Department of Health and Human Services March 2019 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 280
Agency Information Collection Activities; Proposed Collection; Comment Request; Clinical Laboratory Improvement Amendments Waiver Applications
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 collections of information associated with Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver applications.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs During Production; Recordkeeping and Registration Provisions
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 the information collection provisions of FDA's recordkeeping and registration requirements for shell egg producers.
Solicitation of Nominations for Appointment to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
The U.S. Department of Health and Human Services (HHS) is soliciting nominations of individuals who are interested in being considered for appointment to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council) as a voting member or as a non-voting liaison representative member from an organization and/or interest group. Nominations from qualified individuals who wish to be considered for appointment to either member category of the Advisory Council are currently being accepted.
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability; Amendment
A notice was published in the Federal Register on Monday, March 11, 2019 (Vol. 84, No. 47, pages 8731-8732), to give notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting on April 15-16, 2019. The notice is being amended to include a registration link for any individuals who wish to attend the meeting in-person, as well as a link to the ACBTSA website for more information.
World Trade Center Health Program; Petition 021-Deep Vein Thrombosis and Pulmonary Embolism; Finding of Insufficient Evidence
On November 28, 2018, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 021) to add ``multiple deep vein thrombosis and pulmonary embolism'' 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 deep vein thrombosis or pulmonary embolism 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.
Head Start Service Duration Requirements
The Office of Head Start currently requires Head Start programs to operate 100-percent of their preschool center-based slots for 1,020 annual hours by August 1, 2021, which would substantially increase the minimum amount of time preschool children must receive Head Start services. We believe the approach to require all center- based programs to increase their hours of operation was too prescriptive and will reduce grant recipients' flexibility to meet the needs of the communities they serve. It would be costly for grantees to meet the increased service-duration requirement and would likely result in a reduction in the number of children served by Head Start. For these reasons, we propose to remove the 100-percent service duration requirement from the HSPPS. We also propose technical changes to our Program Structure regulations.
Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pulmonary-Allergy Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease; Public Workshop; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease.'' The purpose of the public workshop is to discuss the clinical trial design considerations, including endpoints, related to the development of antibacterial drug products for treatment of nontuberculous mycobacterial (NTM) disease.
Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops; Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops.'' This guidance provides FDA's interpretation of, and a compliance policy for, the requirement that the label of tobacco products contain an accurate statement of the percentage of foreign and domestic grown tobacco under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance document is also intended to assist retailers who sell deemed products by explaining whether engaging in certain activities subjects such establishments to additional requirements of the FD&C Act and the limited circumstances under which FDA does not intend to enforce compliance.
Rare Diseases: Natural History Studies for Drug Development; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Rare Diseases: Natural History Studies for Drug Development.'' FDA is publishing this draft guidance to help inform the design and implementation of natural history studies that can be used to support the development of safe and effective drugs and biological products for rare diseases. A natural history study collects information about the natural history of a disease in the absence of an intervention, from the disease's onset until either its resolution or the individual's death. Although knowledge of a disease's natural history can benefit drug development for many disorders and conditions, natural history information is usually not available or is incomplete for most rare diseases; therefore, natural history information is particularly needed for these diseases.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this meeting.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Agency Information Collection Activities; Submission for OMB Review; the State Plan for Independent Living (SPIL) (0985-0044)
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to State Plan for Independent Living (SPIL) (Information Collection Request Ext (ICR Ext)).
Agency Information Collection Request; 30-Day Public Comment Request
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.
Advisory Council for the Elimination of Tuberculosis (ACET); Notice of Charter Renewal
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Advisory Council for the Elimination of Tuberculosis Meeting (ACET), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through March 15, 2021.
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 33 people. The public is welcome to participate during the public comment period, 12:30 p.m. to 12:40 p.m. EDT May 30, 2019. Please note that the public comment period ends at the time indicated above or following the last call for comments, whichever is earlier. Members of the public who wish to address the NIOSH BSC are requested to contact the Executive Secretary for scheduling purposes (see contact information below). Alternatively, written comments to the BSC may be submitted via an on-line form at the following website: https://www.cdc.gov/niosh/bsc/contact.html. Each commenter will be provided up to five minutes for comment. A limited number of time slots are available and will be assigned on a first come-first served basis. Written comments will also be accepted from those unable to attend the public session via an on-line form at the following website: https:// www.cdc.gov/niosh/bsc/contact.html. The meeting is also open to the public via webcast. If you wish to attend in person or by webcast, please see the NIOSH website to register (https://www.cdc.gov/niosh/bsc/ ) or call (404-498-2539) at least five business days in advance of the meeting. Teleconference is available toll-free; please dial (888) 397- 9578, Participant Pass Code 63257516. Adobe Connect webcast will be available at https://odniosh.adobeconnect.com/nioshbsc/ for participants wanting to connect remotely.
Decision To Evaluate a Petition To Designate a Class of Employees From the Y-12 Plant in Oak Ridge, Tennessee, To Be Included in the Special Exposure Cohort
NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from the Y-12 Plant in Oak Ridge, Tennessee, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Final National Occupational Research Agenda for Immune, Infectious, and Dermal Disease Prevention (IID)
NIOSH announces the availability of the final National Occupational Research Agenda for Immune, Infectious, and Dermal Disease Prevention.
The Science of Interoception and Its Roles in Nervous System Disorders
The objectives of this workshop are to identify gaps in research related to the science of interoception, its role(s) in nervous system disorders, and to develop strategies and recommendations to facilitate the advancement of this area of research. The workshop will bring together expertise from diverse fields including basic neuroscience, psychology, physiology, and clinical research to deliberate two important dynamic connectionsthe connections between brain and body and the connections between basic research and human/ clinical research. The primary focus areas for the workshop include: the neural circuitry underlying the dynamic interactions between the central and peripheral nervous systems; interoceptive processes in associated diseases and disorders; effect of modulating interoceptive processes for potential interventions/therapies; and development of technologies and methodologies to enhance interoceptive research.
Proposed Information Collection Activity; National Directory of New Hires
The Office of Child Support Enforcement, Administration for Children and Families (ACF) is requesting a three-year extension of the National Directory of New Hires (OMB #0970-0166, expiration 7/31/2019). The NDNH Guide for Data Submission/Record Specifications and the Multistate Employer Registration form underwent minor revisions.
Medicaid; Revisions to State Medicaid Fraud Control Unit Rules
This final rule amends the regulation governing State Medicaid Fraud Control Units (MFCUs or Units). The rule incorporates statutory changes affecting the Units as well as policy and practice changes that have occurred since the regulation was initially issued in 1978. These changes include a recognition of OIG's delegated authority; Unit authority, functions, and responsibilities; disallowances; and issues related to organization, prosecutorial authority, staffing, recertification, and the Units' relationship with Medicaid agencies. The rule is designed to assist the MFCUs in understanding their authorities and responsibilities under the grant program, clarify the flexibilities the MFCUs have to operate their programs, and reduce administrative burden, where appropriate, by eliminating duplicative and unnecessary reporting requirements.
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.
Pediatric Human Immunodeficiency Virus Infection: Drug Product Development for Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Pediatric HIV Infection: Drug Product Development for Treatment.'' The purpose of this guidance is to provide general recommendations on the development of antiretroviral drug products for the treatment of human immunodeficiency virus (HIV) infection in pediatric patients. The guidance addresses when to initiate pediatric formulation development and begin pediatric studies and offers approaches for enrollment of subjects into pediatric studies to help facilitate drug product development. This guidance incorporates the comments received for and finalizes the draft guidance for industry ``Pediatric HIV Infection: Drug Development for Treatment'' issued on May 14, 2018.
Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.'' The purpose of this guidance is to provide to sponsors nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long- acting systemic drug products (including small molecules and monoclonal antibodies). This guidance incorporates the comments received for and finalizes the draft guidance of the same name issued in June 2018.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 the National Syndromic Surveillance Program (NSSP). The NSSP promotes and advances development of a syndromic surveillance system for the timely exchange of syndromic data.
Proposed Data Collection Submitted for Public Comment and Recommendations
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 ``Ingress/egress and work boot outsole wear investigation at surface mines.'' The goal of this work is to investigate how ingress/egress systems on mobile equipment and personal protective footwear (work boots) used by miners may lead to slips, trips and falls by interviewing and surveying mine workers and examining work boot outsole characteristics.
Patient Safety Organizations: Voluntary Relinquishment From Quality Alliance Patient Safety Organization
The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (PSO) an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from the Quality Alliance Patient Safety Organization, PSO number P0163, of its status as a PSO, and has delisted the PSO accordingly.
Mitigation Strategies To Protect Food Against Intentional Adulteration: Draft Guidance for Industry; Public Meeting; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration: Draft Guidance for Industry.'' The purpose of the public meeting is to discuss the draft guidance for compliance and implementation of the ``Mitigation Strategies to Protect Food Against Intentional Adulteration'' rule, which was issued under the FDA Food Safety Modernization Act.
Supplemental Evidence and Data Request on Opioid Treatments for Chronic Pain
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 on Opioid Treatments for Chronic Pain, 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
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: ``Child Hospital Consumer Assessment of Healthcare Providers and Systems (Child HCAHPS) Survey Database.'' This proposed information collection was previously published in the Federal Register on November 7th, 2018, and allowed 60 days for public comments. AHRQ received and responded to one substantive comment from a member of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Supplemental Evidence and Data Request on Noninvasive Nonpharmacologic Treatment for Chronic Pain
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 on Noninvasive Nonpharmacologic Treatment for Chronic Pain, 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.
Supplemental Evidence and Data Request on Nonopioid Pharmacologic Treatments for Chronic Pain
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 on Nonopioid Pharmacologic Treatments for Chronic Pain, 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.
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