Department of Health and Human Services February 2014 – Federal Register Recent Federal Regulation Documents

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 November 22, 2013, pages 70062-70063 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 Office of Extramural Research (OER), the National Institutes of Health (NIH), 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. 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, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment 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. For Further Information: To obtain a copy of the data collection plans and instruments or request more information on the proposed project contact: Dr. Paula Y. Goodwin, Special Assistant to the Director, Office of Extramural Programs, OER, NIH, 6705 Rockledge Drive, Suite 350, Bethesda, MD 20892, or call non-toll-free number (301) 496-9232 or Email your request, including your address to: OEPMailbox@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: Generic Clearance for Surveys of Customers and Partners of the Office of Extramural Research of the National Institutes of Health0925-0627ExtensionOffice of the Director (OD), Office of Extramural Research (OER), Office of Extramural Programs (OEP), National Institutes of Health (NIH). Need and Use of Information Collection: OER develops, coordinates the implementation of, and evaluates NIH-wide policies and procedures for the award of extramural funds. To move forward with our initiatives to ensure success in accomplishing the NIH mission, input from partners and customers is essential. Quality management principles have been integrated into OER's culture and these surveys will provide customer satisfaction input on various elements of OER's business processes. The approximately 14 (10 quantitative and 4 qualitative) customer satisfaction surveys that will be conducted under this generic clearance will gather and measure customer and partner satisfaction with OER processes and operations. The data collected from these surveys will provide the feedback to track and gauge satisfaction with NIH's statutorily mandated operations and processes. OER/OD/NIH will present data and outcomes from these surveys to inform the NIH staff, officers, leadership, advisory committees, and other decision-making bodies as appropriate. Based on feedback from these stakeholders, OER/ OD/NIH will formulate improvement plans and take action when necessary. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 2,485.

The Food and Drug Administration (``FDA'' or ``we'') is announcing the opening of a docket to obtain comments and scientific data and information that will help us to implement the section of the FDA Food Safety Modernization Act (FSMA) that requires FDA to designate high-risk foods. We are providing an opportunity for interested parties to submit comments and scientific data and information that will help us develop our process for implementing this provision.

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. 209 and 37 CFR Part 404 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.

This notice provides eligible entities with the information necessary to apply for participation in the Frontier Community Health Integration Project (FCHIP) demonstration. The demonstration is designed to better integrate the delivery of acute care, extended care and other health care services, and improve access to care for Medicare and Medicaid beneficiaries residing in very sparsely populated areas. A competitive application process will be used to select eligible entities for participation in this demonstration. The demonstration is planned for up to 3 years.

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 paperwork burden of animal drug sponsors to fill out the Animal Drug User Fee Act (ADUFA) cover sheet.

The Food and Drug Administration (FDA) is requesting nominations to serve on the Science Board to FDA (Science Board). FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA) is publishing this companion proposed rule to the direct final rule, issuing a new regulation to adjust for inflation the maximum civil money penalty (CMP) amounts for the various CMP authorities within our jurisdiction and to amend the process for initiating certain CMP administrative actions. We are taking these actions to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended, and to streamline our internal processes. The last CMP adjustment was published in the Federal Register of November 12, 2008, and the FCPIAA requires Federal Agencies to adjust their CMPs at least once every 4 years. We are using direct final rulemaking for these actions because the Agency expects that there will be no significant adverse comment on the rule.

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: the necessity and utility of the proposed information collection for the proper performance of the agency's functions; the accuracy of the estimated burden; ways to enhance the quality, utility, and clarity of the information to be collected; and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or we) is extending the comment period for the notice of proposed rulemaking that appeared in the Federal Register of October 29, 2013 (78 FR 64736), entitled ``Current Good Manufacturing Practice and Hazard Analysis and Risk- Based Preventive Controls for Food for Animals '' and its information collection provisions. We are taking this action in response to requests for an extension to allow interested persons more time to comment given that in addition to the proposed preventive control requirements, the proposed current good manufacturing practice (CGMP) requirements are also new to the animal food industry, unlike the human food industry. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.