Department of Health and Human Services 2018 – Federal Register Recent Federal Regulation Documents

Results 101 - 150 of 3,334
Medicare and Medicaid Programs: Approval of the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC) Application for Continued Approval of Its Ambulatory Surgical Center Accreditation Program
Document Number: 2018-27592
Type: Notice
Date: 2018-12-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the Accreditation Association for Ambulatory Health Care, Inc. for continued recognition as a national accrediting organization for ambulatory surgical centers that wish to participate in the Medicare or Medicaid programs.
Food Labeling; Revision of the Nutrition and Supplement Facts Labels; Technical Amendments
Document Number: 2018-27431
Type: Rule
Date: 2018-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the regulations pertaining to the Nutrition Facts and Supplement Facts labels. The amendments correct errors that were made in labeling examples, restore incorrect deletions, correct the edition of a reference cited in the rule, and correct cross-references to other regulations. This action is ministerial or editorial in nature.
Proposed Information Collection Activity; ACF's Generic Clearance for Grant Reviewer Recruitment Forms (OMB #0970-0477)
Document Number: 2018-27551
Type: Notice
Date: 2018-12-20
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Planning, Research, and Evaluation (OPRE) is proposing an extension of a currently approved generic clearance (OMB no. 0970-0477) for Grant Reviewer Recruitment (GRR) forms. The GRR forms will be used to select reviewers who will participate in the grant review process for the purpose of selecting successful applications.
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Extension of Comment Period
Document Number: 2018-27519
Type: Proposed Rule
Date: 2018-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of November 15, 2018. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Solicitation of Nominations for Organizational Representatives to the Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2018-27518
Type: Notice
Date: 2018-12-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations from organizations to send a representative to be a liaison to the Advisory Committee on Heritable Disorders in Newborns and Children (Committee). Selections will be based on a review of the organization's subject area of expertise, mission, relevancy, and benefit provided relative to the Committee's purpose. The organizational representatives are non-voting liaisons. The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS. HRSA is seeking nominations of qualified organizations to fill up to three positions. Authority: Section 1111 of the Public Health Service (PHS) Act, as amended by the Newborn Screening Saves Lives Reauthorization Act of 2014 (42 U.S.C. 300b-10). The Committee is governed by the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. App.), and 41 CFR part 102-3, which set forth standards for the formation and use of advisory committees.
Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information
Document Number: 2018-27506
Type: Proposed Rule
Date: 2018-12-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This request for information (RFI) seeks public comment regarding the appropriateness of the practices of some Medicare- approved Accrediting Organizations (AOs) to provide fee-based consultative services for Medicare-participating providers and suppliers as part of their business model. We wish to determine whether AO practices of consulting with the same facilities which they accredit under their CMS approval could create actual or perceived conflicts of interest between the accreditation and consultative entities. We intend to consider information received in response to this RFI to assist in future rulemaking.
Uniform Compliance Date for Food Labeling Regulations
Document Number: 2018-27429
Type: Rule
Date: 2018-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is establishing January 1, 2022, as the uniform compliance date for food labeling regulations that are published on or after January 1, 2019, and on or before December 31, 2020. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes.
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2018-27470
Type: Notice
Date: 2018-12-19
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: 2018-27469
Type: Notice
Date: 2018-12-19
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.
Administrative Simplification: Rescinding the Adoption of the Standard Unique Health Plan Identifier and Other Entity Identifier
Document Number: 2018-27435
Type: Proposed Rule
Date: 2018-12-19
Agency: Department of Health and Human Services, Office of the Secretary
This proposed rule would rescind the adopted standard unique health plan identifier (HPID) and the implementation specifications and requirements for its use and the other entity identifier (OEID) and implementation specifications for its use. The decision to propose to rescind the adopted standards was made following a careful assessment of industry input, as well as HHS's intention to explore options for a more effective standard unique health plan identifier in the future.
Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-27433
Type: Notice
Date: 2018-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled ``Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff.'' This guidance document describes policies that FDA intends to use to implement the new Breakthrough Devices Program, established by the 21st Century Cures Act (Cures Act). The Breakthrough Devices Program supersedes and combines elements from FDA's Expedited Access Pathway (EAP), which was intended to facilitate the development and expedite review of certain devices that demonstrate the potential to address unmet medical needs, as well as the Priority Review Program, which implemented statutory criteria for granting priority review to premarket approval applications (PMAs) and applied those criteria to other types of premarket submissions for medical devices. This guidance is intended to clarify certain principles and features of the new program, the designation criteria for Breakthrough Devices, the designation request review process, the process for withdrawing from the program, as well as the recommended information device manufacturers should provide in their designation request for entrance into the program.
Submission for OMB Review; Comment Request
Document Number: 2018-27398
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, Administration for Children and Families
National Library of Medicine; Notice of Meetings
Document Number: 2018-27387
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meetings
Document Number: 2018-27384
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences Notice of Closed Meeting
Document Number: 2018-27383
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meetings
Document Number: 2018-27382
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2018-27381
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Notice of Meeting
Document Number: 2018-27380
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2018-27379
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Meeting
Document Number: 2018-27378
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 2018-27377
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 2018-27376
Type: Notice
Date: 2018-12-19
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: 2018-27375
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Meeting
Document Number: 2018-27374
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2018-27366
Type: Notice
Date: 2018-12-18
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.
Notice To Announce Webinar To Request Public Input on Upcoming Surgeon General's Report on Oral Health
Document Number: 2018-27363
Type: Notice
Date: 2018-12-18
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR), is announcing a webinar to provide background information pertaining to the commissioning of a new report on oral health by the Surgeon General and to obtain public input on the report.
Supplemental Evidence and Data Request on Diagnostic and Treatment of Clinical Alzheimer's-Type Dementia (CATD)
Document Number: 2018-27361
Type: Notice
Date: 2018-12-18
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 of Diagnostic and Treatment of Clinical Alzheimer's-type Dementia (CATD), 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-27359
Type: Notice
Date: 2018-12-18
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: ``Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP).''
Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies; New Date for Public Hearing; Request for Comments
Document Number: 2018-27352
Type: Proposed Rule
Date: 2018-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing a new date for the public hearing to discuss its efforts to eliminate youth electronic cigarette (e-cigarette) use as well as other tobacco product use, with a focus on the potential role of drug therapies to support youth e-cigarette cessation and the issues impacting the development of such therapies. FDA is also extending the comment period.
Intent To Consider the Appropriate Classification of Hyaluronic Acid Intra-articular Products Intended for the Treatment of Pain in Osteoarthritis of the Knee Based on Scientific Evidence
Document Number: 2018-27351
Type: Notice
Date: 2018-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing our intent to consider the appropriate classification of hyaluronic acid (HA) intra-articular products intended for the treatment of pain in osteoarthritis (OA) of the knee. Although HA products intended for this use have been regulated as devices (Procode MOZ; acid, hyaluronic, intra-articular), the current published scientific literature supports that HA achieves its primary intended purpose of treatment of pain in OA of the knee through chemical action within the body. Because HA for this use may not meet the definition of a device, sponsors of HA products who intend to submit a premarket approval application (PMA) or a supplement to a PMA for a change in indications for use, formulation, or route of administration are encouraged to obtain an informal or formal classification and jurisdiction determination through a Pre- Request for Designation (Pre-RFD) or Request for Designation (RFD), respectively, from FDA prior to submission. If a sponsor believes their product meets the device definition, they may provide relevant evidence in the Pre-RFD or RFD.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The Maternal, Infant, and Early Childhood Home Visiting Program Quarterly Data Collection, OMB No. 0906-0016-Revision
Document Number: 2018-27348
Type: Notice
Date: 2018-12-18
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. A 60-day Federal Register Notice was published in the Federal Register on February 21, 2018. There were 24 public comments. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-27335
Type: Notice
Date: 2018-12-18
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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: HRSA AIDS Education and Training Centers Evaluation Activities, OMB No. 0915-0281-Revision
Document Number: 2018-27328
Type: Notice
Date: 2018-12-18
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 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.
National Institute of Allergy and Infectious Diseases Notice of Closed Meetings
Document Number: 2018-27282
Type: Notice
Date: 2018-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research Notice of Closed Meeting
Document Number: 2018-27277
Type: Notice
Date: 2018-12-18
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
Document Number: 2018-27238
Type: Rule
Date: 2018-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy and readability of the regulations.
Child Support Technical Corrections Notice of Proposed Rulemaking
Document Number: 2018-27224
Type: Proposed Rule
Date: 2018-12-18
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Support Enforcement proposes to eliminate regulations rendered outdated or unnecessary and make technical amendments to the Flexibility, Efficiency, and Modernization in Child Support Enforcement (FEM) final rule, published on December 20, 2016, including proposing to amend the compliance date for review and adjustment of child support orders. We are also proposing conforming amendments to the regulations as a result of Bipartisan Budget Act of 2018, Public Law 115-123.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-27182
Type: Notice
Date: 2018-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-27178
Type: Notice
Date: 2018-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Manufacturing Site Change Supplements: Content and Submission; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-27237
Type: Notice
Date: 2018-12-17
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 entitled ``Manufacturing Site Change Supplements: Content and Submissions; Guidance for Industry and Food and Drug Administration Staff.'' This guidance describes the decision-making steps that FDA recommends to determine whether a premarket approval application (PMA) supplement should be submitted when a manufacturer intends to change the manufacturing site (including a change to the processing, packaging, or sterilization site) of its legally marketed PMA-approved device. This guidance also discusses the general factors FDA intends to consider when determining whether to conduct an establishment inspection prior to approval of a site change supplement.
Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-27236
Type: Notice
Date: 2018-12-17
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 ``Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment.'' This draft guidance provides clarification to industry and FDA staff of the Federal regulations that relate to diagnostic x-ray systems and their major components. These regulations pertain to the recordkeeping, reporting, manufacturing, importing, and installation of ``electronic products,'' as defined in FDA regulations. This draft guidance, when finalized, will supersede FDA's guidance entitled ``Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment.'' This draft guidance is not final nor is it in effect at this time.
Submission for OMB Review; Annual Survey of Refugees (OMB #0907-0033)
Document Number: 2018-27235
Type: Notice
Date: 2018-12-17
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) seeks to continue data collection for the Annual Survey of Refugees with minor updates to improve survey administration procedures. The Annual Survey of Refugees is a yearly sample survey of refugees entering the U.S. in the previous five fiscal years. No changes to the survey instrument or estimated response burden are proposed.
Listing of Color Additives Subject to Certification; D&C Yellow No. 8; Confirmation of Effective Date
Document Number: 2018-27234
Type: Rule
Date: 2018-12-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is confirming the effective date of October 26, 2018, for the final rule that appeared in the Federal Register of September 25, 2018, and that amended the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-27223
Type: Notice
Date: 2018-12-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-27222
Type: Notice
Date: 2018-12-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-27221
Type: Notice
Date: 2018-12-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare and Medicaid Programs, and Other Program Initiatives, and Priorities; Request for Nominations to the Advisory Panel on Outreach and Education (APOE)
Document Number: 2018-27198
Type: Notice
Date: 2018-12-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice requests nominations for individuals to serve on the Advisory Panel on Outreach and Education (APOE).
Proposed Information Collection Activity; Comment Request
Document Number: 2018-27185
Type: Notice
Date: 2018-12-17
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-27180
Type: Notice
Date: 2018-12-17
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2018-27179
Type: Notice
Date: 2018-12-17
Agency: Department of Health and Human Services, National Institutes of Health