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

The Food and Drug Administration (FDA) is announcing the referral of ZINECARD (dexrazoxane) and RELPAX (eletriptan) Written Requests for the conduct of pediatric studies to the Foundation for the National Institutes of Health (the Foundation). FDA referred the ZINECARD (dexrazoxane) and RELPAX (eletriptan) Written Requests to the Foundation on August 29, 2005, and is publishing this notice of the referrals in accordance with the Best Pharmaceuticals for Children Act (BPCA).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Record Retention Requirements for the Soy Protein and Risk of Coronary Heart Disease Health Claim'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 reporting and recordkeeping requirements for food irradiation processors.

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.

The Department of Health and Human Services, the National Institutes of Health (NIH), has decided, after completion of a Final Environmental Impact Statement (FEIS) and a thorough consideration of the public comments on the Draft EIS and Supplemental EIS, to implement the Proposed Action, which is identified as the Preferred Alternative in the Final EIS. This action is to partially fund the construction of a state-of-the-art National Biocontainment Laboratory (NBL), to be called the National Emerging Infectious Diseases Laboratories (NEIDL), at the Boston University Medical Center (BUMC) Campus in Boston, Massachusetts.

The Food and Drug Administration (FDA) has determined the regulatory review period for OMACOR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of three applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of three patents that claim that human drug product.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1) (i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent No. 6,596,690 B2 entitled ``Vasostatin as Marrow Protectant'' (HHS Reference E-230-2000/0); U.S. Patent Application No. 09/807,148 filed April 5, 2001, entitled ``Use of Calreticulin and Calreticulin Fragments To Inhibit Endothelial Cell Growth and Angiogenesis and Suppress Tumor Growth'' (HHS Reference E- 082-1998/0-US-03); PCT Application No. PCT/US99/23240 filed October 5, 1999 entitled ``Use of Calreticulin and Calreticulin Fragments To Inhibit Endothelial Cell Growth and Angiogenesis and Suppress Tumor Growth'' (HHS Reference E-082-1998/0-PCT-02); to RxKinetix, Inc. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide and the field of use may be limited to development and sale of a pharmaceutical product useful in protecting bone marrow stem cells from the toxic effects of chemotherapy and radiotherapy.

The Food and Drug Administration (FDA) is issuing this notice, under the Federal Food, Drug, and Cosmetic Act (the act), of the termination, by expiration, of the declaration of emergency justifying emergency use authorization of Anthrax Vaccine Adsorbed (AVA) that was issued by the former Secretary of Health and Human Services Secretary Tommy G. Thompson (the former HHS Secretary) on January 14, 2005. The declaration of emergency terminated by expiration on January 14, 2006, which is the end of the 1-year period that began on the date that the declaration was made. Under the act, advance notice of the termination of the declaration was provided to the Department of Defense.

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 license worldwide to practice the invention embodied in U.S. Patent Application Number 60/654,331 filed February 18, 2005, entitled ``Identification of Molecular Markers for Endometriosis in Blood Lymphocytes Using DNA Microarrays,'' to Ortho-Clinical Diagnostics, having a place of business in Raritan, NJ 08869. The contemplated exclusive license may be limited to an FDA approvable human DNA diagnostic test for endometriosis. The United States of America is the assignee of the patent rights in this invention.