Department of Health and Human Services 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is establishing January 1, 2010, as the uniform compliance date for food labeling regulations that are issued between January 1, 2007, and December 31, 2008. FDA periodically announces uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes. On March 14, 2005, FDA established January 1, 2008, as the uniform compliance date for food labeling regulations that issued between March 14, 2005, and December 31, 2006.

This notice announces the fifth meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the 12th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).

This notice announces the sixth meeting of the American Health Information Community Confidentiality, Privacy and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92- 463, 5 U.S.C., App.).

This notice announces the first meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)

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 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.

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 Food and Drug Administration (FDA) is issuing a final rule to improve the barrier quality of medical gloves marketed in the United States. The rule will accomplish this by reducing the current acceptable quality levels (AQLs) for leaks and visual defects observed during FDA testing of medical gloves. By reducing the AQLs for medical gloves, FDA will also harmonize its AQLs with consensus standards developed by the International Organization for Standardization (ISO) and ASTM International (ASTM).

On Friday, November 24, 2006 (71 FR 67873), the Centers of Medicare & Medicaid Services (CMS) published a Notice document titled ``Agency Information Collection Activities; Proposed Collection; Comment Request''. That notice invited public comments on three separate information collections. Through the publication of this document, CMS is retracting the portion of that notice requesting public comment on the Information Collection Requirement titled ``Medicaid Drug Program Monthly Quarterly Drug Reporting Format'', form number CMS-367 (OMB 0938-0578).

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 Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the U.S. position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, March 12 to 16, 2007. This notice is issued under the Controlled Substances Act.

The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved drug products containing quinine (including quinine sulfate and any other salt of quinine) and persons who cause the manufacture of such products or their shipment in interstate commerce. Drug products containing quinine, quinine sulfate, and any other salt of quinine are new drugs that require approved applications. One firm has an approved application to market a drug product containing quinine sulfate to treat malaria; this product has been designated an orphan drug product. Other manufacturers who wish to market a drug product containing quinine, quinine sulfate, or any other salt of quinine must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA); consideration of any such applications will be subject to the rights of the current NDA holder under the Orphan Drug Act.

Influenza viruses have threatened the health of animal and human populations for centuries. A pandemic occurs when a novel strain of influenza virus emerges that has the ability to infect and be passed between humans. Because humans lack immunity to the new virus, a worldwide epidemic, or pandemic, can ensue. Three human influenza pandemics occurred in the 20th century. In the U.S., each pandemic led to illness in approximately 30 percent of the population and death in between 2 in 100 and 2 in 1,000 of those infected. It is projected that a modern pandemic, absent effective control measures, could result in the deaths of 200,000 to 2 million people in the United States alone. Extensive information on Federal government strategic and implementation plans for pandemic flu is available at https:// www.pandemicflu.gov. A critical part of the United States Government (USG) strategy to control the spread of a pandemic and reduce its health and societal impact is through the use of vaccines. The U. S. Government is working toward a goal of expanding domestic influenza vaccine surge capacity for the production of pandemic influenza vaccines for the entire population within six months of a pandemic declaration. However, at the beginning of a pandemic, the scarcity of pre-pandemic influenza vaccine and pandemic influenza vaccine (which could include up to two doses) will require that the limited supply be prioritized for distribution and administration. Pre-pandemic vaccine refers to influenza vaccine that is produced against a virus strain that is believed to have pandemic potential and is maintained in a national stockpile. Depending on what influenza strain actually causes the pandemic, stockpiled pre- pandemic vaccine may provide some protection. Total quantities of pre- pandemic vaccines will be limited. Accordingly, the Federal government has initiated a process to provide guidance to assist State and local governments, communities, tribal and territorial governments, and the private sector in defining groups that should be considered for priority access to scarce vaccine. Guidance will be drafted by a Federal interagency task force that will seek information and advice from relevant individual stakeholders, a public engagement process in selected communities across the country, and through this Request for Information (RFI). The Federal government plans to issue draft guidance resulting from this process for public comment before finalization. With this RFI, the Department of Health and Human Services (HHS) requests input from the public on considerations in developing guidance for prioritization of the distribution and administration of both pre- pandemic and pandemic influenza vaccines based on various pandemic severity and vaccine supply scenarios. Specifically, HHS is seeking input on pandemic influenza vaccine prioritization considerations from all interested and affected parties, including but not limited to public health and health care individuals and organizations, as well as those from other sectors of the economy including, for example, travel and transportation, commerce and trade, law enforcement, emergency management and responders, other critical infrastructure sectors and the general public. Previous reports relating to pandemic influenza vaccine prioritization issues are available at https:// www.pandemicflu.gov.