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

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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
National Institute on Aging; Notice of Closed Meeting
Document Number: 2020-00474
Type: Notice
Date: 2020-01-15
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2020-00473
Type: Notice
Date: 2020-01-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00472
Type: Notice
Date: 2020-01-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00471
Type: Notice
Date: 2020-01-15
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-00426
Type: Notice
Date: 2020-01-14
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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-00424
Type: Notice
Date: 2020-01-14
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.
Notice of Closed Meeting
Document Number: 2020-00372
Type: Notice
Date: 2020-01-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute on Aging; Notice of Closed Meetings
Document Number: 2020-00371
Type: Notice
Date: 2020-01-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-00370
Type: Notice
Date: 2020-01-14
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: 2020-00369
Type: Notice
Date: 2020-01-14
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher
Document Number: 2020-00295
Type: Rule
Date: 2020-01-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification (510(k)) requirements for powered wheeled stretchers (product code INK). These devices are battery-powered tables with wheels that are intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions). This order exempts powered wheeled stretchers, class II devices, from 510(k) requirements, subject to certain conditions for exemption. This exemption from 510(k) requirements is immediately in effect for powered wheeled stretchers. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
Meeting of the Advisory Committee on Minority Health
Document Number: 2020-00307
Type: Notice
Date: 2020-01-13
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS or Department) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration by January 24, 2020, is required for the public to attend the meeting, provide comments, and/or distribute printed material(s) to ACMH members. Information about the meeting is available from the designated contact person and will be posted on the website for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH website under the heading About OMH.
Peripheral Percutaneous Transluminal Angioplasty and Specialty Catheters-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2020-00296
Type: Notice
Date: 2020-01-13
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 ``Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff.'' The FDA is issuing this draft guidance document to provide recommendations for 510(k) submissions for peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis (ISR), scoring/cutting balloons). This draft guidance is not final nor is it in effect at this time.
National Institute on Minority Health and Health Disparities; Notice of Closed Meetings
Document Number: 2020-00273
Type: Notice
Date: 2020-01-13
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: 2020-00272
Type: Notice
Date: 2020-01-13
Agency: Department of Health and Human Services, National Institutes of Health