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

Results 301 - 350 of 26,202
National Institute of Biomedical Imaging and Bioengineering Notice of Meeting
Document Number: 2018-08566
Type: Notice
Date: 2018-04-25
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: 2018-08565
Type: Notice
Date: 2018-04-25
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-08564
Type: Notice
Date: 2018-04-25
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Notice of Closed Meetings
Document Number: 2018-08562
Type: Notice
Date: 2018-04-25
Agency: Department of Health and Human Services, National Institutes of Health
Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals; Draft Guidance for Industry; Availability
Document Number: 2018-08548
Type: Notice
Date: 2018-04-24
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.'' The purpose of this guidance is to provide information to assist sponsors in the design of an appropriate program of nonclinical studies for the development of pharmaceuticals used to treat patients with severely debilitating or life-threatening hematologic disorders (SDLTHDs). While FDA has guidance for oncology indications (most of which are considered severely debilitating or life-threatening diseases) and for rare diseases (which include some SDLTHD conditions), FDA has no guidance to facilitate nonclinical development specifically for pharmaceuticals used to treat nononcology patients with SDLTHDs. A streamlined approach to drug development is necessary to allow patients with SDLTHDs earlier and continued access to new and potentially effective therapies.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program Statewide Needs Assessment Update
Document Number: 2018-08539
Type: Notice
Date: 2018-04-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit a Supplemental Information Request (SIR), described below, to the Office of Management and Budget (OMB). Prior to submitting the SIR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the SIR.
Draft-National Occupational Research Agenda for Wholesale and Retail Trade
Document Number: 2018-08473
Type: Notice
Date: 2018-04-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft NORA Agenda entitled National Occupational Research Agenda for Wholesale and Retail Trade for public comment. To view the notice and related materials, visit https:// www.regulations.gov and enter CDC-2018-0028 in the search field and click ``Search.''
Research Plan, Continuing To Protect the Nanotechnology Workforce: NIOSH Nanotechnology Research Plan for 2018-2025
Document Number: 2018-08472
Type: Notice
Date: 2018-04-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft research plan entitled Continuing To Protect the Nanotechnology Workforce: NIOSH Nanotechnology Research Plan for 2018-2025 for public comment. To view the notice and related materials, visit https://www.regulations.gov and enter CDC-2018-0038 in the search field and click ``Search.''
World Trade Center Health Program; Petition 018-Hypertension; Finding of Insufficient Evidence
Document Number: 2018-08456
Type: Proposed Rule
Date: 2018-04-24
Agency: Department of Health and Human Services
On January 5, 2018, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 018) to add hypertension (high blood pressure) to the List of WTC-Related Health Conditions (List). Upon reviewing the scientific and medical literature, including information provided by the petitioner, the Administrator has determined that the available evidence does not have the potential to provide a basis for a decision on whether to add hypertension to the List. The Administrator also finds that insufficient evidence exists to request a recommendation of the WTC Health Program Scientific/Technical Advisory Committee (STAC), to publish a proposed rule, or to publish a determination not to publish a proposed rule.
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD); Notice of Meeting
Document Number: 2018-08447
Type: Notice
Date: 2018-04-24
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Cancellation Notice of Meeting
Document Number: 2018-08446
Type: Notice
Date: 2018-04-24
Agency: Department of Health and Human Services
National Cancer Institute Notice of Closed Meetings
Document Number: 2018-08445
Type: Notice
Date: 2018-04-24
Agency: Department of Health and Human Services
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-08444
Type: Notice
Date: 2018-04-24
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-08443
Type: Notice
Date: 2018-04-24
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine Amended Notice of Meeting
Document Number: 2018-08442
Type: Notice
Date: 2018-04-24
Agency: Department of Health and Human Services, National Institutes of Health
National Advisory Committee on Children and Disasters and National Preparedness and Response Science Board Joint Public Teleconference
Document Number: 2018-08421
Type: Notice
Date: 2018-04-23
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) and National Preparedness and Response Science Board (NPRSB) will hold a joint public teleconference on May 10, 2018.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-08383
Type: Notice
Date: 2018-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Formative Research and Tool Development''.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-08382
Type: Notice
Date: 2018-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National HIV Prevention Program Monitoring and Evaluation (NHM&E), which collects standardized HIV prevention program evaluation data from health departments and community-based organizations (CBOs) who receive federal funds for HIV prevention activities.
Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR)
Document Number: 2018-08367
Type: Notice
Date: 2018-04-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR). This meeting is open to the public, limited only by available seating. The meeting room accommodates approximately 60 people. The public is also welcome to listen to the meeting by calling 888-989-4501, passcode 9885805, limited by 100 lines. The deadline for notification of attendance is May 14, 2018. The public comment period is scheduled on June 5, 2018 from 2:30 p.m. until 2:45 p.m., EDT and June 6, 2018 from 10:10 a.m. until 10:25 a.m., EDT. Individuals wishing to make a comment during Public Comment period, please email your name, organization, and phone number by May 7, 2018 to Amanda Malasky at amalasky@cdc.gov.
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-08364
Type: Notice
Date: 2018-04-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meeting
Document Number: 2018-08363
Type: Notice
Date: 2018-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-08362
Type: Notice
Date: 2018-04-23
Agency: Department of Health and Human Services, National Institutes of Health
Opioid Dependence: Developing Depot Buprenorphine Products for Treatment; Draft Guidance for Industry; Availability
Document Number: 2018-08361
Type: Notice
Date: 2018-04-23
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 ``Opioid Dependence: Developing Depot Buprenorphine Products for Treatment.'' This draft guidance addresses drug development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified- release products for injection or implantation).
Advisory Committee; Arthritis Advisory Committee, Renewal
Document Number: 2018-08358
Type: Notice
Date: 2018-04-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Arthritis Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Arthritis Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until April 5, 2020.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-08329
Type: Notice
Date: 2018-04-20
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-08325
Type: Notice
Date: 2018-04-20
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.
National Advisory Committee on Children and Disasters Public Teleconference
Document Number: 2018-08278
Type: Notice
Date: 2018-04-20
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) will hold a public teleconference on May 1, 2018.
National Advisory Council on Nurse Education and Practice
Document Number: 2018-08263
Type: Notice
Date: 2018-04-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Nurse Education and Practice (NACNEP) will hold a public meeting.
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers; International Council for Harmonisation; Guidance for Industry; Availability
Document Number: 2018-08252
Type: Notice
Date: 2018-04-20
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 entitled ``Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This question and answer (Q&A) guidance addresses questions about implementation of FDA's guidance ``Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients'' (ICH Q7). The Q&A guidance is intended to clarify uncertainties due to the interpretation of certain sections of ICH Q7 and to help ensure that all active pharmaceutical ingredients (APIs) meet the standards for quality and purity they purport or are represented to possess.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-08244
Type: Notice
Date: 2018-04-20
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.
Proposed Collection; 60-Day Comment Request; NIH NeuroBioBank Tissue Access Request Form, National Institute of Mental Health
Document Number: 2018-08243
Type: Notice
Date: 2018-04-20
Agency: Department of Health and Human Services, National Institutes of Health
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 Mental Health (NIMH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period
Document Number: 2018-08231
Type: Proposed Rule
Date: 2018-04-20
Agency: Agency for International Development, Agencies and Commissions, Department of Transportation, Social Security Administration, National Science Foundation, National Aeronautics and Space Administration, Department of Labor, Department of Housing and Urban Development, Department of Homeland Security, Department of Health and Human Services, Environmental Protection Agency, Department of Energy, Department of Education, Department of Defense, Consumer Product Safety Commission, Department of Commerce, Department of Agriculture, Department of Veterans Affairs
In a final rule published on January 19, 2017, federal departments and agencies made revisions to the Federal Policy for the Protection of Human Subjects (hereafter the ``2018 Requirements''). The Consumer Product Safety Commission (CPSC) adopted the same regulatory changes in a separate final rule published on September 18, 2017. The 2018 Requirements were scheduled to become effective on January 19, 2018, with a general compliance date of January 19, 2018 (with the exception of the revisions to the cooperative research provision). The departments and agencies listed in this document have also published an interim final rule delaying the effective date and general compliance date for the 2018 Requirements for six months, to cover the time period of January 19, 2018 until July 19, 2018. As per the interim final rule, the effective date of the 2018 Requirements is now July 19, 2018. The departments and agencies listed in this document propose delaying the general compliance date for the 2018 Requirements for an additional six months, for the time period of July 19, 2018 until January 21, 2019. This proposed rule is intended to provide additional time to regulated entities for the preparations necessary to implement the 2018 Requirements. This proposed rule, if finalized, would require regulated entities to continue to comply with the requirements of the current Federal Policy for the Protection of Human Subjects (hereafter the ``pre-2018 Requirements'') until January 21, 2019. This proposal also takes comment on whether to permit institutions to implement, for certain research studies, the following provisions in the 2018 Requirements during the period from July 19, 2018, until January 21, 2019, that the general compliance date is delayed. Those three provisions, intended to reduce burdens on regulated entities, are the 2018 Requirements' definition of ``research,'' which deems certain activities not to be research, the allowance for no annual continuing review of certain categories of research, and the elimination of the requirement that institutional review boards (IRBs) review grant applications related to the research. The way that this option is proposed, regulated entities would be required to comply with all pre- 2018 Requirements during the period that the general compliance date is delayed, except for provisions substituted by the three burden-reducing provisions of the 2018 Requirements. As described in section III, below, this flexibility is proposed only for studies for which an institution makes a choice to transition to comply with the 2018 Requirements, beginning on July 19, 2018. In order to clearly describe this proposed flexibility, including how it would impact institutions choosing to transition research to comply with the 2018 Requirements, this document proposes a redrafted transition provision.
Submission for OMB Review; Comment Request
Document Number: 2018-08233
Type: Notice
Date: 2018-04-19
Agency: Department of Health and Human Services, Administration for Children and Families
Metered Dose Inhaler and Dry Powder Inhaler Drug Products-Quality Considerations; Draft Guidance for Industry; Availability
Document Number: 2018-08200
Type: Notice
Date: 2018-04-19
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 draft guidance for industry entitled ``Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug ProductsQuality Considerations.'' The purpose of this guidance is to provide recommendations to industry on the development and manufacture of inhalation aerosols (also known as metered dose inhalers, or MDIs) and inhalation powders (also known as dry powder inhalers, or DPIs). Although not explicitly discussed, some of the principles and recommendations provided in this guidance may be applicable to nasal delivery products, as well. The recommendations in this guidance can apply to MDI and DPI products intended for local or systemic effect.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-08171
Type: Notice
Date: 2018-04-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-08170
Type: Notice
Date: 2018-04-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-08166
Type: Notice
Date: 2018-04-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-08165
Type: Notice
Date: 2018-04-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-08164
Type: Notice
Date: 2018-04-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-08163
Type: Notice
Date: 2018-04-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-08147
Type: Notice
Date: 2018-04-19
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Evaluation of the third decade of the National Occupational Research Agenda (NORA) Council Effectiveness''. This is a survey to collect information from NORA council members and leaders about council activities and satisfaction with council functioning.
Proposed Substances To Be Evaluated for Toxicological Profile Development
Document Number: 2018-08090
Type: Notice
Date: 2018-04-18
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR) within the Department of Health and Human Services is initiating the development of another set of Toxicological Profiles. This notice solicits public nominations of substances for ATSDR to evaluate for Toxicological Profile development. ATSDR will consider nominations from the Substance Priority List, as well as any non-Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERLA) substances that may have public health implications, on the basis of ATSDR's authority to prepare Toxicological Profiles for substances not found at sites on the National Priorities List. The agency will do so in order to ``. . . establish and maintain inventory of literature, research, and studies on the health effects of toxic substances'', to respond to requests for consultation, and to support the site-specific response actions conducted by ATSDR, as otherwise necessary.
Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030
Document Number: 2018-08065
Type: Notice
Date: 2018-04-18
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) announces the next meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee) regarding the development of national health promotion and disease prevention objectives for 2030. This meeting will be held online via webinar and is open to the public. The Committee will discuss the nation's health promotion and disease prevention objectives and will provide recommendations to improve health status and reduce health risks for the nation by the year 2030. The Committee will further develop recommendations regarding Leading Health Indicators and recommendations for setting targets for the Healthy People 2030 objectives. Pursuant to the Committee's charter, the Committee's advice must assist the Secretary in reducing the number of objectives while ensuring that the selection criteria identifies the most critical public health issues that are high-impact priorities supported by current national data.
National Institute of Neurological Disorders and Stroke Notice of Closed Meeting
Document Number: 2018-08062
Type: Notice
Date: 2018-04-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2018-08050
Type: Notice
Date: 2018-04-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2018-08049
Type: Notice
Date: 2018-04-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Meeting
Document Number: 2018-08048
Type: Notice
Date: 2018-04-18
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: 2018-08047
Type: Notice
Date: 2018-04-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-08046
Type: Notice
Date: 2018-04-18
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2018-08045
Type: Notice
Date: 2018-04-18
Agency: Department of Health and Human Services, National Institutes of Health