Department of Health and Human Services March 7, 2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is announcing a public workshop entitled ``Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation.'' The purposes of the workshop are to share current FDA experiences on the application of mechanism-based absorption modeling and simulation in regulatory activities; discuss current and future utility of mechanism-based absorption modeling and simulation in the development of bioequivalent oral drug products and regulatory reviews; obtain input from various stakeholders on when, where, and how to conduct mechanism-based absorption modeling and simulations in the context of bioequivalent product development; and request comments on these topics.

The Food and Drug Administration (FDA or we) is announcing the availability of a revised guidance for industry entitled ``A Dietary Supplement Labeling Guide: Chapter II. Identity Statement.'' This guidance is part of a longer guidance entitled ``A Dietary Supplement Labeling Guide,'' which covers the most frequently raised questions about the labeling of dietary supplements using a question and answer format and is intended to help ensure that the dietary supplements sold in the United States are properly labeled. We are revising the guidance to correct an inaccurate statement.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails.'' This guidance is intended to provide recommendations regarding clinical trial design for medical devices intended either to provide improvement in the appearance of nails affected by onychomycosis or to treat onychomycosis (fungal nail infection).

The Food and Drug Administration (FDA or we) is announcing the extension of temporary permits issued to Bumble Bee Foods, LLC; Chicken of the Sea International; and StarKist Seafood Company (the applicants) to market test products (designated as ``canned tuna'') that deviate from the U.S. standard of identity for canned tuna. The extension allows the applicants to continue to measure consumer acceptance of the products and assess the commercial feasibility of the products, in support of a petition to amend the standard of identity for canned tuna. We also invite other interested parties to participate in the market test.

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 required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection entitled ``DELTA FOCUS Program Evaluation.'' CDC will use the information collected to improve the national DELTA FOCUS program, and to develop strategy interactions to help the DELTA FOCUS program meet the requirements of the Funding Opportunity Announcement.

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 required by the Paperwork Reduction Act of 1995. This notice invites comment on the information collection request Qualitative Information Collection on Emerging Diseases among the Foreign-born in the US that enables CDC improve the planning and implementation of disease prevention and control strategies targeting communicable diseases and other emerging health issues among high-risk foreign-born communities in specific and limited geographic areas in the United States where high numbers of those populations live.

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below 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 or Agency) is announcing the availability of a document entitled ``Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry.'' The guidance document provides establishments that make donor eligibility (DE) determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) with recommendations for screening donors for evidence of, and risk factors for, infection with Zika virus (ZIKV). The guidance identifies ZIKV as a relevant communicable disease agent or disease (RCDAD) and adds to recommendations contained in the guidance entitled ``Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)'' dated August 2007.