Department of Health and Human Services February 2022 – 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 (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.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $1,000,000 for Year 1 of funding to the Servicos Provinciais de Sa[uacute]de de Inhambane (SPS Inhambane), Mozambique. The award will strengthen the institutional capacity of SPS Inhambane to plan, coordinate, and supervise HIV-related activities to contribute to accelerated progress towards the 95-95-95 goals (95% of HIV-positive individuals knowing their status, 95% of those receiving ART [Antiretroviral therapy], and 95% of those achieving viral suppression) and ensure sustainable control of the epidemic in Mozambique. Funding amounts for years 2-5 will be set at continuation.

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 Homeless Service Providers Knowledge, Attitudes, and Practices Regarding Body Lice, Fleas and Associated Diseases. This proposed study is designed to improve CDC's understanding of homeless service providers knowledge, attitudes, and practices regarding vector-borne diseases that can affect persons experiencing homelessness.

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.

The Food and Drug Administration (FDA, Agency, or we) is classifying the integrated continuous glucose monitoring system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the integrated continuous glucose monitoring system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

The Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting an extension with minor changes to the approved information collection: Regional Partnership Grants National Cross-Site Evaluation and Evaluation Technical Assistance (OMB #0970-0527). The proposed information collection will be used in a national cross-site evaluation of the fifth and sixth cohorts of CB's Regional Partnership Grants (RPG). The cross-site evaluation will use surveys, interviews, progress reports, and data on participant enrollment, services, and outcomes.

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 certain Center for Devices and Radiological Health (CDRH) appeals processes.

The Office of Community Services (OCS), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting an extension of approval for an information request to collect data from Low Income Household Water Assistance Program (LIHWAP) grant recipients. This information collection was originally approved for 6 months as an emergency approval. OCS is proposing revisions to the information collection based on feedback received to date.

The Department of Health and Human Services (HHS or Department) is issuing this final rule to make effective the exemptions that were previously proposed for a subset of records covered in a new Privacy Act system of records, No. 09-25-0165, NIH Loan Repayment Records, which is maintained by the National Institutes of Health (NIH). The system of records covers records used to manage and evaluate the Loan Repayment Programs (LRPs) at NIH. The exemptions are necessary to maintain the integrity of the NIH peer review and award processes by enabling NIH to protect the identities of reviewers.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, Office of Policy and Extramural Research Administration (OPERA), Office of Extramural Research (OER) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA, the 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.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Peripheral and Central Nervous System 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.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that SPIKEVAX (COVID-19 Vaccine, mRNA), meets the criteria for a material threat priority review voucher, which has been issued to ModernaTX, Inc., the holder of the biologics license application.

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.

The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2022. This notice is issued under the Controlled Substances Act (CSA).