Department of Health and Human Services January 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 238
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Interstate Shellfish Dealers Certificate
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Interstate Shellfish Dealers Certificate'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Memorandum of Understanding Between the United States Food and Drug Administration and the Veterans Health Administration
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Veterans Health Administration. The purpose of this MOU is to enhance knowledge and efficiency by providing for the sharing of information and expertise related to the review and use of FDA-regulated drugs, biologics, and medical devices between the two agencies. The goals of the collaboration are to explore ways to: Further enhance information sharing efforts through more efficient and robust interagency activities; promote efficient utilization of tools and expertise for product risk identification, validation, and analysis; and build infrastructure and processes that meet the common needs for evaluating the safety, efficacy, and utilization of drugs, biologics, and medical devices.
Submission for OMB Review; Comment Request; California Health Interview Survey 2007
Under the provisions of Section 3507(a)(1)(D) 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 Sept. 11, 2006, p. 53456 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.
James T. Kimball; Denial of Hearing; Final Debarment Order
The Food and Drug Administration (FDA) is denying Mr. James T. Kimball's request for a hearing and is issuing a final order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Mr. James T. Kimball from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Kimball was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the act. In addition, Mr. Kimball has failed to file with the agency information and analyses sufficient to create a basis for a hearing concerning this action.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
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.
Indevus Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application
The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for REDUX (dexfenfluramine hydrochloride (HCl)) Capsules held by Indevus Pharmaceuticals, Inc. (Indevus), 33 Hayden Ave., Lexington, MA 02421-7971. Indevus has requested that approval of this application be withdrawn because the product is no longer marketed, thereby waiving its opportunity for a hearing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Prospective Grant of Exclusive License: Use of Inhaled Nitrite Therapy for the Treatment of Pulmonary Conditions
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.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Prospective Grant of Co-Exclusive License: Prevention and Treatment of Human Cancer and Tumors by Inhibitors of Any or All of the Adenosine Receptor Subtypes Covered by the Licensed Patent Rights
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.
Office of the National Coordinator for Health Information Technology; American Health Information Community Population CARE and Clinical Care Connections Workgroup Meeting
This notice announces the 13th meeting of the American Health Information Community Population Care and Clinical Care Connections Workgroup [formerly Biosurveillance Workgroup] in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Chronic Care Workgroup Meeting
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.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup Meeting
This notice announces the 5th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)
Proposed Collection; Comment Request; Monitoring and Evaluation of the NIDA Goes Back to School National Dissemination Campaign
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.
Office of the Secretary; Amendment To Extend the January 24, 2003, Declaration Regarding Administration of Smallpox Countermeasures, as Amended on January 24, 2004, January 24, 2005, and January 24, 2006
Concern that terrorists may have access to the smallpox virus and attempt to use it against the American public and United States Government facilities abroad continues to exist. The January 24, 2003, declaration regarding administration of smallpox countermeasures is revised to incorporate statutory definitions from the Smallpox Emergency Personnel Protection Act of 2003 and extended for one year until and including January 23, 2008.
Proposed Collection; Comment Request; Phase II of a Prospective Cohort Study of Diet and Cancer in Members of the American Association of Retired Persons
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 Cancer Institute (NCI), 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: Phase II of A Prospective Cohort Study of Diet and Cancer in Members of the American Association of Retired Persons. Type of Information Collection Request: New. Need and Use of Information Collection: The specific objectives of the current study are to: (1) Examine prospectively the relation between diet and major cancers (especially those of the breast, colorectal, prostate, and non- Hodgkin's lymphoma; (2) in a series of pilot studies, evaluate the quality and completeness of dietary data collected from automated web- based dietary assessment instruments, individually and collectively, in a large cohort, and; (3) in a calibration substudy, compare energy expenditure (measured by doubly labeled water) and protein and potassium intakes (measured by 24-hour urinary nitrogen and potassium excretion) with intakes of energy, protein, and potassium as reported on web-based, automated 24-Hour Dietary Record (24HR), an automated Diet History Questionnaire (DHQ), and an automated DHQ adjusted by automated 7-Day Food Lists (7DFLs) to assess measurement error structure in the instruments. The proposed study will build on the existing Prospective Study of Diet and Cancer in members of the American Association of Retired Persons by updating exposure information in the existing cohort and allowing for continued tracking and follow-up; (2) expanding the cohort by recruiting additional participants and surveying their diet and other exposures. In addition to the 566,403 persons from the original cohort, a new cohort of 2.5 million 50-59 year olds from the same states as the original AARP cohort, and 4 million 50-69 year olds from 8 new states will be contacted as part of the recruitment and data collection effort. Phase II will apply the latest technology to use web-based data collection instruments for economical and efficient assessment of dietary exposures of study participants. This uniquely designed cohort study has a capacity greater than that of any previous study for evaluating connections between dietary factors and major cancers. Frequency of Response: The frequency of response is dependent on the instrument and the portion of the study that the respondent is participating in (pilot, main study, and/or calibration substudy), as described in the table below. Affected Public: Individuals. Type of Respondents: U.S. adults (person ages 50-85). The annual reporting burden is as follows:
Medicare and Medicaid Programs; Reapproval of Deeming Authority of the Accreditation Association for Ambulatory Health Care, Inc. for Medicare Advantage Health Maintenance Organizations and Local Preferred Provider Organizations
This notice announces our decision to approve Medicare Advantage Deeming Authority of the Accreditation Association for Ambulatory Health Care, Inc. for health maintenance organizations and local preferred provider organizations for a term of 6 years.
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