a change in the DATES portion of the document. There are no other changes.
Advisory Committee; Gastrointestinal Drugs Advisory Committee, Renewal
Document Number: 2018-06063
Type: Notice
Date: 2018-03-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Gastrointestinal Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Gastrointestinal Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until March 3, 2020.
Request for Nominations for Voting Members on a Public Advisory Committee; Pharmacy Compounding Advisory Committee
Document Number: 2018-06062
Type: Notice
Date: 2018-03-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Pharmacy Compounding Advisory Committee (Committee), Division of Advisory Committee Consultant Management, Center for Drug Evaluation and Research. The Committee provides advice on scientific, technical, and medical issues concerning human 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 makes appropriate recommendations to the Commissioner of Food and Drugs. 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.
Elemental Impurities in Animal Drug Products-Questions and Answers; Draft Guidance for Industry; Availability
Document Number: 2018-06061
Type: Notice
Date: 2018-03-27
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 (GFI) #255 entitled ``Elemental Impurities in Animal Drug ProductsQuestions and Answers.'' This guidance is intended to assist sponsors of animal drug products in addressing changes in the United States Pharmacopeia (USP) requirements for the control of elemental impurities in drug products marketed in the United States.
Advisory Council for the Elimination of Tuberculosis (ACET); Correction
Document Number: 2018-06059
Type: Notice
Date: 2018-03-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services