Department of Health and Human Services March 16, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) Chicago District, in cosponsorship with the Association of Food and Drug Officials (AFDO), is announcing a public workshop entitled ``Drugs and DevicesPromoting and Protecting the Public Health Through Risk Management and Product Cycle Improvement.'' This 2-day public workshop is intended to provide information about FDA drug and device regulation to the regulated industry. Date and Time: The public workshop will be held on Monday, June 8, 2009, from 10:20 a.m. to 5 p.m. and Tuesday, June 9, 2009, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Doubletree Hotel ChicagoOakbrook, 1909 Spring Rd., Oak Brook, IL 60523, 800-222-TREE, 800-222-8733, or 630-472-6000, FAX: 630-573-1909. Attendees are responsible for their own accommodations. To make reservations at the Doubletree Hotel ChicagoOakBrook, at the reduced conference rate, contact the Doubletree Hotel ChicagoOakBrook before May 5, 2009, citing meeting code ``AFDO Conference''. Contact: William Weissinger, Food and Drug Administration, 550 W. Jackson Blvd., 15th Fl., Chicago, IL 60661, 312-596-4210, FAX: 312-596- 4242, e-mail: William.weissinger@fda.hhs.gov. Registration: You are encouraged to register by May 12, 2009. The AFDO registration fees cover the cost of facilities, materials, and breaks. Seats are limited; please submit your registration as soon as possible. Course space will be filled in order of receipt of registration. Those accepted into the course will receive confirmation. Registration will close after the course is filled. Registration at the site is not guaranteed but may be possible on a space available basis on the day of the public workshop beginning at 7:30 a.m. The cost of registration follows:

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following document which encompasses progress to-date and planned future activities of the NIOSH Childhood Agricultural Injury Prevention Initiative. The document, NIOSH Childhood Agricultural Injury Prevention Initiative: Progress and Proposed Future Activities, can be found at https://www.cdc.gov/niosh/ review/public/145/. Public Comment Period: March 16, 2009 to May 15, 2009. Purpose: To seek comments on the progress and proposed future activities of the Childhood Agricultural Injury Prevention Initiative begun by NIOSH in October 1996, in order to ensure that the program is meeting the needs of stakeholders (e.g., national youth agricultural injury prevention organizations, agricultural youth injury prevention groups, individuals, etc.) and other interested members of the public, and to identify ways in which the program can be improved to increase its impact on the safety of children in agriculture. A review of progress and public comment on the proposed future activities of the NIOSH Childhood Agricultural injury Prevention Initiative is desired periodically to assess whether the NIOSH Childhood Agricultural Injury Prevention Initiative is addressing the most pressing issues and areas of childhood agricultural injury prevention. NIOSH will compile and consider all comments received through the NIOSH docket and use them in making decisions on how to proceed with the Childhood Agricultural Injury Prevention Initiative. Background: The problem of children being injured while living, working, or visiting agricultural work environments (farms) has been recognized for several decades. The most recent data suggest about 100 youths under the age of 20 die on farms each year and about 27,600 farm-related injuries occur to the same age group. Many individuals and groups have advocated for the prevention of agricultural injuries experienced by youths, and media attention has been generated on the issue, but until 1996 a national coordinated effort to address the problem had not existed. In April 1996, the National Committee for Childhood Agricultural Injury Prevention (NCCAIP) published a report entitled Children and Agriculture: Opportunities for Safety and Health, A National Action Plan to promote the health and safety of children exposed to agricultural hazards. The National Action Plan recommends leadership, surveillance, research, education, and public policy. The plan specifically recommended that NIOSH serve as the lead federal agency in preventing childhood agricultural injury. Due in large part to the efforts by NCCAIP to raise awareness and concern about childhood agricultural injury issues, in October 1996, NIOSH began implementing a Childhood Agricultural Injury Prevention Initiative. In July, 1999, a review was conducted by NIOSH to seek input on the progress and direction of the Childhood Agricultural Injury Prevention Initiative to date. The input provided by stakeholders at that meeting was useful in providing insight into stakeholder needs and in helping to improve the Childhood Agricultural Injury Prevention Initiative. In 2001, a Childhood Agricultural Injury Prevention Summit was organized and convened by the National Children's Center for Rural and Agricultural Health and Safety (NCCRAHS), an extramurally funded component, five years after the implementation of the NIOSH Childhood Agricultural Injury Prevention Initiative. The goal of the summit was to conduct a five-year review of the 1996 National Action Plan and to use a consensus development process to generate strategies for the future. Specifically, participants were asked to consider: (a) Successes to date, (b) gaps and barriers in achieving objectives, (c) current and potential effective interventions not addressed in the National Action Plan, and (d) strategies for the future. To date, NIOSH has undertaken a number of activities, both intramurally and extramurally, to address the recommendations in the 1996 National Action Plan and the 2001 Childhood Agricultural Injury Prevention Summit. Status: The Document, NIOSH Childhood Agricultural Injury Prevention Initiative: Progress and Proposed Future Activities, will be available for comment by stakeholders and other interested members of the public. Written comments should be submitted to the NIOSH Docket Office as outlined in the next section. Docket: Written comments on the usefulness of the Childhood Agricultural Injury Prevention Initiative for improving childhood agricultural safety and suggestions for enhancing or improving the impact of the Initiative should be mailed to the NIOSH Docket Office, Robert A. Taft Laboratories, MS-C34, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone (513) 533-8303, facsimile (513) 533-8285. Comments may also be submitted by e-mail to niocindocket@cdc.gov. E- mail attachments should be formatted in Microsoft Word. All materials submitted to the Agency should reference NIOSH docket number 145 and must be submitted by May 15, 2009 to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226. After the comment period has closed, comments may be accessed electronically at https:// www.cdc.gov/niosh under the link to the NIOSH docket. As appropriate, NIOSH will post comments with the commenters' names, affiliations, and other information, on the Internet. Contact Person for Technical Information: David Hard, Health Scientist, Analysis and Field Investigations Branch, Division of Safety Research, telephone (304) 285-6068, E-mail DHard@cdc.gov, facsimile (304) 285-6235.

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.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.