Department of Health and Human Services September 2018 – Federal Register Recent Federal Regulation Documents

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 ``Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products.''

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 Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees 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 Anesthetic and Analgesic Drug Products 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 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 for tobacco product user fees.

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled ``Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions.'' The purpose of the meeting is to give stakeholders, including health care providers, patients, manufacturers, wholesalers, pharmacists, pharmacy benefit managers, veterinarians, public and private insurers, academic researchers, and the public, the opportunity to provide input on the underlying systemic causes of drug shortages, and make recommendations for actions to prevent or mitigate drug shortages. Members of Congress have asked the Agency to examine the root causes and drivers of these shortages, and to recommend measures that will provide more enduring solutions. To this end, the Commissioner has convened an inter-Agency task force of senior Federal officials of FDA, the Centers for Medicare & Medicaid Services, the Department of Veterans Affairs, and the Department of Defense. After receiving input from stakeholders, the task force intends to provide a report to Congress regarding the root causes of drug shortages. The report will also include recommendations regarding new authorities FDA or other Federal agencies could use to help provide enduring solutions to shortages.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the availability of the Systematic Review and Final CDC Guideline on the Diagnosis and Management of Mild Traumatic Brain Injury Among Children.

The Food and Drug Administration (FDA or the Agency) is announcing the availability for public comment of a revised draft standard memorandum of understanding (MOU) entitled ``Memorandum of Understanding Addressing Certain Distributions of Compounded Drug Products Between the State of [insert State] and the U.S. Food and Drug Administration'' (revised draft standard MOU). The revised draft standard MOU describes the responsibilities of a State that chooses to sign the MOU in investigating and responding to complaints related to compounded drug products compounded in the State and distributed outside the State and in addressing the interstate distribution of inordinate amounts of compounded drug products. FDA is also announcing the withdrawal of an earlier draft standard MOU entitled ``Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State of [insert State] and the U.S. Food and Drug Administration,'' which was issued in February 2015 (2015 draft standard MOU). The 2015 draft standard MOU is superseded by the revised draft standard MOU.

The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services announces the next meeting of the Community Preventive Services Task Force (CPSTF) on October 17- 18, 2018, in Atlanta, Georgia.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the withdrawal of the notice published under the same title on August 22, 2018 for public comment.

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 Foreign Quarantine Regulations, an information collection related to illness and death reports from airplanes and maritime vessels coming to the United States, illness and death investigations of travelers, and information from importers of certain items specified under 42 CFR 71 subpart F.

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled ``Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials.'' The draft guidance, when finalized, will advise firms that manufacturer, market, or distribute dietary supplements of FDA's intent to exercise enforcement discretion if a firm wishes to specify the amount of a live microbial in colony forming units (CFUs) in addition to the currently required unit of measure (milligrams) in the Supplement Facts label.

The U.S. Department of Homeland Security (DHS) and the Department of Health and Human Services (HHS) (``the Departments'') propose to amend regulations relating to the apprehension, processing, care, custody, and release of alien juveniles. In 1985, plaintiffs in a class action lawsuit, Flores v. Reno, challenged the policies of the legacy Immigration and Naturalization Service (INS) relating to the detention, processing, and release of alien juveniles. The parties reached a settlement agreement, referred to as the Flores Settlement Agreement (FSA). The FSA, as modified in 2001, provides that it will terminate forty-five days after publication of final regulations implementing the agreement. The rule would adopt in regulations provisions that parallel the relevant and substantive terms of the FSA, consistent with the HSA and TVPRA, with some modifications discussed further below to reflect intervening statutory and operational changes while still providing similar substantive protections and standards. It therefore would terminate the FSA. The rule would satisfy the basic purpose of the FSA in ensuring that all juveniles in the government's custody are treated with dignity, respect, and special concern for their particular vulnerability as minors, while doing so in a manner that is workable in light of subsequent changes. The rule would also implement closely related provisions of the HSA and TVPRA. Most prominently, the rule would create an alternative to the existing licensed program requirement for family residential centers, so that ICE may use appropriate facilities to detain family units together during their immigration proceedings, consistent with applicable law.

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 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 identification of a suspect product and the termination of notifications regarding an illegitimate product.