Department of Health and Human Services September 24, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) has determined that ATROPINE SULFATE ANSYR PLASTIC SYRINGE (atropine sulfate solution) intravenous, intramuscular, subcutaneous, and endotracheal, 0.5 milligram (mg)/5 milliliters (mL) (0.1 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for atropine sulfate solution intravenous, intramuscular, subcutaneous, and endotracheal, 0.5 mg/5 mL (0.1 mg/mL), if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MED-EL Electric and Acoustic Stimulation Hybrid Hearing Prosthesis System (MED-EL EAS) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Wholesale Distributor Verification Requirement for Saleable Returned Drug ProductCompliance Policy.'' This guidance describes FDA's intention regarding enforcement of the Drug Supply Chain Security Act (DSCSA) provision requiring wholesale distributors to verify a product identifier prior to further distributing returned product beginning on November 27, 2019. Given concerns expressed by stakeholders and to minimize possible disruptions in the pharmaceutical distribution supply chain, FDA does not intend to take action against wholesale distributors who do not, prior to November 27, 2020, verify a product identifier prior to further distributing returned product as required under the DSCSA. This represents a 1-year delay in enforcement of this DSCSA requirement.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.'' The Patient Engagement Advisory Committee (PEAC) recommended that FDA and industry develop some type of framework to clarify how patient advisors can engage in the clinical investigation process. This draft guidance focuses on the applications, perceived barriers, and common challenges of patient engagement in the design and conduct of medical device clinical investigations. This draft guidance is not final nor is it in effect at this time.

The development of a National Vaccine Plan (NVP) was mandated by Congress as a mechanism for the Director of the National Vaccine Program (as delegated by the Assistant Secretary for Health) to communicate priorities for achieving the Program's responsibilities of ensuring adequate supply of and access to vaccines and ensuring the effective and optimal use of vaccines. The most recent NVP, released in 2010, provided a comprehensive 10-year national strategy for enhancing all aspects of the plan, including vaccine research and development, supply, financing, distribution, and safety; informed decision-making by consumers and health care providers; vaccine-preventable disease surveillance; vaccine effectiveness and use monitoring; and global cooperation (https://www.hhs.gov/nvpo/vacc_plan/). To help inform the development of the National Vaccine Plan 2020, HHS is issuing a Request for Information (RFI). The RFI will solicit specific information regarding the priorities, goals, and objectives in the next iteration of the NVP, remaining gaps, and stakeholder perspectives for the 2020-2025 timeframe.