Department of Health and Human Services June 9, 2006 – Federal Register Recent Federal Regulation Documents
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Carbinoxamine Products; Enforcement Action Dates
The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved drug products containing carbinoxamine and persons who cause the manufacture of such products. Numerous drug products containing carbinoxamine are marketed without approved applications and many are inappropriately labeled for use in infants and young children. Drug products containing carbinoxamine are new drugs that require approved applications. One firm has approved applications to market products containing carbinoxamine. In addition, there is information showing that carbinoxamine should not be used in children under 2 years of age. Manufacturers who wish to market carbinoxamine products that do not already have FDA approval must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance entitled ``Marketed Unapproved Drugs Compliance Policy Guide.''
Guidance on Marketed Unapproved Drugs; Compliance Policy Guide; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Marketed Unapproved Drugs Compliance Policy Guide.'' The guidance describes how FDA intends to exercise its enforcement discretion with regard to drugs marketed in the United States that do not have required FDA approval for marketing. This document supersedes section 440.100 entitled ``Marketed New Drugs Without Approved NDAs or ANDAs'' (CPG 7132c.02) of the Compliance Policy Guide (CPG). It applies to any new drug required to have FDA approval for marketing, including new drugs covered by the over-the- counter (OTC) review.
Determination of Regulatory Review Period for Purposes of Patent Extension; CETROTIDE
The Food and Drug Administration (FDA) has determined the regulatory review period for CETROTIDE 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 that claims that human drug product.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Assistant Secretary for Planning & Evaluation Medicaid Program; Meeting of the Medicaid Commission
This notice announces a public meeting of the Medicaid Commission. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, 10(a)(1) and (a)(2)). The Medicaid Commission will advise the Secretary on ways to modernize the Medicaid program so that it can provide high-quality health care to its beneficiaries in a financially sustainable way.
National Vaccine Injury Compensation Program: Calculation of Average Cost of a Health Insurance Policy
Subtitle 2 of Title XXI of the Public Health Service Act, as enacted by the National Childhood Vaccine Injury Act of 1986, as amended (the Act), governs the National Vaccine Injury Compensation Program (VICP). The VICP, administered by the Secretary of Health and Human Services (the Secretary), provides that a proceeding for compensation for a vaccine-related injury or death shall be initiated by service upon the Secretary, and the filing of a petition with the United States Court of Federal Claims (the Court). In some cases, the injured individual may receive compensation for future lost earnings, less appropriate taxes and the ``average cost of a health insurance policy, as determined by the Secretary.'' The Secretary now proposes a new method of calculating the average cost of a health insurance policy.
Alltech, Inc.; Withdrawal of Food Additive Petition
The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2253) proposing that the food additive regulations be amended to provide for the safe use of polyurethane polymer coating in ruminant feed.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs: Study 1
The Food and Drug Administration (FDA) is announcing that a collection of information entitled `` Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer Print Advertisements for Prescription Drugs: Study 1'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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