Department of Health and Human Services August 24, 2018 – Federal Register Recent Federal Regulation Documents

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.

HRSA is requesting nominations to fill vacancies on the National Advisory Council on Nurse Education and Practice (NACNEP). The NACNEP is authorized by Section 851 of the Public Health Service (PHS) Act, as amended. The Advisory Council is governed by the provisions of the Federal Advisory Committee Act (FACA), as amended, which sets forth standards for the formation and use of advisory committees, and applies to the extent that the provisions of FACA do not conflict with the requirements of PHS Act Section 851.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development.'' This draft guidance provides recommendations to industry regarding the use of placebos and blinding in randomized controlled clinical trials in development programs for drug or biological products for the treatment of hematologic malignancies and oncologic diseases regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes the Food and Drug Administration (FDA or Agency) to award priority review vouchers (PRVs) to tropical disease product applicants when the applications meet certain criteria. The FD&C Act lists the diseases that are considered tropical diseases for purposes of obtaining PRVs and provides for Agency expansion of that list to include other diseases that satisfy the definition of ``tropical diseases'' as set forth in the FD&C Act. The Agency has determined that chikungunya virus disease, Lassa fever, rabies, and cryptococcal meningitis satisfy this definition and is therefore adding them to the list of designated tropical diseases whose product applications may result in the award of PRVs. Sponsors submitting certain drug or biological product applications for the prevention or treatment of chikungunya virus disease, Lassa fever, rabies, and cryptococcal meningitis may be eligible to receive a PRV if such applications are approved by FDA.

The Food and Drug Administration (FDA or Agency) has determined that PLASMA-LYTE M AND DEXTROSE 5% (calcium chloride, 37 milligrams (mg)/100 milliliters (mL); dextrose, 5 grams (g)/100 mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 119 mg/100 mL; sodium acetate, 161 mg/100 mL; sodium chloride, 94 mg/100 mL; sodium lactate, 138 mg/100 mL) and PLASMA LYTE 148 AND DEXTROSE 5% (dextrose, 5 g/100 mL; magnesium chloride, 30 mg/100 mL; potassium chloride, 37 mg/100 mL; sodium acetate, 368 mg/100 mL; sodium chloride, 526 mg/100 mL; sodium gluconate, 502 mg/100 mL) were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements.

The Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) is announcing the Fiscal Year 2019 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. The purpose of this document is to invite pharmaceutical companies interested in participating in this program to submit a site visit proposal to CDER's OPQ.

In compliance with of 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.