Draft Guideline Update-CDC Recommendations on Use of Chlorhexidine-Impregnated Dressings for Prevention of Intravascular Catheter-Related Infections
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces the opening of a docket to obtain public comment on the Draft Update of CDC Recommendations on Use of Chlorhexidine-Impregnated Dressings for Prevention of Intravascular Catheter-Related Infections (Draft Recommendation Update). The Draft Recommendation Update addresses new and updated strategies for the prevention of intravascular catheter- related infections in healthcare settings. CDC is providing a supporting appendix in the docket that includes primary evidence, study evaluation, and data evaluation tables that were used in developing the Draft Recommendation Update.
Bioequivalence Recommendations for Cyclobenzaprine Hydrochloride; Revised Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a revised draft guidance for industry on generic cyclobenzaprine hydrochloride extended release capsules, entitled ``Draft Guidance on Cyclobenzaprine Hydrochloride.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cyclobenzaprine hydrochloride extended release capsules.
Uniform Compliance Date for Food Labeling Regulations
The Food and Drug Administration (FDA or we) is establishing January 1, 2020, as the uniform compliance date for food labeling regulations that are issued between January 1, 2017, and December 31, 2018. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes.
Submission of Quality Metrics Data; Draft Guidance for Industry; Availability; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Submission of Quality Metrics Data.'' In order to help develop compliance and inspection policies and practices, improve the Agency's ability to predict, and therefore possibly mitigate, future drug shortages, and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing, FDA intends to initiate a quality metrics reporting program. The revised draft guidance describes FDA's plans for an initial, voluntary phase of this program. FDA expects that this voluntary phase will allow the Agency to learn more about a limited set of quality metrics and associated analytics, and to help inform future FDA decisionmaking about its quality metrics program. This revised draft also provides an opportunity to gain additional perspectives from industry participants on the future use of quality metrics data.
Request for Nominations on the Blood Products Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Blood Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Blood Products Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.