Department of Health and Human Services November 2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is announcing the availability of a draft risk profile entitled ``FDA Draft Risk Profile: Pathogens and Filth in Spices'' (draft risk profile). Our main objectives were to: Describe the nature and extent of the public health risk posed by consumption of spices in the United States by identifying the most commonly occurring microbial hazards and filth in spice; describe and evaluate current mitigation and control options designed to reduce the public health risk posed by consumption of contaminated spices in the United States; identify potential additional mitigation or control options designed to reduce the public health risk posed by the consumption of contaminated spices in the United States; and identify data gaps and research needs. The draft risk profile is intended to provide information for FDA risk managers to use in regulatory decision making related to the safety of spices in the U.S. food supply. The information may also be useful to stakeholders and interested parties such as spice producers and importers, spice and food manufacturers, retail food establishments, and consumers.

This notice solicits nominations for five new members to the Advisory Panel on Hospital Outpatient Payment (HOP, the Panel). There are five vacancies on the Panel effective September 30, 2013. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on the clinical integrity of the Ambulatory Payment Classification (APC) groups and their associated weights, and supervision of hospital outpatient services. The Secretary rechartered the Panel in 2012 for a 2-year period effective through November 19, 2014.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (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.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (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.

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), 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 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. 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: Irene Prabhu Das, Division of Cancer Control & Population Sciences, National Cancer Institute, 9609 Medical Center Drive, Room 3E-518, Rockville, MD 20850-9704 or call non-toll-free number 240-276-6799 or Email your request, including your address to: prabhudasi@mail.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: Multidisciplinary Treatment Planning (MTP) within the NCI Community Cancer Centers Program (NCI), 0925NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The aim of this data collection is to characterize how NCI Community Cancer Centers Program (NCCCP) hospitals define, structure, and implement multidisciplinary treatment planning (MTP), which initiates a coordinated approach to multidisciplinary care. The web-based, organizational survey will gather data on sites' definitions and terms for multidisciplinary treatment planning, composition of provider teams, meeting process, and patient involvement in the process. Information collected from NCCCP hospitals will add to the knowledge being generated and provide the foundation for research on multidisciplinary care in cancer. A total of 21 hospitals participating in the NCCCP through June 2014 will be requested to complete the survey. OMB approval is requested for 1 year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 22.

The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our proposed collection of certain information. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies must publish a notice in the Federal Register concerning each proposed collection of information, including each proposed reinstatement of an existing collection of information and allow 60 days for public comment. This notice invites comments on a voluntary consumer survey entitled, ``Food Safety Survey.''

The Food and Drug Administration (FDA or we) 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 information collection provisions of our regulations requiring that the Agency receive prior notice before food is imported or offered for import into the United States.