Department of Health and Human Services July 29, 2021 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2021-16205
Type: Notice
Date: 2021-07-29
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: 2021-16202
Type: Notice
Date: 2021-07-29
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: 2021-16200
Type: Notice
Date: 2021-07-29
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; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types
Document Number: 2021-16199
Type: Notice
Date: 2021-07-29
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.
Proposed Substances To Be Evaluated for Toxicological Profile Development
Document Number: 2021-16195
Type: Notice
Date: 2021-07-29
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR) within the Department of Health and Human Services is initiating the development of another set of Toxicological Profiles. This notice solicits public nominations of substances for ATSDR to evaluate for Toxicological Profile development. ATSDR will consider nominations from the Substance Priority List found at www.atsdr.cdc.gov/SPL/. ATSDR also accepts nominations for substances not on the Substance Priority List (SPL) that may have public health implications, on the basis of ATSDR's authority to prepare Toxicological Profiles for substances not found at sites on the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) National Priorities List (see CERCLA Section 104(i)(1)(B); 42 U.S.C. 9604(i)(1)(B)). For more information on the CERCLA National Priorities List, visit www.epa.gov/superfund/ superfund-national-priorities-list-npl. The agency accepts these nominations in order to establish and maintain an inventory of literature, research, and studies on the health effects of toxic substances, to respond to requests for consultation, and to support the site-specific response actions conducted by ATSDR, as otherwise necessary.
Agency Information Collection Activities; Proposed Collection; Comment Request; Pilot Survey To Develop Standardized Reporting Forms for Federally Funded Public Health Projects
Document Number: 2021-16192
Type: Notice
Date: 2021-07-29
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, 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 a pilot survey to develop standardized reporting forms for capturing performance data for federally funded public health projects.
The National Institutes of Health (NIH) Scientific Workshop on Violence & Related Health Outcomes in Sexual & Gender Minority Communities Open Session
Document Number: 2021-16190
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) will hold the Phase IV open session for the NIH Scientific Workshop on Violence and Related Health Outcomes in Sexual and Gender Minority (SGM) Communities to enhance our understanding of violence against SGM individuals and identify opportunities in violence-related research. The primary objectives of NIH's Phase IV meeting are: (1) To allow the public to participate, and (2) to further refine research opportunities.
Availability of Six Draft Toxicological Profiles
Document Number: 2021-16188
Type: Notice
Date: 2021-07-29
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comments on drafts of six updated Toxicological Profiles: Acetone, Aldrin/Dieldrin, Chlorophenols, 3,3- Dichlorobenzidine, Disulfoton, and Pentachlorophenol.
Electronic Study Data Submission; Data Standards; Technical Rejection Criteria for Study Data Effective Date
Document Number: 2021-16187
Type: Notice
Date: 2021-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA or Agency) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the effective date for Electronic Common Technical Document (eCTD) validations referenced in FDA's ``Technical Rejection Criteria for Study Data'' (TRC).
Actavis Elizabeth LLC, et al.; Withdrawal of Approval of 85 Abbreviated New Drug Applications
Document Number: 2021-16178
Type: Notice
Date: 2021-07-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 85 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis; Draft Guidance for Industry; Availability
Document Number: 2021-16175
Type: Notice
Date: 2021-07-29
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 ``Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis.'' The purpose of this draft guidance is to help sponsors in the development of anti-rabies virus monoclonal antibody (mAb) cocktails as an alternative to anti-rabies virus immunoglobulin (RIG) as the passive immunization component of post-exposure prophylaxis (PEP) for the prevention of rabies when given immediately after contact with a rabid or possibly rabid animal.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2021-16162
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2021-16161
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2021-16160
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2021-16159
Type: Notice
Date: 2021-07-29
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; Public Comment Request; State Annual Long-Term Care Ombudsman Report-National Ombudsman Reporting System; OMB #0985-0005
Document Number: 2021-16132
Type: Notice
Date: 2021-07-29
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 section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the State Annual Long-Term Care Ombudsman Report-National Ombudsman Reporting System [OMB #0985-0005].
Notice of Federal Review of the Missouri Protection and Advocacy System (P&A)
Document Number: 2021-16131
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services
Representatives of the Administration on Disabilities (AoD), Administration for Community Living (ACL), will be conducting a federal review of the Missouri Protection and Advocacy System (P&A) on September 13-17, 2021. AoD is soliciting comments from interested parties on your experiences with the program, and strategies employed by P&A in meeting the needs of individuals with developmental disabilities and their families in Missouri. You are encouraged to share your experiences by way of email or telephone.
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
Document Number: 2021-16120
Type: Notice
Date: 2021-07-29
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 recommendations to improve the supply chain and data infrastructure that supports the blood industry, especially during public health emergencies. To facilitate this discussion, key stakeholders from across the nation and around the world will present on hemovigilance, preparedness, inventory management systems and other relevant issues.
Workshop on Exploring the Science Surrounding the Safe Use of Bioactive Ingredients in Infant Formula: Considerations for an Assessment Framework
Document Number: 2021-16118
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services, National Institutes of Health
This 2-day, virtual workshopExploring the Science Surrounding the Safe Use of Bioactive Ingredients in Infant Formula: Considerations for an Assessment Frameworkfocuses on the functional state-of-the-science of biologically active human milk components and analogs and the implications for safety assessments when used in infant formula.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2021-16112
Type: Notice
Date: 2021-07-29
Agency: Department of Health and Human Services, National Institutes of Health