Department of Health and Human Services February 2013 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Office of the Assistant Secretary for Financial Resources, Office of Grants and Acquisition Policy and Accountability, Division of Acquisition; Public Availability of the Department of Health and Human Services FY 2011 Service Contract Inventory
In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (Pub. L. 111-117), Department of Health and Human Services (HHS) is publishing this notice to advise the public of the availability of its FY 2011 Service Contract inventory. This inventory provides information on service contract actions over $25,000 that were made in FY 2011. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010 and December 19, 2011 by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP). OFPP's guidance is available at https://www.whitehouse.gov/ sites/default/files/omb/procurement/memo/service-contract-inv entories- guidance-11052010.pdf. HHS has posted its inventory and a summary of the inventory on the HHS homepage at the following link: https:// www.hhs.gov/grants/servicecontractsfy11.html.
Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements
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 estimated reporting, recordkeeping, and third-party disclosure burden associated with the Mammography Quality Standards Act requirements.
Proposed Collection; 60-Day Comment Request: Request for Human Embryonic Stem Cell Line To Be Approved for Use in NIH Funded Research
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 Office of Extramural Research (OER), 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. Written comments and/or suggestions from the public and affected agencies are invited to address 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 assumptions used; (3) The quality, utility, and clarity of the information to be collected; and (4) 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. To Submit Comments and For Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Ellen Gadbois, Office of Science Policy, Office of the Director, NIH, Building 1, Room 218, MSC 0166, 9000 Rockville Pike, Bethesda, MD 20892, or call non-toll-free number (301)-496-1454 or Email your request, including your address to: gadboisel@od.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Request for Human Embryonic Stem Cell Line to be Approved for Use in NIH Funded Research. OMB No. 0925-0601 Expiration Date 4/30/2013ExtensionOffice of Extramural Research (OER), National Institutes of Health (NIH). Need and Use of Information Collection: The form is used by applicants to request that human embryonic stem cell lines be approved for use in NIH funded research. Applicants may submit applications at any time. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 3,375.
Determination of Regulatory Review Period for Purposes of Patent Extension; LAVIV
The Food and Drug Administration (FDA) has determined the regulatory review period for LAVIV 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 human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZYTIGA
The Food and Drug Administration (FDA) has determined the regulatory review period for ZYTIGA 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 human drug product.
Disease, Disability, and Injury Prevention and Control Special Emphasis Panels (SEP): Initial Review
Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled ``Pediatric Information Incorporated into Human Prescription Drug and Biological Products Labeling.'' This draft guidance is intended to assist applicants and FDA review staff in making decisions about the placement and content of pediatric information in human prescription drug and biological products labeling in accordance with the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), as well as FDA prescription drug and biological product labeling regulations.
Prospective Grant of Exclusive License: The Development of m971 and m972 Chimeric Antigen Receptors (CARs) for the Treatment of B Cell Malignancies
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, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in (a) U.S. Patent Application 61/717,960 entitled ``M971 Chimeric Antigen Receptors'' [HHS Ref. E-291-2012/0-US-01], and (b) U.S. Patent Application 61/042,239 entitled ``Human Monoclonal Antibodies Specific for CD22'' [HHS Ref. E-080-2008/0-US-01], PCT Application PCT/US2009/ 124109 entitled ``Human and Improved Murine Monoclonal Antibodies Against CD22'' [HHS Ref. E-080-2008/0-PCT-02], US patent application 12/934,214 entitled ``Human Monoclonal Antibodies Specific for CD22 '' [HHS Ref. E-080-2008/0-US-03], and all related continuing and foreign patents/patent applications for these technology families, to Neomune, Inc. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to:
Submission for OMB Review; Comment Request: Clinical Mythteries: A Video Game About Clinical Trials
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, 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 June 13, 2012, page 35407 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: Clinical Mythteries: A Video Game About Clinical Trials. Type of Information Collection Request: NEW. Need and Use of Information Collection: New England Research Institutes as a contractor for the National Heart Lung and Blood Institute is planning to create an engaging, informational ``serious video game'' for adolescents about clinical studies which: (1) Incorporates core learning objectives; and (2) dispels misconceptions. Two types of information collection are planned: Usability testing to understand game-play/usability. This information will be collected by focus group and will be digitally recorded 90 minute groups. A pre/post randomized trial to measure change in knowledge. This information will be collected electronically through on-line questionnaire. The game will be incorporated with a larger initiative to provide information about clinical research (https://www.nhlbi.nih.gov/ childrenandclinicalstudies/index.php). Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adolescentsaged 8- 14. The annual reporting burden is as follows: Estimated Number of Respondents: 280; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: Wave 190/60 (1.5 hours), Wave 2 80/60 (1.33 hours); and Estimated Total Annual Burden Hours Requested: 378. The annualized cost to respondents is estimated at: $3,783. There are no Capital Costs to report. The Operating Costs to collect this information is estimated at $42,425.00.
Medicare Program; Changes to the Semi-Annual Meeting of the Advisory Panel on Hospital Outpatient Payment (HOP Panel)-March 11 and March 12, 2013
This notice announces changes to the meeting date and time, location, and format of the first semi-annual public meeting of 2013 that was announced and published in the Federal Register on November 26, 2012, entitled ``Medicare Program; Semi-Annual Meeting of the Advisory Panel on Hospital Outpatient Payment (HOP Panel)March 11 and 12, 2013.''
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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