Department of Health and Human Services February 3, 2006 – Federal Register Recent Federal Regulation Documents

Under the provisions of Section 3507(c)(2)(A) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on November 1, 2005, page 65906 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comments. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Tobacco Use Supplement to the Current Population Survey Series: 2006-2007 Tobacco Use Supplement to the Current Population Survey. Type of information request: Reinstatement With Change of OMB 0925-0368, Expiration 01/31/2004. Need and Use of Information Collection: The 2006-2007 Tobacco Use Supplement to the Current Population Survey conducted by the Census Bureau will collect data from the civilian non-institutionalized population on tobacco use, smoking prevalence and attempts at cessation; workplace smoking policies; health professional advice to stop smoking; and changes in smoking norms and attitudes. This survey will provide invaluable information to government agencies and departments, other scientists and the general public necessary for tobacco control research, as well as measure progress toward tobacco control as part of the National Cancer Institute's (NCI's) Cancer Progress Report, and the Department of Health and Human Services' Healthy People 2010 Goals. It is also relevant to past reports of NCI plans for the National Investment in Cancer Research and NCI's long term strategic plan for eliminating the suffering and death due to cancer. This survey is part of a continuing series of surveys that were sponsored by NCI and fielded periodically over the 1990's by the Census Bureau as part of the American Stop Smoking Intervention Study for Cancer Prevention (ASSIST) project (OMB 0925-0368, exp. 01/31/ 01, 12/31/99, 03/31/97, 06/30/93) and made available for general public use. The Tobacco Use Supplements since 2001-02 have been fielded and will be continuing over the next decade alternating between a standard or core tobacco use survey (such as this 2006-2007 survey) and a special topic survey focusing on emerging tobacco control issues (such as the 2003 Tobacco Use Special Cessation Supplement). The survey will allow state specific estimates to be made. Data will be collected in May 2006, August 2006 and January 2007 from approximately 285,000 respondents. The National Cancer Institute is co-sponsoring this survey with the Centers for Disease Control and Prevention. Frequency of Response: One-time study. Affected Public: Individuals or households. Type of Respondents: Persons 15 years of age or older. The annual reporting burden is presented in exhibit 1 below. The annualized cost to respondents is estimated at $177,691. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Food and Drug Administration (FDA) is announcing an initiative, the Information Sheet Guidance Initiative, to update its process for developing, issuing, and making available guidances intended for institutional review boards (IRBs), clinical investigators, and sponsors. Known as ``Information Sheets,'' these guidances have provided recommendations for IRBs, clinical investigators, and sponsors to help them fulfill their responsibilities to protect human subjects who participate in research regulated by FDA since the early 1980s. The Information Sheet Guidance Initiative is intended to provide updated information and to issue the Information Sheets in accordance with FDA's good guidance practices (GGPs). As part of the initiative, which will be ongoing, the agency plans to rescind Information Sheets that are obsolete, revise and reissue Information Sheet Guidances that address current issues, and develop new Information Sheet Guidances as needed. The agency is also announcing the availability of five revised Information Sheet Guidances.

The Food and Drug Administration (FDA) has determined the regulatory review period for CYPHER and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA) has determined the regulatory review period for SURPASS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Merial Ltd. The NADA provides for veterinary prescription use of firocoxib oral paste in horses for the control of pain and inflammation associated with osteoarthritis.

Pursuant to section 814 of the Native American Programs Act of 1974 (the Act) as amended by 42 U.S.C. 2992b-1, ANA herein describes its proposed interpretive rules and general statements of policy and rules of agency procedure or practice in relation to the Social and Economic Development Strategies (SEDS) Special Initiative Program Announcement: Improving the Well-Being of Children/Native American Healthy Marriage Initiative (NAHMI). Under the Act, ANA is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules and general statements of policy and rules of agency procedure or practice and give notice of the final adoption of such changes at least thirty (30) days before the changes become effective. This Notice also provides additional information about ANA's plan for administering NAHMI.