Source: https://www.federalregister.gov/articles/2012/12/19/2012-30516/impact-of-approved-drug-labeling-on-chronic-opioid-therapy-public-hearing-request-for-comments
Timestamp: 2015-03-27 06:59:07
Document Index: 791405811

Matched Legal Cases: ['art 15', 'art 15', '§ 15', 'art 15', 'art 10', 'art 10', '§ 10', '§ 15', 'art 15', '§ 15']

Federal Register | Impact of Approved Drug Labeling on Chronic Opioid Therapy; Public Hearing; Request for Comments
Dates: The public hearing will be held on February 7 and 8, 2013, from 9 a.m. to 4 p.m. Submit electronic or written requests to make oral presentations and comments by January 18, 2013. Electronic or written comments will be accepted after the hearing until April 8, 2013.
77 FR 75177
-75179 (3 pages)
Docket No. FDA-2012-N-1172
Shorter URL: https://federalregister.gov/a/2012-30516 Regulations.gov Docket Info
FDA-2012-N-1172
The public hearing will be held at the Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814, 301-897-9400, Fax 1-301-897-0192.
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. All comments should be identified with the docket number found in brackets in the heading of this document. Transcripts of the hearing will be available for review at the Division of Dockets Management and on the Internet at http://www.regulations.gov within 30 days of the meeting.
Over the past several years, the role of opioid drugs in treating chronic pain has been an increasingly common subject of public discussion. FDA and other policymakers have been at the forefront of these debates, striving to find a balance between minimizing opioid drug abuse and misuse, while simultaneously enabling appropriate access to pain-relieving drugs. The July 9, 2012, approval of the Risk Evaluation Management Strategy for extended-release (ER) and long-acting (LA) opioid analgesics is a recent example of FDA's ongoing commitment to ensuring that the benefits of these types of opioid drugs continue to outweigh their risks.
3. How do professionals accurately categorize a patient's pain as mild, moderate, or severe? For example, what tests or assessments do they use?
3. If the pain threshold described in the indication (e.g., moderate, moderate to severe, severe pain) differed based on the pain's etiology, how would such an approach impact:
III. Attendance at and/or Participation in the Public Hearing Back to Top
If you wish to attend the hearing or make an oral presentation during the hearing, you must register by submitting either an electronic request (see the Web address listed at the end of this paragraph) or written request (see FOR FURTHER INFORMATION CONTACT) by close of business on January 18, 2013. You must provide your name, title, business affiliation (if applicable), address, and type of organization you represent (e.g., industry, consumer organization), and a brief summary of your presentation, if applicable (including the discussion topic(s) that will be addressed), to https://www.surveymonkey.com/s/2R5QWZP by January 18, 2013.
FDA will notify registered presenters of their scheduled presentation times. Persons registered to make an oral presentation should check in before the hearing and are encouraged to arrive early to ensure the designated order of presentation times. We will try to accommodate all persons who wish to present; however, the duration of each speaker's testimony may be limited by time constraints. An agenda of the meeting and other background material will be made available 5 days before the meeting at http://www.fda.gov/Drugs/NewsEvents/ucm326450.htm.
Questions about the meeting may also be also submitted to IssuesWithOpioids@fda.hhs.gov prior to the February 7 and February 8, 2013, meeting dates.
The hearing is free and seating will be on a first-come, first-served basis. Early registration is recommended because seating is limited. FDA may limit the numbers of participants from individual organizations as well as total number of attendees based on space limitations. Registrants will receive confirmation once they have been accepted to attend the hearing. For those who cannot attend in person, information regarding viewing a live Web cast of the public hearing will be located at: http://www.fda.gov/Drugs/NewsEvents/ucm326450.htm.
If you need special accommodations due to a disability, contact Elizabeth Giaquinto or Mary Gross (see FOR FURTHER INFORMATION CONTACT).
The Commissioner of Food and Drugs is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). The hearing will be conducted by a presiding officer, who will be accompanied by FDA senior management from the Center for Drug Evaluation and Research.
Under § 15.30(f), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (part 10 (21 CFR part 10), subpart C). Under § 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants.
The hearing will be transcribed as stipulated in § 15.30(b). A transcript will be available for review at the Division of Dockets Management (see ADDRESSES) and on the Internet at http://www.regulations.gov within 30 days of the meeting. A transcript will also be available in either hard copy or on CD-ROM after submission of a Freedom of Information request. Submit written requests to the Division of Freedom of Information (ELEM-1029), Office of Management Programs, Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
To the extent that the conditions for the hearing, as described in this notice, conflict with any provisions set out in part 15, this notice acts as a waiver of those provisions as specified in § 15.30(h).
Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments for consideration by April 8, 2013. Persons who wish to provide additional materials for consideration should file these materials with the Division of Dockets Management. You should annotate and organize your comments so that they identify the specific questions to which they refer. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
[FR Doc. 2012-30516 Filed 12-18-12; 8:45 am]