Department of Health and Human Services December 28, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
Guidance for Industry: Prevention of Salmonella
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.'' The document provides guidance to egg producers on how to comply with certain provisions contained in FDA's final rule ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' (the final rule), including how to implement Salmonella Enteritidis (SE) prevention measures, how to sample for SE., and how to maintain records documenting compliance with the final rule.
Administration on Children, Youth and Families; Statement of Organization, Functions, and Delegations of Authority
Statement of Organizations, Functions, and Delegations of Authority The Administration for Children and Families (ACF) has reorganized the Administration on Children, Youth and Families (ACYF). This reorganization realigns the Children's Bureau Data and Technology Team and the Family and Youth Services Bureau Research, Data, and Evaluation Team to create the Office of Data Analysis, Research, and Evaluation. It also renames the Division of Research and Innovation to the Division of Program Innovation. It renames the Division of Youth Services to the Division of Adolescent Development and Support. It deletes the Division of Abstinence Programs. Additionally, it deletes the Mentoring Children of Prisoners program.
Draft Guidance for Industry and Food and Drug Administration Staff; the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and Food and Drug Administration Staff; The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].'' FDA developed this draft guidance document to provide a contemporary perspective on how FDA reviews premarket notification (510(k)) submissions as well as on the Special and Abbreviated 510(k) programs. This guidance addresses the major aspects of the 510(k) decision-making process and updates FDA's policies with respect to the Special and Abbreviated 510(k) programs. This draft guidance is not final nor is it in effect at this time.
Draft Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Center for Devices and Radiological Health (CDRH) Appeals Processes.'' This document describes the processes available to outside stakeholders to request additional review of decisions and actions by CDRH employees. The document also provides general information about each process as well as guidance on how to submit related requests to CDRH and FDA. This draft guidance is not final nor is it in effect at this time.
Communications and Activities Related to Off-Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed; Request for Information and Comments
The Food and Drug Administration (FDA) is announcing the establishment of a docket to assist with our evaluation of our policies on communications and activities related to off-label uses of marketed products, as well as communications and activities related to use of products that are not yet legally marketed for any use, we would like to obtain comments and information related to scientific exchange. FDA is interested in obtaining comments and information regarding scientific exchange about both unapproved new uses of products already legally marketed (``off-label'' use) and use of products not yet legally marketed for any use.
Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers; Correction
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Thursday, March 3, 2011 (76 FR 11892). The final rule amended FDA's regulations for thermally processed low-acid foods packaged in hermetically sealed containers to allow for use of other temperature-indicating devices, in addition to mercury-in-glass thermometers, during processing. The final rule was published with one error. This document corrects that error.
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