December 4, 2014 – Federal Register Recent Federal Regulation Documents
Results 51 - 54 of 54
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological ProductsContent and Format.'' This draft guidance is intended to assist applicants in complying with the new content and format requirements in the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products, as described in the final rule, Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling. The rule, which is being published concurrently with this draft guidance, is referred to as the ``Pregnancy and Lactation Labeling Rule'' (PLLR). The draft guidance will assist applicants in developing labeling for new products, revising existing labeling, and implementing the content and format requirements of the PLLR for human prescription drug and biological products.
Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling
The Food and Drug Administration (FDA) is amending its regulations governing the content and format of the ``Pregnancy,'' ``Labor and delivery,'' and ``Nursing mothers'' subsections of the ``Use in Specific Populations'' section of the labeling for human prescription drug and biological products. The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling. For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the ``Labor and delivery'' subsection because information about labor and delivery is included in the ``Pregnancy'' subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential. The final rule creates a consistent format for providing information about the risks and benefits of prescription drug and/or biological product use during pregnancy and lactation and by females and males of reproductive potential. These revisions will facilitate prescriber counseling for these populations.
Fisheries of the Northeastern United States; Atlantic Herring Fishery; Framework Adjustment 3
NMFS implements final regulations to establish a process for setting river herring (alewife and blueback) and shad (American and hickory) catch caps for the herring fishery. This action also sets these catch caps for the 2014 and 2015 fishing years. The river herring and shad caps in the herring fishery will limit how much of these species will be caught in the herring fishery. This action will allow the New England Fishery Management Council to set river herring and shad catch caps and associated measures in future years through specifications or frameworks, whichever is appropriate. The measures in this action are a positive step in conservation efforts for river herring and shad.
Post-Employment Conflict of Interest Restrictions; Revision of Departmental Component Designations
The Office of Government Ethics (OGE) is issuing this final rule to revoke the designation of one departmental component of one agency and designate a new bureau as a departmental component for purposes of the one-year post-employment conflict of interest restriction in the United States Code; to revoke the designation of two departmental components of another agency and designate their successor bureau as a departmental component; to change the name of an existing departmental component; and to revoke the designation of a departmental component that was abolished.
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