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

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Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Chronic Disease Self-Management Education Program; OMB# 0985-0036
Document Number: 2019-23121
Type: Notice
Date: 2019-10-23
Agency: Department of Health and Human Services
The Administration for Community Living 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 ACL's Chronic Disease Self-Management Education grant program (Proposed Extension with Changes of a Currently Approved Collection [ICR Rev]).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-23075
Type: Notice
Date: 2019-10-23
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 (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.
Clinical Center; Notice of Closed Meeting
Document Number: 2019-23042
Type: Notice
Date: 2019-10-23
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Meeting
Document Number: 2019-23041
Type: Notice
Date: 2019-10-23
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-23040
Type: Notice
Date: 2019-10-23
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2019-23037
Type: Notice
Date: 2019-10-23
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2019-23031
Type: Notice
Date: 2019-10-23
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-23018
Type: Notice
Date: 2019-10-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-23017
Type: Notice
Date: 2019-10-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Violent Death Reporting System (NVDRS). The NVDRS is designed to continue collection of detailed and timely state-based surveillance data on violent deaths.
Determination That PROAMATINE (Midodrine Hydrochloride) Tablets, 2.5 Milligrams, 5 Milligrams, and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-23014
Type: Notice
Date: 2019-10-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that PROAMATINE (midodrine hydrochloride) tablets, 2.5 milligrams (mg), 5 mg, and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to approve abbreviated new drug applications (ANDAs) for midodrine hydrochloride tablets, 2.5 mg, 5 mg, and 10 mg, if all other legal and regulatory requirements are met.
Notice of a Maternal and Child Health Bureau (MCHB)-Initiated Supplemental Award to the National Academy for State Health Policy (NASHP) for the Supporting State Maternal and Child Health Policy Innovation Program (MCH PIP)
Document Number: 2019-22993
Type: Notice
Date: 2019-10-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA announces the award of a supplement of $74,841 for the Supporting State MCH PIP for the period of May 1, 2019-April 30, 2020. The supplement will allow the current recipient to investigate and evaluate opportunities for strengthening collaboration and coordination among federal, state, community, and other stakeholders to effectively leverage Medicaid for evidence-based home visiting and related maternal and child health services.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2019-22989
Type: Notice
Date: 2019-10-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Notice To Announce Project Period Extensions With Funding for Health Center Program Award Recipients in Pago Pago, American Samoa; Bishop, California; Baltimore, Maryland; and Worcester, Massachusetts
Document Number: 2019-22984
Type: Notice
Date: 2019-10-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
Additional grant funds were provided to four Health Center Program award recipients with project periods ending in fiscal year (FY) 2019 to extend their project periods by up to four months to ensure the ongoing delivery of services until a new award could be made.
Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID)
Document Number: 2019-22980
Type: Notice
Date: 2019-10-22
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID). This meeting is open to the public, limited only by the space available; the meeting room will accommodate up to 100 people. The public is also welcome to listen to the meeting by telephone, limited only by the number of ports available (100); the toll-free dial-in number is 1-877-951-7311, with a pass code of 5421098.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2019-22951
Type: Notice
Date: 2019-10-22
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: 2019-22930
Type: Notice
Date: 2019-10-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2019-22929
Type: Notice
Date: 2019-10-22
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee
Document Number: 2019-22947
Type: Notice
Date: 2019-10-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS in making coverage determinations under the Medicare program. The MEDCACs fundamental purpose is to support the principles of an evidence-based determination process for Medicare's coverage policies. MEDCAC panels provide advice to CMS on the strength of the evidence available for specific medical treatments and technologies through a public, participatory, and accountable process.
Drug Master Files; Draft Guidance for Industry; Availability
Document Number: 2019-22821
Type: Notice
Date: 2019-10-21
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 ``Drug Master Files.'' Once finalized, this guidance will provide FDA's current thinking on drug master files (DMFs), which are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs are submitted solely at the discretion of their holders and are not required by statute or regulation. This draft guidance, when finalized, will revise the guidance for industry ``Drug Master Files: Guidelines'' that published in September 1989.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2019-22803
Type: Notice
Date: 2019-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Site Visit Training Program for Office of Pharmaceutical Quality Staff; Information Available to Industry
Document Number: 2019-22767
Type: Notice
Date: 2019-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) is announcing an invitation for participation in the Fiscal Year (FY) 2020 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. The purpose of this document is to invite pharmaceutical companies interested in participating in this program to submit a site visit proposal to CDER's OPQ.
Health Canada and United States Food and Drug Administration Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting; Request for Comments
Document Number: 2019-22760
Type: Notice
Date: 2019-10-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``Health Canada and U.S. Food and Drug Administration Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The purpose of the public meeting is to provide information and solicit public input on the current activities of the ICH, as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Singapore scheduled for November 16 through November 20, 2019. The topics to be addressed at the public meeting are the current ICH guideline topics under development that will be discussed at the forthcoming ICH Assembly Meeting in Singapore.
Proposed Information Collection Activity; Office of Community Services (OCS) Community Economic Development (CED) Standard Reporting Format (OMB #0970-0386)
Document Number: 2019-22741
Type: Notice
Date: 2019-10-18
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Community Services (OCS) is requesting a three- year extension of the semi-annual reporting format for Community Economic Development (CED) grantees, the Performance Progress Report (PPR), which collects information concerning the outcomes and management of CED projects (OMB #0970-0386, expiration 6/30/2020). There are no changes requested to the form.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-22735
Type: Notice
Date: 2019-10-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 Standardized National Hypothesis Generating Questionnaire. The information collected will be used to define a core set of data elements to be used for hypothesis generation once a given situation is determined to be a multistate foodborne outbreak investigation.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2019-22732
Type: Notice
Date: 2019-10-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 ``Data Calls for the Laboratory Response Network.'' This is data collected from its members concerning their capacity to respond to public health emergencies.
Agency Information Collection Activities: Proposed Collection; Comment Request; Correction
Document Number: 2019-22726
Type: Notice
Date: 2019-10-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects the information provided for [Document Identifier: CMS-10344] titled ``Elimination of Cost-Sharing for Full Benefit Dual Eligible Individuals Receiving Home and Community-Based Services.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-22718
Type: Notice
Date: 2019-10-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-22715
Type: Notice
Date: 2019-10-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (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.
Office of the Secretary; Notice of Meeting
Document Number: 2019-22713
Type: Notice
Date: 2019-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Meetings
Document Number: 2019-22712
Type: Notice
Date: 2019-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2019-22711
Type: Notice
Date: 2019-10-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2019-22710
Type: Notice
Date: 2019-10-18
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-22709
Type: Notice
Date: 2019-10-18
Agency: Department of Health and Human Services, National Institutes of Health
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: C1-2019-21176
Type: Notice
Date: 2019-10-17
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products; Guidance for Industry; Availability
Document Number: 2019-22690
Type: Notice
Date: 2019-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products.'' This guidance provides recommendations to applicants planning to request a waiver or reduction in user fees. This guidance finalizes the draft guidance for industry of the same title issued in June 2018.
Request for Nominations for Voting Members on the Tobacco Products Scientific Advisory Committee
Document Number: 2019-22685
Type: Notice
Date: 2019-10-17
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 Tobacco Products Scientific Advisory Committee, in the Center for Tobacco Products. 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.
Request for Nominations of a Nonvoting Representative of the Interest of the Tobacco Manufacturing Industry on the Tobacco Products Scientific Advisory Committee
Document Number: 2019-22683
Type: Notice
Date: 2019-10-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is requesting nominations for a nonvoting representative of the interests of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory Committee (TPSAC), in the Center for Tobacco Products. 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. A nominee may either be self-nominated or nominated by an organization. In addition, FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting representative of the interests of the tobacco manufacturing industry to serve on the TPSAC notify FDA in writing. Nominations will be accepted for either the representative to serve on TPSAC or for the selection group effective with this notice.
Meeting of the Advisory Committee on Training and Primary Care Medicine and Dentistry
Document Number: 2019-22650
Type: Notice
Date: 2019-10-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Training and Primary Care Medicine and Dentistry (ACTPCMD) will hold public meetings for the 2020 calendar year (CY). Information about ACTPCMD, agendas, and materials for these meetings can be found on the ACTPCMD website at https://www.hrsa.gov/advisory-committees/primarycare-dentist/ index.html.
Meeting of the Council on Graduate Medical Education
Document Number: 2019-22649
Type: Notice
Date: 2019-10-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
In accordance with the Federal Advisory Committee Act, this notice announces that the Council on Graduate Medical Education (COGME or Council) will hold public meetings for the 2020 calendar year (CY). Information about COGME, agendas, and materials for these meetings can be found on the COGME website at https://www.hrsa.gov/advisory- committees/graduate-medical-edu/index.html.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Evaluation of the Maternal and Child Health Bureau Pediatric Mental Health Care Access (PMHCA) 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: 2019-22636
Type: Notice
Date: 2019-10-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
National Eye Institute; Notice of Closed Meeting
Document Number: 2019-22573
Type: Notice
Date: 2019-10-17
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2019-22572
Type: Notice
Date: 2019-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Amended Notice of Meeting
Document Number: 2019-22571
Type: Notice
Date: 2019-10-17
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations
Document Number: 2019-22028
Type: Proposed Rule
Date: 2019-10-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would address any undue regulatory impact and burden of the physician self-referral law. This proposed rule is being issued in conjunction with the Centers for Medicare & Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care. This proposed rule proposes exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. It would also create a new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician; create a new exception for donations of cybersecurity technology and related services; and amend the existing exception for electronic health records (EHR) items and services. This proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.
Medicare and State Healthcare Programs: Fraud and Abuse; Revisions To Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements
Document Number: 2019-22027
Type: Proposed Rule
Date: 2019-10-17
Agency: Department of Health and Human Services, Office of Inspector General
This proposed rule is being issued by the Office of Inspector General (OIG) in conjunction with the Department of Health and Human Services' Regulatory Sprint to Coordinated Care. It proposes to add, on a prospective basis only after a final rule is issued, safe harbor protections under the Federal anti-kickback statute for certain coordinated care and associated value-based arrangements between or among clinicians, providers, suppliers, and others that squarely meet all safe harbor conditions. It also would add protections under the anti-kickback statute and civil monetary penalty (CMP) law that prohibits inducements offered to patients for certain patient engagement and support arrangements to improve quality of care, health outcomes, and efficiency of care delivery that squarely meet all safe harbor conditions. The proposed rule would add a new safe harbor for donations of cybersecurity technology and amend the existing safe harbors for electronic health records (EHR) arrangements, warranties, local transportation, and personal services and management contracts. Further, the proposed rule would add a new safe harbor pursuant to a statutory change set forth in the Bipartisan Budget Act of 2018 (Budget Act of 2018) related to beneficiary incentives under the Medicare Shared Savings Program and a new CMP exception for certain telehealth technologies offered to patients receiving in-home dialysis, also pursuant to the Budget Act of 2018.
Proposed Collection; 60-Day Comment Request; Office of Minority Health Research Coordination (OMHRC) Research Training and Mentor Programs Applications (National Institute of Diabetes and Digestive and Kidney Diseases)
Document Number: 2019-22538
Type: Notice
Date: 2019-10-16
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2019-22450
Type: Notice
Date: 2019-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-22449
Type: Notice
Date: 2019-10-16
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Cancellation of Meeting
Document Number: 2019-22448
Type: Notice
Date: 2019-10-16
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-22446
Type: Notice
Date: 2019-10-16
Agency: Department of Health and Human Services, National Institutes of Health