Department of Health and Human Services January 30, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

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 (HHS), is contemplating the grant of an exclusive license to practice the invention embodied in: PCT patent applications PCT/US2004/21985 and PCT/US2004/22232, filed July 9, 2004, both entitled ``Use of Nitrite Salts for the Treatment of Cardiovascular Conditions'' [HHS Reference Number: E-254-2003/2-3-PCT- 01], to Aires Pharmaceuticals, Inc., a portfolio company of ProQuest Investments LLC, Princeton, N.J. The field of use of inhaled administration of nitrite salts for this exclusive license may be limited to the use of inhaled formulations of nitrite salts for the treatment of Pulmonary Hypertension and pulmonary and/or cardiopulmonary conditions. The United States of America is an assignee of the patent rights in these inventions.

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 a co-exclusive license to practice the invention embodied in Patent Applications U.S. 60/340,772, filed on 12/12/2001, U.S. 60/342,582, filed on 12/19/2001, PCT/US2002/036829, filed on 11/14/2002, and corresponding EP, CA, AU, and JP filings, as well as U.S. 10/498,416, filed on 06/10/2004; entitled ``Methods for using extracellular adenosine inhibitors and adenosine receptor inhibitors to enhance immune response and inflammation'', all by Michail V. Sitkovsky, and Akio Ohta, to Redox Therapies, Inc., having a place of business in Boston, MA. The patent rights in this invention have been assigned to the United States of America.

This notice announces the 13th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C.; App.)

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collection of information, 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. Proposed Collection: Title: Monitoring and Evaluation of the NIDA Goes Back to School National Dissemination Campaign. Type of Information Collection Request: New. Need and Use of Information Collection: This is a request for a one-time clearance to collect information on the use of the NIDA Goes Back to School (NGBTS) dissemination materials that can be requested by interested persons from the NIDA Internet site. The National Institute on Drug Abuse (NIDA) launched an initiative to increase awareness of the Institute and its mission to bring the power of science to bear on the treatment and prevention of drug abuse and addiction. NIDA has been developing science education materials for grades K-12 for use by students, teachers, parents, school counselors, school health educators, school resources officers, community organizers, and state and local government agencies. The number of requestors has been an average of 7,500 per year. These large numbers indicate that the dissemination reach is considerable. The pattern of requests also indicates that the number of requests increases dramatically in the early weeks after a dissemination activity is launched. The purpose of this information collection is to determine the level of use by school personnel and community leaders who request the NGBTS materials, and if there is a difference in use level between those requestors responding to a campaign activity and those requestors who were not reached by campaign activities. The information will identify barriers to the use of the materials among these occupational groups and the populations they serve. It will help make the materials more productive in raising the awareness of the harms from substance abuse among children, youth, and parents. It will be used to refine the focus of the dissemination activities, so that dissemination resources are used more productively. The information will be collected from requestors who have requested NIDA NGBTS materials using the requestor forms from the NIDA site, from October 2003 to September 2005. All information collection in the evaluation will be conducted on-line. The estimated total time for a survey is 5 minutes. Prior to the monitoring and evaluation study, the information collection instruments will be pilot-tested via telephone interview format, with a sample of 8 individuals who have requested these materials during the chosen study years. The surveys will include the following elements: (1) Use of the NGBTS materials, (2) Opinion of the NGBTS materials, (3) Respondent information on gender, present occupation and its duration, (4) Background information on the school or Organization/Community. Frequency of Response: This project will be conducted once. Affected Public: School personnel, and Community Leaders who have requested the NGBTS materials. Type of Respondent: School personnel, and Community Leaders who have requested the NGBTS materials from the NIDA site. Estimated Total Annual Number of Respondents: 400. Estimated Number of Responses per Respondent: 1. Average Burden Hours per Response: .08. Estimated Total Annual Burden Hours Requested: 32.0. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. The estimated annualized burden is summarized below.