Department of Health and Human Services September 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) is announcing a scientific workshop to solicit feedback on the risks and benefits associated with the long- term use of nicotine replacement therapy (NRT) products. NRT products facilitate smoking cessation by ameliorating the symptoms of nicotine withdrawal and are available as approved nonprescription and prescription drugs. No currently-approved NRT product is intended for use beyond 12 weeks to relieve the acute withdrawal symptoms experienced when quitting smoking.

The Health Resources and Services Administration (HRSA) will transfer Health Center Program (Section 330(h) of the Public Health Service Act) funds originally awarded to Saint Vincent's Catholic Medical Centers of New York to Sunset Park Health Council, Inc., to ensure the continuity of services to low-income, underserved, homeless patients in New York City.

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 (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Patent Application No. 10/209,331, filed July 30, 2002, which was issued as U.S. Patent 6,828,309 on December 07, 2004, entitled, ``USE OF PENTOSAN POLYSULFATE TO TREAT CERTAIN CONDITIONS OF THE PROSTATE,'' developed by Dr. Gary Striker (formerly of NIDDK) [HHS Ref. No. E-104- 1997/0-US-03], to Swati Spentose Private Limited, having a place of business in Mumbai, India. The patent rights in this invention have been assigned to the United States of America.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of August 23, 2010 (75 FR 51829). The notice announced the public workshop entitled ``Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.'' The notice was published with an incorrect registration Web site. This document corrects that Web site.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of August 6, 2010 (75 FR 47602). The document announced the availability of grant funds for the support of FDA's Office of Orphan Products Development (OPD) grant program. The document was published with an error. This document corrects that error.