The Federal Register

Agency Information Collection Activities; Proposed Collection; Comment Request; State Enforcement Notifications

Fri, Jul 18 2008 11:00:00 GMT

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 reporting requirements contained in existing FDA regulations governing State enforcement notifications.

Compliance Policy Guide Sec. 540.575 Fish--Fresh and Frozen-- Adulteration Involving Decomposition (CPG 7108.05);

Fri, Jul 18 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the withdrawal of Compliance Policy Guide Sec. 540.575 FishFresh and FrozenAdulteration Involving Decomposition (CPG 7108.05) (CPG Sec. 540.575). This action is being taken because the guidance in CPG Sec. 540.575 relating to decomposition in fresh and frozen fish is not current.

Draft Compliance Policy Guide Sec. 540.370 Fish and Fishery Products -- Decomposition; Availability

Fri, Jul 18 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of draft Compliance Policy Guide Sec. 540.370 Fish and Fishery Products Decomposition (the draft CPG). The draft CPG, when final, will provide FDA staff with current regulatory action guidance relating to decomposition in fish and fishery products.

Animal Models for the Treatment of Acute Radiation Syndrome; Public Workshop

Fri, Jul 18 2008 11:00:00 GMT

The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research, and the National Institutes of Health, National Institute of Allergy and Infectious Diseases, are announcing a public workshop entitled ``Animal Models for the Treatment of Acute Radiation Syndrome (ARS).'' The purpose of the public workshop is to discuss issues that should be considered when developing animal models to assist in developing and demonstrating the efficacy of products intended for treatment of ARS.

Date and Time: The public workshop will be held on September 17, 2008, from 8:30 a.m. to 5:30 p.m., and on September 18, 2008, from 8:30 a.m. to 1 p.m.

Location: The public workshop will be held at the Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.

Contact Person: Bernadette Kawaley, Center for Biologics Evaluation and Research (HFM43), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Roc

Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza

Fri, Jul 18 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Rapid Methods for Detecting Mycoplasma Contamination in the Manufacture of Vaccines, Including Pandemic Influenza Vaccines, and Other Biological Products.'' The purpose of the public workshop is to provide a forum on recent scientific and technical achievements in the development of rapid methods for mycoplasma testing during the manufacture of vaccines and other biological products. Such discussion may help to assess how these methods compare with currently used methods. Expedited manufacture may be of particular importance to public health during an influenza pandemic.

Date and Time: The public workshop will be held on September 22, 2008, from 8:30 a.m. to 5 p.m., and September 23, 2008, from 8:30 a.m. to 12 noon.

Location: The public workshop will be held at the Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877.

Contact Person: Bernadette Kawaley, Center for Biologi

[Docket No. FDA-1995-N-0400 (formerly Docket No. 1995N-0245), FDA-1995- N-0029 (formerly Docket No. 1995N-0282),

Fri, Jul 18 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a small entity compliance guide (SECG) for a final rule published in the Federal Register of September 23, 1997, entitled ``Food Labeling; Nutrient Content Claims; Definition for ``High Potency'' and Definition of ``Antioxidant'' for Use in Nutrient Content Claims for Dietary Supplements and Conventional Foods.'' This SECG is intended to set forth in plain language the requirements of the regulation and to help small businesses understand the regulation.