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

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Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-11166
Type: Notice
Date: 2018-05-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. At least one portion of the meeting will be closed to the public. FDA is establishing a docket for public comment on this document.
Food and Drug Administration's Evaluation of Approaches To Demonstrate Effectiveness of Heartworm Preventatives for Dogs; Request for Comments
Document Number: 2018-11132
Type: Notice
Date: 2018-05-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is evaluating its current thinking regarding the design of studies intended to generate data to support substantial evidence of effectiveness for investigational new animal drugs intended for the prevention of heartworm disease in dogs. We are specifically requesting public input on possible alternative approaches for evaluating such products or information to assist in the potential development of alternative recommended study designs.
Office of the Deputy Assistant Secretary for Administration Statement of Organization, Functions, and Delegations of Authority
Document Number: 2018-11125
Type: Notice
Date: 2018-05-24
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) has realigned The Office of the Deputy Assistant Secretary for Administration (ODASA). This realignment removes the Office of the Chief Information Officer as a direct report to the Assistant Secretary for Children and Families and realigns the Office within the ODASA. It moves the National Grants Center of Excellence to the ODASA's Immediate Office. It also removes the Ethics and Facilities team from the Immediate Office of the ODASA and places the functions in the Office of Workforce Planning and Development.
Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax; Guidance for Industry; Availability
Document Number: 2018-11117
Type: Notice
Date: 2018-05-24
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 guidance for industry entitled ``Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.'' The purpose of this guidance is to assist sponsors in the development of new drugs for the prophylaxis of inhalational anthrax. This guidance finalizes the draft guidance of the same name issued on February 16, 2016.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
Document Number: 2018-11114
Type: Notice
Date: 2018-05-24
Agency: Food and Drug Administration, Department of Health and Human Services
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 requirements associated with current good manufacturing practice, hazard analysis, and risk-based preventive controls for animal food.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing; Administrative Procedures, Policies, and Requirements
Document Number: 2018-11113
Type: Notice
Date: 2018-05-24
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.
Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR); Correction
Document Number: 2018-11097
Type: Notice
Date: 2018-05-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-11081
Type: Notice
Date: 2018-05-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-11080
Type: Notice
Date: 2018-05-24
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-11056
Type: Notice
Date: 2018-05-23
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.
Solicitation of Nominations for Membership To Serve on the National Advisory Council on the National Health Service Corps
Document Number: 2018-11034
Type: Notice
Date: 2018-05-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the National Advisory Council on the National Health Service Corps (NACNHSC). NACNHSC advises the Secretary of HHS and, by designation, HRSA's Administrator on the priorities and policies impacting the National Health Service Corps (NHSC) and provides specific recommendations for policy revisions.
Enhancement and Update of the National HIV Curriculum e-Learning Platform
Document Number: 2018-11033
Type: Notice
Date: 2018-05-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA's HIV/AIDS Bureau (HAB) intends to issue a single source award to the University of Washington for $300,000 for activities authorized under Section 2692(a) of the Public Health Service (PHS) Act as amended by the Ryan White HIV/AIDS Treatment Extension Act of 2009. This notice is subject to the appropriation of funds and is a contingency action taken to ensure that, should funds become available for this purpose, HRSA can award funds in a timely manner. Subject to the availability of funds and the University of Washington's satisfactory performance, HAB will also issue non- competitive, single source awards of $300,000 each in fiscal years (FYs) 2019 to 2022. This will allow the University of Washington to update and enhance the National HIV Curriculum (NHC) and the electronic platform that supports it, and to keep pace with the latest HIV science, federal guidelines, and treatment protocols and practices for educating health professionals on the optimal care and treatment of people living with HIV over its four-year project period.
Notice of Correction
Document Number: 2018-11032
Type: Notice
Date: 2018-05-23
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is correcting a notice published in the September 26, 2017 issue of the Federal Register entitled Improving Care for Children and YouthIncentive Prize. This correction amends the subject of the challenge and the timeline. Please note, however, that this correction notice, along with future updates, as needed and pursuant to recent changes to the applicable law, will be posted on challenge.gov and mchbgrandchallenges.hrsa.gov.
Enforcement Policy-Over-the-Counter Sunscreen Drug Products Marketed Without an Approved Application; Guidance for Industry; Availability
Document Number: 2018-10994
Type: Notice
Date: 2018-05-23
Agency: Food and Drug Administration, Department of Health and Human Services, Department of Health and Human Service
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Enforcement PolicyOTC Sunscreen Drug Products Marketed Without an Approved Application.'' This guidance describes FDA's approach to enforcement for over-the-counter (OTC) sunscreen products marketed without approved applications before a final OTC sunscreen drug monograph becomes effective. This guidance finalizes the draft guidance of the same name issued June 17, 2011.
Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Draft Guidance for Industry; Availability
Document Number: 2018-10993
Type: Notice
Date: 2018-05-23
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 ``Maximal Usage Trials for Topical Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.'' This draft guidance addresses FDA's current thinking on the conduct of in vivo absorption trials for topical active ingredients that are under consideration for inclusion in an over-the-counter (OTC) monograph.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-10935
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-10934
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-10933
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-10932
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment; Guidance for Industry; Availability
Document Number: 2018-10928
Type: Notice
Date: 2018-05-22
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 ``Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment.'' This guidance provides recommendations to industry for establishing the clinical effectiveness of drugs for the treatment of acne vulgaris (acne). This guidance finalizes the draft guidance for industry entitled ``Acne Vulgaris: Developing Drugs for Treatment,'' issued September 19, 2005.
Framework for Assessing pH-Dependent Drug-Drug Interactions; Establishment of a Public Docket; Request for Comments
Document Number: 2018-10927
Type: Notice
Date: 2018-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing a public docket to assist with the development of a policy or guidance document on the assessment of pH-dependent drug-drug interactions (DDIs). In October 2017, FDA published two draft guidance documents on DDIs entitled ``In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies'' (In Vitro Studies Draft Guidance) and ``Clinical Drug Interaction StudiesStudy Design, Data Analysis, and Clinical Implications'' (Clinical Drug Interaction Studies Draft Guidance). These two draft guidances focus on enzyme- and transporter-based DDIs and do not include a framework to assess pH-dependent DDIs. FDA is seeking public input on best practices in the planning and evaluation of pH-dependent DDIs.
Bioanalytical Method Validation; Guidance for Industry; Availability
Document Number: 2018-10926
Type: Notice
Date: 2018-05-22
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 ``Bioanalytical Method Validation.'' This final guidance incorporates public comments to the revised draft published in 2013 as well as the latest scientific feedback concerning bioanalytical method validation and provides the most up-to-date information needed by drug developers to ensure the bioanalytical quality of their data.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Document Number: 2018-10924
Type: Notice
Date: 2018-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.
Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year; Corrections
Document Number: 2018-10923
Type: Rule
Date: 2018-05-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the final rule with comment period and interim final rule with comment period published in the Federal Register on November 16, 2017 entitled ``Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year'' (hereinafter referred to as the ``CY 2018 Quality Payment Program final rule'').
Proposed Information Collection Activity; Comment Request
Document Number: 2018-10910
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2018-10888
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Controlled Correspondence Related to Generic Drug Development
Document Number: 2018-10856
Type: Notice
Date: 2018-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, 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 controlled correspondence related to generic drug development.
Advisory Committee; Blood Products Advisory Committee; Renewal
Document Number: 2018-10848
Type: Notice
Date: 2018-05-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Blood Products 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 Blood Products Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 13, 2020.
National Institute of Environmental Health Sciences; Notice to Close Meeting
Document Number: 2018-10838
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2018-10837
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2018-10836
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-10835
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review: Notice of Closed Meetings
Document Number: 2018-10834
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request; Grants to States for Access and Visitation
Document Number: 2018-10820
Type: Notice
Date: 2018-05-22
Agency: Department of Health and Human Services, Administration for Children and Families
Request for Information for the Development of the Fiscal Year 2021-2023 Trans-NIH Strategic Plan for HIV and HIV-Related Research
Document Number: 2018-10784
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services, National Institutes of Health
Through this Request for Information (RFI), the Office of AIDS Research (OAR) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), National Institutes of Health (NIH), invites feedback from investigators in academia, industry, health care professionals, patient advocates and health advocacy organizations, scientific or professional organizations, federal agencies, community, and other interested constituents on the development of the fiscal year (FY) 2021-2023 Trans-NIH Strategic Plan for HIV and HIV-Related Research (the Plan). The Plan is designed to identify and articulate future directions to maximize the NIH's investments in HIV research.
Blood Products Advisory Committee; Notice of Meeting
Document Number: 2018-10734
Type: Notice
Date: 2018-05-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.
Cytomegalovirus in Transplantation: Developing Drugs To Treat or Prevent Disease; Draft Guidance for Industry; Availability
Document Number: 2018-10733
Type: Notice
Date: 2018-05-21
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 ``Cytomegalovirus in Transplantation: Developing Drugs to Treat or Prevent Disease.'' The purpose of this guidance is to assist sponsors in all phases of development of drugs and biologics for the treatment or prevention of cytomegalovirus (CMV) disease in patients who have undergone solid organ transplantation (SOT) or hematopoietic stem cell transplantation (HSCT).
Establishing Effectiveness for Drugs Intended To Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders; Guidance for Industry; Availability
Document Number: 2018-10732
Type: Notice
Date: 2018-05-21
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 ``Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders.'' This guidance provides recommendations for establishing clinical effectiveness for drugs intended to treat male hypogonadotropic hypogonadism associated with obesity and other conditions that do not cause structural disorders of the hypothalamus or pituitary gland. This guidance incorporates advice FDA received at a December 2014 advisory committee meeting on the appropriate indicated population for testosterone therapy and a December 2016 advisory committee meeting on hypogonadotropic hypogonadism. This guidance finalizes the draft guidance of the same name issued on January 3, 2018.
Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee, Renewal
Document Number: 2018-10731
Type: Notice
Date: 2018-05-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee (the Committee) by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 1, 2020.
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigation of Consumer Perceptions of Expressed Modified Risk Claims
Document Number: 2018-10723
Type: Notice
Date: 2018-05-21
Agency: Food and Drug Administration, Department of Health and Human Services
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 the investigation of consumer perceptions of expressed modified risk claims.
Documenting Electronic Data Files and Statistical Analysis Programs; Draft Guidance for Industry; Availability
Document Number: 2018-10722
Type: Notice
Date: 2018-05-21
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 revised guidance for industry (GFI) #197 entitled ``Documenting Electronic Data Files and Statistical Analysis Programs.'' This draft revised guidance is provided to inform sponsors of recommendations for documenting electronic data files and statistical analyses submitted to the Center for Veterinary Medicine (CVM) to support new animal drug applications.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-10717
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-10716
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Grocery Manufacturers Association; Denial of Food Additive Petition
Document Number: 2018-10715
Type: Proposed Rule
Date: 2018-05-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is denying a food additive petition (FAP 5A4811), submitted by the Grocery Manufacturers Association (GMA), requesting that the food additive regulations be amended to provide for the safe use of partially hydrogenated vegetable oils (PHOs) in certain food applications. We are denying the petition because we have determined that the petitioner did not provide sufficient information for us to conclude that the requested uses of PHOs are safe. To allow the food industry sufficient time to identify suitable replacement substances for the petitioned uses of PHOs, elsewhere in this issue of the Federal Register we have extended the compliance date for certain uses of PHOs, including the conditions of use covered by the FAP.
Final Determination Regarding Partially Hydrogenated Oils
Document Number: 2018-10714
Type: Rule
Date: 2018-05-21
Agency: Food and Drug Administration, Department of Health and Human Services
Based on the available scientific evidence and the findings of expert scientific panels, the Food and Drug Administration (FDA or we) made a final determination that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially produced trans fatty acids (IP-TFA), are generally recognized as safe (GRAS) for any use in human food. In a declaratory order announcing our final determination, we set a compliance date of June 18, 2018. We are now extending the compliance date for certain uses of PHOs.
Recruitment of Sites for Assignment of National Health Service Corps Scholarship Program Participants
Document Number: 2018-10699
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice announces that the listing of entities that will receive priority for assignments of National Health Service Corps (NHSC) Scholarship recipients (NHSC scholars) was posted on the Health Workforce Connector website (formerly known as the NHSC Jobs Center) at https://connector.hrsa.gov/. The Health Workforce Connector includes sites approved to receive an assignment of NHSC scholars who are available for service during the period of October 1, 2018, through September 30, 2019, as well as the site's Health Professional Shortage Area (HPSA) scores. Please note that entities on this list may or may not have current job vacancies.
Mary C. Holloway; Order Revoking a Proposed Order of Debarment
Document Number: 2018-10685
Type: Notice
Date: 2018-05-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is revoking a proposed order, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), to debar Mary C. Holloway (Holloway) for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. Holloway, through counsel, filed a request for a hearing, as well as information and analysis in support of that request, in response to the proposed debarment order. FDA has determined that pursuing debarment of Holloway is no longer appropriate.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2018-10682
Type: Notice
Date: 2018-05-21
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: 2018-10681
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-10680
Type: Notice
Date: 2018-05-21
Agency: Department of Health and Human Services, National Institutes of Health