Department of Health and Human Services January 8, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Agency Information Collection Activities; Proposed Collection; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on requests for exemption from the food additive listing regulation requirements that are submitted under part 170 (21 CFR part 170).
International Conference on Harmonisation; Draft Guidance on E15 Terminology in Pharmacogenomics; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``E15 Terminology in Pharmacogenomics.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories. In the effort to develop harmonized approaches to drug regulation, it is important to ensure that consistent definitions of terminology are being applied across all constituents of the ICH. The draft guidance is intended facilitate the integration of the discipline of pharmacogenomics and pharmacogenetics into global drug development and approval processes.
Conventional Foods Being Marketed as “Functional Foods”; Extension of Comment Period
The Food and Drug Administration (FDA) is extending to March 5, 2007, the comment period for the notice of public hearing that appeared in the Federal Register of October 25, 2006 (71 FR 62400). In the notice of public hearing, FDA requested comments on how the agency should regulate conventional foods marketed as ``functional foods'' under its existing legal authority. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
New Animal Drugs For Use in Animal Feeds; Monensin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA revises the concentration of monensin in Type C medicated feeds used for improved feed efficiency, and for the prevention and control of coccidiosis in cattle fed in confinement for slaughter.
Notice of Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.
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