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

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the National Mammography Quality Assurance Advisory Committee in the Center for Devices and Radiological Health. Nominations will be accepted for upcoming vacancies effective with this notice. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee (MDAC or Committee) in the Center for Devices and Radiological Health (CDRH) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device panels of the MDAC in the CDRH. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current and upcoming vacancies effective with this notice.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment.'' There is pharmaceutical and stakeholder interest in the development of new drugs for patients with IC/BPS. This draft guidance provides FDA's recommendations for clinical trials intended to establish clinical effectiveness and safety for drugs intended to treat IC/BPS.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LUXTURNA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 biological product.

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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's regulations regarding current good manufacturing practice (CGMP) for dietary supplements.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. This notice is being published less than 15 days prior to the date of the meeting. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The National Institute of Mental Health (NIMH) is updating its Strategic Plan for Research to guide the Institute's research efforts and priorities over the next five years. The purpose of this Notice is to seek comments from the public about the draft 2020 NIMH Strategic Plan for Research. The draft Strategic Plan will be publicly available via https://www.nimh.nih.gov/about/strategic-planning-reports/202 0- draft-strategic-plan.pdf for a 30-day period beginning on the publication of this Notice. The public is invited to provide comments.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain public comment to identify topics of public health importance that will form the basis of Community Preventive Services Task Force (CPSTF) evidence-based recommendations. CDC will use this information to support the CPSTF in its selection of priority topics to guide its work over the next five years. This docket will provide the opportunity to expand the current body of knowledge and identify important evidence gaps.

The Health Information Technology Advisory Committee (HITAC) was established in accordance with section 4003(e) of the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2020. See list of public meetings below.

This document corrects errors that appeared in the notice published in the November 14, 2019, Federal Register entitled ``Findings of Research Misconduct.''

The Expert Panel Working Group of the NHLBI National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC) is soliciting comments and suggestions from the public on ``Update on Selected Topics in Asthma Management 2020: A Report from the Expert Panel Report-4 (EPR-4) Working Group.'' This Request for Information (RFI) invites the scientific community, health professionals, organizations, patient communities, and the general public to provide comments and suggestions, including particular emphasis on the feasibility, acceptability, and capacity for implementation, of the proposed recommendations and implementation guidance. Responses to this RFI will be used to update and revise the report as necessary.

The Administration for Children and Families (ACF) is requesting a three-year extension of the previously approved forms that include satisfaction surveys; surveys to assess jurisdiction's foundational capacity; a workshop follow-up survey; webinar and online learning registration forms; and service-specific feedback forms and interview protocol (OMB Number: 0970-0494, expiration March 31, 2020). This request includes one new innovation survey, and requests minor changes to the webinar and online learning registration forms. Three instruments from the original approval are not included with this request. This requested extension relates to a second set of instruments, which are part of a larger data collection effort being conducted for the evaluation of the Child Welfare Capacity Building Collaborative. An extension request for the first group of evaluation instruments was submitted on April 24, 2019, (OMB Number: 0970-0484, FR, 84(79)).

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 21 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA or we) is announcing that Alzchem Trostberg GmbH has filed a petition proposing that the food additive regulations be amended to provide for the safe use of guanidinoacetic acid as a precursor of creatine in poultry feeds.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https:// www.samhsa.gov/workplace.

This notice announces the 2020 meetings of the Physician- Focused Payment Model Technical Advisory Committee (PTAC). These meetings will include deliberation and voting on proposals for physician-focused payment models (PFPMs) submitted by individuals and stakeholder entities. All meetings are open to the public.

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.