Department of Health and Human Services April 8, 2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the following public workshop: ``The Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program: Educate, Enable, Enlist and ExploreHoW to Improve the Health of Women.'' CDRH is developing the HoW Program to explore unique issues in the regulation of medical devices related to the health of women and seeks public input on the priority activities. The CDRH HoW program seeks to bring together industry, clinicians, researchers, academia, government agencies, and patient/advocacy groups in an effort to: (1) Highlight device-specific clinical Study recruitment and retention strategies; (2) improve analysis and communication of sex-specific findings to providers and patients; (3) develop a priority research road map for the HoW device ecosystem. The workshop focus will be device- and disease-specific, patient centered, and action oriented. Dates and Times: The public workshop will be held on June 24, 2013, from 8 a.m. to 5 p.m. and June 25, 2013, from 8 a.m. to 5 p.m. Location: The public workshop will be held on FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993. Contact: Nada Hanafi, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5422, Silver Spring, MD 20993-0002, 301-796-5427, Nada.Hanafi@fda.hhs.gov; or Kathryn O'Callaghan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5568, Silver Spring, MD 20993-0002, 301-796-6349, Kathryn.OCallaghan@fda.hhs.gov. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 5 p.m. on June 14, 2013. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permits, onsite registration will be provided beginning at 7:30 a.m. on the day of the public workshop. If you need special accommodations due to a disability, please contact Joyce Raines (Joyce.Raines@fda.hhs.gov or 301-796-5709) by 5 p.m. on June 14, 2013. To register for the public workshop, please visit FDA's Medical Devices News & EventsWorkshops & Conferences calendar at https:// www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/de fault.htm and select this public workshop from the posted events list. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, telephone number and primary HoW Program area of expertise or interest. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the public workshop: The plenary portions of this workshop will be Webcast. Persons interested in viewing the Webcast must register online by 5 p.m. on June 14, 2013. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and connection access information after June 19, 2013. An archived file of the Webcast will be available approximately 45 days after the public workshop on the Internet at https://www.fda.gov/MedicalDevices/NewsEvents/ WorkshopsConferences/default.htm. (Select this public workshop from the posted events list). Workshop format: This workshop will begin with plenary sessions to outline the three primary areas of focus for the CDRH HoW Program. In each area, panels will examine major themes using data-driven case studies with a focus on practical strategies relevant to particular challenges in the medical device arena. Participants will then rotate through breakout sessions, collectively building an action plan for each activity area. The meeting will conclude with specific commitments by stakeholder groups to partner with CDRH and each other in a collaborative effort to educate, enable, enlist and explore, with a common goal of improving the health of women. Comments: In order to permit the widest possible opportunity to obtain public information from interested persons on the workshop topics, FDA is opening the docket to gather electronic or written comments on the three areas of focus for the HoW workshop identified in section II. Comments received will be reviewed by FDA as part of this effort. The deadline for submitting comments related to this public workshop topic is July 31, 2013. Regardless of attendance at the public workshop, interested persons may submit either electronic or written comments. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Please identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific topics as outlined in section II, please identify the topic you are addressing. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov.

The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' which explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.