Department of Health and Human Services July 2006 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 242
National Institute of Environmental Health Sciences; Division of Extramural Research and Training; Submission for OMB Review; Comment Request; Hazardous Waste Worker Training
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), 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 April 5, 2006, page 17119, 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: Hazardous Waste Worker Training42 CFR Part 65. Type of Information Collection Request: Revision of OMB No. 0925-0348, expiration date August 31, 2006. Need and Use of Information Collection: This request for OMB review and approval of the information collection is required by regulation 42 CFR part 65(a)(6). The National Institute of Environmental Health Sciences (NIEHS) has been given major responsibility for initiating a worker safety and health training program under section 126 of the Superfund Amendments and Reauthorization Act of 1986 (SARA) for hazardous waste workers and emergency responders. A network of non-profit organizations that are committed to protecting workers and their communities by delivering high-quality, peer-reviewed safety and health curricula to target populations of hazardous waste workers and emergency responders has been developed. In seventeen years (FY 1987-2004), the NIEHS Worker Training program has successfully supported 20 primary grantees that have trained more than 1.3 million workers across the country and presented over 69,000 classroom and hands-on training courses, which have accounted for nearly 18 million contact hours of actual training. Generally, the grant will initially be for one year, and subsequent continuation awards are also for one year at a time. Grantees must submit a separate application to have the support continued for each subsequent year. Grantees are to provide information in accordance with S65.4(a), (b), (c) and 65.6(b) on the nature, duration, and purpose of the training, selection criteria for trainees' qualifications and competency of the project director and staff, cooperative agreements in the case of joint applications, the adequacy of training plans and resources, including budget and curriculum, and response to meeting training criteria in OSHA's Hazardous Waste Operations and Emergency Response Regulations (29 CFR 1910.120). As a cooperative agreement, there are additional requirements for the progress report section of the application. Grantees are to provide their information in hard copy as well as enter information into the WETP Grantee Data Management System. The information collected is used by the Director through officers, employees, experts, and consultants to evaluate applications based on technical merit to determine whether to make awards. Frequency of Response: Biannual. Affected Public: Non-profit organizations. Type of Respondents: Grantees. The annual reporting burden is as follows: Estimated Number of Respondents: 18; Estimated Number of Responses per Respondent: 2; Average Burden Hours per Response: 10; and Estimated Total Annual Burden Hours Requested: 360. The annualized cost to respondents is estimated at: $10,764. There are no Capital Costs, Operating Costs and/or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumption use; (3) Ways to enhance the quality, utility and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Joseph T. Hughes, Jr., Director, Worker Education and Training Program, Division of Extramural Research and Training, NIEHS, P.O. Box 12333, Research Triangle Park, NC 27709 or call non-toll-free number (919) 541-0217 or E-mail your request, including your address to wetp@niehs.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
Submission for OMB Review; Comment Request; Outcome Evaluation of NCI's Activities To Promote Research Collaboration (APRC) Program
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 for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 13, 2006, page 12703-12704 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.
Submission for OMB Review; Comment Request; Collection of Demographic and Smoking/Tobacco Use Information from NCI Cancer Information Service Clients
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection below. This proposed information collection was previously published in the Federal Register on Friday, January 20, 2006, page 3313 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 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: Collection of Demographic and Smoking/ Tobacco Use Information from NCI Cancer Information Service Clients. Type of Information Collection Request: Revision. Need and Use of Information Collection: The NCI's Cancer Information Service (CIS) provides accurate and up-to-date cancer information to the public through a toll-free telephone number (1-800- 4-CANCER) and LiveHelp, an online instant messaging service. In addition, CIS provides smoking cessation assistance through a telephone quitline (accessed through 1-800-44U-QUIT or 1-800-QUITNOW). Eligible smoking cessation clients have the opportunity to participate in a callback service, which provides up to four follow-up counseling calls. Characterizing CIS clients is essential to customer service, program planning, and promotion. Currently CIS conducts a brief survey of a sample of telephone and LiveHelp clients at the end of usual service (OMB No. 0925-0208); the survey includes three customer service and five demographic questions (age, sex, race, ethnicity, education). This request is to supplement the current data collection activity by adding: (1) Four demographic questions related to income, health insurance coverage, and regular source of health care; (2) 20 smoking intake questions for individuals seeking smoking cessation assistance; and (3) one smoking follow-up question for smoking cessation clients participating in the callback service. The demographic questions will allow CIS to better measure the program's reach to underserved populations and program impacts on these populations. The smoking intake questions are necessary as part of the needs assessment process for smoking cessation clients. Information about clients smoking history, previous quit attempts, and motivations to quit smoking will enable Information Specialists to provide effective individualized counseling. The smoking follow-up question will allow CIS to track clients smoking behavior and measure quit rates over the period of the callback service. Consistent with the current data collection, the proposed questions will be asked of clients who are cancer patients, family members and friends of patients, and the general public. The proposed sampling is consistent with the current data collection, with 25% of telephone and quitline clients sampled for the proposed demographic questions. If the call is the result of a special promotion, 50% of callers will be surveyed. Overall, it is estimated that 36% of telephone and quitline clients will be sampled for the demographic questions. The demographic questions will be asked of 50% of LiveHelp clients; the higher sampling rate is necessary due to the lower response rate among online clients. The proposed smoking intake questions will be asked of 100% of smoking cessation clients and the smoking follow-up question will be asked of 100% of smoking cessation clients participating in the callback service. Table 1 presents the estimated numbers of respondents, numbers of responses per respondent, average burden hours per response, and annual burden hours for each subgroup of respondents. The combined total to be surveyed each year is approximately 49,400 CIS clients for a total of 1,578 annual burden hours. Frequency of Response: Single time for demographic and smoking intake questions; up to four times for the smoking follow-up question. Affected Public: Individuals or households. Type of Respondents: Cancer patients, family members and friends of cancer patients, and general public who contact CIS via telephone or online. The annual reporting burden is presented in Table 1.
Submission for OMB Review; Comment Request; Survey of Estimated Glomerular Filtration Rate Reporting Practices of Clinical Laboratories
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) 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 25, 2006, page 4151-4152 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. This 30-day submission is modified in order to reflect an increase in sample size. 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.
Office of the National Coordinator; American Health Information Community Biosurveillance Data Steering Group Meeting
This notice announces the second meeting of the American Health Information Community Biosurveillance Data Steering Group in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Guidance on Useful Written Consumer Medication Information; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Useful Written Consumer Medication Information (CMI).'' CMI is written information developed for consumers about prescription drugs that is distributed to consumers when they have prescriptions filled. The guidance discusses general issues and makes recommendations on the content of useful written CMI.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance: Emergency Use Authorization of Medical Products
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.
Request for Nominations for Voting Members on a Public Advisory Committee; Pediatric Advisory Committee
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Pediatric Advisory Committee in the Office of the Commissioner. Nominations will be accepted for vacancies that have occurred on or before June 30, 2006. FDA has special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.
Notice of Listing of Construction Grant Programs
Section 52b.1(b) of the regulations governing National Institutes of Health (NIH) construction grants, codified at 42 CFR part 52b, authorizes the NIH Director to publish periodically a list of the construction grant programs to which the construction grant regulations apply. This Notice announces the most recent list of the programs covered by the regulations.
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the seventh meeting of the American Health Information Community (``Community'') Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Medical Devices; Anesthesiology Devices; Neurological Devices; Denial of Request for Change in Classification of Breathing Frequency Monitor and Electroencephalograph
The Food and Drug Administration (FDA) is denying the petitions submitted by IM Systems to reclassify the SleepCheck, the ActiTrac, and PAM-RL devices from class II (special controls) to class I (general controls). The agency is denying the petitions because the petitioner failed to provide sufficient new information to establish that general controls would provide reasonable assurance of the safety and effectiveness of the devices.
Oral Dosage Form New Animal Drugs; Ivermectin Paste
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Med-Pharmex, Inc. The ANADA provides for oral use of ivermectin paste in horses for treatment and control of various internal parasites or parasitic conditions.
Determination That PHENERGAN (Promethazine Hydrochloride) Tablets, 12.5 Milligrams and 50 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that PHENERGAN (promethazine hydrochloride (HCl)) tablets, 12.5 milligrams (mg) and 50 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for promethazine HCl tablets, 12.5 mg and 50 mg.
Office of the National Coordinator; American Health Information Community Chronic Care Workgroup Meeting
This notice announces the seventh meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator; American Health Information Community Electronic Health Records Workgroup Meeting
This notice announces the seventh meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator; American Health Information Community Biosurveillance Workgroup Meeting
This notice announces the seventh meeting of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator; American Health Information Community Meeting
This notice announces the seventh meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).
Privacy Act of 1974, as Amended; Computer Matching Program
In compliance with the Privacy Act of 1974, as amended by Pub. L. 100-503, the Computer Matching and Privacy Protection Act of 1988, we are publishing a notice of a computer matching program. The purpose of this computer match is to identify specific individuals who are receiving benefits from the VA and also receiving payments pursuant to various benefit programs administered by both HHS and Department of Agriculture. ACF will facilitate this program on behalf of the State Public Assistance Agencies (SPAAs) that participate in the Public Assistance Reporting Information System (PARIS) for verification of continued eligibility for public assistance. The match will utilize Department of Veterans Affairs (VA) records and SPAA records.
Prospective Grant of Exclusive License: Convection Enhanced Delivery and Tracking of Gadolinium Conjugated Therapeutic Agents to the Central Nervous System
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 worldwide license to practice the invention embodied: HHS. Ref. No. E-202-2002 ``Method for Convection Enhanced Delivery of Therapeutic Agents,'' Provisional Patent Application, 60/413,673; International Patent Application PCT/US03/30155, U.S. Patent Application Serial No. 10/528,310; European Patent Applications Serial No. 03756863.1; Australian Patent Application No. 2003299140; Canadian Patent Application No. 2,499,573; and HHS Ref. No. E-206-2000/0 and/1 ``Method for Increasing the Distribution of Therapeutic Agents;'' and ``Method for Increasing the Distribution of Nucleic Acids;'' Provisional, Patent Application 60/250,286; Provisional Patent Application No. 60/286,308; U.S. Patent Application No. 09/999,203; U.S. Patent Application No. 10/132,681; and Canadian Patent Application No. 2327208, to MedGenesis Therapeutix, Inc. a Canadian company having its headquarters in Victoria, British Columbia. The United States of America is the assignee of the patent rights of the above invention. The contemplated exclusive license may be granted in a field of use limited to the convection enhanced delivery and tracking of gadolinium conjugated peptides, polypeptides or lipid-based therapeutic agents within the central nervous system of subjects with cancer, Parkinson's disease, Dementia with Lewy bodies or Alzheimer's disease.
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.
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