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

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Establishing Effectiveness for Drugs Intended To Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders; Guidance for Industry; Availability
Document Number: 2018-10732
Type: Notice
Date: 2018-05-21
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 guidance for industry entitled ``Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders.'' This guidance provides recommendations for establishing clinical effectiveness for drugs intended to treat male hypogonadotropic hypogonadism associated with obesity and other conditions that do not cause structural disorders of the hypothalamus or pituitary gland. This guidance incorporates advice FDA received at a December 2014 advisory committee meeting on the appropriate indicated population for testosterone therapy and a December 2016 advisory committee meeting on hypogonadotropic hypogonadism. This guidance finalizes the draft guidance of the same name issued on January 3, 2018.
Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee, Renewal
Document Number: 2018-10731
Type: Notice
Date: 2018-05-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee (the Committee) by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 1, 2020.
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigation of Consumer Perceptions of Expressed Modified Risk Claims
Document Number: 2018-10723
Type: Notice
Date: 2018-05-21
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 investigation of consumer perceptions of expressed modified risk claims.
Documenting Electronic Data Files and Statistical Analysis Programs; Draft Guidance for Industry; Availability
Document Number: 2018-10722
Type: Notice
Date: 2018-05-21
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 revised guidance for industry (GFI) #197 entitled ``Documenting Electronic Data Files and Statistical Analysis Programs.'' This draft revised guidance is provided to inform sponsors of recommendations for documenting electronic data files and statistical analyses submitted to the Center for Veterinary Medicine (CVM) to support new animal drug applications.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-10717
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-10716
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Grocery Manufacturers Association; Denial of Food Additive Petition
Document Number: 2018-10715
Type: Proposed Rule
Date: 2018-05-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is denying a food additive petition (FAP 5A4811), submitted by the Grocery Manufacturers Association (GMA), requesting that the food additive regulations be amended to provide for the safe use of partially hydrogenated vegetable oils (PHOs) in certain food applications. We are denying the petition because we have determined that the petitioner did not provide sufficient information for us to conclude that the requested uses of PHOs are safe. To allow the food industry sufficient time to identify suitable replacement substances for the petitioned uses of PHOs, elsewhere in this issue of the Federal Register we have extended the compliance date for certain uses of PHOs, including the conditions of use covered by the FAP.
Final Determination Regarding Partially Hydrogenated Oils
Document Number: 2018-10714
Type: Rule
Date: 2018-05-21
Agency: Food and Drug Administration, Department of Health and Human Services
Based on the available scientific evidence and the findings of expert scientific panels, the Food and Drug Administration (FDA or we) made a final determination that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially produced trans fatty acids (IP-TFA), are generally recognized as safe (GRAS) for any use in human food. In a declaratory order announcing our final determination, we set a compliance date of June 18, 2018. We are now extending the compliance date for certain uses of PHOs.
Recruitment of Sites for Assignment of National Health Service Corps Scholarship Program Participants
Document Number: 2018-10699
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice announces that the listing of entities that will receive priority for assignments of National Health Service Corps (NHSC) Scholarship recipients (NHSC scholars) was posted on the Health Workforce Connector website (formerly known as the NHSC Jobs Center) at https://connector.hrsa.gov/. The Health Workforce Connector includes sites approved to receive an assignment of NHSC scholars who are available for service during the period of October 1, 2018, through September 30, 2019, as well as the site's Health Professional Shortage Area (HPSA) scores. Please note that entities on this list may or may not have current job vacancies.
Mary C. Holloway; Order Revoking a Proposed Order of Debarment
Document Number: 2018-10685
Type: Notice
Date: 2018-05-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is revoking a proposed order, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), to debar Mary C. Holloway (Holloway) for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. Holloway, through counsel, filed a request for a hearing, as well as information and analysis in support of that request, in response to the proposed debarment order. FDA has determined that pursuing debarment of Holloway is no longer appropriate.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2018-10682
Type: Notice
Date: 2018-05-21
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: 2018-10681
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-10680
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2018-10679
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-10678
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-10677
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-10676
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-10673
Type: Notice
Date: 2018-05-18
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: 2018-10672
Type: Notice
Date: 2018-05-18
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.
Submission for OMB Review; Comment Request
Document Number: 2018-10656
Type: Notice
Date: 2018-05-18
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; 30-Day Comment Request Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (National Institute of Nursing Research)
Document Number: 2018-10651
Type: Notice
Date: 2018-05-18
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories
Document Number: 2018-10610
Type: Rule
Date: 2018-05-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to classify blood establishment computer software (BECS) and BECS accessories (regulated under product code MMH) into class II (special controls). FDA has identified special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also giving notice that the Agency does not intend to exempt BECS and BECS accessories from premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Findings of Research Misconduct
Document Number: 2018-10592
Type: Notice
Date: 2018-05-18
Agency: Department of Health and Human Services
Findings of research misconduct have been made on the part of Maria Cristina Miron Elqutub, Research Interviewer, University of Texas MD Anderson Cancer Center (MDACC). Dr. Elqutub engaged in research misconduct in research supported by National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH), grant U01 DE019765-01. The administrative actions, including three (3) years of supervision, were implemented beginning on April 26, 2018, and are detailed below.
National Institute of Neurological Disorders and Stroke
Document Number: 2018-10590
Type: Notice
Date: 2018-05-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-10589
Type: Notice
Date: 2018-05-18
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel
Document Number: 2018-10563
Type: Rule
Date: 2018-05-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is publishing this final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the exemption to single-use, disposable respiratory protective devices (RPD) used in a healthcare setting and worn by healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These devices, commonly referred to as N95 filtering facepiece respirators (FFRs) and surgical N95 respirators (herein collectively referred to as N95s) are currently regulated by FDA under product code MSH. This exemption will decrease regulatory burden on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. All other class II devices classified under FDA's surgical apparel classification regulation continue to be subject to premarket notification requirements. FDA is also amending the codified language for the surgical apparel devices classification regulation to reflect this final determination.
Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2018-10552
Type: Notice
Date: 2018-05-17
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 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Certificate Application Process
Document Number: 2018-10551
Type: Notice
Date: 2018-05-17
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.
Proposed Information Collection Activity; Comment Request
Document Number: 2018-10550
Type: Notice
Date: 2018-05-17
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2018-10512
Type: Notice
Date: 2018-05-17
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: 2018-10511
Type: Notice
Date: 2018-05-17
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.
Institutional Review Board Written Procedures: Guidance for Institutions and Institutional Review Boards; Availability
Document Number: 2018-10441
Type: Notice
Date: 2018-05-17
Agency: Department of Health and Human Services
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and the Food and Drug Administration (FDA) are announcing the availability of a guidance entitled ``Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs.'' The guidance is intended for institutions and IRBs responsible for review and oversight of human subject research under the Department of Health and Human Services (HHS) and FDA regulations. The purpose of this guidance is to assist staff at institutions and IRBs who are responsible for preparing and maintaining written procedures. The guidance announced in this notice finalizes the draft guidance of the same title dated August 2016.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2018-10473
Type: Notice
Date: 2018-05-16
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-10472
Type: Notice
Date: 2018-05-16
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meetings
Document Number: 2018-10471
Type: Notice
Date: 2018-05-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-10470
Type: Notice
Date: 2018-05-16
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2018-10461
Type: Notice
Date: 2018-05-16
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
Document Number: 2018-10457
Type: Notice
Date: 2018-05-16
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).
HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs
Document Number: 2018-10435
Type: Notice
Date: 2018-05-16
Agency: Department of Health and Human Services, Office of the Secretary
Through this request for information, HHS seeks comment from interested parties to help shape future policy development and agency action.
Blood Products Advisory Committee; Notice of Meeting
Document Number: 2018-10414
Type: Notice
Date: 2018-05-16
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 Blood Products Advisory Committee. The general function of the Blood Products Advisory Committee is to provide advice and recommendations to the Agency on regulatory issues related to blood and products derived from blood. On the first day of the meeting, the Committee will provide advice regarding bacterial risk control strategies to enhance the safety and availability of platelets for transfusion. On the second day of the meeting, the Committee, supplemented with members from the Microbiology Devices Panel of the Medical Devices Advisory Committee, will function as a medical device panel to provide advice and recommendations to the Agency on classification of devices. The meeting will be open to the public.
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2018-10394
Type: Notice
Date: 2018-05-16
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 Recordkeeping/Reporting Requirements Under Emergency Review by the Office of Management and Budget (OMB); Comment Request
Document Number: 2018-10452
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, Administration for Children and Families
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
Document Number: 2018-10359
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. The meeting is open to the public and registration is requested for both attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/165.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-10356
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-10355
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences: Notice of Closed Meetings
Document Number: 2018-10354
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-10353
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2018-10352
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Amended: Notice of Meeting
Document Number: 2018-10351
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services