Department of Health and Human Services April 25, 2017 – Federal Register Recent Federal Regulation Documents

The Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) will hold a public forum to share information and facilitate direct communication of ideas and suggestions from stakeholders. Interested persons may attend in person or view the meeting remotely by webcast. Time will be set aside for questions and public statements on the topics discussed. Registration is requested for both public attendance and oral statements, and required for remote access. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/iccvamforum- 2017.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for government public health and emergency response stakeholders entitled ``Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles.'' This document, once finalized, will provide guidance to government stakeholders on testing to extend the shelf life (i.e., expiration date) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. This draft guidance has been prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality beyond the manufacturer's labeled expiration date so the replacement of stockpiled product could be deferred. This guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any other non- emergency purpose.

The Food and Drug Administration (FDA, the Agency, or we), in association with National Science Foundation (NSF) and Department of Homeland Security, Science and Technology (DHS S&T) is announcing the following public workshop entitled ``Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis.'' The objective of the workshop is to facilitate a discussion on the current state of regulatory science in the field of cybersecurity of medical devices, with a focus on patient safety. The purpose of this public workshop is to catalyze collaboration among Health Care and Public Health (HPH) stakeholders to identify regulatory science challenges, discuss innovative strategies to address those challenges, and encourage proactive development of analytical tools, processes, and best practices by the stakeholder community to strengthen medical device cybersecurity.

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), together with the Center for Devices and Radiological Health (CDRH), is sponsoring a 2-day public conference entitled ``FDA Small Business and Industry Assistance Regulatory Education for Industry (REdI) Spring Conference.'' The goal of this public conference is to provide direct, relevant, and helpful information on the key aspects of drug and medical device regulations in order to increase regulatory certainty and predictability for pharmaceutical and/or medical device industry. Our primary audience is that of small manufacturers of drug and/or medical devices who want to learn about how FDA approaches the regulation of drugs and medical devices and for whom increased certainty and predictability will help to decrease the regulatory burdens that can be associated with a lack of understanding of, or familiarity with, FDA's drug and medical device regulations. However, anyone involved in the pharmaceutical and/or medical device industry may attend.

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 PRA).

The Food and Drug Administration (FDA) 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 good laboratory practice (GLP) regulations for nonclinical laboratory studies.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Sentinel Training at FDA.'' The purpose of the public workshop is to provide training to understand the kinds of questions that can be asked using health care claims data generally and within the FDA Sentinel System specifically, allowing an understanding of the capabilities of the Sentinel System.

The Food and Drug Administration (FDA) 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 contained in regulations governing the use of radioactive drugs for basic informational research.

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.

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.