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

HHS gives notice of a decision to designate a class of employees from Simonds Saw and Steel Co., Lockport, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On January 6, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees from Texas City Chemicals, Inc., Texas City, Texas, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On January 6, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Department of Health and Human Services (HHS) seeks nominations of public and private sector organizations to receive the 2011 Healthy Living Innovation Awards. The Awards are a part of Secretary Sebelius' Healthy Weight Initiative and HHS' continuing focus on highlighting preventive health and recognizing organizations that implement innovative approaches to address chronic diseases and promote healthier lifestyles. The statutory authority for this health promotion activity is Section 1703[42 U.S.C. 300u-2] from Title XVII of the Public Health Service Act. The Healthy Living Innovation Awards will identify and acknowledge innovative health promotion projects that demonstrated a significant impact on the health status of a community. Eligible organizations must have an innovative project in at least one of three health promotion areas: (1) Healthy weight; (2) Physical activity; and (3) Nutrition. The Department intends that these awards will provide an opportunity to increase public awareness of creative approaches to develop and expand innovative health programs and encourage duplication of successful strategies. Awards will be given in the following categories: Faith-Based and/or Community Initiatives Health Care Delivery Healthy Workplace [cir] Large Employer> 500 employees [cir] Small Employer< 500 employees Non-Profit Public Sector Schools (K-12) Let's Move! Cities and Towns The following criteria will be taken into consideration upon review: Creativity and Innovation Leadership Sustainability Replicability Results/Outcomes

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Office of Orphan Products Development (OOPD) Pediatric Device Consortia Grant Program. The goal of the Pediatric Device Consortia Grant Program is to promote pediatric device development by providing grants to nonprofit consortia whose business model and approach to device development will either result in, or substantially contribute to, market approval of medical devices designed specifically for use in children. The program does not support the development of single device projects. Although administered by the Office of Orphan Products Development, this grant program is intended to encompass devices that could be used in all pediatric conditions or diseases, not just rare diseases. The pediatric population (neonates, infants, children, and adolescents) includes patients who are 21 years of age or younger at the time of diagnosis or treatment.

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 October 12, 2010, page 62544, and allowed 60 days for public comment. No 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: The Atherosclerosis Risk in Communities Study (ARIC). Type of Information Collection Request: Revision of a currently approved collection (OMB NO. 0925-0281). Need and Use of Information Collection: ARIC will conduct a clinical examination of the cohort over a 24-month period (May 2011 to April 2013). In addition, this project involves biennual follow-up by telephone of participants in the ARIC study, review of their medical records, and interviews with doctors and family to identify disease occurrence. Interviewers will contact doctors and hospitals to ascertain participants' cardiovascular events. Information gathered will be used to further describe the risk factors, occurrence rates, and consequences of cardiovascular disease in middle aged and older men and women. Frequency of Response: The participants will be contacted bi-annually for follow-up. A subset of the cohort may choose to volunteer for the clinical examination; these individually will be contacted once in a 3 year period. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; doctors and staff of hospitals and nursing homes. The annual reporting burden is as follows: Estimated Number of Respondents: 12,673; Estimated Number of Responses per Respondent: 2.7; Average Burden Hours per Response: 0.5916; and Estimated Total Annual Burden Hours Requested: 20,434. The annualized cost to respondents is estimated at $355,882, assuming respondent's time at the rate of $17.00 per hour and physician time at the rate of $75.00 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Size of Beads in Drug Products Labeled for Sprinkle.'' This draft guidance provides sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics licensing applications (BLAs) the Center for Drug Evaluation and Research's (CDER's) current thinking on appropriate size ranges for beads in drug products that are labeled to be administered via sprinkling (e.g., capsules or packets containing beads).

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for follicle stimulating hormone from Ausa International, Inc., to Therio, Inc.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should either e-mail nvpo@hhs.gov or call 202-690-5566 to register and provide name, organization, and e-mail address.