Department of Health and Human Services September 2008 – Federal Register Recent Federal Regulation Documents

This rule amends Part 2 of Title 45 of the Code of Federal Regulations, which provides that employees and former employees of the Department of Health and Human Services (HHS or Department) may not provide testimony as part of their official duties in litigation where the United States or a federal agency is not a party, without the approval of the head of the agency. The purpose of these amendments is to modify the definition of ``employee'' contained in 45 CFR part 2. Under these amendments, the definition of employee will be revised to reflect changes in Medicare contracting, including changes brought about by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173). In addition, the definition of employee will be modified to include employees of a state agency performing survey, certification, or enforcement functions under Title XVIII of the Social Security Act or Section 353 of the Public Health Service Act. Further, the definition of employee with respect to employees of entities covered by the Federally Supported Health Centers Assistance Act, as amended, 42 U.S.C. 233(g)-(n) (FSHCAA), will be limited to testimony requested in medical malpractice tort litigation which relates to medical functions performed at a time when the center was covered under FSHCAA.

The Food and Drug Administration (FDA) is announcing the opening of a public docket to receive information and comments on laser-assisted in situ keratomileusis (LASIK). We are opening the docket to gather additional information from interested persons on the post market experience associated with the use of LASIK devices.

The Food and Drug Administration is announcing a call-for-data for safety and effectiveness information on the following condition as part of FDA's ongoing review of over-the-counter (OTC) drug products: Ecamsule (terephthalylidene dicamphor sulfonic acid), in concentrations of up to 10 percent, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients that are generally recognized as safe and effective (GRASE) and are found in the sunscreen monograph regulations. FDA reviewed a time and extent application (TEA) for ecamsule and determined that it is eligible for consideration in our OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether ecamsule can be generally recognized as safe and effective (GRASE) for its proposed OTC use.

The Food and Drug Administration (FDA) is reopening until October 14, 2008, the comment period for a draft guidance entitled ``Class II Special Controls Guidance Document: Absorbable Hemostatic Device.'' The draft guidance describes a means by which the absorbable hemostatic device may comply with the requirements of special controls if it is reclassified. FDA is reopening the comment period to update comments and to receive any new information. Elsewhere in this issue of the Federal Register, FDA is reopening the comment period on a proposed rule to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls).

The Food and Drug Administration (FDA) is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on the Devices Good Manufacturing Practice Advisory Committee (DGMPAC) and certain device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health notify FDA in writing. A nominee may either be self nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 020'' (Recognition List Number: 020), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the University of Pennsylvania (Penn). The purpose of this MOU is to establish terms of collaboration between FDA and Penn focused primarily but not exclusively, in the areas of translational therapeutics, diagnostics, bioinformatics, new clinical trial models, drug/device co-development, and pharmacoepidemiology. Beyond the collaborations in the traditional academic programs for training, research, and outreach, this MOU will also include collaborations with Penn extended partnerships such as the Institute for Translational Medicine and Therapeutics which includes the Children's Hospital of Philadelphia, the Wistar Institute, and the University of Sciences in Philadelphia.