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

Results 251 - 291 of 291
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-19161
Type: Notice
Date: 2021-09-07
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 HIV Prevention Capacity Development Needs Assessments of Federally funded Health Departments and Community-Based Organizations. This data collection seeks to understand the training and technical assistance needs of federally funded health departments and community-based organizations by improving the performance of the HIV prevention workforce.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2021-19160
Type: Notice
Date: 2021-09-07
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 National Wastewater Surveillance System for COVID-19. The proposed information collection project aims to collect SARS-CoV-2 wastewater and associated sewershed-level case data from participating jurisdictions in the United States to inform COVID-19 prevention and control efforts.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2021-19155
Type: Notice
Date: 2021-09-07
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-19154
Type: Notice
Date: 2021-09-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-19153
Type: Notice
Date: 2021-09-07
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2021-19152
Type: Notice
Date: 2021-09-07
Agency: Department of Health and Human Services, National Institutes of Health
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.
Privacy Act of 1974; Matching Program
Document Number: 2021-19067
Type: Notice
Date: 2021-09-02
Agency: Department of Health and Human Services, Administration for Children and Families
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services, Administration for Children and Families, Office of Planning, Research, and Evaluation (HHS/ACF/ OPRE), is providing notice of a re-established matching program between the Department of Defense, Defense Manpower Data Center (DoD/DMDC) and State Public Assistance Agencies (SPAAs), ``Verification of Continued Eligibility for Benefits Through the Public Assistance Reporting Information System (PARIS) Program.'' HHS/ACF/OPRE facilitates the matching program.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-19012
Type: Notice
Date: 2021-09-02
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.
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract
Document Number: 2021-18995
Type: Rule
Date: 2021-09-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of an aqueous extract of butterfly pea flower (Clitoria ternatea) as a color additive in various food categories at levels consistent with good manufacturing practice. We are taking this action in response to a color additive petition (CAP) submitted by Exponent, Inc., on behalf of Sensient Colors, LLC (Sensient).
Food and Drug Administration; Delegation of Authority
Document Number: 2021-18985
Type: Notice
Date: 2021-09-02
Agency: Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-18980
Type: Notice
Date: 2021-09-02
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 and Oral Fluid Drug Testing for Federal Agencies
Document Number: 2021-18974
Type: Notice
Date: 2021-09-02
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).
Proposal To Refuse To Approve a New Drug Application for ITCA 650 (Exenatide in DUROS Device); Opportunity for a Hearing
Document Number: 2021-18928
Type: Notice
Date: 2021-09-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Director of the Center for Drug Evaluation and Research (Center Director) at the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a new drug application (NDA) submitted by Intarcia Therapeutics, Inc. (Intarcia), for ITCA 650 (exenatide in DUROS device) in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Intarcia an opportunity to request a hearing on the matter.
Submission for OMB Review; Head Start REACH: Strengthening Outreach, Recruitment, and Engagement Approaches With Families (New Collection)
Document Number: 2021-18917
Type: Notice
Date: 2021-09-01
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is proposing to collect data on different approaches that Head Start programs use for the recruitment, selection, enrollment, and retention (RSER) of families facing adversities and the community organizations with which it partners to support these activities. This study aims to present an internally valid description of RSER approaches used by six purposively selected programs, not to promote statistical generalization to different sites or service populations.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-18916
Type: Notice
Date: 2021-09-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2021-18915
Type: Notice
Date: 2021-09-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2021-18892
Type: Notice
Date: 2021-09-01
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 Psychopharmacologic 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.
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2021-18886
Type: Notice
Date: 2021-09-01
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 Request. 30-Day Public Comment Request
Document Number: 2021-18871
Type: Notice
Date: 2021-09-01
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.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2021-18860
Type: Notice
Date: 2021-09-01
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2021-18859
Type: Notice
Date: 2021-09-01
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: 2021-18854
Type: Notice
Date: 2021-09-01
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2021-18845
Type: Notice
Date: 2021-09-01
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2021-18841
Type: Notice
Date: 2021-09-01
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; 30-Day Comment Request Electronic Individual Development Plan (eIDP) (National Eye Institute); Correction
Document Number: 2021-18812
Type: Notice
Date: 2021-09-01
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on August 26, 2021. That Notice requires a correction in the SUPPLEMENTARY INFORMATION section.
Meeting of the National Vaccine Advisory Committee
Document Number: 2021-18809
Type: Notice
Date: 2021-09-01
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 the National Vaccine Advisory Committee (NVAC) will hold a virtual meeting. The meeting will be open to the public and public comment will be heard during the meeting.