Department of Health and Human Services February 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Brenda K. Marmas for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Ms. Marmas engaged in a pattern of importing or offering for import misbranded drugs (i.e., in an amount, frequency, or dosage that is inconsistent with her personal or household use) that are not designated in an authorized electronic data interchange system as products regulated by FDA. Ms. Marmas was given notice of the proposed debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of December 12, 2021 (30 days after receipt of the notice), Ms. Marmas had not responded. Ms. Marmas' failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this matter.

The Food and Drug Administration (FDA) 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 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 Department of Health and Human Services (HHS) is modifying a system of records maintained by the Office of Refugee Resettlement (ORR) within HHS' Administration for Children and Families (ACF), number 09-80-0325, titled ``Internet Refugee Arrivals Data System (iRADS),'' and is renaming it ``Refugee Arrivals Data System (RADS).'' In addition, HHS is rescinding system of records number 09-80-0329, titled ``ORR Unaccompanied Refugee Minors Records,'' as duplicative of modified system of records 09-80-0325. The modifications are explained in the SUPPLEMENTARY INFORMATION section of this notice.

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 (PRA).

In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on the National Health Service Corps (NACNHSC) will hold public meetings for the 2022 calendar year (CY). Information about NACNHSC, agendas, and materials for these meetings can be found on the NACNHSC website at: https:// www.hrsa.gov/advisory-committees/national-health-service-corp s.

On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the ``generic'' clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are ``usually voluntary, low-burden, and uncontroversial collections,'' do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. On October 23, 2011, OMB approved our initial request to use the generic clearance process under control number 0938-1148 (CMS-10398). It was last approved on April 26, 2021, via the standard PRA process which included the publication of 60- and 30-day Federal Register notices. The scope of the April 2021 umbrella accounts for Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit 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 Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 IC Revision solicits comments on the information collection requirements relating to the One Protection and Advocacy Annual Program Performance Report [OMB #0985-0063].

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 Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act.

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.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA, the Agency, or we) is proposing national standards for the licensing of prescription drug wholesale distributors (``wholesale distributors'' or ``wholesale drug distributors'') and third-party logistics providers (``3PLs''), as directed under the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality and Security Act). Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the DSCSA, the proposed rule would establish standards for all State and Federal licenses issued.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend certain prescription drug marketing regulations to reflect changes to affected provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) resulting from enactment of the Drug Supply Chain Security Act (DSCSA), Title II of the Drug Quality and Security Act (DQSA). This action, if finalized, will remove or revise outdated and conflicting regulatory requirements to align with changes to affected provisions of the FD&C Act following enactment of the DSCSA.

In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this Notice has closed.

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 Food and Drug Administration (FDA or we) is classifying the carbon dioxide gas controlled tissue expander 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 carbon dioxide gas controlled tissue expander'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.