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

Results 351 - 400 of 26,202
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-08044
Type: Notice
Date: 2018-04-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-08043
Type: Notice
Date: 2018-04-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-08042
Type: Notice
Date: 2018-04-18
Agency: Department of Health and Human Services, National Institutes of Health
Loan Repayment Program for Repayment of Health Professions Educational Loans Announcement Type: Initial
Document Number: 2018-07892
Type: Notice
Date: 2018-04-18
Agency: Department of Health and Human Services, Indian Health Service
Pilot Meetings Program for Model-Informed Drug Development Approaches
Document Number: 2018-08010
Type: Notice
Date: 2018-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The sixth iteration of the Prescription Drug User Fee Act (PDUFA VI), incorporated as part of the FDA Reauthorization Act of 2017 (FDARA), highlights the goal of advancing model-informed drug development (MIDD). The Food and Drug Administration (FDA or Agency) is announcing a pilot program that affords sponsors or applicants who are selected for participation the opportunity to meet with Agency staff to discuss MIDD approaches in medical product development. Meetings under the pilot program will be conducted by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) during fiscal years 2018 to 2022. This pilot program is being conducted to fulfill FDA's performance commitment under PDUFA VI. For this pilot program, MIDD is defined as the application of exposure- based, biological, and/or statistical models derived from preclinical and clinical data sources to address drug development and/or regulatory issues (see Supplementary Information, I. Background, and II. Eligibility and Selection for Participation of this notice). For each approved proposal, the pilot program consists of two meetings between sponsors or applicants and the relevant center and will provide an opportunity for drug developers and FDA to discuss the application of MIDD approaches to the development and regulatory evaluation of medical products in development.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-08009
Type: Notice
Date: 2018-04-17
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Outcome Measure Repository (OMR).'' This proposed information collection was previously published in the Federal Register on January 29, 2018, and allowed 60 days for public comment. AHRQ received no substantive comments from the public. The purpose of this notice is to allow an additional 30 days for public comment.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-08007
Type: Notice
Date: 2018-04-17
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, Environmental Health Specialists Network (EHS-NET) Program Generic Package. The goal of this food safety research program is to collect data in retail food establishments that will identify and help to understand environmental factors (e.g., manager food safety certification, implementation of food safety practices, etc.) associated with retail-related foodborne illness and outbreaks.
Medicare and Medicaid Program; Application From DNV GL-Healthcare (DNV GL) for Continued Approval of Its Hospital Accreditation Program
Document Number: 2018-07982
Type: Notice
Date: 2018-04-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from DNV GLHealthcare for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs. The statute requires that we publish, within 60 days of receipt of an organization's complete application, a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Advisory Committees; Filing of Closed Meeting Reports
Document Number: 2018-07981
Type: Notice
Date: 2018-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2017.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 513(g) Request for Information
Document Number: 2018-07980
Type: Notice
Date: 2018-04-17
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.
Listing of Ingredients in Tobacco Products; Guidance for Industry; Availability
Document Number: 2018-07973
Type: Notice
Date: 2018-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a revised final guidance for industry entitled ``Listing of Ingredients in Tobacco Products.'' The revised guidance document is intended to assist persons making tobacco product ingredient submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and “Lookback”
Document Number: 2018-07972
Type: Notice
Date: 2018-04-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Fresh Empire Campaign on Tobacco
Document Number: 2018-07971
Type: Notice
Date: 2018-04-17
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 (the PRA).
Office of Tribal Self-Governance; Planning Cooperative Agreement
Document Number: 2018-07942
Type: Notice
Date: 2018-04-17
Agency: Department of Health and Human Services, Indian Health Service
Office of Tribal Self-Governance; Negotiation Cooperative Agreement
Document Number: 2018-07941
Type: Notice
Date: 2018-04-17
Agency: Department of Health and Human Services, Indian Health Service
National Committee on Vital and Health Statistics: Meeting
Document Number: 2018-07928
Type: Notice
Date: 2018-04-17
Agency: Department of Health and Human Services
National Committee on Vital and Health Statistics: Meeting
Document Number: 2018-07926
Type: Notice
Date: 2018-04-17
Agency: Department of Health and Human Services
Office of the Secretary; Notice of Meetings
Document Number: 2018-07918
Type: Notice
Date: 2018-04-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institutes of Health
Document Number: 2018-07917
Type: Notice
Date: 2018-04-17
Agency: Department of Health and Human Services
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 2018-07916
Type: Notice
Date: 2018-04-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-07915
Type: Notice
Date: 2018-04-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases Notice of Closed Meetings
Document Number: 2018-07914
Type: Notice
Date: 2018-04-17
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Committee on Training in Primary Care Medicine and Dentistry
Document Number: 2018-07910
Type: Notice
Date: 2018-04-17
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 Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD) will hold a public meeting.
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2019
Document Number: 2018-07355
Type: Rule
Date: 2018-04-17
Agency: Department of Health and Human Services
This final rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters; and user fees for Federally- facilitated Exchanges and State Exchanges on the Federal platform. It finalizes changes that provide additional flexibility to States to apply the definition of essential health benefits (EHB) to their markets, enhance the role of States regarding the certification of qualified health plans (QHPs); and provide States with additional flexibility in the operation and establishment of Exchanges, including the Small Business Health Options Program (SHOP) Exchanges. It includes changes to standards related to Exchanges; the required functions of the SHOPs; actuarial value for stand-alone dental plans; the rate review program; the medical loss ratio program; eligibility and enrollment; exemptions; and other related topics.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-07872
Type: Notice
Date: 2018-04-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Special Protocol Assessment; Guidance for Industry; Availability
Document Number: 2018-07871
Type: Notice
Date: 2018-04-16
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 ``Special Protocol Assessment.'' This guidance provides information about the procedures and general policies adopted by the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research for special protocol assessment (SPA). This guidance is intended to improve the quality of requests for SPAs and accompanying submission materials, and the quality of the resulting interactions between sponsors and FDA. This guidance finalizes the draft guidance of the same name issued May 4, 2016, and replaces the guidance of the same name issued May 17, 2002.
Submission for OMB Review; 30-Day Comment Request; Generic Clearance for the Research Domain Criteria (RDoC) Initiative (National Institute of Mental Health)
Document Number: 2018-07859
Type: Notice
Date: 2018-04-16
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with 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.
Proposed Information Collection Activity; Comment Request
Document Number: 2018-07843
Type: Notice
Date: 2018-04-16
Agency: Department of Health and Human Services, Administration for Children and Families
Highly Concentrated Caffeine in Dietary Supplements; Guidance for Industry; Availability
Document Number: 2018-07836
Type: Notice
Date: 2018-04-16
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry, ``Highly Concentrated Caffeine in Dietary Supplements.'' FDA considers some dietary supplements that consist of only or primarily pure or highly concentrated caffeine to be adulterated. FDA is issuing this document to provide guidance to firms that manufacture, market, or distribute dietary supplement products that contain pure or highly concentrated caffeine, or are considering doing so. This guidance should help such parties determine whether their products are or would be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to help them understand how to reduce the likelihood that their products will be considered adulterated.
Notice of Closed Meeting; Correction
Document Number: 2018-07835
Type: Notice
Date: 2018-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Policy Clarification and Premarket Notification Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-07824
Type: Notice
Date: 2018-04-16
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 guidance entitled ``Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff.'' This guidance clarifies FDA's policy related to compliance with applicable performance standards and conformance to International Electrotechnical Commission (IEC) consensus standards for ultrasonic diathermy devices. This guidance provides recommendations for information to provide in 510(k) submissions for ultrasonic diathermy devices.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-07822
Type: Notice
Date: 2018-04-16
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-07821
Type: Notice
Date: 2018-04-16
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2018-07820
Type: Notice
Date: 2018-04-16
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Closed Meeting
Document Number: 2018-07818
Type: Notice
Date: 2018-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2018-07817
Type: Notice
Date: 2018-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2018-07816
Type: Notice
Date: 2018-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2018-07815
Type: Notice
Date: 2018-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2018-07814
Type: Notice
Date: 2018-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2018-07813
Type: Notice
Date: 2018-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Draft Guidance for Industry; Availability
Document Number: 2018-07812
Type: Notice
Date: 2018-04-16
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 ``Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.'' This guidance, developed by the Oncology Center of Excellence, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) at FDA, describes an optional streamlined submission process to determine whether an investigational in vitro diagnostic in an oncology clinical trial under an investigational new drug application (IND) (an oncology co-development program) is significant risk. In the streamlined process, all information about the oncology trial (including information about the investigational in vitro diagnostic) is submitted to the IND. As part of IND review, CBER or CDER works with CDRH to determine if the investigational in vitro diagnostic is significant risk.
Findings of Research Misconduct
Document Number: 2018-07782
Type: Notice
Date: 2018-04-16
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that on April 2, 2018, the Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the findings of research misconduct made by the Office of Research Integrity (ORI) against H.M. Krishna Murthy, Ph.D., former Research Associate Professor, Department of Vision Sciences, University of Alabama at Birmingham (UAB). Dr. Murthy engaged in research misconduct in research supported by U.S. Public Health Service (PHS) grants, specifically National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants R01 AI051615, R01 AI032078, and R01 AI045623; National Heart, Lung, and Blood Institute (NHLBI), NIH, grants P01 HL034343 and R01 HL064272; and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, grant R01 DK046900. The administrative actions, including ten (10) years of debarment, were implemented beginning on April 2, 2018, and are detailed below.
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-State, Tribal, Local and Territorial Subcommittee (STLT)
Document Number: 2018-07772
Type: Notice
Date: 2018-04-16
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 Advisory Committee to the Director, Centers for Disease Control and PreventionState, Tribal, Local and Territorial Subcommittee (ACD, CDC-STLT). This meeting is open to the public, limited only by the room seating, audio phone lines and net conference access available. The public is also welcome to listen to the meeting by dialing (877) 692-1879, entering participant code 57852858, with 100 ports available. The public comment period is from 2:00 p.m.-2:15 p.m. No advance registration is required.
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Health Disparities Subcommittee (HDS)
Document Number: 2018-07771
Type: Notice
Date: 2018-04-16
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 Advisory Committee to the Director, Centers for Disease Control and PreventionHealth Disparities Subcommittee (ACD, CDC-HDS). This meeting is open to the public, limited only by the by the space and phone lines available. The public is also welcome to listen to the meeting by teleconference call in number is (866) 918-8397 and enter code 9346283. The public comment period is from 12:45 p.m.-12:50 p.m.
Advisory Board on Radiation and Worker Health (ABRWH); Notice of Charter Renewal
Document Number: 2018-07770
Type: Notice
Date: 2018-04-16
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Advisory Board on Radiation and Worker Health (ABRWH), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through March 22, 2020.
Mine Safety and Health Research Advisory Committee (MSHRAC)
Document Number: 2018-07761
Type: Notice
Date: 2018-04-16
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 Mine Safety and Health Research Advisory Committee (MSHRAC). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 33 people. If you wish to attend in person or by phone, please contact Marie Chovanec by email at MChovanec@cdc.gov or by phone at 412-386-5302 at least 5 business days in advance of the meeting.
Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program
Document Number: 2018-07179
Type: Rule
Date: 2018-04-16
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule will revise the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Comprehensive Addiction and Recovery Act (CARA) to further reduce the number of beneficiaries who may potentially misuse or overdose on opioids while still having access to important treatment options; implement certain provisions of the 21st Century Cures Act; support innovative approaches to improve program quality, accessibility, and affordability; offer beneficiaries more choices and better care; improve the CMS customer experience and maintain high beneficiary satisfaction; address program integrity policies related to payments based on prescriber, provider and supplier status in MA, Medicare cost plan, Medicare Part D and the PACE programs; provide an update to the official Medicare Part D electronic prescribing standards; and clarify program requirements and certain technical changes regarding treatment of Medicare Part A and Part B appeal rights related to premiums adjustments.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2018-07757
Type: Notice
Date: 2018-04-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2018-07756
Type: Notice
Date: 2018-04-13
Agency: Department of Health and Human Services, National Institutes of Health