Department of Health and Human Services June 2017 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 296
Reducing Regulatory Burdens Imposed by the Patient Protection and Affordable Care Act & Improving Healthcare Choices To Empower Patients
The Department of Health and Human Services (HHS) is actively working to reduce regulatory burdens and improve health insurance options under Title I of the Patient Protection and Affordable Care Act. Executive Order 13765, ``Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal,'' directs the Secretary of Health and Human Services to achieve these aims. HHS seeks comment from interested parties to inform its ongoing efforts to create a more patient-centered health care system that adheres to the key principles of affordability, accessibility, quality, innovation, and empowerment.
World Trade Center Health Program Scientific/Technical Advisory Committee: Notice of Charter Renewal
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Products
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Utilization of Adequate Provision Among Low to Non-Internet Users
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 research entitled ``Utilization of Adequate Provision among Low to Non-Internet Users.''
Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, U.S. Department of Health and Human Services has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery '' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).
Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Board to the Food and Drug Administration. The general function of the committee is to provide advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science, input into the Agency's research agenda, and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. This meeting is open to the public.
Tribal Management Grant Program; Extension of Due Dates
The Indian Health Service published a document in the Federal Register (FR) on May 1, 2017, for the Fiscal Year 2017 Tribal Management Grant Program. Several Key Dates have been modified.
Medical Devices; Validated Instructions for Use and Validation Data Requirements for Certain Reusable Medical Devices in Premarket Notifications
The Food and Drug Administration (FDA or Agency) has determined that it is necessary for manufacturers of certain reusable medical devices to include in their premarket notifications (510(k)s) instructions for use which have been validated and validation data regarding cleaning, disinfection, and sterilization, for which a substantial equivalence determination may be based. This notice includes a list of these reusable devices that will require validated instructions for use and validation data in their premarket notification. FDA is publishing this list in accordance with the requirements established by the 21st Century Cures Act. This action ensures that the premarket requirements for these device types are clear and predictable which facilitates more efficient review of these 510(k)s.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Title V Maternal and Child Health Services Block Grant to States Program: Guidance and Forms for the Title V Application/Annual Report OMB No. 0915-0172-Revision
In compliance with the requirement for opportunity for public comment on proposed data collection projects, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Electronic Learning (E-Learning) Collaborative Resource Center for SV and IPV Prevention Practitioners
The U.S. Centers for Disease Control and Prevention (CDC) is providing $536,733 in funds.
Announcement of the Award of 48 Single-Source Low-Cost Extension Supplement Grants Within the Office of Refugee Resettlement's Unaccompanied Alien Children's (UAC) Program
ACF, ORR, announces the award of 48 single source low-cost extension supplement grants for a total of $110,480,457 under the Unaccompanied Alien Children's (UAC) Program.
Meeting of the 2018 Physical Activity Guidelines Advisory Committee
As stipulated by the Federal Advisory Committee Act (FACA), the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the fourth meeting of the 2018 Physical Activity Guidelines Advisory Committee (2018 PAGAC or Committee) will be held. This meeting will be open to the public via video cast.
Draft National Toxicology Program Technical Reports; Availability of Documents; Request for Comments; Notice of Meeting
The National Toxicology Program (NTP) announces the availability of three draft NTP Technical Reports (TRs) scheduled for peer review: p-chloro-[alpha],[alpha],[alpha]-trifluorotoluene, dietary zinc, and 2,3-butanedione. The peer review meeting is open to the public. Registration is requested for both public attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/ 36051.
Medicare and Medicaid Programs; Revision of Requirements for Long-Term Care Facilities: Arbitration Agreements
This proposed rule would revise the requirements that Long- Term Care (LTC) facilities must meet to participate in the Medicare and Medicaid programs. Specifically, it would remove provisions prohibiting binding pre-dispute arbitration and strengthen requirements regarding the transparency of arbitration agreements in LTC facilities. This proposal would support the resident's right to make informed choices about important aspects of his or her health care. In addition, this proposal is consistent with our approach to eliminating unnecessary burden on providers.
Bacteriophage Therapy: Scientific and Regulatory Issues; Public Workshop
The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, and the National Institutes of Health, National Institute of Allergy and Infectious Diseases are announcing a public workshop entitled ``Bacteriophage Therapy: Scientific and Regulatory Issues.'' The purpose of the public workshop is to exchange information with the medical and scientific community about the regulatory and scientific issues associated with bacteriophage therapy.
Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys
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 voluntary customer satisfaction service surveys to implement Executive Order 12862.
Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's third party disclosure and recordkeeping requirements for reportable food.
Developing Rabies Monoclonal Antibody Products as a Component of Rabies Post-Exposure Prophylaxis; Public Workshop; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop regarding development of rabies monoclonal antibody products to be used in conjunction with licensed rabies vaccine as part of a rabies post-exposure prophylaxis (PEP) regimen. This public workshop is intended to provide information for, and gain perspective from, health care providers, other U.S. Government Agencies, academic experts, industry, and other stakeholders on various aspects of development efforts pertaining to animal models, laboratory assays, and clinical trials.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Oncologic Drugs 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. FDA is establishing a docket for public comment on this meeting.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Oncologic Drugs 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. FDA is establishing a docket for public comment on this document.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Oncologic Drugs 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. FDA is establishing a docket for public comment on this document.
Humanitarian Use Devices; 21st Century Cures Act; Technical Amendment
The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Secondary Review
This meeting was announced in the Federal Register on May 15, 2017, Volume 82, Number 92, pages 22335 and 22336. This meeting is canceled in its entirety.
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