Department of Health and Human Services 2019 – Federal Register Recent Federal Regulation Documents
Results 301 - 350 of 3,514
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Shortages Data Collection System
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; Certification of Identity for Freedom of Information Act and Privacy Act Requests
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with certain Freedom of Information Act and Privacy Act requests.
HHS Policy for the Protection of Human Research Subjects
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health (OASH), Department of Health and Human Services (HHS), excepts two categories of research from the required use of a single institutional review board (IRB) to review cooperative research under the HHS regulations for the protection of human subjects. This determination is specific to research conducted or supported by HHS.
Board of Scientific Counselors, Center for Preparedness and Response (BSC, CPR); (Formerly Known as the Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR)); Notice of Charter Renewal
This gives notice under (specific statutes and regulations citations and) the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, Center for Preparedness and Response (BSC, CPR); (formerly known as the Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR)), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 5, 2021.
Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID); (Formerly Known as the Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)); Notice of Charter Renewal
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID); (formerly known as the Board of Scientific Counselors, Office of Infectious Diseases, (BSC, OID)), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through October 31, 2021.
Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC); Notice of Charter Renewal
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 5, 2021.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dear Health Care Provider Letters: Improving Communication of Important Safety Information
The Food and Drug Administration (FDA, the 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; Collection of Information for Participation in the Food and Drug Administration Non-Employee Fellowship and Traineeship Programs
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 ``Collection of Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs.''
Agency Information Collection Activities; Proposed Additional Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications; Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants
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/revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``General Licensing Provisions; Section 351(k) Biosimilar Applications; Formal Meetings Between the FDA and Sponsors or Applicants.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Tracking Network for PETNet, LivestockNet, and SampleNet
The Food and Drug Administration (FDA, the 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 our use of a tracking network to collect and share safety information about animal food from Federal, State, and Territorial Agencies.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
``Ruby Chocolate'' Deviating From Identity Standard; Temporary Permit for Market Testing
The Food and Drug Administration (FDA or we) is announcing that a temporary permit has been issued to Barry Callebaut U.S.A. LLC (the applicant) to market test a product identified as ``ruby chocolate'' that deviates from the U.S. standards of identity for chocolate products. The temporary permit will allow the applicant to evaluate commercial viability of the product and to collect data on consumer acceptance of the product.
Agency Information Collection Activities: Proposed Collection; Comment Request; Correction
This document corrects the information provided for [Document Identifier: CMS-10718] titled ``Model Medicare Advantage and Medicare Prescription Drug Plan Individual Enrollment Request Form.''
Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Web-Based Pilot Survey To Assess Allergy to Cosmetics in the United States
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).
Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Dermatologic and Ophthalmic 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.
Transdermal and Topical Delivery Systems-Product Development and Quality Considerations; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Transdermal and Topical Delivery SystemsProduct Development and Quality Considerations.'' This guidance provides recommendations to applicants and manufacturers of transdermal and topical delivery systems (TDS) regarding the pharmaceutical development and quality information to include in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Specifically, the guidance discusses FDA's current thinking on product design and pharmaceutical development, manufacturing process and control, and finished product control. It also addresses special considerations for areas where quality is closely tied to product performance and potential safety issues, such as adhesion failure and the impact of applied heat on drug delivery.
2019 Public Meeting on Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``2019 Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program.'' The purpose of the public meeting is to help ensure that as standard core sets of clinical outcome assessments (COAs) are developed as part of the FDA pilot grant program, the identified concepts, COAs, and endpoints reflect what is most important to patients and relevant to regulatory and potentially other stakeholder decision making. To facilitate this, stakeholders including patients, care partners, FDA reviewers, drug developers, other government and academic researchers, health care providers, health technology assessors and health payers are encouraged to attend the meeting.
Request for Information; Innovative Approaches and Knowledge Gaps Related To Enhancing Nonresident Parents' Ability To Support Their Children Economically and Emotionally
Through this Request for Information (RFI), the Administration for Children and Families (ACF), in the U.S. Department of Health and Human Services (HHS), seeks to further the development of employment programs for nonresident parents by soliciting information and recommendations from a broad array of stakeholders in the public and private sectors, including state, regional, tribal, and local areas. The Foundations for Evidence-Based Policymaking Act of 2018 (Evidence Act) requires federal agencies to develop evidence-building plans to identify and address policy questions relevant to programs, policies, and regulations of the agency. In this vein, ACF will analyze information collected from this RFI to continue developing a learning and action agenda to better understand the effectiveness of employment programs for nonresident parents.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 Pilot Project: Work Organization Risks to Short-haul Truck Drivers' Health & Safety. This study is designed to assess how local/short haul drivers perceive their work environments, and how that relates to their well-being.
List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals; Request for Nominations
FDA is establishing a public docket for interested parties to nominate bulk drug substances or renominate bulk drug substances that were previously nominated without adequate supporting information, for inclusion on a list of bulk drug substances for compounding certain animal drugs without a patient specific prescription (i.e., office stock) for use in nonfood-producing animals or as antidotes for food- producing animals, as described in the draft guidance for industry #256, ``Compounding Animal Drugs from Bulk Drug Substances,'' when that guidance is finalized. Individuals may also comment on bulk drug substances that have been reviewed by FDA and added to this list, or nominations that are currently under FDA review.
Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry (GFI) #256 entitled ``Compounding Animal Drugs from Bulk Drug Substances.'' The draft guidance, if finalized, will describe FDA's current thinking about compounding animal drugs from bulk drug substances. FDA has generally exercised enforcement discretion with regard to animal drug compounding from bulk drug substances under certain circumstances when no other medically appropriate treatment options exist. This draft guidance, a continuation of this practice, is intended to provide additional information and clarity to veterinarians and pharmacists about FDA's current thinking with respect to animal drug compounding from bulk drug substances. FDA previously published draft guidance on this issue for public comment in May 2015 (Draft GFI #230, ``Compounding Animal Drugs from Bulk Drug Substances''). We received over 150 comments on that draft guidance. Based on those comments, we decided to withdraw the May 2015 draft guidance and publish this draft guidance for public comment.
A New Era of Smarter Food Safety; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of public meeting and request for comments that appeared in the Federal Register of September 18, 2019. The notice announced a public meeting entitled ``A New Era of Smarter Food Safety'' that was held on October 21, 2019. In the notice of public meeting and request for comments, FDA requested comments on a modern approach the Agency is taking to strengthen its protection of the food supply to help shape an FDA blueprint for a new era of smarter food safety. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Proposed Collection; 60-Day Comment Request; National Institute of Neurological Disorders and Stroke FITBIR Data Access Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, to provide opportunity for public comment on proposed data collection projects, the National Institute of Neurological Disorders and Stroke (NINDS), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
National Vaccine Injury Compensation Program; List of Petitions Received
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Submission for OMB Review; Evaluation of the National Human Trafficking Hotline Program (New Collection)
The Office of Planning, Research, and Evaluation (OPRE) is proposing a data collection activity as part of the Evaluation of the National Human Trafficking Hotline (NHTH) Program. This data collection activity will examine the experiences of individuals who seek assistance from the NHTH after their interactions with the NHTH. The study will collect information via voluntary phone and Web-based surveys at two time points: (1) Immediately after an individual has contacted the NHTH by phone, text, or live online chat; and (2) two weeks later.
Proposed Collection; 60-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (National Library of Medicine)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Library of Medicine (NLM), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
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