Department of Health and Human Services October 15, 2010 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) is pleased to announce the upcoming 5th Annual Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop and BARDA Industry Day to be held January 10-12, 2011 at the Walter E. Washington Convention Center in Washington, DC. This annual PHEMCE event will bring together private- and public-sector stakeholders including: Federal Officials, International Governments, Industry, Healthcare Providers, First Responders, Community-Based Organizations, and other interested audiences. Attendees will have opportunities to participate in Medical Countermeasure focused forums on: Pre-Event Positioning of Medical Countermeasures. Emergency Planning for Vulnerable Populations. Industry Feedback on Contracting Issue. Medical Countermeasures Development: Expanding the Pipeline and Exploring Multi-Use Potential. BARDA Industry Day Presentations. This free Workshop will also address current state of public health emergency medical countermeasure preparedness plans and opportunities to enhance national response capabilities. BARDA Industry Day provides a unique opportunity for biotechnology and pharmaceutical industry representatives to showcase their latest advances in vaccines, therapeutics, diagnostics, and platform technologies targeting chemical, biological, radiological, nuclear, and naturally emerging threats, including pandemic influenza.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on August 4, 2010, pages 46945-6, and allowed 60-days for public comment. Only one comment was 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: Multi-Ethnic Study of Atherosclerosis (MESA) Event Surveillance. Type of Information Request: Renewal (OMB No. 0925-0493). Need and Use of Information Collection: The study, MESA, is identifying and quantifying factors associated with the presence and progression of subclinical cardiovascular disease (CVD) that is, atherosclerosis and other forms of CVD that have not produced signs and symptoms. The findings provide important information on subclinical CVD in individuals of different ethnic backgrounds and provide information for studies on new interventions to prevent CVD. The aspects of the study that concern direct participant evaluation received a clinical exemption from OMB clearance (CE-99-11-08) in April 2000. OMB clearance is being sought for the contact of physicians and participant proxies to obtain information about clinical CVD events that participants experience during the follow-up period. Frequency of response: Once per CVD event. Affected public: Individuals. Types of Respondents: Physicians and selected proxies of individuals recruited for MESA. The annual reporting burden is as follows: Estimated Number of Respondents: 74; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours Per Response: 0.20; and Estimated Total Annual Burden Hours Requested: 14.7. The annualized cost to respondents is estimated at: $500. There are no capital, operating, or maintenance costs to report.

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 on Alcohol Abuse and Alcoholism (NIAAA), 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: National Epidemiologic Survey on Alcohol and Related ConditionsIII. Type of Information Collection Request: NEW. Need and Use of Information Collection: This study will determine the prevalence of alcohol use patterns and alcohol use disorders and their associated disabilities in a representative sample of adults in the United States population. The primary objectives of this study are to: (1) Understand the relationships between alcohol use patterns and alcohol use disorders and their related psychological and medical disabilities with a view toward designing more effective treatment, prevention and intervention programs; (2) identify subgroups at high risk for alcohol use disorders that are complicated by associated disabilities; (3) understand treatment utilization, unmet treatment need, barriers to treatment, health disparities, and economic costs of alcohol use disorders and their associated disabilities; and (4) identify environmental and genetic risk factors and their interactions that are associated with harmful consumption patterns and alcohol use disorders and their associated disabilities. Frequency of Response: On occasion. Affected Public: Individuals. Type of Respondents: Adults. Estimated Total Annual Burden:

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Partnerships to Advance the National Occupational Research Agenda (NORA)''. Public Meeting Time and Date: 10 a.m.-3:30 p.m. EST, January 26, 2011. Place: Patriots Plaza, 395 E Street, SW., Conference Room 9000, Washington, DC 20201. 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 as well as updates from approximately half of the NORA Sector Councils on their progress, priorities, and implementation plans to date, including the NORA Agriculture, Forestry, and Fishing; Healthcare and Social Assistance; Mining; Oil and Gas Extraction; and Transportation, Warehousing, and Utilities Sector Councils. Updates will also be given on the Mid-Decade Review of NORA and the NORA Symposium 2011. After each update, there will be time to discuss partnership opportunities. Status: The meeting is open to the public, limited only by the capacities of the conference call and conference room facilities. There is limited space available in the meeting room (capacity 34). Therefore, information to allow participation in the meeting through the Internet (to see the slides) and a teleconference call (capacity 50) will be provided to registered participants. Participants are encouraged to consider attending by this method. Each participant is requested to register for the free meeting by sending an e-mail to noracoordinator@cdc.gov containing the participant's name, organization name, contact telephone number on the day of the meeting, and preference for participation by Web meeting (requirements include: computer, Internet connection, and telephone, preferably with `mute' capability) or in person. An e-mail confirming registration will include the details needed to participate in the Web meeting. Non-US citizens are encouraged to participate in the Web meeting. Non-US citizens who do not register to attend in person on or before January 7, 2011, will not be granted access to the meeting site and will not be able to attend the meeting in-person due to mandatory security clearance procedures at the Patriots Plaza facility. 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 have been working to define sector-specific strategic plans for conducting research and moving the results into widespread practice. During 2008-10, most of these Councils posted draft strategic plans for public comment and eight have posted finalized National Sector Agendas after considering comments on the drafts. For the National Sector Agendas, see https://www.cdc.gov/niosh/nora/.

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of Intramural Training & Education, 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 July 20, 2010 (Vol. 75, No. 138 on pages 42097-42098) 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: NIH Office of Intramural Training & Education Application. Type of Information Collection Request: Revision. Need and Use of Information Collection: The Office of Intramural Training & Education (OITE) administers a variety of programs and initiatives to recruit pre-college through post-doctoral educational level individuals into the National Institutes of Health Intramural Research Program (NIH-IRP) to facilitate develop into future biomedical scientists. The proposed information collection is necessary in order to determine the eligibility and quality of potential awardees for traineeships in these programs. The applications for admission consideration include key areas such as: Personal information, eligibility criteria, contact information, student identification number, training program selection, scientific discipline interests, educational history, standardized examination scores, reference information, resume components, employment history, employment interests, dissertation research details, letters of recommendation, financial aid history, sensitive data, future networking contact, travel information, as well as feedback questions about interviews and application submission experiences. Sensitive data collected on the applicants, race, gender, ethnicity and recruitment method, are made available only to OITE staff members or in aggregate form to select NIH offices and are not used by the admission committee for admission consideration; optional to submit. Over the last several years the OITE has used three OMB Clearance Numbers for the collection of applications for the training programs. To improve announcement of all training programs and lessen the burden of applicants, the OITE proposes to merge the following: 0925-0299NIH Intramural Research Training Award, Program Application 0925-0438Undergraduate Scholarship Program (UGSP) 0925-0501Graduate Student Training Program Application Renewing 0925-0299 OMB Clearance Number with the new name ``Office of Intramural Training & Education Application''. Frequency of Response: On Occasion. Affected Public: Individuals seeking intramural training opportunities and references for these individuals. Type of Respondents: Students, post-baccalaureates, technicians, graduate students, and post-doctorates. There are no capital costs, operating costs, and/or maintenance costs to report. The annual reporting burden is displayed in the following table: