Attn: Desk Officer for the Administration for Children and Families. Department of Health and Human Services Food and Drug Administration Development and Regulation of Abuse- Deterrent Formulations of Opioid Medications; Public Meeting

The Food and Drug Administration (FDA) is announcing a public meeting to discuss the development, assessment, and regulation of abuse-deterrent formulations of opioid medications. The meeting will focus on scientific and technical issues related to the development and in vitro assessment of these products, as well as FDA’s approach towards assessing the benefits and risks of all opioid medications, including those with abuse-deterrent properties. FDA is seeking input on these issues from all stakeholders, including patients, health care providers, the pharmaceutical industry, patient advocates, academics, researchers, and other governmental entities. DATES: The public meeting will be held on October 30, 2014, from 8:30 a.m. to 5 p.m. and October 31, 2014, from 8:30 a.m. to 3 p.m. The public meeting may be extended or may end early depending on the level of public participation. Individuals who wish to present at the meeting must register by October 14, 2014. Individuals who wish to attend the meeting but do not wish to make a presentation should register by October 24, 2014. See section III under the SUPPLEMENTARY INFORMATION section for information on how to register to speak at the meeting. Submit either electronic or written comments by January 9, 2015. ADDRESSES: The public meeting will be held at the Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910, 301–589–0800, FAX: 301–587– 4791. Submit electronic comments to http:// 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. Identify all comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Mary C. Gross, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 301–796–3519, FAX: 301–796– 9899, email: [email protected]; or Brutrinia D. Cain, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–4633, email: [email protected]; or Georgiann Ienzi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301–796–3515, FAX: 301–847– 8737, email: Georgiann.Ienzi@ fda.hhs.gov.