Department of Health and Human Services July 1, 2021 – Federal Register Recent Federal Regulation Documents

Request for Information: Inviting Comments To Inform the Women's Health Consensus Conference (WHCC)
Document Number: 2021-14151
Type: Notice
Date: 2021-07-01
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) Office of Research on Women's Health (ORWH) is planning a Women's Health Consensus Conference (WHCC) in October 2021, in response to a Congressional request to address NIH research efforts related to women's health research as well as the following specific conditions, rising maternal morbidity and mortality rates, increasing rates of chronic debilitating conditions in women, and stagnant cervical cancer survival rates. The ORWH is seeking comments and testimonies from the extramural scientific community, professional societies, and the general public regarding the topics mentioned above to assist with identifying research gaps, pitfalls in clinical practices, and obtaining real-life testimonial experiences (direct or indirect) caused by any or all of the listed public health issues.
Request for Information on Drinking Water Contaminants of Emerging Concern for the National Emerging Contaminant Research Initiative; Reopening of Comment Period
Document Number: 2021-14150
Type: Notice
Date: 2021-07-01
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS), on behalf of the Office of Science and Technology Policy (OSTP), published a Notice in the Federal Register on May 25, 2021, requesting input from all interested parties on research needed to identify, analyze, monitor, and mitigate drinking water contaminants of emerging concern (DW CECs). Comments provided through this Request for Information (RFI) will inform the development of a National Emerging Contaminant Research Initiative (NECRI). The NECRI will be the precursor to Federal coordination of DW CEC research; and agencies will publish external grant solicitations that align with the goals of the NECRI. The purpose of this Notice is to provide a reopening of the comment period for an additional 30 days to provide more time to receive comments by interested parties.
Government-Owned Inventions; Availability for Licensing
Document Number: 2021-14129
Type: Notice
Date: 2021-07-01
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Prospective Grant of Exclusive License, Inter-Institutional Agreement-Institution Lead: Biomarkers and Immunogenic Compositions for Filarial Parasites
Document Number: 2021-14128
Type: Notice
Date: 2021-07-01
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, sublicensable patent license to New York Blood Center, Inc. (``NYBC''), located in New York, New York, in its rights to the technologies and patent applications listed in the Supplementary Information section of this notice.
National Advisory Committee on Individuals With Disabilities and Disasters: Establishment; Correction
Document Number: 2021-14059
Type: Notice
Date: 2021-07-01
Agency: Department of Health and Human Services
The Office of the Secretary has extended the application period for accepting application submissions from qualified individuals who wish to be considered for membership on the National Advisory Committee on Individuals with Disabilities and Disasters (NACIDD). Up to seven new voting members with expertise disability accessibility, medical disaster planning, preparedness, response, or recovery will be selected for the Committee. Please visit the NACIDD website at www.phe.gov/nacidd for all application submission information and instructions. Application submissions will be accepted until July 12, 2021.
National Advisory Committee on Seniors and Disasters: Establishment
Document Number: 2021-14053
Type: Notice
Date: 2021-07-01
Agency: Department of Health and Human Services
The Office of the Secretary has extended the application period for accepting application submissions from qualified individuals who wish to be considered for membership on the National Advisory Committee on Seniors and Disasters (NACSD). Up to seven new voting members with expertise in senior medical disaster planning, preparedness, response, or recovery will be selected for the Committee. Please visit the NACSD website at www.phe.gov/nacsd for all application submission information and instructions. Application submissions will be accepted until July 12, 2021. Application Period: The application period has been extended and will now end on July 12, 2021.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
Document Number: 2021-14044
Type: Notice
Date: 2021-07-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).
Meeting of the Substance Abuse and Mental Health Services Administration, Center for Mental Health Services National Advisory Council
Document Number: 2021-14031
Type: Notice
Date: 2021-07-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Notice is hereby given of the meeting on August 17, 2021 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 March 18, 2021, SAMHSA, CMHS NAC meeting; updates from the CMHS Director to include discussions on the Mental Health Block Grant, Certified Community Behavioral Health Clinic, and Children Services; and updates from the Office of the Assitant Secretary for Mental Health and Substance Use.
Agency Information Collection Request: 60-Day Public Comment Request
Document Number: 2021-14030
Type: Notice
Date: 2021-07-01
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-14028
Type: Notice
Date: 2021-07-01
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: 2021-14027
Type: Notice
Date: 2021-07-01
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 National Advisory Council for Healthcare Research and Quality
Document Number: 2021-14010
Type: Notice
Date: 2021-07-01
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Healthcare Infection Control Practices Advisory Committee (HICPAC) Meeting
Document Number: 2021-14008
Type: Notice
Date: 2021-07-01
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 Healthcare Infection Control Practices Advisory Committee (HICPAC). This virtual meeting is open to the public, limited only by audio and web conference lines (300 audio and web conference lines are available). Registration is required. To register for this web conference, please go to: www.cdc.gov/hicpac. All registered participants will receive the meeting link and instructions shortly before the meeting.
Advisory Committee on Immunization Practices (ACIP); Cancellation of Meeting
Document Number: 2021-14007
Type: Notice
Date: 2021-07-01
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Patient Protection and Affordable Care Act; Updating Payment Parameters, Section 1332 Waiver Implementing Regulations, and Improving Health Insurance Markets for 2022 and Beyond Proposed Rule
Document Number: 2021-13993
Type: Proposed Rule
Date: 2021-07-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Department of the Treasury
This proposed rule sets forth proposed revised 2022 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs); proposes repeal of separate billing requirements related to the collection of separate payments for the portion of QHP premiums attributable to coverage for certain abortion services; proposes to expand the annual open enrollment period and Navigator duties; proposes a new monthly special enrollment period for qualified individuals or enrollees, or the dependents of a qualified individual or enrollee, who are eligible for advance payments of the premium tax credit (APTC) and whose household income does not exceed 150 percent of the federal poverty level (FPL); proposes to repeal the recent establishment of a Direct Enrollment option for Exchanges; and proposes to modify regulations and policies related to section 1332 waivers.