Department of Health and Human Services October 5, 2017 – Federal Register Recent Federal Regulation Documents

The Office of Disease Prevention and Health Promotion (ODPHP) is hosting a listening session titled, ``Partnering to Prevent Hypoglycemia.'' The purpose of this listening session is to exchange information about the public health importance of hypoglycemia, and discuss federal efforts to reduce preventable hypoglycemia from diabetes medications. The Department of Health and Human Services invites public and private professionals, organizations, and consumer representatives to register to attend this listening session at https://health.gov/news/.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry #236 entitled ``Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products.'' This guidance provides information regarding regulatory oversight of mosquito-related products, defined as those articles for use in or on mosquitoes. We are clarifying circumstances under which such products are regulated by the Food and Drug Administration (FDA) as new animal drugs under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and other circumstances under which such products are regulated by the Environmental Protection Agency (EPA) as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

In compliance with 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.

The Food and Drug Administration (FDA, the Agency, or we) is announcing a forthcoming public meeting entitled ``Animal Drug User Fee Act.'' The topic to be discussed is proposed recommendations for the reauthorization of the Animal Drug User Fee Act (ADUFA IV). The meeting will be open to the public.

The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The purpose of this public meeting is to provide information and solicit public input on the current activities of ICH as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Geneva, Switzerland, scheduled for November 11 through 16, 2017. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting in Geneva.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TECFIDERA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR). This meeting is open to the public, limited in the room by 60 people and 75 lines over the phone. The public is also welcome to listen to the meeting by 1-888-790-2009, passcode: 7865774, with 75 lines. The deadline for notification of attendance is November 10, 2017. The public comment period is scheduled on Wednesday, November 15, 2017 from 2:00 p.m. until 2:15 p.m.; and from 3:25 p.m. until 3:40 p.m. EST, and on Thursday, November 16, 2017 from 10:10 a.m. until 10:25 a.m. EST. Individuals wishing to make a comment during Public Comment period, please email your name, organization, and phone number by November 6, 2017 to William Cibulas at wic1@cdc.gov.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the October meeting, the Advisory Council will welcome its new members and invite them to share their experiences and where they see the Council going over the length of their terms. The Advisory Council will also spend some time discussing the process of developing recommendations and how those recommendations relate to the National Plan. The Council will then spend much of the meeting discussing the National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers, held on October 16-17.