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

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), National Cancer Institute (NCI), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 20, 2006, page 3309 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 comment. 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: National Survey of Primary Care Physicians' Recommendations and Practice for Breast, Cervical, Colorectal, and Lung Cancer Screening. Type of Information Collection Request: New. Need and Use of Information Collection: This study will obtain current, national data on primary care physicians' knowledge, attitudes, recommendations, and practices related to screening for breast, cervical, colorectal, and lung cancer. There have been substantial changes in guidelines and/or technologies for these types of cancer screening in recent years. The data collected in this study will support and further NCI work in monitoring and evaluating providers' cancer control knowledge, attitudes, and practices and their impact on population health, as well as enable monitoring of progress toward major cancer control goals. Two questionnaires, one covering breast and cervical cancer screening and the other colorectal and lung cancer screening, will be administered by mail or telephone to a randomly-selected national sample of primary care physicians. Frequency of Response: One Time. Affected Public: Medical practices, clinics, or other health care organizations. Type of Respondents: Primary Care Physicians. Burden estimates are as follows:

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in: 1. E-177- 1990/2-US-01, ``Activity-dependent Neurotrophic Factor'' by Douglas E. Brenneman and Illana Gozes, patent number 5,767,240 (issue date June 16, 1998); 2. E-177-1990/3-US-01, ``Activity-dependent Neurotrophic Factor'' by Douglas E. Brenneman and Illana Gozes, patent number 6,174,862 (issue date January 16, 2001); 3. E-177-1990/1-PCT-01, ``Activity-dependent Neurotrophic Factor'' by Douglas E. Brenneman and Illana Gozes, patent application number PCT/US92/03109 (filing date April 22, 1992) and all related foreign patent applications; 4. E-177- 1990/3-PCT-02, ``Activity-dependent Neurotrophic Factor'' by Douglas E. Brenneman and Illana Gozes, patent application number PCT/US95/12929 (issue date October 16, 1995) and all related foreign patent applications; 5. E-209-2001/0-US-01, ``Neurotrophic Components of the ADNF I Complex'' by Brenneman et al., patent application number 60/ 322,760 (filing date September 12, 2001); 6. E-209-2001/2-US-01, ``Neurotrophic Components of the ADNF I Complex'' by Brenneman et al., patent application number 60/371,961 (filing date April 10, 2002); 7. E-209-2001/1-PCT-01, ``Neurotrophic Components of the ADNF I Complex'' by Brenneman et al., patent application number PCT/US02/29146 (filing date September 12, 2002); 8. E-209-2001/1-US-02, ``Neurotrophic Components of the ADNF I Complex'' by Brenneman et al., patent application number 10/489,515 (filing date March 11, 2004); to Allon Therapeutics, having a place of business in Vancouver, BC, Canada. 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 therapeutics for the treatment of human neurodegenerative diseases.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (178) entitled ``Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims.'' This draft guidance provides recommendations to industry relating to study design and describes the criteria that the Center for Veterinary Medicine (CVM) intends to use to evaluate effectiveness studies for swine respiratory disease (SRD) claims.

The Food and Drug Administration (FDA) is announcing the availability for comment of a draft revised guidance for industry (73) entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)'' VICH GL3(R). This draft revised guidance, which updates a guidance on the same topic for which a notice of availability was published in the Federal Register of October 12, 1999 (64 FR 55293) (the 1999 guidance), has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft revised document is intended to provide guidance regarding the development of stability testing data new animal drug applications (referred to as registration applications in the guidance) submitted to the European Union (EU), Japan, and United States.

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 Institute on Drug Abuse (NIDA), the 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 proposed information collection was previously published in the Federal Register on December 8, 2004, page 71060 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 comment. 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.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``S8 Immunotoxicity Studies for Human Pharmaceuticals.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides recommendations on nonclinical testing approaches to identify compounds that have the potential to be immunotoxic and guidance on a weight-of-evidence decisionmaking approach for immunotoxicity testing. The guidance is intended to provide recommendations on nonclinical testing for immunotoxicity induced by human pharmaceuticals. The guidance applies to unintended immunosuppression and immunoenhancement, excluding allergenicity or drug-specific autoimmunity.

The Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice regarding changes to the National Registry of Evidence-based Programs and Practices (NREPP) in the March 14, 2006 Federal Register. This document contained several comments from the American Psychological Association's Division 50 Committee on Evidence- based Practice that were incorrectly attributed to the full American Psychological Association.

This notice announces the fourth meeting of the American Health Information Community Consumer Empowerment workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92463, 5 U.S.C., App.).