Department of Health and Human Services March 2020 – 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 Food and Drug Administration (FDA, the Agency, or we) is revising chapter I of its regulations. These revisions are necessary to reflect changes to the Agency's organizational structure, including the reorganization of the Office of Regulatory Affairs. The revisions replace references to the District Director with references to the Division Director and make other related changes. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

The Office of the Assistant Secretary for Health in the Department of Health and Human Services seeks public comment regarding Section 209 of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act. Congress passed the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA) in June 2019. Section 209 of this legislation states that the Secretary of Health and Human Services shall submit to Congress a report containing recommendations related to maintaining an adequate national blood supply. The legislation poses four specific questions regarding the adequacy of the national blood supply. HHS welcomes any public feedback related to how these questions should be addressed and/or potential solutions. The set of questions is available in the SUPPLEMENTARY INFORMATION section below.

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, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the type of information recommended for a Pre-Request for Designation (Pre-RFD) submission.

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 Disease Surveillance ProgramII. Disease Summaries information collection. This collection is used to determine the prevalence of disease and for planning and evaluating programs for prevention and control of infectious diseases.

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Submission of Plans for Cigarette Packages and Cigarette Advertisements.'' This guidance is intended to assist those required to submit cigarette plans for cigarette packages and cigarette advertisements by providing content, timing, and other recommendations related to those submissions.

Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) has reorganized the Administration on Children, Youth and Families (ACYF). The reorganization has no impact on existing delegations of authority. The reorganization within the ACYF Office of the Commissioner amends the functions of the Office of Management Services and creates the Office of Budget. Within the Children's Bureau (CB), it creates the Division of Performance Measurement and Improvement. It removes the Office of Data Analysis, Research and Evaluation from the Office of the Commissioner and transfers the functions to the Division of Performance Measurement and Improvement. Within the Family and Youth Services Bureau (FYSB), it renames the Division of Adolescent Development and Support to the Division for Optimal Adolescent Development and elevates the Runaway Homeless Youth office to the Division of Runaway and Homeless Youth. It also creates the Division of Evaluation, Data and Policy. Lastly, it renames the Division of Family Violence Prevention to the Division of Family Violence Prevention and Services.

The Advisory Committee on Organ Transplantation (ACOT) meeting will be held by webinar and conference call, rather than in-person as previously announced, due to unforeseen circumstances. The webinar link, conference call-in number, registration information, and meeting materials can be accessed through the registration link posted on the ACOT website at https://www.organdonor.gov/about-dot/acot/ meetings.html.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Stephen Kalinoski from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Kalinoski was convicted of a felony for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Kalinoski was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Kalinoski failed to respond. Mr. Kalinoski's failure to request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice entitled ``Development of a Shared System REMS; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of June 1, 2018. The Agency is taking this action to allow interested persons additional time to submit comments.

The Department of Health and Human Services has received an extension to the deadline to comply with Executive Order 13891: Promoting the Rule of Law Through Improved Agency Guidance Documents. Executive Order 13891, through Subsections (a) and (b), requires the establishment of a new guidance portal and the rescission of any guidance documents that are not included in it, respectively. The Office of Management and Budget (OMB), through its implementing memorandum (https://www.whitehouse.gov/wp-content/uploads/2019/10/M-20- 02-Guidance-Memo.pdf), has determined the deadlines for these subsections to be February 28, 2020. OMB granted the Department of Health and Human Services an extension for subsections (a) and (b) on February 27, 2020. The Department will establish its guidance portal by August 31, 2020. A full copy of the extension letter can be found on the HHS website at, https://www.hhs.gov/regulations/.