Department of Health and Human Services August 11, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``FDA/NHLBI/NSF Workshop on Computer Methods for Medical Devices.'' FDA is cosponsoring the conference workshop with the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health and the National Science Foundation (NSF). The purpose of the workshop is to facilitate discussion between FDA and other interested parties on the use of computational modeling in the design, development and evaluation of medical devices. Dates and Times: The public workshop will be held on September 7, 8, and 9, 2011, from 9 a.m. to 5 p.m. An optional FDA Microstructure Modeling session will be held from 1 to 5 p.m. on September 6, 2011. Participants are encouraged to arrive early to ensure time for parking and security screening before the meeting. Security screening will begin at 8 a.m. Persons interested in attending this public workshop must register by 5 p.m. on August 30, 2011. Location: The public workshop and optional session will be held at the FDA White Oak Campus, 10903 New Hampshire Ave, Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993- 0002. Contact Persons: Donna R. Lochner, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, rm. 3220, Silver Spring, MD 20993-0002, 301-796-6309, e-mail: donna.lochner@fda.hhs.gov; or Tina M. Morrison, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1272, Silver Spring, MD 20993-0002, 301-796-6310, e-mail: tina.morrison@fda.hhs.gov. Registration: To register for the public workshop and optional session, please visit the following Web site: https://www.fda.gov/ MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (or go to https://www.fda.gov and select the FDA Medical Devices News & Events Workshops & Conferences calendar and select this public workshop from the posted events list). Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. For those without Internet access, please call the contact person to register. Registration is mandatory as space is limited and onsite registration will not be available. FDA may limit the number of participants from each organization. There is no registration fee for the public workshop. Registrants requesting to present written materials or to make oral presentations at the public workshop, please call the contact persons by August 23, 2011. If you need special accommodations because of a disability, please contact Susan Monahan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4321, Silver Spring, MD 20993-0002, 301-796-5661 at least 7 days before the public workshop.

The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule published in the Federal Register of December 8, 2010, proposing to amend regulations on plant sterol/ stanol esters and risk of coronary heart disease (CHD). FDA is reopening the comment period because the Agency received a request for additional time to comment on the proposed rule.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Bar Code Label RequirementsQuestions and Answers'' dated August 2011. The guidance announced in this notice amends the October 2006 guidance document of the same title by incorporating a revised response to question 12 (Q12). The revised response concerns the ability of vaccine manufacturers to use alternative coding technologies to the linear bar code requirement. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Bar Code Label RequirementsQuestions and Answers (Question 12 Update)'' dated August 2010, and is superseding the guidance entitled ``Guidance for Industry: Bar Code Label RequirementsQuestions and Answers'' dated October 2006.