Department of Health and Human Services October 6, 2016 – Federal Register Recent Federal Regulation Documents

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp-committee/meetings/ .

The Food and Drug Administration (FDA) is announcing a public meeting to discuss scientific and technical issues relating to formulation development and pre-market evaluation of opioid drug products with abuse-deterrent properties. The meeting is intended to give FDA the opportunity to discuss, and seek public input from stakeholders on, the approach to testing FDA recommended in its draft guidance ``General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products.'' The meeting will also provide an opportunity to discuss FDA's efforts to develop standardized in vitro testing methodologies for evaluating the abuse deterrence of opioid drug products. FDA is seeking input from all stakeholders, including patients, health care providers, health care payers, the pharmaceutical industry, patient advocates, academics, researchers, and other government entities. FDA may hold one or more additional meetings in the future to discuss the risk-benefit paradigm for opioid drug products to ensure that FDA is appropriately considering the full public health impact of prescription opioid drug products and the post-market impact (``real world effects'') of abuse-deterrent opioid drug products.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Tropical Disease Priority Review Vouchers.'' There has been significant outside interest in FDA's interpretation of the priority review voucher section in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Food and Drug Administration Amendments Act (FDAAA). This section makes provisions for awarding priority review vouchers for future applications to sponsors of tropical disease product applications that meet the criteria specified by the FD&C Act. This guidance explains to internal and external stakeholders how FDA is implementing the provisions of this section. This guidance finalizes the draft guidance of the same name issued October 2008.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as requires by the Paperwork Reduction Act of 1995. This notice invites comments on Early Hearing Detection and Intervention (EDHI) Hearing and Screening Follow-up Survey.