Department of Health and Human Services 2011 – Federal Register Recent Federal Regulation Documents

This proposed rule would revise the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These proposed changes are an integral part of our efforts to reduce procedural burdens on providers. This proposed rule reflects the Centers for Medicare and Medicaid Services' (CMS') commitment to the general principles of the President's Executive Order 13563, released January 18, 2011, entitled ``Improving Regulation and Regulatory Review.''

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in US Patent Application 61/144,501 entitled ``Ratio Based Biomarker of Survival Utilizing PTEN and Phospho-AKT'' [HHS Ref. E-025-2009/0-US- 01], and all continuing applications and foreign counterparts, to 20/20 GeneSystems, Inc. The patent rights in this invention have been assigned 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:

The Food and Drug Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for December 1, 2011. The meeting was announced in the Federal Register of Friday, October 7, 2011 (76 FR 62419). The meeting is postponed so that FDA can review and consider additional information that was submitted. A future meeting date will be announced in the Federal Register.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation GuideData Elements and Message Specification'' (the draft E2B(R3) implementation guidance) and an appendix to the draft guidance entitled ``ICSRs: Appendix to the Implementation GuideBackwards and Forwards Compatibility'' (the draft BFC appendix). The draft E2B(R3) implementation guidance and draft BFC appendix were prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft E2B(R3) implementation guidance is intended to revise the standards for submission of ICSRs and improve the inherent quality of the data, enabling improved handling and analysis of ICSR reports. The draft BFC appendix describes the relationship between data elements from the 2001 ICH E2B guidance and draft E2B(R3) implementation guidance.

The Office of the National Coordinator for Health Information Technology has reorganized its office in order to more effectively meet the mission outlined by The Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009 (ARRA). The reorganization adds the position of Principal Deputy.

The Food and Drug Administration (FDA) is undertaking a collaboration with Health Canada, the Canadian Food Inspection Agency, Environment Canada, and Fisheries and Oceans Canada, to conduct a quantitative food safety risk assessment on norovirus in bivalve molluscan shellfish, specifically, oysters, clams, and mussels. FDA, on behalf of the collaborative team, is requesting submission of comments and scientific data and information that would assist in the development of the risk assessment.

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 of Environmental Health Sciences (NIEHS), 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: DERT Extramural Grantee Data Collection. Type of Information Collection Request: New. Need and Use of Information Collection: In order to make informed management decisions about its research programs and to demonstrate the outputs, outcomes and impacts of its research programs NIEHS will collect, analyze and report on data from extramural grantees who are currently receiving funding or who have received funding in the past on topics such as: (1) Key scientific outcomes achieved through the research and the impact on the field of environmental health science; (2) Contribution of research findings to program goals and objectives; (3) Satisfaction with the program support received; (4) Challenges and benefits of the funding mechanism used to support the science; and (5) Emerging research areas and gaps in the research. Information gained from this primary data collection will be used in conjunction with data from grantee progress reports and presentations at grantee meetings to inform internal programs and new funding initiatives. Outcome information to be collected includes measures of agency-funded research resulting in dissemination of findings, investigator career development, grant-funded knowledge and products, commercial products and drugs, laws, regulations and standards, guidelines and recommendations, information on patents and new drug applications and community outreach and public awareness relevant to extramural research funding and emerging areas of research. Satisfaction information to be collected includes measures of satisfaction with the type of funding or program management mechanism used, challenges and benefits with the program support received, and gaps in the research. Frequency of Response: Once per grantee, per NIEHS research portfolio. Affected Public: Current or past NIEHS grantees. Type of Respondents: Principal Investigators with current or past NIEHS research or training grants. The annual reporting burden is as follows: Estimated Number of Respondents: 600 over 3 years; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: .5; and Estimated Total Annual Burden Hours Requested: 100. The annualized cost to respondents is estimated at: Approximately $17. There are no Capital Costs to report. There are no Operating 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 assumptions used; (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.

The Food and Drug Administration (FDA) is proposing to amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued.

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.