Department of Health and Human Services November 14, 2005 – Federal Register Recent Federal Regulation Documents
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Obstetrical and Gynecological Devices; Designation of Special Control for Condom and Condom With Spermicidal Lubricant
The Food and Drug Administration (FDA) is proposing to amend the classification regulations for condoms and condoms with spermicidal lubricant containing nonoxynol-9 (condoms with spermicidal lubricant) to designate a special control for natural rubber latex (latex) condoms with and without spermicidal lubricant. FDA is proposing the draft guidance document entitled ``Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex,'' as the special control that the agency believes will help provide a reasonable assurance of the safety and effectiveness of the devices. Elsewhere in this issue of the Federal Register, FDA is announcing a notice of availability of the draft special controls guidance document for public comment.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex.'' This draft guidance document describes a means by which natural rubber latex (latex) condoms with and without spermicidal lubricant containing nonoxynol-9 (N-9) may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to amend the classification regulations for condoms with and without spermicidal lubricant to designate this draft guidance as the special control for latex condoms with and without spermicidal lubricant. This draft guidance is neither final nor is it in effect at this time.
Solicitation of Potential Partners to Participate in Programs of the Office of the President's Council on Physical Fitness and Sports During 2006 50th Anniversary Celebration
The Office of the President's Council on Physical Fitness and Sports (PCPFS) is soliciting proposals for the establishment of partnerships with non-Federal public and private sector organizations, with the goal of developing, implementing, promoting, and evaluating physical activity, fitness, and sports participation activities and initiatives. These partnerships are particularly targeted at calendar year 2006, which marks the 50th anniversary of the PCPFS. This Partnership Initiative is not a grant or contract award program. It is intended to provide opportunities for the Office of the PCPFS and non- Federal public and private sector organizations to work together both to enhance and integrate existing partnerships and also to create new physical activity, fitness, and sports initiatives at the national, state, and local levels to promote better health and fitness for all Americans in a synergistic and collaborative environment. These partnerships will be voluntary, and each partner will be responsible for supporting its own activities. Potential co-sponsors must have a demonstrated interest in physical activity, fitness, and/or sports activities and be willing to participate substantively in the co- sponsored activity.
Revised Compliance Policy Guide Regarding Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised compliance policy guide (CPG) Sec. 110.310 entitled ``Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.'' The CPG provides written guidance to FDA's and Customs and Border Protection's (CBP's) staff on enforcement of section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulations, which require prior notice for food imported or offered for import into the United States. The CPG has been revised to finalize the sections pertaining to routine shipments of food that are transshipped through the United States, arriving from and exiting to the same country, and regarding the Harmonized Tariff Schedule (HTS) code that is part of the planned shipment information.
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