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

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.

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.

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.

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.

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).

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.

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.

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.

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.