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

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Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-17945
Type: Notice
Date: 2019-08-20
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 for OMB Review; Comment Request
Document Number: 2019-17939
Type: Notice
Date: 2019-08-20
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.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-17934
Type: Notice
Date: 2019-08-20
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 Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New Drug Applications; Correction
Document Number: 2019-17933
Type: Notice
Date: 2019-08-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 8, 2011. The document announced the withdrawal of approval of 70 new drug applications (NDAs) and 97 abbreviated new drug applications from multiple applicants, effective July 8, 2011. The document contained the incorrect applicant information for NDA 018380. The correct applicant for NDA 018380 is Hospira, Inc. This document corrects that error.
Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-17932
Type: Notice
Date: 2019-08-20
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 Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Request for Nominations for Voting Members on a Public Advisory Committee; Blood Products Advisory Committee
Document Number: 2019-17924
Type: Notice
Date: 2019-08-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Blood Products Advisory Committee (the Committee) in the Center for Biologics Evaluation and Research. Nominations will be accepted for upcoming vacancies effective with this notice. 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 Request; 30-Day Public Comment Request
Document Number: 2019-17887
Type: Notice
Date: 2019-08-20
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; 30-Day Public Comment Request
Document Number: 2019-17886
Type: Notice
Date: 2019-08-20
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 Activities; Proposed Collection; Comment Request; Adult Protective Services Client Outcome Study
Document Number: 2019-17879
Type: Notice
Date: 2019-08-20
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 Proposed new information collection and solicits comments on the information collection requirements related to the ``Adult Protective Services Client Outcome Study''.
Fit for Use Pilot Program Invitation for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide: Version 3.1
Document Number: 2019-17877
Type: Notice
Date: 2019-08-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing that it intends to conduct a Fit for Use (FFU) pilot program to test the processing and analysis of nonclinical study data provided electronically for the Clinical Data Interchange Standards Consortium (CDISC) for Standard for Exchange of Nonclinical Data (SEND) Implementation Guide (IG): Version 3.1 (SEND 3.1). The Agency's Center for Drug Evaluation and Research (CDER) will test the processing and analysis of nonclinical study data provided electronically in SEND 3.1 format. FDA is inviting individual firms that wish to participate in this pilot program to submit participation requests via email or in writing.
Implementing the Food and Drug Administration's Predictive Toxicology Roadmap: An Update of the Food and Drug Administration's Activities; Public Workshop
Document Number: 2019-17876
Type: Notice
Date: 2019-08-20
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 ``Implementing FDA's Predictive Toxicology Roadmap: An Update of FDA's Activities.'' The purpose of the public workshop is to highlight the work FDA has been doing to support and implement FDA's Predictive Toxicology Roadmap.
Determination That Dextrose, 20 Grams/100 Milliliters, and Dextrose, 50 Grams/100 Milliliters, in Plastic Containers, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-17874
Type: Notice
Date: 2019-08-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that Dextrose, 20 grams (g)/100 milliliters (mL), and Dextrose, 50 g/100 mL, in plastic containers, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic containers, if all other legal and regulatory requirements are met.
Submission for OMB Review; American Indian and Alaska Native (AIAN) Facility Survey (New Collection)
Document Number: 2019-17871
Type: Notice
Date: 2019-08-20
Agency: Department of Health and Human Services, Administration for Children and Families
The Office Head Start (OHS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data on the condition and ownership of American Indian and Alaska Native (AIAN) facilities to meet congressional reporting requirements under the Head Start Act.
Submission for OMB Review; Head Start Program Performance Standards (OMB #0970-0148)
Document Number: 2019-17870
Type: Notice
Date: 2019-08-20
Agency: Department of Health and Human Services, Administration for Children and Families
The Office Head Start (OHS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a three-year extension of the Head Start Program Performance Standards (HSPPS) information collection (OMB #0970-0148, expiration 1/ 31/2020). There are no changes requested to these record keeping requirements.
Government-Owned Inventions; Availability for Licensing
Document Number: 2019-17868
Type: Notice
Date: 2019-08-20
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government 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.
Government-Owned Inventions; Availability for Licensing
Document Number: 2019-17867
Type: Notice
Date: 2019-08-20
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government 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.
Prospective Grant of an Exclusive Patent License: Development and Commercialization of CD19/CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies
Document Number: 2019-17866
Type: Notice
Date: 2019-08-20
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 Patents and Patent Applications listed in the Supplementary Information section of this Notice to Lyell Immunopharma, Inc. (``Lyell''), located in South San Francisco, CA.
Office of the Director, National Institutes of Health; Amended Notice of Meeting
Document Number: 2019-17821
Type: Notice
Date: 2019-08-20
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2019-17820
Type: Notice
Date: 2019-08-20
Agency: Department of Health and Human Services, National Institutes of Health
State-Based Occupational Health Surveillance; Request for Information and Meeting Notice
Document Number: 2019-17782
Type: Notice
Date: 2019-08-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), announces a public teleconference meeting and an opportunity to comment on funding mechanisms and other considerations for state-based occupational health surveillance.
Submission for OMB Review; Evaluation of the Child Welfare Capacity Building Collaborative
Document Number: 2019-17775
Type: Notice
Date: 2019-08-19
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting a three-year extension of 20 previously approved forms that include satisfaction surveys; a leadership interview protocol; a web- based collaboration survey; assessment tools; and service-specific feedback forms (OMB #0970-0484, expiration 8/31/2019). There are no changes to these forms. An extension is not being sought for four instruments originally included (Tribal Organizational Assessment Interviews: Caseworker Interview; Community Provider Interview; Community Member/Elder Interview; Family Interview).
Request for Public Comment: 30-Day Information Collection: Indian Health Service Forms To Implement the Privacy Rule
Document Number: 2019-17761
Type: Notice
Date: 2019-08-19
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``IHS Forms to Implement the Privacy Rule'' Office of Management and Budget (OMB) Control Number 0917-0030. This previously approved information collection project was last published in the Federal Register (84 FR 19088) on May 3, 2019, and allowed 60 days for public comment. One public comment was received in response to the notice. The comment was not pertinent to the collection itself. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_0001).
Notice of Meeting
Document Number: 2019-17753
Type: Notice
Date: 2019-08-19
Agency: Department of Health and Human Services, Administration for Children and Families
Notice is hereby given, pursuant to the provisions of the Federal Advisory Committee Act (FACA) and the Preventing Sex Trafficking and Strengthening Families Act, that a meeting of the National Advisory Committee on the Sex Trafficking of Children and Youth in the United States (Committee) will be held on October 4, 2019. The purpose of the meeting is for the Committee to discuss its work on its interim report on recommended best practices for states to follow to combat the sex trafficking of children and youth based on multidisciplinary research and promising, evidence-based models, and programs. The members of the Committee request any examples and comments from the public to inform their work and have also requested input on the following specific topics pertaining to combating the sex trafficking of children and youth in the United States: Screening and Identification: Intersections with interpersonal violence; screening or universal approaches. Service Provision: Models for multi-agency response protocols; evaluated training curricula for service providers; case management and specialized service models. Housing: Prevention efforts of public housing authorities. Prevention: Initiatives of city, county, and state public health departments. Data: Strategies for state Medicaid offices to collect quality measures regarding violence or exploitation; collection and protection of exploitation data in health records. Child Welfare: Evidence-informed or -based curricula for child welfare providers, child and youth service providers, and foster parents; child welfare policies and procedures for identifying and responding to trafficking; interagency data sharing agreements that pertain to child sex trafficking cases; specialized foster care models including residential treatment; screening tools used in child welfare agencies and whether or not they've been validated. State funding sources for prevention, training, and/or services in addition to federal non-IV-E funding. Please submit your examples and/or comments to adonald@nhttac.org with the subject ``NAC Comments'' as soon as possible and before August 30.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements
Document Number: 2019-17734
Type: Notice
Date: 2019-08-19
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.
Nonprescription Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2019-17724
Type: Notice
Date: 2019-08-19
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 Nonprescription Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
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; Guidance for Industry; Availability
Document Number: 2019-17721
Type: Notice
Date: 2019-08-19
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 (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 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 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 guidance document provides recommendations on what should be included in a marker residue depletion study design for aquatic food-producing species.
National Institute on Minority Health and Health Disparities; Notice of Meeting
Document Number: 2019-17718
Type: Notice
Date: 2019-08-19
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: 2019-17717
Type: Notice
Date: 2019-08-19
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2019-17716
Type: Notice
Date: 2019-08-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Review Transparency and Communication in Reviews of 351(k) Biologics License Applications in Biosimilars User Fee Act
Document Number: 2019-17713
Type: Notice
Date: 2019-08-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Dear Health Care Provider Letters: Improving Communication of Important Safety Information
Document Number: 2019-17708
Type: Notice
Date: 2019-08-19
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 associated with Agency guidance entitled ``Dear Health Care Provider Letters: Improving Communication of Important Safety Information.'' The guidance offers specific recommendations to industry on the content and format of Dear Health Care Provider (DHCP) letters. These letters are sent by manufacturers or distributors to health care providers to communicate an important drug warning, a change in prescribing information, or a correction of misinformation in prescription drug promotional labeling or advertising. This guidance provides recommendations on when to use a DHCP letter, the types of information to include in the DHCP letter, how to organize the information so that it is communicated effectively to health care providers, and formatting techniques to make the information more accessible.
Food and Drug Administration Science Forum 2019; Public Workshop
Document Number: 2019-17703
Type: Notice
Date: 2019-08-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled ``FDA Science Forum 2019.'' The purpose of the public workshop is to share with the public the unique scientific research and collaborative efforts of FDA's 11,000 scientists and researchers, who use novel science and technologies to inform FDA's regulatory decision-makingand drive innovation.
Solicitation of Nominations for Appointment to the Advisory Council for the Elimination of Tuberculosis (ACET)
Document Number: 2019-17691
Type: Notice
Date: 2019-08-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACET. The ACET consists of 10 experts in fields associated with public health, epidemiology, immunology, infectious disease, pulmonary disease, pediatrics, tuberculosis, microbiology, or preventive health care delivery. They are selected by the Secretary of the U.S. Department of Health and Human Services (HHS). ACET provides advice and recommendations regarding eliminating tuberculosis (TB) to the Secretary, HHS; the Assistant Secretary for Health, HHS; and the CDC Director. ACET (a) makes recommendations regarding TB prevention and control policies, strategies, objectives, and priorities; (b) addresses development and application of new technologies; (c) provides guidance and review of CDC's TB prevention research portfolio and program priorities; and (d) reviews the extent to which progress has been made toward eliminating TB. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of ACET's objectives. Nominees will be selected on the basis of their expertise in public health, epidemiology, immunology, infectious diseases, pulmonary disease, pediatrics, tuberculosis, microbiology, or preventive health care delivery. Federal employees are ineligible for membership. Members may be invited to serve for up to four year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of ACET's objectives.
National Institute for Occupational Safety and Health (NIOSH); World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC)
Document Number: 2019-17690
Type: Notice
Date: 2019-08-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC National Institute for Occupational Safety and Health (NIOSH), announces the following meeting for the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC). This meeting is open to the public, limited only by the number of telephone lines. The room will accommodate approximately 100 persons. The public is also welcome to listen to the meeting by dial-in 1 (800) 988-0212, the passcode 1440561, and will accommodate up to 50 callers. To view the web conference, enter the following web address in your web browser: https://odniosh.adobeconnect.com/wtchpstac19-1/.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-17679
Type: Notice
Date: 2019-08-19
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.
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2019-17676
Type: Notice
Date: 2019-08-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-17663
Type: Notice
Date: 2019-08-16
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.
Meeting of the Community Preventive Services Task Force (CPSTF)
Document Number: 2019-17658
Type: Notice
Date: 2019-08-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention within the Department of Health and Human Services announces the next meeting of the Community Preventive Services Task Force (CPSTF) on October 16-17, 2019, in Atlanta, Georgia.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-17652
Type: Notice
Date: 2019-08-16
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Systematic Review Data Repository.'' This proposed information collection was previously published in the Federal Register on June 14, 2019 and allowed 60 days for public comment. There were no substantive comments received by AHRQ. The purpose of this notice is to allow an additional 30 days for public comment.
National Institute of Neurological Disorders and Stroke, Interagency Pain Research Coordinating Committee Call for Committee Membership Nominations
Document Number: 2019-17631
Type: Notice
Date: 2019-08-16
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services (HHS) (Department) has created the Interagency Pain Research Coordinating Committee (IPRCC) and is seeking nominations for this committee.
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2019-17609
Type: Notice
Date: 2019-08-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-17608
Type: Notice
Date: 2019-08-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-17606
Type: Notice
Date: 2019-08-16
Agency: Department of Health and Human Services, National Institutes of Health
Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
Document Number: 2019-17481
Type: Proposed Rule
Date: 2019-08-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing a proposed rule to establish new required cigarette health warnings for cigarette packages and advertisements. The proposed rule would implement a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) of 1965 to require each cigarette package and advertisement to bear one of the new required warnings. This proposed rule, once finalized, would specify the color graphics that must accompany the new textual warning statements. FDA is proposing to take this action to promote greater public understanding of the negative health consequences of cigarette smoking.
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 2020 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals
Document Number: 2019-16762
Type: Rule
Date: 2019-08-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2020 and to implement certain recent legislation. We also are making changes relating to Medicare graduate medical education (GME) for teaching hospitals and payments to critical access hospital (CAHs). In addition, we are providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2020. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2020. In this FY 2020 IPPS/LTCH PPS final rule, we are addressing wage index disparities impacting low wage index hospitals; providing for an alternative IPPS new technology add-on payment pathway for certain transformative new devices and qualified infectious disease products; and revising the calculation of the IPPS new technology add-on payment. In addition, we are revising and clarifying our policies related to the substantial clinical improvement criterion used for evaluating applications for the new technology add-on payment under the IPPS. We are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). We also are establishing new requirements and revising existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare and Medicaid Promoting Interoperability Programs. We are updating policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Document Number: 2019-17478
Type: Notice
Date: 2019-08-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization
Document Number: 2019-17477
Type: Notice
Date: 2019-08-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA 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.
Gastroparesis: Clinical Evaluation of Drugs for Treatment; Draft Guidance for Industry; Availability
Document Number: 2019-17463
Type: Notice
Date: 2019-08-14
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 ``Gastroparesis: Clinical Evaluation of Drugs for Treatment.'' This draft guidance is intended to provide the FDA's current thinking regarding clinical trial design and clinical endpoint assessments to support development of drugs for the treatment of diabetic and idiopathic gastroparesis. This draft guidance replaces the draft guidance for industry of the same name issued July 23, 2015.
Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects; Informed Consent; and Institutional Review Boards
Document Number: 2019-17462
Type: Notice
Date: 2019-08-14
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 found in Agency regulations pertaining to the protection of human subjects and responsibilities of institutional review boards (IRBs).
Drugs Intended for Human Use That Are Improperly Listed Due to Lack of Annual Certification or Identification of a Manufacturing Establishment Not Duly Registered With the Food and Drug Administration; Action Dates
Document Number: 2019-17436
Type: Notice
Date: 2019-08-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing its intention to begin inactivating drug listing records that are improperly listed in accordance with FDA requirements because these drug listings are not certified as being active and up to date or are associated with a manufacturing establishment that is not currently registered with FDA. FDA's regulations governing drug establishment registration and drug listing require registrants to notify FDA if commercial distribution of a listed drug is discontinued. They also require firms to submit drug listing updates if any material changes are made to information previously submitted, including a change in manufacturing establishment(s). FDA has found that listings for many drug products do not comply with these regulations because they have not been updated in over a year, they have not been certified as being up to date, or they identify within the listing information at least one manufacturing establishment that is not currently registered with FDA. Many of the drugs that are the subject of these listings appear to no longer be in commercial distribution. The purpose of this notice is to remind registrants of their legal obligations and announce that, if drug listings are not appropriately updated, certified, or associated with a registered establishment, they will be marked by FDA as ``inactive,'' and the date of inactivation will be added to the listing record. This process will result in the closure of drug records in all public drug listing databases maintained by FDA, including the National Drug Code (NDC) Directory and the NDC SPL Data Elements (NSDE) file, until corrections to the relevant listings are made.