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

The Food and Drug Administration (FDA, the Agency, or we) is proposing to delay the effective date of certain portions of a final rule published in the Federal Register of January 9, 2017. In the Federal Register of February 7, 2017, we delayed until March 21, 2017, the effective date of the final rule. In the Federal Register of March 20, 2017, we further delayed the effective date of the final rule until March 19, 2018, and invited public comment on the rule. This action, if finalized, will delay until further notice the effective date of the portions of the final rule amending FDA's existing regulations describing the types of evidence that may be considered in determining a medical product's intended uses. FDA received a number of comments on the final rule that raise questions about the amendments to the existing medical product ``intended use'' regulations. FDA is proposing to delay the effective date of the amendments to the existing medical product ``intended use'' regulations to allow further consideration of the substantive issues raised in the comments received. This action, if finalized, will not further delay the effective date of the new regulation that describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance for industry and FDA Staff entitled ``Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.'' This guidance describes FDA's intention with respect to the enforcement of unique device identification requirements for certain class I and unclassified devices. FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements under Agency regulations for these devices before September 24, 2020. In addition, FDA does not intend to enforce direct mark requirements under an Agency regulation for these devices before September 24, 2022. The policy described in this guidance does not apply to implantable, life-supporting, or life-sustaining devices. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ICSH. The ICSH consists of 5 experts in fields that represent private entities involved in informing the public about the health effects of smoking. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of the health effects of smoking. Additionally, desirable qualifications include: (1) Knowledge of the intersection of behavioral health conditions (mental and/or substance use disorders) and tobacco use/ tobacco control; and/or (2) familiarity and expertise in developing or contributing to the development of policies and/or programs for reducing health disparities in tobacco use in the United States; and/or (3) knowledge of emerging tobacco control policies and experience in analyzing, evaluating, and interpreting Federal, State and/or local health or regulatory policy. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of ICSH objectives https:// www.cdc.gov/tobacco/about/icsh/index.htm.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Office of Public Health Preparedness and Response, (BSC, OPHPR). This meeting is open to the public. The public is welcome to listen to the meeting via Adobe Connect. Pre-registration is required by clicking the links below. WEB ID: (100 seats) https:// adobeconnect.cdc.gov/e9qxcduyr42/event/registration.html; Dial in number: 866-817-6648; Participant code: 48225449 (100 seats).

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 January meeting, the Research Subcommittee will be taking charge of the theme, focusing on the process from targets to treatments. The Council will hear speakers on the preclinical pipeline, the clinical trial pipeline, and the industry perspective. The meeting will also include discussion of a driver diagram to guide the Council's future work, updates and a report from the October Care Summit, and federal workgroup updates.

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice of availability, published in the Federal Register of October 13, 2017. In that document, FDA requested comments on the draft guidance for industry entitled ``Determining Whether to Submit an ANDA or 505(b)(2) Application.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

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) announces a forthcoming public advisory committee meeting of the Risk Communication 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) 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.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA) 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, we, or Agency) 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 Centers for Disease Control and Prevention (CDC) announces the Adapting Clinical Guidelines for the Digital Age meeting. Adapting Clinical Guidelines for the Digital Age is an initiative to improve patient care and health outcomes by working to ensure that clinical guidelines are not only evidence-based but also are used in practice. Because there are multiple roles in developing and disseminating clinical guidelines, it is important to get a comprehensive understanding of the current challenges in translating guidelines in order to develop a standardized process for the future. The meeting will use the Kaizen approach to ensure stakeholder perspectives and experiences along the clinical guideline continuum are collected. Kaizen focuses on continuous improvement by bringing together stakeholders to gather individual perspectives and experiences so that improvements can be made to a specific area of focus in a process. Additional information about Kaizen is available at the Electronic Clinical Quality Improvement Resource Center website (https:// ecqi.healthit.gov/ecqi/kaizen). The scope of the meeting will encompass the following: Gathering individual perspectives and experiences about guideline creation and summarizing the evidence; informatics framework for guideline translation; dissemination modalities and communication methods; translation and implementation support; and evidence.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.