Department of Health and Human Services June 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' explaining the process that would be used to make product- specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of final product- specific BE recommendations.

This notice announces the second meeting of the HIT Policy Committee in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This interim final rule with comment period implements revised Medicare severity long-term care diagnosis-related group (MS-LTC-DRG) relative weights for payment under the long-term care hospital (LTCH) prospective payment system (PPS) for federal fiscal year (FY) 2009. We are revising the MS-LTC-DRG relative weights for FY 2009 due to the misapplication of our established methodology in the calculation of the budget neutrality factor. The revised FY 2009 MS-LTC-DRG relative weights are effective for the remainder of FY 2009 (that is, from June 3, 2009 through September 30, 2009).

The Food and Drug Administration (FDA) is announcing a public meeting to solicit recommendations from interested persons on ways in which FDA can make useful and understandable information about FDA activities and decisionmaking more readily available to the public.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/932,451, filed May 31, 2007, now abandoned, [HHS Ref. No. E-217-2007/0-US-01]; PCT Patent Application No. PCT/ US2008/006895, filed May 30, 2008, [HHS Ref. No. E-217-2007/0-PCT-02], both of which are entitled, ``N-Acetyl-Mannosamine as a Therapeutic Agent'' (Inventors: Drs. Marjan Huizing, William A. Gahl, Irini Manoli, and Enriko Klootwijk, NHGRI) to New Zealand Pharmaceuticals, Ltd., having an office in at Palmerston North, New Zealand. The patent rights in these inventions have been assigned to the United States of America.

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 the information collection provisions of the regulation requiring manufacturers, packers, and distributors of dietary supplements to notify FDA that they are marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act (the act).