Department of Health and Human Services September 3, 2021 – Federal Register Recent Federal Regulation Documents

Federal Licensing of Office of Refugee Resettlement Facilities Request for Information
Document Number: 2021-19263
Type: Notice
Date: 2021-09-03
Agency: Department of Health and Human Services
The Unaccompanied Children (UC) Program is responsible for the administration of childcare facilities throughout the country that care for unaccompanied children arriving in the United States prior to those children being placed with viable sponsors in the United States. To inform a strategic and impactful plan for the administration of these facilities HHS is issuing this Request for Information (RFI). The RFI solicits specific input regarding options for a Federal licensure process to ensure continued program operations.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-19142
Type: Notice
Date: 2021-09-03
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 Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
Document Number: 2021-19116
Type: Notice
Date: 2021-09-03
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; Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form FDA 3601a
Document Number: 2021-19113
Type: Notice
Date: 2021-09-03
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.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-19110
Type: Notice
Date: 2021-09-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health: Notice of Closed Meetings
Document Number: 2021-19109
Type: Notice
Date: 2021-09-03
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Committee; National Mammography Quality Assurance Advisory Committee; Renewal
Document Number: 2021-19108
Type: Notice
Date: 2021-09-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the National Mammography Quality Assurance Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the National Mammography Quality Assurance Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until July 7, 2023, expiration date.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2021-19105
Type: Notice
Date: 2021-09-03
Agency: Department of Health and Human Services, National Institutes of Health
``Ruby Chocolate'' Deviating From Identity Standard; Temporary Permit for Market Testing
Document Number: 2021-19096
Type: Notice
Date: 2021-09-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the extension of a temporary permit issued to Barry Callebaut U.S.A. LLC (the applicant) to market test products (designated as ``ruby chocolate'') that deviate from the U.S. standards of identity for cacao products. The extension allows the applicant to continue to evaluate commercial viability of the product and to collect data on consumer acceptance of the product in support of a petition to establish a standard of identity for ``ruby chocolate.'' We also invite other interested parties to participate in the market test.
Humanitarian Exemption Approved for All Afghan Evacuees Subject to CDC's Global Testing Order
Document Number: 2021-19089
Type: Notice
Date: 2021-09-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces a blanket humanitarian exemption to the agency's Requirement for Negative Pre-Departure COVID-19 Test Result for individuals relocating to the United States from Afghanistan, including U.S. citizens, lawful permanent residents (LPRs), third country nationals, and Afghans at risk, including Afghan Special Immigrant Visa (SIV) applicants.
Agency Information Collection Activities; Proposed Collection; Comment Request; Drug Supply Chain Security Act Implementation
Document Number: 2021-19061
Type: Notice
Date: 2021-09-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Notice of Award of Single-Source Cooperative Agreements To Fund the Council of Medical Specialty Societies (CMSS) and the Society for Post-Acute and Long-Term Care Medicine (AMDA)
Document Number: 2021-19050
Type: Notice
Date: 2021-09-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the award of approximately $26,000,000 in COVID-19 funding to the Council of Medical Specialty Societies (CMSS) and the Society for Post-Acute and Long-Term Care Medicine (AMDA) to address the need to incorporate adult vaccination into the standard of care for subspecialty providers, including occupational health and long term care (LTC), and improve adult vaccination rates.
Meetings of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
Document Number: 2021-19027
Type: Notice
Date: 2021-09-03
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that two meetings are scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meetings will be open to the public via WebEx and teleconference; a pre-registered public comment session will be held during both meetings. Pre-registration is required for members of the public who wish to attend the meetings via WebEx/teleconference. Individuals who wish to send in their written public comment should send an email to CARB@hhs.gov. Registration information is available on the website http://www.hhs.gov/paccarb and must be completed by October 1, 2021 for the October 6, 2021 virtual Public Meeting; and, by November 29, 2021 for the November 30-December 1, 2021 virtual Public Meeting. Additional information about registering for the meeting and providing public comment can be obtained at http://www.hhs.gov/paccarb on the Upcoming Meetings page.
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
Document Number: 2021-19026
Type: Notice
Date: 2021-09-03
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a virtual meeting. The meeting will be open to the public. The committee will discuss and vote on recommendations to improve the supply chain and data infrastructure that supports the blood industry, especially during public health emergencies. This meeting will build upon the presentations and discussions held during the 53rd ACBTSA meeting from August 17-18, 2021.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-19024
Type: Notice
Date: 2021-09-03
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 Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.