Department of Health and Human Services June 23, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for ERAXIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) is amending its regulations to implement a nomenclature change and to ensure accuracy and clarity in the agency's regulations.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The uniform protocol for the analysis of nicotine, total moisture, and pH in smokeless tobacco products, originally published in the Federal Register in 1999 (64 FR 14086), ``Notice Regarding Requirement for Annual Submission of the Quantity of Nicotine Contained in Smokeless Tobacco Products Manufactured, Imported, or Packaged in the United States,'' and revised in the Federal Register on March 14, 2008 (73 FR 13903), implements the requirement of the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA) of 1986 (15 U.S.C. 4401 et seq., Pub. L. 99-252) that each entity manufacturing, packaging, or importing smokeless tobacco products shall annually provide the Secretary of Health and Human Services (HHS) with a specification of the quantity of nicotine contained in each smokeless tobacco product. CDC is re-publishing the notice published in the Federal Register on March 14, 2008 (73 FR 13903) concerning the revision of the protocol for analysis of nicotine in smokeless tobacco products (hereinafter referred to as ``Protocol'') to (1) make a technical change to correct the date when the first report of information under the revised Protocol is due; (2) solicit public comments concerning a change in the Protocol that increased the volume of water in the pH determination from 10 mL to 20 mL, and (3) solicit public comments concerning the addition of the following commercial smokeless tobacco product categories: Dry snuff portion packs, snus, snus portion packs, and pellet or compressed. The Protocol as published in the Federal Register on March 14, 2008 (73 FR 13903), remains in effect with the technical correction to the date described below. Technical change: The language in the March 14, 2008 notice stated that ``The first report of information is due June 30, 2008, with subsequent submissions due by March 31 of each year.'' The first report date of information should be 2009 so that the sentence correctly reads: ``The first report of information is due June 30, 2009, with subsequent submissions due by March 31 of each year.''