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

Results 101 - 150 of 52,742
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-00474
Type: Notice
Date: 2020-01-15
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2020-00473
Type: Notice
Date: 2020-01-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00472
Type: Notice
Date: 2020-01-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00471
Type: Notice
Date: 2020-01-15
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-00426
Type: Notice
Date: 2020-01-14
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: 2020-00424
Type: Notice
Date: 2020-01-14
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.
Notice of Closed Meeting
Document Number: 2020-00372
Type: Notice
Date: 2020-01-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute on Aging; Notice of Closed Meetings
Document Number: 2020-00371
Type: Notice
Date: 2020-01-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00370
Type: Notice
Date: 2020-01-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-00369
Type: Notice
Date: 2020-01-14
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher
Document Number: 2020-00295
Type: Rule
Date: 2020-01-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification (510(k)) requirements for powered wheeled stretchers (product code INK). These devices are battery-powered tables with wheels that are intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions). This order exempts powered wheeled stretchers, class II devices, from 510(k) requirements, subject to certain conditions for exemption. This exemption from 510(k) requirements is immediately in effect for powered wheeled stretchers. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
Meeting of the Advisory Committee on Minority Health
Document Number: 2020-00307
Type: Notice
Date: 2020-01-13
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS or Department) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration by January 24, 2020, is required for the public to attend the meeting, provide comments, and/or distribute printed material(s) to ACMH members. Information about the meeting is available from the designated contact person and will be posted on the website for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH website under the heading About OMH.
Peripheral Percutaneous Transluminal Angioplasty and Specialty Catheters-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2020-00296
Type: Notice
Date: 2020-01-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff.'' The FDA is issuing this draft guidance document to provide recommendations for 510(k) submissions for peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis (ISR), scoring/cutting balloons). This draft guidance is not final nor is it in effect at this time.
National Institute on Minority Health and Health Disparities; Notice of Closed Meetings
Document Number: 2020-00273
Type: Notice
Date: 2020-01-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2020-00272
Type: Notice
Date: 2020-01-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2020-00271
Type: Notice
Date: 2020-01-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-00270
Type: Notice
Date: 2020-01-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2020-00269
Type: Notice
Date: 2020-01-13
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2020-00268
Type: Notice
Date: 2020-01-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00267
Type: Notice
Date: 2020-01-13
Agency: Department of Health and Human Services, National Institutes of Health
Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc; Public Meeting; Request for Comments
Document Number: 2020-00259
Type: Notice
Date: 2020-01-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing a public meeting entitled ``Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc.'' The purpose of the public meeting is to discuss and obtain scientific information on topics related to testing methodologies, terminology, and criteria that can be applied to characterize and measure asbestos and other potentially harmful elongate mineral particles (EMPs) that may be present as contaminants in talc and cosmetic products manufactured using talc as an ingredient.
Notice of Closed Meeting
Document Number: 2020-00257
Type: Notice
Date: 2020-01-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2020-00256
Type: Notice
Date: 2020-01-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Committee on Immunization Practices (ACIP); Notice of Meeting and Request for Comment
Document Number: 2020-00254
Type: Notice
Date: 2020-01-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public, limited only by room seating. The meeting room accommodates 216 for public seating. Room 245, adjacent to the meeting room, will be available once the meeting room reaches capacity, providing up to 18 additional seats. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for meeting registration and more information on ACIP please visit the ACIP website: http://www.cdc.gov/vaccines/acip/ index.html.
Research Project To Evaluate and Control Hazards to Landscaping and Grounds Management Workers; Request for Participants
Document Number: 2020-00246
Type: Notice
Date: 2020-01-10
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), is initiating a research study to evaluate workplace hazards to landscapers, groundskeepers, hardscapers and arborists and to develop appropriate controls to minimize or eliminate those hazards. NIOSH is seeking up to nine firms in the landscaping and grounds management fields to participate in the pilot study that will evaluate how outdoor power tools can create hazards that may result in occupational health impacts. NIOSH will use this information to design effective solutions, such as engineering controls for power tools. The findings and controls information will be shared with participating workers and companies.
National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting
Document Number: 2020-00194
Type: Notice
Date: 2020-01-10
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: 2020-00193
Type: Notice
Date: 2020-01-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting
Document Number: 2020-00192
Type: Notice
Date: 2020-01-10
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00191
Type: Notice
Date: 2020-01-10
Agency: Department of Health and Human Services, National Institutes of Health
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2020-00181
Type: Notice
Date: 2020-01-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Meeting of the the Substance Abuse and Mental Health Services Administration's National Advisory Council
Document Number: 2020-00171
Type: Notice
Date: 2020-01-09
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice is hereby given of the meeting on January 28, 2020, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Advisory Council (SAMHSA NAC). The meeting is open to the public and can also be accessed remotely. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory-councils/meetings. The meeting will include remarks and dialogue from the Assistant Secretary for Mental Health and Substance Use; updates from the SAMHSA Centers Directors, and a council discussion on clinical trends and emerging national issues with SAMHSA NAC members.
Agency Information Collection Activities; Proposed Collection; Comment Request; General Administrative Practice and Procedures
Document Number: 2020-00151
Type: Notice
Date: 2020-01-09
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 information collection associated with our General Administrative Practice and Procedures regulations.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Tissue Intended for Transplantation
Document Number: 2020-00144
Type: Notice
Date: 2020-01-09
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.
Fresenius USA, Inc., et al.; Proposal To Withdraw Approval of 249 Abbreviated New Drug Applications; Opportunity for a Hearing
Document Number: 2020-00120
Type: Notice
Date: 2020-01-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of 249 abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs and is announcing an opportunity for the ANDA holders to request a hearing on this proposal. The basis for the proposal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2020-00113
Type: Notice
Date: 2020-01-08
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2020-00112
Type: Notice
Date: 2020-01-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2020-00111
Type: Notice
Date: 2020-01-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00110
Type: Notice
Date: 2020-01-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00109
Type: Notice
Date: 2020-01-08
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Data Collection for the Next Generation of Enhanced Employment Strategies Project (New Collection)
Document Number: 2020-00107
Type: Notice
Date: 2020-01-08
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Planning, Research, and Evaluation (OPRE) within the Administration for Children and Families (ACF) is proposing data collection activities conducted for the Next Generation of Enhanced Employment Strategies (NextGen) Project. The objective of this project is to identify and rigorously evaluate innovative interventions designed to promote employment and economic security among low-income individuals with complex challenges to employment. The project will include an experimental impact study, descriptive study, and cost study.
Supplemental Evidence and Data Request on Treatments for Acute Pain: A Systematic Review
Document Number: 2020-00104
Type: Notice
Date: 2020-01-08
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 on Treatments for Acute Pain: 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.
Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry; Extension of Comment Period
Document Number: 2020-00091
Type: Notice
Date: 2020-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice entitled ``Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry'' that appeared in the Federal Register of October 25, 2019. The Agency is taking this action to allow interested persons additional time to submit comments.
Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications
Document Number: 2020-00076
Type: Notice
Date: 2020-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 23 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.
Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19 New Drug Applications
Document Number: 2020-00075
Type: Notice
Date: 2020-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 19 new drug applications (NDAs) 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Focus Groups as Used by the Food and Drug Administration (All Food and Drug Administration-Regulated Products)
Document Number: 2020-00074
Type: Notice
Date: 2020-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
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 (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 collection of information for the generic collection for focus groups as used by FDA (all FDA-regulated products).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Feed Regulatory Program Standards
Document Number: 2020-00073
Type: Notice
Date: 2020-01-08
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.
Alaco, Inc., et al.; Proposal To Withdraw Approval of Seven New Animal Drug Applications; Opportunity for a Hearing
Document Number: 2020-00072
Type: Notice
Date: 2020-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Veterinary Medicine (CVM) is proposing to withdraw approval of seven new animal drug applications (NADAs) and is announcing an opportunity for the NADA holders to request a hearing on this proposal. The basis for the proposal is that the NADA holders have repeatedly failed to file required annual reports for those NADAs.
Modernizing the Food and Drug Administration's Data Strategy; Public Meeting; Request for Comments
Document Number: 2020-00071
Type: Notice
Date: 2020-01-08
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 meeting entitled ``Modernizing FDA's Data Strategy.'' The purpose of the public meeting and the request for comments is to discuss possible Agency level approaches to modernizing FDA's data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics.
Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff; Extension of Comment Period
Document Number: 2020-00070
Type: Notice
Date: 2020-01-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice entitled ``Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff; Availability'' that appeared in the Federal Register of November 25, 2019. The Agency is taking this action to allow interested persons additional time to submit comments before finalization of the guidance.