Department of Health and Human Services June 2021 – Federal Register Recent Federal Regulation Documents

Results 101 - 150 of 259
Request for Information Regarding Reporting on Pharmacy Benefits and Prescription Drug Costs
Document Number: 2021-13138
Type: Proposed Rule
Date: 2021-06-23
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury, Office of Personnel Management
This document is a request for information on issues related to certain reporting requirements under section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 (CAA) that are applicable to group health plans and health insurance issuers offering group or individual health insurance coverage. The Departments of Health and Human Services, Labor, and the Treasury (the Departments) are issuing this request for information to gather input from the public regarding implementation considerations for the data collection required under section 204 of Title II of Division BB of the CAA, and the associated impact on group health plans and health insurance issuers. As part of this request for information, the Office of Personnel Management (OPM) is also seeking input from the public regarding implementation considerations for the data collection required under section 204 of Title II of Division BB of the CAA as it pertains to Federal Employees Health Benefits (FEHB) carriers (whether or not they are also health insurance issuers). The Departments and OPM also seek input on specific data elements, including the level of detail that is feasible to report for entities subject to the data collection requirements and the associated burdens and potential compliance costs. Public comments will inform the Departments' and OPM's implementation of section 204 through rulemaking and the establishment of processes to receive the required information.
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2021-13132
Type: Notice
Date: 2021-06-23
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2021-13126
Type: Notice
Date: 2021-06-23
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the renewal of the information collection project ``Nursing Home Survey on Patient Safety Culture Database.''
Advisory Committee on Immunization Practices (ACIP); Amended Notice of Meeting
Document Number: 2021-13120
Type: Notice
Date: 2021-06-23
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment. The meeting will be webcast live via the World Wide Web; for more information on ACIP please visit the ACIP website: http:/ /www.cdc.gov/vaccines/acip/index.html.
Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC)
Document Number: 2021-13119
Type: Notice
Date: 2021-06-23
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, National Center for Injury Prevention and Control (BSC, NCIPC). This meeting is partially open to the public. There will be 15 minutes allotted for public comments at the end of the open session from 11:40 a.m., to 11:55 p.m., EDT.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-12835
Type: Notice
Date: 2021-06-17
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: 2021-12828
Type: Notice
Date: 2021-06-17
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: Submission for OMB Review; Comment Request
Document Number: 2021-12807
Type: Notice
Date: 2021-06-17
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.
National Library of Medicine; Notice of Meetings
Document Number: 2021-12766
Type: Notice
Date: 2021-06-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-12765
Type: Notice
Date: 2021-06-17
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Amended Notice of Meeting
Document Number: 2021-12739
Type: Notice
Date: 2021-06-17
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-12734
Type: Notice
Date: 2021-06-17
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2021-12733
Type: Notice
Date: 2021-06-17
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2021-12625
Type: Notice
Date: 2021-06-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-12624
Type: Notice
Date: 2021-06-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2021-12623
Type: Notice
Date: 2021-06-16
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-12622
Type: Notice
Date: 2021-06-16
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-12583
Type: Notice
Date: 2021-06-16
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.
Proposed Rescission of Executive Order 13937, “Executive Order on Access to Affordable Life-Saving Medications”
Document Number: 2021-12545
Type: Proposed Rule
Date: 2021-06-16
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) proposes to rescind the final rule entitled ``Implementation of Executive Order on Access to Affordable Life-Saving Medications,'' published in the December 23, 2020, Federal Register. HHS is proposing the rescission due to undue administrative costs and burdens that implementation would impose on health centers. In particular, the final rule would require health centers to create and sustain new practices necessary to determine patients' eligibility to receive certain drugs at or below the discounted price paid by the health center or subgrantees under the 340B Program, resulting in reduced resources available to support critical services to their patientsincluding those who use insulin and injectable epinephrine. These challenges would be significantly exacerbated by the multitude of demands on health centers related to the COVID-19 pandemic. HHS is seeking public comment on this notice of proposed rulemaking (NPRM). As Executive Order 13937 remains in effect, should the final rule be rescinded, other implementation approaches will be considered to effectuate the Executive Order.
Temporary Suspension of Dogs Entering the United States From High-Risk Rabies Countries
Document Number: 2021-12418
Type: Notice
Date: 2021-06-16
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) announces a temporary suspension in the importation of dogs from high-risk rabies-enzootic countries (hereinafter referred to as high-risk country or countries) into the United States. Due to the unprecedented global response to the Coronavirus Disease 2019 (COVID-19) pandemic and limited availability of public health resources at the Federal, state, and local level, this action is necessary to protect the public health against the reintroduction of canine rabies virus variant (CRVV) into the United States and to ensure the welfare of dogs being imported into the U.S. This suspension, with limited exceptions, includes dogs imported from low-risk or CRVV-free countries if the dogs have been in any high-risk countries during the previous six months.
Advisory Committee on Immunization Practices (ACIP)
Document Number: 2021-12578
Type: Notice
Date: 2021-06-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. The meeting will be webcast live via the World Wide Web. Time will be available for public comment.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-12572
Type: Notice
Date: 2021-06-15
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meetings
Document Number: 2021-12571
Type: Notice
Date: 2021-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Lederle Laboratories et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications; Correction
Document Number: 2021-12557
Type: Notice
Date: 2021-06-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on May 12, 2021. The document announced the withdrawal of approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of June 11, 2021. The document indicated that FDA was withdrawing the approval of ANDA 060164, Nystatin Ointment, held by Lederle Laboratories. However, the document published with an incorrect application number for this product. This document corrects that error.
National Cancer Institute; Notice of Meeting
Document Number: 2021-12511
Type: Notice
Date: 2021-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-12510
Type: Notice
Date: 2021-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport
Document Number: 2021-12505
Type: Notice
Date: 2021-06-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting exemption from the premarket notification requirements for the generic device type, powered patient transport, all other powered patient transport. These devices are motorized devices used to mitigate mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs. This device type does not include motorized three-wheeled vehicles or wheelchairs, and is distinct from the device type, powered patient transport, powered patient stairway chair lifts, which is classified separately within the same regulation. FDA is publishing this notice to obtain comments in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Evaluation of Study Data Exchange Standards for Submission of Study Data to the Center for Veterinary Medicine; Request for Comments
Document Number: 2021-12503
Type: Notice
Date: 2021-06-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is soliciting comments on the use of study data exchange standards from persons involved in study conduct, data collection, data management, and submission of animal study data intended to support the approval of new animal drug applications, abbreviated new animal drug applications, or applications for conditional approval.
Proposed Information Collection Activity; Tribal Maternal, Infant, and Early Childhood Home Visiting Program: Guidance for Submitting an Annual Report to the Secretary (OMB #0970-0409)
Document Number: 2021-12464
Type: Notice
Date: 2021-06-15
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Child Care (OCC) is requesting a 3-year extension of the Tribal Maternal, Infant, and Early Childhood Home Visiting (MIECHV) Program: Guidance for Submitting an Annual Report to the Secretary (OMB #0970- 0409; expiration 9/30/2021). There are minor updates to the annual guidance which reflects a change in timing for the due date of the final report.
Medicare Program; Virtual Public Meetings in July 2021 for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Code Set
Document Number: 2021-12453
Type: Notice
Date: 2021-06-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the dates and times of virtual Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in July 2021 to discuss our preliminary coding recommendations for new revisions to the HCPCS Level II code set.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2021-12451
Type: Notice
Date: 2021-06-15
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2021-12415
Type: Notice
Date: 2021-06-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2021-12414
Type: Notice
Date: 2021-06-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2021-12413
Type: Notice
Date: 2021-06-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2021-12412
Type: Notice
Date: 2021-06-14
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; Small Health Care Provider Quality Improvement Program, OMB No. 0915-0387-Extension
Document Number: 2021-12381
Type: Notice
Date: 2021-06-14
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with of 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.
Office of the Director; Notice of Charter Renewal
Document Number: 2021-12380
Type: Notice
Date: 2021-06-14
Agency: Department of Health and Human Services, National Institutes of Health
Senior Executive Service Performance Review Board
Document Number: 2021-12366
Type: Notice
Date: 2021-06-14
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA, an operating division of HHS, is publishing a list of individuals who may be named to serve on the Senior Executive Service Performance Review Board that oversees the evaluation of performance appraisals for Senior Executive Service members for the Fiscal Years 2021 and 2022.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-12365
Type: Notice
Date: 2021-06-14
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.
Meeting of the COVID-19 Health Equity Task Force
Document Number: 2021-12320
Type: Notice
Date: 2021-06-11
Agency: Department of Health and Human Services
As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the COVID-19 Health Equity Task Force (Task Force) will hold a virtual meeting on June 25, 2021. The purpose of this meeting is to consider interim recommendations addressing the inequities and the impact of long-COVID or Post-Acute Sequelae of SARS-CoV-2 infection (PASC), and access to personal protection equipment, testing, and therapeutics that are related to this pandemic. This meeting is open to the public and will be live-streamed at www.hhs.gov/live. Information about the meeting will be posted on the HHS Office of Minority Health website: www.minorityhealth.hhs.gov/healthequitytaskforce/ prior to the meeting.
Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available as Over-the-Counter; Guidance for Industry; Availability
Document Number: 2021-12297
Type: Notice
Date: 2021-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance for industry (GFI) #263 entitled ``Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to Be Available as Over-the-Counter.'' This guidance document provides information to sponsors of medically important antimicrobial new animal drug products who are interested in changing the approved marketing status of these products from over-the-counter (OTC) to by veterinary prescription (Rx) consistent with FDA's recommendation that the use of such drugs in animals be limited to uses that include veterinary oversight to mitigate development of antimicrobial resistance. It also establishes timelines for stakeholders wishing to comply voluntarily with this guidance.
Determination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO; Correction
Document Number: 2021-12284
Type: Notice
Date: 2021-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) published a notice in the Federal Register of February 12, 2018. After review of a timely request for reconsideration by the applicant of the determination of the regulatory review period of the animal drug, BRAVECTO, in that notice, FDA has determined that a revision of the SUPPLEMENTARY INFORMATION section is warranted. This document presents the revised regulatory review period.
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2021-12266
Type: Notice
Date: 2021-06-11
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 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Disclosures to Healthcare Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug
Document Number: 2021-12265
Type: Notice
Date: 2021-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, 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 (PRA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites
Document Number: 2021-12264
Type: Notice
Date: 2021-06-11
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed study entitled ``Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug websites.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federal Import Milk Act
Document Number: 2021-12263
Type: Notice
Date: 2021-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
Document Number: 2021-12259
Type: Notice
Date: 2021-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
Document Number: 2021-12256
Type: Notice
Date: 2021-06-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) 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.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2021-12235
Type: Notice
Date: 2021-06-11
Agency: Department of Health and Human Services, National Institutes of Health