Department of Health and Human Services March 26, 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 December 3, 2013, page 72682-72683 and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute Drug Abuse (NIDA), 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. 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.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting, which will be held as a webinar: ``Partnerships to Advance the National Occupational Research Agenda (NORA)''. Public Meeting Time and Date: 1 p.m.-2:30 p.m. EDT, April 22, 2014. Place: Online and teleconference only, see details below. Purpose of the Meeting: The National Occupational Research Agenda (NORA) has been structured to engage partners with each other and/or with NIOSH to advance NORA priorities. The NORA Liaison Committee continues to be an opportunity for representatives from organizations with national scope to learn about NORA progress and to suggest possible partnerships based on their organization's mission and contacts. This opportunity is now structured as a public meeting via the Internet to attract participation by a larger number of organizations and to further enhance the success of NORA. Some of the types of organizations of national scope that are especially encouraged to participate are employers, unions, trade associations, labor associations, professional associations, and foundations. Others are welcome. This meeting will include: Updates from NIOSH leadership on NORA and on plans for evaluating the second decade of NORA; A discussion of a variety of metrics NIOSH is considering for measuring its performance as a research agency; Brief written updates from most of the NORA Sector Councils on their progress, priorities, and implementation plans to date, likely including the NORA Agriculture, Forestry and Fishing; Construction; Healthcare and Social Assistance; Manufacturing; Mining; Oil and Gas Extraction; Public Safety; Services; Transportation, Warehousing and Utilities; and Wholesale and Retail Trade Sector Councils; and Time to ask questions and discuss partnership opportunities. Status: The meeting is open to the public, limited only by the capacities of the conference call and online system for sharing slides. Everyone can participate through the Internet (to see the slides) and a teleconference call (capacity 50). Each participant is requested to register for the free meeting by sending an email to noracoordinator@cdc.gov containing the participant's name, organization name, and contact telephone number on the day of the meeting. Requirements include: computer, Internet connection, and telephone, preferably with `mute' capability. An email confirming registration will include the details needed to participate in the Web meeting. Background: NORA is a partnership program to stimulate innovative research in occupational safety and health leading to improved workplace practices. Unveiled in 1996, NORA has become a research framework for the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Partners then work together to develop goals and objectives for addressing those needs and to move the research results into practice. The NIOSH role is facilitator of the process. For more information about NORA, see http:/ /www.cdc.gov/niosh/nora/about.html. Since 2006, NORA has been structured according to industrial sectors. Ten major sector groups have been defined using the North American Industrial Classification System (NAICS). After receiving public input through the Web and town hall meetings, ten NORA Sector Councils defined sector-specific strategic plans for conducting research and moving the results into widespread practice. To view the National Sector Agendas, see https://www.cdc.gov/niosh/nora/.

The Food and Drug Administration (FDA) is announcing that DSM Nutritional Products has filed a petition proposing that the food additive regulations be amended to provide for the safe use of 25- hydroxyvitamin D3 in feed for turkeys.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to solicit comments, data, and information to assist the Agency in implementing the FDA Food Safety Modernization Act (FSMA), which added new provisions to the Reportable Food Registry (RFR) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Under the new provisions, FDA may require a responsible party to also submit to FDA ``consumer-oriented'' information regarding certain reportable foods, including information necessary to enable a consumer to accurately identify whether the consumer is in possession of a reportable food. FDA must prepare and publish on FDA's Internet Web site a one-page summary of the consumer- oriented information that can be easily printed by a grocery store for the purposes of consumer notification. A grocery store that sold a reportable food that is the subject of an FDA one-page summary, and that is part of a chain of establishments with 15 or more physical locations, is required to prominently display the FDA one-page summary, or the information from the summary, within 24 hours after the one-page summary is published on FDA's Web site, through a method identified by FDA. FDA is seeking input on topics including consumer-oriented information submissions, consumer notifications, posting consumer notifications in grocery stores, and grocery stores subject to the new requirements.

The National Vaccine Advisory Committee (NVAC) was established in 1987 to comply with Title XXI of the Public Health Service Act (Pub. L. 99-660) (Sec. 2105) (42 U.S. Code 300aa-5 (PDF-78 KB) ). Its purpose is to advise and make recommendations to the Director of the National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services (HHS) as the Director of the National Vaccine Program. The National Vaccine Program Office (NVPO) is located within the Office of the Assistant Secretary for Health (OASH), Office of the Secretary, U.S. Department of Health and Human Services (HHS). NVPO provides leadership and fosters collaboration among the various federal agencies involved in vaccine and immunization activities. The NVPO also supports the National Vaccine Advisory Committee (NVAC). The NVAC advises and makes recommendations to the ASH in his capacity as the Director of National Vaccine Program on matters related to vaccine program responsibilities. In June 2012, the NVAC accepted a charge from the ASH to review the current state of maternal immunization and existing best practices and identify programmatic barriers to the implementation of current recommendations related to maternal immunization. The NVAC formed the Maternal Immunizations Working Group in August 2012 to address this charge. Through a series of teleconferences, electronic communications, and public discussions during NVAC meetings, the working group developed a number of draft recommendations for consideration by the NVAC. The NVAC draft report details the background and rationale for each of these recommendations and provides input on how the ASH might support HHS activities in these areas. The draft report and draft recommendations from the working group will inform NVAC deliberations as the NVAC finalizes their recommendations for transmittal to the ASH. NVPO is soliciting public comment on the draft report and draft recommendations from a variety of stakeholders, including the general public, for consideration by the NVAC as they develop their final recommendations to the ASH. It is anticipated that the draft report and draft recommendations, as revised with consideration given to public comment and stakeholder input, will be presented to the NVAC for adoption in June 2014 at the quarterly NVAC meeting.