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

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Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2020-00896
Type: Notice
Date: 2020-01-22
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Meeting
Document Number: 2020-00895
Type: Notice
Date: 2020-01-22
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer
Document Number: 2020-00497
Type: Rule
Date: 2020-01-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological CADx software for lesions suspicious for cancer's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Medical Devices; Radiology Devices; Classification of the Radiological Computer Aided Triage and Notification Software
Document Number: 2020-00496
Type: Rule
Date: 2020-01-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the radiological computer aided triage and notification software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological computer aided triage and notification software's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Radiology Devices; Reclassification of Medical Image Analyzers
Document Number: 2020-00494
Type: Rule
Date: 2020-01-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, postamendments class III devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. These devices are intended to direct the clinician's attention to portions of an image that may reveal abnormalities during interpretation of patient radiology images by the clinician. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device type.
Meeting of the National Vaccine Advisory Committee
Document Number: 2020-00882
Type: Notice
Date: 2020-01-21
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a two-day meeting in-person meeting. The meeting will be open to the public and public comment sessions will be held during the meeting.
Findings of Research Misconduct
Document Number: 2020-00874
Type: Notice
Date: 2020-01-21
Agency: Department of Health and Human Services, Office of the Secretary
Findings of research misconduct have been made against Ozgur Tataroglu, Ph.D. (Respondent), former postdoctoral fellow, Department of Neurobiology, University of Massachusetts Medical School (UMMS). Dr. Tataroglu engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grants R01 GM066777 and R01 GM079182. The administrative actions, including supervision for a period of three (3) years, were implemented beginning on December 30, 2019, and are detailed below.
Agency Information Collection Activities; Proposed Collection; Comment Request; Radioactive Drug Research Committees
Document Number: 2020-00873
Type: Notice
Date: 2020-01-21
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, 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 information collection requirements contained in regulations governing the use of radioactive drugs for basic informational research.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
Document Number: 2020-00869
Type: Notice
Date: 2020-01-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Food and Drug Administration Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development; Public Meeting; Request for Comments
Document Number: 2020-00829
Type: Notice
Date: 2020-01-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing a public meeting and an opportunity for public comment on ``FDA Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development.'' Developing a treatment for a rare disease can present unique challenges. The goal of this meeting is to obtain stakeholders' perspectives on challenges and solutions in rare disease product development and identify commonalities that can support product development across a variety of rare diseases.
Agency Information Collection Activities; Proposed Collection; Comment Request; Empirical Study of Promotional Implications of Proprietary Prescription Drug Names
Document Number: 2020-00823
Type: Notice
Date: 2020-01-21
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 a proposed study entitled ``Empirical Study of Promotional Implications of Proprietary Prescription Drug Names.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys
Document Number: 2020-00822
Type: Notice
Date: 2020-01-21
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, 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.
Achieving Health Equity in the Advancement of Tobacco Control Practices To Prevent Initiation of Tobacco Use Among Youth and Young Adults, Eliminate Exposure to Secondhand Tobacco Product Emissions, and Identify and Eliminate Disparities in Tobacco Use and Secondhand Exposure Among Population Groups; Request for Information
Document Number: 2020-00819
Type: Notice
Date: 2020-01-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) leads comprehensive efforts to prevent the initiation of tobacco use among youth and young adults; eliminate exposure to secondhand tobacco product emissions (e.g., secondhand smoke and aerosol); help current smokers quit; and identify and eliminate tobacco-related disparities. From 2017 to late 2018, CDC solicited input from the public through a Federal Register Notice (FRN Docket Number: CDC-2017-0103); regarding these comprehensive prevention efforts. CDC has reviewed these comments, posted to www.regulations.gov, and received helpful feedback. Now, CDC is seeking additional information to inform future activities that assist in achieving health equity in tobacco prevention and control by eliminating differences in tobacco use and dependency and exposure to secondhand tobacco product emissions (e.g., secondhand smoke and aerosol) among certain population groups.
Coordinating Care From Out-of-State Providers for Medicaid-Eligible Children With Medically Complex Conditions
Document Number: 2020-00796
Type: Proposed Rule
Date: 2020-01-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document is a request for information (RFI) to seek public comments regarding the coordination of care from out-of-state providers for Medicaid-eligible children with medically complex conditions. We wish to identify best practices for using out-of-state providers to provide care to children with medically complex conditions; determine how care is coordinated for such children when that care is provided by out-of-state providers, including when care is provided in emergency and non-emergency situations; reduce barriers that prevent such children from receiving care from out-of-state providers in a timely fashion; and identify processes for screening and enrolling out-of-state providers in Medicaid, including efforts to streamline such processes for out-of-state providers or to reduce the burden of such processes on them. We intend to use the information received in response to this RFI to issue guidance to state Medicaid directors on the coordination of care from out-of-state providers for children with medically complex conditions.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00788
Type: Notice
Date: 2020-01-21
Agency: Department of Health and Human Services, National Institutes of Health
Patient Protection and Affordable Care Act; Exchange Program Integrity
Document Number: C1-2019-27713
Type: Rule
Date: 2020-01-17
Agency: Department of Health and Human Services
Annual Update of the HHS Poverty Guidelines
Document Number: 2020-00858
Type: Notice
Date: 2020-01-17
Agency: Department of Health and Human Services, Office of the Secretary
This notice provides an update of the Department of Health and Human Services (HHS) poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2020-00787
Type: Notice
Date: 2020-01-17
Agency: Department of Health and Human Services, National Institutes of Health
Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR); Amended Notice of Meeting
Document Number: 2020-00749
Type: Notice
Date: 2020-01-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Information Collection Activity: ACF Program Instruction-Children's Justice Act (OMB #0970-0425)
Document Number: 2020-00739
Type: Notice
Date: 2020-01-17
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting a 3-year extension of the Children's Justice Act Program Instruction (OMB #0970-0425, expiration 4/30/2020). There are no changes requested to the form.
Annual Civil Monetary Penalties Inflation Adjustment
Document Number: 2020-00738
Type: Rule
Date: 2020-01-17
Agency: Department of Health and Human Services
The Department of Health and Human Services is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, and to make changes to reflect an amendment to the Federal Food, Drug, and Cosmetic Act by the Further Consolidated Appropriations Act, 2020 (effective January 1, 2020).
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Evaluation of the Maternal and Child Health Bureau Pediatric Mental Health Care Access Program and the Maternal and Child Health Bureau Screening and Treatment for Maternal Depression and Related Behavioral Disorders Program, OMB No. 0906-xxxx-NEW
Document Number: 2020-00736
Type: Notice
Date: 2020-01-17
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. 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. OMB may act on HRSA's ICR only after the 30 day comment period for this Notice has closed.
Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee
Document Number: 2020-00733
Type: Notice
Date: 2020-01-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting nominations for members to serve on the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) in the Center for Devices and Radiological Health. Nominations will be accepted for current and upcoming vacancies effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h
Document Number: 2020-00729
Type: Notice
Date: 2020-01-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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.
Prospective Grant of Exclusive Patent License: Development of RegulatoryT-Cell Therapies for the Treatment of Hemophilia A (HA)
Document Number: 2020-00721
Type: Notice
Date: 2020-01-17
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to TeraImmune, Inc. (``TeraImmune'') located in Rockville, Maryland.
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2020-00717
Type: Notice
Date: 2020-01-17
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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00693
Type: Notice
Date: 2020-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2020-00691
Type: Notice
Date: 2020-01-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00690
Type: Notice
Date: 2020-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2020-00688
Type: Notice
Date: 2020-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2020-00687
Type: Notice
Date: 2020-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2020-00686
Type: Notice
Date: 2020-01-17
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Maternal, Infant, and Early Childhood Home Visiting Program Home Visiting Budget Assistance Tool, OMB No. 0906-0025-Revision
Document Number: 2020-00674
Type: Notice
Date: 2020-01-17
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. 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. OMB may act on HRSA's ICR only after the 30-day comment period for this Notice has closed.
Ensuring Equal Treatment of Faith-Based Organizations
Document Number: 2019-26923
Type: Proposed Rule
Date: 2020-01-17
Agency: Department of Health and Human Services
This proposed rule would amend the Department of Health and Human Services' (``Department'') general regulations to implement Executive Order 13831, on the Establishment of a White House Faith and Opportunity Initiative. This proposed rule proposes changes to provide clarity about the rights and obligations of faith-based organizations participating in Department programs, clarify the Department's guidance documents for financial assistance with regard to faith-based organizations, and eliminate certain requirements for faith-based organizations that no longer reflect executive branch guidance or Supreme Court precedent. This proposed rulemaking is intended to ensure that the Department's programs are implemented in a manner consistent with the requirements of federal law, including the First Amendment to the Constitution and the Religious Freedom Restoration Act.
Privacy Act of 1974; System of Records Notice
Document Number: 2020-00633
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, National Institutes of Health
In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) through the National Institutes of Health (NIH) is modifying system of records 09-90-0067 to reflect that the records are now maintained by NIH, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) and to rename the system of records ``Invention, Patent, and Licensing Documents Related to Inventions By Public Health Service Employees, Grantees, Fellowship Recipients, and Contractors.'' In addition, HHS/NIH is rescinding a related NIH system of records, 09- 25-0168.
Submission for OMB Review; Building Capacity To Evaluate Child Welfare Community Collaborations To Strengthen and Preserve Families (CWCC) Cross-Site Process Evaluation (New Collection)
Document Number: 2020-00594
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) intends to collect data for an evaluation of the initiative, Community Collaborations to Strengthen and Preserve Families (also referred to as Child Welfare Community Collaborations [CWCC]). The cross-site process evaluation will provide insight to ACF about the various factors that promote or impede the implementation of child welfare community collaborations.
Submission for OMB Review; Tribal Maternal, Infant, and Early Childhood Home Visiting Program Form 2: Grantee Performance Measures (OMB #0970-0500)
Document Number: 2020-00593
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) is requesting a 3-year extension of the ACFTribal Maternal, Infant, and Early Childhood Home Visiting (Tribal MIECHV) Program Form 2: Grantee Performance Measures (OMB #0970-0500; Expiration date 8/31/2020). There are no changes requested to the form.
Pediatric Study Plans for Oncology Drugs: Questions and Answers; Draft Guidance for Industry; Availability
Document Number: 2020-00592
Type: Notice
Date: 2020-01-16
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 ``Pediatric Study Plans for Oncology Drugs: Questions and Answers.'' This draft guidance provides information to sponsors regarding the submission of an initial pediatric study plan (iPSP), as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act), for oncology drugs only. Specifically, when finalized, this draft guidance will provide FDA's current thinking regarding iPSPs for oncology drugs in light of the amendments to the FD&C Act made by the FDA Reauthorization Act of 2017 (FDARA). FDA has received a number of questions on this topic and, as a result, is providing this draft guidance in a question and answer format, addressing the most frequently asked questions.
Meeting of the Substance Abuse and Mental Health Services Administration, Center for Mental Health Services National Advisory Council
Document Number: 2020-00584
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice is hereby given of the meeting on February 20, 2020 of the Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Mental Health Services National Advisory Council (CMHS NAC). The meeting is open to the public and can be accessed remotely. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory- councils/meetings. The meeting will include consideration of the minutes from the August 21, 2019, SAMHSA, CMHS NAC meeting; updates from the CMHS Director and SAMHSA Policy Lab Director; presentation from the National Academies of Sciences, Engineering, and Medicine; and discussions on Trauma Informed Care and Certified Community Behavioral Health Clinics.
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2020-00579
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00578
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-00577
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-00576
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-00575
Type: Notice
Date: 2020-01-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institutes of Health Statement of Delegation of Authority
Document Number: 2020-00550
Type: Notice
Date: 2020-01-15
Agency: Department of Health and Human Services
Solicitation for Public Comments on Questions From the National Clinical Care Commission
Document Number: 2020-00505
Type: Notice
Date: 2020-01-15
Agency: Department of Health and Human Services
The National Clinical Care Commission (the Commission) solicits public comments on a set of questions concerning the context, policies, effectiveness, promising practices, and limitations and gaps related to prevention and treatment of diabetes and its complications. The Commission is charged to evaluate and make recommendations to the Secretary of Health and Human Services (HHS) and Congress regarding improvements to the coordination and leveraging of federal programs related to awareness and clinical care for diabetes and its complications. The set of questions is available in the SUPPLEMENTARY INFORMATION section, below.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-00501
Type: Notice
Date: 2020-01-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Supplemental Evidence and Data Request on Treatments for Acute Episodic Migraine
Document Number: 2020-00488
Type: Notice
Date: 2020-01-15
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 on Treatments for Acute Episodic Migraine, 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.
National Institute of Dental & Craniofacial Research; Notice of Closed Meetings
Document Number: 2020-00476
Type: Notice
Date: 2020-01-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2020-00475
Type: Notice
Date: 2020-01-15
Agency: Department of Health and Human Services, National Institutes of Health