Department of Health and Human Services March 18, 2020 – Federal Register Recent Federal Regulation Documents

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/.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting expedited review of an information collection request from the Office of Management and Budget (OMB) and inviting public comments on the proposed revisions. The request consists of the addition of questions to the Medical Complaint Form to track instances of COVID-19.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting expedited review of an information collection request from the Office of Management and Budget (OMB) and inviting public comments on the proposed revisions. The request consists of the addition of questions to the Initial Medical Exam Form to track instances of COVID-19.

For the ``Opioid Management in Older Adults'' project, AHRQ is seeking to identify innovative approaches to managing opioid medications for chronic pain that are particularly relevant for older adults. Use of long-term opioid therapy in older adults can be especially problematic because of increased risks such as delirium, falls, and dementia.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Michael P. Casey for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Casey was convicted, as defined in the FD&C Act, of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Casey was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of November 4, 2019 (30 days after receipt of the notice), Mr. Casey has not responded. Mr. Casey's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to establish new cigarette health warnings for cigarette packages and advertisements. The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning label statements. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) of 1965 to require each cigarette package and advertisement to bear one of the new required warnings. The final rule specifies the 11 new textual warning label statements and accompanying color graphics. FDA is taking this action to promote greater public understanding of the negative health consequences of cigarette smoking.