Department of Health and Human Services September 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``A New Era of Smarter Food Safety'' to get input from a broad cross-section of stakeholders on a modern approach the Agency is taking to strengthen its protection of the food supply. The purpose of this meeting is to foster a dialogue with our domestic and international regulatory and public health partners, industry, consumers, academia, and others. The input received at this meeting, and in comments submitted to the docket, will be used to shape an FDA Blueprint for a New Era of Smarter Food Safety. This Blueprint will outline how this modern approach will address public health challenges, ranging from being able to trace sources of contaminated foods, to using new predictive analytics tools like artificial intelligence to assess risks, and help prioritize the Agency's work and resources.

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) announces the launch of the REACH Lark Galloway-Gilliam Nomination for Advancing Health Equity Award (REACH Lark Award). Racial and ethnic disparities in health remain pervasive across the United States. Over the last 20 years, the Racial and Ethnic Approaches to Community Health (REACH) program has demonstrated success in addressing these disparities and promoting health equity by engaging with diverse communities and implementing culturally tailored interventions. For more information about the REACH Program, visit https://www.cdc.gov/nccdphp/dnpao/state- local-programs/reach/index.htm. This award honors extraordinary individuals, organizations, or community coalitions associated with the REACH program that have made significant advances in the science and/or practice of improving health equity, and the elimination of health disparities at the national, state, or local levels. The intent of the challenge is to recognize efforts made by individuals or teams that meaningfully engage communities to remove barriers to health by addressing factors such as race, ethnicity, education, income, location, and other social determinants of health. To support the science and practice of improving health equity, this challenge can help further the goals of the REACH program by documenting and further disseminating the innovative or unique interventions that led to reduced health disparities achieved by those applying for this award.

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 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 ``Assessment of Potential Exposure from Private Wells for Drinking Water.'' The goal of this generic clearance information collection request is to expedite investigations to assess private well water for drinking in response to specific investigation requests.

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Reconditioning of Fish and Fishery Products by Segregation.'' The draft guidance, when finalized, will provide industry with an explanation of two potential approaches to recondition fish and fishery products by effectively segregating adulterated portions of an article from portions not containing the adulterant to ensure that only safe and wholesome product reaches consumers.

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 proposing to amend the requirements that specify the analytical method FDA uses to determine the concentration of sulfites in food. This action, if finalized, would, among other things, provide a new analytical method that can be used as an alternative to the existing analytical method and should improve the efficiency of FDA testing for sulfites in food.

The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting exemption from the premarket notification requirements for powered wheeled stretchers. These devices are battery-powered tables with wheels that are intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions). FDA is publishing this notice to obtain comments in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance of Senior Executive Service (SES) members, Title 42 (T42) executives, and Senior Level (SL) employees for Fiscal Year 2019.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a telephone conference call. This call will be open to the public. Preregistration is required for both public participation and comment. Any individual who wishes to participate in the call should email OMH-ACMH@hhs.gov by September 25, 2019. Information about the meeting is available from the designated contact person noted below and will be posted on the website for the Office of Minority Health (OMH): www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH website under the heading About OMH.

The Food and Drug Administration (FDA or Agency) is withdrawing the approval of abbreviated new drug application (ANDA) 077895 for Ursodiol Capsules USP, 300 milligrams (mg), held by Impax Laboratories, LLC (Impax). Impax requested withdrawal of this application and has waived its opportunity for a hearing.

This notice announces the issuance of the August 2, 2019 single-source funding opportunity titled ``Drug Vial Size Report'' available solely to the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine [the Academies] to conduct a study on the Federal healthcare costs, safety, and quality concerns associated with discarded drugs that results from weight-based dosing of medicines contained in single dose vials as stated in Senate report 114-274.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services (HHS), is publishing the following summary of a proposed collection for public comment.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC)/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC) has scheduled a public meeting. Information about CHAC can be found on the CHAC website at https://www.cdc.gov/maso/facm/ facmCHACHSPT.html. Meeting information and the agenda can be found at https://www.chachspt.com.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Science Board to the Food and Drug Administration. The Science Board provides advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments including in regulatory science, input into the Agency's research agenda, and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency sponsored intramural and extramural scientific research programs. The meeting will be open to the public.